Trial Outcomes & Findings for A Multi-center Trial of IMPaCT CHW Support for Chronically-ill Patients (NCT NCT02347787)

NCT ID: NCT02347787

Last Updated: 2019-08-05

Results Overview

The main dependent variable is mean change in standardized score for SF-12 PCS. The SF-12 is a survey designed for use with patients with multiple chronic conditions. This 12-item scale can be used to assess the physical and mental health of respondents. 10 of the 12 questions are answered on a 5 point likert scale and 2 are answered on a 3 point likert scale. The questions are then scored and weighted into 2 subscales, physical health and mental health. Respondents can have a score that ranges from 0-100 with 100 being the best score and indicating high physical or mental health. A 3 point change in SF-12 score reflects a meaningful difference. We measure the between-arm difference in mean change in SF-12 PCS between baseline and 6-month follow-up assessment.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 592 participants
• Primary outcome timeframe: Baseline, 6 months
• Results posted on: 2019-08-05

Participant Flow

Study enrollment took place at: a Veterans Affairs medical center primary care practice, a federally qualified health center and an academic family medicine clinic. Patients were recruited between January 28th, 2015 and March 28, 2016 at which time the trial was stopped because we had reached our pre-specified sample size target.

Participant milestones

Measure	Usual Clinician Support Prior to randomization, patients in this arm will already have set a chronic disease management goal with their primary care provider (who will have received training in collaborative goal-setting). After randomization, patients in the usual clinician support arm will receive usual care in accordance with guidelines at each site. Usual care	CHW Support Prior to randomization, patients in this arm will already have set a chronic disease management goal with their primary care provider (who will have received training in collaborative goal-setting). After randomization, patients in the CHW arm will receive the IMPaCT intervention. IMPaCT: The IMPaCT intervention has three stages: 1. Goal-setting: CHWs will help patients to deconstruct the chronic disease management goal they set with their PCP into patient-driven short-term goals and action plans. 2. Tailored Support: CHWs will conduct weekly follow-up for 6 months through either telephone or home visit in order to support the achievement of patients' short-term goals. 3. Connection with longitudinal support: IMPaCT CHWs will also facilitate a weekly patient support group.
6 Month Follow-Up STARTED	288	304
6 Month Follow-Up COMPLETED	222	248
6 Month Follow-Up NOT COMPLETED	66	56
9 Month Follow-Up STARTED	288	304
9 Month Follow-Up COMPLETED	227	233
9 Month Follow-Up NOT COMPLETED	61	71

Reasons for withdrawal

Measure	Usual Clinician Support Prior to randomization, patients in this arm will already have set a chronic disease management goal with their primary care provider (who will have received training in collaborative goal-setting). After randomization, patients in the usual clinician support arm will receive usual care in accordance with guidelines at each site. Usual care	CHW Support Prior to randomization, patients in this arm will already have set a chronic disease management goal with their primary care provider (who will have received training in collaborative goal-setting). After randomization, patients in the CHW arm will receive the IMPaCT intervention. IMPaCT: The IMPaCT intervention has three stages: 1. Goal-setting: CHWs will help patients to deconstruct the chronic disease management goal they set with their PCP into patient-driven short-term goals and action plans. 2. Tailored Support: CHWs will conduct weekly follow-up for 6 months through either telephone or home visit in order to support the achievement of patients' short-term goals. 3. Connection with longitudinal support: IMPaCT CHWs will also facilitate a weekly patient support group.
6 Month Follow-Up Lost to Follow-up	63	47
6 Month Follow-Up Withdrawal by Subject	3	9
9 Month Follow-Up Lost to Follow-up	52	59
9 Month Follow-Up Withdrawal by Subject	9	12

Baseline Characteristics

Not all participants answered this question.

Baseline characteristics by cohort

Measure	Usual Clinician Support n=288 Participants Prior to randomization, patients in this arm will already have set a chronic disease management goal with their primary care provider (who will have received training in collaborative goal-setting). After randomization, patients in the usual clinician support arm will receive usual care in accordance with guidelines at each site. Usual care	CHW Support n=304 Participants Prior to randomization, patients in this arm will already have set a chronic disease management goal with their primary care provider (who will have received training in collaborative goal-setting). After randomization, patients in the CHW arm will receive the IMPaCT intervention. IMPaCT: The IMPaCT intervention has three stages: 1. Goal-setting: CHWs will help patients to deconstruct the chronic disease management goal they set with their PCP into patient-driven short-term goals and action plans. 2. Tailored Support: CHWs will conduct weekly follow-up for 6 months through either telephone or home visit in order to support the achievement of patients' short-term goals. 3. Connection with longitudinal support: IMPaCT CHWs will also facilitate a weekly patient support group.	Total n=592 Participants Total of all reporting groups
Age, Continuous	52.1 years STANDARD_DEVIATION 11.5 • n=288 Participants	53.1 years STANDARD_DEVIATION 10.7 • n=304 Participants	52.6 years STANDARD_DEVIATION 11.5 • n=592 Participants
Sex: Female, Male Female	176 Participants n=288 Participants	194 Participants n=304 Participants	370 Participants n=592 Participants
Sex: Female, Male Male	112 Participants n=288 Participants	110 Participants n=304 Participants	222 Participants n=592 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=288 Participants	11 Participants n=304 Participants	11 Participants n=592 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	285 Participants n=288 Participants	285 Participants n=304 Participants	570 Participants n=592 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	3 Participants n=288 Participants	8 Participants n=304 Participants	11 Participants n=592 Participants
Race/Ethnicity, Customized African American	274 Participants n=288 Participants	284 Participants n=304 Participants	558 Participants n=592 Participants
Employed	48 Participants n=286 Participants • Not all participants answered this question.	47 Participants n=303 Participants • Not all participants answered this question.	95 Participants n=589 Participants • Not all participants answered this question.
Household Income < 15K	186 Participants n=288 Participants	197 Participants n=304 Participants	383 Participants n=592 Participants
Household Income > 15K	69 Participants n=288 Participants	69 Participants n=304 Participants	138 Participants n=592 Participants
Household Income Unknown	33 Participants n=288 Participants	38 Participants n=304 Participants	71 Participants n=592 Participants
Trauma History	280 Participants n=286 Participants • Not all participants answered this question.	297 Participants n=304 Participants • Not all participants answered this question.	577 Participants n=590 Participants • Not all participants answered this question.
Low Social Support	57 Participants n=286 Participants • Not all participants answered this question.	76 Participants n=304 Participants • Not all participants answered this question.	133 Participants n=590 Participants • Not all participants answered this question.
Short Grit Scale (Grit-S)	2.7 units on a scale STANDARD_DEVIATION 0.5 • n=285 Participants • Not all participants answered this question.	2.7 units on a scale STANDARD_DEVIATION 0.6 • n=304 Participants • Not all participants answered this question.	2.7 units on a scale STANDARD_DEVIATION 0.5 • n=589 Participants • Not all participants answered this question.
Adult Attachment Questionnaire (AAQ) Secure	3.4 units on a scale STANDARD_DEVIATION 0.9 • n=288 Participants	3.4 units on a scale STANDARD_DEVIATION 0.9 • n=304 Participants	3.4 units on a scale STANDARD_DEVIATION 0.9 • n=592 Participants
Adult Attachment Questionnaire (AAQ) Avoidant	3.6 units on a scale STANDARD_DEVIATION 1.3 • n=288 Participants	3.7 units on a scale STANDARD_DEVIATION 1.3 • n=304 Participants	3.6 units on a scale STANDARD_DEVIATION 1.3 • n=592 Participants
Adult Attachment Questionnaire (AAQ) Anxious	2.9 units on a scale STANDARD_DEVIATION 1.8 • n=288 Participants	2.8 units on a scale STANDARD_DEVIATION 1.8 • n=304 Participants	2.9 units on a scale STANDARD_DEVIATION 1.8 • n=592 Participants
Delayed Health Need	129 Participants n=283 Participants • Not all participants answered this question.	143 Participants n=302 Participants • Not all participants answered this question.	272 Participants n=585 Participants • Not all participants answered this question.
Unmet health Need	81 Participants n=283 Participants • Not all participants answered this question.	76 Participants n=303 Participants • Not all participants answered this question.	157 Participants n=586 Participants • Not all participants answered this question.
Lack of Basic needs	118 Participants n=288 Participants	120 Participants n=304 Participants	238 Participants n=592 Participants
Alcohol Overuse	73 Participants n=259 Participants • Not all participants answered this question.	81 Participants n=272 Participants • Not all participants answered this question.	154 Participants n=531 Participants • Not all participants answered this question.
Drug Use	69 Participants n=283 Participants • Not all participants answered this question.	63 Participants n=303 Participants • Not all participants answered this question.	132 Participants n=586 Participants • Not all participants answered this question.
Short Form Health Survey (SF-12) Mental Health Component	43.1 score on a scale STANDARD_DEVIATION 12.9 • n=286 Participants • Not all participants answered these questions.	42.2 score on a scale STANDARD_DEVIATION 14.1 • n=304 Participants • Not all participants answered these questions.	42.7 score on a scale STANDARD_DEVIATION 13.5 • n=590 Participants • Not all participants answered these questions.
Short Form Health Survey (SF-12) Physical Health Component	33.6 score on a scale STANDARD_DEVIATION 9.9 • n=286 Participants • Not all participants answered these questions.	34.0 score on a scale STANDARD_DEVIATION 10.7 • n=304 Participants • Not all participants answered these questions.	33.8 score on a scale STANDARD_DEVIATION 10.3 • n=590 Participants • Not all participants answered these questions.
Patient Activation Measure (PAM)	60.8 units on a scale STANDARD_DEVIATION 14.3 • n=286 Participants • Not all participants answered these questions.	59.4 units on a scale STANDARD_DEVIATION 14.2 • n=304 Participants • Not all participants answered these questions.	60.1 units on a scale STANDARD_DEVIATION 14.3 • n=590 Participants • Not all participants answered these questions.
Perceived Stress Scale (PSS)	6.7 units on a scale STANDARD_DEVIATION 3.3 • n=286 Participants • Not all participants answered these questions.	6.7 units on a scale STANDARD_DEVIATION 3.5 • n=304 Participants • Not all participants answered these questions.	6.7 units on a scale STANDARD_DEVIATION 3.4 • n=590 Participants • Not all participants answered these questions.
Single Item Literacy Screener (SILS)	1.9 units on a scale STANDARD_DEVIATION 1.1 • n=286 Participants • Not all participants answered this question.	2.1 units on a scale STANDARD_DEVIATION 1.3 • n=304 Participants • Not all participants answered this question.	2.0 units on a scale STANDARD_DEVIATION 1.2 • n=590 Participants • Not all participants answered this question.
ER visits in prior 12 months	2.2 Avg # of visits STANDARD_DEVIATION 3.5 • n=288 Participants	1.8 Avg # of visits STANDARD_DEVIATION 2.1 • n=304 Participants	2.0 Avg # of visits STANDARD_DEVIATION 2.9 • n=592 Participants
Admissions in prior 12 months	1.0 Avg # of admissions STANDARD_DEVIATION 2.5 • n=288 Participants	0.7 Avg # of admissions STANDARD_DEVIATION 1.1 • n=304 Participants	0.9 Avg # of admissions STANDARD_DEVIATION 1.9 • n=592 Participants
Chronic Disease Prevalence - Hypertension	257 Participants n=288 Participants	263 Participants n=304 Participants	520 Participants n=592 Participants
Chronic Disease Prevalence - Obesity	228 Participants n=288 Participants	240 Participants n=304 Participants	468 Participants n=592 Participants
Chronic Disease Prevalence - Diabetes	134 Participants n=288 Participants	139 Participants n=304 Participants	273 Participants n=592 Participants
Chronic Disease Prevalence - Tobacco Dependence	104 Participants n=288 Participants	124 Participants n=304 Participants	228 Participants n=592 Participants
Selected Condition Hypertension	33 Participants n=288 Participants	30 Participants n=304 Participants	63 Participants n=592 Participants
Selected Condition Obesity	149 Participants n=288 Participants	157 Participants n=304 Participants	306 Participants n=592 Participants
Selected Condition Diabetes	35 Participants n=288 Participants	34 Participants n=304 Participants	69 Participants n=592 Participants
Selected Condition Tobacco Dependence	71 Participants n=288 Participants	83 Participants n=304 Participants	154 Participants n=592 Participants
Hypertension Baseline Control	159.8 mmHg STANDARD_DEVIATION 26.5 • n=33 Participants • Each participant was asked to focus on one chronic condition to set a health goal for the study. Because of this, the number of participants analyzed for this outcome is less than the overall number of participants in the study.	163.4 mmHg STANDARD_DEVIATION 19.3 • n=30 Participants • Each participant was asked to focus on one chronic condition to set a health goal for the study. Because of this, the number of participants analyzed for this outcome is less than the overall number of participants in the study.	161.6 mmHg STANDARD_DEVIATION 23.3 • n=63 Participants • Each participant was asked to focus on one chronic condition to set a health goal for the study. Because of this, the number of participants analyzed for this outcome is less than the overall number of participants in the study.
Hypertension Hypertension Goal	-26.4 mmHg STANDARD_DEVIATION 34.6 • n=33 Participants • Each participant was asked to focus on one chronic condition to set a health goal for the study. Because of this, the number of participants analyzed for this outcome is less than the overall number of participants in the study.	-24.1 mmHg STANDARD_DEVIATION 17.9 • n=30 Participants • Each participant was asked to focus on one chronic condition to set a health goal for the study. Because of this, the number of participants analyzed for this outcome is less than the overall number of participants in the study.	-25.3 mmHg STANDARD_DEVIATION 27.7 • n=63 Participants • Each participant was asked to focus on one chronic condition to set a health goal for the study. Because of this, the number of participants analyzed for this outcome is less than the overall number of participants in the study.
Diabetes Baseline Control	10.5 HbA1c% STANDARD_DEVIATION 2.0 • n=35 Participants • Each participant was asked to focus on one chronic condition to set a health goal for the study. Because of this, the number of participants analyzed for this outcome is less than the overall number of participants in the study.	10.5 HbA1c% STANDARD_DEVIATION 2.0 • n=34 Participants • Each participant was asked to focus on one chronic condition to set a health goal for the study. Because of this, the number of participants analyzed for this outcome is less than the overall number of participants in the study.	10.5 HbA1c% STANDARD_DEVIATION 2.0 • n=69 Participants • Each participant was asked to focus on one chronic condition to set a health goal for the study. Because of this, the number of participants analyzed for this outcome is less than the overall number of participants in the study.
Diabetes Diabetes Goal	-2.3 HbA1c% STANDARD_DEVIATION 1.8 • n=35 Participants • Each participant was asked to focus on one chronic condition to set a health goal for the study. Because of this, the number of participants analyzed for this outcome is less than the overall number of participants in the study.	-2.3 HbA1c% STANDARD_DEVIATION 2.2 • n=34 Participants • Each participant was asked to focus on one chronic condition to set a health goal for the study. Because of this, the number of participants analyzed for this outcome is less than the overall number of participants in the study.	-2.3 HbA1c% STANDARD_DEVIATION 2.0 • n=69 Participants • Each participant was asked to focus on one chronic condition to set a health goal for the study. Because of this, the number of participants analyzed for this outcome is less than the overall number of participants in the study.
Obesity - Baseline Clinical Parameters	42.2 kg/m^2 (BMI) STANDARD_DEVIATION 6.9 • n=149 Participants • Each participant was asked to focus on one chronic condition to set a health goal for the study. Because of this, the number of participants analyzed for this outcome is less than the overall number of participants in the study.	42.8 kg/m^2 (BMI) STANDARD_DEVIATION 8.1 • n=157 Participants • Each participant was asked to focus on one chronic condition to set a health goal for the study. Because of this, the number of participants analyzed for this outcome is less than the overall number of participants in the study.	42.5 kg/m^2 (BMI) STANDARD_DEVIATION 7.5 • n=306 Participants • Each participant was asked to focus on one chronic condition to set a health goal for the study. Because of this, the number of participants analyzed for this outcome is less than the overall number of participants in the study.
Obesity - Health Goal	-15.1 pounds STANDARD_DEVIATION 5.6 • n=149 Participants • Each participant was asked to focus on one chronic condition to set a health goal for the study. Because of this, the number of participants analyzed for this outcome is less than the overall number of participants in the study.	-14.7 pounds STANDARD_DEVIATION 6.3 • n=157 Participants • Each participant was asked to focus on one chronic condition to set a health goal for the study. Because of this, the number of participants analyzed for this outcome is less than the overall number of participants in the study.	-14.9 pounds STANDARD_DEVIATION 6.0 • n=306 Participants • Each participant was asked to focus on one chronic condition to set a health goal for the study. Because of this, the number of participants analyzed for this outcome is less than the overall number of participants in the study.
Tobacco Use	9.7 number of cigarettes STANDARD_DEVIATION 7.2 • n=71 Participants • Each participant was asked to focus on one chronic condition to set a health goal for the study. Because of this, the number of participants analyzed for this outcome is less than the overall number of participants in the study.	8.9 number of cigarettes STANDARD_DEVIATION 6.4 • n=83 Participants • Each participant was asked to focus on one chronic condition to set a health goal for the study. Because of this, the number of participants analyzed for this outcome is less than the overall number of participants in the study.	9.3 number of cigarettes STANDARD_DEVIATION 6.8 • n=154 Participants • Each participant was asked to focus on one chronic condition to set a health goal for the study. Because of this, the number of participants analyzed for this outcome is less than the overall number of participants in the study.

PRIMARY outcome

Timeframe: Baseline, 6 months

The main dependent variable is mean change in standardized score for SF-12 PCS. The SF-12 is a survey designed for use with patients with multiple chronic conditions. This 12-item scale can be used to assess the physical and mental health of respondents. 10 of the 12 questions are answered on a 5 point likert scale and 2 are answered on a 3 point likert scale. The questions are then scored and weighted into 2 subscales, physical health and mental health. Respondents can have a score that ranges from 0-100 with 100 being the best score and indicating high physical or mental health. A 3 point change in SF-12 score reflects a meaningful difference. We measure the between-arm difference in mean change in SF-12 PCS between baseline and 6-month follow-up assessment.

Outcome measures

Measure	Usual Clinician Support n=222 Participants Prior to randomization, patients in this arm will already have set a chronic disease management goal with their primary care provider (who will have received training in collaborative goal-setting). After randomization, patients in the usual clinician support arm will receive usual care in accordance with guidelines at each site. Usual care	CHW Support n=248 Participants Prior to randomization, patients in this arm will already have set a chronic disease management goal with their primary care provider (who will have received training in collaborative goal-setting). After randomization, patients in the CHW arm will receive the IMPaCT intervention. IMPaCT: The IMPaCT intervention has three stages: 1. Goal-setting: CHWs will help patients to deconstruct the chronic disease management goal they set with their PCP into patient-driven short-term goals and action plans. 2. Tailored Support: CHWs will conduct weekly follow-up for 6 months through either telephone or home visit in order to support the achievement of patients' short-term goals. 3. Connection with longitudinal support: IMPaCT CHWs will also facilitate a weekly patient support group.	Usual Clinician Support - 9 Months Prior to randomization, patients in this arm will already have set a chronic disease management goal with their primary care provider (who will have received training in collaborative goal-setting). After randomization, patients in the usual clinician support arm will receive usual care in accordance with guidelines at each site. Usual care	CHW Support - 9 Months Prior to randomization, patients in this arm will already have set a chronic disease management goal with their primary care provider (who will have received training in collaborative goal-setting). After randomization, patients in the CHW arm will receive the IMPaCT intervention. IMPaCT: The IMPaCT intervention has three stages: 1. Goal-setting: CHWs will help patients to deconstruct the chronic disease management goal they set with their PCP into patient-driven short-term goals and action plans. 2. Tailored Support: CHWs will conduct weekly follow-up for 6 months through either telephone or home visit in order to support the achievement of patients' short-term goals. 3. Connection with longitudinal support: IMPaCT CHWs will also facilitate a weekly patient support group.
Short Form Health Survey (SF-12) Physical Component Score (PCS)	2.3 score on a scale Standard Deviation 11.3	0.6 score on a scale Standard Deviation 12.7	—	—

SECONDARY outcome

Timeframe: Baseline, 6 months, 9 months

Population: Each participant was only analyzed for their chosen chronic condition.

We will asses change in chronic disease control using biometric testing (HgA1c). At six months after enrollment, all patients underwent a clinic visit and the appropriate laboratory testing: HgbA1c. Patients' measurements on this parameter will be used to determine their change in standardized score for their outcome of interest.

Outcome measures

Measure	Usual Clinician Support n=29 Participants Prior to randomization, patients in this arm will already have set a chronic disease management goal with their primary care provider (who will have received training in collaborative goal-setting). After randomization, patients in the usual clinician support arm will receive usual care in accordance with guidelines at each site. Usual care	CHW Support n=27 Participants Prior to randomization, patients in this arm will already have set a chronic disease management goal with their primary care provider (who will have received training in collaborative goal-setting). After randomization, patients in the CHW arm will receive the IMPaCT intervention. IMPaCT: The IMPaCT intervention has three stages: 1. Goal-setting: CHWs will help patients to deconstruct the chronic disease management goal they set with their PCP into patient-driven short-term goals and action plans. 2. Tailored Support: CHWs will conduct weekly follow-up for 6 months through either telephone or home visit in order to support the achievement of patients' short-term goals. 3. Connection with longitudinal support: IMPaCT CHWs will also facilitate a weekly patient support group.	Usual Clinician Support - 9 Months n=29 Participants Prior to randomization, patients in this arm will already have set a chronic disease management goal with their primary care provider (who will have received training in collaborative goal-setting). After randomization, patients in the usual clinician support arm will receive usual care in accordance with guidelines at each site. Usual care	CHW Support - 9 Months n=23 Participants Prior to randomization, patients in this arm will already have set a chronic disease management goal with their primary care provider (who will have received training in collaborative goal-setting). After randomization, patients in the CHW arm will receive the IMPaCT intervention. IMPaCT: The IMPaCT intervention has three stages: 1. Goal-setting: CHWs will help patients to deconstruct the chronic disease management goal they set with their PCP into patient-driven short-term goals and action plans. 2. Tailored Support: CHWs will conduct weekly follow-up for 6 months through either telephone or home visit in order to support the achievement of patients' short-term goals. 3. Connection with longitudinal support: IMPaCT CHWs will also facilitate a weekly patient support group.
Change in Chronic Disease Control - Diabetes	-6.5 HbA1c% Standard Deviation 26.0	-10.9 HbA1c% Standard Deviation 16.3	-10.4 HbA1c% Standard Deviation 22.5	-17.9 HbA1c% Standard Deviation 19.5

SECONDARY outcome

Timeframe: Baseline, 6 months, 9 months

Population: Each participant was only analyzed for their chosen chronic condition.

We will asses change in chronic disease control using biometric testing (kg/m^2). At six and nine months after enrollment, all patients underwent a clinic visit and the appropriate laboratory testing: height and weight. Patients' measurements on this parameter will be used to determine their change in standardized score for their outcome of interest.

Outcome measures

Measure	Usual Clinician Support n=118 Participants Prior to randomization, patients in this arm will already have set a chronic disease management goal with their primary care provider (who will have received training in collaborative goal-setting). After randomization, patients in the usual clinician support arm will receive usual care in accordance with guidelines at each site. Usual care	CHW Support n=135 Participants Prior to randomization, patients in this arm will already have set a chronic disease management goal with their primary care provider (who will have received training in collaborative goal-setting). After randomization, patients in the CHW arm will receive the IMPaCT intervention. IMPaCT: The IMPaCT intervention has three stages: 1. Goal-setting: CHWs will help patients to deconstruct the chronic disease management goal they set with their PCP into patient-driven short-term goals and action plans. 2. Tailored Support: CHWs will conduct weekly follow-up for 6 months through either telephone or home visit in order to support the achievement of patients' short-term goals. 3. Connection with longitudinal support: IMPaCT CHWs will also facilitate a weekly patient support group.	Usual Clinician Support - 9 Months n=120 Participants Prior to randomization, patients in this arm will already have set a chronic disease management goal with their primary care provider (who will have received training in collaborative goal-setting). After randomization, patients in the usual clinician support arm will receive usual care in accordance with guidelines at each site. Usual care	CHW Support - 9 Months n=120 Participants Prior to randomization, patients in this arm will already have set a chronic disease management goal with their primary care provider (who will have received training in collaborative goal-setting). After randomization, patients in the CHW arm will receive the IMPaCT intervention. IMPaCT: The IMPaCT intervention has three stages: 1. Goal-setting: CHWs will help patients to deconstruct the chronic disease management goal they set with their PCP into patient-driven short-term goals and action plans. 2. Tailored Support: CHWs will conduct weekly follow-up for 6 months through either telephone or home visit in order to support the achievement of patients' short-term goals. 3. Connection with longitudinal support: IMPaCT CHWs will also facilitate a weekly patient support group.
Change in Chronic Disease Control - Obesity	-0.3 kg/m^2 (BMI) Standard Deviation 2.5	-0.5 kg/m^2 (BMI) Standard Deviation 2.3	-0.4 kg/m^2 (BMI) Standard Deviation 2.7	-0.5 kg/m^2 (BMI) Standard Deviation 3.0

SECONDARY outcome

Timeframe: Baseline, 6 months, 9 months

Population: Each participant was only analyzed for their chosen chronic condition.

We will asses change in chronic disease control using patient self-report (cigarettes per day). At six and nine months after enrollment, all patients underwent a clinic visit and the appropriate laboratory testing. Patients' measurements on this parameter will be used to determine their change in standardized score for their outcome of interest.

Outcome measures

Measure	Usual Clinician Support n=52 Participants Prior to randomization, patients in this arm will already have set a chronic disease management goal with their primary care provider (who will have received training in collaborative goal-setting). After randomization, patients in the usual clinician support arm will receive usual care in accordance with guidelines at each site. Usual care	CHW Support n=68 Participants Prior to randomization, patients in this arm will already have set a chronic disease management goal with their primary care provider (who will have received training in collaborative goal-setting). After randomization, patients in the CHW arm will receive the IMPaCT intervention. IMPaCT: The IMPaCT intervention has three stages: 1. Goal-setting: CHWs will help patients to deconstruct the chronic disease management goal they set with their PCP into patient-driven short-term goals and action plans. 2. Tailored Support: CHWs will conduct weekly follow-up for 6 months through either telephone or home visit in order to support the achievement of patients' short-term goals. 3. Connection with longitudinal support: IMPaCT CHWs will also facilitate a weekly patient support group.	Usual Clinician Support - 9 Months n=48 Participants Prior to randomization, patients in this arm will already have set a chronic disease management goal with their primary care provider (who will have received training in collaborative goal-setting). After randomization, patients in the usual clinician support arm will receive usual care in accordance with guidelines at each site. Usual care	CHW Support - 9 Months n=67 Participants Prior to randomization, patients in this arm will already have set a chronic disease management goal with their primary care provider (who will have received training in collaborative goal-setting). After randomization, patients in the CHW arm will receive the IMPaCT intervention. IMPaCT: The IMPaCT intervention has three stages: 1. Goal-setting: CHWs will help patients to deconstruct the chronic disease management goal they set with their PCP into patient-driven short-term goals and action plans. 2. Tailored Support: CHWs will conduct weekly follow-up for 6 months through either telephone or home visit in order to support the achievement of patients' short-term goals. 3. Connection with longitudinal support: IMPaCT CHWs will also facilitate a weekly patient support group.
Change in Chronic Disease Control - Tobacco Use	-3.1 cigarettes per day Standard Deviation 7.1	-3.5 cigarettes per day Standard Deviation 6.4	-3.5 cigarettes per day Standard Deviation 6.5	-4.1 cigarettes per day Standard Deviation 5.4

SECONDARY outcome

Timeframe: Baseline, 6 months, 9 months

Population: Each participant was only analyzed for their chosen chronic condition.

We will asses change in chronic disease control using biometric testing (systolic blood pressure in mm Hg). At six and nine months after enrollment, all patients underwent a clinic visit and the appropriate laboratory testing. Patients' measurements on this parameter will be used to determine their change in standardized score for their outcome of interest.

Outcome measures

Measure	Usual Clinician Support n=29 Participants Prior to randomization, patients in this arm will already have set a chronic disease management goal with their primary care provider (who will have received training in collaborative goal-setting). After randomization, patients in the usual clinician support arm will receive usual care in accordance with guidelines at each site. Usual care	CHW Support n=27 Participants Prior to randomization, patients in this arm will already have set a chronic disease management goal with their primary care provider (who will have received training in collaborative goal-setting). After randomization, patients in the CHW arm will receive the IMPaCT intervention. IMPaCT: The IMPaCT intervention has three stages: 1. Goal-setting: CHWs will help patients to deconstruct the chronic disease management goal they set with their PCP into patient-driven short-term goals and action plans. 2. Tailored Support: CHWs will conduct weekly follow-up for 6 months through either telephone or home visit in order to support the achievement of patients' short-term goals. 3. Connection with longitudinal support: IMPaCT CHWs will also facilitate a weekly patient support group.	Usual Clinician Support - 9 Months n=29 Participants Prior to randomization, patients in this arm will already have set a chronic disease management goal with their primary care provider (who will have received training in collaborative goal-setting). After randomization, patients in the usual clinician support arm will receive usual care in accordance with guidelines at each site. Usual care	CHW Support - 9 Months n=23 Participants Prior to randomization, patients in this arm will already have set a chronic disease management goal with their primary care provider (who will have received training in collaborative goal-setting). After randomization, patients in the CHW arm will receive the IMPaCT intervention. IMPaCT: The IMPaCT intervention has three stages: 1. Goal-setting: CHWs will help patients to deconstruct the chronic disease management goal they set with their PCP into patient-driven short-term goals and action plans. 2. Tailored Support: CHWs will conduct weekly follow-up for 6 months through either telephone or home visit in order to support the achievement of patients' short-term goals. 3. Connection with longitudinal support: IMPaCT CHWs will also facilitate a weekly patient support group.
Change in Chronic Disease Control - Hypertension	-6.2 mm Hg Standard Deviation 26.0	-10.9 mm Hg Standard Deviation 16.3	-10.4 mm Hg Standard Deviation 22.5	-17.9 mm Hg Standard Deviation 19.5

SECONDARY outcome

Timeframe: Baseline, 6 months, 9 months

The SF-12 is a survey designed for use with patients with multiple chronic conditions. This 12-item scale can be used to assess the physical and mental health of respondents. 10 of the 12 questions are answered on a 5 point likert scale and 2 are answered on a 3 point likert scale. The questions are then scored and weighted into 2 subscales, physical health and mental health. Respondents can have a score that ranges from 0-100 with 100 being the best score and indicating high physical or mental health. A 3 point change in SF-12 score reflects a meaningful difference. We will assess this outcome using the SF-12 Mental Component Summary (MCS) score. The MCS reliably detects differences in mental health over time. We will measure the between-arm difference in mean change in SF-12 MCS score between baseline, 6- and 9- month follow-up.

Outcome measures

Measure	Usual Clinician Support n=222 Participants Prior to randomization, patients in this arm will already have set a chronic disease management goal with their primary care provider (who will have received training in collaborative goal-setting). After randomization, patients in the usual clinician support arm will receive usual care in accordance with guidelines at each site. Usual care	CHW Support n=248 Participants Prior to randomization, patients in this arm will already have set a chronic disease management goal with their primary care provider (who will have received training in collaborative goal-setting). After randomization, patients in the CHW arm will receive the IMPaCT intervention. IMPaCT: The IMPaCT intervention has three stages: 1. Goal-setting: CHWs will help patients to deconstruct the chronic disease management goal they set with their PCP into patient-driven short-term goals and action plans. 2. Tailored Support: CHWs will conduct weekly follow-up for 6 months through either telephone or home visit in order to support the achievement of patients' short-term goals. 3. Connection with longitudinal support: IMPaCT CHWs will also facilitate a weekly patient support group.	Usual Clinician Support - 9 Months n=227 Participants Prior to randomization, patients in this arm will already have set a chronic disease management goal with their primary care provider (who will have received training in collaborative goal-setting). After randomization, patients in the usual clinician support arm will receive usual care in accordance with guidelines at each site. Usual care	CHW Support - 9 Months n=233 Participants Prior to randomization, patients in this arm will already have set a chronic disease management goal with their primary care provider (who will have received training in collaborative goal-setting). After randomization, patients in the CHW arm will receive the IMPaCT intervention. IMPaCT: The IMPaCT intervention has three stages: 1. Goal-setting: CHWs will help patients to deconstruct the chronic disease management goal they set with their PCP into patient-driven short-term goals and action plans. 2. Tailored Support: CHWs will conduct weekly follow-up for 6 months through either telephone or home visit in order to support the achievement of patients' short-term goals. 3. Connection with longitudinal support: IMPaCT CHWs will also facilitate a weekly patient support group.
Short Form Health Survey (SF-12) - Mental Component Summary (MCS)	1.7 score on a scale Standard Deviation 14.1	2.2 score on a scale Standard Deviation 13.3	1.2 score on a scale Standard Deviation 13.7	2.2 score on a scale Standard Deviation 14.1

SECONDARY outcome

Timeframe: 6 months, 9 months

We will assess this outcome using the Consumer Assessment of Healthcare Providers and Systems Patient-Centered Medical Home (CAHPS PCMH) survey. This survey assesses the quality of patient-centered primary care and can be used by any practice (not just PCMH practices). We will measure the CAHPS PCMH domains pertaining to Self-Management Support and Comprehensiveness of Care. We will measure the number of patients who gave the highest rating of care for the comprehensiveness question at 6 and 9 months post-enrollment.

Outcome measures

Measure	Usual Clinician Support n=222 Participants Prior to randomization, patients in this arm will already have set a chronic disease management goal with their primary care provider (who will have received training in collaborative goal-setting). After randomization, patients in the usual clinician support arm will receive usual care in accordance with guidelines at each site. Usual care	CHW Support n=248 Participants Prior to randomization, patients in this arm will already have set a chronic disease management goal with their primary care provider (who will have received training in collaborative goal-setting). After randomization, patients in the CHW arm will receive the IMPaCT intervention. IMPaCT: The IMPaCT intervention has three stages: 1. Goal-setting: CHWs will help patients to deconstruct the chronic disease management goal they set with their PCP into patient-driven short-term goals and action plans. 2. Tailored Support: CHWs will conduct weekly follow-up for 6 months through either telephone or home visit in order to support the achievement of patients' short-term goals. 3. Connection with longitudinal support: IMPaCT CHWs will also facilitate a weekly patient support group.	Usual Clinician Support - 9 Months n=227 Participants Prior to randomization, patients in this arm will already have set a chronic disease management goal with their primary care provider (who will have received training in collaborative goal-setting). After randomization, patients in the usual clinician support arm will receive usual care in accordance with guidelines at each site. Usual care	CHW Support - 9 Months n=233 Participants Prior to randomization, patients in this arm will already have set a chronic disease management goal with their primary care provider (who will have received training in collaborative goal-setting). After randomization, patients in the CHW arm will receive the IMPaCT intervention. IMPaCT: The IMPaCT intervention has three stages: 1. Goal-setting: CHWs will help patients to deconstruct the chronic disease management goal they set with their PCP into patient-driven short-term goals and action plans. 2. Tailored Support: CHWs will conduct weekly follow-up for 6 months through either telephone or home visit in order to support the achievement of patients' short-term goals. 3. Connection with longitudinal support: IMPaCT CHWs will also facilitate a weekly patient support group.
Number of Participants Reporting Highest Rating for Quality of Patient-centered Care - Comprehensiveness	83 Participants	137 Participants	97 Participants	139 Participants

SECONDARY outcome

Timeframe: 6 months and 9 months

We will measure admission to hospital at 6- and 9 months after enrollment. This data will be obtained through 1) self-report, 2) the Pennsylvania Cost Containment Council (PHC4), a state-based initiative that tracks utilization data across the state of Pennsylvania, 3) the Veterans Affairs electronic medical record, 4) the Penn electronic medical record

Outcome measures

Measure	Usual Clinician Support n=222 Participants Prior to randomization, patients in this arm will already have set a chronic disease management goal with their primary care provider (who will have received training in collaborative goal-setting). After randomization, patients in the usual clinician support arm will receive usual care in accordance with guidelines at each site. Usual care	CHW Support n=248 Participants Prior to randomization, patients in this arm will already have set a chronic disease management goal with their primary care provider (who will have received training in collaborative goal-setting). After randomization, patients in the CHW arm will receive the IMPaCT intervention. IMPaCT: The IMPaCT intervention has three stages: 1. Goal-setting: CHWs will help patients to deconstruct the chronic disease management goal they set with their PCP into patient-driven short-term goals and action plans. 2. Tailored Support: CHWs will conduct weekly follow-up for 6 months through either telephone or home visit in order to support the achievement of patients' short-term goals. 3. Connection with longitudinal support: IMPaCT CHWs will also facilitate a weekly patient support group.	Usual Clinician Support - 9 Months n=227 Participants Prior to randomization, patients in this arm will already have set a chronic disease management goal with their primary care provider (who will have received training in collaborative goal-setting). After randomization, patients in the usual clinician support arm will receive usual care in accordance with guidelines at each site. Usual care	CHW Support - 9 Months n=233 Participants Prior to randomization, patients in this arm will already have set a chronic disease management goal with their primary care provider (who will have received training in collaborative goal-setting). After randomization, patients in the CHW arm will receive the IMPaCT intervention. IMPaCT: The IMPaCT intervention has three stages: 1. Goal-setting: CHWs will help patients to deconstruct the chronic disease management goal they set with their PCP into patient-driven short-term goals and action plans. 2. Tailored Support: CHWs will conduct weekly follow-up for 6 months through either telephone or home visit in order to support the achievement of patients' short-term goals. 3. Connection with longitudinal support: IMPaCT CHWs will also facilitate a weekly patient support group.
Number of Participants With Any Hospital Admission	35 Participants	38 Participants	51 Participants	52 Participants

SECONDARY outcome

Timeframe: 6 months

Population: This data point contains qualitative, not quantitative data. The study team is still analyzing this data set and has not yet completed analysis for this outcome. Below, we report the number of interviews completed for each clinical site (VA, Federally Qualified Health Center, Academic Site). We will not complete any more interviews.

At 6-months post-enrollment, a trained qualitative interviewer on our study team will conduct an in-depth qualitative semi-structured interview with 40 intervention arm patients and their CHWs. Qualitative interviews will be audio-taped and transcribed. Patients will be purposively sampled across each study site in order to be able to make comparisons between those who achieved a minimally important improvement in the primary outcome and those who did not. These interviews will be guided by the Integrative Behavior Model (IBM). UPDATE: After beginning interviews, our team decided that 26 interviews was sufficient to reach thematic saturation.

Outcome measures

Measure	Usual Clinician Support n=26 Participants Prior to randomization, patients in this arm will already have set a chronic disease management goal with their primary care provider (who will have received training in collaborative goal-setting). After randomization, patients in the usual clinician support arm will receive usual care in accordance with guidelines at each site. Usual care	CHW Support Prior to randomization, patients in this arm will already have set a chronic disease management goal with their primary care provider (who will have received training in collaborative goal-setting). After randomization, patients in the CHW arm will receive the IMPaCT intervention. IMPaCT: The IMPaCT intervention has three stages: 1. Goal-setting: CHWs will help patients to deconstruct the chronic disease management goal they set with their PCP into patient-driven short-term goals and action plans. 2. Tailored Support: CHWs will conduct weekly follow-up for 6 months through either telephone or home visit in order to support the achievement of patients' short-term goals. 3. Connection with longitudinal support: IMPaCT CHWs will also facilitate a weekly patient support group.	Usual Clinician Support - 9 Months Prior to randomization, patients in this arm will already have set a chronic disease management goal with their primary care provider (who will have received training in collaborative goal-setting). After randomization, patients in the usual clinician support arm will receive usual care in accordance with guidelines at each site. Usual care	CHW Support - 9 Months Prior to randomization, patients in this arm will already have set a chronic disease management goal with their primary care provider (who will have received training in collaborative goal-setting). After randomization, patients in the CHW arm will receive the IMPaCT intervention. IMPaCT: The IMPaCT intervention has three stages: 1. Goal-setting: CHWs will help patients to deconstruct the chronic disease management goal they set with their PCP into patient-driven short-term goals and action plans. 2. Tailored Support: CHWs will conduct weekly follow-up for 6 months through either telephone or home visit in order to support the achievement of patients' short-term goals. 3. Connection with longitudinal support: IMPaCT CHWs will also facilitate a weekly patient support group.
Qualitative Assessment of Intervention and Mechanisms Affecting Achievement of Primary Outcome VA	10 Participants	—	—	—
Qualitative Assessment of Intervention and Mechanisms Affecting Achievement of Primary Outcome FQHC	10 Participants	—	—	—
Qualitative Assessment of Intervention and Mechanisms Affecting Achievement of Primary Outcome Academic Site	6 Participants	—	—	—

SECONDARY outcome

Timeframe: 6 months, 9 months

We will assess this outcome using the Consumer Assessment of Healthcare Providers and Systems Patient-Centered Medical Home (CAHPS PCMH) survey. This survey assesses the quality of patient-centered primary care and can be used by any practice (not just PCMH practices). We will measure the CAHPS PCMH domains pertaining to Self-Management Support and Comprehensiveness of Care. We will measure the number of patients who gave the highest rating of care for the supportiveness of disease self-management question at 6 and 9 months post-enrollment.

Outcome measures

Measure	Usual Clinician Support n=222 Participants Prior to randomization, patients in this arm will already have set a chronic disease management goal with their primary care provider (who will have received training in collaborative goal-setting). After randomization, patients in the usual clinician support arm will receive usual care in accordance with guidelines at each site. Usual care	CHW Support n=248 Participants Prior to randomization, patients in this arm will already have set a chronic disease management goal with their primary care provider (who will have received training in collaborative goal-setting). After randomization, patients in the CHW arm will receive the IMPaCT intervention. IMPaCT: The IMPaCT intervention has three stages: 1. Goal-setting: CHWs will help patients to deconstruct the chronic disease management goal they set with their PCP into patient-driven short-term goals and action plans. 2. Tailored Support: CHWs will conduct weekly follow-up for 6 months through either telephone or home visit in order to support the achievement of patients' short-term goals. 3. Connection with longitudinal support: IMPaCT CHWs will also facilitate a weekly patient support group.	Usual Clinician Support - 9 Months n=227 Participants Prior to randomization, patients in this arm will already have set a chronic disease management goal with their primary care provider (who will have received training in collaborative goal-setting). After randomization, patients in the usual clinician support arm will receive usual care in accordance with guidelines at each site. Usual care	CHW Support - 9 Months n=233 Participants Prior to randomization, patients in this arm will already have set a chronic disease management goal with their primary care provider (who will have received training in collaborative goal-setting). After randomization, patients in the CHW arm will receive the IMPaCT intervention. IMPaCT: The IMPaCT intervention has three stages: 1. Goal-setting: CHWs will help patients to deconstruct the chronic disease management goal they set with their PCP into patient-driven short-term goals and action plans. 2. Tailored Support: CHWs will conduct weekly follow-up for 6 months through either telephone or home visit in order to support the achievement of patients' short-term goals. 3. Connection with longitudinal support: IMPaCT CHWs will also facilitate a weekly patient support group.
Number of Participants Reporting the Highest Rating for Quality of Patient-centered Care - Supportiveness of Self-management	95 Participants	157 Participants	112 Participants	145 Participants

SECONDARY outcome

Timeframe: 6 months and 9 months

Population: This outcome was only assessed for participants who had hospital admission. Therefore the number of participants analyzed is smaller than that for the overall study.

We will measure admission to hospital at 6- and 9 months after enrollment. This data will be obtained through 1) self-report, 2) the Pennsylvania Cost Containment Council (PHC4), a state-based initiative that tracks utilization data across the state of Pennsylvania, 3) the Veterans Affairs electronic medical record, 4) the Penn electronic medical record

Outcome measures

Measure	Usual Clinician Support n=35 Participants Prior to randomization, patients in this arm will already have set a chronic disease management goal with their primary care provider (who will have received training in collaborative goal-setting). After randomization, patients in the usual clinician support arm will receive usual care in accordance with guidelines at each site. Usual care	CHW Support n=38 Participants Prior to randomization, patients in this arm will already have set a chronic disease management goal with their primary care provider (who will have received training in collaborative goal-setting). After randomization, patients in the CHW arm will receive the IMPaCT intervention. IMPaCT: The IMPaCT intervention has three stages: 1. Goal-setting: CHWs will help patients to deconstruct the chronic disease management goal they set with their PCP into patient-driven short-term goals and action plans. 2. Tailored Support: CHWs will conduct weekly follow-up for 6 months through either telephone or home visit in order to support the achievement of patients' short-term goals. 3. Connection with longitudinal support: IMPaCT CHWs will also facilitate a weekly patient support group.	Usual Clinician Support - 9 Months n=51 Participants Prior to randomization, patients in this arm will already have set a chronic disease management goal with their primary care provider (who will have received training in collaborative goal-setting). After randomization, patients in the usual clinician support arm will receive usual care in accordance with guidelines at each site. Usual care	CHW Support - 9 Months n=52 Participants Prior to randomization, patients in this arm will already have set a chronic disease management goal with their primary care provider (who will have received training in collaborative goal-setting). After randomization, patients in the CHW arm will receive the IMPaCT intervention. IMPaCT: The IMPaCT intervention has three stages: 1. Goal-setting: CHWs will help patients to deconstruct the chronic disease management goal they set with their PCP into patient-driven short-term goals and action plans. 2. Tailored Support: CHWs will conduct weekly follow-up for 6 months through either telephone or home visit in order to support the achievement of patients' short-term goals. 3. Connection with longitudinal support: IMPaCT CHWs will also facilitate a weekly patient support group.
Number of Participants With Multiple Hospital Admissions	14 Participants	4 Participants	21 Participants	15 Participants

SECONDARY outcome

Timeframe: 30 days

Population: This outcome was only assessed for participants who had hospital admission. Therefore the number of participants analyzed is smaller than that for the overall study.

We will measure admission to hospital at 30 days after enrollment. This data will be obtained through 1) self-report, 2) the Pennsylvania Cost Containment Council (PHC4), a state-based initiative that tracks utilization data across the state of Pennsylvania, 3) the Veterans Affairs electronic medical record, 4) the Penn electronic medical record

Outcome measures

Measure	Usual Clinician Support n=35 Participants Prior to randomization, patients in this arm will already have set a chronic disease management goal with their primary care provider (who will have received training in collaborative goal-setting). After randomization, patients in the usual clinician support arm will receive usual care in accordance with guidelines at each site. Usual care	CHW Support n=38 Participants Prior to randomization, patients in this arm will already have set a chronic disease management goal with their primary care provider (who will have received training in collaborative goal-setting). After randomization, patients in the CHW arm will receive the IMPaCT intervention. IMPaCT: The IMPaCT intervention has three stages: 1. Goal-setting: CHWs will help patients to deconstruct the chronic disease management goal they set with their PCP into patient-driven short-term goals and action plans. 2. Tailored Support: CHWs will conduct weekly follow-up for 6 months through either telephone or home visit in order to support the achievement of patients' short-term goals. 3. Connection with longitudinal support: IMPaCT CHWs will also facilitate a weekly patient support group.	Usual Clinician Support - 9 Months n=51 Participants Prior to randomization, patients in this arm will already have set a chronic disease management goal with their primary care provider (who will have received training in collaborative goal-setting). After randomization, patients in the usual clinician support arm will receive usual care in accordance with guidelines at each site. Usual care	CHW Support - 9 Months n=52 Participants Prior to randomization, patients in this arm will already have set a chronic disease management goal with their primary care provider (who will have received training in collaborative goal-setting). After randomization, patients in the CHW arm will receive the IMPaCT intervention. IMPaCT: The IMPaCT intervention has three stages: 1. Goal-setting: CHWs will help patients to deconstruct the chronic disease management goal they set with their PCP into patient-driven short-term goals and action plans. 2. Tailored Support: CHWs will conduct weekly follow-up for 6 months through either telephone or home visit in order to support the achievement of patients' short-term goals. 3. Connection with longitudinal support: IMPaCT CHWs will also facilitate a weekly patient support group.
Number of Participants With 30 Day Hospital Readmissions	9 Participants	3 Participants	14 Participants	6 Participants

SECONDARY outcome

Timeframe: 6 months and 9 months

We will measure admission to hospital at 6- and 9 months after enrollment. This data will be obtained through 1) self-report, 2) the Pennsylvania Cost Containment Council (PHC4), a state-based initiative that tracks utilization data across the state of Pennsylvania, 3) the Veterans Affairs electronic medical record, 4) the Penn electronic medical record

Outcome measures

Measure	Usual Clinician Support n=288 Participants Prior to randomization, patients in this arm will already have set a chronic disease management goal with their primary care provider (who will have received training in collaborative goal-setting). After randomization, patients in the usual clinician support arm will receive usual care in accordance with guidelines at each site. Usual care	CHW Support n=304 Participants Prior to randomization, patients in this arm will already have set a chronic disease management goal with their primary care provider (who will have received training in collaborative goal-setting). After randomization, patients in the CHW arm will receive the IMPaCT intervention. IMPaCT: The IMPaCT intervention has three stages: 1. Goal-setting: CHWs will help patients to deconstruct the chronic disease management goal they set with their PCP into patient-driven short-term goals and action plans. 2. Tailored Support: CHWs will conduct weekly follow-up for 6 months through either telephone or home visit in order to support the achievement of patients' short-term goals. 3. Connection with longitudinal support: IMPaCT CHWs will also facilitate a weekly patient support group.	Usual Clinician Support - 9 Months n=288 Participants Prior to randomization, patients in this arm will already have set a chronic disease management goal with their primary care provider (who will have received training in collaborative goal-setting). After randomization, patients in the usual clinician support arm will receive usual care in accordance with guidelines at each site. Usual care	CHW Support - 9 Months n=304 Participants Prior to randomization, patients in this arm will already have set a chronic disease management goal with their primary care provider (who will have received training in collaborative goal-setting). After randomization, patients in the CHW arm will receive the IMPaCT intervention. IMPaCT: The IMPaCT intervention has three stages: 1. Goal-setting: CHWs will help patients to deconstruct the chronic disease management goal they set with their PCP into patient-driven short-term goals and action plans. 2. Tailored Support: CHWs will conduct weekly follow-up for 6 months through either telephone or home visit in order to support the achievement of patients' short-term goals. 3. Connection with longitudinal support: IMPaCT CHWs will also facilitate a weekly patient support group.
Hospital Admission - Total Hospital Days	345 Days	155 Days	471 Days	300 Days

SECONDARY outcome

Timeframe: 6 months and 9 months

Population: This outcome was only assessed for participants who had a hospital admission. Therefore the number of participants analyzed is smaller than that for the overall study.

We will measure admission to hospital at 6- and 9 months after enrollment. This data will be obtained through 1) self-report, 2) the Pennsylvania Cost Containment Council (PHC4), a state-based initiative that tracks utilization data across the state of Pennsylvania, 3) the Veterans Affairs electronic medical record, 4) the Penn electronic medical record

Outcome measures

Measure	Usual Clinician Support n=35 Participants Prior to randomization, patients in this arm will already have set a chronic disease management goal with their primary care provider (who will have received training in collaborative goal-setting). After randomization, patients in the usual clinician support arm will receive usual care in accordance with guidelines at each site. Usual care	CHW Support n=38 Participants Prior to randomization, patients in this arm will already have set a chronic disease management goal with their primary care provider (who will have received training in collaborative goal-setting). After randomization, patients in the CHW arm will receive the IMPaCT intervention. IMPaCT: The IMPaCT intervention has three stages: 1. Goal-setting: CHWs will help patients to deconstruct the chronic disease management goal they set with their PCP into patient-driven short-term goals and action plans. 2. Tailored Support: CHWs will conduct weekly follow-up for 6 months through either telephone or home visit in order to support the achievement of patients' short-term goals. 3. Connection with longitudinal support: IMPaCT CHWs will also facilitate a weekly patient support group.	Usual Clinician Support - 9 Months n=51 Participants Prior to randomization, patients in this arm will already have set a chronic disease management goal with their primary care provider (who will have received training in collaborative goal-setting). After randomization, patients in the usual clinician support arm will receive usual care in accordance with guidelines at each site. Usual care	CHW Support - 9 Months n=52 Participants Prior to randomization, patients in this arm will already have set a chronic disease management goal with their primary care provider (who will have received training in collaborative goal-setting). After randomization, patients in the CHW arm will receive the IMPaCT intervention. IMPaCT: The IMPaCT intervention has three stages: 1. Goal-setting: CHWs will help patients to deconstruct the chronic disease management goal they set with their PCP into patient-driven short-term goals and action plans. 2. Tailored Support: CHWs will conduct weekly follow-up for 6 months through either telephone or home visit in order to support the achievement of patients' short-term goals. 3. Connection with longitudinal support: IMPaCT CHWs will also facilitate a weekly patient support group.
Hospital Admission - Mean Number of Hospitalizations	1.5 Hospitalizations Standard Deviation 0.7	1.1 Hospitalizations Standard Deviation 0.4	1.6 Hospitalizations Standard Deviation 1.0	1.4 Hospitalizations Standard Deviation 0.8

SECONDARY outcome

Timeframe: 6 months and 9 months

Population: This outcome was only assessed for participants who had a hospital admission. Therefore the number of participants analyzed is smaller than that for the overall study.

We will measure admission to hospital at 6- and 9 months after enrollment. This data will be obtained through 1) self-report, 2) the Pennsylvania Cost Containment Council (PHC4), a state-based initiative that tracks utilization data across the state of Pennsylvania, 3) the Veterans Affairs electronic medical record, 4) the Penn electronic medical record

Outcome measures

Measure	Usual Clinician Support n=35 Participants Prior to randomization, patients in this arm will already have set a chronic disease management goal with their primary care provider (who will have received training in collaborative goal-setting). After randomization, patients in the usual clinician support arm will receive usual care in accordance with guidelines at each site. Usual care	CHW Support n=38 Participants Prior to randomization, patients in this arm will already have set a chronic disease management goal with their primary care provider (who will have received training in collaborative goal-setting). After randomization, patients in the CHW arm will receive the IMPaCT intervention. IMPaCT: The IMPaCT intervention has three stages: 1. Goal-setting: CHWs will help patients to deconstruct the chronic disease management goal they set with their PCP into patient-driven short-term goals and action plans. 2. Tailored Support: CHWs will conduct weekly follow-up for 6 months through either telephone or home visit in order to support the achievement of patients' short-term goals. 3. Connection with longitudinal support: IMPaCT CHWs will also facilitate a weekly patient support group.	Usual Clinician Support - 9 Months n=51 Participants Prior to randomization, patients in this arm will already have set a chronic disease management goal with their primary care provider (who will have received training in collaborative goal-setting). After randomization, patients in the usual clinician support arm will receive usual care in accordance with guidelines at each site. Usual care	CHW Support - 9 Months n=52 Participants Prior to randomization, patients in this arm will already have set a chronic disease management goal with their primary care provider (who will have received training in collaborative goal-setting). After randomization, patients in the CHW arm will receive the IMPaCT intervention. IMPaCT: The IMPaCT intervention has three stages: 1. Goal-setting: CHWs will help patients to deconstruct the chronic disease management goal they set with their PCP into patient-driven short-term goals and action plans. 2. Tailored Support: CHWs will conduct weekly follow-up for 6 months through either telephone or home visit in order to support the achievement of patients' short-term goals. 3. Connection with longitudinal support: IMPaCT CHWs will also facilitate a weekly patient support group.
Hospital Admission - Mean Length of Stay (Among Participants With Hospitalization)	9.9 days Standard Deviation 17.5	4.1 days Standard Deviation 3.1	9.2 days Standard Deviation 15.3	5.8 days Standard Deviation 6.5

Adverse Events

Usual Clinician Support

Serious events: 32 serious events

Other events: 0 other events

Deaths: 3 deaths

CHW Support

Serious events: 35 serious events

Other events: 0 other events

Deaths: 1 deaths

Serious adverse events

Measure	Usual Clinician Support n=288 participants at risk Prior to randomization, patients in this arm will already have set a chronic disease management goal with their primary care provider (who will have received training in collaborative goal-setting). After randomization, patients in the usual clinician support arm will receive usual care in accordance with guidelines at each site. Usual care	CHW Support n=304 participants at risk Prior to randomization, patients in this arm will already have set a chronic disease management goal with their primary care provider (who will have received training in collaborative goal-setting). After randomization, patients in the CHW arm will receive the IMPaCT intervention. IMPaCT: The IMPaCT intervention has three stages: 1. Goal-setting: CHWs will help patients to deconstruct the chronic disease management goal they set with their PCP into patient-driven short-term goals and action plans. 2. Tailored Support: CHWs will conduct weekly follow-up for 6 months through either telephone or home visit in order to support the achievement of patients' short-term goals. 3. Connection with longitudinal support: IMPaCT CHWs will also facilitate a weekly patient support group.
Respiratory, thoracic and mediastinal disorders COPD	0.35% 1/288 • Number of events 1 • Adverse event data were collected for 6 months when participants were actively working on their chronic disease management goals. We did not collect or monitor any adverse event data after 6 months as participants were no longer engaged with a CHW/working on their health goals at that time.	0.33% 1/304 • Number of events 1 • Adverse event data were collected for 6 months when participants were actively working on their chronic disease management goals. We did not collect or monitor any adverse event data after 6 months as participants were no longer engaged with a CHW/working on their health goals at that time.
Injury, poisoning and procedural complications Injuries due to fall	0.35% 1/288 • Number of events 1 • Adverse event data were collected for 6 months when participants were actively working on their chronic disease management goals. We did not collect or monitor any adverse event data after 6 months as participants were no longer engaged with a CHW/working on their health goals at that time.	0.00% 0/304 • Adverse event data were collected for 6 months when participants were actively working on their chronic disease management goals. We did not collect or monitor any adverse event data after 6 months as participants were no longer engaged with a CHW/working on their health goals at that time.
Reproductive system and breast disorders Gynecological Issues	0.35% 1/288 • Number of events 1 • Adverse event data were collected for 6 months when participants were actively working on their chronic disease management goals. We did not collect or monitor any adverse event data after 6 months as participants were no longer engaged with a CHW/working on their health goals at that time.	0.66% 2/304 • Number of events 2 • Adverse event data were collected for 6 months when participants were actively working on their chronic disease management goals. We did not collect or monitor any adverse event data after 6 months as participants were no longer engaged with a CHW/working on their health goals at that time.
Blood and lymphatic system disorders Blood infection	0.00% 0/288 • Adverse event data were collected for 6 months when participants were actively working on their chronic disease management goals. We did not collect or monitor any adverse event data after 6 months as participants were no longer engaged with a CHW/working on their health goals at that time.	0.33% 1/304 • Number of events 1 • Adverse event data were collected for 6 months when participants were actively working on their chronic disease management goals. We did not collect or monitor any adverse event data after 6 months as participants were no longer engaged with a CHW/working on their health goals at that time.
Metabolism and nutrition disorders Allergic reaction to meds	0.35% 1/288 • Number of events 1 • Adverse event data were collected for 6 months when participants were actively working on their chronic disease management goals. We did not collect or monitor any adverse event data after 6 months as participants were no longer engaged with a CHW/working on their health goals at that time.	0.33% 1/304 • Number of events 2 • Adverse event data were collected for 6 months when participants were actively working on their chronic disease management goals. We did not collect or monitor any adverse event data after 6 months as participants were no longer engaged with a CHW/working on their health goals at that time.
Cardiac disorders Angioplasty	0.35% 1/288 • Number of events 1 • Adverse event data were collected for 6 months when participants were actively working on their chronic disease management goals. We did not collect or monitor any adverse event data after 6 months as participants were no longer engaged with a CHW/working on their health goals at that time.	0.00% 0/304 • Adverse event data were collected for 6 months when participants were actively working on their chronic disease management goals. We did not collect or monitor any adverse event data after 6 months as participants were no longer engaged with a CHW/working on their health goals at that time.
Respiratory, thoracic and mediastinal disorders Asthma	1.0% 3/288 • Number of events 3 • Adverse event data were collected for 6 months when participants were actively working on their chronic disease management goals. We did not collect or monitor any adverse event data after 6 months as participants were no longer engaged with a CHW/working on their health goals at that time.	0.33% 1/304 • Number of events 6 • Adverse event data were collected for 6 months when participants were actively working on their chronic disease management goals. We did not collect or monitor any adverse event data after 6 months as participants were no longer engaged with a CHW/working on their health goals at that time.
Gastrointestinal disorders Bowel Issues	0.69% 2/288 • Number of events 2 • Adverse event data were collected for 6 months when participants were actively working on their chronic disease management goals. We did not collect or monitor any adverse event data after 6 months as participants were no longer engaged with a CHW/working on their health goals at that time.	0.00% 0/304 • Adverse event data were collected for 6 months when participants were actively working on their chronic disease management goals. We did not collect or monitor any adverse event data after 6 months as participants were no longer engaged with a CHW/working on their health goals at that time.
Infections and infestations Bacterial Infection	0.35% 1/288 • Number of events 1 • Adverse event data were collected for 6 months when participants were actively working on their chronic disease management goals. We did not collect or monitor any adverse event data after 6 months as participants were no longer engaged with a CHW/working on their health goals at that time.	0.33% 1/304 • Number of events 1 • Adverse event data were collected for 6 months when participants were actively working on their chronic disease management goals. We did not collect or monitor any adverse event data after 6 months as participants were no longer engaged with a CHW/working on their health goals at that time.
Endocrine disorders Diabetes Complications	0.35% 1/288 • Number of events 1 • Adverse event data were collected for 6 months when participants were actively working on their chronic disease management goals. We did not collect or monitor any adverse event data after 6 months as participants were no longer engaged with a CHW/working on their health goals at that time.	0.99% 3/304 • Number of events 3 • Adverse event data were collected for 6 months when participants were actively working on their chronic disease management goals. We did not collect or monitor any adverse event data after 6 months as participants were no longer engaged with a CHW/working on their health goals at that time.
Blood and lymphatic system disorders Blood Pressure Issues	0.35% 1/288 • Number of events 2 • Adverse event data were collected for 6 months when participants were actively working on their chronic disease management goals. We did not collect or monitor any adverse event data after 6 months as participants were no longer engaged with a CHW/working on their health goals at that time.	1.3% 4/304 • Number of events 4 • Adverse event data were collected for 6 months when participants were actively working on their chronic disease management goals. We did not collect or monitor any adverse event data after 6 months as participants were no longer engaged with a CHW/working on their health goals at that time.
Renal and urinary disorders Kidney Issues	0.69% 2/288 • Number of events 2 • Adverse event data were collected for 6 months when participants were actively working on their chronic disease management goals. We did not collect or monitor any adverse event data after 6 months as participants were no longer engaged with a CHW/working on their health goals at that time.	0.33% 1/304 • Number of events 1 • Adverse event data were collected for 6 months when participants were actively working on their chronic disease management goals. We did not collect or monitor any adverse event data after 6 months as participants were no longer engaged with a CHW/working on their health goals at that time.
Musculoskeletal and connective tissue disorders Knee Replacement	0.35% 1/288 • Number of events 1 • Adverse event data were collected for 6 months when participants were actively working on their chronic disease management goals. We did not collect or monitor any adverse event data after 6 months as participants were no longer engaged with a CHW/working on their health goals at that time.	0.66% 2/304 • Number of events 2 • Adverse event data were collected for 6 months when participants were actively working on their chronic disease management goals. We did not collect or monitor any adverse event data after 6 months as participants were no longer engaged with a CHW/working on their health goals at that time.
Musculoskeletal and connective tissue disorders Swelling and pain in lower extremities	1.0% 3/288 • Number of events 4 • Adverse event data were collected for 6 months when participants were actively working on their chronic disease management goals. We did not collect or monitor any adverse event data after 6 months as participants were no longer engaged with a CHW/working on their health goals at that time.	0.33% 1/304 • Number of events 1 • Adverse event data were collected for 6 months when participants were actively working on their chronic disease management goals. We did not collect or monitor any adverse event data after 6 months as participants were no longer engaged with a CHW/working on their health goals at that time.
Musculoskeletal and connective tissue disorders Muscle Spasms	0.35% 1/288 • Number of events 1 • Adverse event data were collected for 6 months when participants were actively working on their chronic disease management goals. We did not collect or monitor any adverse event data after 6 months as participants were no longer engaged with a CHW/working on their health goals at that time.	0.00% 0/304 • Adverse event data were collected for 6 months when participants were actively working on their chronic disease management goals. We did not collect or monitor any adverse event data after 6 months as participants were no longer engaged with a CHW/working on their health goals at that time.
Respiratory, thoracic and mediastinal disorders Sleep Apnea	1.0% 3/288 • Number of events 3 • Adverse event data were collected for 6 months when participants were actively working on their chronic disease management goals. We did not collect or monitor any adverse event data after 6 months as participants were no longer engaged with a CHW/working on their health goals at that time.	0.00% 0/304 • Adverse event data were collected for 6 months when participants were actively working on their chronic disease management goals. We did not collect or monitor any adverse event data after 6 months as participants were no longer engaged with a CHW/working on their health goals at that time.
General disorders Death - Cause Unknown	0.69% 2/288 • Number of events 2 • Adverse event data were collected for 6 months when participants were actively working on their chronic disease management goals. We did not collect or monitor any adverse event data after 6 months as participants were no longer engaged with a CHW/working on their health goals at that time.	0.00% 0/304 • Adverse event data were collected for 6 months when participants were actively working on their chronic disease management goals. We did not collect or monitor any adverse event data after 6 months as participants were no longer engaged with a CHW/working on their health goals at that time.
Respiratory, thoracic and mediastinal disorders Pneumonia	0.35% 1/288 • Number of events 1 • Adverse event data were collected for 6 months when participants were actively working on their chronic disease management goals. We did not collect or monitor any adverse event data after 6 months as participants were no longer engaged with a CHW/working on their health goals at that time.	0.66% 2/304 • Number of events 2 • Adverse event data were collected for 6 months when participants were actively working on their chronic disease management goals. We did not collect or monitor any adverse event data after 6 months as participants were no longer engaged with a CHW/working on their health goals at that time.
Pregnancy, puerperium and perinatal conditions Pregnancy Complications	0.35% 1/288 • Number of events 2 • Adverse event data were collected for 6 months when participants were actively working on their chronic disease management goals. We did not collect or monitor any adverse event data after 6 months as participants were no longer engaged with a CHW/working on their health goals at that time.	0.33% 1/304 • Number of events 1 • Adverse event data were collected for 6 months when participants were actively working on their chronic disease management goals. We did not collect or monitor any adverse event data after 6 months as participants were no longer engaged with a CHW/working on their health goals at that time.
Vascular disorders Stroke	1.7% 5/288 • Number of events 5 • Adverse event data were collected for 6 months when participants were actively working on their chronic disease management goals. We did not collect or monitor any adverse event data after 6 months as participants were no longer engaged with a CHW/working on their health goals at that time.	0.33% 1/304 • Number of events 1 • Adverse event data were collected for 6 months when participants were actively working on their chronic disease management goals. We did not collect or monitor any adverse event data after 6 months as participants were no longer engaged with a CHW/working on their health goals at that time.
Skin and subcutaneous tissue disorders Ulcers	0.35% 1/288 • Number of events 1 • Adverse event data were collected for 6 months when participants were actively working on their chronic disease management goals. We did not collect or monitor any adverse event data after 6 months as participants were no longer engaged with a CHW/working on their health goals at that time.	0.00% 0/304 • Adverse event data were collected for 6 months when participants were actively working on their chronic disease management goals. We did not collect or monitor any adverse event data after 6 months as participants were no longer engaged with a CHW/working on their health goals at that time.
Ear and labyrinth disorders Vertigo	0.35% 1/288 • Number of events 1 • Adverse event data were collected for 6 months when participants were actively working on their chronic disease management goals. We did not collect or monitor any adverse event data after 6 months as participants were no longer engaged with a CHW/working on their health goals at that time.	0.00% 0/304 • Adverse event data were collected for 6 months when participants were actively working on their chronic disease management goals. We did not collect or monitor any adverse event data after 6 months as participants were no longer engaged with a CHW/working on their health goals at that time.
Musculoskeletal and connective tissue disorders Gout	0.35% 1/288 • Number of events 1 • Adverse event data were collected for 6 months when participants were actively working on their chronic disease management goals. We did not collect or monitor any adverse event data after 6 months as participants were no longer engaged with a CHW/working on their health goals at that time.	0.00% 0/304 • Adverse event data were collected for 6 months when participants were actively working on their chronic disease management goals. We did not collect or monitor any adverse event data after 6 months as participants were no longer engaged with a CHW/working on their health goals at that time.
General disorders Pain	0.35% 1/288 • Number of events 1 • Adverse event data were collected for 6 months when participants were actively working on their chronic disease management goals. We did not collect or monitor any adverse event data after 6 months as participants were no longer engaged with a CHW/working on their health goals at that time.	0.00% 0/304 • Adverse event data were collected for 6 months when participants were actively working on their chronic disease management goals. We did not collect or monitor any adverse event data after 6 months as participants were no longer engaged with a CHW/working on their health goals at that time.
Skin and subcutaneous tissue disorders Cellulitis	0.00% 0/288 • Adverse event data were collected for 6 months when participants were actively working on their chronic disease management goals. We did not collect or monitor any adverse event data after 6 months as participants were no longer engaged with a CHW/working on their health goals at that time.	0.33% 1/304 • Number of events 1 • Adverse event data were collected for 6 months when participants were actively working on their chronic disease management goals. We did not collect or monitor any adverse event data after 6 months as participants were no longer engaged with a CHW/working on their health goals at that time.
Social circumstances Dog Bite	0.00% 0/288 • Adverse event data were collected for 6 months when participants were actively working on their chronic disease management goals. We did not collect or monitor any adverse event data after 6 months as participants were no longer engaged with a CHW/working on their health goals at that time.	0.33% 1/304 • Number of events 1 • Adverse event data were collected for 6 months when participants were actively working on their chronic disease management goals. We did not collect or monitor any adverse event data after 6 months as participants were no longer engaged with a CHW/working on their health goals at that time.
General disorders Skin wound	0.00% 0/288 • Adverse event data were collected for 6 months when participants were actively working on their chronic disease management goals. We did not collect or monitor any adverse event data after 6 months as participants were no longer engaged with a CHW/working on their health goals at that time.	0.33% 1/304 • Number of events 1 • Adverse event data were collected for 6 months when participants were actively working on their chronic disease management goals. We did not collect or monitor any adverse event data after 6 months as participants were no longer engaged with a CHW/working on their health goals at that time.
Renal and urinary disorders Gallstones	0.00% 0/288 • Adverse event data were collected for 6 months when participants were actively working on their chronic disease management goals. We did not collect or monitor any adverse event data after 6 months as participants were no longer engaged with a CHW/working on their health goals at that time.	0.33% 1/304 • Number of events 1 • Adverse event data were collected for 6 months when participants were actively working on their chronic disease management goals. We did not collect or monitor any adverse event data after 6 months as participants were no longer engaged with a CHW/working on their health goals at that time.
Vascular disorders Heart Attack	0.00% 0/288 • Adverse event data were collected for 6 months when participants were actively working on their chronic disease management goals. We did not collect or monitor any adverse event data after 6 months as participants were no longer engaged with a CHW/working on their health goals at that time.	0.33% 1/304 • Number of events 1 • Adverse event data were collected for 6 months when participants were actively working on their chronic disease management goals. We did not collect or monitor any adverse event data after 6 months as participants were no longer engaged with a CHW/working on their health goals at that time.
General disorders Hernia Repair	0.00% 0/288 • Adverse event data were collected for 6 months when participants were actively working on their chronic disease management goals. We did not collect or monitor any adverse event data after 6 months as participants were no longer engaged with a CHW/working on their health goals at that time.	0.66% 2/304 • Number of events 2 • Adverse event data were collected for 6 months when participants were actively working on their chronic disease management goals. We did not collect or monitor any adverse event data after 6 months as participants were no longer engaged with a CHW/working on their health goals at that time.
Social circumstances Hit by a car	0.00% 0/288 • Adverse event data were collected for 6 months when participants were actively working on their chronic disease management goals. We did not collect or monitor any adverse event data after 6 months as participants were no longer engaged with a CHW/working on their health goals at that time.	0.33% 1/304 • Number of events 1 • Adverse event data were collected for 6 months when participants were actively working on their chronic disease management goals. We did not collect or monitor any adverse event data after 6 months as participants were no longer engaged with a CHW/working on their health goals at that time.
Social circumstances Inpatient Psych Evaluation	0.00% 0/288 • Adverse event data were collected for 6 months when participants were actively working on their chronic disease management goals. We did not collect or monitor any adverse event data after 6 months as participants were no longer engaged with a CHW/working on their health goals at that time.	0.33% 1/304 • Number of events 1 • Adverse event data were collected for 6 months when participants were actively working on their chronic disease management goals. We did not collect or monitor any adverse event data after 6 months as participants were no longer engaged with a CHW/working on their health goals at that time.
General disorders	0.00% 0/288 • Adverse event data were collected for 6 months when participants were actively working on their chronic disease management goals. We did not collect or monitor any adverse event data after 6 months as participants were no longer engaged with a CHW/working on their health goals at that time.	0.33% 1/304 • Number of events 1 • Adverse event data were collected for 6 months when participants were actively working on their chronic disease management goals. We did not collect or monitor any adverse event data after 6 months as participants were no longer engaged with a CHW/working on their health goals at that time.
Respiratory, thoracic and mediastinal disorders Respiratory Issues	0.00% 0/288 • Adverse event data were collected for 6 months when participants were actively working on their chronic disease management goals. We did not collect or monitor any adverse event data after 6 months as participants were no longer engaged with a CHW/working on their health goals at that time.	0.99% 3/304 • Number of events 3 • Adverse event data were collected for 6 months when participants were actively working on their chronic disease management goals. We did not collect or monitor any adverse event data after 6 months as participants were no longer engaged with a CHW/working on their health goals at that time.
Social circumstances Dehydration	0.00% 0/288 • Adverse event data were collected for 6 months when participants were actively working on their chronic disease management goals. We did not collect or monitor any adverse event data after 6 months as participants were no longer engaged with a CHW/working on their health goals at that time.	0.33% 1/304 • Number of events 1 • Adverse event data were collected for 6 months when participants were actively working on their chronic disease management goals. We did not collect or monitor any adverse event data after 6 months as participants were no longer engaged with a CHW/working on their health goals at that time.
Blood and lymphatic system disorders Blood Transfusion	0.00% 0/288 • Adverse event data were collected for 6 months when participants were actively working on their chronic disease management goals. We did not collect or monitor any adverse event data after 6 months as participants were no longer engaged with a CHW/working on their health goals at that time.	0.33% 1/304 • Number of events 1 • Adverse event data were collected for 6 months when participants were actively working on their chronic disease management goals. We did not collect or monitor any adverse event data after 6 months as participants were no longer engaged with a CHW/working on their health goals at that time.

Other adverse events

Adverse event data not reported

Additional Information

Lindsey Norton

University of Pennsylvania School of Medicine

Phone: 215-573-9961

Email: lindsey.turr@uphs.upenn.edu

Results disclosure agreements

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