A Multicenter Trial of a Shared DECision Support Intervention for Patients offered implantable Cardioverter-DEfibrillators: DECIDE - ICD Trial

对提供植入式心脏复律除颤器的患者进行共同决策支持干预的多中心试验：DECIDE - ICD 试验

• 批准号: 9484150
• 负责人: Daniel D Matlock
• 金额: $ 75.69万
• 依托单位: UNIVERSITY OF COLORADO DENVER
• 依托单位国家: 美国
• 财政年份: 2017
• 资助国家: 美国
• 起止时间: 2017-05-15 至 2022-02-28
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9484150
• 关键词: Address; Adoption; Affordable Care Act; Anxiety; Attitude; Cessation of life; Clinical; Complex; Conflict (Psychology); Counseling; Data; Decision Aid; Decision Making; Devices; Documentation; Effectiveness; Electrophysiology (science); Equipment Malfunction; Evaluation; Family; Goals; Guidelines; Healthcare; Heart failure; Hybrids; Implantable Defibrillators; Intervention; Knowledge; Left; Maintenance; Malignant neoplasm of lung; Measures; Medical Care Team; Medicare; Mental Depression; Methods; Modeling; Multicenter Trials; Multimedia; Nature; Outcome; Patients; Perception; Policies; Politics; Post-Traumatic Stress Disorders; Prevention; Primary Health Care; Primary Prevention; Process; Quality of life; Reproducibility; Research; Research Infrastructure; Risk; Risk Reduction; Science; Shock; Site; Sleep; Sudden Death; Variant; Work; auricular appendage; base; cost; design; efficacy trial; end of life; experience; high risk; implementation strategy; improved; individual patient; mortality; patient-clinician communication; prevent; psychosocial; randomized trial; response; shared decision making; surrogate decision maker; theories; virtual

Project Summary/Abstract Shared decision making (SDM) is growing in clinical and political importance. Based on a large Cochrane review, the science supporting the assertion that patient decision aids (PtDAs) result in SDM and improve decision outcomes is strong. However, the benefits of real-world use of PtDAs remains unrealized as PtDAs are largely unused in routine health care. Previous attempts at real-world implementation of PtDAs have been characterized by a focus on low-risk decisions in primary care. The problem with this approach is that, since the stakes are so low, busy clinicians perceive PtDAs to be of little value, undermining their implementation. This team's overall goal is to assess real-world effectiveness (Aim 1) and implementation (Aim 2) of patient decision aids (PtDA) for high-risk decisions using the implantable cardioverter-defibrillator (ICD) as a model. ICDs are ideal to study because they are common and involve complex trade-offs. While they can prolong lives, they do not improve quality of life (QOL) and come with a host of risks including device failure, inappropriate shocks, shocks (and subsequent suffering) at the end of life, anxiety, depression, and post- traumatic stress disorder. While most patients see prevention of sudden death as desirable, they also prefer to die peacefully in their sleep (which the ICD would try to prevent). In recognition of the personal nature of ICDs, professional guidelines now recommend SDM for eligible patients. This proposal addresses two big problems: 1) a lack of effectiveness data for PtDAs in real world settings, as efficacy trials comprise virtually all of the data supporting PtDAs; and 2) the optimal implementation strategy for PtDAs is unknown. This team has developed a reproducible, sustainable, low-cost strategy to facilitate implementation across diverse clinical settings. This application proposes the DECIDE-ICD trial: a type II effectiveness implementation hybrid trial of three ICD PtDAs. The DECIDE-ICD trial is a 6-site stepped-wedge randomized trial, with implementation guided by normalization process theory and a mixed methods evaluation guided by the RE-AIM framework. The study team has the relationships, infrastructure, and transdisciplinary expertise to execute this project. By simultaneously exploring effectiveness and implementation, this project will provide pragmatic information that will inform a growing national agenda to better involve patients in their health care via SDM.

项目摘要/摘要 共享决策(SDM)在临床和政治上的重要性越来越大。基于一只大型Cochrane 回顾，支持患者决策辅助(PtDA)导致SDM和改善的断言的科学 决策结果是强有力的。然而，在现实世界中使用PtDA的好处仍然没有实现为PtDA 很大程度上没有在常规医疗保健中使用。之前在真实世界中实施PtDA的尝试已经 其特点是注重初级保健中的低风险决定。这种方法的问题是，由于 赌注如此之低，忙碌的临床医生认为PTDA几乎没有价值，破坏了它们的实施。 该团队的总体目标是评估患者的实际有效性(目标1)和实施情况(目标2 以植入式心律转复除颤器(ICD)为模型的高风险决策辅助工具(PtDA)。 ICD是理想的研究对象，因为它们很常见，涉及复杂的权衡。虽然他们可以延长 生活，它们没有提高生活质量(QOL)，而且伴随着包括设备故障在内的一系列风险， 生命末期不适当的电击、电击(和随后的痛苦)、焦虑、抑郁和后 创伤性应激障碍。虽然大多数患者认为预防猝死是可取的，但他们也更喜欢 在睡梦中平静地死去(ICD将试图阻止)。认识到ICD的个人性质， 专业指南现在向符合条件的患者推荐SDM。这项建议解决了两大问题： 1)缺乏真实世界环境中PtDA的有效性数据，因为有效性试验几乎包括所有 数据支持PtDAS；以及2)PtDAS的最佳实施策略未知。这支球队有 制定了可重复、可持续、低成本的战略，以促进在不同临床领域的实施 设置。本申请提出了Decision-ICD试验：一种II型有效性实施的混合试验 三个ICD PtDA。Decision-ICD试验是一项6个站点的阶梯式楔形随机试验， 以标准化过程理论为指导，以RE-AIM框架为指导，采用混合方法进行评价。 研究团队拥有执行该项目所需的关系、基础设施和跨学科专业知识。通过 同时探索有效性和实施，该项目将提供务实的信息， 将为越来越多的国家议程提供信息，通过SDM更好地让患者参与他们的医疗保健。