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

NCT ID: NCT05169359

Last Updated: 2025-07-20

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 512 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-10-01
• Study Completion Date: 2026-03-31

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.

Detailed Description

Background: Type 2 diabetes mellitus (T2D) affects almost one in five VA patients overall and almost one in four VA patients who are racial and ethnic minorities. Adherence to medication regimens and lifestyle factors (such as diet and exercise) is important to improve outcomes in T2D. Adherence to these factors and subsequent achievement of outcomes is related, at least in part, to effective communication in medical encounters. Empowering and activating patients to use more effective communication behaviors with their providers leads to better adherence to treatment and better biomedical outcomes. However, interventions to improve communication have not been adopted in practice largely due to the cost of trained personnel to deliver the training. Thus, there is a gap in effective interventions that can improve communication related outcomes. In a recent VA HSR&D funded trial the investigators showed efficacy of the Speak Up! video. Veterans watching the video had significantly higher self-efficacy to communicate and lower hemoglobin A1c at follow-up.

Significance: Type 2 diabetes (T2D) is common, expensive, and chronic. Estimates put the prevalence of T2D at almost 20 percent. The proposed study is highly significant because the condition under study, T2D, is highly prevalent and has negative impacts for Veterans with the symptoms and sequelae of T2D. The objective to activate patients' communication to achieve goals of care and to improve outcomes of T2D is responsive to VA priorities to improve customer service, primary care practice, and care of complex chronic diseases.

Innovation: The proposal to engage patients in communication in medical visits is innovative because addressing patients' communication as contrasted with providers' communication is unique in the VA. It is also innovative because activating patients facilitates patient-centered care and shared decision making which are key goals in the VA/DOD guideline for the management of T2D and contributes to VA's commitment to the Whole Health model. Also, the intervention could be a paradigm for encouraging patients with other conditions to use active participatory communication. Specifically, the design and communication content of Speak Up! Could serve as a model for the development of activation interventions for Veterans with other conditions.

Specific Aims: The proposed Hybrid Type 2 study has two specific aims:

Aim 1. Implementation aim - In partnership with key clinical staff develop a strategy to deliver the Speak Up! video in VA outpatient primary care clinics using a facilitated Plan Do Study Act (PDSA) process.

Aim 2. Effectiveness aim - Examine the effectiveness of the Speak Up! video using the RE-AIM framework to evaluate Reach into the patient population, Effectiveness to improve outcomes (Hemoglobin A1c, communication self-efficacy, diabetes distress), Adoption by providers and clinics, Implementation (completion, fidelity, and intensity), and Maintenance after the end of external facilitation.

Hypothesis 1. Patients will have improvements in outcomes (A1c, diabetes distress, communication self-efficacy) from before to after watching the video.

Exploratory Hypothesis 2. Patients that are at higher risk of having challenges communicating with physicians (patients with low health literacy, African-American patients, patients with depression) will also have improvements in outcomes.

Methodology: The proposed study is a Hybrid Type 2 effectiveness - implementation trial of the intervention using a cluster-randomized stepped-wedge design in eight clinics. The investigators will test the implementation strategies using a formative evaluation guided by the Promoting Action on Research Implementation in Health Services (PARIHS) framework, and the investigators will use the Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) framework: to examine effectiveness of the Speak Up! Video; to supplement the formative evaluation from PARIHS; and to conduct a summative evaluation to evaluate success of the implementation strategies.

Implementation/Next Steps: This proposal will test the feasibility of implementing the Speak Up! video in primary care and if successful will generate the evidence to justify widespread dissemination of the video.

Conditions

Diabetes Mellitus (Type 2)

Study Design

• Allocation Method: NA
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Intervention

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.

Group Type: OTHER

Speak Up! Video

Intervention Type: 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.

Interventions

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

VA Office of Research and Development

FED

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Howard S. Gordon, MD BS

Role: PRINCIPAL_INVESTIGATOR

Jesse Brown VA Medical Center, Chicago, IL

Locations

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

Countries

United States

Provided Documents

Document Type: Informed Consent Form

View Document

Other Identifiers

IIR 19-442

Identifier Type: -

Identifier Source: org_study_id