Consent and enrollment process: achieving high enrollment rates for obstetric research.

Aim: The aim was to study the development, design, and implementation of a patient consent and enrollment initiative to identify strategies that enhanced participation.

Background: Consent and enrollment of patients, especially pregnant women, remains a challenge in healthcare research. Although many barriers have been identified, strategies to consistently improve consent and enrollment are less defined.

Methods: A case study was conducted on a consent and enrollment approach aimed at optimizing participation of mothers who delivered their infants from July 1, 2010 through June 30, 2013. Data were gathered through practitioner interviews, focus groups, and documentation review for each year of the study.

Results: A total of 19,236 mothers enrolled, representing an 85% enrollment rate at the five study sites. Enrollment rates improved over time with increased nursing engagement in patient recruitment, site specific adaptations and patient education strategies.

Conclusions: Nursing's active role in implementation and rapid feedback loop of a multifaceted consent and enrollment program showed promise.