Development of a Veteran-Centered Approach to ICD Decision-making in the VA

背景：与退伍军人管理局战略计划和卓越蓝图1保持一致，确保退伍军人- 以价值为中心、协调一致的护理(退伍军人接受反映其目标和 治疗偏好)，通过知情、共享的决策。这一点对于以下方面尤其重要 ICDS(植入式心脏转复除颤器)-永久性的、通过手术植入的心脏装置 用电击监测和治疗危及生命的心律失常。ICD呈现了一个复杂的平衡 患者福利(即危险心律的检测和治疗)、程序风险、长期 维护(即电池和铅监测)和对心理健康的影响(即。更高水平的 ICD电击导致的创伤后应激障碍、焦虑和抑郁)。2，3 意义/影响：鉴于退伍军人4、5心力衰竭发生率高，全美ICD植入率 在过去的十年中，VA急剧上升，平均每次手术植入超过25,000个ICD 费用为64,5006美元。然而，这种增长可能并不意味着消息灵通、价值观一致的关怀。 大量先前的研究表明，患者对风险、益处、心理影响和 与ICD植入相关的并发症-经常留下错误的印象，如ICD是治疗 心脏衰竭，不需要维护，不会导致不适当的电击。之前的数据也证明了 供应商过度强调ICD的好处，患者明显高估了好处。 2018年，CMS在ICD植入前强制使用和记录共享决定。很可能是一个 低估了，目前退伍军人制度中约有135 000名符合ICD资格的退伍军人。 创新：在全国和VHA内部，这种分歧导致了对决策支持工具的呼吁，以帮助 患者在做出明智的、个性化的决定时，特别是对于具有复杂风险的侵入性治疗- 8创新方面包括：(1)显著改进的综合工具 为支持ICD通信，(2)设计用于在退伍军人管理局临床护理中的常规实施，(3)研究 工具从非退伍军人环境向退伍军人环境的过渡，(4)处理高风险决策(国家授权通过 用于SDM工具的CMS)和(5)与现有退伍军人管理局质量改进基础设施(CART-EP)的集成。 具体目标：这项提议的中心假设是，目前的ICD决策过程是 多种多样，缺乏足够的老手视角。我们将通过以下方式解决这一问题： 目的1：确定围绕ICD决策的退伍军人和退伍军人的特定因素。 目标2：开发由退伍军人协会主导的工具，以满足退伍军人在退伍军人管理局内的日常使用需求。 目标3：对新开发的用于支持ICD通信的工具进行可行性测试。 方法：本项目将面向符合以下条件的退伍军人：(1)符合ICD资格，(2)在原地有ICD，或(3)有 拒绝ICD治疗和退伍军人护理提供者。在目标1中，半结构化面对面 访谈将以归纳-演绎的形式进行定性数据分析。输出将直接 告知目标2-开发工具以个性化、增强和支持资深提供商ICD 退伍军人事务部内部的通信。AIM 3将使用RE-AIM框架在4个不同的退伍军人管理局站点中测试该工具。 实施和后续步骤：在完成本CDA后，这些工具将准备好立即进行测试 通过一个IIR项目(IIR#2)，寻求在多个VA下，对照护理标准来评估这一工具 网站。桑杜博士正在领导CART-EP的开发，这是一个由退伍军人管理局资助的项目，扩大了CART的使用范围 (侵入性心血管手术的质量体系)到ICD。我们将结合使用此ICD SDM工具 作为在VA内植入ICD之前进入CART-EP的质量测量。Cart-EP将作为一种方法 研究这一工具在全国范围内的大规模传播和实施(即。阶梯式效率-- 在退伍军人管理局临床实践的广泛代表性中进行实施试验)。

Background: Aligned with the VA Strategic Plan and Blueprint for Excellence1, it is critical to ensure Veteran- centered, values-concordant care (extent to which Veterans receive therapies that reflect their goals and treatment preferences) through informed, shared decision-making. This is especially important with regards to ICDs (implantable cardioverter-defibrillators) - permanent, surgically implanted cardiac devices with intent to monitor and treat life-threatening heart rhythms with an electrical shock. ICDs present a complicated balance of patient benefit (ie. detection and treatment of dangerous heart rhythms), procedural risk, long-term maintenance (ie. battery and lead monitoring) and impact on psychological health (ie. heightened levels of PTSD, anxiety and depression from ICD shocks).2,3 Significance / Impact: Given high rates of heart failure among Veterans4,5, ICD implantation rates across the VA have risen sharply over the past decade with over 25,000 ICDs implanted at an average per-procedure cost of $64,5006. However, this rise may not be indicative of well-informed, values-concordant care. Numerous prior studies show patients poorly comprehend risks, benefits, psychological effects and complications associated with ICD implantation - often left with false impressions such as ICD is a “cure” for heart failure, requires no maintenance, and does not lead to inappropriate shocks. Prior data also demonstrate that providers overemphasize the benefit of ICDs and patients markedly overestimate benefit.7 In February 2018, CMS mandated use and documentation of shared decision prior to ICD implantation. Likely an underestimation, currently there are approximately 135,000 ICD-eligible Veterans in the VA system. Innovation: Nationally and within the VHA, this discord has led to a call for decision-support tools to aid patients in making informed, personalized decisions, particularly for invasive therapies with complex risk- benefit tradeoffs such as ICDs.8 Innovative aspects include: (1) a significantly improved, comprehensive tool to support ICD communications, (2) designed for routine implementation within VA clinical care, (3) study of transition of tools from a non-VA to VA setting, (4) addressing a high-stakes decision (national mandate by CMS for SDM tools) and (5) integration into existing VA quality-improvement infrastructure (CART-EP). Specific Aims: The central hypothesis of this proposal is that current ICD decision-making processes are heterogeneous and lack sufficient Veteran perspective. We will address this through: Aim 1: Determine Veteran and VA-provider specific factors surrounding ICD decision-making. Aim 2: Develop an VA-provider led tool that meets Veteran needs for routine use within the VA. Aim 3: Feasibility testing of the newly developed tools designed to support ICD communications. Methodology: This project will target Veterans that are (1) ICD-eligible, (2) have ICDs in situ or (3) have refused ICD therapy and VA-providers who care for such Veterans. In Aim 1, semi-structured face-to-face interviews will be conducted with qualitative data analyzed in an inductive-deductive format. Output will directly inform Aim 2 – development of tools to personalize, enhance and support Veteran-provider ICD communications within the VA. Aim 3 will test the tool using the RE-AIM framework among 4 diverse VA sites. Implementation and Next Steps: At the completion of this CDA, the tools will be ready for immediate testing through an IIR project (IIR #2) seeking to evaluate this tool, in comparison to standard of care, at multiple VA- sites. Dr. Sandhu is leading the development of CART-EP, a VA-funded project extending use of CART (quality system for invasive cardiovascular procedures) to ICDs. We will incorporate use of this ICD SDM tool as a quality measure into CART-EP prior to ICD implantation within the VA. CART-EP will serve as a method to study large-scale dissemination and implementation of this tool nationally (ie. step-wedge effectiveness- implementation trial among a broad representation of VA clinical practices).