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ACTIVE NOT RECRUITING
NCT05169359
NA

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

Sponsor: VA Office of Research and Development

View on ClinicalTrials.gov

Summary

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 Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

512

Start Date

2022-10-01

Completion Date

2026-03-31

Last Updated

2025-07-20

Healthy Volunteers

No

Interventions

BEHAVIORAL

Speak Up! Video

Once a clinic begins active implementation (is ready to show the video) patients will view the Speak Up! Video intervention prior to their visit. The 10-minute video program will be provided to patients for viewing on an iPad (or a portable DVD player, computer or TV as appropriate to the site based on PDSA activities during implementation planning). The clinic staff will set patients up with comfortable headphones.

Locations (3)

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