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)总体上几乎影响五分之一的VA患者和几乎三分之一的VA患者 4名退伍军人管理局患者，他们是种族和少数民族。坚持服药方案和生活方式因素 (如饮食和运动)对于改善T2D的预后很重要。坚持这些因素以及随后的 结果的实现至少在一定程度上与医疗接触中的有效沟通有关。 授权和激活患者与其提供者使用更有效的沟通行为会导致 更好地坚持治疗和更好的生物医学结果。然而，改善的干预措施 通信在实践中没有被采用，这主要是由于受过培训的人员交付 训练。因此，在能够改善与传播相关的结果的有效干预措施方面存在差距。在一个 最近VA HSR&D资助的试验我们展示了发声的功效！录像。观看视频的退伍军人 显著提高沟通的自我效能感，降低随访时的血红蛋白A1c。 意义：2型糖尿病(T2D)是常见的、昂贵的和慢性的。据估计，T2D的流行率 接近20%。这项拟议的研究具有重要意义，因为研究中的条件T2D非常重要 很普遍，对有T2D症状和后遗症的退伍军人有负面影响。我们的目标是 激活患者沟通以实现护理目标并改善T2D对VA的反应结果 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：我们提出的让患者在就诊时进行沟通的建议是创新的，因为 在退伍军人事务部，与提供者的沟通相比，解决患者的沟通是独一无二的。它也是 创新是因为激活患者有助于以患者为中心的护理和共享决策，这是 退伍军人事务部/国防部指导方针中用于T2D管理的关键目标，并有助于退伍军人事务部对整体的承诺 健康模式。此外，我们的干预可以成为鼓励其他疾病患者使用 积极的参与式沟通。具体地说，畅所欲言的设计和沟通内容！能不能 作为为患有其他疾病的退伍军人制定激活干预措施的典范。 具体目标：我们提议的混合类型2研究有两个具体目标：目标1.实施目标-- 与关键的临床工作人员建立合作伙伴关系，制定一项战略，让我们畅所欲言！退伍军人事务部门诊初级保健视频 使用促进计划做研究法案(PDSA)流程的诊所。目标2.有效性目标--检查 实效性的发声吧！使用RE-AIM框架评估患者群体覆盖范围的视频， 改善结局的有效性(血红蛋白A1c、沟通自我效能、糖尿病困扰)、收养 提供者和诊所、实施(完成、保真度和强度)以及结束后的维护 外部促进。假设1.患者的预后将有所改善(糖化血红蛋白、糖尿病痛苦、 沟通自我效能感)从观看视频前到观看后。探索性假设2.患者 与医生沟通遇到困难的风险更高(健康素养低的患者、非洲人- 美国患者、抑郁症患者)也将在结果上有所改善。 方法：建议的研究是干预措施的混合型2型有效性实施试验 在六个诊所采用整群随机阶梯楔形设计。我们将使用以下工具测试我们的实施策略 以促进卫生服务研究实施行动(PARIHS)为导向的形成性评价 框架，我们将使用REACH、有效性、采用、实施和维护(RE-AIM) 框架：检视成效，畅所欲言！视频；补充形成性评价 并进行一次总结性评价，以评价实施战略的成功。 实施/下一步：这项建议将考验实施发声的可行性！视频输入 初级保健，如果成功，将产生证据，证明视频的广泛传播是合理的。