Aim: To pilot test a home end-of-life and palliative care intervention for family caregivers and patients with rare advanced lung diseases and to estimate effect-size for the power analysis in a future clinical trial.
Design: This study uses a parallel randomized control trial. Families are randomly assigned to the intervention group or the control group in a 1:1 fashion.
Methods: The study population includes patients with rare advanced lung diseases and their family caregivers who are involved in patients' home care. The control group receives standard care through their hospital or outpatient clinics. The intervention group receives standard care plus 2-weekly home end-of-life and palliative care coaching by experienced community nurses. Primary outcome is breathlessness measured by shortness of breath scale. Secondary outcomes are: (a) caregivers' anxiety and depression measures; (b) the presence of patient's signed advance directives in the medical record or not; and (c) Helpfulness of intervention measured by self-report Helpfulness scale. The study was funded in October 2018 and received ethical Institutional Review Board approval in February 2019.
Discussion: West Virginia has one of the highest incidence rates of lung disease deaths in the nation. However, there is inadequate home end-of-life and palliative care for this underserved population. This is an initial interventional study of nurse-led coaching home-based palliative care for rare advanced lung diseases in rural Appalachia. Developing research collaboration with clinicians is essential for enrolment. Enrolment was successful due to regular meetings with pulmonologists who screened patients per the study inclusion criteria in their specialty clinic and made direct referrals to the research assistants. Results of this study will be used in the future trial.
Impact: The findings will contribute to the evidence-based home nursing care, planning for family/patient preferences and supportive end-of-life palliative care for managing advanced lung diseases at home.
Trial registration: ClinicalTrials.gov identifier NCT03813667; registered January 23, 2019. https://clinicaltrials.gov/ct2/show/NCT03813667.
目的: 本研究旨在初步检验针对家庭护理人员和罕见晚期肺疾病患者的家庭临终和姑息治疗干预措施,并评估效应量,以便在未来临床试验中进行功效分析。 设计: 本研究采用平行随机对照试验。家庭以1:1的方式随机分配到干预组或对照组。 方法: 研究对象包括罕见晚期肺疾病患者及其参与患者家庭护理的家庭护理人员。对照组受试者通过其医院或门诊接受标准护理。干预组受试者接受标准护理,加上由经验丰富的社区护士提供的两周一次的家庭临终关怀和姑息治疗指导。主要预后是利用呼吸急促量表测量是否呼吸困难。次要预后是:(a)护理人员的焦虑和抑郁指标;(b)病历中是否存在患者签署的预先指示;以及(c)通过自我报告有用性量表,衡量干预措施的有用性。本研究于2018年10月获得资助,并于2019年2月获得伦理机构审查委员会的批准。 讨论: 西弗吉尼亚州是全美肺病死亡发病率最高的地区之一。然而,针对这一缺医少药的群体,并未提供足够的家庭临终关怀和姑息治疗。这是一项关于在阿巴拉契亚农村地区对罕见的晚期肺疾病的护士指导型家庭姑息治疗的初步干预研究。在(受试者)入选方面,与临床医生建立研究合作关系至关重要。鉴于会与那些在专业诊所根据研究纳入标准筛选患者且将患者直接转诊给研究助理的肺科医生定期会面,因此可成功入选。本研究结果将用于未来试验。 影响: 对于循证型家庭护理、家属/患者偏好的规划以及家庭晚期肺疾病管理支持性临终姑息护理,本研究结果是有用的。 试验注册: ClinicalTrials.gov标识符NCT03813667;注册日期:2019年1月23日。https://clini caltr ials.gov/ct2/show/NCT03 813667.
Keywords: advance directives; advanced lung diseases; end-of-life care; nursing intervention; palliative.
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