Accepted for/Published in: JMIR Formative Research
Date Submitted: Jul 24, 2024
Open Peer Review Period: Jul 23, 2024 - Sep 17, 2024
Date Accepted: Sep 2, 2024
(closed for review but you can still tweet)
Electronic Health Record (EHR)-based medication alerts for appropriate prescribing: Lessons learned from a randomized controlled trial of a system-wide pilot intervention for direct oral anticoagulants
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 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 multi-stage 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 that did not follow package label instructions. Alerts appeared whenever a DOAC that did not follow package label instructions was being prescribed. Clinician responses measured acceptability, accuracy, feasibility, and utilization of the alerts.
Results:
The study ran from August 1, 2022, through April 30, 2023. Only one prescriber requested trial exclusion, demonstrating acceptability. The error rate for false alerts due to incomplete data was 6.6%. 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% of the 243 encounters (134 prescribers) led to a prescription change.
Conclusions:
The pilot implementation study demonstrated acceptability, accuracy, feasibility, and estimates of 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. Clinical Trial: ClinicalTrials.gov NCT05351749. Registered 4/27/2022, https://clinicaltrials.gov/study/NCT05351749
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