BACKGROUND Heart failure (HF) afflicts 6.5 million Americans with devastating consequences to patients and their family caregivers. Families are rarely prepared for worsening HF and are not informed about end-of-life and palliative care (EOLPC) conservative comfort options especially during the end stage. West Virginia (WV) has the highest rate of HF deaths in the U.S. where 14% of the population over 65 years have HF. Thus, there is a need to investigate a new family EOLPC intervention (FamPALcare), where nurses coach family-managed advanced HF care at home. METHODS This study uses a randomized controlled trial (RCT) design stratified by gender to determine any differences in the FamPALcare HF patients and their family caregiver outcomes versus standard care group outcomes (N = 72). Aim 1 is to test the FamPALcare nursing care intervention with patients and family members managing home supportive EOLPC for advanced HF. Aim 2 is to assess implementation of the FamPALcare intervention and research procedures for subsequent clinical trials. Intervention group will receive routine standard care, plus 5-weekly FamPALcare intervention delivered by community-based nurses. The intervention sessions involve coaching patients and family caregivers in advanced HF home care and supporting EOLPC discussions based on patients' preferences. Data are collected at baseline, 3, and 6 months. Recruitment is from sites affiliated with a large regional hospital in WV and community centers across the state. DISCUSSION The outcomes of this clinical trial will result in new knowledge on coaching techniques for EOLPC and approaches to palliative and end-of-life rural home care. The HF population in WV will benefit from a reduction in suffering from the most common advanced HF symptoms, selecting their preferred EOLPC care options, determining their advance directives, and increasing skills and resources for advanced HF home care. The study will provide a long-term collaboration with rural community leaders, and collection of data on the implementation and research procedures for a subsequent large multi-site clinical trial of the FamPALcare intervention. Multidisciplinary students have opportunity to engage in the research process. TRIAL REGISTRATION ClinicalTrials.gov NCT04153890, Registered on 4 November 2019.

中文翻译：

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阿巴拉契亚农村晚期心力衰竭患者及其家庭护理人员临终姑息治疗指导的研究方案：一项随机对照试验。

背景技术 心力衰竭 (HF) 困扰着 650 万美国人，给患者及其家庭护理人员带来毁灭性后果。家庭很少对心力衰竭恶化做好准备，也不了解临终关怀和姑息治疗 (EOLPC) 保守舒适选择，尤其是在最后阶段。西弗吉尼亚州 (WV) 是美国心力衰竭死亡率最高的地区，65 岁以上人口中有 14% 患有心力衰竭。因此，有必要研究一种新的家庭 EOLPC 干预措施 (FamPALcare)，护士在家中指导家庭管理的高级心力衰竭护理。方法 本研究采用按性别分层的随机对照试验 (RCT) 设计，以确定 FamPALcare 心力衰竭患者及其家庭护理人员结果与标准护理组结果 (N = 72) 之间的差异。目标 1 是测试 FamPALcare 护理干预措施，让患者和家庭成员对晚期心力衰竭进行家庭支持性 EOLPC。目标 2 是评估 FamPALcare 干预措施的实施情况和后续临床试验的研究程序。干预组将接受常规标准护理，以及由社区护士提供的每 5 周一次的 FamPALcare 干预。干预课程包括指导患者和家庭护理人员进行高级心力衰竭家庭护理，并根据患者的喜好支持 EOLPC 讨论。数据在基线、3 个月和 6 个月时收集。招聘是从西弗吉尼亚州一家大型地区医院和全州社区中心的附属网站进行的。讨论 这项临床试验的结果将带来关于 EOLPC 辅导技术以及姑息和临终农村家庭护理方法的新知识。西弗吉尼亚州的心力衰竭人群将受益于减少最常见的晚期心力衰竭症状、选择他们首选的 EOLPC 护理方案、确定他们的预先指示以及增加高级心力衰竭家庭护理的技能和资源。该研究将与农村社区领导人进行长期合作，并收集有关 FamPALcare 干预措施后续大型多中心临床试验的实施和研究程序的数据。多学科学生有机会参与研究过程。试验注册 ClinicalTrials.gov NCT04153890，于 2019 年 11 月 4 日注册。