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

ABSTRACT

OBJECTIVES: To analyze barriers to recruitment encountered during a prospective study in the PICU and evaluate strategies implemented to improve recruitment. DESIGN: Prospective observational study of continuous electroencephalogram monitoring in comatose children. SETTING: PICUs at four North American institutions. PATIENTS Patients with a Glasgow Coma Scale score of less than or equal to 8 for at least an hour. INTERVENTIONS: Four strategies to increase recruitment were sequentially implemented. MEASUREMENTS AND MAIN RESULTS: The baseline enrollment rate was 2.1 subjects/mo, which increased following the single-site introduction of real-time patient screening using an online dashboard (4.5 subjects/mo), deferred consenting (5.2 subjects/mo), and weekend screening (6.1 subjects/mo). However, the subsequent addition of three new study sites was the greatest accelerator of enrollment (21 subjects/mo), 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.