Therese S. Richmond PhD, CRNP, FAAN1

Rose Cheney PhD2

Liana Soyfer BA3

Rebecca Kimmel BA1

Adrian Raine D.Phil2,3

EMPIRICALLY-BASED RECOMMENDATIONS FOR

RECRUITMENT OF COMMUNITY-RESIDING YOUTH INTO

RANDOMIZED CLINICAL TRIALS

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

1 Krug 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

Public Health Translation:

Cheney, Fein, Richmond

Public Health Translation:

Cheney, Fein, Richmond

Intervention:

Richmond, Cheney

Biosocial Prediction:Raine, Gur

Follow-up

Recruitment

4. Develop a new biosocial approach for treatment of aggression

1. Assess risk factors in order to predict early adolescent violence

2. Identify factors that protect children socially at risk

5. Test differential prediction and treatment of 2 variants of aggression

Genetic Mouse Model

Brodkin

Genetic Mouse Model

Brodkin

3. Assess biosocial risk factors and efficacy of nutritional intervention in a mouse model

Subjects (mice)

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 Phila School 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 COSTSSource Enrolled n (%)* Est. Cost (staff effort) Cost/Enrolled

Targeted mailings 73 (33%) $4,000 (low-med) $55

Community flyer 49 (22%) $360 (high) $7

Metro news ads 26 (12%) $2,200 (low) $85

Personal referral** 25 (11%) $625 (low) $25

Craigslist 18 (8%) $0 (low) $0

Healthcare providers 11 (5%) $0 (medium) $0

School targeted mailings 7 (3%) $340 (high) $49

Mass transit ads 5 (2%) $830 (low) $166

Other news ads 3 (1%) $410 (low) $137

Other 17 (8%) - -

*n = 234 (of 354 participants) who provided information on referral source**Participants received $25 for personal referrals into the study

TRAVEL TIME & RECRUITMENT RATE Region Est. Car Travel

Time (min)Est. Public Transit Travel Time (min)

# Youth Recruited

Recruitment Rate per 1,000

West Phila 8.6 21.4 143 14.5

Center City 10.1 17.0 0 0

South Phila 12.6 37.2 29 6.12

Lower North Phila 13.9 36.8 43 7.05

Upper North Phila 18.2 45.5 41 2.78

Northwest Phila 19.7 47.2 15 2.51

Northeast Phila 26.2 64.3 14 1.09

Delaware Cty* 16.0 37.4 43 6.83

Montgomery Cty* 26.3 60.0 10 1.58

Bucks Cty* 32.2 83.2 1 0.35

*county zip codes contiguous to Phila County

CONTRIBUTORS TO RECRUITMENT RATE

Variable B Beta SigTargeted mailing 0.015 0.419 0.001Travel time by public transit -0.087 -0.299 0.002% Black residing in zip code 3.516 0.200 0.048

N = 69 zip codes; R2 = 0.562Non-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