Addressing Diffusion of Responsibility and Prescribing Burden to Improve Use of Diabetes Medications

This study will test the impact of addressing diffusion of responsibility with and without additional reduction of prescribing burden on SGLT-2i and GLP-1RAs prescribing compared to usual care.

Population: MGH primary care physicians caring for at least 2 eligible patients. Eligible patients are individuals age18 years or older with type 2 diabetes and HbA1c >7.5% and a compelling indication for an SGLT-2i or GLP-1RA (including cardiovascular disease, kidney disease, heart failure, or obesity), who are not already prescribed one of these therapies.

Intervention: PCPs will be randomized to one of three arms: 1) intervention to address diffusion of responsibility, 2) Intervention to address diffusion of responsibility with additional simplification of prescribing, 3) usual care.

Study Overview

• Status: Completed
• Conditions: Diabetes; SGLT-2i and GLP-1RA Therapies; Diffusion of Responsibility; Prescribing Burden
• Intervention / Treatment: Behavioral: Intervention to address diffusion of responsibility; Behavioral: Intervention to address diffusion of responsibility + simplification of prescribing

Detailed Description

This study will be conducted within MGH primary care. As with prior work, the investigators will use the hospital's EHR database, the Epic Enterprise Data Warehouse, to identify patients. Patients will be eligible if they are: adults 18-84 years of age with poorly controlled type 2 diabetes (defined as HbA1c >7.5% for ages 18-69 and >8.5% for ages 70-84) and a compelling indication for an SGLT-2i or GLP-1RA (including cardiovascular disease, kidney disease, heart failure, or obesity), who are not already prescribed one of these therapies. The investigators will exclude individuals with end stage renal disease, dementia, type I diabetes, or an EHR indicator of hospice care. The investigators will also exclude patients who are not on the MGH diabetes registry, because patients who are excluded from the registry typically have a clinical reason for alternative diabetes goals or care plans. PCPs caring for at least one eligible patient will be included in the trial. Eligible PCPs will be randomized to one of three arms: (1) intervention to address diffusion of responsibility, (2) intervention to address diffusion of responsibility plus additional simplification of the prescribing process, and (3) usual care. Providers randomized to arm 1, the intervention to address diffusion of responsibility will receive an email from a peer offering encouragement and support in prescribing SGLT-2is and GLP-1RAs that includes specific components designed to reduce diffusion of responsibility. The email will also contain a link to clinical and administrative information to support prescribing and an offer for direct support from the peer. Providers randomized to arm 2, the intervention addressing diffusion of responsibility and simplifying the prescribing process will receive the same contact addressing diffusion of responsibility as in arm 1, but they will additionally have access to an experienced administrative team for diabetes medication insurance authorization support. The primary outcome will be the rate of prescriptions for SGLT-2is and GLP-1RAs among eligible patients.

• Study Type: Interventional
• Enrollment (Actual): 1580
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02120
      • Massachusetts General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

Patients:

We will use EHR data to identify patients

• 18-84 years of age
• Diagnosed with type 2 diabetes
• Has poorly controlled diabetes (defined as HbA1c >7.5% for ages 18-69 and >8.5% for ages 70-84)
• Have a compelling indication for an SGLT-2i or GLP-1RA who are not already prescribed one of these therapies. A compelling indication includes individuals with cardiovascular disease, kidney disease, heart failure, or obesity.

Physicians:

Physicians will be included if they are

• Practicing in primary care at Massachusetts General Hospital
• Caring for at least 1 patient: (1) age 18-84, (2) diagnosed with type 2 diabetes, (3) has poorly controlled diabetes (defined as HbA1c >7.5% for ages 18-69 and >8.5% for ages 70-84) (4) has a compelling indication for an SGLT-2i or GLP-1RA (including cardiovascular disease, kidney disease, heart failure, or obesity), who are not already prescribed one of these therapies.

Exclusion Criteria:

Patients:

• We will exclude individuals with end stage renal disease, dementia, type I diabetes, or an EHR indicator of hospice care.
• We will also exclude patients who are not on the MGH diabetes registry, because patients who are excluded from the registry typically have a clinical reason for alternative diabetes goals or care plans.

Physicians:

- Providers will be excluded if they are involved in the design or conduct of this study (e.g. Drs. Haff and Horn, and the peer PCPs delivering the study intervention).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention to address diffusion of responsibility; PCPs will receive an email from a peer offering encouragement and support in prescribing SGLT-2is and GLP-1RAs that includes specific components designed to reduce diffusion of responsibility. Specifically, these elements will be adapted from interventions that mitigate diffusion of responsibility in other contexts, including: (1) assigning responsibility to individuals or smaller groups, (2) increased perceived harm of the situation to be addressed (3) highlighting competence to act, and (4) modeling the desired behavior. The email will also contain a link to clinical and administrative information to support prescribing and an offer for direct support from the peer.	Behavioral: Intervention to address diffusion of responsibility; PCPs will receive an email from a peer offering encouragement and support in prescribing SGLT-2is and GLP-1RAs that includes specific components designed to reduce diffusion of responsibility. Specifically, these elements will be adapted from interventions that mitigate diffusion of responsibility in other contexts, including: (1) assigning responsibility to individuals or smaller groups, (2) increased perceived harm of the situation to be addressed (3) highlighting competence to act, and (4) modeling the desired behavior. The email will also contain a link to clinical and administrative information to support prescribing and an offer for direct support from the peer.
Experimental: Intervention to address diffusion of responsibility + simplification of prescribing; PCPs will receive the same contact addressing diffusion of responsibility as in the "Intervention to address diffusion of responsibility" arm, but will additionally have access to an experienced administrative team for diabetes medication insurance authorization support, by "routing" their clinic note through the EHR. PCPs will be informed, suing the same email outreach, how to access the administrative team, which consists of medical and administrative assistants and currently supports prescribing within the endocrinology division. The team will follow up with the pharmacy to determine coverage, complete prior authorizations, determine alternate covered options, and track progress.	Behavioral: Intervention to address diffusion of responsibility + simplification of prescribing; PCPs will receive the same contact addressing diffusion of responsibility as in the "Intervention to address diffusion of responsibility" arm, but will additionally have access to an experienced administrative team for diabetes medication insurance authorization support, by "routing" their clinic note through the EHR. PCPs will be informed, suing the same email outreach, how to access the administrative team, which consists of medical and administrative assistants and currently supports prescribing within the endocrinology division. The team will follow up with the pharmacy to determine coverage, complete prior authorizations, determine alternate covered options, and track progress.
No Intervention: Usual care; PCPs in this arm will receive no additional outreach or resources than standard MGH primary care practice.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Prescriptions for SGLT-2i or GLP-1RA Medications Among Eligible Patients in Each Arm	Electronic health record (EHR) prescribing data was used to identify the number of patients with prescriptions for SGLT-2i and GLP-1RA medications beginning 3 business days before the targeted patient visit and continuing through 28 days after the visit. The primary outcome only includes patients who attended the targeted visit.	Beginning 3 days before the targeted visit and continuing through 28 days after the visit

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Prescriptions for SGLT-2i or GLP-1RA Medications Among All Study-eligible Patients, Compared Across Study Arms	Electronic health record (EHR) prescribing data was used to identify patients with prescriptions for SGLT-2i and GLP-1RA medications beginning 3 business days before the targeted patient visit and continuing through 28 days after the visit. This outcome includes all study-eligible patients, regardless of whether they attended the targeted visit.	Beginning 3 days before the targeted visit and continuing through 28 days after the visit
Change in Hemoglobin A1c (A1c) Over 6 Months, Compared Across Study Arms	EHR data was used to identify Hemoglobin A1c values. The baseline A1c was the last A1c measured within the 6-months prior to the targeted visit, and the follow-up A1c was the A1c measured between 3 and 9 months after the targeted visit and closest to 6 months after the targeted visit. The change in A1c was calculated and compared across study arms. This analysis includes all patients who had an A1c in follow-up.	6 months

Collaborators and Investigators

• Sponsor: Brigham and Women's Hospital
• Collaborators: National Institute on Aging (NIA)

Study record dates

Study Major Dates

• Study Start (Actual): May 4, 2023
• Primary Completion (Actual): November 22, 2023
• Study Completion (Actual): August 22, 2024

Study Registration Dates

• First Submitted: July 7, 2022
• First Submitted That Met QC Criteria: July 14, 2022
• First Posted (Actual): July 19, 2022

Study Record Updates

• Last Update Posted (Estimated): November 19, 2024
• Last Update Submitted That Met QC Criteria: October 25, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endocrine System Diseases; Metabolic Diseases; Glucose Metabolism Disorders; Diabetes Mellitus
• Other Study ID Numbers: 2022P001663; 5P30AG064199-02 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No