Abstract
BackgroundPragmatic randomized clinical trials are essential to determine the effectiveness of interventions in “real-world” clinical practice. These trials frequently use a cluster-randomized methodology, with randomization at the site level. Despite policymakers’ increased interest in supporting pragmatic randomized clinical trials, no studies to date have reported on the unique recruitment challenges faced by cluster-randomized pragmatic trials. We investigated key challenges and successful strategies for hospital recruitment in the Comprehensive Post-Acute Stroke Services (COMPASS) study.MethodsThe COMPASS study is designed to compare the effectiveness of the COMPASS model versus usual care in improving functional outcomes, reducing the numbers of hospital readmissions, and reducing caregiver strain for patients discharged home after stroke or transient ischemic attack. This model integrates early supported discharge planning with transitional care management, including nurse-led follow-up phone calls after 2, 30, and 60 days and an in-person clinic visit at 7–14 days involving a functional assessment and neurological examination. We present descriptive statistics of the characteristics of successfully recruited hospitals compared with all eligible hospitals, reasons for non-participation, and effective recruitment strategies.ResultsWe successfully recruited 41 (43%) of 95 eligible North Carolina hospitals. Leading, non-exclusive reasons for non-participation included: insufficient staff or financial resources (n = 33, 61%), lack of health system support (n = 16, 30%), and lack of support of individual decision-makers (n = 11, 20%). Successful recruitment strategies included: building and nurturing relationships, engaging team members and community partners with a diverse skill mix, identifying gatekeepers, finding mutually beneficial solutions, having a central institutional review board, sharing published pilot data, and integrating contracts and review board administrators.ConclusionsAlthough we incorporated strategies based on the best available evidence at the outset of the study, hospital recruitment required three times as much time and considerably more staff than anticipated. To reach our goal, we tailored strategies to individuals, hospitals, and health systems. Successful recruitment of a sufficient number and representative mix of hospitals requires considerable preparation, planning, and flexibility. Strategies presented here may assist future trial organizers in implementing cluster-randomized pragmatic trials.Trial registrationClinicaltrials.gov, NCT02588664. Registered on 23 October 2015.
Highlights
Pragmatic randomized clinical trials are essential to determine the effectiveness of interventions in “real-world” clinical practice
Strategies for pragmatic site-level recruitment were not included in the Pragmatic Explanatory Continuum Indicator Summary (PRECIS)-2 report, and despite policymakers’ increased interest in supporting pragmatic randomized clinical trials, to our knowledge, no studies to date have reported on the unique recruitment challenges faced by cluster-randomized pragmatic trials [3, 4]
The 41 hospitals successfully recruited to participate in the Comprehensive PostAcute Stroke Services (COMPASS) study are distributed across North Carolina, with the majority located in the central “Piedmont” region, where much of the state’s population resides (Table 1)
Summary
Pragmatic randomized clinical trials are essential to determine the effectiveness of interventions in “real-world” clinical practice These trials frequently use a cluster-randomized methodology, with randomization at the site level. Despite policymakers’ increased interest in supporting pragmatic randomized clinical trials, no studies to date have reported on the unique recruitment challenges faced by cluster-randomized pragmatic trials. They provide high external validity without compromising internal validity but present unique challenges in design and implementation compared with traditional randomized clinical trials [1]. Strategies for pragmatic site-level recruitment were not included in the PRECIS-2 report, and despite policymakers’ increased interest in supporting pragmatic randomized clinical trials, to our knowledge, no studies to date have reported on the unique recruitment challenges faced by cluster-randomized pragmatic trials [3, 4]
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