The Trajectories and Clinical Experiences of ICD Therapy (TRACER-ICD) Study

项目概要/摘要X 每年有超过50，000个植入式心律转复除颤器（ICD）植入≥65岁的患者体内 估计成本超过20亿美元。ICD指南借鉴了一些老年患者的试验，但这些患者中有一半 将在植入后5年内死亡或入组临终关怀。尽管医疗保险现在要求共享 尽管ICD的决策（SDM），很少有研究调查对老年患者至关重要的问题，包括健康 状态轨迹和生活质量。改善老年患者的SDM需要超越平均治疗 效果估计，以纳入这些结果的精确建模。因此，迫切需要 纵向数据，以支持老年人以患者为中心的SDM。为了扩展我们先前的工作， 为考虑ICD的老年人改进SDM，我们提出了轨迹和临床经验 ICD治疗（TRACER-ICD）研究，一项多中心前瞻性队列研究，旨在更好地定义 在接受ICD植入的老年患者中以患者为中心的目标和经验。我们将 前瞻性收集5个研究中心患者的老年疾病和生活质量数据， 监测心律失常和身体活动的数据，以评估其临床和功能轨迹（目标1）。 该队列将支持进一步完善我们的统计模型，以个性化预测治疗结果 (Aim 2）。最后，我们将使用混合方法来确定翻译这些内容的最佳实施策略。 将个体化的预测特征纳入ICD的SDM（目标3）。该提案由早期研究者领导 他们在心脏电生理学、老年医学和结果研究方面的专业知识将得到补充， 由一个经验丰富的研究团队与强大的合作记录。 影响：作为第一项针对老年ICD患者的全面前瞻性研究，TRACER-ICD将产生 独特的以患者为中心和个性化的数据，对于表征这一常见程序的结果至关重要 在弱势群体中。就像其他老年人的大型队列研究一样， 从TRACER-ICD中产生的信息将作为一种丰富的资源， 考虑植入ICD，并提供必要的，基于证据的指导， 将结果分析纳入可持续发展机制的经验。

Project Summary / Abstract X Over 50,000 implantable cardioverter-defibrillators (ICDs) are implanted annually in patients ≥65 years old at an estimated cost of >$2 billion. ICD guidelines draw upon trials enrolling few older patients, yet half of these patients will either be dead or enrolled in hospice within 5 years of implantation. Though Medicare now mandates shared decision-making (SDM) for ICDs, few studies have investigated questions vital for older patients, including health status trajectories and quality of life. Improved SDM for older patients requires moving beyond average treatment effect estimates to incorporate precision modeling of these outcomes. There is therefore a pressing need for longitudinal data to support patient-centered SDM for older adults. To extend our prior work and further improve SDM for older adults considering an ICD, we propose the TRAjectories and Clinical ExpeRiences of ICD Therapy (TRACER-ICD) Study, a multi-center prospective cohort with the goal of better defining patient-centered goals and experiences in older patients undergoing ICD implantation. We will prospectively collect data on geriatric conditions and quality of life from patients at 5 sites, enriched with remote monitoring data on arrhythmias and physical activity, to evaluate their clinical and functional trajectories (Aim 1). This cohort will support further refinement of our statistical model to personalize prediction of treatment outcomes (Aim 2). Lastly, we will use mixed methods to identify optimal implementation strategies for translating these individualized prediction profiles into SDM for ICDs (Aim 3).This proposal is led by an Early Stage Investigator whose expertise in cardiac electrophysiology, geriatric medicine, and outcomes research will be complemented by an experienced research team with a strong record of collaboration. IMPACT: As the first comprehensive, prospective study of older ICD patients, TRACER-ICD will generate unique patient-centered and personalized data essential for characterizing outcomes of this common procedure in a vulnerable population. Much like other large cohort studies in older persons, we anticipate the robust data emerging from TRACER-ICD will serve as a rich resource that will improve care for millions of patients considering ICD implantation, and provide essential, evidence-based guidance for translating personalized outcome profiling into the SDM experience.