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

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.