Empowering Veterans to Actively Communicate and Engage in Shared Decision Making in Medical Visits, A randomized controlled trial

背景：2型糖尿病（T2D）影响了几乎五分之一的VA患者，几乎每五名VA患者中就有一名

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 we 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 sequalae of T2D. Our 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: Our 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, our 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: Our 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 six clinics. We will test our implementation strategies using a formative evaluation guided by the Promoting Action on Research Implementation in Health Services (PARIHS) framework, and we 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.