Strategies to Maximize Enrollment in a Prospective Study of Comatose Children in the PICU*

Abstract

Objective To analyze barriers to recruitment encountered during a prospective study in the pediatric intensive care unit and evaluate strategies implemented to improve recruitment. Design Prospective observational study of continuous EEG monitoring in comatose children. Setting Pediatric intensive care units at four North American institutions. Patients Patients with a Glasgow Coma Score ≤8 for at least an hour. Interventions Four strategies to increase recruitment were sequentially implemented. Measurements Enrollment rates before and after implementation of novel recruitment strategies. Main Results The baseline enrollment rate was 2.1 subjects/month, which increased following the single-site introduction of real-time patient screening using an online dashboard (4.5 subjects/month), deferred consenting (5.2 subjects/month), and weekend screening (6.1 subjects/month). However, the subsequent addition of three new study sites was the greatest accelerator of enrollment (21 subjects/month), representing a 10-fold increase from baseline (P<0.0001). Conclusions Identifying barriers to recruitment and implementing creative strategies to increase recruitment can successfully increase enrollment rates in the challenging ICU environment.