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

退伍军人事务部制定以退伍军人为中心的 ICD 决策方法

• 批准号: 10315819
• 负责人: Amneet Sandhu
• 金额: --
• 依托单位: VA EASTERN COLORADO HEALTH CARE SYSTEM
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-07-01 至 2026-06-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10315819
• 关键词: Address; Anxiety; Arrhythmia; Benefits and Risks; Cardiovascular system; Caring; Chronic Disease; Clinical; Communication; Communication Methods; Complement; Complex; Conflict (Psychology); Dangerousness; Data; Data Analyses; Decision Aid; Decision Making; Detection; Development; Devices; Dissemination and Implementation; Documentation; Ensure; Equilibrium; Feedback; Funding; Future; Goals; Health; Health Services; Heart Rate; Heart failure; Implant; Implantable Defibrillators; Implantation procedure; In Situ; Individual; Infection; Infrastructure; Intervention; Interview; Knowledge; Lead; Left; Life; Maintenance; Measures; Mental Depression; Mental Health; Methodology; Methods; Modeling; Monitor; Operative Surgical Procedures; Outcome; Output; Pamphlets; Paper; Paternalism; Patients; Post-Traumatic Stress Disorders; Procedures; Process; Provider; Reach Effectiveness Adoption Implementation and Maintenance; Regrets; Research; Research Personnel; Risk; Shock; Site; Special Population; Strategic Planning; Structure; System; Testing; Texas; Travel; Variant; Veterans; Work; auricular appendage; base; blood pressure control; cardiac device; cardiac implant; career; clinical care; clinical practice; comorbidity; compliance behavior; design; diabetic; effectiveness implementation trial; evidence base; expectation; feasibility testing; follow-up; heart rhythm; implantation; implementation tool; impression; improved; innovation; mortality; patient-clinician communication; personalized decision; preference; prevent; procedure cost; professional atmosphere; psychologic; satisfaction; shared decision making; skills; standard of care; sudden cardiac death; support tools; theories; tool; tool development; uptake; usability; web site

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).

背景：与退伍军人事务部战略计划和卓越蓝图1保持一致，确保退伍军人 以价值观为中心的、价值观一致的护理（退伍军人接受反映其目标和目标的治疗的程度） 通过知情、共同决策来确定治疗偏好），这对于以下方面尤其重要。 ICD（植入式心律转复除颤器）——永久的、通过手术植入的心脏装置，旨在 通过电击监测和治疗危及生命的心律，ICD 呈现出复杂的平衡。 患者利益（即危险心律的检测和治疗）、手术风险、长期 维护（即电池和铅监测）以及对心理健康的影响（即。 PTSD、ICD 电击引起的焦虑和抑郁）2,3 意义/影响：鉴于退伍军人心力衰竭率较高4、5，整个国家的 ICD 植入率 VA 在过去十年中急剧增长，平均每次手术植入超过 25,000 个 ICD 费用为 64,5006 美元，但是，这一增长可能并不表明护理信息灵通、价值观一致。 先前的大量研究表明，患者对风险、益处、心理影响和风险知之甚少。 与 ICD 植入相关的并发症 - 常常留下错误的印象，例如 ICD 可以“治愈” 心脏衰竭，不需要维护，并且不会导致不适当的电击。 医疗服务提供者过分强调 ICD 的益处，而患者则明显高估了益处。7 二月 2018 年，CMS 强制要求在 ICD 植入之前使用并记录共同决策。 据低估，目前 VA 系统中约有 135,000 名符合 ICD 资格的退伍军人。 创新：在全国范围内和 VHA 内部，这种不和谐导致人们呼吁使用决策支持工具来提供帮助 患者做出明智的、个性化的决定，特别是对于具有复杂风险的侵入性治疗 利益权衡，例如 ICD。8 创新方面包括：(1) 显着改进的综合工具 支持 ICD 通信，(2) 设计用于 VA 临床护理中的常规实施，(3) 研究 将工具从非 VA 环境过渡到 VA 设置，(4) 解决高风险决策（国家授权） 用于 SDM 工具的 CMS）以及 (5) 集成到现有的 VA 质量改进基础设施 (CART-EP)。 具体目标：该提案的中心假设是当前的 ICD 决策过程是 异构且缺乏足够的退伍军人观点，我们将通过以下方式解决这个问题： 目标 1：确定退伍军人和 VA 提供者围绕 ICD 决策的具体因素。 目标 2：开发一款由 VA 提供商主导的工具，满足退伍军人在 VA 内日常使用的需求。 目标 3：对旨在支持 ICD 通信的新开发工具进行可行性测试。 方法：该项目将针对以下退伍军人：(1) 符合 ICD 资格，(2) 现场佩戴 ICD 或 (3) 拥有 ICD 拒绝 ICD 治疗和照顾此类退伍军人的 VA 提供者 In 目标 1，半结构化面对面。 访谈将直接以归纳演绎的形式进行定性数据分析。 告知目标 2 – 开发工具来个性化、增强和支持退伍军人提供者 ICD Aim 3 将使用 RE-AIM 框架在 4 个不同的 VA 站点之间测试该工具。 实施和后续步骤：完成此 CDA 后，工具将准备好立即进行测试 通过一个 IIR 项目（IIR #2）寻求评估该工具，与多个 VA- 的护理标准进行比较 Sandhu 博士正在领导 CART-EP 的开发，这是一个由 VA 资助的项目，扩展了 CART 的使用。 （侵入性心血管手术的质量体系）到 ICD 我们将整合此 ICD SDM 工具的使用。 作为在 VA 内植入 ICD 之前对 CART-EP 的质量衡量标准。 研究该工具在全国范围内的大规模传播和实施（即阶梯楔形有效性- 在 VA 临床实践的广泛代表性中进行实施试验）。