Stakeholder-engaged process for refining the design of a clinical trial in home hospice

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.

A Rapid Review of the Factors That Influence Service User Involvement in Interprofessional Education, Practice, and Research

“…Germany [ 38 , 39 ] and the UK [ 40 , 41 ] had two publications each. Australia [ 42 ], Norway [ 43 ], Sweden [ 44 ], Switzerland [ 45 ], the USA [ 46 ], and Canada and the USA combined [ 47 ] had one publication each.…”

“…A spike to two to four publications was observed in 2014 [ 39 , 44 ], 2015 [ 34 , 42 , 43 , 47 ], and 2017 [ 35 , 36 ]. Subsequently, there was one publication in 2018 [ 37 ], and two in 2019 [ 33 , 45 ] and 2021 [ 32 , 46 ]. Overall, the number of publications on this topic over the last ten years appears to have risen and peaked in 2015, after which the numbers have lowered and remained steady.…”

“…One study did not thoroughly describe the process of study selection [ 34 ]. Seven studies utilized an inductive approach to data analysis [ 32 , 33 , 37 , 41 , 43 , 45 , 46 ]. Only one qualitative study identified the assumptions and biases of the researcher [ 32 ].…”

“…The study by Sæbjørnsen and Willumsen [ 43 ] engaged service users in a variety of ways including case conferences, evaluations, and roundtable discussions. Some studies outlined the involvement of service users in novel strategies such as a partnership group or model of care related to cancer care [ 41 ], and engagement in medication review [ 46 ].…”

“…Relationships : Poor relationships between patients and their care providers [ 42 ], conflicts [ 45 ], distrust in healthcare workers due to breach in confidentiality [ 43 ], and service users being a vulnerable group (e.g., palliative care patients; [ 46 ]) can all impede engagement and participation in IPECP.…”