School of Nursing, University of Alabama at Birmingham, Birmingham.
Division of Gerontology, Geriatrics and Palliative Care, UAB Center for Palliative and Supportive Care, Department of Medicine, University of Alabama at Birmingham, Birmingham.
JAMA Intern Med. 2020 Sep 1;180(9):1203-1213. doi: 10.1001/jamainternmed.2020.2861.
National guidelines recommend early palliative care for patients with advanced heart failure, which disproportionately affects rural and minority populations.
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.
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.
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).
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]).
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.
ClinicalTrials.gov Identifier: NCT02505425.
重要性：国家指南建议为晚期心力衰竭患者提供早期姑息治疗，而这些患者在农村和少数族裔人群中不成比例地受到影响。
目的：确定一项为期 16 周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、地点和参与者：这是一项单盲、干预与常规护理的随机临床试验，于 2015 年 10 月 1 日至 2019 年 5 月 31 日在一家大型美国东南部学术三级医疗中心和一家为大量农村居民和非裔美国人服务的退伍军人事务医疗中心进行，共纳入 415 名 50 岁及以上、纽约心脏协会 III 或 IV 级心力衰竭或美国心脏病学会 C 或 D 级心力衰竭的患者。
干预措施：ENABLE CHF-PC（为患者和护理人员提供全面的临终关怀教育、培养、建议）干预包括一次面对面的姑息治疗咨询和 6 次每周由护士教练进行的电话会议（20-40 分钟），以及每月随访 48 周。
主要结果和措施：主要结果是生活质量（通过堪萨斯城心肌病问卷[KCCQ]衡量：评分范围 0-100；分数越高表示健康状况越好，临床总结评分≥50 被认为是“相当好”的生活质量；以及慢性疾病治疗-姑息治疗功能评估-14 项[FACIT-Pal-14]：评分范围 0-56；分数越高表示生活质量越好）和情绪（通过医院焦虑和抑郁量表[HADS]衡量）在 16 周内的变化。次要结果是整体健康（患者报告的结果测量系统整体健康）、疼痛（患者报告的结果测量系统疼痛强度和干扰）和资源利用（住院天数和急诊就诊次数）。
结果：在 415 名参与者（221 名男性；基线平均[SD]年龄 63.8[8.5]岁）中，随机分配到 ENABLE CHF-PC 组（n=208）或常规护理组（n=207），226 名（54.5%）为非裔美国人，108 名（26.0%）居住在农村地区，190 名（45.8%）受教育程度为高中或以下，基线 KCCQ 平均（SD）得分为 52.6（21.0）。在第 16 周时，干预组的 KCCQ 评分平均（SE）提高了 3.9（1.3）分，而常规护理组提高了 2.3（1.2）分（差异，1.6；SE，1.7；d=0.07[95%CI，-0.09 至 0.24]），而 FACIT-Pal-14 评分平均（SE）提高了 1.4（0.6）分，干预组提高了 0.2（0.5）分（差异，1.2；SE，0.8；d=0.12[95%CI，-0.03 至 0.28]）。两组之间在情绪（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]）方面没有显著差异。
结论和相关性：这项随机临床试验的参与者主要为非裔美国人，基线生活质量较好，结果显示，16 周的早期姑息治疗远程医疗干预并没有改善生活质量或情绪。然而，疼痛强度和干扰（次要结果）显示出了有临床意义的改善。
试验注册：ClinicalTrials.gov 标识符：NCT02505425。
