Recruitment strategy effectiveness for a cryotherapy intervention for a venous leg ulcer prevention study.

摘要

PURPOSE: To describe the strategies and costs associated with recruiting African American and white adults into a randomized controlled pilot trial. DESIGN: Cryotherapy for Venous Disorders: A Pilot Study trial designed to determine the effects of a cool gel wrap and leg elevation intervention versus a leg elevation alone intervention on skin temperature, skin microcirculation, quality of life, and pain in adults with stages 4 and 5 chronic venous disorders. We sought to recruit 60 participants (21 African Americans, 37 whites, and 2 Hispanic or Latino) to complete the study. These enrollment targets reflect the demographic distribution of the community in which the study was conducted (33% African American, 66% white, and 2% Latino). Proactive and reactive recruitment strategies were implemented to recruit subjects. RESULTS: Seventy-three individuals (9 African American men, 29 African American women, 11 white men, 22 white women, 1 Asian woman, and 1 Hispanic woman) were screened, and of those, 67 were randomized (9 African American men, 25 African American women, 9 white men, 22 white women, 1 Asian woman, and 1 Hispanic women). Fifty-eight completed the study, yielding an overall 11% attrition rate. An additional 8 subjects canceled or did not show up for a first appointment. Reactive recruitment strategies were most successful for recruiting men, women, African American, and white participants. The 3 most successful reactive strategies were referrals from providers/clinics (34%), flyers posted in the hospital elevators (22%), and targeted mailings from a business (16%). Of the healthcare provider referrals (19), wound care nurses referred 12 completed participants. The amount budgeted for advertisement was Dollars 5,000 (2% of the total grant award). The amount spent on recruitment including labor was Dollars 5,978, which averaged Dollars 103 per participant who completed the study (N = 58). Reactive strategies per participant completer proved more cost-efficient than proactive strategies (Dollars 83 vs Dollars 215). However, the time spent by the principal investigator (approximately 100 hours or 2.5 hours per week x 40 weeks) on recruitment, particularly maintaining frequent face-to-face contact with providers, increased success in the area of healthcare provider referrals. CONCLUSION: A variety of recruitment strategies are needed to ensure a diverse participant response to clinical research studies. As nurses become more involved in research activities, and particularly in recruitment, it is important to understand the most effective types of strategies and costs associated with these activities.