Addressing Diffusion of Responsibility and Prescribing Burden to Improve Use of Diabetes Medications
NCT ID: NCT05463705
Last Updated: 2024-11-19
Study Results
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View full resultsBasic Information
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COMPLETED
NA
1580 participants
INTERVENTIONAL
2023-05-04
2024-08-22
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
HEALTH_SERVICES_RESEARCH
SINGLE
Study Groups
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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
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.
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.
Usual care
PCPs in this arm will receive no additional outreach or resources than standard MGH primary care practice.
No interventions assigned to this group
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
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
* 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).
18 Years
ALL
No
Sponsors
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National Institute on Aging (NIA)
NIH
Brigham and Women's Hospital
OTHER
Responsible Party
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Nancy Haff, MD, MPH
Associate Epidemiologist, Division of Pharmacoepidemiology
Locations
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Massachusetts General Hospital
Boston, Massachusetts, United States
Countries
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References
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Haff N, Horn DM, Bhatkhande G, Sung M, Colling C, Wood W, Robertson T, Gaposchkin D, Simmons L, Yang J, Yeh J, Crum KL, Hanken KE, Lauffenburger JC, Choudhry NK. Encouraging the prescribing of SGLT2i and GLP-1RA medications to reduce cardiovascular and renal risk in patients with type 2 diabetes: Rationale and design of a randomized controlled trial. Am Heart J. 2025 Jul;285:39-51. doi: 10.1016/j.ahj.2025.02.007. Epub 2025 Feb 20.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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2022P001663
Identifier Type: -
Identifier Source: org_study_id
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