In February 2022, the IRB approved adding a small additional substudy for exploratory outcomes only, involving up to 8 primary care physicians. Because this is distinct from any primary or secondary outcome measure data collection, their inclusion exclusion criteria are not listed, nor does the data collection from them show in the study completion date. However these physicians and their patients are counted in the actual enrollment total.
This is a pragmatic, single center, feasibility pilot cluster randomized trial with embedded individual randomization to evaluate implementation strategies to increase the use of evidence-based practices to reduce upper gastrointestinal bleeding risk in patients using combination antithrombotic therapy (including warfarin) and that are managed by the Michigan Medicine anticoagulation monitoring service.