Feasibility and acceptability of patient- and clinician-level antithrombotic stewardship interventions to reduce gastrointestinal bleeding risk in patients using warfarin (AEGIS): a factorial randomized controlled pilot trial

Background Overuse of antiplatelet therapy and underuse of gastroprotection contribute to preventable bleeding in patients taking anticoagulants. Objective (1) Determine the feasibility of a factorial trial testing patient activation and clinician outreach to reduce gastrointestinal (GI) bleeding risk in patients prescribed warfarin-antiplatelet therapy without proton pump inhibitor gastroprotection, and (2) assess intervention acceptability. Methods Pragmatic 2x2 factorial cluster-randomized controlled pilot comparing (1) a patient activation booklet vs. usual care; and (2) clinician notification vs. clinician notification plus nurse facilitation. The primary feasibility outcome was % of patients completing a structured telephone assessment after 5 weeks. Exploratory outcomes, including effectiveness, were evaluated using chart review, surveys, and semi-structured interviews. Results Among 47 eligible patients, 35/47 (74.5%, 95% CI 58.6-85.7) met the feasibility outcome. In the subset confirmed to be high risk for upper GI bleeding, 11/29 (37.9%, 95% CI 16.9-64.7) made a medication change, without differences between intervention arms. In interviews, few patients reported reviewing the activation booklet; barriers included underestimating GI bleeding risk, misunderstanding the booklet’s purpose, and receiving excessive health communication materials. Clinicians responded to notification messages for 24/47 patients (51.1%, 95% CI 26.4-75.4), which was lower for surgeons than non-surgeons (22.7% vs. 76.0%). Medical specialists but not surgeons viewed clinician notification as acceptable. Conclusions The proposed trial design and outcome ascertainment strategy were feasible, but the patient activation intervention is unlikely to be effective as designed. While clinician notification appears promising, it may not be acceptable to surgeons, findings which support further refinement and testing of a clinician notification intervention.