# Management of Direct Oral Anticoagulants to Lower Adverse Events in Atrial Fibrillation (MODL-AF)

> **NIH AHRQ R18** · UTAH STATE HIGHER EDUCATION SYSTEM--UNIVERSITY OF UTAH · 2020 · $419,195

## Abstract

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 imp...

## Key facts

- **NIH application ID:** 10019586
- **Project number:** 5R18HS026156-04
- **Recipient organization:** UTAH STATE HIGHER EDUCATION SYSTEM--UNIVERSITY OF UTAH
- **Principal Investigator:** Jordan Bradley King
- **Activity code:** R18 (R01, R21, SBIR, etc.)
- **Funding institute:** AHRQ
- **Fiscal year:** 2020
- **Award amount:** $419,195
- **Award type:** 5
- **Project period:** 2018-08-01 → 2022-05-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10019586

## Citation

> US National Institutes of Health, RePORTER application 10019586, Management of Direct Oral Anticoagulants to Lower Adverse Events in Atrial Fibrillation (MODL-AF) (5R18HS026156-04). Retrieved via AI Analytics 2026-05-22 from https://api.ai-analytics.org/grant/nih/10019586. Licensed CC0.

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