Utilization of an undergraduate emergency department research associate program for the screening and recruitment of research subjects with heart failure into a clinical study

Abstract

Background: Enrolling heart failure (HF) patients in clinical studies is challenging. Emergency department (ED) may use students as research associates programs, such as the University of Rochester Medical Center (URMC) ED Research Associate (EDRA) program, to screen and consent patients for clinical studies. This manuscript examines the effectiveness of the URMC EDRA program in consenting HF patients into a clinical study. Methods: The URMC EDRA program recruited and consented HF patients presenting at URMC's ED. Research associates in the EDRA program identified potential patients based on age (>18 years) and chief complaints indicative of HF. After identifying potential patients, a thorough chart review was conducted, and any uncertainties were discussed with the patient and treating provider before patients were consented into the study. Descriptive statistics were used to assess the program's effectiveness. Results: Over one fiscal year, the URMC EDRA program screened 1669 unique patients, of whom 118 (7.1 %) were consented. Consented patients tended to be younger (65 ± 12 years) than those who refused consent (70 ± 14 years) (p = 0.007). Of the 1551 patients not consented, 1021 (65.8 %) were deemed ineligible. Compared to a full time research associate, the URMC EDRA program was cheaper and more productive. Conclusion: The URMC EDRA program was highly effective in screening and consenting HF patients, successfully consenting 118 patients (14 per month). This is a significant achievement, especially given the study's strict inclusion and exclusion criteria. Compared to other studies and a full time research associate, the URMC EDRA program demonstrated remarkable productivity.

Keywords

• Heart failure
• Patient selection
• Emergency Service
• Hospital
• Research Personnel
• Informed consent