Sustaining quality of life of the aged: Heart transplant or mechanical support?

维持老年人的生活质量：心脏移植还是机械支持？

• 批准号: 9110086
• 负责人: KATHLEEN L GRADY
• 金额: $ 60.15万
• 依托单位: NORTHWESTERN UNIVERSITY AT CHICAGO
• 依托单位国家: 美国
• 财政年份: 2015
• 资助国家: 美国
• 起止时间: 2015-07-15 至 2020-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9110086
• 关键词: Adverse event; Age; Age-Years; Anxiety; Benchmarking; Caregiver Burden; Caregivers; Caring; Clinical; Comorbidity; Comparative Study; Decision Making; Destinations; Devices; Disease; Distress; Elderly; Evaluation; Freedom; Gastrointestinal Hemorrhage; Health; Health Policy; Heart Transplantation; Heart failure; Implant; Infection; Inferior; Kidney Failure; Malignant Neoplasms; Mechanics; Medical; Mental Depression; Modeling; Morbidity - disease rate; Operative Surgical Procedures; Outcome; Patient Care; Patient-Centered Care; Patients; Postoperative Period; Prevalence; Psyche structure; Quality of life; Quality-Adjusted Life Years; Reporting; Risk; Risk Factors; Stroke; Survival Rate; Symptoms; Transplantation; aged; clinical practice; comparative effectiveness; effectiveness research; experience; frailty; health related quality of life; hospital readmission; improved outcome; longitudinal design; older patient; prospective; social

 DESCRIPTION (provided by applicant): The purpose of this proposed study is to compare health-related quality of life (HRQOL) outcomes in older (60-80 years) advanced heart failure (HF) patients who undergo heart transplantation (HT) or mechanical circulatory support (MCS) as a permanent implant (i.e., destination therapy [DT]) and their caregivers, risk factors for poor HRQOL, adverse event and symptom burden, and quality-adjusted life years (QALYs). We will use a theoretical framework which models the influence of disease, treatment, adverse events, and symptoms on HRQOL to guide our proposed study. Advanced HF patients, 60-80 years of age, are an appropriate target group for this proposed study because they are receiving HTs and implant of MCS devices more frequently, and despite a greater risk for poor clinical outcomes, they have acceptable rates of survival. Our proposed study may contribute to better patient-centered care of older advanced HF patients and their caregivers, by informing decision making and guiding strategies to enhance post-operative HRQOL. Our proposed study will also provide critical information to support a paradigm shift, from DT MCS implant only after evaluation for HT, to concurrent consideration of both therapies, given that as 2-year survival after MCS approaches the benchmark 2-year survival after HT, HRQOL assumes a much higher priority. Using a prospective, longitudinal design, our proposed comparative effectiveness research will compare HRQOL outcomes in patients who receive HT or DT MCS and their caregivers, from baseline to 2 years post-operatively. The primary aim of this proposed study is to determine whether older advanced HF patients who undergo DT MCS, as compared to patients who undergo HT, experience non-inferior change in overall HRQOL (primary), and domains of HRQOL (physical, mental, and social) from baseline through 2 years after surgery. Secondary Aims are (1.) to determine whether caregivers of older advanced HF patients who undergo DT MCS, compared to caregivers of older advanced HF patients who undergo HT, experience non-inferior change in overall HRQOL and domains from baseline through 2 years after surgery; (2.-3.) to identify risk factors related to poorer overall HRQOL in older DT MCS patients and their caregivers, as compared to older HT patients and their caregivers, at 2 years after surgery; (4.) to determine whether older advanced HF patients who undergo DT MCS, as compared to patients who undergo HT, have non-inferior rates of freedom from adverse events & symptoms at 1 and 2 years after surgery; and (5) to evaluate the distribution of QALYs in older advanced HF patients who undergo DT MCS, as compared to patients who undergo HT at 2 years after surgery.

 描述(申请人提供)：这项拟议研究的目的是比较接受心脏移植(HT)或机械循环支持(MCS)作为永久植入物(即，目的地疗法[DT])的老年(60-80岁)晚期心力衰竭(HF)患者和他们的照顾者的健康相关生活质量(HRQOL)结果，贫困的危险因素 HRQOL、不良事件和症状负担以及质量调整寿命年(QALY)。我们将使用一个理论框架来模拟疾病、治疗、不良事件和症状对HRQOL的影响，以指导我们拟议的研究。60-80岁的晚期心力衰竭患者是这项拟议研究的合适目标群体，因为他们接受HTS和植入MCS设备的频率更高，尽管临床结果较差的风险更大，但他们的存活率可接受。我们建议的研究可能有助于更好地以患者为中心的老年晚期心衰患者及其照顾者的护理，为提高术后HRQOL提供决策和指导策略。我们建议的研究还将提供关键信息来支持范式的转变，从仅在评估了HT后植入DT MCS，到同时考虑两种治疗方法，因为MCS后的2年生存率接近HT后的基准2年生存率，HRQOL具有更高的优先级。采用前瞻性、纵向设计，我们建议的比较有效性研究将比较接受HTTMCS或DTMCS的患者和他们的照顾者从基线到术后2年的HRQOL结果。这项拟议研究的主要目的是确定接受DT MCS的老年晚期心衰患者，与接受HT的患者相比，是否在总体HRQOL(主要)和HRQOL的领域(从基线到术后2年)经历了非劣质的变化。次要目标是(1)。确定接受DT MCS的老年晚期心力衰竭患者的照顾者与接受高龄晚期心力衰竭患者的照顾者相比，是否经历了从基线到术后2年的总体HRQOL和领域的非劣质变化；明确老年DT MCS患者及其照顾者术后2年整体HRQOL较老年HT患者及其照顾者差的危险因素；确定接受DT MCS的老年晚期心衰患者在术后1年和2年的不良事件和症状的发生率是否不低于接受HT的患者；以及(5)评估接受DT MCS的老年晚期HF患者与术后2年接受HT的患者相比，QALY的分布情况。