Improving recruitment and retention rates in a randomized controlled trial

Abstract

High recruitment and retention rates in randomized controlled trials are essential to ensure validity and broad generalizability. We used quality improvement methods, including run charts and intervention cycles, to achieve and sustain high recruitment and retention rates during the Hospital-To-Home Outcomes randomized controlled trial. This study is examining the effects of a single nurse-led home health care visit after discharge for an acute pediatric hospitalization. A total of 1500 participants were enrolled in the 15-month study period. For study recruitment, we assessed the percentage of patients who enrolled in the study among those randomly selected to approach (goal ≥50%) and the percentage of patients who refused to enroll from those randomly selected to approach (goal ≤30%). For intervention completion, we examined the percentage of patients who completed the home visit intervention among those randomized to receive the intervention (goal ≥95%) were examined. Follow-up rates were tracked as the percentage of patients who completed the 14-day follow-up telephone survey (goal ≥95%). The study goals for 2 of the 4 metrics were met and sustained, with statistically significant improvements over time in 3 metrics. The median enrollment rate increased from 50% to 59%, and the median refusal rate decreased from 37% to 32%. The median intervention completion rate remained unchanged at 88%. The 14-day follow-up completion median rate increased from 94% to 96%. These results indicate that quality improvement methods can be used within the scope of a large research study to achieve and sustain high recruitment and retention rates.