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.