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

授权退伍军人在医疗就诊中积极沟通和参与共同决策，一项随机对照试验

• 批准号: 10552528
• 负责人: Howard S. Gordon
• 金额: --
• 依托单位: JESSE BROWN VA MEDICAL CENTER
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-01-01 至 2025-12-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10552528
• 关键词: Achievement; Address; Adherence; Adopted; Affect; African American; Caring; Chronic; Chronic Disease; Clinic; Clinical; Communication; Complex; Education; Effectiveness; Evaluation; Focus Groups; Funding; Glycosylated hemoglobin A; Goals; Guidelines; Health Services; Human Resources; Hybrids; Intervention; Intervention Trial; Life Style; Maintenance; Medical; Medical center; Mental Depression; Methodology; Modeling; Non-Insulin-Dependent Diabetes Mellitus; Outcome; Outpatients; Patient-Centered Care; Patients; Performance; Pharmaceutical Preparations; Phase; Physicians; Preparation; Prevalence; Primary Care; Process; Promoting Action on Research Implementation in Health Services framework; Provider; Randomized; Randomized, Controlled Trials; Reach, Effectiveness, Adoption, Implementation, and Maintenance; Recommendation; Regimen; Registered nurse; Reporting; Research; Self Efficacy; Services; Site; Symptoms; Testing; Training; Veterans; Visit; Work; active control; communication behavior; complex chronic conditions; cost; design; diabetes distress; diet and exercise; effective intervention; effectiveness evaluation; effectiveness testing; effectiveness/implementation hybrid; effectiveness/implementation trial; empowerment; ethnic minority; feasibility testing; follow-up; formative assessment; group intervention; high risk; hybrid type 2 design; implementation evaluation; implementation strategy; improved; improved outcome; innovation; lifestyle factors; low health literacy; model development; patient engagement; patient oriented; patient population; pragmatic intervention; primary care clinic; primary care practice; provider adoption; provider communication; racial minority; shared decision making; success; video delivery; whole health

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.

背景：2型糖尿病（T2 D）影响几乎五分之一的VA患者， 四名退伍军人管理局患者是少数种族和民族。药物治疗方案依从性和生活方式因素 (such如饮食和运动）对于改善T2 D的结局很重要。坚持这些因素， 结果的实现至少部分与医疗接触中的有效沟通有关。 授权和激活患者使用更有效的沟通行为与他们的供应商导致 更好地坚持治疗和更好的生物医学结果。然而，改善措施 在实践中没有采用这种方法，主要是由于训练有素的人员提供培训的费用， 训练因此，在能够改善沟通相关成果的有效干预措施方面存在差距。中 最近VA HSR&D资助的试验，我们表明了说话的功效！视频.观看视频的退伍军人 随访时，沟通自我效能显著提高，血红蛋白A1 c降低。 2型糖尿病（T2 D）是常见的，昂贵的，慢性的。据估计，T2 D的患病率 接近20%。所提出的研究是非常重要的，因为所研究的条件下，T2 D，是高度 普遍存在，并对退伍军人的症状和后遗症的T2 D的负面影响。我们的目标 激活患者的沟通，以实现护理目标，并改善T2 D的结局对VA有反应 优先改善客户服务、初级保健实践和复杂慢性病的护理。 创新：我们让患者在医疗访问中进行沟通的建议是创新的，因为 与提供者的沟通相比，解决患者的沟通在VA中是独特的。也是 创新，因为激活患者有助于以患者为中心的护理和共同决策， 这是VA/DOD T2 D管理指南中的关键目标，有助于VA对整个 健康模式。此外，我们的干预可能是一个范例，鼓励患者与其他条件使用 积极参与沟通。具体来说，《大声说出来》的设计和传播内容！可以 作为为患有其他疾病的退伍军人制定激活干预措施的模型。 具体目标：我们提出的混合2型研究有两个具体目标：目标1。实施目标-在 与主要临床工作人员合作，制定战略，以实现“大声说出来”！视频在VA门诊初级保健 使用便利的计划做研究法案（PDSA）过程的诊所。目标2.有效性目标----审查 #36825;的有效性！使用RE-AIM框架评估患者人群覆盖率的视频， 改善结局的有效性（血红蛋白A1 c、沟通自我效能、糖尿病困扰），采用 由提供者和诊所，实施（完成，保真度和强度），并在结束后的维护 外部便利化。假设1.患者的结局将得到改善（A1 c，糖尿病窘迫， 沟通自我效能）从观看视频之前到之后。探索性假设2的患者 与医生沟通困难的风险更高（健康素养低的患者，非洲人， 美国患者，抑郁症患者）的结果也会有所改善。 方法：拟议的研究是一个混合型2有效性-实施试验的干预 在六个诊所中使用群集随机化阶梯楔形设计。我们将测试我们的实施策略， 由促进卫生服务研究实施行动（PARIHS）指导的形成性评价 框架，我们将使用范围，有效性，采用，实施和维护（RE-AIM） 框架：审查的有效性，说出来！视频;补充形成性评估， 进行总结性评价，以评价执行战略的成功。 实施/后续步骤：本提案将测试实施“大声说出来”的可行性！视频 初级保健，如果成功的话，将产生证据，证明视频的广泛传播是合理的。