Recruitment and retention of participants in a pragmatic randomized intervention trial at three community health clinics: Results and lessons learned
Recruitment and retention of participants in a pragmatic randomized intervention trial at three community health clinics: Results and lessons learned
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DOI：
10.1186/1471-2458-13-192
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发表时间：
2013-03-06
影响因子：
4.5
通讯作者：
Colditz, Graham A.
中科院分区：
文献类型：
--
作者：
Warner, Erica T.;Glasgow, Russell E.;Colditz, Graham A.
背景：肥胖和高血压及其相关的健康并发症不成比例地影响有色人种和社会经济地位较低的人群。在研究试验中招募和保留这些人群，以及在减肥试验中保留这些人群一直是一个挑战。方法：Be Fit， Be Well是一项实用的随机减肥和高血压管理试验，患者在马萨诸塞州波士顿的三个社区卫生中心之一就诊。参与者被要求在两年内每6个月完成一次随访评估。我们描述了在24个月的干预中招募和留住试验参与者所遇到的挑战和实施的策略。我们还确定了与保留状态相关的基线参与者特征。保留策略包括财政激励、评估访问之间的联系、与卫生中心初级保健提供者（pcp）和工作人员建立关系以及将参与者的便利放在首位。结果：2631例患者中有130例拒绝参与（4.9%），积极拒绝率较低。在完成电话筛查的474名符合条件的人中，365人（77.0%）完成了基线访问，并被随机分配到研究中。研究人群主要是非西班牙裔黑人（71.2%），女性（68.5%），家庭年收入低于35000美元（70.1%）。招聘策略包括使用pcp对潜在参与者的被动批准，使用兼职员工，以及将呼叫外包给呼叫中心。共有314人（86.0%）完成了为期24个月的访问。保留水平在研究访问和干预条件下有所不同。大多数参与者完成了三次或更多的访问（69.6%），205人（56.2%）完成了全部四次访问。在24个月时，观察到男性和干预条件下的保留率较低。保留策略包括与诊所工作人员建立牢固的关系，通过使用出租车代金券、夜间和周末预约来灵活克服参与者障碍，以及通过新闻通讯和社交聚会保持参与者的参与。结论：我们能够在24个月时保留86.0%的参与者。通过规划、与可信赖的社区环境和工作人员（例如社区保健中心和社区保健中心）协调、适应能力和建立牢固的关系，可以招聘和保留高比例的种族/少数民族和低收入样本。
Background: Obesity and hypertension and their associated health complications disproportionately affect communities of color and people of lower socioeconomic status. Recruitment and retention of these populations in research trials, and retention in weight loss trials has been an ongoing challenge.Methods: Be Fit, Be Well was a pragmatic randomized weight loss and hypertension management trial of patients attending one of three community health centers in Boston, Massachusetts. Participants were asked to complete follow-up assessments every 6-months for two years. We describe challenges encountered and strategies implemented to recruit and retain trial participants over the 24-month intervention. We also identify baseline participant characteristics associated with retention status. Retention strategies included financial incentives, contact between assessment visits, building relationships with health center primary care providers (PCPs) and staff, and putting participant convenience first.Results: Active refusal rates were low with 130 of 2,631 patients refusing participation (4.9%). Of 474 eligible persons completing telephone screening, 365 (77.0%) completed their baseline visit and were randomized into the study. The study population was predominantly non-Hispanic Black (71.2%), female (68.5%) and reported annual household income of less than $35,000 (70.1%). Recruitment strategies included use of passive approval of potential participants by PCPs, use of part-time staff, and outsourcing calls to a call center. A total of 314 (86.0%) people completed the 24-month visit. Retention levels varied across study visits and intervention condition. Most participants completed three or more visits (69.6%), with 205 (56.2%) completing all four. At 24-months, lower retention was observed for males and the intervention condition. Retention strategies included building strong relationships with clinic staff, flexibility in overcoming participant barriers through use of taxi vouchers, night and weekend appointments, and keeping participants engaged via newsletters and social gatherings.Conclusion: We were able to retain 86.0% of participants at 24-months. Recruitment and retention of high percentages of racial/ethnic minorities and lower income samples is possible with planning, coordination with a trusted community setting and staff (e.g. community health centers and RAs), adaptability and building strong relationships.