N/A
N=1,580
Addressing Diffusion of Responsibility and Prescribing Burden to Improve Use of Diabetes Medications
Diabetes · SGLT-2i and GLP-1RA Therapies · Diffusion of Responsibility · Prescribing Burden
Bottom Line
View on ClinicalTrials.gov: NCT05463705 ↗Enrolled (actual)
1,580
Serious AEs
0.0%
Results posted
Nov 2024
Primary outcome: Primary: Number of Participants With Prescriptions for SGLT-2i or GLP-1RA Medications Among Eligible Patients in Each Arm — 109; 92; 92 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Intervention to address diffusion of responsibility (Behavioral); Intervention to address diffusion of responsibility + simplification of prescribing (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Brigham and Women's Hospital
- Primary completion
- Nov 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Prescriptions for SGLT-2i or GLP-1RA Medications Among Eligible Patients in Each Arm |
109; 92; 92 | — |
| SECONDARY Number of Participants With Prescriptions for SGLT-2i or GLP-1RA Medications Among All Study-eligible Patients, Compared Across Study Arms |
134; 110; 117 | — |
| SECONDARY Change in Hemoglobin A1c (A1c) Over 6 Months, Compared Across Study Arms |
-0.51; -0.51; -0.58 | — |
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.
Eligibility Criteria
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).
Data sourced from ClinicalTrials.gov (NCT05463705). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.