Johnson Anna M, Jones Sara B, Duncan Pamela W, Bushnell Cheryl D, Coleman Sylvia W, Mettam Laurie H, Kucharska-Newton Anna M, Sissine Mysha E, Rosamond Wayne D
Department of Epidemiology, University of North Carolina Gillings School of Global Public Health, 2101 McGavran-Greenberg Hall, CB #7435, Chapel Hill, NC, 27599-7435, USA.
Department of Neurology, Wake Forest School of Medicine, Medical Center Blvd, Winston-Salem, NC, 27157, USA.
Trials. 2018 Jan 26;19(1):74. doi: 10.1186/s13063-017-2434-1.
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. We investigated key challenges and successful strategies for hospital recruitment in the Comprehensive Post-Acute Stroke Services (COMPASS) study.
The 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.
We 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.
Although 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.
Clinicaltrials.gov, NCT02588664 . Registered on 23 October 2015.
实用随机临床试验对于确定干预措施在“现实世界”临床实践中的有效性至关重要。这些试验经常采用整群随机方法，在机构层面进行随机分组。尽管政策制定者对支持实用随机临床试验的兴趣日益浓厚，但迄今为止尚无研究报告整群随机实用试验所面临的独特招募挑战。我们在综合急性卒中后服务（COMPASS）研究中调查了医院招募的关键挑战和成功策略。
COMPASS研究旨在比较COMPASS模式与常规护理在改善功能结局、减少医院再入院次数以及减轻卒中或短暂性脑缺血发作后出院回家患者的照料者负担方面的有效性。该模式将早期支持性出院计划与过渡性护理管理相结合，包括在第2天、30天和60天由护士主导的随访电话，以及在第7 - 14天进行的包含功能评估和神经学检查的门诊就诊。我们展示了成功招募的医院与所有符合条件医院的特征描述性统计数据、未参与的原因以及有效的招募策略。
我们成功招募了北卡罗来纳州95家符合条件医院中的41家（43%）。未参与的主要非排他性原因包括：工作人员或财政资源不足（n = 33，61%）、缺乏卫生系统支持（n = 16，30%）以及缺乏个人决策者的支持（n = 11，20%）。成功的招募策略包括：建立和培养关系、让具有不同技能组合的团队成员和社区合作伙伴参与、确定把关人、找到互利的解决方案、设立中央机构审查委员会、分享已发表的试点数据以及整合合同和审查委员会管理人员。
尽管我们在研究开始时就纳入了基于现有最佳证据的策略，但医院招募所需的时间是预期的三倍，工作人员也比预期多得多。为了实现我们的目标，我们针对个人、医院和卫生系统调整了策略。成功招募足够数量且具有代表性的医院组合需要大量的准备、规划和灵活性。这里介绍的策略可能有助于未来的试验组织者开展整群随机实用试验。
Clinicaltrials.gov，NCT02588664。于2015年10月23日注册。
