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

NCT05169359 | Active Not Recruiting DMC

• 1 other identifier: IIR 19-442
• Study Type: interventional
• Target: 512
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Diabetes Mellitus (Type 2)

Outcome Measures

Primary Outcomes (3)

• Change from baseline HgbA1c at 3 months post-visit

  HgbA1c is regarded as the standard laboratory measurement (blood test) for assessing the control of diabetes over approximately three months preceding the test. HgbA1c is usually checked several times a year in patients with poorly controlled diabetes.

  Collected at baseline and 3 months post-visit

• Change from pre-visit communication self-efficacy score at 1 week post visit

  Communication Self-Efficacy (pre and post visit) is the degree to which a patient feels able to interact with his/her provider in order to provide information about problems, obtain desired information about diagnosis, treatment and prognosis, and participate in formulating a plan. The Perceived Efficacy in Physician-Patient Interactions scale (PEPPI) is a valid and reliable measure of patients' perceived self-efficacy in interacting with physicians (alpha 0.83). The short form of the PEPPI (PEPPI-5) has 5-items. Score on the PEPPI-5 ranges from 5-25. Higher scores reflect a better perceived self-efficacy in interacting with physicians.

  Collected at pre-visit and 1 week post-visit

• Change from pre-visit diabetes distress score at 1 week post visit

  Diabetes Distress is a 17-item scale that measures the emotional burden of diabetes on four subscales: emotional burden, physician-related distress, regimen-related distress, and diabetes-related interpersonal distress subscale. The Diabetes Distress scale is internally consistent and is well correlated with measures of depression, meal planning, exercise, and cholesterol levels. The scale ranges from 17 to 102. Higher scores indicate higher distress.

  Collected at pre-visit and 1 week post-visit

Secondary Outcomes (11)

• Change from baseline trust in provider score at 1 week post visit

  Collected at baseline and 1 week post-visit

• Change from pre-visit patient engagement score at 1 week post visit

  Collected at pre-visit and 1 week post-visit

• Change from pre-visit medication adherence at 1 week post visit

  Collected at pre-visit and 1 week post-visit

• Change from pre-visit self-care score at 1 week post visit

  Collected at pre-visit and 1 week post-visit

• Shared decision making

  Collected 1 week post visit

Study Arms (1)

Intervention

OTHER

The study is a type 2 hybrid Effectiveness Implementation trial. The study uses a stepped wedge design. Patients are in a usual care phase until their clinic begins active implementation. Once active implementation begins, 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 other modality such as a portable DVD player, computer, or TV as appropriate to the site based on PDSA activities during implementation planning). Nurses may also send a video link to the patient via secured messaging as a method of watching the video before the primary care visit.

Behavioral: Speak Up! Video

Interventions

Speak Up! Video BEHAVIORAL

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.

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (3)

Jesse Brown VA Medical Center, Chicago, IL

Chicago, Illinois, 60612, United States

Location

Edward Hines Jr. VA Hospital, Hines, IL

Hines, Illinois, 60141-3030, United States

Location

Adam Benjamin Jr VA Outpatient Clinic, Crown Point, IN

Crown Point, Indiana, 46307, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Howard S. Gordon, MD BS

  Jesse Brown VA Medical Center, Chicago, IL

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: No masking
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SEQUENTIAL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: Stepped wedge design

Study Record Dates

• First Submitted: December 2, 2021
• First Posted: December 23, 2021
• Study Start: October 1, 2022
• Primary Completion: June 30, 2025
• Study Completion: March 31, 2026
• Last Updated: July 20, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL

Locations

US (3)