Studies in emergency department data collection: shared versus split responsibility for patient enrollment

Abstract

Objectives: To compare patient enrollment in six clinical studies using shared coverage (24 emergency department [ED] rooms-two students share enrollment responsibility) with enrollment using split coverage (12 rooms each per student). The academic associate (AA) program uses undergraduate students to collect data for clinical studies in the ED by providing double coverage 16 hours/day, seven days/week. Prior studies have shown that this system captures >85% of eligible patients. Methods to obtain closer to 100% enrollment are desired.

Methods: During consecutive 15-day periods with the same 24 AAs, the daily ED census, hours of AA coverage, and enrollment in each of six studies were evaluated prospectively in the ED. Data are presented as means with 95% confidence intervals (CIs).

Results: There was no difference between the shared and split enrollment periods with respect to hours of AA coverage (30.3 vs. 30.7 hours/day; p = 0.7) or average daily ED census (133.7 vs. 141.8; p = 0.15). Overall, the percentages of ED patients recruited for study participation were not different depending on whether the split versus shared recruitment strategy was used (907 patients recruited out of 2005 ED patients (45.2%; 95% CI = 43.0 to 47.4) vs. 937 of 2127 (44.0%; 95% CI = 41.9 to 46.1). The 95% CI for the 1.2% difference was -1.8% to 4.2%. Patient enrollments in six individual studies were similar regardless of recruitment strategy. Following the 30-day trial, AAs were surveyed: 17 of 24 (71%) found the split strategy to be "more helpful in enrolling subjects," and 20 of 24 (83%) found split strategy helped them "keep better track" of patients.

Conclusions: Study subject enrollment was not affected by the use of either the shared or split responsibility strategy for recruitment. Students generally preferred the split strategy because it was more helpful and easier to monitor. Therefore, this may be the best option for similar student-oriented data collection programs.