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A Mixed-Methods Study of Patient Identification Barriers and Facilitators in a Pediatric Surgery Randomized Control
Charesa J Smith1, Maxwell J Wilberding1, Mehul V Raval2
1Center for Health Services and Outcomes Research, Institute of Public Health and Medicine, Northwestern University Feinberg School of Medicine, Chicago, Illinois; Northwestern Quality Improvement, Research, & Education in Surgery (NQUIRES), Department of Surgery, Feinberg School of Medicine, Northwestern University, Chicago, Illinois.
Introduction:
Successful clinical trials require robust patient enrollment, yet study sites often struggle to identify potentially eligible patients, particularly in pediatric populations. During a stepped-wedge, cluster randomized clinical trial, ENhanced Recovery in CHildren Undergoing Surgery (ENRICH-US), concerns about adequate recruitment led us to assess the relationship between site characteristics and enrollment rates.
Methods:
We conducted a mixed-methods, explanatory, sequential design study using (a) secondary quantitative data from the Pediatric Health Information System (PHIS) database to identify potentially eligible patients (ages 10-18 undergoing elective gastrointestinal surgery) at 10 ENRICH-US study sites and (b) qualitative data from semi-structured focus groups to assess site-specific enrollment barriers and facilitators. The number of potentially eligible patients identified through PHIS (07/01/20-04/30/23) was compared to the actual ENRICH-US enrollment to calculate site enrollment rates. Semi-structured interviews (10/01/19-04/01/23) were then analyzed to identify themes of barriers and facilitators.
Results:
Of 485 potentially eligible patients, 312 (64.3%) were enrolled. Enrollment rates varied (27.6%-88.5%). High-enrollment rate sites (>60%) had dedicated staff, engaged study leaders, clinical trial experience, and expanded the intervention beyond the study population. Automated tools facilitated patient identification, mitigating personnel turnover challenges.
Conclusions:
Using secondary quantitative databases to assess clinical trial enrollment is a novel approach. When combined with qualitative insights, these data can inform strategies to enhance recruitment and enrollment.
