Prospective Investigation of Palliative and End-of-Life ExpeRiences with ICDs (PIPER-ICD) Study

使用 ICD 进行姑息治疗和临终经历的前瞻性调查 (PIPER-ICD) 研究

• 批准号: 10517570
• 负责人: Daniel Bruce Kramer
• 金额: $ 84.44万
• 依托单位: BETH ISRAEL DEACONESS MEDICAL CENTER
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-07-15 至 2026-06-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10517570
• 关键词: Advance Care Planning; Area Under Curve; Arrhythmia; Bereavement; Bioethics; Cardiac; Caregivers; Caring; Cause of Death; Cessation of life; Clinical; Cognition; Cohort Studies; Collaborations; Complement component C6; Data; Data Sources; Decision Making; Devices; Elderly; Electronic Health Record; Enrollment; Family; Foundations; Geriatric Assessment; Geriatrics; Goals; Guidelines; Health Status; Heterogeneity; Impaired cognition; Implant; Implantable Defibrillators; Implantation procedure; Intervention; Interview; Investigation; Knowledge; Life; Life Experience; Measures; Methods; Modeling; Outcome; Outcomes Research; Pain; Palliative Care; Patient Care; Patient risk; Patients; Performance; Persons; Physical activity; Pilot Projects; Prospective Studies; Prospective cohort; Proxy; Quality of life; Registries; Research; Resources; Risk; Services; Shock; Site; Symptoms; Telephone; Vulnerable Populations; Work; aged; base; cardiometabolism; cohort; comorbidity; end of life; end of life care; evidence base; experience; frailty; functional status; health care service utilization; health service use; hospice environment; human old age (65+); implantation; improved; individual patient; innovation; mortality; multiple chronic conditions; novel; older patient; palliative; patient oriented; personalized predictions; prospective; remote monitoring; satisfaction

Summary X Implantable cardioverter-defibrillator (ICD) guidelines draw on trials with few older patients, yet ~50,000 ICDs are implanted annually in patients ≥65 years old. Half of older ICD recipients will either be dead or enrolled in hospice within 5 years of implantation, and little evidence supports critical long-term decisions including (1) whether to replace ICDs when the battery declines, or (2) timing of ICD deactivation to avoid painful shocks at the end of life. There is therefore a pressing need for longitudinal data on patient health status and clinical experiences in the years after ICD implantation to support patient-centered decisions. To extend our prior work and further improve the care of patients living and dying with ICDs, we now propose the Prospective Investigation of Palliative and End-of-Life ExpeRiences with ICDs (PIPER-ICD) Study, a rigorous, multi- center cohort with the goal of defining patient-centered experiences of older ICD patients >5 years post implantation. We will prospectively collect data on geriatric conditions and quality of life from 1200 patients at 5 sites, enriched with remote monitoring data on arrhythmias and physical activity, to evaluate clinical and functional trajectories (Aim 1). This cohort will support novel application of a semi-competing risks approach to personalizing individualized outcome profiles for death and ICD shocks (Aim 2). Lastly, we will apply mixed methods to the decedent cohort (N~200) to quantify ICD shocks at the end of life and identify potential targets for interventions to improve their care (Aim 3). This proposal is led by cardiac electrophysiologist with expertise in geriatrics, outcomes research, and bioethics, supported by an experienced research team with a strong record of collaboration. IMPACT: As the first comprehensive, prospective study of older ICD patients focused on long- term and end-of-life experiences, PIPER-ICD will generate patient-centered and personalized data essential for evidence-based guidance to serve a vulnerable population. PIPER-ICD will thus serve as a rich resource to support decision-making for millions of patients considering replacement or deactivation of their ICDs.

摘要十 植入式心律转复除颤器（ICD）指南借鉴了一些老年患者的试验，但约50，000个ICD 每年在≥ 65岁的患者中植入。一半的老年ICD接受者要么已经死亡，要么已经登记 植入后5年内的临终关怀，几乎没有证据支持关键的长期决策，包括（1） 是否在电池电量下降时更换ICD，或（2）ICD失活的时机，以避免在 生命的终结因此，迫切需要关于患者健康状况和临床症状的纵向数据。 ICD植入后几年的经验，以支持以患者为中心的决策。为了扩展我们之前的工作 为了进一步改善ICD患者的生存和死亡护理，我们现在提出前瞻性 使用ICD的姑息性和临终经历调查（PIPER-ICD）研究，一项严格的、多方面的研究， 中心队列，目标是定义> 5年后老年ICD患者的以患者为中心的经验 置入我们将前瞻性地收集1200名患者的老年疾病和生活质量数据， 5个研究中心，丰富了关于心律失常和体力活动的远程监测数据，以评估临床和 功能轨迹（目标1）。该队列将支持半竞争风险方法的新应用， 个性化死亡和ICD电击的个体化结局特征（目标2）。最后，我们将混合 死亡队列（N~200）的方法，以量化生命末期的ICD电击并识别潜在靶点 为改善他们的护理而采取的干预措施（目标3）。该提案由心脏电生理学家领导， 在老年医学，结果研究和生物伦理学，由经验丰富的研究团队与强大的记录支持 合作。影响：作为第一项针对老年ICD患者的全面前瞻性研究， 根据足月和临终经验，PIPER-ICD将生成以患者为中心的个性化数据，对于 以证据为基础的指导，为弱势群体服务。因此，PIPER-ICD将作为一种丰富的资源， 为数百万考虑更换或停用ICD的患者提供决策支持。