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Prescribing Intervention for Type 2 Diabetes

N/A

Waitlist Available

Research Sponsored by Brigham and Women's Hospital

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients must have poorly controlled diabetes (defined as HbA1c >7.5% for ages 18-69 and >8.5% for ages 70-84)

Patients must be diagnosed with type 2 diabetes

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 months

Awards & highlights

Study Summary

This trial will test if intervention to reduce diffusion of responsibility and simplify prescribing helps primary care doctors prescribe SGLT-2i or GLP-1RA more often to eligible patients with type 2 diabetes.

Who is the study for?

This trial is for adults aged 18-84 with type 2 diabetes and an HbA1c level over the set threshold, indicating poor control of their diabetes. They must have a specific need (like heart or kidney disease) for SGLT-2i or GLP-1RA therapies but haven't been prescribed these yet. Participating physicians should be from MGH primary care, not involved in the study's design, and caring for at least one eligible patient.Check my eligibility

What is being tested?

The study tests if addressing 'diffusion of responsibility' among doctors improves prescribing rates of certain diabetes medications (SGLT-2i and GLP-1RAs). It compares usual care to two interventions: one that addresses this issue alone, and another that also simplifies the prescription process.See study design

What are the potential side effects?

Since this trial focuses on physician behavior rather than direct patient treatments, it does not directly involve medication side effects. However, SGLT-2i and GLP-1RA therapies can have side effects like urinary infections or digestive issues.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My diabetes is not well-controlled, with an HbA1c above the recommended level for my age group.

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I have been diagnosed with type 2 diabetes.

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I am between 18 and 84 years old.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Rate of prescriptions for SGLT-2i or GLP-1RA among eligible patients in each arm, compared across study arms

Secondary outcome measures

Change in Hemoglobin A1c (A1c) over the 6-month intervention period among eligible patients, compared across study arms

Rate of prescriptions for SGLT-2i or GLP-1RA medications among all patients with diabetes, compared across study arms

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: Intervention to address diffusion of responsibility + simplification of prescribingExperimental Treatment1 Intervention

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.

Group II: Intervention to address diffusion of responsibilityExperimental Treatment1 Intervention

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.

Group III: Usual careActive Control1 Intervention

PCPs in this arm will receive no additional outreach or resources than standard MGH primary care practice.

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Brigham and Women's HospitalLead Sponsor

1,609 Previous Clinical Trials

11,470,136 Total Patients Enrolled

National Institute on Aging (NIA)NIH

1,669 Previous Clinical Trials

28,004,923 Total Patients Enrolled

Media Library

Intervention to address diffusion of responsibility + simplification of prescribing Clinical Trial Eligibility Overview. Trial Name: NCT05463705 — N/A

Diffusion of Responsibility Research Study Groups: Intervention to address diffusion of responsibility + simplification of prescribing, Intervention to address diffusion of responsibility, Usual care

Diffusion of Responsibility Clinical Trial 2023: Intervention to address diffusion of responsibility + simplification of prescribing Highlights & Side Effects. Trial Name: NCT05463705 — N/A

Intervention to address diffusion of responsibility + simplification of prescribing 2023 Treatment Timeline for Medical Study. Trial Name: NCT05463705 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is it still feasible to join this experiment?

"The records on clinicaltrials.gov demonstrate that this research study is not currently accepting new recruits, with the post date and update date being identical at May 4th 2023. Nonetheless, 1284 other trials are actively recruiting participants right now."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

Nancy Haff, MD, MPH 2023. "Addressing Diffusion of Responsibility and Prescribing Burden to Improve Use of Diabetes Medications". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05463705.