Management of Direct Oral Anticoagulants to Lower Adverse Events in Atrial Fibrillation (MODL-AF)
Project Number5R18HS026156-04
Contact PI/Project LeaderKING, JORDAN BRADLEY
Awardee OrganizationUNIVERSITY OF UTAH
Description
Abstract Text
PROJECT SUMMARY/ABSTRACT: The use of direct oral anticoagulants (DOACs) for stroke prophylaxis in
patients with atrial fibrillation (AF) has markedly increased in the U.S. over the past 5 years, now accounting for
2 in 3 oral anticoagulant prescriptions. This increase is driven in part by a perception that DOACs are simpler
to use than traditional therapy (i.e., warfarin) given their monitoring convenience. However, effect monitoring is
not the only relevant consideration. Incorrect dosing and poor adherence are both common with DOACs,
contributing to increased rates of adverse events, including bleeding, stroke, and death. To address the
substantial clinical concerns associated with safe and effective ambulatory DOAC use, Kaiser Permanente
Colorado enrolls patients treated with a DOAC in the anticoagulation management services originally
developed to monitor warfarin therapy. In this proactive DOAC management model, all patients prescribed a
DOAC are comprehensively evaluated and longitudinally monitored by anticoagulation specialists. Although
this approach may prevent adverse events, it is very resource-intensive. It is possible that targeting patients
who are at risk of dosage errors or adherence problems could provide the same benefit more cost-effectively.
In 2016, Kaiser Permanente Southern California adopted such an approach. Their data-driven DOAC
management model relies on administrative reports to detect potential dosing and adherence concerns and
refers those at risk to anticoagulant specialists. This difference in practice amongst otherwise highly similar
health care organizations provides a unique natural experiment to evaluate the effectiveness and efficiency of
these management approaches. Using robust methods from pharmacoepidemiology and computer simulation
methodologies, and with Kaiser Permanente Northwest, which does not provide system-level DOAC
management services, as a reference population, we propose to determine the comparative (1) safety, (2)
effectiveness, and (3) cost-effectiveness of each of these models of DOAC care. Preliminary evidence
suggests both proactive and data-driven care models may improve stroke and bleed outcomes relative to usual
care. DOAC management services must be studied at the health system level as health systems bear most of
the cost burden for DOAC management and are responsible for making decisions about implementing care
models. Our proposal and setting are uniquely suited for such an assessment. This study will provide reliable
evidence on the comparative effectiveness of these care models more quickly and efficiently than would be
possible with a randomized trial, and results will have greater generalizability due to lack of selection bias.
Results from our careful analysis of these innovative programs will answer important and timely questions
concerning optimal strategies for ambulatory DOAC care. They will have immediate impact on clinical practice,
leading to safer use of DOACs and improving efficiency. They will also open new avenues for future research.
Public Health Relevance Statement
PROJECT NARRATIVE: Real-world rates of inappropriate use of direct oral anticoagulants is high, leading to
increased bleeding, stroke, and death in patients with atrial fibrillation. We propose to evaluate two promising,
novel services that utilize pharmacist and nurse anticoagulation specialists to provide coordinated care to
patients taking direct oral anticoagulants. We will determine the optimal approach to efficiently maximize the
safety and effectiveness of these medications in the ambulatory setting.
No Sub Projects information available for 5R18HS026156-04
Publications
Publications are associated with projects, but cannot be identified with any particular year of the project or fiscal year of funding. This is due to the continuous and cumulative nature of knowledge generation across the life of a project and the sometimes long and variable publishing timeline. Similarly, for multi-component projects, publications are associated with the parent core project and not with individual sub-projects.
No Publications available for 5R18HS026156-04
Patents
No Patents information available for 5R18HS026156-04
Outcomes
The Project Outcomes shown here are displayed verbatim as submitted by the Principal Investigator (PI) for this award. Any opinions, findings, and conclusions or recommendations expressed are those of the PI and do not necessarily reflect the views of the National Institutes of Health. NIH has not endorsed the content below.
No Outcomes available for 5R18HS026156-04
Clinical Studies
No Clinical Studies information available for 5R18HS026156-04
News and More
Related News Releases
No news release information available for 5R18HS026156-04
History
No Historical information available for 5R18HS026156-04
Similar Projects
No Similar Projects information available for 5R18HS026156-04