Abstract
BackgroundThe Fred Hutchinson Cancer Research Center has engaged an External Stakeholder Advisory Group (ESAG) in the planning and implementation of the TrACER Study (S1415CD), a five-year pragmatic clinical trial assessing the effectiveness of a guideline-based colony stimulating factor standing order intervention. The trial is being conducted by SWOG through the National Cancer Institute Community Oncology Research Program in 45 clinics. The ESAG includes ten patient partners, two payers, two pharmacists, two guideline experts, four providers and one medical ethicist. This manuscript describes the ESAG’s role and impact on the trial.MethodsDuring early trial development, the research team assembled the ESAG to inform plans for each phase of the trial. ESAG members provide feedback and engage in problem solving to improve trial implementation. Each year, members participate in one in-person meeting, web conferences and targeted email discussion. Additionally, they complete a survey that assesses their satisfaction with communication and collaboration. The research team collected and reviewed stakeholder input from 2014 to 2018 for impact on the trial.ResultsThe ESAG has informed trial design, implementation and dissemination planning. The group advised the trial’s endpoints, regimen list and development of cohort and usual care arms. Based on ESAG input, the research team enhanced patient surveys and added pharmacy-related questions to the component application to assess order entry systems. ESAG patient partners collaborated with the research team to develop a patient brochure and study summary for clinic staff. In addition to identifying recruitment strategies and patient-oriented platforms for publicly sharing results, ESAG members participated as co-authors on this manuscript and a conference poster presentation highlighting stakeholder influence on the trial. The annual satisfaction survey results suggest that ESAG members were satisfied with the methods, frequency and target areas of their engagement in the trial during project years 1–3.ConclusionsDiverse stakeholder engagement has been essential in optimizing the design, implementation and planned dissemination of the TrACER Study. The lessons described in the manuscript may assist others to effectively partner with stakeholders on clinical research.
Highlights
The Fred Hutchinson Cancer Research Center has engaged an External Stakeholder Advisory Group (ESAG) in the planning and implementation of the TrACER Study (S1415CD), a five-year pragmatic clinical trial assessing the effectiveness of a guideline-based colony stimulating factor standing order intervention
The ESAG is comprised of 21 national leaders from 14 different states and territories in the United States, including ten patient partners, two payers, two pharmacists, two guideline experts, four providers and one medical ethicist
In alignment with Patient-Centered Outcomes Research Institute (PCORI)’s compensation framework [22], patient partners received financial compensation for their time and effort as study advisors and were reimbursed for all costs related to travel to ESAG meetings
Summary
The Fred Hutchinson Cancer Research Center has engaged an External Stakeholder Advisory Group (ESAG) in the planning and implementation of the TrACER Study (S1415CD), a five-year pragmatic clinical trial assessing the effectiveness of a guideline-based colony stimulating factor standing order intervention. The ESAG includes ten patient partners, two payers, two pharmacists, two guideline experts, four providers and one medical ethicist This manuscript describes the ESAG’s role and impact on the trial. Recognition of the value and importance of integrating stakeholder engagement into comparative effectiveness research (CER) and patient-centered outcomes research (PCOR) to improve health care delivery continues to grow [1, 2]. The purpose of this manuscript is to describe one model for longitudinal stakeholder engagement that has been effectively implemented to support a pragmatic clinical trial in cancer care delivery
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