A Time-and-Motion Study of Clinical Trial Eligibility Screening in a Pediatric Emergency Department.

OBJECTIVE: Challenges with efficient patient recruitment including sociotechnical barriers for clinical trials are major barriers to the timely and efficacious conduct of translational studies. We conducted a time-and-motion study to investigate the workflow of clinical trial enrollment in a pediatric emergency department.

METHODS: We observed clinical research coordinators during 3 clinically staffed shifts. One clinical research coordinator was shadowed at a time. Tasks were marked in 30-second intervals and annotated to include patient screening, patient contact, performing procedures, and physician contact. Statistical analysis was conducted on the patient enrollment activities.

RESULTS: We conducted fifteen 120-minute observations from December 12, 2013, to January 3, 2014 and shadowed 8 clinical research coordinators. Patient screening took 31.62% of their time, patient contact took 18.67%, performing procedures took 17.6%, physician contact was 1%, and other activities took 31.0%.

CONCLUSIONS: Screening patients for eligibility constituted the most time. Automated screening methods could help reduce this time. The findings suggest improvement areas in recruitment planning to increase the efficiency of clinical trial enrollment.