Improving Recruitment and Retention Rates in a Randomized Controlled Trial

Area of Science:

• Clinical Research
• Quality Improvement Science
• Health Services Research

Background:

• High participant recruitment and retention are critical for the validity and generalizability of randomized controlled trials (RCTs).
• Sustaining these rates can be challenging in large-scale studies.

Purpose of the Study:

• To implement and evaluate quality improvement (QI) methods to enhance recruitment and retention in the Hospital-To-Home Outcomes RCT.
• To assess the impact of QI methods on enrollment, refusal, intervention completion, and follow-up rates.

Main Methods:

• Utilized QI methods, including run charts and intervention cycles, within a large pediatric RCT.
• Monitored four key metrics: enrollment rate, refusal rate, intervention completion rate, and 14-day follow-up completion rate.

Main Results:

• Achieved and sustained target goals for 2 of 4 metrics, with statistically significant improvements in 3 metrics over time.
• Median enrollment rate increased from 50% to 59%; median refusal rate decreased from 37% to 32%.
• Median 14-day follow-up completion rate improved from 94% to 96%, though intervention completion remained at 88%.

Conclusions:

• Quality improvement methods are effective tools for improving and sustaining high recruitment and retention rates in clinical research.
• QI strategies can be successfully integrated into RCTs to enhance data quality and study outcomes.