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责任蓝图1保持一致，确保退伍军人 以价值观为中心的和谐护理（退伍军人接受反映其目标和 治疗偏好），通过知情的，共同的决策。这一点尤其重要， ICD（植入式心律转复器）-永久性外科植入心脏器械，旨在 用电击来监测和治疗危及生命的心律失常。ICD呈现出复杂的平衡 患者的利益（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）和对心理健康的影响（即，高强度的 ICD电击引起的PTSD、焦虑和抑郁）。2，3 意义/影响：鉴于退伍军人心力衰竭的高发生率4，5， VA在过去十年中急剧上升，平均每次手术植入超过25，000个ICD 价格645006元然而，这一上升可能并不表明知情，价值观一致的照顾。 许多先前的研究表明，患者对风险、益处、心理影响和 与ICD植入相关的并发症-通常会留下错误的印象，例如ICD是一种“治愈”， 心力衰竭，不需要维护，并且不会导致不适当的电击。此前的数据也表明， 提供者过分强调ICD的益处，而患者明显高估了益处。 2018年，CMS强制要求在ICD植入前使用和记录共享决策。有可能是 据估计，目前VA系统中约有135，000名符合ICD条件的退伍军人。 创新：在全国范围内和VHA内部，这种不和谐导致了对决策支持工具的呼吁， 患者做出明智的个性化决策，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， 支持ICD通信，（2）设计用于VA临床护理中的常规实施，（3）研究 将工具从非脆弱性和适应性评估环境过渡到脆弱性和适应性评估环境，（4）处理高风险决策（国家授权， 用于SDM工具的CMS）和（5）与现有VA质量改进基础设施（CART-EP）的集成。 具体目标：本提案的核心假设是，目前的ICD决策过程 缺乏足够的经验和丰富的视角。我们将通过以下方式解决这一问题： 目标1：确定退伍军人和VA提供者围绕ICD决策的特定因素。 目标2：开发一个VA供应商主导的工具，满足退伍军人在VA内日常使用的需求。 目标3：对新开发的旨在支持疾病分类通信的工具进行可行性测试。 方法：本项目将针对退伍军人，（1）符合ICD条件，（2）原位植入ICD或（3） 拒绝ICD治疗和VA提供者谁照顾这样的退伍军人。在目标1中，半结构化面对面 访谈将以归纳-演绎的形式分析定性数据。输出将直接 告知目标2 -开发工具，以个性化、增强和支持退伍军人提供者ICD 在VA的通信。目标3将使用RE-AIM框架在4个不同的VA站点中测试该工具。 实施和后续步骤：完成本CDA后，工具将准备好立即进行测试 通过一个IIR项目（IIR#2），与标准治疗相比，在多个VA- 网站. Sandhu博士正在领导CART-EP的开发，这是一个VA资助的项目，用于扩展CART的使用 （侵入性心血管手术的质量体系）与ICD。我们将使用ICD SDM工具 在VA内植入ICD之前，将其作为CART-EP的质量指标。CART-EP将作为一种方法 研究在全国范围内大规模传播和实施这一工具的情况（即，阶梯楔效应- 广泛代表性VA临床实践中的实施试验）。