Effects of a Telehealth Early Palliative Care Intervention for Family Caregivers of Persons With Advanced Heart Failure The ENABLE CHF-PC Randomized Clinical Trial
Effects of a Telehealth Early Palliative Care Intervention for Family Caregivers of Persons With Advanced Heart Failure The ENABLE CHF-PC Randomized Clinical Trial
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DOI：
10.1001/jamanetworkopen.2020.2583
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发表时间：
2020-04-13
影响因子：
13.8
通讯作者：
Bakitas, Marie A.
中科院分区：
文献类型：
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作者：
Dionne-Odom, J. Nicholas;Ejem, Deborah B.;Bakitas, Marie A.
问题：与常规护理相比，远程医疗早期姑息护理干预对16周以上晚期心力衰竭患者家庭照顾者的生活质量、情绪和负担有何影响？结果在这项随机临床试验中，包括158名家庭护理人员，其中一半是非裔美国人，其中大多数人在基线时没有痛苦，16周内的主要结局没有显着差异。早期姑息治疗干预在改善生活质量、情绪、和家庭照顾者的负担。这项随机临床试验调查了护士-引导姑息治疗远程医疗干预对晚期心力衰竭患者家庭照顾者生活质量和情绪的影响无法完成许多日常工作以帮助其亲属，并处于痛苦和生活质量差的高风险之中。目的确定护士主导的姑息治疗远程健康干预（教育、培育、建议、患者和护理者生命结束前的综合性心力衰竭[ENABLE CHF-PC]）对纽约心脏协会III/IV级心力衰竭患者家庭护理者16周以上的生活质量和情绪的影响。设计、设置和参与者这项单盲随机临床试验招募了18岁及以上的护理人员，他们自认为是无薪的亲密朋友或家庭成员，熟悉患者并参与患者的日常医疗护理。参与者是从2016年8月至2018年10月在一家大型学术三级医疗中心和一家退伍军人事务医疗中心的心力衰竭门诊招募的。干预每周四次的心理社会和解决问题的支持电话会议，持续20至60分钟，由训练有素的护士教练协助，每月随访48周。常规护理组没有接受额外的干预。主要结局和测量主要结局是16周内的生活质量（使用Bakas护理者结局量表测量）、情绪（使用医院焦虑和抑郁量表测量的焦虑和/或抑郁症状）和负担（使用Montgomery-Borgatta护理者负担量表测量）。次要结果是全球健康（使用PROMIS全球健康工具测量）和积极的方面。结果158名家庭照顾者被随机分为干预组82名和常规组76名。平均（SD）年龄为57.9（11.6）岁，135（85.4%）例为女性，82（51.9%）例为非洲裔美国人，103（65.2%）例为患者的配偶或伴侣。第16周时，平均（SE）Bakas护理者结局量表评分为66.9干预组为2.1，（1.7）在常规护理组;超过16周，平均（SE）Bakas护理者结局量表评分提高0.7干预组为1.7分，常规护理组为1.1（1.6）分（差异，-0.4; 95% CI，-5.1至4.3; Cohen d = -0.03）。在第16周，在医院焦虑和抑郁量表焦虑测量方面，干预组和常规护理组之间没有观察到相关的组间差异（较基线的平均[SE]改善，0.3 [0.3] vs 0.4 [0.3];差异，-0.1 [0.5]; d = -0.02）或抑郁测量（平均[SE]较基线改善，-0.2 [0.4] vs -0.3 [0.3];差异，0.1 [0.5]; d = 0.03）。在Montgomery-Borgatta照顾者负担量表中未观察到组间差异（d范围，-0.18至0.0）。次要结局的差异也不显著（d范围，-0.22至0.0）。结论和相关性这两个网站的远程医疗干预的家庭照顾者与晚期心力衰竭患者的随机临床试验，超过一半的人是非洲裔美国人，其中大多数人在基线时没有痛苦，并没有表现出临床上更好的生活质量，情绪，或负担相比，常规护理超过16周。未来的干预措施应针对痛苦的照顾者，并评估照顾者对患者预后的影响。
Question What is the impact of a telehealth early palliative care intervention compared with usual care on the quality of life, mood, and burden of family caregivers of persons with advanced heart failure over 16 weeks? Findings In this randomized clinical trial that included 158 family caregivers, half of whom were African American and most of whom were not distressed at baseline, there were no significant differences in primary outcomes over 16 weeks. Meaning An early palliative care intervention was not significantly better than usual care at improving the quality of life, mood, and burden of family caregivers of patients with advanced heart failure.This randomized clinical trial investigates the effect of a nurse-led palliative care telehealth intervention on quality of life and mood of family caregivers of individuals with advanced heart failure.Importance Family caregivers of persons with advanced heart failure perform numerous daily tasks to assist their relatives and are at high risk for distress and poor quality of life. Objective To determine the effect of a nurse-led palliative care telehealth intervention (Educate, Nurture, Advise, Before Life Ends Comprehensive Heart Failure for Patients and Caregivers [ENABLE CHF-PC]) on quality of life and mood of family caregivers of persons with New York Heart Association Class III/IV heart failure over 16 weeks. Design, Setting, and Participants This single-blind randomized clinical trial enrolled caregivers aged 18 years and older who self-identified as an unpaid close friend or family member who knew the patient well and who was involved with their day-to-day medical care. Participants were recruited from outpatient heart failure clinics at a large academic tertiary care medical center and a Veterans Affairs medical center from August 2016 to October 2018. Intervention Four weekly psychosocial and problem-solving support telephonic sessions lasting between 20 and 60 minutes facilitated by a trained nurse coach plus monthly follow-up for 48 weeks. The usual care group received no additional intervention. Main Outcomes and Measures The primary outcomes were quality of life (measured using the Bakas Caregiver Outcomes Scale), mood (anxiety and/or depressive symptoms measured using the Hospital Anxiety and Depression Scale), and burden (measured using the Montgomery-Borgatta Caregiver Burden scales) over 16 weeks. Secondary outcomes were global health (measured using the PROMIS Global Health instrument) and positive aspects of caregiving. Results A total of 158 family caregivers were randomized, 82 to the intervention and 76 to usual care. The mean (SD) age was 57.9 (11.6) years, 135 (85.4%) were female, 82 (51.9%) were African American, and 103 (65.2%) were the patient's spouse or partner. At week 16, the mean (SE) Bakas Caregiver Outcomes Scale score was 66.9 (2.1) in the intervention group and 63.9 (1.7) in the usual care group; over 16 weeks, the mean (SE) Bakas Caregiver Outcomes Scale score improved 0.7 (1.7) points in the intervention group and 1.1 (1.6) points in the usual care group (difference, -0.4; 95% CI, -5.1 to 4.3; Cohen d = -0.03). At week 16, no relevant between-group differences were observed between the intervention and usual care groups for the Hospital Anxiety and Depression Scale anxiety measure (mean [SE] improvement from baseline, 0.3 [0.3] vs 0.4 [0.3]; difference, -0.1 [0.5]; d = -0.02) or depression measure (mean [SE] improvement from baseline, -0.2 [0.4] vs -0.3 [0.3]; difference, 0.1 [0.5]; d = 0.03). No between-group differences were observed in the Montgomery-Borgatta Caregiver Burden scales (d range, -0.18 to 0.0). Differences in secondary outcomes were also not significant (d range, -0.22 to 0.0). Conclusions and Relevance This 2-site randomized clinical trial of a telehealth intervention for family caregivers of patients with advanced heart failure, more than half of whom were African American and most of whom were not distressed at baseline, did not demonstrate clinically better quality of life, mood, or burden compared with usual care over 16 weeks. Future interventions should target distressed caregivers and assess caregiver effects on patient outcomes.