Shikany James M, Safford Monika M, Cherrington Andrea L, Halladay Jacqueline R, Anabtawi Muna, Richman Erica L, Adams Alyssa D, Holt Charlotte, Oparil Suzanne, Soroka Orysya, Cummings Doyle M
Division of Preventive Medicine, Heersink School of Medicine, University of Alabama at Birmingham, Birmingham, AL, USA.
Division of General Internal Medicine, Weill Cornell Medicine, New York, NY, USA.
Contemp Clin Trials Commun. 2023 Jan 16;32:101059. doi: 10.1016/j.conctc.2023.101059. eCollection 2023 Apr.
Racial disparities related to hypertension prevalence and control persist, with Black persons continuing to have both high prevalence and suboptimal control. The Black Belt region of the US Southeast is characterized by multiple critical priority populations: rural, low-income, and minority (Black).
In a cluster-randomized, controlled, pragmatic implementation trial, the Southeastern Collaboration to Improve Blood Pressure Control evaluated two multi-component, multi-level functional interventions - peer coaching (PC) and practice facilitation (PF) (separately and combined) - as adjuncts to usual care to improve blood pressure control in the Black Belt. The overall goal was to randomize 80 primary care practices (later reduced to 69 practices) in Alabama and North Carolina to one of four interventions: 1) enhanced usual care (EUC); 2) EUC plus PC; 3) EUC plus PF; or 4) EUC plus both PC and PF. Several measures to facilitate recruitment and retention of practices were employed, including practice readiness assessment.
Contact was initiated with 248 practices during the study enrollment period. Of these, 99 declined participation, 39 were ineligible, and 41 were being evaluated for inclusion when the target number of practices was reached. The remaining 69 practices eventually were enrolled, with 18 practices randomized to EUC, 19 to PC, 16 to PF, and 16 to PC plus PF. Only two practices (2.9%) were withdrawn during the study. Several facilitators of and barriers to practice recruitment and retention were identified.
Our findings underscore the importance of a structured approach to recruiting primary care practices in a pragmatic implementation trial.ClinicalTrials.gov registration number NCT02866669.
与高血压患病率和控制相关的种族差异依然存在，黑人的患病率和控制效果仍不理想。美国东南部的黑带地区有多个关键重点人群：农村、低收入和少数族裔（黑人）。
在一项整群随机、对照、务实的实施试验中，东南部改善血压控制协作组评估了两种多成分、多层次的功能性干预措施——同伴辅导（PC）和实践促进（PF）（单独及联合使用）——作为常规护理的辅助手段，以改善黑带地区的血压控制。总体目标是将阿拉巴马州和北卡罗来纳州的80家初级保健机构（后来减少到69家）随机分为四种干预措施之一：1）强化常规护理（EUC）；2）EUC加PC；3）EUC加PF；或4）EUC加PC和PF。采取了多项措施促进机构的招募和留存，包括评估机构的准备情况。
在研究招募期间，与248家机构进行了联系。其中，99家拒绝参与，39家不符合条件，在达到机构目标数量时，有41家正在评估是否纳入。其余69家机构最终被纳入，18家机构被随机分配到EUC组，19家到PC组，16家到PF组，16家到PC加PF组。研究期间只有两家机构（2.9%）退出。确定了机构招募和留存的几个促进因素和障碍。
我们的研究结果强调了在务实的实施试验中采用结构化方法招募初级保健机构的重要性。ClinicalTrials.gov注册号NCT02866669。
