Effect of a research nurse on patient enrollment in a clinical study

OBJECTIVES: To assess the effect of adding a shared research nurse on patient enrollment in an ongoing clinical study. DESIGN: Before/after comparison of recruitment rates and consent rates involving patients eligible for a study of blood culture collection strategies for methods on the detection of bacteremia and determination of inter-rater agreement regarding study eligibility between the research nurse and primary investigator. SETTING: An urban pediatric emergency department (ED). PARTICIPANTS: Patients presenting to the ED between February 1, 1991, and February 1, 1993, with suspected bacteremia. INTERVENTION: Addition of a research nurse to the study group to identify, educate, and enroll eligible study patients. MAIN OUTCOME MEASURE: Patient enrollment rates. RESULTS: Successful enrollment of eligible study patients was 14% (40/281) during the year prior to the addition of the research nurse and 50% (126/253) after the addition (P < 0.001). Refusal rates were 21% (22/106) when recruitment was carried out by the nurse and 15% (13/86) when done by physicians (P = 0.41). Review of records to identify eligible study patients showed agreement between the study nurse and physician on 78/80 (97.5%) of the charts reviewed (kappa = 0.94). CONCLUSIONS: Addition of a shared research nurse increased recruitment of patients and demonstrated equivalent judgment of the research nurse and physician investigators regarding patient eligibility for the study. This arrangement demonstrates a practical and effective means of increasing the efficiency of ED-based clinical research.