Patient-Centered Outcomes of Implantable Defibrillator Therapy in Older Patients

老年患者植入式除颤器治疗以患者为中心的结果

• 批准号: 8726279
• 负责人: Daniel Bruce Kramer
• 金额: $ 20.49万
• 依托单位: HEBREW REHABILITATION CENTER FOR AGED
• 依托单位国家: 美国
• 财政年份: 2013
• 资助国家: 美国
• 起止时间: 2013-09-30 至 2017-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8726279
• 关键词: Address; Admission activity; Advance Care Planning; Advance Directives; Age; Cardiac; Cardiology; Cardiovascular system; Caring; Cessation of life; Characteristics; Clinical; Data; Data Set; Databases; Devices; Elderly; Ethics; Face; Family; Goals; Guidelines; Health; Health Services; Healthcare; Healthcare Power of Attorney; Heart Diseases; Heart failure; Home Nursing Care; Hospice Care; Hospitalization; Hospitals; Implant; Implantable Defibrillators; Incidence; Individual; Institutionalization; Intervention; Interview; Israel; Knowledge; Left Ventricular Ejection Fraction; Life; Life Support Care; Link; Medical center; Medicare; Methodology; Nursing Homes; Outcome; Patient-Focused Outcomes; Patients; Pattern; Persons; Policies; Population Study; Predisposing Factor; Prospective Studies; Provider; Proxy; Recruitment Activity; Registries; Renal function; Research; Research Personnel; Risk; Risk Factors; Schedule; Shock; Site; Stratification; Sudden Death; Telephone; Time; Uncertainty; Work; aged; base; clinical decision-making; clinical risk; cost; data registry; disability; end of life; experience; follow-up; hospice environment; implantation; improved; mortality; novel; older patient; patient oriented; tool; trend

DESCRIPTION (provided by applicant): More than 50,000 implantable cardioverter-defibrillators (ICDs) are placed annually in patients aged > 65. Demographic trends and the associated burden of heart disease will make millions more older cardiac patients eligible for these devices in the coming years. These patients face important uncertainties regarding their clinical course and health care needs after ICD implantation, which must be weighed against the risk of sudden death without the device. Two of the most challenging and costly health care transitions for older patients include nursing home (NH) and hospice admission. Which ICD recipients ultimately require NH or hospice care, and when, is entirely unknown. Additionally, their broader end-of-life experiences have not been well- characterized. This proposal addresses knowledge gaps related to the clinical course, health care needs, and end-of-life experiences of older ICD patients using 2 complementary approaches. First, data in the National Cardiovascular Data Registry - ICD Registry from 2005 to 2010 will be linked to Minimum Data Set and Medicare data to examine the utilization patterns and outcomes of older ICD patients needing NH and hospice care following ICD implantation. Second, primary data will be collected from ICD patients > 65 at the Beth Israel Deaconess Medical Center to examine key end-of-life outcomes unavailable in the secondary dataset. The Specific Aims are: 1: To describe the incidence and identify baseline risk factors for (a) long-term NH care and (b) hospice admission among ~ 300,000 ICD recipients > 65 up to 3 years after ICD implantation; 2: To describe and compare outcomes among ICD recipients, including: a) survival following implantation for those who were and were not admitted to NHs, and (b) i. burdensome transitions (hospitalization or NH admission) in last 90-days of life and ii. site of death for decedents (N~ 90,000) who were and were not admitted to hospice; and 3: To conduct a 2-year pilot prospective study among 75 ambulatory ICD patients > 65 to ascertain the following: advance care planning (e.g. formal power of attorney for health care; advance directives; discussions with providers); main goal of care (e.g. life prolongation vs. comfort); health service use (e.g. hospitalizations, hospice, NH); and end-of-life outcomes (site, ICD shocks/deactivation, interventions, hospice use) and quality of end-of-life care (Toolkit After-death Bereaved Family Interview) among those who die (N~20). IMPACT: This research will yield novel data about the clinical course, health care needs and end- of-life experiences of older patients with ICDs. Aims 1 and 2 will leverage national databases to examine the incidence and outcomes of older ICD patients needing long-term NH and hospice care post-implantation. Aim 3 will establish the feasibility of conducting a prospective study of older ICD patients and yield preliminary data regarding their end-of-life experiences. This work represents key steps towards better informing clinical and policy decisions regarding the use of ICDs among older patients.

描述（由申请人提供）：每年有超过50，000个植入式心律转复器（ICD）植入65岁以上的患者。人口统计学趋势和相关的心脏病负担将使数百万老年心脏病患者在未来几年有资格使用这些设备。这些患者在植入ICD后面临着关于其临床病程和医疗保健需求的重要不确定性，这必须与没有该设备的猝死风险进行权衡。对于老年患者来说，两个最具挑战性和最昂贵的医疗保健过渡包括疗养院（NH）和临终关怀入院。哪些ICD接受者最终需要NH或临终关怀，以及何时，完全未知。此外，他们更广泛的临终经历还没有得到很好的描述。该提案使用2种互补方法解决了与老年ICD患者的临床过程、医疗保健需求和临终经历相关的知识差距。首先，2005年至2010年国家心血管数据登记处- ICD登记处的数据将与最小数据集和医疗保险数据相关联，以检查ICD植入后需要NH和临终关怀的老年ICD患者的使用模式和结局。其次，将从Beth Israel Deaconess Medical Center的> 65岁ICD患者中收集主要数据，以检查次要数据集中不可用的关键临终结局。具体目标是：一曰：描述ICD植入后3年内约300，000名> 65岁的ICD接受者中（a）长期NH护理和（B）临终关怀住院的发生率并确定基线风险因素; 2：描述并比较ICD接受者的结局，包括：a）接受和未接受NH治疗的患者植入后的生存率，以及（B）i.在生命的最后90天中的繁重过渡（住院或NH入院），以及ii.死者的死亡地点（N~ 90，000）已入住和未入住临终关怀医院;和3：在75名> 65岁的门诊ICD患者中进行一项为期2年的试点前瞻性研究，以确定以下内容：提前护理计划（例如，正式的保健委托书;预先指示;与提供者的讨论）;保健的主要目标死亡者（N~20）的临终结局（部位、ICD电击/失活、干预措施、临终关怀使用）和临终关怀质量（工具包死亡后家属访谈）。影响：本研究将产生关于ICD老年患者的临床病程、医疗保健需求和临终经历的新数据。目标1和2将利用国家数据库来检查植入后需要长期NH和临终关怀的老年ICD患者的发生率和结局。目标3将确定对老年ICD患者进行前瞻性研究的可行性，并获得有关其临终经历的初步数据。这项工作代表了更好地为老年患者使用ICD的临床和政策决策提供信息的关键步骤。