Stakeholder-driven development and implementation of CRICIT: an app to support high-quality data capture and protocol monitoring for outpatient clinical trials with vulnerable populations

Abstract

Abstract Introduction:Choosing an appropriate electronic data capture system (EDC) is a critical decision for all randomized controlled trials (RCT). In this paper, we document our process for developing and implementing an EDC for a multisite RCT evaluating the efficacy and implementation of an enhanced primary care model for individuals with opioid use disorder who are returning to the community from incarceration. Methods:Informed by the Knowledge-to-Action conceptual framework and user-centered design principles, we used Claris Filemaker software to design and implement CRICIT, a novel EDC that could meet the varied needs of the many stakeholders involved in our study. Results:CRICIT was deployed in May 2021 and has been continuously iterated and adapted since. CRICIT’s features include extensive participant tracking capabilities, site-specific adaptability, integrated randomization protocols, and the ability to generate both site-specific and study-wide summary reports. Conclusions:CRICIT is highly customizable, adaptable, and secure. Its implementation has enhanced the quality of the study’s data, increased fidelity to a complicated research protocol, and reduced research staff’s administrative burden. CRICIT and similar systems have the potential to streamline research activities and contribute to the efficient collection and utilization of clinical research data.

Keywords

• Data science
• data collection
• database management systems
• health information management
• longitudinal studies
• randomized controlled trial
• electronic data capture (EDC)
• opioid use disorder
• incarceration