Trial Outcomes & Findings for Diabetes Remote Intervention to improVe Use of Evidence-based Medications (NCT NCT06046560)

NCT ID: NCT06046560

Last Updated: 2024-10-23

Results Overview

Number of patients with prescriptions of SGLT2i or GLP1-RA at any time

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 200 participants
• Primary outcome timeframe: Any time between 0-months (baseline) to 6-months following enrollment
• Results posted on: 2024-10-23

Participant Flow

Participant milestones

Measure	Medication & Education-First Patient will immediately begin participation in a remote, pharmacist-driven heart failure clinic that will initiate and titrate medications according to a standardized medical algorithm. SGLT2 inhibitor, GLP-1 RA: Immediate initiation of guideline-directed medical therapy. Will also immediately receive the same educational services provided in the "Education-First" intervention.	Education-First Patient will first receive curated patient education, an alert to providers, and provider education, and then after 2 months begin participation in the remote clinic. SGLT2 inhibitor, GLP-1 RA: Immediate initiation of guideline-directed medical therapy. Will also immediately receive the same educational services provided in the "Education-First" intervention. Education-First: For the first 2-months of their participation, patients in this arm will receive curated patient education, an alert to providers, provider education, and then after 2 months, be invited to participate in the remote clinic. The patient education would consist of curated video content and informational worksheets provided by email or secure patient messaging. Provider alerts would happen through notifying of a patient's eligibility for therapy.
Overall Study STARTED	116	84
Overall Study COMPLETED	116	84
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Diabetes Remote Intervention to improVe Use of Evidence-based Medications

Baseline characteristics by cohort

Measure	Medication & Education-First n=116 Participants Patient will immediately begin participation in a remote, pharmacist-driven heart failure clinic that will initiate and titrate medications according to a standardized medical algorithm. SGLT2 inhibitor, GLP-1 RA: Immediate initiation of guideline-directed medical therapy. Will also immediately receive the same educational services provided in the "Education-First" intervention.	Education-First n=84 Participants Patient will first receive curated patient education, an alert to providers, and provider education, and then after 2 months begin participation in the remote clinic. SGLT2 inhibitor, GLP-1 RA: Immediate initiation of guideline-directed medical therapy. Will also immediately receive the same educational services provided in the "Education-First" intervention. Education-First: For the first 2-months of their participation, patients in this arm will receive curated patient education, an alert to providers, provider education, and then after 2 months, be invited to participate in the remote clinic. The patient education would consist of curated video content and informational worksheets provided by email or secure patient messaging. Provider alerts would happen through notifying of a patient's eligibility for therapy.	Total n=200 Participants Total of all reporting groups
Age, Continuous	66.6 Years STANDARD_DEVIATION 7.7 • n=93 Participants	66.4 Years STANDARD_DEVIATION 7.5 • n=4 Participants	66.5 Years STANDARD_DEVIATION 7.6 • n=27 Participants
Sex: Female, Male Female	42 Participants n=93 Participants	31 Participants n=4 Participants	73 Participants n=27 Participants
Sex: Female, Male Male	74 Participants n=93 Participants	53 Participants n=4 Participants	127 Participants n=27 Participants
Race/Ethnicity, Customized White	92 Participants n=93 Participants	64 Participants n=4 Participants	156 Participants n=27 Participants
Race/Ethnicity, Customized Black	14 Participants n=93 Participants	10 Participants n=4 Participants	24 Participants n=27 Participants
Race/Ethnicity, Customized Asian	6 Participants n=93 Participants	4 Participants n=4 Participants	10 Participants n=27 Participants
Race/Ethnicity, Customized Other	1 Participants n=93 Participants	3 Participants n=4 Participants	4 Participants n=27 Participants
Race/Ethnicity, Customized Unknown	2 Participants n=93 Participants	2 Participants n=4 Participants	4 Participants n=27 Participants
Race/Ethnicity, Customized Declined	1 Participants n=93 Participants	1 Participants n=4 Participants	2 Participants n=27 Participants

PRIMARY outcome

Timeframe: Any time between 0-months (baseline) to 6-months following enrollment

Number of patients with prescriptions of SGLT2i or GLP1-RA at any time

Outcome measures

Measure	Medication & Education-First n=116 Participants Patient will immediately begin participation in a remote, pharmacist-driven heart failure clinic that will initiate and titrate medications according to a standardized medical algorithm. SGLT2 inhibitor, GLP-1 RA: Immediate initiation of guideline-directed medical therapy. Will also immediately receive the same educational services provided in the "Education-First" intervention.	Education-First n=84 Participants Patient will first receive curated patient education, an alert to providers, and provider education, and then after 2 months begin participation in the remote clinic. SGLT2 inhibitor, GLP-1 RA: Immediate initiation of guideline-directed medical therapy. Will also immediately receive the same educational services provided in the "Education-First" intervention. Education-First: For the first 2-months of their participation, patients in this arm will receive curated patient education, an alert to providers, provider education, and then after 2 months, be invited to participate in the remote clinic. The patient education would consist of curated video content and informational worksheets provided by email or secure patient messaging. Provider alerts would happen through notifying of a patient's eligibility for therapy.
Number of Patients With Prescriptions of SGLT2i or GLP1-RA at Any Time	81 Participants	47 Participants

SECONDARY outcome

Timeframe: 2-months following enrollment

Number of patients with prescriptions of SGLT2i or GLP1 RA at 2-months

Outcome measures

Measure	Medication & Education-First n=116 Participants Patient will immediately begin participation in a remote, pharmacist-driven heart failure clinic that will initiate and titrate medications according to a standardized medical algorithm. SGLT2 inhibitor, GLP-1 RA: Immediate initiation of guideline-directed medical therapy. Will also immediately receive the same educational services provided in the "Education-First" intervention.	Education-First n=84 Participants Patient will first receive curated patient education, an alert to providers, and provider education, and then after 2 months begin participation in the remote clinic. SGLT2 inhibitor, GLP-1 RA: Immediate initiation of guideline-directed medical therapy. Will also immediately receive the same educational services provided in the "Education-First" intervention. Education-First: For the first 2-months of their participation, patients in this arm will receive curated patient education, an alert to providers, provider education, and then after 2 months, be invited to participate in the remote clinic. The patient education would consist of curated video content and informational worksheets provided by email or secure patient messaging. Provider alerts would happen through notifying of a patient's eligibility for therapy.
Number of Patients With Prescriptions of SGLT2i or GLP1-RA at 2-months	62 Participants	7 Participants

SECONDARY outcome

Timeframe: At 6-months following enrollment

Number of patients with prescriptions of SGLT2i or GLP1-RA at 6-months

Outcome measures

Measure	Medication & Education-First n=116 Participants Patient will immediately begin participation in a remote, pharmacist-driven heart failure clinic that will initiate and titrate medications according to a standardized medical algorithm. SGLT2 inhibitor, GLP-1 RA: Immediate initiation of guideline-directed medical therapy. Will also immediately receive the same educational services provided in the "Education-First" intervention.	Education-First n=84 Participants Patient will first receive curated patient education, an alert to providers, and provider education, and then after 2 months begin participation in the remote clinic. SGLT2 inhibitor, GLP-1 RA: Immediate initiation of guideline-directed medical therapy. Will also immediately receive the same educational services provided in the "Education-First" intervention. Education-First: For the first 2-months of their participation, patients in this arm will receive curated patient education, an alert to providers, provider education, and then after 2 months, be invited to participate in the remote clinic. The patient education would consist of curated video content and informational worksheets provided by email or secure patient messaging. Provider alerts would happen through notifying of a patient's eligibility for therapy.
Number of Patients With Prescriptions of SGLT2i or GLP1-RA at 6-months	81 Participants	47 Participants

SECONDARY outcome

Timeframe: From 0-months (baseline) to 6-months following enrollment

Change in Short-form Patient Activation Measure (PAM)

The score is measured on a 0.0 - 4.0 point scale and indicates participants' relationships with and understanding of their health care. A higher value represents a better outcome. This measure indicates the change in participants' scores from the point of enrollment (0-months) to program completion (6-months).

0.0 - 1.0 (Disengaged & Overwhelmed)

1.1 - 2.0 (Becoming Aware But Still Struggling)

2.1 - 3.0 (Taking Action & Gaining Control)

3.1 - 4.0 (Maintaining Behaviors & Pushing Further)

Outcome measures

Measure	Medication & Education-First n=65 Participants Patient will immediately begin participation in a remote, pharmacist-driven heart failure clinic that will initiate and titrate medications according to a standardized medical algorithm. SGLT2 inhibitor, GLP-1 RA: Immediate initiation of guideline-directed medical therapy. Will also immediately receive the same educational services provided in the "Education-First" intervention.	Education-First n=46 Participants Patient will first receive curated patient education, an alert to providers, and provider education, and then after 2 months begin participation in the remote clinic. SGLT2 inhibitor, GLP-1 RA: Immediate initiation of guideline-directed medical therapy. Will also immediately receive the same educational services provided in the "Education-First" intervention. Education-First: For the first 2-months of their participation, patients in this arm will receive curated patient education, an alert to providers, provider education, and then after 2 months, be invited to participate in the remote clinic. The patient education would consist of curated video content and informational worksheets provided by email or secure patient messaging. Provider alerts would happen through notifying of a patient's eligibility for therapy.
Change in Short-form Patient Activation Measure (PAM)	0.3 score on a scale Standard Deviation 0.9	0.0 score on a scale Standard Deviation 1.1

OTHER_PRE_SPECIFIED outcome

Timeframe: From 0-months (baseline) to 6-months following enrollment

Change in body weight (kg)

Outcome measures

Measure	Medication & Education-First n=116 Participants Patient will immediately begin participation in a remote, pharmacist-driven heart failure clinic that will initiate and titrate medications according to a standardized medical algorithm. SGLT2 inhibitor, GLP-1 RA: Immediate initiation of guideline-directed medical therapy. Will also immediately receive the same educational services provided in the "Education-First" intervention.	Education-First n=84 Participants Patient will first receive curated patient education, an alert to providers, and provider education, and then after 2 months begin participation in the remote clinic. SGLT2 inhibitor, GLP-1 RA: Immediate initiation of guideline-directed medical therapy. Will also immediately receive the same educational services provided in the "Education-First" intervention. Education-First: For the first 2-months of their participation, patients in this arm will receive curated patient education, an alert to providers, provider education, and then after 2 months, be invited to participate in the remote clinic. The patient education would consist of curated video content and informational worksheets provided by email or secure patient messaging. Provider alerts would happen through notifying of a patient's eligibility for therapy.
Change in Body Weight (kg)	-4.2 kg Standard Deviation 5.0	-2.5 kg Standard Deviation 2.0

OTHER_PRE_SPECIFIED outcome

Timeframe: From 0-months (baseline) to 6-months following enrollment

Change in body weight (%)

Outcome measures

Measure	Medication & Education-First n=116 Participants Patient will immediately begin participation in a remote, pharmacist-driven heart failure clinic that will initiate and titrate medications according to a standardized medical algorithm. SGLT2 inhibitor, GLP-1 RA: Immediate initiation of guideline-directed medical therapy. Will also immediately receive the same educational services provided in the "Education-First" intervention.	Education-First n=84 Participants Patient will first receive curated patient education, an alert to providers, and provider education, and then after 2 months begin participation in the remote clinic. SGLT2 inhibitor, GLP-1 RA: Immediate initiation of guideline-directed medical therapy. Will also immediately receive the same educational services provided in the "Education-First" intervention. Education-First: For the first 2-months of their participation, patients in this arm will receive curated patient education, an alert to providers, provider education, and then after 2 months, be invited to participate in the remote clinic. The patient education would consist of curated video content and informational worksheets provided by email or secure patient messaging. Provider alerts would happen through notifying of a patient's eligibility for therapy.
Change in Body Weight (%)	-2.5 % weight change Standard Deviation 5.3	-2.0 % weight change Standard Deviation 4.2

OTHER_PRE_SPECIFIED outcome

Timeframe: From 0-months (baseline) to 6-months following enrollment

Change in laboratory measured HbA1c

Outcome measures

Measure	Medication & Education-First n=116 Participants Patient will immediately begin participation in a remote, pharmacist-driven heart failure clinic that will initiate and titrate medications according to a standardized medical algorithm. SGLT2 inhibitor, GLP-1 RA: Immediate initiation of guideline-directed medical therapy. Will also immediately receive the same educational services provided in the "Education-First" intervention.	Education-First n=84 Participants Patient will first receive curated patient education, an alert to providers, and provider education, and then after 2 months begin participation in the remote clinic. SGLT2 inhibitor, GLP-1 RA: Immediate initiation of guideline-directed medical therapy. Will also immediately receive the same educational services provided in the "Education-First" intervention. Education-First: For the first 2-months of their participation, patients in this arm will receive curated patient education, an alert to providers, provider education, and then after 2 months, be invited to participate in the remote clinic. The patient education would consist of curated video content and informational worksheets provided by email or secure patient messaging. Provider alerts would happen through notifying of a patient's eligibility for therapy.
Change in Laboratory Measured HbA1c	-0.3 % change in HbA1c Standard Deviation 0.8	-0.3 % change in HbA1c Standard Deviation 0.7

Adverse Events

Medication & Education-First

Serious events: 2 serious events

Other events: 36 other events

Deaths: 1 deaths

Education-First

Serious events: 0 serious events

Other events: 14 other events

Deaths: 0 deaths

Serious adverse events

Measure	Medication & Education-First n=69 participants at risk Patient will immediately begin participation in a remote, pharmacist-driven heart failure clinic that will initiate and titrate medications according to a standardized medical algorithm. SGLT2 inhibitor, GLP-1 RA: Immediate initiation of guideline-directed medical therapy. Will also immediately receive the same educational services provided in the "Education-First" intervention.	Education-First n=37 participants at risk Patient will first receive curated patient education, an alert to providers, and provider education, and then after 2 months begin participation in the remote clinic. SGLT2 inhibitor, GLP-1 RA: Immediate initiation of guideline-directed medical therapy. Will also immediately receive the same educational services provided in the "Education-First" intervention. Education-First: For the first 2-months of their participation, patients in this arm will receive curated patient education, an alert to providers, provider education, and then after 2 months, be invited to participate in the remote clinic. The patient education would consist of curated video content and informational worksheets provided by email or secure patient messaging. Provider alerts would happen through notifying of a patient's eligibility for therapy.
Infections and infestations Urinary Tract Infection	1.4% 1/69 • Adverse event data was collected from Enrollment (Month 0) to the time of program completion. Participants are queued for graduation six months after enrollment or after initiating medication therapy and completing laboratory test and monitoring follow-up, whichever is later. Adverse events were only assessed for participants who started a study medication. Serious Adverse Events were only assessed if deemed "Possibly Related" or "Probably Related" to the study drug. The SAE definition also included urgent care visits. Systematic assessments were performed through phone call questionaires given to participants. Non-systematic assessment was performed for SAEs only at the end of the study through analysis of the electronic health records.	0.00% 0/37 • Adverse event data was collected from Enrollment (Month 0) to the time of program completion. Participants are queued for graduation six months after enrollment or after initiating medication therapy and completing laboratory test and monitoring follow-up, whichever is later. Adverse events were only assessed for participants who started a study medication. Serious Adverse Events were only assessed if deemed "Possibly Related" or "Probably Related" to the study drug. The SAE definition also included urgent care visits. Systematic assessments were performed through phone call questionaires given to participants. Non-systematic assessment was performed for SAEs only at the end of the study through analysis of the electronic health records.
Gastrointestinal disorders Abdominal Pain	1.4% 1/69 • Adverse event data was collected from Enrollment (Month 0) to the time of program completion. Participants are queued for graduation six months after enrollment or after initiating medication therapy and completing laboratory test and monitoring follow-up, whichever is later. Adverse events were only assessed for participants who started a study medication. Serious Adverse Events were only assessed if deemed "Possibly Related" or "Probably Related" to the study drug. The SAE definition also included urgent care visits. Systematic assessments were performed through phone call questionaires given to participants. Non-systematic assessment was performed for SAEs only at the end of the study through analysis of the electronic health records.	0.00% 0/37 • Adverse event data was collected from Enrollment (Month 0) to the time of program completion. Participants are queued for graduation six months after enrollment or after initiating medication therapy and completing laboratory test and monitoring follow-up, whichever is later. Adverse events were only assessed for participants who started a study medication. Serious Adverse Events were only assessed if deemed "Possibly Related" or "Probably Related" to the study drug. The SAE definition also included urgent care visits. Systematic assessments were performed through phone call questionaires given to participants. Non-systematic assessment was performed for SAEs only at the end of the study through analysis of the electronic health records.

Other adverse events

Measure	Medication & Education-First n=69 participants at risk Patient will immediately begin participation in a remote, pharmacist-driven heart failure clinic that will initiate and titrate medications according to a standardized medical algorithm. SGLT2 inhibitor, GLP-1 RA: Immediate initiation of guideline-directed medical therapy. Will also immediately receive the same educational services provided in the "Education-First" intervention.	Education-First n=37 participants at risk Patient will first receive curated patient education, an alert to providers, and provider education, and then after 2 months begin participation in the remote clinic. SGLT2 inhibitor, GLP-1 RA: Immediate initiation of guideline-directed medical therapy. Will also immediately receive the same educational services provided in the "Education-First" intervention. Education-First: For the first 2-months of their participation, patients in this arm will receive curated patient education, an alert to providers, provider education, and then after 2 months, be invited to participate in the remote clinic. The patient education would consist of curated video content and informational worksheets provided by email or secure patient messaging. Provider alerts would happen through notifying of a patient's eligibility for therapy.
Infections and infestations Genital Mycotic Infection	8.7% 6/69 • Adverse event data was collected from Enrollment (Month 0) to the time of program completion. Participants are queued for graduation six months after enrollment or after initiating medication therapy and completing laboratory test and monitoring follow-up, whichever is later. Adverse events were only assessed for participants who started a study medication. Serious Adverse Events were only assessed if deemed "Possibly Related" or "Probably Related" to the study drug. The SAE definition also included urgent care visits. Systematic assessments were performed through phone call questionaires given to participants. Non-systematic assessment was performed for SAEs only at the end of the study through analysis of the electronic health records.	0.00% 0/37 • Adverse event data was collected from Enrollment (Month 0) to the time of program completion. Participants are queued for graduation six months after enrollment or after initiating medication therapy and completing laboratory test and monitoring follow-up, whichever is later. Adverse events were only assessed for participants who started a study medication. Serious Adverse Events were only assessed if deemed "Possibly Related" or "Probably Related" to the study drug. The SAE definition also included urgent care visits. Systematic assessments were performed through phone call questionaires given to participants. Non-systematic assessment was performed for SAEs only at the end of the study through analysis of the electronic health records.
Infections and infestations Urinary Tract Infection	2.9% 2/69 • Adverse event data was collected from Enrollment (Month 0) to the time of program completion. Participants are queued for graduation six months after enrollment or after initiating medication therapy and completing laboratory test and monitoring follow-up, whichever is later. Adverse events were only assessed for participants who started a study medication. Serious Adverse Events were only assessed if deemed "Possibly Related" or "Probably Related" to the study drug. The SAE definition also included urgent care visits. Systematic assessments were performed through phone call questionaires given to participants. Non-systematic assessment was performed for SAEs only at the end of the study through analysis of the electronic health records.	0.00% 0/37 • Adverse event data was collected from Enrollment (Month 0) to the time of program completion. Participants are queued for graduation six months after enrollment or after initiating medication therapy and completing laboratory test and monitoring follow-up, whichever is later. Adverse events were only assessed for participants who started a study medication. Serious Adverse Events were only assessed if deemed "Possibly Related" or "Probably Related" to the study drug. The SAE definition also included urgent care visits. Systematic assessments were performed through phone call questionaires given to participants. Non-systematic assessment was performed for SAEs only at the end of the study through analysis of the electronic health records.
Cardiac disorders Hypovolemia	14.5% 10/69 • Adverse event data was collected from Enrollment (Month 0) to the time of program completion. Participants are queued for graduation six months after enrollment or after initiating medication therapy and completing laboratory test and monitoring follow-up, whichever is later. Adverse events were only assessed for participants who started a study medication. Serious Adverse Events were only assessed if deemed "Possibly Related" or "Probably Related" to the study drug. The SAE definition also included urgent care visits. Systematic assessments were performed through phone call questionaires given to participants. Non-systematic assessment was performed for SAEs only at the end of the study through analysis of the electronic health records.	5.4% 2/37 • Adverse event data was collected from Enrollment (Month 0) to the time of program completion. Participants are queued for graduation six months after enrollment or after initiating medication therapy and completing laboratory test and monitoring follow-up, whichever is later. Adverse events were only assessed for participants who started a study medication. Serious Adverse Events were only assessed if deemed "Possibly Related" or "Probably Related" to the study drug. The SAE definition also included urgent care visits. Systematic assessments were performed through phone call questionaires given to participants. Non-systematic assessment was performed for SAEs only at the end of the study through analysis of the electronic health records.
Endocrine disorders Hypoglycemia	2.9% 2/69 • Adverse event data was collected from Enrollment (Month 0) to the time of program completion. Participants are queued for graduation six months after enrollment or after initiating medication therapy and completing laboratory test and monitoring follow-up, whichever is later. Adverse events were only assessed for participants who started a study medication. Serious Adverse Events were only assessed if deemed "Possibly Related" or "Probably Related" to the study drug. The SAE definition also included urgent care visits. Systematic assessments were performed through phone call questionaires given to participants. Non-systematic assessment was performed for SAEs only at the end of the study through analysis of the electronic health records.	0.00% 0/37 • Adverse event data was collected from Enrollment (Month 0) to the time of program completion. Participants are queued for graduation six months after enrollment or after initiating medication therapy and completing laboratory test and monitoring follow-up, whichever is later. Adverse events were only assessed for participants who started a study medication. Serious Adverse Events were only assessed if deemed "Possibly Related" or "Probably Related" to the study drug. The SAE definition also included urgent care visits. Systematic assessments were performed through phone call questionaires given to participants. Non-systematic assessment was performed for SAEs only at the end of the study through analysis of the electronic health records.
Endocrine disorders Severe hypoglycemia	0.00% 0/69 • Adverse event data was collected from Enrollment (Month 0) to the time of program completion. Participants are queued for graduation six months after enrollment or after initiating medication therapy and completing laboratory test and monitoring follow-up, whichever is later. Adverse events were only assessed for participants who started a study medication. Serious Adverse Events were only assessed if deemed "Possibly Related" or "Probably Related" to the study drug. The SAE definition also included urgent care visits. Systematic assessments were performed through phone call questionaires given to participants. Non-systematic assessment was performed for SAEs only at the end of the study through analysis of the electronic health records.	0.00% 0/37 • Adverse event data was collected from Enrollment (Month 0) to the time of program completion. Participants are queued for graduation six months after enrollment or after initiating medication therapy and completing laboratory test and monitoring follow-up, whichever is later. Adverse events were only assessed for participants who started a study medication. Serious Adverse Events were only assessed if deemed "Possibly Related" or "Probably Related" to the study drug. The SAE definition also included urgent care visits. Systematic assessments were performed through phone call questionaires given to participants. Non-systematic assessment was performed for SAEs only at the end of the study through analysis of the electronic health records.
Gastrointestinal disorders Nausea	10.1% 7/69 • Adverse event data was collected from Enrollment (Month 0) to the time of program completion. Participants are queued for graduation six months after enrollment or after initiating medication therapy and completing laboratory test and monitoring follow-up, whichever is later. Adverse events were only assessed for participants who started a study medication. Serious Adverse Events were only assessed if deemed "Possibly Related" or "Probably Related" to the study drug. The SAE definition also included urgent care visits. Systematic assessments were performed through phone call questionaires given to participants. Non-systematic assessment was performed for SAEs only at the end of the study through analysis of the electronic health records.	16.2% 6/37 • Adverse event data was collected from Enrollment (Month 0) to the time of program completion. Participants are queued for graduation six months after enrollment or after initiating medication therapy and completing laboratory test and monitoring follow-up, whichever is later. Adverse events were only assessed for participants who started a study medication. Serious Adverse Events were only assessed if deemed "Possibly Related" or "Probably Related" to the study drug. The SAE definition also included urgent care visits. Systematic assessments were performed through phone call questionaires given to participants. Non-systematic assessment was performed for SAEs only at the end of the study through analysis of the electronic health records.
Gastrointestinal disorders Vomitting	2.9% 2/69 • Adverse event data was collected from Enrollment (Month 0) to the time of program completion. Participants are queued for graduation six months after enrollment or after initiating medication therapy and completing laboratory test and monitoring follow-up, whichever is later. Adverse events were only assessed for participants who started a study medication. Serious Adverse Events were only assessed if deemed "Possibly Related" or "Probably Related" to the study drug. The SAE definition also included urgent care visits. Systematic assessments were performed through phone call questionaires given to participants. Non-systematic assessment was performed for SAEs only at the end of the study through analysis of the electronic health records.	2.7% 1/37 • Adverse event data was collected from Enrollment (Month 0) to the time of program completion. Participants are queued for graduation six months after enrollment or after initiating medication therapy and completing laboratory test and monitoring follow-up, whichever is later. Adverse events were only assessed for participants who started a study medication. Serious Adverse Events were only assessed if deemed "Possibly Related" or "Probably Related" to the study drug. The SAE definition also included urgent care visits. Systematic assessments were performed through phone call questionaires given to participants. Non-systematic assessment was performed for SAEs only at the end of the study through analysis of the electronic health records.
Gastrointestinal disorders Diarrhea	4.3% 3/69 • Adverse event data was collected from Enrollment (Month 0) to the time of program completion. Participants are queued for graduation six months after enrollment or after initiating medication therapy and completing laboratory test and monitoring follow-up, whichever is later. Adverse events were only assessed for participants who started a study medication. Serious Adverse Events were only assessed if deemed "Possibly Related" or "Probably Related" to the study drug. The SAE definition also included urgent care visits. Systematic assessments were performed through phone call questionaires given to participants. Non-systematic assessment was performed for SAEs only at the end of the study through analysis of the electronic health records.	8.1% 3/37 • Adverse event data was collected from Enrollment (Month 0) to the time of program completion. Participants are queued for graduation six months after enrollment or after initiating medication therapy and completing laboratory test and monitoring follow-up, whichever is later. Adverse events were only assessed for participants who started a study medication. Serious Adverse Events were only assessed if deemed "Possibly Related" or "Probably Related" to the study drug. The SAE definition also included urgent care visits. Systematic assessments were performed through phone call questionaires given to participants. Non-systematic assessment was performed for SAEs only at the end of the study through analysis of the electronic health records.
Gastrointestinal disorders Abdominal pain	5.8% 4/69 • Adverse event data was collected from Enrollment (Month 0) to the time of program completion. Participants are queued for graduation six months after enrollment or after initiating medication therapy and completing laboratory test and monitoring follow-up, whichever is later. Adverse events were only assessed for participants who started a study medication. Serious Adverse Events were only assessed if deemed "Possibly Related" or "Probably Related" to the study drug. The SAE definition also included urgent care visits. Systematic assessments were performed through phone call questionaires given to participants. Non-systematic assessment was performed for SAEs only at the end of the study through analysis of the electronic health records.	5.4% 2/37 • Adverse event data was collected from Enrollment (Month 0) to the time of program completion. Participants are queued for graduation six months after enrollment or after initiating medication therapy and completing laboratory test and monitoring follow-up, whichever is later. Adverse events were only assessed for participants who started a study medication. Serious Adverse Events were only assessed if deemed "Possibly Related" or "Probably Related" to the study drug. The SAE definition also included urgent care visits. Systematic assessments were performed through phone call questionaires given to participants. Non-systematic assessment was performed for SAEs only at the end of the study through analysis of the electronic health records.

Additional Information

Alexander Blood, MD

Mass General Brigham

Phone: 617-732-7144

Email: ablood3@mgb.org

Results disclosure agreements

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