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

Publication/Presentation Date

3-1-2016

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.

Volume

17

Issue

3

First Page

246

Last Page

250

ISSN

1529-7535

Disciplines

Medicine and Health Sciences | Pediatrics

PubMedID

26825045

Department(s)

Department of Pediatrics

Document Type

Article

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