Research site mentoring: A novel approach to improving study recruitment

Marcus R Johnson; Tawni Kenworthy-Heinige; Danielle J Beck; Aliya Asghar; Emily B Broussard; Karen Bratcher; Lynn M Tommessilli; Margaret Antonelli; Beata M Planeta

doi:10.1016/j.conctc.2018.01.011

Research site mentoring: A novel approach to improving study recruitment

Contemp Clin Trials Commun. 2018 Feb 3:9:172-177. doi: 10.1016/j.conctc.2018.01.011. eCollection 2018 Mar.

Authors

Marcus R Johnson¹, Tawni Kenworthy-Heinige², Danielle J Beck³, Aliya Asghar⁴, Emily B Broussard⁵, Karen Bratcher⁶, Lynn M Tommessilli⁷, Margaret Antonelli⁷, Beata M Planeta⁷

Affiliations

¹ Cooperative Studies Program Epidemiology Center-Durham, Durham VA Health Care System, 508 Fulton Street (152), Durham, NC 27705, USA.
² VA Portland Health Care System, 3710 SW US Veterans Hospital Road, Portland, OR 97239, USA.
³ VA San Diego Healthcare System, 3350 La Jolla Village Drive, San Diego, CA 92161, USA.
⁴ Tibor Rubin VA Medical Center, 5901 E. 7th Street (09/151-C2), Long Beach, CA 90822, USA.
⁵ Michael E. DeBakey VA Medical Center, 2002 Holcombe Boulevard, MHCL 116 Room 6B-310, Houston, TX 77030, USA.
⁶ VA Palo Alto Health Care System, 3801 Miranda Avenue, Building 4, Third Floor B-325, Palo Alto, CA 94304, USA.
⁷ Cooperative Studies Program Coordinating Center, VA Connecticut Healthcare System, 950 Campbell Avenue (151A), West Haven, CT 06516, USA.

Abstract

Background/aims: The VA Cooperative Studies Program's (CSP) Network of Dedicated Enrollment Sites (NODES) is a consortium of nine VA medical centers (VAMCs) with teams (nodes) dedicated to enhance performance, compliance, and management of CSP multi-site clinical trials. The West Haven CSP Coordinating Center (WH-CSPCC), study coordinating center for CSP #577, Colonoscopy Versus Fecal Immunochemical Test (FIT) in Reducing Mortality from Colorectal Cancer (CONFIRM) trial, and NODES piloted a "site mentoring" (hub-and-spoke) model. In this model, a node site would work one-on-one with a low enrolling CONFIRM site to identify and overcome barriers to recruitment. The aim was to determine the impact of a research site mentoring model on study recruitment and examine site-level characteristics that facilitate or impede it.

Results: Sites in the mentorship pilot had an average improvement of 5 ± 4 participants randomized per month (min -2.6; max 11.6; SD 4.3). Four of ten sites (40%) demonstrated continuous improvement in the average number of randomized participants per month after the pilot intervention and at three-month follow-up (post-intervention), as compared to the five-month period preceding the intervention. An additional two sites (20%) demonstrated improvement in the average number of randomized participants per month after the pilot intervention, and sustained that level of improvement at three-month follow-up (post-intervention). Additionally, six of ten sites (60%) demonstrated an increased number of participants screened for eligibility immediately following the intervention and at three-month follow-up (post-intervention). Only one site showed a decreased monthly average of randomized participants shortly after the intervention and through the three-month follow-up period.

Conclusions: The site mentoring model was successful in improving recruitment at low enrolling CONFIRM sites. An additional feasibility assessment is needed to determine if this mentoring model will be effective with other CSP trials.

Keywords: CONFIRM; Clinical research site mentorship; Cooperative Studies Program (CSP); Department of Veterans Affairs; Network of Dedicated Enrollment Sites (NODES); Site-based recruitment.