Abstract
BackgroundClinical 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.MethodsA 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.ResultsFive 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.ConclusionsAn 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 registrationClinicaltrials.gov, NCT03972163, Registered June 3, 2019.
Highlights
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
Clinical trials in home hospice are critical to building the evidence base for practice
Balancing the burden and benefit of clinical trial conduct for clinicians, patients, and family caregivers is an ongoing challenge. This challenge is even more complex when designing a feasible study to be executed in home hospice that engages hospice patients and their family caregivers and presents an ideal situation for meaningful stakeholder engagement
Summary
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. 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. Balancing the burden and benefit of clinical trial conduct for clinicians, patients, and family caregivers is an ongoing challenge This challenge is even more complex when designing a feasible study to be executed in home hospice that engages hospice patients and their family caregivers and presents an ideal situation for meaningful stakeholder engagement. Questions to be addressed include: the optimal design of a high-yield, low burden, clinical workflow-friendly approach to family caregiver-patient recruitment at hospice admission; selection and frequency of appropriate family caregivers and patient outcome measures; and heterogeneity of hospice team interactions that affect research implementation across different hospice sites
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