Stakeholder-engaged process for refining the design of a clinical trial in home hospice.
Stakeholder-engaged process for refining the design of a clinical trial in home hospice.
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DOI：
10.1186/s12874-021-01275-0
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发表时间：
2021-04-30
影响因子：
4
通讯作者：
DeSanto-Madeya S
中科院分区：
文献类型：
--
作者：
Tjia J;Clayton M;Chiriboga G;Staples B;Puerto G;Rappaport L;DeSanto-Madeya S
家庭临终关怀环境中的临床试验对于建立实践证据基础很重要，但平衡临床试验对临床医生、患者和家庭护理人员的负担和益处具有挑战性。利益相关者参与的流程可以帮助告知和完善家庭临终关怀临床试验的关键方面。本研究的目的是描述利益相关者参与的过程，以完善、设计和实施家庭临终关怀教育干预试验的各个方面，包括改进干预内容和实施、招募和注册策略以及结果测量的内容和频率的建议。根据专业知识，系统地选择并邀请了一个由跨专业人士组成的小组（1 名临终关怀医院管理员、3 名护士、2 名医生、2 名药剂师）和 2 名前家庭护理人员利益相关者参加，代表 2 个参与临床试验的不同地理位置的临终关怀医院。电话会议遵循预定的程序顺序： 1. 会前材料分发和审查； 2. 会前通过电子邮件征求对材料的关注； 3. 电话会议，进行结构化和引导性讨论； 4. 记录和分发会议记录，以供准确性审查和未来会议指导。每次小组会议的讨论主题都有所不同。从小组成员那里收集了有关利益相关者参与流程的书面反思，以进一步完善我们的流程。最初的五次每两周一次的电话会议就招募策略、入组流程、测量频率、患者纳入以及患者参与试验的初级保健医生通知提出了建议。该小组继续参加季度电话会议，以审查进展情况以及意外的问题和担忧。小组成员的反思揭示了参与带来的个人和职业利益。跨专业的利益相关者流程对于开展家庭临终关怀干预研究、促进更好的科学、成功的试验实施以及相关的有效结果是可行且非常宝贵的。 ClinicalTrials.gov，NCT03972163，注册于 2019 年 6 月 3 日。
Clinical trials in home hospice settings are important to build the evidence base for practice, but balancing the burden and benefit of clinical trial conduct for clinicians, patients, and family caregivers is challenging. A stakeholder-engaged process can help inform and refine key aspects of home hospice clinical trials. The aim of this study was to describe a stakeholder-engaged process to refine, design, and implement aspects of an educational intervention trial in home hospice, including recommendations for refining intervention content and delivery, recruitment and enrollment strategies, and content and frequency of outcome measurement. A panel of interprofessional (1 hospice administrator, 3 nurses, 2 physicians, 2 pharmacists) and 2 former family caregiver stakeholders was systematically selected and invited to participate based on expertise, representing 2 geographically distinct hospices who were participating in the clinical trial. Teleconferences followed a predetermined procedural sequence: 1. pre-meeting materials distribution and review; 2. pre-meeting email solicitation of concerns in response to materials; 3. teleconference with structured and guided discussion; and 4. documentation and distribution of minutes for accuracy review and future meeting guidance. Discussion topics were distinct for each panel meeting. Written reflections on the stakeholder engagement process were collected from panel members to further refine our process. Five initial biweekly teleconferences resulted in recommendations for recruitment strategy, enrollment process, measurement frequency, patient inclusion, and primary care physician notification of the patient’s trial involvement. The panel continues to participate in quarterly teleconferences to review progress and unexpected questions and concerns. Panelist reflections reveal personal and professional benefit from participation. An interprofessional stakeholder process is feasible and invaluable for developing home hospice intervention studies, contributing to better science, successful trial implementation, and relevant, valid outcomes. Clinicaltrials.gov, NCT03972163, Registered June 3, 2019.
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