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

ICD 治疗 (TRACER-ICD) 研究的轨迹和临床经验

• 批准号: 10608085
• 负责人: Daniel Bruce Kramer
• 金额: $ 71.49万
• 依托单位: BETH ISRAEL DEACONESS MEDICAL CENTER
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-04-15 至 2026-03-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10608085
• 关键词: Advance Care Planning; Area Under Curve; Arrhythmia; Cardiac Electrophysiologic Techniques; Cardiovascular system; Caring; Cessation of life; Clinic; Clinical; Clinical Trials; Cognition; Cohort Studies; Collaborations; Colorado; Complement; Data; Devices; Elderly; Electronic Health Record; Enrollment; Foundations; Geriatric Assessment; Geriatrics; Goals; Guidelines; Health Status; Heterogeneity; Impaired cognition; Implant; Implantable Defibrillators; Implantation procedure; Interview; Knowledge; Maps; Measures; Medicare; Methods; Modeling; Outcome; Outcomes Research; Patients; Performance; Persons; Physical activity; Pilot Projects; Probability; Procedures; Process; Prospective Studies; Prospective cohort; Quality of life; Recording of previous events; Research; Research Personnel; Resources; Risk; Shock; Site; Statistical Models; Structure; Symptoms; Telephone; Translating; Treatment outcome; Validation; Vulnerable Populations; Work; aged; cohort; comorbidity; cost estimate; evidence base; experience; frailty; functional status; health service use; hospice environment; human old age (65+); implantation; implementation strategy; impression; improved; individual patient; instrumental activity of daily living; mortality; novel; older patient; outcome prediction; patient oriented; personalized approach; personalized decision; personalized predictions; predictive modeling; preference; prospective; prototype; recruit; remote monitoring; shared decision making; tool; treatment effect; trial enrollment

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.

项目摘要/摘要 X 每年有超过 50,000 个植入式心律转复除颤器 (ICD) 被植入 ≥65 岁的患者体内 预计成本>20亿美元。 ICD 指南借鉴了招募少数老年患者的试验，但其中一半患者 植入后 5 年内要么死亡，要么进入临终关怀医院。尽管医疗保险现在强制共享 ICD 决策 (SDM) 方面，很少有研究调查对老年患者至关重要的问题，包括健康问题 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 效应估计​​结合了这些结果的精确建模。因此迫切需要 支持老年人以患者为中心的 SDM 的纵向数据。为了扩展我们之前的工作并进一步 为了改善考虑 ICD 的老年人的 SDM，我们提出了轨迹和临床经验 ICD 治疗 (TRACER-ICD) 研究是一项多中心前瞻性队列，旨在更好地定义 接受 ICD 植入的老年患者以患者为中心的目标和经历。我们将 前瞻性地收集 5 个地点患者的老年状况和生活质量数据，并通过远程 监测心律失常和体力活动数据，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 （目标 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 将个性化预测配置文件纳入 ICD 的 SDM（目标 3）。该提案由早期研究人员领导 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 由经验丰富、合作记录良好的研究团队负责。 影响：作为第一项针对老年 ICD 患者的综合前瞻性研究，TRACER-ICD 将产生 独特的以患者为中心的个性化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。就像其他针对老年人的大型队列研究一样，我们预计会有可靠的数据 TRACER-ICD 的出现将成为丰富的资源，改善数百万患者的护理 考虑 ICD 植入，并为翻译个性化提供必要的、基于证据的指导 将结果分析到 SDM 体验中。