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 e ligible for a study of blood culture collection strategies for methods on the detection of bacteremia and determination of infer-rater agree ment regarding study eligibility between the research nurse and primar y 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: Additi on of a research nurse to the study group to identify, educate, and en roll eligible study patients. Main outcome measure: Patient enrollment rates. Results: Successful enrollment of eligible study patients was 14% (40/281) during the gear prior to the addition of the research nur se and 50% (126/253) after the addition (P < 0.001). Refusal rates wer e 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 identi fy eligible study patients showed agreement between the study nurse an d physician on 78/80 (97.5%) of the charts reviewed (kappa = 0.94). Co nclusions: Addition of a shared research nurse increased recruitment o f patients and demonstrated equivalent judgment of the research nurse and physician investigators regarding patient eligibility for the stud y. This arrangement demonstrates a practical and effective means of in creasing the efficiency of ED-based clinical research.