MC08
The Clinical Research Navigator: A Novel Role and Its Impact on Research Participation By Clinic Patients.
There is a need to streamline recruitment efforts from clinical spaces in large multiple sclerosis (MS) practices, such as the University of California, San Francisco (UCSF) MS Center.
Objectives:
To evaluate the impact of a pilot position, the Research Navigator, on recruitment workflow and enrollment in clinical research studies.
Methods:
Annually, investigators in the UCSF MS Center see over 5,000 patients with MS and other demyelinating diseases, recruit for over 20 observational and interventional studies, and employ over a dozen research coordinators. The Research Navigator screens clinic patients for their eligibility for ongoing studies and from a designated central location in the clinic, communicates with clinicians, individual study coordinators, and administrative staff to coordinate approaching and referring patients. To evaluate the effectiveness of this position, enrollment data for recruiting studies were compared over two 2-week periods: just before the position opened, and 6 months after. Additionally, to evaluate the impact of the Research Navigator on clinical research operations, qualitative feedback was obtained from research and clinic administrative staff (>70% response rate).
Results:
The proportion of eligible clinic patients referred to studies increased significantly, from 11% of patients referred in the 2 weeks prior to Research Navigator, to 19% in the 2 week-period 6 months after (p = 0.022). Enrollment of eligible patients also increased, from 5% prior, to 13% after (p = 0.009), and the proportion of patients referred from clinicians other than a study’s Principal Investigator increased. Additionally, the Research Navigator role received overwhelmingly positive feedback from both research and clinical administrative staff. For example, 63% of Clinical Research Coordinators spent more than 1 hour weekly screening patients for eligibility prior to Research Navigator (mean = 4-5hrs/week); 80% of these reported a decrease in time spent screening patients after the introduction of the Research Navigator (new mean= 0-1hr/week). All Clinical Administrative Staff (100%) either strongly agreed or agreed that having the Research Navigator in clinic increased their confidence in forwarding patients to appropriate Research Coordinators.
Conclusions:
The Research Navigator presents a more streamlined and unbiased way to refer and enroll patients from a busy clinical academic practice to a broad platform of clinical studies and trials.