Towards a Scalable Informatics Platform for Enhancing Accrual into Clinical Research Studies

Research Overview: This summarizes the work being done at the Center for Clinical and Translational Sciences, University of Utah in developing an informatics platform for enhancing research recruitment, Utah Utility for Research Recruitment (U2R2), and its evaluation for a back pain study. Objectives/Goals: Issues with recruiting the targeted number of participants in a timely manner often results in underpowered studies, with more than 60% of clinical studies failing to complete or requiring extensions due to enrollment issues. The objective of this study is to develop and implement a scalable, organization wide platform to enhance accrual into clinical research studies. Methods/Study Population: We are developing and evaluating an informatics platform called Utah Utility for Research Recruitment (U2R2). U2R2 consists of two components: (i) Semantic Matcher: an automated trial criterion to patient matching component that also reports uncertainty associated with the match, and (ii) Match Delivery: mechanisms to deliver the list of matched patients for different research and clinical settings. As a first step, we limited the Semantic Matcher to utilize only structured data elements from the patient record and trial criteria. We are now including distributional semantic methods to match complete patient records and trial criteria as documents. We evaluated the first phase of U2R2 based on a randomized trial with a target enrollment of 220 participants that compares two treatment strategies for managing back pain (physical therapy and usual care) for individuals consulting a non-surgical provider and symptomatic less than 90 days. Results/Anticipated Results: U2R2 identified 9370 patients from the University of Utah Hospitals and Clinics as potential matches. Of these 9370, 1145 responded to the Back Pain study research team’s email or phone communications, and were further screened by phone. 250 participants completed a screening visit, resulting in the current study enrollment of 130 participants. 43 of 1145 patients refused to participate, and 50 participants no-showed their screening visit.This work has been supported by the Utah Center for Clinical and Translational Science funded by NCATS award 1UL1TR001067, NLM Training grant 5T15LM007124 and 1R18 HS022641-01A1. Computer resources were provided by the University of Utah Center for High Performance Computing