Abstract
The Comprehensive Post-Acute Stroke Services (COMPASS) Study is one of the first large pragmatic randomized-controlled clinical trials using comparative effectiveness research methods, funded by the Patient-Centered Outcomes Research Institute. In the COMPASS Study, we compare the effectiveness of a patient-centered, transitional care intervention versus usual care for stroke patients discharged home from acute care. Outcomes include stroke patient post-discharge functional status and caregiver strain 90 days after discharge, and hospital readmissions. A central tenet of Patient-Centered Outcomes Research Institute-funded research is stakeholder engagement throughout the research process. However, evidence on how to successfully implement a pragmatic trial that changes systems of care in combination with robust stakeholder engagement is limited. This combination is not without challenges. We present our approach for broad-based stakeholder engagement in the context of a pragmatic trial with the participation of patients, caregivers, community stakeholders, including the North Carolina Stroke Care Collaborative hospital network, and policy makers. To maximize stakeholder engagement throughout the COMPASS Study, we employed a conceptual model with the following components: (1) Patient and Other Stakeholder Identification and Selection; (2) Patient and Other Stakeholder Involvement Across the Spectrum of Research Activities; (3) Dedicated Resources for Patient and Other Stakeholder Involvement; (4) Support for Patient and Other Stakeholder Engagement Through Organizational Processes; (5) Communication with Patients and Other Stakeholders; (6) Transparent Involvement Processes; (7) Tracking of Engagement; and (8) Evaluation of Engagement. In this paper, we describe how each component of the model is being implemented and how this approach addresses existing gaps in the literature on strategies for engaging stakeholders in meaningful and useful ways when conducting pragmatic trials.
Highlights
Engaging patients and other stakeholders in the continuum of biomedical research is a promising approach to creating more effective interventions and accelerating translation of effective interventions into practice [1,2,3,4,5,6]
The Comprehensive Post-Acute Stroke Services (COMPASS) model of care combines early supported discharge (ESD) with Centers for Medicare and Medicaid Services (CMS) transitional care services provided by advanced practice providers (APP) and ESD services coordinated by the APPs and adapted for the US health-care system
We developed an engagement database within the Research Electronic Data CAPture (REDCap) software system, a secure platform for research data collection and analyses developed within the Clinical and Translational Science Award network [21]
Summary
Engaging patients and other stakeholders in the continuum of biomedical research is a promising approach to creating more effective interventions and accelerating translation of effective interventions into practice [1,2,3,4,5,6]. Stakeholder engagement is a collaborative approach to research that values the unique perspectives and strengths of nontraditional research partners. It shares the spirit and goals of community-based participatory research (CBPR), but does not require the full model of CBPR as a starting point. Evidence on how to successfully implement a pragmatic trial that changes systems of care in combination with robust stakeholder engagement is limited.
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