Empowering Veterans to Actively Communicate and Engage in Shared Decision Making in Medical Visits, A Randomized Controlled Trial

Running, not enrolling · Not applicable

Conditions studied: Diabetes Mellitus (Type 2)

In brief

Type 2 diabetes is a significant condition in VA affecting 20% of VA patients. Adherence to medication regimens and lifestyle factors is important to achieve care goals for these patients. Patients who use active participatory communication behaviors with their providers have better adherence to treatment and better biomedical outcomes, yet many patients are not prepared to engage in active communication with their providers. Existing coaching interventions have not been adopted in practice because of the cost of trained personnel. The investigators have shown the efficacy of a low-cost video that did not require trained personnel. This proposal proposes to test implementation strategies to deliver that video in VA primary care clinics and to test the effectiveness of the video to improve outcomes in a Hybrid Type 2 effectiveness-implementation trial using a cluster randomized stepped wedge design at eight sites. This proposal will test feasibility of implementing the video and if successful will generate the evidence to justify widespread dissemination of the video.

Key facts

Study ID

NCT05169359

Run by

VA Office of Research and Development

People needed

512

Starts

2022-10-01

Expected to finish

2026-03-31

Last updated by the study team

2025-07-20

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Dx of T2D
• Hemoglobin A1c ("A1c") 7 or greater
• Adults, age 18 or older
• Visit at a participating site
• Receives care from primary care provider more than once a year at VA

You may not qualify if…

• Lives in skilled nursing facility
• Dementia (abnormal SBT)63
• Creatinine >3 (or eGFR<20), recent MI or admission for HF
• Terminal medical condition
• Drug- (e.g., steroid) induced diabetes.
• Blind or deaf (e.g., unable to view/hear video

Where it is running

• Jesse Brown VA Medical Center, Chicago, IL — Chicago, Illinois, United States
• Edward Hines Jr. VA Hospital, Hines, IL — Hines, Illinois, United States
• Adam Benjamin Jr VA Outpatient Clinic, Crown Point, IN — Crown Point, Indiana, United States

Full record on ClinicalTrials.gov

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