Trial Outcomes & Findings for Incentives and Case Management to Improve Cardiac Care: Healthy Lifestyle Program (NCT NCT03759873)

NCT ID: NCT03759873

Last Updated: 2024-10-09

Results Overview

Number of cardiac rehabilitation sessions completed out of a possible 36

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 209 participants
• Primary outcome timeframe: Within 4 months of the intake assessment
• Results posted on: 2024-10-09

Participant Flow

Participant milestones

Measure	Incentives Patient earns incentives for completing cardiac rehabilitation sessions. Incentives: Patient earns financial incentives (gift cards) on an escalating schedule for completing cardiac rehabilitation sessions.	Case Management Patient is assigned a case manager while in hospital. Case Management: A case manager is available by phone to assist patient with attending cardiac rehabilitation sessions as well as to provide advice about cardiac symptoms and healthy behavior change.	Incentives and Case Management Patient receives both the Incentives and Case Management interventions. Incentives: Patient earns financial incentives (gift cards) on an escalating schedule for completing cardiac rehabilitation sessions. Case Management: A case manager is available by phone to assist patient with attending cardiac rehabilitation sessions as well as to provide advice about cardiac symptoms and healthy behavior change.	Usual Care This control condition does not receive either intervention.
Overall Study STARTED	57	57	57	38
Overall Study COMPLETED	53	51	52	36
Overall Study NOT COMPLETED	4	6	5	2

Reasons for withdrawal

Measure	Incentives Patient earns incentives for completing cardiac rehabilitation sessions. Incentives: Patient earns financial incentives (gift cards) on an escalating schedule for completing cardiac rehabilitation sessions.	Case Management Patient is assigned a case manager while in hospital. Case Management: A case manager is available by phone to assist patient with attending cardiac rehabilitation sessions as well as to provide advice about cardiac symptoms and healthy behavior change.	Incentives and Case Management Patient receives both the Incentives and Case Management interventions. Incentives: Patient earns financial incentives (gift cards) on an escalating schedule for completing cardiac rehabilitation sessions. Case Management: A case manager is available by phone to assist patient with attending cardiac rehabilitation sessions as well as to provide advice about cardiac symptoms and healthy behavior change.	Usual Care This control condition does not receive either intervention.
Overall Study Not appropriate for cardiac rehab	4	4	4	2
Overall Study Moved outside eligible area	0	2	0	0
Overall Study Withdrawal by Subject	0	0	1	0

Baseline Characteristics

Incentives and Case Management to Improve Cardiac Care: Healthy Lifestyle Program

Baseline characteristics by cohort

Measure	Incentives n=53 Participants Patient earns incentives for completing cardiac rehabilitation sessions. Incentives: Patient earns financial incentives (gift cards) on an escalating schedule for completing cardiac rehabilitation sessions.	Case Management n=51 Participants Patient is assigned a case manager while in hospital. Case Management: A case manager is available by phone to assist patient with attending cardiac rehabilitation sessions as well as to provide advice about cardiac symptoms and healthy behavior change.	Incentives and Case Management n=52 Participants Patient receives both the Incentives and Case Management interventions. Incentives: Patient earns financial incentives (gift cards) on an escalating schedule for completing cardiac rehabilitation sessions. Case Management: A case manager is available by phone to assist patient with attending cardiac rehabilitation sessions as well as to provide advice about cardiac symptoms and healthy behavior change.	Usual Care n=36 Participants This control condition does not receive either intervention.	Total n=192 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Age, Categorical Between 18 and 65 years	39 Participants n=5 Participants	39 Participants n=7 Participants	42 Participants n=5 Participants	27 Participants n=4 Participants	147 Participants n=21 Participants
Age, Categorical >=65 years	14 Participants n=5 Participants	12 Participants n=7 Participants	10 Participants n=5 Participants	9 Participants n=4 Participants	45 Participants n=21 Participants
Age, Continuous	57.6 years STANDARD_DEVIATION 11.2 • n=5 Participants	57.9 years STANDARD_DEVIATION 12.7 • n=7 Participants	57.9 years STANDARD_DEVIATION 10.9 • n=5 Participants	57.1 years STANDARD_DEVIATION 10.5 • n=4 Participants	57.7 years STANDARD_DEVIATION 11.3 • n=21 Participants
Sex: Female, Male Female	12 Participants n=5 Participants	21 Participants n=7 Participants	20 Participants n=5 Participants	14 Participants n=4 Participants	67 Participants n=21 Participants
Sex: Female, Male Male	41 Participants n=5 Participants	30 Participants n=7 Participants	32 Participants n=5 Participants	22 Participants n=4 Participants	125 Participants n=21 Participants
Race/Ethnicity, Customized Hispanic White	0 participants n=5 Participants	3 participants n=7 Participants	0 participants n=5 Participants	0 participants n=4 Participants	3 participants n=21 Participants
Race/Ethnicity, Customized Hispanic Other/Multiracial	1 participants n=5 Participants	0 participants n=7 Participants	0 participants n=5 Participants	0 participants n=4 Participants	1 participants n=21 Participants
Race/Ethnicity, Customized Black or African American	3 participants n=5 Participants	4 participants n=7 Participants	1 participants n=5 Participants	1 participants n=4 Participants	9 participants n=21 Participants
Race/Ethnicity, Customized Asian	1 participants n=5 Participants	0 participants n=7 Participants	0 participants n=5 Participants	2 participants n=4 Participants	3 participants n=21 Participants
Race/Ethnicity, Customized American Indian	2 participants n=5 Participants	1 participants n=7 Participants	1 participants n=5 Participants	1 participants n=4 Participants	5 participants n=21 Participants
Race/Ethnicity, Customized Other/Multiracial	2 participants n=5 Participants	2 participants n=7 Participants	2 participants n=5 Participants	3 participants n=4 Participants	9 participants n=21 Participants
Race/Ethnicity, Customized Non-Hispanic White	44 participants n=5 Participants	41 participants n=7 Participants	48 participants n=5 Participants	29 participants n=4 Participants	162 participants n=21 Participants
Region of Enrollment United States	53 participants n=5 Participants	51 participants n=7 Participants	52 participants n=5 Participants	36 participants n=4 Participants	192 participants n=21 Participants
Primary Diagnosis Percutaneous Intervention	27 Participants n=5 Participants	27 Participants n=7 Participants	31 Participants n=5 Participants	23 Participants n=4 Participants	108 Participants n=21 Participants
Primary Diagnosis Coronary Artery Bypass Graft	12 Participants n=5 Participants	7 Participants n=7 Participants	6 Participants n=5 Participants	4 Participants n=4 Participants	29 Participants n=21 Participants
Primary Diagnosis Valve Replacement/Repair	7 Participants n=5 Participants	8 Participants n=7 Participants	5 Participants n=5 Participants	2 Participants n=4 Participants	22 Participants n=21 Participants
Primary Diagnosis Chronic Systolic Heart Failure	6 Participants n=5 Participants	6 Participants n=7 Participants	4 Participants n=5 Participants	5 Participants n=4 Participants	21 Participants n=21 Participants
Primary Diagnosis Myocardial Infarction	1 Participants n=5 Participants	1 Participants n=7 Participants	5 Participants n=5 Participants	2 Participants n=4 Participants	9 Participants n=21 Participants
Primary Diagnosis Stable Angina	0 Participants n=5 Participants	2 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	3 Participants n=21 Participants
Currently Smoking	23 Participants n=5 Participants	21 Participants n=7 Participants	23 Participants n=5 Participants	18 Participants n=4 Participants	85 Participants n=21 Participants
Patient Health Questionnaire-2 Screen Negative (0-2)	39 Participants n=5 Participants	41 Participants n=7 Participants	40 Participants n=5 Participants	25 Participants n=4 Participants	145 Participants n=21 Participants
Patient Health Questionnaire-2 Screen Positive (0-2)	13 Participants n=5 Participants	10 Participants n=7 Participants	11 Participants n=5 Participants	11 Participants n=4 Participants	45 Participants n=21 Participants
Patient Health Questionnaire-2 Data Missing	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	2 Participants n=21 Participants
Enrolled in Medicaid	52 Participants n=5 Participants	48 Participants n=7 Participants	50 Participants n=5 Participants	35 Participants n=4 Participants	185 Participants n=21 Participants
Education Less Than High School/GED	11 Participants n=5 Participants	19 Participants n=7 Participants	8 Participants n=5 Participants	11 Participants n=4 Participants	49 Participants n=21 Participants
Education High School/Some College	28 Participants n=5 Participants	22 Participants n=7 Participants	28 Participants n=5 Participants	15 Participants n=4 Participants	93 Participants n=21 Participants
Education College/Advanced Degree	13 Participants n=5 Participants	10 Participants n=7 Participants	16 Participants n=5 Participants	10 Participants n=4 Participants	49 Participants n=21 Participants
Education Data Missing	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants
Region Rural	16 Participants n=5 Participants	14 Participants n=7 Participants	15 Participants n=5 Participants	3 Participants n=4 Participants	48 Participants n=21 Participants
Region Urban	37 Participants n=5 Participants	37 Participants n=7 Participants	37 Participants n=5 Participants	33 Participants n=4 Participants	144 Participants n=21 Participants
Peak Oxygen Uptake (Peak VO2)	17.9 milliliters per kilogram per minute STANDARD_DEVIATION 6.3 • n=5 Participants	16.8 milliliters per kilogram per minute STANDARD_DEVIATION 5.5 • n=7 Participants	18.8 milliliters per kilogram per minute STANDARD_DEVIATION 5.5 • n=5 Participants	17.7 milliliters per kilogram per minute STANDARD_DEVIATION 6.7 • n=4 Participants	17.9 milliliters per kilogram per minute STANDARD_DEVIATION 5.9 • n=21 Participants
Estimated Metabolic Equivalent of Task (METs)	5.8 kilocalories per kilogram per hour STANDARD_DEVIATION 2.7 • n=5 Participants	5.5 kilocalories per kilogram per hour STANDARD_DEVIATION 2.3 • n=7 Participants	6.2 kilocalories per kilogram per hour STANDARD_DEVIATION 2.2 • n=5 Participants	6.4 kilocalories per kilogram per hour STANDARD_DEVIATION 3.0 • n=4 Participants	5.9 kilocalories per kilogram per hour STANDARD_DEVIATION 2.5 • n=21 Participants
MacNew Heart Disease Health-related Quality of Life Questionnaire	5.0 units on a scale STANDARD_DEVIATION 1.0 • n=5 Participants	4.9 units on a scale STANDARD_DEVIATION 1.1 • n=7 Participants	5.1 units on a scale STANDARD_DEVIATION 1.0 • n=5 Participants	4.7 units on a scale STANDARD_DEVIATION 1.3 • n=4 Participants	4.9 units on a scale STANDARD_DEVIATION 1.1 • n=21 Participants
Waist Circumference	41.3 inches STANDARD_DEVIATION 6.4 • n=5 Participants	44.6 inches STANDARD_DEVIATION 8.7 • n=7 Participants	43.0 inches STANDARD_DEVIATION 6.8 • n=5 Participants	42.2 inches STANDARD_DEVIATION 6.3 • n=4 Participants	42.8 inches STANDARD_DEVIATION 7.2 • n=21 Participants
Beck Depression Inventory	9.3 units on a scale STANDARD_DEVIATION 7.5 • n=5 Participants	14.6 units on a scale STANDARD_DEVIATION 10.4 • n=7 Participants	11.1 units on a scale STANDARD_DEVIATION 8.2 • n=5 Participants	17.5 units on a scale STANDARD_DEVIATION 13.7 • n=4 Participants	12.6 units on a scale STANDARD_DEVIATION 10.0 • n=21 Participants
EuroQol Visual Analogue Scale	64.1 units on a scale STANDARD_DEVIATION 16.4 • n=5 Participants	55.2 units on a scale STANDARD_DEVIATION 22.4 • n=7 Participants	60.1 units on a scale STANDARD_DEVIATION 19.3 • n=5 Participants	62.4 units on a scale STANDARD_DEVIATION 20.9 • n=4 Participants	60.2 units on a scale STANDARD_DEVIATION 19.9 • n=21 Participants

PRIMARY outcome

Timeframe: Within 4 months of the intake assessment

Number of cardiac rehabilitation sessions completed out of a possible 36

Outcome measures

Measure	Incentives n=53 Participants Patient earns incentives for completing cardiac rehabilitation sessions. Incentives: Patient earns financial incentives (gift cards) on an escalating schedule for completing cardiac rehabilitation sessions.	Case Management n=51 Participants Patient is assigned a case manager while in hospital. Case Management: A case manager is available by phone to assist patient with attending cardiac rehabilitation sessions as well as to provide advice about cardiac symptoms and healthy behavior change.	Incentives and Case Management n=52 Participants Patient receives both the Incentives and Case Management interventions. Incentives: Patient earns financial incentives (gift cards) on an escalating schedule for completing cardiac rehabilitation sessions. Case Management: A case manager is available by phone to assist patient with attending cardiac rehabilitation sessions as well as to provide advice about cardiac symptoms and healthy behavior change.	Usual Care n=36 Participants This control condition does not receive either intervention.
Cardiac Rehabilitation Attendance	16.9 sessions of CR Interval 12.7 to 21.1	12.0 sessions of CR Interval 7.7 to 16.1	24.1 sessions of CR Interval 19.9 to 28.4	10.9 sessions of CR Interval 5.8 to 15.9

PRIMARY outcome

Timeframe: Within 4 months of the intake assessment

Proportion of patients who complete 30+ sessions of cardiac rehabilitation

Outcome measures

Measure	Incentives n=53 Participants Patient earns incentives for completing cardiac rehabilitation sessions. Incentives: Patient earns financial incentives (gift cards) on an escalating schedule for completing cardiac rehabilitation sessions.	Case Management n=51 Participants Patient is assigned a case manager while in hospital. Case Management: A case manager is available by phone to assist patient with attending cardiac rehabilitation sessions as well as to provide advice about cardiac symptoms and healthy behavior change.	Incentives and Case Management n=52 Participants Patient receives both the Incentives and Case Management interventions. Incentives: Patient earns financial incentives (gift cards) on an escalating schedule for completing cardiac rehabilitation sessions. Case Management: A case manager is available by phone to assist patient with attending cardiac rehabilitation sessions as well as to provide advice about cardiac symptoms and healthy behavior change.	Usual Care n=36 Participants This control condition does not receive either intervention.
Cardiac Rehabilitation Completion	22 Participants	13 Participants	32 Participants	4 Participants

SECONDARY outcome

Timeframe: Within 4 months of the intake assessment

Changes in fitness level (peak oxygen uptake) will be measured from intake to completion of the intervention (4 months after intake).

Outcome measures

Measure	Incentives n=53 Participants Patient earns incentives for completing cardiac rehabilitation sessions. Incentives: Patient earns financial incentives (gift cards) on an escalating schedule for completing cardiac rehabilitation sessions.	Case Management n=51 Participants Patient is assigned a case manager while in hospital. Case Management: A case manager is available by phone to assist patient with attending cardiac rehabilitation sessions as well as to provide advice about cardiac symptoms and healthy behavior change.	Incentives and Case Management n=52 Participants Patient receives both the Incentives and Case Management interventions. Incentives: Patient earns financial incentives (gift cards) on an escalating schedule for completing cardiac rehabilitation sessions. Case Management: A case manager is available by phone to assist patient with attending cardiac rehabilitation sessions as well as to provide advice about cardiac symptoms and healthy behavior change.	Usual Care n=36 Participants This control condition does not receive either intervention.
Change in Fitness (Peak Oxygen Uptake)	20.9 milliliters per kilogram per minute Interval 20.0 to 21.9	18.3 milliliters per kilogram per minute Interval 17.3 to 19.3	18.6 milliliters per kilogram per minute Interval 17.7 to 19.5	21.2 milliliters per kilogram per minute Interval 19.8 to 22.6

SECONDARY outcome

Timeframe: Within 4 months of the intake assessment

Changes in fitness level (Metabolic Equivalent of Tasks) will be measured from intake to completion of the intervention (4 months after intake).

Outcome measures

Measure	Incentives n=53 Participants Patient earns incentives for completing cardiac rehabilitation sessions. Incentives: Patient earns financial incentives (gift cards) on an escalating schedule for completing cardiac rehabilitation sessions.	Case Management n=51 Participants Patient is assigned a case manager while in hospital. Case Management: A case manager is available by phone to assist patient with attending cardiac rehabilitation sessions as well as to provide advice about cardiac symptoms and healthy behavior change.	Incentives and Case Management n=52 Participants Patient receives both the Incentives and Case Management interventions. Incentives: Patient earns financial incentives (gift cards) on an escalating schedule for completing cardiac rehabilitation sessions. Case Management: A case manager is available by phone to assist patient with attending cardiac rehabilitation sessions as well as to provide advice about cardiac symptoms and healthy behavior change.	Usual Care n=36 Participants This control condition does not receive either intervention.
Change in Fitness (Estimated Metabolic Equivalent of Task)	7.4 milliliters per kilogram per minute Interval 6.8 to 8.1	6.5 milliliters per kilogram per minute Interval 5.8 to 7.2	7.0 milliliters per kilogram per minute Interval 6.3 to 7.7	6.7 milliliters per kilogram per minute Interval 5.7 to 7.8

SECONDARY outcome

Timeframe: Within 4 months of the intake assessment

Changes in waist measurement will be measured from intake to completion of the intervention (4 months after intake).

Outcome measures

Measure	Incentives n=53 Participants Patient earns incentives for completing cardiac rehabilitation sessions. Incentives: Patient earns financial incentives (gift cards) on an escalating schedule for completing cardiac rehabilitation sessions.	Case Management n=51 Participants Patient is assigned a case manager while in hospital. Case Management: A case manager is available by phone to assist patient with attending cardiac rehabilitation sessions as well as to provide advice about cardiac symptoms and healthy behavior change.	Incentives and Case Management n=52 Participants Patient receives both the Incentives and Case Management interventions. Incentives: Patient earns financial incentives (gift cards) on an escalating schedule for completing cardiac rehabilitation sessions. Case Management: A case manager is available by phone to assist patient with attending cardiac rehabilitation sessions as well as to provide advice about cardiac symptoms and healthy behavior change.	Usual Care n=36 Participants This control condition does not receive either intervention.
Change in Body Composition	42.1 inches Interval 41.6 to 42.6	42.7 inches Interval 42.1 to 43.2	42.1 inches Interval 41.7 to 42.6	42.0 inches Interval 41.3 to 42.7

SECONDARY outcome

Timeframe: Within 4 months of the intake assessment

Population: Overall number of participants analyzed represents the total number of participants from each arm of the study who completed this measure and for whom data were collected.

Changes in smoking status will be measured from intake to completion of the intervention (4 months after intake).

Outcome measures

Measure	Incentives n=30 Participants Patient earns incentives for completing cardiac rehabilitation sessions. Incentives: Patient earns financial incentives (gift cards) on an escalating schedule for completing cardiac rehabilitation sessions.	Case Management n=28 Participants Patient is assigned a case manager while in hospital. Case Management: A case manager is available by phone to assist patient with attending cardiac rehabilitation sessions as well as to provide advice about cardiac symptoms and healthy behavior change.	Incentives and Case Management n=39 Participants Patient receives both the Incentives and Case Management interventions. Incentives: Patient earns financial incentives (gift cards) on an escalating schedule for completing cardiac rehabilitation sessions. Case Management: A case manager is available by phone to assist patient with attending cardiac rehabilitation sessions as well as to provide advice about cardiac symptoms and healthy behavior change.	Usual Care n=17 Participants This control condition does not receive either intervention.
Changes in Smoking Status	8 Participants	10 Participants	11 Participants	5 Participants

SECONDARY outcome

Timeframe: Within 4 months of the intake assessment

Changes in perceived quality of life (MacNew) questionnaires will be measured from intake to completion of the intervention (4 months after intake). The MacNew Heart Disease Health-Related Quality of Life Questionnaire was used. Scores range from 1 to 7, with higher scores indicating better outcomes.

Outcome measures

Measure	Incentives n=53 Participants Patient earns incentives for completing cardiac rehabilitation sessions. Incentives: Patient earns financial incentives (gift cards) on an escalating schedule for completing cardiac rehabilitation sessions.	Case Management n=51 Participants Patient is assigned a case manager while in hospital. Case Management: A case manager is available by phone to assist patient with attending cardiac rehabilitation sessions as well as to provide advice about cardiac symptoms and healthy behavior change.	Incentives and Case Management n=52 Participants Patient receives both the Incentives and Case Management interventions. Incentives: Patient earns financial incentives (gift cards) on an escalating schedule for completing cardiac rehabilitation sessions. Case Management: A case manager is available by phone to assist patient with attending cardiac rehabilitation sessions as well as to provide advice about cardiac symptoms and healthy behavior change.	Usual Care n=36 Participants This control condition does not receive either intervention.
Changes in Quality of Life - Cardiac Specific	5.4 score on a scale Interval 5.3 to 5.6	5.4 score on a scale Interval 5.2 to 5.6	5.2 score on a scale Interval 5.1 to 5.4	5.4 score on a scale Interval 5.2 to 5.7

SECONDARY outcome

Timeframe: Within 4 months of the intake assessment

Changes in perceived quality of life (EuroQoL) questionnaires will be measured from intake to completion of the intervention (4 months after intake). The Visual Analogue Scale of the EuroQol-5D-3L was used. Scores range from 0 to 100, with higher scores indicating better outcomes.

Outcome measures

Measure	Incentives n=53 Participants Patient earns incentives for completing cardiac rehabilitation sessions. Incentives: Patient earns financial incentives (gift cards) on an escalating schedule for completing cardiac rehabilitation sessions.	Case Management n=51 Participants Patient is assigned a case manager while in hospital. Case Management: A case manager is available by phone to assist patient with attending cardiac rehabilitation sessions as well as to provide advice about cardiac symptoms and healthy behavior change.	Incentives and Case Management n=52 Participants Patient receives both the Incentives and Case Management interventions. Incentives: Patient earns financial incentives (gift cards) on an escalating schedule for completing cardiac rehabilitation sessions. Case Management: A case manager is available by phone to assist patient with attending cardiac rehabilitation sessions as well as to provide advice about cardiac symptoms and healthy behavior change.	Usual Care n=36 Participants This control condition does not receive either intervention.
Changes in Quality of Life - Non-specific	66.0 score on a scale Interval 61.9 to 70.2	66.2 score on a scale Interval 61.5 to 70.9	70.3 score on a scale Interval 66.2 to 74.3	64.0 score on a scale Interval 57.7 to 70.4

SECONDARY outcome

Timeframe: Within 4 months of the intake assessment

Changes in mental health (Adult Self-Report) questionnaires will be measured from intake to completion of the intervention (4 months after intake) using the Achenbach System of Empirically Based Assessment (ASEBA). T-scores are reported. A T-score of 50 indicates the population mean, and 10 is the standard deviation. Higher T-scores indicate worse outcomes. T-scores above 63 indicate clinically significant problems, and those between 60 and 63 fall within the borderline clinical range.

Outcome measures

Measure	Incentives n=53 Participants Patient earns incentives for completing cardiac rehabilitation sessions. Incentives: Patient earns financial incentives (gift cards) on an escalating schedule for completing cardiac rehabilitation sessions.	Case Management n=51 Participants Patient is assigned a case manager while in hospital. Case Management: A case manager is available by phone to assist patient with attending cardiac rehabilitation sessions as well as to provide advice about cardiac symptoms and healthy behavior change.	Incentives and Case Management n=52 Participants Patient receives both the Incentives and Case Management interventions. Incentives: Patient earns financial incentives (gift cards) on an escalating schedule for completing cardiac rehabilitation sessions. Case Management: A case manager is available by phone to assist patient with attending cardiac rehabilitation sessions as well as to provide advice about cardiac symptoms and healthy behavior change.	Usual Care n=36 Participants This control condition does not receive either intervention.
Changes in Mental Health	54.16 T scores Interval 52.45 to 55.86	55.58 T scores Interval 53.7 to 57.46	55.41 T scores Interval 53.86 to 56.96	52.82 T scores Interval 50.33 to 55.31

SECONDARY outcome

Timeframe: Within 4 months of the intake assessment

Changes in reported depressive symptoms "The Beck Depression Inventory (BDI)" will be measured from intake to completion of the intervention (4 months after intake). BDI results will be back transformed due to data being square root transformed. Scores range from 0 to 63, with higher scores indicating worse outcomes.

Outcome measures

Measure	Incentives n=53 Participants Patient earns incentives for completing cardiac rehabilitation sessions. Incentives: Patient earns financial incentives (gift cards) on an escalating schedule for completing cardiac rehabilitation sessions.	Case Management n=51 Participants Patient is assigned a case manager while in hospital. Case Management: A case manager is available by phone to assist patient with attending cardiac rehabilitation sessions as well as to provide advice about cardiac symptoms and healthy behavior change.	Incentives and Case Management n=52 Participants Patient receives both the Incentives and Case Management interventions. Incentives: Patient earns financial incentives (gift cards) on an escalating schedule for completing cardiac rehabilitation sessions. Case Management: A case manager is available by phone to assist patient with attending cardiac rehabilitation sessions as well as to provide advice about cardiac symptoms and healthy behavior change.	Usual Care n=36 Participants This control condition does not receive either intervention.
Changes in Depressive Symptoms	9.0 score on a scale Interval 7.3 to 10.8	6.6 score on a scale Interval 5.1 to 8.3	9.1 score on a scale Interval 7.5 to 10.9	6.6 score on a scale Interval 4.7 to 8.8

SECONDARY outcome

Timeframe: Within 4 months of the intake assessment

Changes in Executive function (delay discounting) will be measured from intake to completion of the intervention (4 months after intake). A 5-trial adjusting delay discounting task was used to calculate k values, numerical representations of the rate of discounting. k values range from 0 to 0.5, with larger values indicating steeper discounting (more impulsivity; greater propensity to devalue delayed rewards in favor of more immediate outcomes). k values were log(10) transformed for analysis. Larger log transformed k values indicate steeper discounting.

Outcome measures

Measure	Incentives n=53 Participants Patient earns incentives for completing cardiac rehabilitation sessions. Incentives: Patient earns financial incentives (gift cards) on an escalating schedule for completing cardiac rehabilitation sessions.	Case Management n=51 Participants Patient is assigned a case manager while in hospital. Case Management: A case manager is available by phone to assist patient with attending cardiac rehabilitation sessions as well as to provide advice about cardiac symptoms and healthy behavior change.	Incentives and Case Management n=52 Participants Patient receives both the Incentives and Case Management interventions. Incentives: Patient earns financial incentives (gift cards) on an escalating schedule for completing cardiac rehabilitation sessions. Case Management: A case manager is available by phone to assist patient with attending cardiac rehabilitation sessions as well as to provide advice about cardiac symptoms and healthy behavior change.	Usual Care n=36 Participants This control condition does not receive either intervention.
Changes in Executive Function (Delay Discounting)	-1.82 log of k Interval -2.11 to -1.52	-1.94 log of k Interval -2.26 to -1.61	-2.32 log of k Interval -2.58 to -2.05	-2.52 log of k Interval -2.91 to -2.13

SECONDARY outcome

Timeframe: Within 4 months of the intake assessment

Changes in Executive function (digit span) will be measured from intake to completion of the intervention (4 months after intake). The Digit Span subtest of the Wechsler Adult Intelligence Scale-IV (WAIS-IV) was used. Scores range from 1 to 19, with higher scores indicating worse outcomes.

Outcome measures

Measure	Incentives n=53 Participants Patient earns incentives for completing cardiac rehabilitation sessions. Incentives: Patient earns financial incentives (gift cards) on an escalating schedule for completing cardiac rehabilitation sessions.	Case Management n=51 Participants Patient is assigned a case manager while in hospital. Case Management: A case manager is available by phone to assist patient with attending cardiac rehabilitation sessions as well as to provide advice about cardiac symptoms and healthy behavior change.	Incentives and Case Management n=52 Participants Patient receives both the Incentives and Case Management interventions. Incentives: Patient earns financial incentives (gift cards) on an escalating schedule for completing cardiac rehabilitation sessions. Case Management: A case manager is available by phone to assist patient with attending cardiac rehabilitation sessions as well as to provide advice about cardiac symptoms and healthy behavior change.	Usual Care n=36 Participants This control condition does not receive either intervention.
Changes in Executive Function (DS)	8.51 score on a scale Interval 8.13 to 8.9	8.21 score on a scale Interval 7.77 to 8.65	9.16 score on a scale Interval 8.82 to 9.51	8.87 score on a scale Interval 8.35 to 9.39

SECONDARY outcome

Timeframe: Within 4 months of the intake assessment

Changes in Executive function (Trail making task) will be measured from intake to completion of the intervention (4 months after intake). The Trail-Making subtest of the Delis-Kaplan Executive Function System (D-KEFS) was used. Scores range from 1 to 19, with higher scores indicating worse outcomes.

Outcome measures

Measure	Incentives n=53 Participants Patient earns incentives for completing cardiac rehabilitation sessions. Incentives: Patient earns financial incentives (gift cards) on an escalating schedule for completing cardiac rehabilitation sessions.	Case Management n=51 Participants Patient is assigned a case manager while in hospital. Case Management: A case manager is available by phone to assist patient with attending cardiac rehabilitation sessions as well as to provide advice about cardiac symptoms and healthy behavior change.	Incentives and Case Management n=52 Participants Patient receives both the Incentives and Case Management interventions. Incentives: Patient earns financial incentives (gift cards) on an escalating schedule for completing cardiac rehabilitation sessions. Case Management: A case manager is available by phone to assist patient with attending cardiac rehabilitation sessions as well as to provide advice about cardiac symptoms and healthy behavior change.	Usual Care n=36 Participants This control condition does not receive either intervention.
Changes in Executive Function (Trail)	10.19 score on a scale Interval 9.59 to 10.78	10.19 score on a scale Interval 9.46 to 10.93	10.29 score on a scale Interval 9.74 to 10.85	11.01 score on a scale Interval 10.22 to 11.8

SECONDARY outcome

Timeframe: Within 4 months of the intake assessment

Changes in self-reported Executive function problems (BRIEF) will be measured from intake to completion of the intervention (4 months after intake). The Global Executive Composite (GEC) of the Behavior Rating Inventory of Executive Function (BRIEF) was used. T-scores are reported. A T-score of 50 indicates the population mean, and 10 is the standard deviation. Higher T-scores indicate worse outcomes. T-scores above 65 indicate clinically significant problems.

Outcome measures

Measure	Incentives n=53 Participants Patient earns incentives for completing cardiac rehabilitation sessions. Incentives: Patient earns financial incentives (gift cards) on an escalating schedule for completing cardiac rehabilitation sessions.	Case Management n=51 Participants Patient is assigned a case manager while in hospital. Case Management: A case manager is available by phone to assist patient with attending cardiac rehabilitation sessions as well as to provide advice about cardiac symptoms and healthy behavior change.	Incentives and Case Management n=52 Participants Patient receives both the Incentives and Case Management interventions. Incentives: Patient earns financial incentives (gift cards) on an escalating schedule for completing cardiac rehabilitation sessions. Case Management: A case manager is available by phone to assist patient with attending cardiac rehabilitation sessions as well as to provide advice about cardiac symptoms and healthy behavior change.	Usual Care n=36 Participants This control condition does not receive either intervention.
Changes in Executive Function (BRIEF)	55.35 T scores Interval 53.54 to 57.15	56.64 T scores Interval 54.44 to 58.84	55.67 T scores Interval 53.96 to 57.39	54.91 T scores Interval 52.43 to 57.39

SECONDARY outcome

Timeframe: Within 4 months of the intake assessment

Changes in Executive function (Stop Signal Task) will be measured from intake to completion of the intervention (4 months after intake).

Outcome measures

Measure	Incentives n=53 Participants Patient earns incentives for completing cardiac rehabilitation sessions. Incentives: Patient earns financial incentives (gift cards) on an escalating schedule for completing cardiac rehabilitation sessions.	Case Management n=51 Participants Patient is assigned a case manager while in hospital. Case Management: A case manager is available by phone to assist patient with attending cardiac rehabilitation sessions as well as to provide advice about cardiac symptoms and healthy behavior change.	Incentives and Case Management n=52 Participants Patient receives both the Incentives and Case Management interventions. Incentives: Patient earns financial incentives (gift cards) on an escalating schedule for completing cardiac rehabilitation sessions. Case Management: A case manager is available by phone to assist patient with attending cardiac rehabilitation sessions as well as to provide advice about cardiac symptoms and healthy behavior change.	Usual Care n=36 Participants This control condition does not receive either intervention.
Changes in Executive Function (SST)	180.86 seconds Interval 162.62 to 199.09	182.53 seconds Interval 163.4 to 201.65	221.77 seconds Interval 206.75 to 236.8	165.26 seconds Interval 141.26 to 189.26

SECONDARY outcome

Timeframe: One year period starting at intake assessment.

Combined measure of number of Emergency Department (ED) visits and overnight hospitalizations.

Outcome measures

Measure	Incentives n=53 Participants Patient earns incentives for completing cardiac rehabilitation sessions. Incentives: Patient earns financial incentives (gift cards) on an escalating schedule for completing cardiac rehabilitation sessions.	Case Management n=51 Participants Patient is assigned a case manager while in hospital. Case Management: A case manager is available by phone to assist patient with attending cardiac rehabilitation sessions as well as to provide advice about cardiac symptoms and healthy behavior change.	Incentives and Case Management n=52 Participants Patient receives both the Incentives and Case Management interventions. Incentives: Patient earns financial incentives (gift cards) on an escalating schedule for completing cardiac rehabilitation sessions. Case Management: A case manager is available by phone to assist patient with attending cardiac rehabilitation sessions as well as to provide advice about cardiac symptoms and healthy behavior change.	Usual Care n=36 Participants This control condition does not receive either intervention.
Health Care Contacts	113 number of visits	180 number of visits	201 number of visits	142 number of visits

SECONDARY outcome

Timeframe: One year period starting at intake assessment.

Costs associated with combined Emergency Department (ED) visits and overnight hospitalizations.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: From completion of intervention (4 months) to follow-up (one-year).

Population: Overall number of participants analyzed represents the total number of participants from each arm of the study who completed this measure and for whom data were collected.

Changes in fitness level (peak oxygen uptake) will be measured from intervention completion until follow-up (8 months after intervention completion).

Outcome measures

Measure	Incentives n=19 Participants Patient earns incentives for completing cardiac rehabilitation sessions. Incentives: Patient earns financial incentives (gift cards) on an escalating schedule for completing cardiac rehabilitation sessions.	Case Management n=15 Participants Patient is assigned a case manager while in hospital. Case Management: A case manager is available by phone to assist patient with attending cardiac rehabilitation sessions as well as to provide advice about cardiac symptoms and healthy behavior change.	Incentives and Case Management n=27 Participants Patient receives both the Incentives and Case Management interventions. Incentives: Patient earns financial incentives (gift cards) on an escalating schedule for completing cardiac rehabilitation sessions. Case Management: A case manager is available by phone to assist patient with attending cardiac rehabilitation sessions as well as to provide advice about cardiac symptoms and healthy behavior change.	Usual Care n=13 Participants This control condition does not receive either intervention.
Maintenance of Fitness Following Intervention (Peak Oxygen Uptake)	20.2 milliliters per kilogram per minute Standard Deviation 5.8	18.5 milliliters per kilogram per minute Standard Deviation 6.3	21.3 milliliters per kilogram per minute Standard Deviation 7.4	19.0 milliliters per kilogram per minute Standard Deviation 7.4

OTHER_PRE_SPECIFIED outcome

Timeframe: From completion of intervention (4 months) to follow-up (one-year).

Population: Overall number of participants analyzed represents the total number of participants from each arm of the study who completed this measure and for whom data were collected.

Changes in fitness level (Estimated Metabolic Equivalent of Task) will be measured from intervention completion until follow-up (8 months after intervention completion).

Outcome measures

Measure	Incentives n=19 Participants Patient earns incentives for completing cardiac rehabilitation sessions. Incentives: Patient earns financial incentives (gift cards) on an escalating schedule for completing cardiac rehabilitation sessions.	Case Management n=15 Participants Patient is assigned a case manager while in hospital. Case Management: A case manager is available by phone to assist patient with attending cardiac rehabilitation sessions as well as to provide advice about cardiac symptoms and healthy behavior change.	Incentives and Case Management n=27 Participants Patient receives both the Incentives and Case Management interventions. Incentives: Patient earns financial incentives (gift cards) on an escalating schedule for completing cardiac rehabilitation sessions. Case Management: A case manager is available by phone to assist patient with attending cardiac rehabilitation sessions as well as to provide advice about cardiac symptoms and healthy behavior change.	Usual Care n=13 Participants This control condition does not receive either intervention.
Maintenance of Fitness Following Intervention (Estimated Metabolic Equivalent of Task)	6.4 milliliters per kilogram per minute Standard Deviation 3.3	6.8 milliliters per kilogram per minute Standard Deviation 3.0	7.4 milliliters per kilogram per minute Standard Deviation 3.5	6.4 milliliters per kilogram per minute Standard Deviation 2.8

OTHER_PRE_SPECIFIED outcome

Timeframe: From completion of intervention (4 months) to follow-up (one-year).

Population: Overall number of participants analyzed represents the total number of participants from each arm of the study who completed this measure and for whom data were collected.

Changes in waist circumference will be measured from intervention completion until follow-up (8 months after intervention completion).

Outcome measures

Measure	Incentives n=23 Participants Patient earns incentives for completing cardiac rehabilitation sessions. Incentives: Patient earns financial incentives (gift cards) on an escalating schedule for completing cardiac rehabilitation sessions.	Case Management n=23 Participants Patient is assigned a case manager while in hospital. Case Management: A case manager is available by phone to assist patient with attending cardiac rehabilitation sessions as well as to provide advice about cardiac symptoms and healthy behavior change.	Incentives and Case Management n=33 Participants Patient receives both the Incentives and Case Management interventions. Incentives: Patient earns financial incentives (gift cards) on an escalating schedule for completing cardiac rehabilitation sessions. Case Management: A case manager is available by phone to assist patient with attending cardiac rehabilitation sessions as well as to provide advice about cardiac symptoms and healthy behavior change.	Usual Care n=18 Participants This control condition does not receive either intervention.
Maintenance of Waist Circumference Following Intervention.	42.5 inches Standard Deviation 7.1	44.2 inches Standard Deviation 8.8	42.0 inches Standard Deviation 7.0	42.2 inches Standard Deviation 7.4

OTHER_PRE_SPECIFIED outcome

Timeframe: From completion of intervention (4 months) to follow-up (one-year).

Population: Overall number of participants analyzed represents the total number of participants from each arm of the study who completed this measure and for whom data were collected.

Changes in smoking status will be measured from intervention completion until follow-up (8 months after intervention completion).

Outcome measures

Measure	Incentives n=24 Participants Patient earns incentives for completing cardiac rehabilitation sessions. Incentives: Patient earns financial incentives (gift cards) on an escalating schedule for completing cardiac rehabilitation sessions.	Case Management n=23 Participants Patient is assigned a case manager while in hospital. Case Management: A case manager is available by phone to assist patient with attending cardiac rehabilitation sessions as well as to provide advice about cardiac symptoms and healthy behavior change.	Incentives and Case Management n=34 Participants Patient receives both the Incentives and Case Management interventions. Incentives: Patient earns financial incentives (gift cards) on an escalating schedule for completing cardiac rehabilitation sessions. Case Management: A case manager is available by phone to assist patient with attending cardiac rehabilitation sessions as well as to provide advice about cardiac symptoms and healthy behavior change.	Usual Care n=18 Participants This control condition does not receive either intervention.
Maintenance of Smoking Status Following Intervention.	7 Participants	9 Participants	12 Participants	3 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: From completion of intervention (4 months) to follow-up (one-year).

Changes in perceived quality of life (MacNew) questionnaires will be measured from intervention completion until follow-up (8 months after intervention completion). The MacNew Heart Disease Health-Related Quality of Life Questionnaire was used. Scores range from 1 to 7, with higher scores indicating better outcomes.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: From completion of intervention (4 months) to follow-up (one-year).

Changes in perceived quality of life (EuroQoL) questionnaires will be measured from intervention completion until follow-up (8 months after intervention completion). The Visual Analogue Scale of the EuroQol-5D-3L was used. Scores range from 0 to 100, with higher scores indicating better outcomes.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: From completion of intervention (4 months) to follow-up (one-year).

Changes in mental health (Adult Self-Report) questionnaires will be measured from intervention completion until follow-up (8 months after intervention completion) using the Achenbach System of Empirically Based Assessment (ASEBA). T-scores are reported. A T-score of 50 indicates the population mean, and 10 is the standard deviation. Higher T-scores indicate worse outcomes. T-scores above 63 indicate clinically significant problems, and those between 60 and 63 fall within the borderline clinical range.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: From completion of intervention (4 months) to follow-up (one-year).

Changes in reported depressive symptoms "The Beck Depression Inventory (BDI)" will be measured from intervention completion until follow-up (8 months after intervention completion). BDI results will be back transformed due to data being square root transformed. Scores range from 0 to 63, with higher scores indicating worse outcomes.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: From completion of intervention (4 months) to follow-up (one-year).

Changes in Executive function (delay discounting) will be measured from intervention completion until follow-up (8 months after intervention completion). A 5-trial adjusting delay discounting task will be used to calculate k values, numerical representations of the rate of discounting. k values range from 0 to 0.5, with larger values indicating steeper discounting (more impulsivity; greater propensity to devalue delayed rewards in favor of more immediate outcomes). k values were log(10) transformed for analysis. Larger log transformed k values indicate steeper discounting.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: From completion of intervention (4 months) to follow-up (one-year).

Changes in Executive function (digit span) will be measured from intervention completion until follow-up (8 months after intervention completion). The Digit Span subtest of the Wechsler Adult Intelligence Scale-IV (WAIS-IV) was used. Scores range from 1 to 19, with higher scores indicating worse outcomes.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: From completion of intervention (4 months) to follow-up (one-year).

Changes in self-reported Executive function problems (BRIEF) will be measured from intervention completion until follow-up (8 months after intervention completion). The Global Executive Composite (GEC) of the Behavior Rating Inventory of Executive Function (BRIEF) was used. T-scores are reported. A T-score of 50 indicates the population mean, and 10 is the standard deviation. Higher T-scores indicate worse outcomes. T-scores above 65 indicate clinically significant problems.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: From completion of intervention (4 months) to follow-up (one-year).

Changes in Executive function (stop signal task) will be measured from intervention completion until follow-up (8 months after intervention completion).

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: From completion of intervention (4 months) to follow-up (one-year).

Changes in Executive function (trail making task) will be measured from intervention completion until follow-up (8 months after intervention completion). The Trail-Making subtest of the Delis-Kaplan Executive Function System (D-KEFS) was used. Scores range from 1 to 19, with higher scores indicating worse outcomes.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: One year period starting at intake assessment.

Cost-effectiveness of the intervention will be determined. Cost-effectiveness is a single outcome (cost per per quality-adjusted life year gained) that is calculated by integrating the cost of delivering the intervention, the cost to the patient of receiving the intervention, and the benefits both in quality of life and in reductions in healthcare utilization.

Outcome measures

Outcome data not reported

Adverse Events

Incentives

Serious events: 15 serious events

Other events: 39 other events

Deaths: 3 deaths

Case Management

Serious events: 25 serious events

Other events: 42 other events

Deaths: 5 deaths

Incentives and Case Management

Serious events: 20 serious events

Other events: 42 other events

Deaths: 3 deaths

Usual Care

Serious events: 16 serious events

Other events: 27 other events

Deaths: 0 deaths

Serious adverse events

Measure	Incentives n=53 participants at risk Patient earns incentives for completing cardiac rehabilitation sessions. Incentives: Patient earns financial incentives (gift cards) on an escalating schedule for completing cardiac rehabilitation sessions.	Case Management n=51 participants at risk Patient is assigned a case manager while in hospital. Case Management: A case manager is available by phone to assist patient with attending cardiac rehabilitation sessions as well as to provide advice about cardiac symptoms and healthy behavior change.	Incentives and Case Management n=52 participants at risk Patient receives both the Incentives and Case Management interventions. Incentives: Patient earns financial incentives (gift cards) on an escalating schedule for completing cardiac rehabilitation sessions. Case Management: A case manager is available by phone to assist patient with attending cardiac rehabilitation sessions as well as to provide advice about cardiac symptoms and healthy behavior change.	Usual Care n=36 participants at risk This control condition does not receive either intervention.
Gastrointestinal disorders Abdominal Pain	0.00% 0/53 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	0.00% 0/51 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	3.8% 2/52 • Number of events 2 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	2.8% 1/36 • Number of events 1 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.
Renal and urinary disorders Acute Kidney Injury	1.9% 1/53 • Number of events 1 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	0.00% 0/51 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	0.00% 0/52 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	2.8% 1/36 • Number of events 1 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adenocarcinoma	1.9% 1/53 • Number of events 1 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	0.00% 0/51 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	0.00% 0/52 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	0.00% 0/36 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.
Injury, poisoning and procedural complications Alcohol Intoxication	1.9% 1/53 • Number of events 1 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	0.00% 0/51 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	0.00% 0/52 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	0.00% 0/36 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.
Cardiac disorders Atrial Fibrillation	0.00% 0/53 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	0.00% 0/51 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	3.8% 2/52 • Number of events 2 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	2.8% 1/36 • Number of events 1 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.
Musculoskeletal and connective tissue disorders Back Pain	0.00% 0/53 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	0.00% 0/51 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	1.9% 1/52 • Number of events 1 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	0.00% 0/36 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.
Cardiac disorders Cardiac Arrest	1.9% 1/53 • Number of events 2 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	2.0% 1/51 • Number of events 1 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	0.00% 0/52 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	0.00% 0/36 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.
Cardiac disorders Cardiac Disorders - Other	1.9% 1/53 • Number of events 1 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	0.00% 0/51 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	1.9% 1/52 • Number of events 1 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	2.8% 1/36 • Number of events 1 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.
Cardiac disorders Cardiogenic Shock	0.00% 0/53 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	2.0% 1/51 • Number of events 1 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	0.00% 0/52 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	0.00% 0/36 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.
Cardiac disorders Chest Pain - Cardiac	3.8% 2/53 • Number of events 2 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	7.8% 4/51 • Number of events 5 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	9.6% 5/52 • Number of events 6 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	19.4% 7/36 • Number of events 10 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.
Hepatobiliary disorders Cholecystitis	0.00% 0/53 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	2.0% 1/51 • Number of events 2 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	0.00% 0/52 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	0.00% 0/36 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.
Gastrointestinal disorders Colorectal Cancer	0.00% 0/53 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	2.0% 1/51 • Number of events 1 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	0.00% 0/52 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	0.00% 0/36 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.
Cardiac disorders Coronary Artery Bypass	0.00% 0/53 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	2.0% 1/51 • Number of events 1 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	0.00% 0/52 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	0.00% 0/36 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.
General disorders Death NOS	5.7% 3/53 • Number of events 3 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	7.8% 4/51 • Number of events 4 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	3.8% 2/52 • Number of events 2 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	0.00% 0/36 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.
Metabolism and nutrition disorders Dehydration	0.00% 0/53 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	0.00% 0/51 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	1.9% 1/52 • Number of events 1 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	0.00% 0/36 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.
Gastrointestinal disorders Diarrhea	0.00% 0/53 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	0.00% 0/51 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	1.9% 1/52 • Number of events 1 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	0.00% 0/36 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.
Nervous system disorders Dizziness	0.00% 0/53 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	2.0% 1/51 • Number of events 1 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	0.00% 0/52 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	0.00% 0/36 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.
Nervous system disorders Dysarthria	0.00% 0/53 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	0.00% 0/51 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	1.9% 1/52 • Number of events 1 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	0.00% 0/36 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.
Respiratory, thoracic and mediastinal disorders Dyspnea	3.8% 2/53 • Number of events 2 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	9.8% 5/51 • Number of events 6 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	1.9% 1/52 • Number of events 1 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	8.3% 3/36 • Number of events 5 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.
General disorders Edema Limbs	1.9% 1/53 • Number of events 1 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	0.00% 0/51 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	0.00% 0/52 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	0.00% 0/36 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.
General disorders Failure to Thrive	0.00% 0/53 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	2.0% 1/51 • Number of events 1 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	0.00% 0/52 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	0.00% 0/36 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.
Injury, poisoning and procedural complications Fall	1.9% 1/53 • Number of events 2 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	2.0% 1/51 • Number of events 1 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	0.00% 0/52 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	0.00% 0/36 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.
Gastrointestinal disorders Gastric Hemorrhage	0.00% 0/53 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	2.0% 1/51 • Number of events 1 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	1.9% 1/52 • Number of events 1 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	0.00% 0/36 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.
Gastrointestinal disorders Gastrointestinal Disorders - Other	0.00% 0/53 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	2.0% 1/51 • Number of events 1 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	1.9% 1/52 • Number of events 1 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	0.00% 0/36 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.
Cardiac disorders Heart Failure	1.9% 1/53 • Number of events 1 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	2.0% 1/51 • Number of events 1 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	1.9% 1/52 • Number of events 3 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	0.00% 0/36 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.
Metabolism and nutrition disorders Hyperglycemia	0.00% 0/53 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	0.00% 0/51 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	1.9% 1/52 • Number of events 1 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	0.00% 0/36 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.
Respiratory, thoracic and mediastinal disorders Hypoxia	1.9% 1/53 • Number of events 1 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	0.00% 0/51 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	0.00% 0/52 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	0.00% 0/36 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.
Infections and infestations Infections and Infestations - Other	0.00% 0/53 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	0.00% 0/51 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	1.9% 1/52 • Number of events 1 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	0.00% 0/36 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.
Infections and infestations Kidney Infection	0.00% 0/53 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	2.0% 1/51 • Number of events 1 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	0.00% 0/52 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	0.00% 0/36 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.
General disorders Malaise	0.00% 0/53 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	0.00% 0/51 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	1.9% 1/52 • Number of events 1 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	0.00% 0/36 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.
Psychiatric disorders Mania	0.00% 0/53 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	0.00% 0/51 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	1.9% 1/52 • Number of events 1 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	0.00% 0/36 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.
Cardiac disorders Myocardial Infarction	0.00% 0/53 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	2.0% 1/51 • Number of events 1 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	0.00% 0/52 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	0.00% 0/36 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.
General disorders Pain	0.00% 0/53 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	0.00% 0/51 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	0.00% 0/52 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	2.8% 1/36 • Number of events 1 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.
Infections and infestations Pneumonia	0.00% 0/53 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	0.00% 0/51 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	1.9% 1/52 • Number of events 1 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	0.00% 0/36 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.
Respiratory, thoracic and mediastinal disorders Pneumonitis	1.9% 1/53 • Number of events 1 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	0.00% 0/51 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	0.00% 0/52 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	0.00% 0/36 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.
Psychiatric disorders Psychosis	0.00% 0/53 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	0.00% 0/51 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	1.9% 1/52 • Number of events 1 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	0.00% 0/36 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.
Infections and infestations Sepsis	1.9% 1/53 • Number of events 1 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	0.00% 0/51 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	0.00% 0/52 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	0.00% 0/36 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.
Gastrointestinal disorders Small Intestinal Obstruction	0.00% 0/53 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	0.00% 0/51 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	1.9% 1/52 • Number of events 1 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	5.6% 2/36 • Number of events 2 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.
Nervous system disorders Stroke	0.00% 0/53 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	0.00% 0/51 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	1.9% 1/52 • Number of events 1 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	5.6% 2/36 • Number of events 2 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.
Psychiatric disorders Suicidal Ideation	1.9% 1/53 • Number of events 1 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	0.00% 0/51 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	0.00% 0/52 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	0.00% 0/36 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.
Surgical and medical procedures Surgical and Medical Procedures - Other	7.5% 4/53 • Number of events 5 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	13.7% 7/51 • Number of events 8 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	3.8% 2/52 • Number of events 2 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	11.1% 4/36 • Number of events 4 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.
Nervous system disorders Syncope	1.9% 1/53 • Number of events 1 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	2.0% 1/51 • Number of events 1 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	3.8% 2/52 • Number of events 2 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	0.00% 0/36 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.
Vascular disorders Thromboembolic Event	0.00% 0/53 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	2.0% 1/51 • Number of events 1 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	0.00% 0/52 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	0.00% 0/36 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.
Infections and infestations Urinary Tract Infection	1.9% 1/53 • Number of events 1 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	0.00% 0/51 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	0.00% 0/52 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	0.00% 0/36 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.
Infections and infestations Vaginal Infection	0.00% 0/53 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	2.0% 1/51 • Number of events 1 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	0.00% 0/52 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	0.00% 0/36 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.
Cardiac disorders Ventricular Tachycardia	0.00% 0/53 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	2.0% 1/51 • Number of events 1 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	0.00% 0/52 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	0.00% 0/36 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.
Vascular disorders Visceral Arterial Ischemia	0.00% 0/53 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	0.00% 0/51 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	1.9% 1/52 • Number of events 1 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	0.00% 0/36 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.
Gastrointestinal disorders Vomiting	0.00% 0/53 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	0.00% 0/51 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	1.9% 1/52 • Number of events 2 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	0.00% 0/36 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.
Injury, poisoning and procedural complications Wound Complication	0.00% 0/53 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	2.0% 1/51 • Number of events 1 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	0.00% 0/52 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	0.00% 0/36 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.

Other adverse events

Measure	Incentives n=53 participants at risk Patient earns incentives for completing cardiac rehabilitation sessions. Incentives: Patient earns financial incentives (gift cards) on an escalating schedule for completing cardiac rehabilitation sessions.	Case Management n=51 participants at risk Patient is assigned a case manager while in hospital. Case Management: A case manager is available by phone to assist patient with attending cardiac rehabilitation sessions as well as to provide advice about cardiac symptoms and healthy behavior change.	Incentives and Case Management n=52 participants at risk Patient receives both the Incentives and Case Management interventions. Incentives: Patient earns financial incentives (gift cards) on an escalating schedule for completing cardiac rehabilitation sessions. Case Management: A case manager is available by phone to assist patient with attending cardiac rehabilitation sessions as well as to provide advice about cardiac symptoms and healthy behavior change.	Usual Care n=36 participants at risk This control condition does not receive either intervention.
Infections and infestations Eye infection	1.9% 1/53 • Number of events 1 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	0.00% 0/51 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	1.9% 1/52 • Number of events 1 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	0.00% 0/36 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.
Eye disorders Eye pain	0.00% 0/53 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	2.0% 1/51 • Number of events 1 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	1.9% 1/52 • Number of events 1 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	0.00% 0/36 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.
Injury, poisoning and procedural complications Fall	1.9% 1/53 • Number of events 1 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	3.9% 2/51 • Number of events 5 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	9.6% 5/52 • Number of events 5 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	13.9% 5/36 • Number of events 5 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.
Gastrointestinal disorders Abdominal distension	0.00% 0/53 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	2.0% 1/51 • Number of events 1 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	1.9% 1/52 • Number of events 1 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	0.00% 0/36 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.
Gastrointestinal disorders Abdominal pain	1.9% 1/53 • Number of events 1 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	5.9% 3/51 • Number of events 3 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	7.7% 4/52 • Number of events 4 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	19.4% 7/36 • Number of events 9 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.
Psychiatric disorders Agitation	0.00% 0/53 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	2.0% 1/51 • Number of events 1 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	0.00% 0/52 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	0.00% 0/36 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.
Immune system disorders Allergic reaction	1.9% 1/53 • Number of events 1 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	0.00% 0/51 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	0.00% 0/52 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	0.00% 0/36 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.
Respiratory, thoracic and mediastinal disorders Allergic rhinitis	0.00% 0/53 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	0.00% 0/51 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	1.9% 1/52 • Number of events 1 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	0.00% 0/36 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.
Blood and lymphatic system disorders Anemia	1.9% 1/53 • Number of events 1 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	0.00% 0/51 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	0.00% 0/52 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	0.00% 0/36 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.
Injury, poisoning and procedural complications Animal bite	0.00% 0/53 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	2.0% 1/51 • Number of events 1 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	0.00% 0/52 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	0.00% 0/36 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.
Psychiatric disorders Anxiety	0.00% 0/53 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	2.0% 1/51 • Number of events 1 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	1.9% 1/52 • Number of events 1 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	0.00% 0/36 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/53 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	2.0% 1/51 • Number of events 1 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	0.00% 0/52 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	0.00% 0/36 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.
Musculoskeletal and connective tissue disorders Arthritis	1.9% 1/53 • Number of events 1 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	2.0% 1/51 • Number of events 1 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	5.8% 3/52 • Number of events 3 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	0.00% 0/36 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.
Cardiac disorders Atrial fibrillation	0.00% 0/53 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	0.00% 0/51 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	0.00% 0/52 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	2.8% 1/36 • Number of events 1 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.
Musculoskeletal and connective tissue disorders Back pain	1.9% 1/53 • Number of events 1 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	7.8% 4/51 • Number of events 4 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	5.8% 3/52 • Number of events 3 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	11.1% 4/36 • Number of events 4 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.
Blood and lymphatic system disorders Blood and lymphatic system disorders - Other	0.00% 0/53 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	2.0% 1/51 • Number of events 2 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	0.00% 0/52 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	0.00% 0/36 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.
Musculoskeletal and connective tissue disorders Bone pain	5.7% 3/53 • Number of events 3 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	0.00% 0/51 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	0.00% 0/52 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	0.00% 0/36 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.
Injury, poisoning and procedural complications Bruising	0.00% 0/53 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	3.9% 2/51 • Number of events 2 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	0.00% 0/52 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	0.00% 0/36 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.
Cardiac disorders Cardiac disorders - Other	1.9% 1/53 • Number of events 1 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	2.0% 1/51 • Number of events 1 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	7.7% 4/52 • Number of events 5 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	2.8% 1/36 • Number of events 1 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.
Cardiac disorders Chest pain - cardiac	11.3% 6/53 • Number of events 8 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	17.6% 9/51 • Number of events 18 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	15.4% 8/52 • Number of events 16 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	19.4% 7/36 • Number of events 15 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.
Cardiac disorders Chest Pressure	0.00% 0/53 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	0.00% 0/51 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	1.9% 1/52 • Number of events 1 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	0.00% 0/36 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.
Musculoskeletal and connective tissue disorders Chest wall pain	1.9% 1/53 • Number of events 1 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	0.00% 0/51 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	5.8% 3/52 • Number of events 4 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	0.00% 0/36 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.
Investigations Cholesterol high	1.9% 1/53 • Number of events 1 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	0.00% 0/51 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	0.00% 0/52 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	0.00% 0/36 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.
Gastrointestinal disorders Colorectal cancer	0.00% 0/53 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	2.0% 1/51 • Number of events 1 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	0.00% 0/52 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	0.00% 0/36 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.
Infections and infestations Common Cold	1.9% 1/53 • Number of events 1 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	0.00% 0/51 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	0.00% 0/52 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	0.00% 0/36 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.
Gastrointestinal disorders Constipation	1.9% 1/53 • Number of events 1 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	0.00% 0/51 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	0.00% 0/52 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	0.00% 0/36 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.
Respiratory, thoracic and mediastinal disorders COPD	1.9% 1/53 • Number of events 1 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	0.00% 0/51 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	0.00% 0/52 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	0.00% 0/36 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.
Respiratory, thoracic and mediastinal disorders Cough	1.9% 1/53 • Number of events 1 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	5.9% 3/51 • Number of events 3 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	1.9% 1/52 • Number of events 1 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	0.00% 0/36 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.
Infections and infestations COVID-19	5.7% 3/53 • Number of events 3 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	3.9% 2/51 • Number of events 2 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	5.8% 3/52 • Number of events 3 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	11.1% 4/36 • Number of events 5 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.
Renal and urinary disorders Cystitis noninfective	0.00% 0/53 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	2.0% 1/51 • Number of events 1 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	0.00% 0/52 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	0.00% 0/36 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.
General disorders Death NOS	0.00% 0/53 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	2.0% 1/51 • Number of events 1 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	0.00% 0/52 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	0.00% 0/36 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.
Metabolism and nutrition disorders Dehydration	0.00% 0/53 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	0.00% 0/51 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	0.00% 0/52 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	2.8% 1/36 • Number of events 2 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.
Infections and infestations Dental abscess	0.00% 0/53 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	2.0% 1/51 • Number of events 1 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	0.00% 0/52 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	0.00% 0/36 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.
Psychiatric disorders Depression	0.00% 0/53 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	3.9% 2/51 • Number of events 2 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	0.00% 0/52 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	2.8% 1/36 • Number of events 1 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.
Gastrointestinal disorders Diarrhea	0.00% 0/53 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	2.0% 1/51 • Number of events 1 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	1.9% 1/52 • Number of events 2 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	2.8% 1/36 • Number of events 2 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.
Nervous system disorders Dizziness	5.7% 3/53 • Number of events 4 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	3.9% 2/51 • Number of events 2 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	9.6% 5/52 • Number of events 7 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	2.8% 1/36 • Number of events 1 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.
Injury, poisoning and procedural complications Domestic violence assault	0.00% 0/53 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	2.0% 1/51 • Number of events 1 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	0.00% 0/52 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	0.00% 0/36 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.
Eye disorders Dry eye	1.9% 1/53 • Number of events 1 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	0.00% 0/51 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	0.00% 0/52 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	0.00% 0/36 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.
Gastrointestinal disorders Dysphagia	0.00% 0/53 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	0.00% 0/51 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	0.00% 0/52 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	2.8% 1/36 • Number of events 1 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.
Respiratory, thoracic and mediastinal disorders Dyspnea	9.4% 5/53 • Number of events 6 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	9.8% 5/51 • Number of events 6 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	7.7% 4/52 • Number of events 4 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	16.7% 6/36 • Number of events 16 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.
Renal and urinary disorders Dysuria	0.00% 0/53 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	0.00% 0/51 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	0.00% 0/52 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	2.8% 1/36 • Number of events 1 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.
Ear and labyrinth disorders Ear pain	0.00% 0/53 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	0.00% 0/51 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	1.9% 1/52 • Number of events 1 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	2.8% 1/36 • Number of events 1 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.
General disorders Edema	0.00% 0/53 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	0.00% 0/51 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	0.00% 0/52 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	2.8% 1/36 • Number of events 1 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.
General disorders Edema face	1.9% 1/53 • Number of events 1 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	0.00% 0/51 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	0.00% 0/52 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	0.00% 0/36 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.
General disorders Edema limbs	0.00% 0/53 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	5.9% 3/51 • Number of events 3 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	3.8% 2/52 • Number of events 2 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	0.00% 0/36 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.
Endocrine disorders Endocrine disorders - Other	0.00% 0/53 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	0.00% 0/51 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	5.8% 3/52 • Number of events 3 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	0.00% 0/36 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.
Respiratory, thoracic and mediastinal disorders Epistaxis	0.00% 0/53 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	3.9% 2/51 • Number of events 3 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	0.00% 0/52 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	0.00% 0/36 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.
Eye disorders Eye disorders - Other	1.9% 1/53 • Number of events 1 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	0.00% 0/51 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	0.00% 0/52 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	0.00% 0/36 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.
General disorders Fatigue	0.00% 0/53 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	3.9% 2/51 • Number of events 2 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	1.9% 1/52 • Number of events 1 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	0.00% 0/36 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.
General disorders Fever	1.9% 1/53 • Number of events 1 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	0.00% 0/51 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	0.00% 0/52 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	0.00% 0/36 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.
Gastrointestinal disorders Flatulence	0.00% 0/53 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	0.00% 0/51 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	0.00% 0/52 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	2.8% 1/36 • Number of events 1 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.
General disorders Flu like symptoms	1.9% 1/53 • Number of events 1 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	3.9% 2/51 • Number of events 2 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	0.00% 0/52 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	2.8% 1/36 • Number of events 1 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.
Injury, poisoning and procedural complications Fracture	0.00% 0/53 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	3.9% 2/51 • Number of events 2 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	0.00% 0/52 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	0.00% 0/36 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.
Gastrointestinal disorders Gastroesophageal reflux disease	1.9% 1/53 • Number of events 1 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	5.9% 3/51 • Number of events 3 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	1.9% 1/52 • Number of events 1 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	0.00% 0/36 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.
Gastrointestinal disorders Gastrointestinal disorders - Other	1.9% 1/53 • Number of events 1 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	2.0% 1/51 • Number of events 1 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	1.9% 1/52 • Number of events 3 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	0.00% 0/36 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.
Musculoskeletal and connective tissue disorders Generalized muscle weakness	0.00% 0/53 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	0.00% 0/51 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	1.9% 1/52 • Number of events 1 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	0.00% 0/36 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.
Infections and infestations Gum infection	0.00% 0/53 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	0.00% 0/51 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	1.9% 1/52 • Number of events 1 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	0.00% 0/36 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.
Nervous system disorders Headache	1.9% 1/53 • Number of events 1 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	3.9% 2/51 • Number of events 2 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	0.00% 0/52 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	2.8% 1/36 • Number of events 5 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.
Vascular disorders Hematoma	1.9% 1/53 • Number of events 1 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	0.00% 0/51 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	1.9% 1/52 • Number of events 1 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	0.00% 0/36 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.
Renal and urinary disorders Hematuria	1.9% 1/53 • Number of events 1 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	0.00% 0/51 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	1.9% 1/52 • Number of events 1 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	0.00% 0/36 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.
Reproductive system and breast disorders Herpes Simplex	1.9% 1/53 • Number of events 1 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	0.00% 0/51 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	0.00% 0/52 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	0.00% 0/36 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.
Metabolism and nutrition disorders Hyperglycemia	0.00% 0/53 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	0.00% 0/51 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	0.00% 0/52 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	11.1% 4/36 • Number of events 4 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.
Vascular disorders Hypertension	0.00% 0/53 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	7.8% 4/51 • Number of events 4 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	3.8% 2/52 • Number of events 2 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	5.6% 2/36 • Number of events 2 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.
Metabolism and nutrition disorders Hypoglycemia	3.8% 2/53 • Number of events 2 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	2.0% 1/51 • Number of events 1 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	5.8% 3/52 • Number of events 4 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	0.00% 0/36 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.
Metabolism and nutrition disorders Hypokalemia	0.00% 0/53 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	2.0% 1/51 • Number of events 1 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	1.9% 1/52 • Number of events 1 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	0.00% 0/36 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.
Vascular disorders Hypotension	0.00% 0/53 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	3.9% 2/51 • Number of events 2 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	3.8% 2/52 • Number of events 2 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	2.8% 1/36 • Number of events 1 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.
Infections and infestations Infections and infestations - Other	0.00% 0/53 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	0.00% 0/51 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	1.9% 1/52 • Number of events 1 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	0.00% 0/36 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.
Infections and infestations Infective myositis	0.00% 0/53 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	0.00% 0/51 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	1.9% 1/52 • Number of events 1 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	0.00% 0/36 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.
Injury, poisoning and procedural complications Injury	0.00% 0/53 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	2.0% 1/51 • Number of events 1 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	0.00% 0/52 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	0.00% 0/36 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.
Psychiatric disorders Insomnia	1.9% 1/53 • Number of events 1 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	0.00% 0/51 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	0.00% 0/52 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	0.00% 0/36 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.
Musculoskeletal and connective tissue disorders Joint range of motion decreased	0.00% 0/53 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	0.00% 0/51 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	1.9% 1/52 • Number of events 1 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	0.00% 0/36 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.
Infections and infestations Kidney infection	0.00% 0/53 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	2.0% 1/51 • Number of events 1 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	1.9% 1/52 • Number of events 1 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	0.00% 0/36 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.
Renal and urinary disorders Kidney Stones	1.9% 1/53 • Number of events 1 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	0.00% 0/51 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	0.00% 0/52 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	0.00% 0/36 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.
Cardiac disorders Left ventricular systolic dysfunction	0.00% 0/53 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	0.00% 0/51 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	0.00% 0/52 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	2.8% 1/36 • Number of events 1 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.
Infections and infestations Lung infection	1.9% 1/53 • Number of events 1 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	0.00% 0/51 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	0.00% 0/52 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	0.00% 0/36 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.
General disorders Malaise	0.00% 0/53 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	0.00% 0/51 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	1.9% 1/52 • Number of events 1 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	0.00% 0/36 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.
Nervous system disorders Memory impairment	0.00% 0/53 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	2.0% 1/51 • Number of events 1 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	0.00% 0/52 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	0.00% 0/36 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.
Injury, poisoning and procedural complications Muscle cramp	0.00% 0/53 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	0.00% 0/51 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	0.00% 0/52 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	2.8% 1/36 • Number of events 1 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.
Musculoskeletal and connective tissue disorders Musculoskeletal and connective tissue disord	0.00% 0/53 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	2.0% 1/51 • Number of events 1 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	0.00% 0/52 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	0.00% 0/36 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.
Gastrointestinal disorders Nausea	0.00% 0/53 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	0.00% 0/51 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	1.9% 1/52 • Number of events 1 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	0.00% 0/36 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.
Musculoskeletal and connective tissue disorders Neck pain	0.00% 0/53 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	2.0% 1/51 • Number of events 1 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	0.00% 0/52 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	0.00% 0/36 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasms benign, malignant and unspecified	0.00% 0/53 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	0.00% 0/51 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	0.00% 0/52 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	2.8% 1/36 • Number of events 1 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.
Psychiatric disorders Nightmares	0.00% 0/53 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	0.00% 0/51 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	1.9% 1/52 • Number of events 1 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	0.00% 0/36 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.
General disorders Non-cardiac chest pain	1.9% 1/53 • Number of events 1 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	0.00% 0/51 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	0.00% 0/52 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	2.8% 1/36 • Number of events 1 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.
Gastrointestinal disorders Oral pain	1.9% 1/53 • Number of events 2 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	0.00% 0/51 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	0.00% 0/52 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	0.00% 0/36 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.
Infections and infestations Otitis media	0.00% 0/53 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	0.00% 0/51 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	1.9% 1/52 • Number of events 1 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	2.8% 1/36 • Number of events 1 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.
General disorders Pain	0.00% 0/53 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	2.0% 1/51 • Number of events 1 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	5.8% 3/52 • Number of events 6 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	0.00% 0/36 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.
Musculoskeletal and connective tissue disorders Pain in extremity	5.7% 3/53 • Number of events 3 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	2.0% 1/51 • Number of events 1 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	15.4% 8/52 • Number of events 11 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	5.6% 2/36 • Number of events 2 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.
Cardiac disorders Palpitations	1.9% 1/53 • Number of events 1 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	3.9% 2/51 • Number of events 2 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	1.9% 1/52 • Number of events 3 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	0.00% 0/36 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.
Nervous system disorders Paresthesia	0.00% 0/53 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	0.00% 0/51 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	1.9% 1/52 • Number of events 1 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	0.00% 0/36 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.
Reproductive system and breast disorders penile pain	0.00% 0/53 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	2.0% 1/51 • Number of events 1 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	0.00% 0/52 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	0.00% 0/36 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.
Vascular disorders Peripheral ischemia	0.00% 0/53 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	0.00% 0/51 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	0.00% 0/52 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	2.8% 1/36 • Number of events 1 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.
Infections and infestations Pharyngitis	0.00% 0/53 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	0.00% 0/51 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	1.9% 1/52 • Number of events 1 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	0.00% 0/36 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.
Respiratory, thoracic and mediastinal disorders Pneumonitis	0.00% 0/53 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	2.0% 1/51 • Number of events 1 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	1.9% 1/52 • Number of events 1 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	0.00% 0/36 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.
Nervous system disorders Presyncope	0.00% 0/53 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	0.00% 0/51 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	1.9% 1/52 • Number of events 1 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	0.00% 0/36 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.
Psychiatric disorders Psychiatric disorders - Other	0.00% 0/53 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	0.00% 0/51 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	1.9% 1/52 • Number of events 2 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	0.00% 0/36 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.
Respiratory, thoracic and mediastinal disorders pulmonary edema	0.00% 0/53 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	0.00% 0/51 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	0.00% 0/52 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	2.8% 1/36 • Number of events 1 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.
Skin and subcutaneous tissue disorders Rash maculo-papular	0.00% 0/53 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	0.00% 0/51 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	3.8% 2/52 • Number of events 2 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	0.00% 0/36 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.
Infections and infestations Rash pustular	0.00% 0/53 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	0.00% 0/51 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	1.9% 1/52 • Number of events 1 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	0.00% 0/36 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.
Gastrointestinal disorders Rectal hemorrhage	1.9% 1/53 • Number of events 1 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	0.00% 0/51 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	1.9% 1/52 • Number of events 1 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	0.00% 0/36 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.
Renal and urinary disorders Renal and urinary disorders - Other	1.9% 1/53 • Number of events 1 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	2.0% 1/51 • Number of events 1 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	0.00% 0/52 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	0.00% 0/36 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.
Respiratory, thoracic and mediastinal disorders Respiratory, thoracic and mediastinal disord	0.00% 0/53 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	2.0% 1/51 • Number of events 1 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	0.00% 0/52 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	0.00% 0/36 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.
Eye disorders Retinopathy	0.00% 0/53 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	0.00% 0/51 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	1.9% 1/52 • Number of events 1 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	0.00% 0/36 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.
Injury, poisoning and procedural complications Rotator cuff injury	0.00% 0/53 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	0.00% 0/51 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	1.9% 1/52 • Number of events 1 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	0.00% 0/36 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.
Reproductive system and breast disorders Scrotal pain	0.00% 0/53 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	0.00% 0/51 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	1.9% 1/52 • Number of events 1 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	0.00% 0/36 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.
Nervous system disorders Seizure	3.8% 2/53 • Number of events 4 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	0.00% 0/51 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	0.00% 0/52 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	0.00% 0/36 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.
Cardiac disorders Sinus tachycardia	0.00% 0/53 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	0.00% 0/51 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	1.9% 1/52 • Number of events 1 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	0.00% 0/36 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.
Infections and infestations Sinusitis	0.00% 0/53 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	0.00% 0/51 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	1.9% 1/52 • Number of events 1 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	0.00% 0/36 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders - Oth	0.00% 0/53 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	9.8% 5/51 • Number of events 5 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	3.8% 2/52 • Number of events 2 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	2.8% 1/36 • Number of events 2 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.
Infections and infestations Skin infection	0.00% 0/53 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	0.00% 0/51 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	0.00% 0/52 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	2.8% 1/36 • Number of events 1 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.
Skin and subcutaneous tissue disorders Skin ulceration	0.00% 0/53 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	0.00% 0/51 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	0.00% 0/52 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	5.6% 2/36 • Number of events 3 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous Cell Carcinoma	0.00% 0/53 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	2.0% 1/51 • Number of events 1 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	0.00% 0/52 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	0.00% 0/36 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.
Psychiatric disorders Suicidal ideation	7.5% 4/53 • Number of events 5 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	13.7% 7/51 • Number of events 10 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	7.7% 4/52 • Number of events 5 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	16.7% 6/36 • Number of events 10 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.
Surgical and medical procedures Surgical and medical procedures - Other	9.4% 5/53 • Number of events 6 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	5.9% 3/51 • Number of events 3 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	13.5% 7/52 • Number of events 11 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	11.1% 4/36 • Number of events 6 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.
Nervous system disorders Syncope	3.8% 2/53 • Number of events 2 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	2.0% 1/51 • Number of events 1 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	0.00% 0/52 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	2.8% 1/36 • Number of events 1 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.
Reproductive system and breast disorders Testicular pain	0.00% 0/53 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	2.0% 1/51 • Number of events 1 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	1.9% 1/52 • Number of events 1 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	0.00% 0/36 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.
Infections and infestations Tooth infection	3.8% 2/53 • Number of events 3 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	0.00% 0/51 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	0.00% 0/52 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	0.00% 0/36 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.
Gastrointestinal disorders Toothache	0.00% 0/53 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	0.00% 0/51 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	1.9% 1/52 • Number of events 1 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	0.00% 0/36 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumor pain	0.00% 0/53 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	2.0% 1/51 • Number of events 1 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	0.00% 0/52 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	0.00% 0/36 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.
Infections and infestations Upper respiratory infection	0.00% 0/53 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	0.00% 0/51 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	1.9% 1/52 • Number of events 1 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	2.8% 1/36 • Number of events 1 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.
Renal and urinary disorders Urinary frequency	0.00% 0/53 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	0.00% 0/51 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	1.9% 1/52 • Number of events 1 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	0.00% 0/36 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.
Renal and urinary disorders Urinary incontinence	0.00% 0/53 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	2.0% 1/51 • Number of events 1 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	1.9% 1/52 • Number of events 1 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	0.00% 0/36 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.
Renal and urinary disorders Urinary retention	0.00% 0/53 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	2.0% 1/51 • Number of events 1 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	0.00% 0/52 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	0.00% 0/36 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.
Infections and infestations Urinary tract infection	0.00% 0/53 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	0.00% 0/51 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	5.8% 3/52 • Number of events 5 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	0.00% 0/36 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.
Renal and urinary disorders Urinary tract pain	0.00% 0/53 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	2.0% 1/51 • Number of events 1 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	0.00% 0/52 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	0.00% 0/36 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.
Injury, poisoning and procedural complications Urostomy leak	0.00% 0/53 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	2.0% 1/51 • Number of events 1 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	0.00% 0/52 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	0.00% 0/36 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.
Vascular disorders Vascular disorders - Other	0.00% 0/53 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	2.0% 1/51 • Number of events 1 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	0.00% 0/52 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	0.00% 0/36 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.
Ear and labyrinth disorders Vertigo	1.9% 1/53 • Number of events 1 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	2.0% 1/51 • Number of events 1 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	0.00% 0/52 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	0.00% 0/36 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.
Infections and infestations Viral Upper Respiratory Infection	1.9% 1/53 • Number of events 1 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	0.00% 0/51 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	0.00% 0/52 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	0.00% 0/36 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.
Eye disorders Vision decreased	0.00% 0/53 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	3.9% 2/51 • Number of events 3 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	0.00% 0/52 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	0.00% 0/36 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.
Gastrointestinal disorders Vomiting	0.00% 0/53 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	3.9% 2/51 • Number of events 3 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	1.9% 1/52 • Number of events 1 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	2.8% 1/36 • Number of events 1 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.
Investigations Weight gain	1.9% 1/53 • Number of events 1 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	0.00% 0/51 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	0.00% 0/52 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	0.00% 0/36 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.
Investigations Weight loss	0.00% 0/53 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	0.00% 0/51 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	1.9% 1/52 • Number of events 1 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	0.00% 0/36 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.
Respiratory, thoracic and mediastinal disorders Wheezing	0.00% 0/53 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	0.00% 0/51 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	1.9% 1/52 • Number of events 1 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	0.00% 0/36 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.
Injury, poisoning and procedural complications Wound complication	3.8% 2/53 • Number of events 2 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	2.0% 1/51 • Number of events 2 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	3.8% 2/52 • Number of events 2 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	2.8% 1/36 • Number of events 1 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.
Infections and infestations Wound infection	0.00% 0/53 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	0.00% 0/51 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	1.9% 1/52 • Number of events 1 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	0.00% 0/36 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.
Injury, poisoning and procedural complications Wound Treatment	0.00% 0/53 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	0.00% 0/51 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	0.00% 0/52 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	2.8% 1/36 • Number of events 1 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.
Injury, poisoning and procedural complications Wrist fracture	0.00% 0/53 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	0.00% 0/51 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	0.00% 0/52 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	2.8% 1/36 • Number of events 1 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.
Injury, poisoning and procedural complications Wrist Pain	0.00% 0/53 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	0.00% 0/51 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	0.00% 0/52 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.	2.8% 1/36 • Number of events 1 • 1 Year All participants were asked about their general health, symptoms, and adverse events once per week during scheduled weekly phone check-ins conducted by the study coordinator. Additionally, participants in the two case management arms had a second weekly check-in with their case manager during which they were asked about adverse events. Finally, the study team was notified via Epic whenever a participant was admitted to the hospital or ED.

Additional Information

Dr. Diann Gaalema

University of Texas Medical Branch, Division of Cardiovascular Medicine

Phone: 409-772-1533

Email: digaalem@utmb.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place