Effective recruitment for practice-based research: Lessons from the REAL HEALTH-Diabetes Study

Valerie Goldman, Amy Dushkin, Deborah J Wexler, Yuchiao Chang, Bianca Porneala, Laurie Bissett, Jeanna McCarthy, Anthony Rodriguez, Barbara Chase, Rajani LaRocca, Amy Wheeler, Linda M Delahanty, Valerie Goldman, Amy Dushkin, Deborah J Wexler, Yuchiao Chang, Bianca Porneala, Laurie Bissett, Jeanna McCarthy, Anthony Rodriguez, Barbara Chase, Rajani LaRocca, Amy Wheeler, Linda M Delahanty

Abstract

Background: 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.

Methods: 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.

Results: 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%).

Conclusions: 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.

Clinical trial registration: NCT02320253.

Keywords: Complex behavioral intervention; Lifestyle intervention; Population health registries; Practice-based clinical trial; Practice-based research; Primary care; Recruitment strategies; Weight loss interventions.

Figures

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Fig. 1
Recruitment funnel.

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Source: PubMed

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