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

Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05463705
• Other study ID #: 2022P001663
• Secondary ID: 5P30AG064199-02
• Status: Active, not recruiting
• Phase: N/A
• Start date: May 4, 2023
• Est. completion date: May 31, 2024

Study information

• Verified date: April 2024
• Source: Brigham and Women's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 191
• Est. completion date: May 31, 2024
• Est. primary completion date: November 22, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Diabetes
• Diabetes Mellitus

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Brigham and Women's Hospital	National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of prescriptions for SGLT-2i or GLP-1RA among eligible patients in each arm, compared across study arms	The study team will use electronic health record (EHR) prescribing data to identify prescriptions for SGLT-2i and GLP-1RA medications during the 6 month study intervention period among eligible patients. Rates of prescribing of these medications will be compared across study arms.	6 months
Secondary	Rate of prescriptions for SGLT-2i or GLP-1RA medications among all patients with diabetes, compared across study arms	The study team will use EHR prescribing data to identify prescriptions for SGLT-2i and GLP-1RA medications during the 6 month study intervention period among all patients with diabetes cared for by study PCPs. Rates of prescribing of these medications will be compared across study arms.	6 months
Secondary	Change in Hemoglobin A1c (A1c) over the 6-month intervention period among eligible patients, compared across study arms	The study team will use EHR data to calculate a change in A1c among eligible patients. The baseline A1c will be the last A1c measured within the 6-months prior to intervention start, and the follow-up A1c will be the last A1c measured in the 6-month intervention period. This change in A1c will be compared across study arms.	6 months