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（T2D）总体上影响了几乎五分之一的VA患者，几乎一名 四名VA患者是种族和少数民族的患者。遵守药物治疗方案和生活方式因素 （例如饮食和运动）对于改善T2D的预后很重要。遵守这些因素和随后的步骤 成果的实现至少部分与医疗相遇中的有效沟通有关。 授权和激活患者与提供者使用更有效的沟通行为导致 更好地遵守治疗和更好的生物医学结果。但是，干预措施改善 在实践中尚未通过沟通来实践，这在很大程度上是由于训练有素的人员的成本 训练。这是有效的干预措施存在差距，可以改善与沟通相关的结果。在 最近，VA HSR＆D资助的试验表明了Skeak Up的效率！视频。看视频的退伍军人有 随访时，自我效率明显更高的自我效率和降低血红蛋白A1c。 意义：2型糖尿病（T2D）很常见，昂贵且慢性。估计值T2D的流行率 近20％。拟议的研究非常重要，因为所研究的条件T2D高度高 普遍存在，对T2D症状和序列的退伍军人产生负面影响。我们的目标 激活患者的沟通以实现护理目标并改善T2D的结果，对VA有反应 改善客户服务，初级保健实践和护理复杂慢性疾病的优先事项。 创新：我们让患者进行沟通进行医疗就诊的建议是创新的，因为 在VA中，解决患者的沟通与提供者的沟通形成对比是独一无二的。也是 创新性，因为激活患者有助于以患者为中心的护理和共享决策做出 VA/DOD管理指南中T2D的主要目标，并为VA对整体的承诺做出了贡献 健康模型。此外，我们的干预可能是鼓励患有其他情况使用的患者的范式 积极参与沟通。具体来说，大声疾呼的设计和通信内容！可以 作为开发具有其他条件的退伍军人激活干预措施的模型。 具体目的：我们拟议的Hybrid 2类研究具有两个具体目的：目标1。实施目标 - 与主要临床人员的合作伙伴关系制定了一项策略来交付演讲！ VA门诊初级保健中的视频 使用促进计划的诊所DO研究法（PDSA）过程。目标2。有效性目标 - 检查 大声疾呼的有效性！视频使用Re-Aim框架评估覆盖范围的视频， 改善结果的有效性（血红蛋白A1C，沟通自我效能，糖尿病困扰），采用 通过提供者和诊所，实施（完成，保真度和强度）以及在结束后维护 外部设施。假设1。患者的结局会有所改善（A1C，糖尿病困扰， 沟通自我效能感）从以前到观看视频之后。探索性假设2。患者 面临与医生交流挑战的风险更高（健康素养低的患者，非洲 - 美国患者，抑郁症患者）的预后也将有所改善。 方法论：拟议的研究是一项混合2型有效性 - 干预的实施试验 在六个诊所中使用集群随机的跨斜边设计。我们将使用 由促进卫生服务研究实施行动（PARIHS）的促进行动指导的形成性评估 框架，我们将利用覆盖范围，有效性，采用，实施和维护（RE-AIM） 框架：检查说话的有效性！视频;补充从 Parihs;并进行总结性评估以评估实施策略的成功。 实施/下一步：该提案将测试实施演讲的可行性！视频中 初级保健和如果成功将产生证据，以证明视频的宽度传播是合理的。