Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2018 Feb 3:9:172-177.
doi: 10.1016/j.conctc.2018.01.011. eCollection 2018 Mar.

Research site mentoring: A novel approach to improving study recruitment

Marcus R Johnson  1 , Tawni Kenworthy-Heinige  2 , Danielle J Beck  3 , Aliya Asghar  4 , Emily B Broussard  5 , Karen Bratcher  6 , Lynn M Tommessilli  7 , Margaret Antonelli  7 , Beata M Planeta  7
Affiliations

Research site mentoring: A novel approach to improving study recruitment

Marcus R Johnson et al. Contemp Clin Trials Commun. .

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.

PubMed Disclaimer

Figures

Fig. 1
Fig. 1
Monthly average of randomized participants trajectories.
Fig. 2
Fig. 2
Common themes: Site mentorship pre-and post intervention.
See this image and copyright information in PMC

References

    1. Kutner J., Smith M., Mellis K. Methodological challenges in conducting a multi-site randomized clinical trial of massage therapy in hospice. J. Palliat. Med. 2010 Jun;13(6):739–744. - PMC - PubMed
    1. Keith S.J. Evaluating characteristics of patient selection and dropout rates. J. Clin. Psychiatr. 2001;62(suppl 9):11–14. - PubMed
    1. Gul R.B., Ali P.A. Clinical Trials: the Challenge of recruitment and retention of participants. J. Clin. Nurs. 2010 Jan;19(1–2):227–233. - PubMed
    1. Institute of Medicine (US) vol. 3. National Academies Press (US); Washington (DC): 2012. Public Engagement and Clinical Trials: New Models and Disruptive Technologies: Workshop Summary.https://www.ncbi.nlm.nih.gov/books/NBK92105/ (Recruitment Challenges in Clinical Trials for Different Diseases and Conditions). Available from: - PubMed
    1. U.S. Department of Veterans Affairs. 2017. Veterans Health Administration. Available from: https://www.va.gov/health/aboutvha.asp (Accessed 11 April 2017).

LinkOut - more resources