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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.
Clinical trial enrollment in pediatric surgery can be improved by analyzing site characteristics and patient data. Identifying eligible patients using databases and qualitative insights enhances recruitment strategies.
Area of Science:
- Pediatric Surgery
- Clinical Trial Management
- Health Informatics
Background:
- Patient enrollment is critical for clinical trial success, yet pediatric populations present unique recruitment challenges.
- The ENhanced Recovery in CHildren Undergoing Surgery (ENRICH-US) trial faced recruitment concerns, prompting an investigation into site-specific enrollment factors.
Purpose of the Study:
- To assess the relationship between study site characteristics and patient enrollment rates in a pediatric surgical clinical trial.
- To identify barriers and facilitators impacting patient recruitment in pediatric clinical research.
Main Methods:
- A mixed-methods approach combining quantitative data from the Pediatric Health Information System (PHIS) with qualitative data from semi-structured focus groups.
- Analysis of 485 potentially eligible patients (ages 10-18, elective gastrointestinal surgery) and comparison with actual enrollment (312 patients, 64.3%) across 10 study sites.
- Qualitative analysis of interviews to identify themes related to enrollment barriers and facilitators.
Main Results:
- Enrollment rates varied significantly across sites (27.6%-88.5%).
- High-enrollment sites (>60%) featured dedicated staff, experienced leaders, prior trial involvement, and intervention expansion.
- Automated patient identification tools proved effective in overcoming personnel turnover issues.
Conclusions:
- Utilizing secondary quantitative databases to evaluate clinical trial enrollment offers a novel approach.
- Combining quantitative enrollment data with qualitative insights provides actionable strategies for enhancing pediatric clinical trial recruitment.
