ABSTRACT
BACKGROUND: 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. METHODS: 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. RESULTS: 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. CONCLUSIONS: 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. TRIAL REGISTRATION: Clinicaltrials.gov, NCT03972163 , Registered June 3, 2019.
