School of Nursing and Department of Medicine, Division of Gerontology, Geriatrics, and Palliative Care, University of Alabama at Birmingham, Birmingham, AL, USA.
School of Nursing, University of Alabama at Birmingham, 1720 2nd Ave South, MT 412C, Birmingham, AL, 35294, USA.
BMC Palliat Care. 2017 Aug 31;16(1):45. doi: 10.1186/s12904-017-0226-8.
Early palliative care (EPC) is recommended but rarely integrated with advanced heart failure (HF) care. We engaged patients and family caregivers to study the feasibility and site differences in a two-site EPC trial, ENABLE CHF-PC (Educate, Nurture, Advise, Before Life Ends Comprehensive Heartcare for Patients and Caregivers).
We conducted an EPC feasibility study (4/1/14-8/31/15) for patients with NYHA Class III/IV HF and their caregivers in academic medical centers in the northeast and southeast U.S. The EPC intervention comprised: 1) an in-person outpatient palliative care consultation; and 2) telephonic nurse coach sessions and monthly calls. We collected patient- and caregiver-reported outcomes of quality of life (QOL), symptom, health, anxiety, and depression at baseline, 12- and 24-weeks. We used linear mixed-models to assess baseline to week 24 longitudinal changes.
We enrolled 61 patients and 48 caregivers; between-site demographic differences included age, race, religion, marital, and work status. Most patients (69%) and caregivers (79%) completed all intervention sessions; however, we noted large between-site differences in measurement completion (38% southeast vs. 72% northeast). Patients experienced moderate effect size improvements in QOL, symptoms, physical, and mental health; caregivers experienced moderate effect size improvements in QOL, depression, mental health, and burden. Small-to-moderate effect size improvements were noted in patients' hospital and ICU days and emergency visits.
Between-site demographic, attrition, and participant-reported outcomes highlight the importance of intervention pilot-testing in culturally diverse populations. Observations from this pilot feasibility trial allowed us to refine the methodology of an in-progress, full-scale randomized clinical efficacy trial.
Clinicaltrials.gov NCT03177447 (retrospectively registered, June 2017).
早期姑息治疗（EPC）已被推荐，但很少与晚期心力衰竭（HF）治疗相结合。我们让患者及其家属参与，以研究在两个地点进行 EPC 试验的可行性和地点差异，该试验为 ENABLE CHF-PC（在生命结束之前为患者及其照顾者提供全面的心脏病护理，包括教育、培养、建议和照顾）。
我们在美国东北部和东南部的学术医疗中心对 NYHA 分级 III/IV 级 HF 患者及其照顾者进行了一项 EPC 可行性研究（2014 年 4 月 1 日至 2015 年 8 月 31 日）。EPC 干预措施包括：1）门诊姑息治疗咨询；2）电话护士教练会议和每月电话。我们收集了基线、12 周和 24 周时患者和照顾者报告的生活质量（QOL）、症状、健康、焦虑和抑郁的结果。我们使用线性混合模型评估了从基线到 24 周的纵向变化。
我们招募了 61 名患者和 48 名照顾者；两个地点的人口统计学差异包括年龄、种族、宗教、婚姻和工作状况。大多数患者（69%）和照顾者（79%）完成了所有干预课程；然而，我们注意到测量完成方面存在很大的地点差异（东南部为 38%，东北部为 72%）。患者在 QOL、症状、身体和心理健康方面的改善具有中等效果大小；照顾者在 QOL、抑郁、心理健康和负担方面的改善具有中等效果大小。患者的住院和 ICU 天数以及急诊就诊次数也有小到中等程度的改善。
地点之间的人口统计学、退出和参与者报告的结果突出了在文化多样化人群中进行干预试验的重要性。这项初步可行性试验的观察结果使我们能够改进正在进行的全面随机临床疗效试验的方法。
Clinicaltrials.gov NCT03177447（回顾性注册，2017 年 6 月）。
