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Empirically-Based Recommendations for Recruitment of Community-Residing Youth into Randomized Clinical Trials. Therese S. Richmond PhD, CRNP, FAAN 1 Rose Cheney PhD 2 Liana Soyfer BA 3 Rebecca Kimmel BA 1 Adrian Raine D.Phil 2,3.
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Empirically-Based Recommendations for Recruitment of Community-Residing Youth into Randomized Clinical Trials Therese S. Richmond PhD, CRNP, FAAN1 Rose Cheney PhD2 Liana Soyfer BA3 Rebecca Kimmel BA1 Adrian Raine D.Phil2,3 1School of Nursing – Biobehavioral Research Center; 2Perelman School of Medicine; 3School of Arts & Sciences/ Criminology
Acknowledgments Funder: PA DOH 2008 Health Research Nonformula Grant Award* *This project is funded, in part, under a grant with the Pennsylvania Department of Health. The Department specifically disclaims responsibility for any analyses, interpretations or conclusions
Background • Violence is a priority public health problem1 • Studies to reduce violence require enrollment of community-residing individuals • Challenging • Data-driven recommendations to enhance recruitment are sparse • Inadequate sample sizes • Generalizability • Timely infusion of findings into practice 1Krug EG et al. (2002). World report on violence and health. Geneva: WHO.
Purpose • To analyze factors & strategies that affect successful recruitment of community-residing youth into RCTs requiring follow-up • Focus – 3 factors that may affect recruitment: • access to study information - recruitment sources, referrals, gatekeepers • minority status - race • personal costs to participate - time, transportation
Healthy Brains & Behavior 1. Assess risk factors in order to predict early adolescent violence 2. Identify factors that protect children socially at risk 3. Assess biosocial risk factors and efficacy of nutritional intervention in a mouse model 4. Develop a new biosocial approach for treatment of aggression 5. Test differential prediction and treatment of 2 variants of aggression Recruitment Subjects (mice) Intervention: Richmond, Cheney Biosocial Prediction:Raine, Gur Public Health Translation: Cheney, Fein, Richmond Genetic Mouse Model Brodkin Follow-up
Approach • Goal- 500 youth from Phila & contiguous zipcodes • 240 square miles, population 1.9 million with 70,000 11-12 year olds • Sampling Frame • 11-12 year old boys & girls • Behavior – ranging from developmentally appropriate to highly aggressive • Plan– enroll from the PhilaSchool District • Reality– Award budget cut by 20%; School District refused access
Recruitment Strategies • Targeted mailings • Study flyers • Cooperating organizations • In study newsletter • Posted & sent home • News/internet/public transportation ads • Referral incentive for current subjects • Incentives, expense reimbursement, bonuses
Data Sources • Recruitment log - ads (date, time, cost) • 2010 census data by zipcode • Travel - Google maps (time/distance) • Centroid of each zip code • Incentives • Recruitment log - contacts & enrollment
Analysis • Mail saturation rates (# of mailings/estimated population of 11-12 year olds in zip code) • Contact # (# of initial contacts to study) • Conversion rate (consented/contacts) • Personal costs1 (travel & opportunity) • Recruitment rate (#consents/11-12y in zip) • Recruitment efficiency (success & cost/source) • Modeled using linear regressions 1Stringer M et al. (2005). The cost of prenatal care attendance and pregnancy outcomes in low –income working women. Journal of Gynecologic & Neonatal Nursing, 34, 551-560.
Results • 1038 contacts yielded 354 (37%) consented subjects • 185 boys/169 girls; 84% Black • Recruitment rate • 1.5/week in first 6 months • Increased to 3.6/week, 9/week, 13.5/week over time as strategies synergistically overlapped & incentives increased
Recruitment Costs *n = 234 (of 354 participants) who provided information on referral source **Participants received $25 for personal referrals into the study
Travel Time & Recruitment Rate *county zip codes contiguous to Phila County
Contributors to Recruitment Rate N = 69 zip codes; R2 = 0.562 Non-significant to model - average household income & travel time by car
Conclusion • Recruitment of community-based youth into complex studies is challenging but can be successful with • careful planning of recruitment strategies • consideration of the personal costs of study participation • alignment of study incentives with personal costs • Targeted mailings proved to be the most efficient strategy in successful recruitment