235 From barriers to breakthroughs: Addressing accrual barriers in pragmatic EHR-embedded trials

Objectives/Goals: Trial accrual via electronic health records (EHRs) are limited by workflow and communication issues. We used a root cause analysis to identify barriers and guide changes in a pragmatic trial of metformin vs lifestyle change for prostate cancer. The goal is to evaluate strategies to increase accrual. Methods/Study Population: We previously conducted a mixed-methods root cause analysis to examine barriers along the enrollment pathway. The study required two consents: 1) prostate cancer research consortium participation and 2) trial specific. We assessed the trial’s EHR-embedded consent workflow and Best Practice Alert (BPA) implementation and aggregated and harmonized data from multiple EHR sources to reconstruct the full enrollment pathway in a CONSORT diagram. We conducted semi-structured interviews with eligible patients ( n = 10) and engaged clinicians ( n = 4). Based on interview findings and enrollment pathway insights, the study team designed and evaluated impact of several accrual enhancement strategies. Results/Anticipated Results: We identified two types of feasible accrual enhancement strategies: 1) patient-focused, including a) tracking consent status in the enrollment pathway report; b) proactively messaging patients with upcoming visits about consent; and 2) clinician-focused, including a) tailored EHR-based messages before eligible patient visits; b) targeted education; and c) BPA optimization to improve reach to appropriate clinicians. In the 6 months prior to strategy implementation, enrollment averaged 0.33 patients/month. In the 6 months post-implementation, enrollment increased to an average of 3.17 patients/month. Discussion/Significance of Impact: Sustained enrollment in pragmatic trials demands greater-than-expected engagement. In partnership, the study and informatics teams oversaw intervention processes based on trial-specific issues, identified issues quickly, explored feasible solutions, and refined the process to support trial success.