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

Area of Science:

• Clinical research operations
• eHealth and digital health interventions
• Behavioral intervention technologies

Background:

• Efficient participant identification, screening, and enrollment are vital for clinical trial success.
• Internet-driven recruitment can overwhelm study staff and frustrate participants.
• Academic research centers face challenges in managing high volumes of potential clinical trial participants.

Purpose of the Study:

• To describe a "do-it-yourself" recruitment support framework (DIY-RSF) for remote participant management.
• To outline a system supporting recruitment, prescreening, enrollment, and management across multiple concurrent eHealth clinical trials.
• To provide a practical guide for leveraging existing technologies in academic settings to enhance clinical trial recruitment.

Main Methods:

• A needs assessment involving interviews identified recruitment barriers and system requirements.
• Development of an automated recruitment framework using readily available software like REDCap and statistical packages (SAS, R).
• Implementation of features for prescreening, consent management, trial triaging, eligibility tracking, and staff management.

Main Results:

• The DIY-RSF successfully supported eight trials between July 2015 and July 2017.
• Generated 14,557 participant records in the referral tracking database and enrolled 5337 participants in the research registry.
• Demonstrated increased staff efficiency and faster processing of potential applicants.

Conclusions:

• An adaptable referral management framework can be built using common academic technologies.
• The DIY-RSF architecture and utilization offer a model for improving clinical trial recruitment procedures.
• Leveraging existing technologies can enhance the management of multiple concurrent clinical trials.