美国阿巴拉契亚地区医疗服务欠缺地区罕见晚期肺病的姑息治疗：一项随机对照试验的研究方案

Palliative care for rare advanced lung diseases in underserved Appalachia: Study protocol for a randomized controlled trial.

作者信息

Piamjariyakul Ubolrat, Smothers Angel, Young Stephanie, Petitte Trisha, Wen Sijin, Morrissey Elizabeth, Shafique Saima, Zulfikar Rafia, Sangani Rahul, Smith Carol E

机构信息

School of Nursing, West Virginia University, Morgantown, WV, USA.

Department of Biostatistics School of Public Health, West Virginia University, Morgantown, WV, USA.

出版信息

J Adv Nurs. 2020 Aug;76(8):2182-2190. doi: 10.1111/jan.14395. Epub 2020 May 2.

DOI:10.1111/jan.14395

PMID:32297352

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC7572472/

Abstract

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.

摘要

目的

对针对患有罕见晚期肺部疾病的家庭照顾者和患者的居家临终关怀与姑息治疗干预措施进行试点测试，并为未来的临床试验估计功效分析的效应大小。

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

研究人群包括患有罕见晚期肺部疾病的患者及其参与患者居家护理的家庭照顾者。对照组通过医院或门诊接受标准护理。干预组在接受标准护理的基础上，由经验丰富的社区护士每两周进行一次居家临终关怀与姑息治疗指导。主要结局是通过气短量表测量的呼吸困难。次要结局包括：（a）照顾者的焦虑和抑郁测量；（b）病历中是否有患者签署的预立医疗指示；（c）通过自我报告的帮助程度量表测量的干预措施的帮助程度。该研究于2018年10月获得资助，并于2019年2月获得机构伦理审查委员会的批准。

讨论

西弗吉尼亚州是美国肺病死亡率最高的地区之一。然而，对于这一服务不足的人群，居家临终关怀与姑息治疗却不足。这是一项针对阿巴拉契亚农村地区罕见晚期肺部疾病的由护士主导的居家姑息治疗指导的初步干预研究。与临床医生开展研究合作对于招募患者至关重要。由于与肺科医生定期会面，肺科医生在其专科诊所按照研究纳入标准对患者进行筛查并直接转介给研究助理，因此招募工作取得了成功。本研究的结果将用于未来的试验。