Clinical trial NCT05169359: Empowering Veterans to Actively Communicate and Engage in Shared Decision Making in Medical Visits, A Randomized Controlled Trial
Official title: Empowering Veterans to Actively Communicate and Engage in Shared Decision Making in Medical Visits, A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Diabetes Mellitus (Type 2)
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2021-12-23
Enrollment: 512
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SEQUENTIAL
Intervention model description: Stepped wedge design
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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

Primary outcomes:
measure: Change from baseline HgbA1c at 3 months post-visit
timeFrame: Collected at baseline and 3 months post-visit
measure: Change from pre-visit communication self-efficacy score at 1 week post visit
timeFrame: Collected at pre-visit and 1 week post-visit
measure: Change from pre-visit diabetes distress score at 1 week post visit
timeFrame: Collected at pre-visit and 1 week post-visit
Secondary outcomes:
measure: Change from baseline trust in provider score at 1 week post visit
timeFrame: Collected at baseline and 1 week post-visit
measure: Change from pre-visit patient engagement score at 1 week post visit
timeFrame: Collected at pre-visit and 1 week post-visit
measure: Change from pre-visit medication adherence at 1 week post visit
timeFrame: Collected at pre-visit and 1 week post-visit
measure: Change from pre-visit self-care score at 1 week post visit
timeFrame: Collected at pre-visit and 1 week post-visit
measure: Shared decision making
timeFrame: Collected 1 week post visit
measure: Communication Ratings
timeFrame: Collected 1 week post visit
measure: Patient Centered Care
timeFrame: Collected 1 week post visit
measure: Change from pre-visit medication adherence at 3 months post visit
timeFrame: Collected at pre-visit and 3 months post visit
measure: Change from baseline functional status score at 1 week post visit
timeFrame: Collected at baseline and 1 week post visit
measure: Change from pre-visit self-management score at 1 week post visit
timeFrame: Collected at pre-visit and 1 week post visit
measure: Promis
timeFrame: Change from baseline promis score at 1 week post visit
Other outcomes:
Locations:
city: Chicago Heights
country: United States
facility: Chicago Heights VA Clinic
state: Illinois
city: Chicago
country: United States
facility: Lakeside VA Clinic
state: Illinois
city: Chicago
country: United States
facility: Jesse Brown VA Medical Center, Chicago, IL
state: Illinois
city: Hines
country: United States
facility: Edward Hines Jr. VA Hospital, Hines, IL
state: Illinois
city: Hoffman Estates
country: United States
facility: Hoffman Estates VA Clinic
state: Illinois
city: Joliet
country: United States
facility: Joliet VA Clinic
state: Illinois
city: North Aurora
country: United States
facility: Aurora VA Clinic
state: Illinois
city: Crown Point
country: United States
facility: Adam Benjamin Jr VA Outpatient Clinic, Crown Point, IN
state: Indiana
Study officials:
affiliation: Jesse Brown VA Medical Center, Chicago, IL
name: Howard S. Gordon, MD BS
role: PRINCIPAL_INVESTIGATOR
References: