A Practical Do-It-Yourself Recruitment Framework for Concurrent eHealth Clinical Trials: Simple Architecture (Part 1)

Abstract

Background: The ability to identify, screen, and enroll potential research participants in an efficient and timely manner is crucial to the success of clinical trials. In the age of the internet, researchers can be confronted with large numbers of people contacting the program, overwhelming study staff and frustrating potential participants.

Objective: This paper describes a "do-it-yourself" recruitment support framework (DIY-RSF) that uses tools readily available in many academic research settings to support remote participant recruitment, prescreening, enrollment, and management across multiple concurrent eHealth clinical trials.

Methods: This work was conducted in an academic research center focused on developing and evaluating behavioral intervention technologies. A needs assessment consisting of unstructured individual and group interviews was conducted to identify barriers to recruitment and important features for the new system.

Results: We describe a practical and adaptable recruitment management architecture that used readily available software, such as REDCap (Research Electronic Data Capture) and standard statistical software (eg, SAS, R), to create an automated recruitment framework that supported prescreening potential participants, consent to join a research registry, triaging for management of multiple trials, capture of eligibility information for each phase of a recruitment pipeline, and staff management tools including monitoring of participant flow and task assignment/reassignment features. The DIY-RSF was launched in July 2015. As of July 2017, the DIY-RSF has supported the successful recruitment efforts for eight trials, producing 14,557 participant records in the referral tracking database and 5337 participants in the center research registry. The DIY-RSF has allowed for more efficient use of staff time and more rapid processing of potential applicants.

Conclusions: Using tools already supported at many academic institutions, we describe the architecture and utilization of an adaptable referral management framework to support recruitment for multiple concurrent clinical trials. The DIY-RSF can serve as a guide for leveraging common technologies to improve clinical trial recruitment procedures.

Keywords: REDCap; eHealth; mHealth; online recruitment; referral management.