Goldman Valerie, Dushkin Amy, Wexler Deborah J, Chang Yuchiao, Porneala Bianca, Bissett Laurie, McCarthy Jeanna, Rodriguez Anthony, Chase Barbara, LaRocca Rajani, Wheeler Amy, Delahanty Linda M
Massachusetts General Hospital (MGH) Diabetes Research Center, MGH Diabetes Unit, Department of Medicine, Boston, MA, USA.
Harvard Medical School, Boston, MA, USA.
Contemp Clin Trials Commun. 2019 May 1;15:100374. doi: 10.1016/j.conctc.2019.100374. eCollection 2019 Sep.
Aims: The REAL HEALTH Diabetes Study is a practice-based randomized clinical trial that compares the effectiveness of lifestyle intervention aimed at weight reduction to medical nutrition therapy in primary care patients with type 2 diabetes. This paper describes a tiered approach to recruitment, the resultant enrollment rates of sequentially more intensive recruitment strategies, and identifies barriers to participation.
Potential participants were identified using patient health registries and classified by recruitment site. Four recruitment strategies were used to achieve target enrollment: (1) mail/telephone outreach; (2) direct referral from providers; (3) orientation sessions; and (4) media/advertising. Reasons for ineligibility and non-participation were tracked.
Fifteen thousand two hundred sixty-nine (15,269) potential participants were identified from all sources, with the clear majority coming from patient registries. Mail/telephone outreach alone had the lowest enrollment rate (1.2%). Direct referral and orientation sessions superimposed on mail/telephone outreach was used for fewer participants but had greater enrollment rates (27% and 52%.) Media/advertising was ineffective. The most commonly reported reasons for non-participation were not wanting to be in a research (30%) or a weight loss program (22%); time commitment (20%); and distance/transportation (14%).
The use of population registries to identify potential participants coupled with successively more intensive recruitment strategies, executed in a tiered approach moving toward personal engagement to establish trust and credibility, maximized recruitment enrollment rates. Our findings regarding facilitators and barriers to recruitment could be used to inform other practice-based research or to engage patients in group interventions in usual care settings.
NCT02320253.
目的：“真实健康糖尿病研究”是一项基于实践的随机临床试验，旨在比较针对2型糖尿病初级护理患者的以减重为目标的生活方式干预与医学营养治疗的效果。本文描述了一种分层招募方法、相继采用的更强化招募策略所产生的入组率，并确定了参与的障碍。
利用患者健康登记册识别潜在参与者，并按招募地点进行分类。采用四种招募策略以实现目标入组人数：（1）邮件/电话 outreach；（2）提供者直接转诊；（3）介绍会；（4）媒体/广告。跟踪不符合资格和不参与的原因。
从所有来源共识别出15269名潜在参与者，其中绝大多数来自患者登记册。仅邮件/电话outreach的入组率最低（1.2%）。叠加在邮件/电话outreach上的直接转诊和介绍会针对的参与者较少，但入组率更高（分别为27%和52%）。媒体/广告无效。最常报告的不参与原因是不想参加研究（30%）或减肥计划（22%）；时间投入（20%）；以及距离/交通（14%）。
利用人群登记册识别潜在参与者，再加上相继采用更强化的招募策略，以分层方式逐步实现个人参与以建立信任和信誉，可使招募入组率最大化。我们关于招募促进因素和障碍的研究结果可用于为其他基于实践的研究提供信息，或促使患者参与常规护理环境中的团体干预。
NCT02320253 。 （注：“outreach”未找到完全匹配的准确中文释义，暂保留英文）
