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

项目总结/摘要 共享决策（SDM）在临床和政治上的重要性越来越大。基于大型科克伦 回顾，科学支持的断言，病人决策辅助（PtDA）的结果SDM和改善 决策结果很强。然而，PtDA在现实世界中的使用的好处仍然没有实现， 在日常医疗中大部分未使用。以前在PtDA的实际实现方面的尝试已经失败。 其特点是侧重于初级保健中的低风险决策。这种方法的问题在于，由于 风险太低，忙碌的临床医生认为PtDA没有什么价值，从而破坏了它们的实施。 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（目标2）。 使用植入式心律转复除颤器（ICD）作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 生命，它们不能改善生活质量（QOL），并伴随着一系列风险，包括设备故障， 不适当的冲击，生命结束时的冲击（和随后的痛苦），焦虑，抑郁，以及 创伤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，他们的心渐渐平静下来。考虑到ICD的个人性质， 专业指南现在推荐SDM用于符合条件的患者。这一提议解决了两大问题： 1)缺乏PtDA在真实的世界环境中的有效性数据，因为有效性试验几乎包括所有 支持PtDA的数据;以及2）PtDA的最佳实施策略未知。这支球队有 开发了一种可重复的、可持续的、低成本的策略，以促进在各种临床应用中的实施。 设置.本申请提出了DECIDE-ICD试验：一项II型有效性实施混合试验， 三个ICD PtDA。DECIDE-ICD试验是一项6中心阶梯楔形随机试验， 以规范化过程理论为指导，以RE-AIM框架为指导的混合方法评估。 研究团队拥有执行该项目的关系，基础设施和跨学科专业知识。通过 该项目将在探索有效性和实施的同时，提供实用信息， 将通过SDM为不断增长的国家议程提供信息，以更好地让患者参与医疗保健。

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.