System-Wide, Electronic Health Record-Based Medication Alerts for Appropriate Prescribing of Direct Oral Anticoagulants: Pilot Randomized Controlled Trial

Abstract

Background: While direct oral anticoagulants (DOACs) have improved oral anticoagulation management, inappropriate prescribing remains prevalent and leads to adverse drug events. Antithrombotic stewardship programs seek to enhance DOAC prescribing but require scalable and sustainable strategies.

Objective: We present a pilot, prescriber-level randomized controlled trial to assess the effectiveness of electronic health record (EHR)-based medication alerts in a large health system.

Methods: The pilot assessed prescriber responses to alerts for initial DOAC prescription errors (apixaban and rivaroxaban). A user-centered, multistage design process informed alert development, emphasizing clear indication, appropriate dosing based on renal function, and drug-drug interactions. Alerts appeared whenever a DOAC was being prescribed in a way that did not follow package label instructions. Clinician responses measured acceptability, accuracy, feasibility, and utilization of the alerts.

Results: The study ran from August 1, 2022, through April 30, 2023. Only 1 prescriber requested trial exclusion, demonstrating acceptability. The error rate for false alerts due to incomplete data was 6.6% (16/243). Two scenarios with alert design and/or execution errors occurred but were quickly identified and resolved, underlining the importance of a responsive quality assurance process in EHR-based interventions. Trial feasibility issues related to alert-data capture were identified and resolved. Trial feasibility was also assessed with balanced randomization of prescribers and the inclusion of various alerts across both medications. Assessing utilization, 34.2% (83/243) of the encounters (with 134 prescribers) led to a prescription change.

Conclusions: The pilot implementation study demonstrated the acceptability, accuracy, feasibility, and estimates of the utilization of EHR-based medication alerts for DOAC prescriptions and successfully established just-in-time randomization of prescribing clinicians. This pilot study sets the stage for large-scale, randomized implementation evaluations of EHR-based alerts to improve medication safety.

Trial registration: ClinicalTrials.gov NCT05351749; https://clinicaltrials.gov/study/NCT05351749.

Keywords: EHR; RCT; alert system optimization; clinical decision support; direct oral anticoagulants; electronic health record; medication safety; oral anticoagulants; pilot randomized controlled trial; prescribing errors; randomized controlled trial.

Figure 1

Examples of alerts in the pilot random controlled trial of electronic health record decision support. This alert indicates a potential problem in the dosing of the drug rivaroxaban to treat atrial fibrillation due to reduced renal function and is shown in the 2 experimental conditions, with a recommendation to consult a pharmacist (left) and without the recommendation to consult a pharmacist (right). CrC: creatinine clearance; eGFR: estimated glomerular filtration rate; FDA: Food and Drug Administration.

Figure 2

CONSORT (Consolidated Standards of Reporting Trials) diagram for pilot randomized controlled trial of electronic health record decision support for direct oral anticoagulant prescribing.