Ignite Creation Date:
2025-12-25 @ 3:33 AM
Ignite Modification Date:
2026-01-10 @ 1:05 AM
Study NCT ID:
NCT05463705
Status:
COMPLETED
Last Update Posted:
2024-11-19
First Post:
2022-07-07
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Addressing Diffusion of Responsibility and Prescribing Burden to Improve Use of Diabetes Medications
Sponsor:
Brigham and Women's Hospital
Organization:
Study Overview
Official Title:
Addressing Diffusion of Responsibility and Prescribing Burden to Improve Use of Diabetes Medications
Status:
COMPLETED
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
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.
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 5P30AG064199-02 | NIH | None | https://reporter.nih.gov/quic… | View |