Study shows novel strategic framework improves retention of minority, low-income children

Recruiting and retaining minority participants in randomized, controlled trials (RCTs) continue to be major challenges for researchers. A new study published in the scientific journal, Contemporary Clinical Trials Communications, showed that innovative strategies used in the Kids' HELP (Health Insurance by Educating Lots of Parents) trial resulted in significantly better retention of minority, low-income children.

"Previous studies have documented the challenge of lower minority trial enrollment, but little is known about how to retain minority participants in clinical trials," says Dr. Glenn Flores, Distinguished Chair of Health Policy Research and lead author of the study. "Our objective in this study was to develop, implement, and evaluate a new approach to retention of minority children, and to identify child and caregiver characteristics that predict attrition in RCTs.

This study is part of the larger Kids' HELP trial, aimed at evaluating whether parent mentors are more cost effective than traditional Medicaid and Children's Health Insurance Program (CHIP) outreach and enrollment methods in insuring eligible, uninsured Latino and African-American children.

The researchers developed a framework for maximizing retention in the Kids' HELP RCT based on their experience with attrition in two previous RCTs, which included the following strategies:

• Optimize cultural and linguistic competency
• Emphasize participant relationships and trust in research staff training
• Develop comprehensive contact information for participants and their relatives, friends, andneighbors
• Utilize an electronic tracking database
• Send reminders for upcoming outcomes-assessment appointments
• Offer incentives for every survey completed
• Take an individualized rapid-cycle quality-improvement approach to non-respondents
• Reinforce the importance of the study
• Visit participant homes as a last resort

Researchers found that the attrition rate in the Kids' HELP trial was only 11 percent, significantly lower than in two previous similar trials, which had 37 percent and 40 percent attrition rates. Analyses also revealed that missing the first follow-up outcomes assessment was a significant risk factor for future attrition, and that maternal age, marital status, and number of children in the household were not significantly associated with attrition.Researchers identified the following five elements as most important in minimizing attrition:

• Build participant relationships and trust through culturally competent interactions with research staff from the same racial and ethnic backgrounds as participating families
• Maintain persistent communication with participants by leveraging multiple possible modes of contact
• Reinforce the importance of the study to children, families, and communities
• Utilize a systematic, electronic approach to tracking and following participants, especially thoseat highest risk for attrition
• Employ a rapid-cycle quality improvement approach to non-respondents

"The retention strategies implemented and evaluated in our study were highly effective in retaining low-income minority children, who are traditionally at highest risk for attrition in clinical trials," stated Dr. Flores. "Recruiting and retaining diverse populations in clinical trials are important steps in eliminating health disparities that exist in research, healthcare, and population health."