Evaluating Informatics-assisted Immune-related Adverse Event Detection to Improve Registration Onto a Biorepository

This is a single institution, randomized controlled trial of an informatics system for automated immune-related adverse event (irAE) detection from the electronic health records (EHR) for eligibility monitoring for an Alliance prospective irAE biorepository (NCT04242095). This study will enroll approximately 100 patients receiving immunotherapy. Our co-primary endpoints test the hypothesis that informatics-assisted EHR monitoring for biorepository eligibility is feasible and improves registration rates onto the biorepository following an eligible irAE. Secondary endpoints evaluate time to data entry after an irAE, and irAE capture rate based on post-hoc subject matter expert review. This study will take place at Dana-Farber/Brigham Cancer Center. Our co-primary objectives are: 1. To establish the feasibility of implementing the informatics system for daily inferencing on EHR data 2. To assess the ability of automated irAE detection to improve registration to a prospective irAE biorepository Our secondary objectives are: 1. To evaluate whether automated irAE detection reduces the time to data entry in a prospective biorepository data management system 2. To evaluate whether automated irAE detection leads to differences in irAE capture rates of patients with an eligible irAE based on clinician expert review of the EHR Subjects will be randomized to standard irAE monitoring for an eligible registration event (control arm) vs. informatics-assisted irAE monitoring for an eligible registration event (experimental arm). There will be a seamless feasibility run-in of the first 10-20 patients to establish feasibility. These subjects will be included in the full analysis.