JMIR Publications

ABSTRACT

Background:

Background:

Warfarin is one of the most commonly prescribed medications in the U.S, and causes a significant proportion of adverse drug events. Patients taking warfarin fall outside of the recommended therapeutic range 30% of the time, largely because of inadequate laboratory monitoring and dose adjustment. This leads to an increased risk of blood clots or bleeding events.

Objective:

We propose a comparative-effectiveness study to examine whether a technology-enabled anticoagulation management program can improve long-term clinical outcomes compared with usual care.

Methods:

Our proposed intervention is the implementation of an electronic dashboard (integrated into a pre-existing electronic health record) and standardized workflow to track patients’ laboratory results, identify patients requiring follow-up, and facilitate the use of a validated nomogram for dose adjustment. We will employ a pre-post quasi-experimental design with a nonequivalent usual-care comparison site and a difference-in-differences approach to compare the effectiveness of a technology-enabled anticoagulation management program compared with usual care at a large University-affiliated safety-net clinic. Our primary outcome is the time-in-therapeutic range (TTR) at six months post-intervention (a validated metric of anticoagulation quality among patients receiving warfarin).

Results:

We used a commercially available Health Information Technology (HIT) platform to host a registry of patients on warfarin therapy and create the electronic dashboard for panel management. We developed the intervention with, and for, front-line clinician users, using principles of user-centered design. This study is funded through September 2019 and approved by the University of California San Francisco Institutional Review Board until June 22, 2019. We expect to complete data collection in July 2019 and complete our proposed analyses by October 2019.

Conclusions:

We anticipate the intervention will increase TTR among patients taking warfarin, and that the use of this HIT platform will facilitate tracking and monitoring of patients on warfarin that could enable outreach to those overdue for visits or laboratory monitoring. We will use these findings to iteratively improve the platform in preparation for a larger, multiple-site, pragmatic clinical trial. If successful, our study will demonstrate the integration HIT platforms into existing electronic health records to improve patient care in real-world clinical settings.