Effect of an Early Palliative Care Telehealth Intervention vs Usual Care on Patients With Heart Failure The ENABLE CHF-PC Randomized Clinical Trial
Effect of an Early Palliative Care Telehealth Intervention vs Usual Care on Patients With Heart Failure The ENABLE CHF-PC Randomized Clinical Trial
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DOI：
10.1001/jamainternmed.2020.2861
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发表时间：
2020-09-01
影响因子：
39
通讯作者：
Pamboukian, Salpy V.
中科院分区：
文献类型：
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作者：
Bakitas, Marie A.;Dionne-Odom, J. Nicholas;Pamboukian, Salpy V.
重要性 国家指南建议对晚期心力衰竭患者进行早期姑息治疗，这对农村和少数民族人口影响尤为严重。 目的 确定 16 周以上的早期姑息治疗远程医疗干预对晚期心力衰竭患者的生活质量、情绪、整体健康、疼痛和资源利用的影响。 设计、环境和参与者 从 10 月 1 日起进行了一项单盲、干预与常规护理随机临床试验， 2015 年至 2019 年 5 月 31 日，在美国东南部大型学术三级医疗中心和退伍军人事务医疗中心，对 415 名 50 岁或以上患有纽约心脏协会 III 级或 IV 级心力衰竭或美国心脏病学会 C 级或 D 级心力衰竭的患者进行研究，该医疗中心为大量农村居民和非裔美国人提供服务。患者和护理人员的心脏护理）干预包括面对面的姑息治疗咨询和每周 6 次护士教练电话会议（20-40 分钟）以及为期 48 周的每月随访。 主要结果和测量 主要结果是生活质量（通过堪萨斯城心肌病问卷 [KCCQ] 测量：评分范围 0-100；分数越高表明感知的健康状况越好，临床总结分数 >= 50 为生活质量）被认为“相当好”的生活质量；慢性病姑息治疗 14 [FACIT-Pal-14] 的功能评估：评分范围 0-56；分数越高表明生活质量越好）和情绪（通过医院焦虑和抑郁量表 [HADS] 测量）。次要结局是全球健康（患者报告结果测量系统全球健康）、疼痛（患者报告结果测量系统疼痛强度和干扰）和资源使用（住院天数和急诊科就诊）。 结果 415 名参与者（221 名男性；基线平均 [SD] 年龄，63.8 [8.5] 岁）随机分配至 ENABLE CHF-PC (n = 208) 或常规护理 (n = 207 人）中，226 人（54.5%）为非裔美国人，108 人（26.0%）生活在农村地区，190 人（45.8%）受过高中或以下教育，平均（SD）基线 KCCQ 分数为 52.6（21.0）。第 16 周时，干预组的平均 (SE) KCCQ 评分提高了 3.9 (1.3) 分，而常规护理组则提高了 2.3 (1.2) 分（差异为 1.6；SE，1.7；d = 0.07 [95% CI，-0.09 至 0.24]），平均 (SE) FACIT-Pal-14 评分提高了 1.4 (0.6) 分。干预组与常规护理组相比为 0.2 (0.5) 分（差异，1.2；SE，0.8；d = 0.12 [95% CI，-0.03 至 0.28]）。情绪方面不存在相关的组间差异（HADS 焦虑，d = -0.02 [95% CI，-0.20 至 0.16]；HADS 抑郁，d = -0.09 [95% CI，-0.24 至 0.06]）。 结论和相关性 这项随机临床试验以非裔美国人为主，基线生活质量良好，并未显示出16 周早期姑息治疗远程医疗干预。然而，疼痛强度和干扰（次要结果）显示出临床上重要的改善。
IMPORTANCE National guidelines recommend early palliative care for patients with advanced heart failure, which disproportionately affects rural and minority populations.OBJECTIVE To determine the effect of an early palliative care telehealth intervention over 16 weeks on the quality of life, mood, global health, pain, and resource use of patients with advanced heart failure.DESIGN, SETTING, AND PARTICIPANTS A single-blind, intervention vs usual care randomized clinical trial was conducted from October 1, 2015, to May 31, 2019, among 415 patients 50 years or older with New York Heart Association class III or IV heart failure or American College of Cardiology stage C or D heart failure at a large Southeastern US academic tertiary medical center and a Veterans Affairs medical center serving high proportions of rural dwellers and African American individuals.INTERVENTIONS The ENABLE CHF-PC (Educate, Nurture, Advise, Before Life Ends Comprehensive Heartcare for Patients and Caregivers) intervention comprises an in-person palliative care consultation and 6 weekly nurse-coach telephonic sessions (20-40 minutes) and monthly follow-up for 48 weeks.MAIN OUTCOMES AND MEASURES Primary outcomes were quality of life (as measured by the Kansas City Cardiomyopathy Questionnaire [KCCQ]: score range, 0-100; higher scores indicate better perceived health status and clinical summary scores >= 50 are considered "fairly good" quality of life; and the Functional Assessment of Chronic Illness Therapy-Palliative-14 [FACIT-Pal-14]: score range, 0-56; higher scores indicate better quality of life) and mood (as measured by the Hospital Anxiety and Depression Scale [HADS]) over 16 weeks. Secondary outcomes were global health (Patient Reported Outcome Measurement System Global Health), pain (Patient Reported Outcome Measurement System Pain Intensity and Interference), and resource use (hospital days and emergency department visits).RESULTS Of 415 participants (221 men; baseline mean [SD] age, 63.8 [8.5] years) randomized to ENABLE CHF-PC (n = 208) or usual care (n = 207), 226 (54.5%) were African American, 108 (26.0%) lived in a rural area, and 190 (45.8%) had a high-school education or less, and a mean (SD) baseline KCCQ score of 52.6 (21.0). At week 16, the mean (SE) KCCQ score improved 3.9 (1.3) points in the intervention group vs 2.3 (1.2) in the usual care group (difference, 1.6; SE, 1.7; d = 0.07 [95% CI, -0.09 to 0.24]) and the mean (SE) FACIT-Pal-14 score improved 1.4 (0.6) points in the intervention group vs 0.2 (0.5) points in the usual care group (difference, 1.2; SE, 0.8; d = 0.12 [95% CI, -0.03 to 0.28]). There were no relevant between-group differences in mood (HADS-anxiety, d = -0.02 [95% CI, -0.20 to 0.16]; HADS-depression, d = -0.09 [95% CI, -0.24 to 0.06]).CONCLUSIONS AND RELEVANCE This randomized clinical trial with a majority African American sample and baseline good quality of life did not demonstrate improved quality of life or mood with a 16-week early palliative care telehealth intervention. However, pain intensity and interference (secondary outcomes) demonstrated a clinically important improvement.