# Leveraging Evidence-based practices for Ambulatory VTE Patients to be Safe with Direct Oral Anticoagulants:  LEAVE Safe with DOACs

> **NIH AHRQ R18** · UNIV OF MASSACHUSETTS MED SCH WORCESTER · 2020 · $499,160

## Abstract

PROJECT SUMMARY/ABSTRACT
Patients with new episodes of venous thromboembolism (VTE) are at an elevated risk for adverse drug events
(ADEs). Although trial data suggest that direct oral anticoagulants (DOACs) are safer than warfarin, data from
non-trial setting suggests problems with dosing and other medication appropriateness criteria (administration, drug-
drug interactions, duration, etc.) in a full 60% of patients prescribed DOACs. This is particularly concerning for
patients with venous thromboembolism (VTE) diagnosed and discharged without hospitalization, i.e. the ambulatory
VTE population, and prescribed direct oral anticoagulants. The ambulatory VTE population includes most patients
with deep vein thrombosis (DVT) and many patients with pulmonary embolism. Unlike patients with atrial
fibrillation, who typically receive follow-up with a cardiologist, or patients attending warfarin clinics, ambulatory VTE
patients prescribed DOACs do not have established pathways for follow-up. They also do not typically have
consultation by a clinical pharmacist as a hospitalized patient often does.
Recently the Anticoagulation Forum, a multidisciplinary nonprofit organization focused on anticoagulation issues,
published the DOAC Checklist for Optimal Care Transitions (DOAC Checklist) to elaborate the steps required to
ensure a safe transition of care in patients prescribed DOACs for treatment of VTE. These steps include evaluation
of the appropriateness of DOAC, confirmation of the affordability and access of DOAC prescribed, patient
education, telephone access to anticoagulation expertise, consolidated documentation and communication to
primary care provider, and renal and hepatic function monitoring. We propose operationalizing the items of the
DOAC Checklist to create a comprehensive intervention delivered by clinical pharmacists and a pharmacy
technician with the goal of preventing DOAC-related clinically important medication errors which includes
preventable ADEs, ameliorable ADEs (ADEs in which the severity or duration could have been reduced), and
potential ADEs (medication errors with the potential to cause harm).
Our proposal includes the following specific aims: (1) operationalize the items of the AC Forum's DOAC checklist to
create a comprehensive, standardized intervention delivered by clinical pharmacists for ambulatory VTE patients
prescribed DOACs; (2) measure the difference in clinically important medication errors with DOAC for 500 patients
randomized to intervention and control arms; (3) conduct a process evaluation assessing fidelity, adaptation,
mechanisms of impact and the influence of contextual factors on implementation of our intervention; and (4) create
a plan for disseminating study findings.
Given the growth of the ambulatory VTE population prescribed DOACs, the associated risks with this class of
medications, and the lack of defined pathways for these patients, our care transition intervention has the potential
for enormous imp...

## Key facts

- **NIH application ID:** 9986802
- **Project number:** 5R18HS026859-02
- **Recipient organization:** UNIV OF MASSACHUSETTS MED SCH WORCESTER
- **Principal Investigator:** Alok Kapoor
- **Activity code:** R18 (R01, R21, SBIR, etc.)
- **Funding institute:** AHRQ
- **Fiscal year:** 2020
- **Award amount:** $499,160
- **Award type:** 5
- **Project period:** 2019-08-01 → 2022-05-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/9986802

## Citation

> US National Institutes of Health, RePORTER application 9986802, Leveraging Evidence-based practices for Ambulatory VTE Patients to be Safe with Direct Oral Anticoagulants:  LEAVE Safe with DOACs (5R18HS026859-02). Retrieved via AI Analytics 2026-05-21 from https://api.ai-analytics.org/grant/nih/9986802. Licensed CC0.

---

*[NIH grants dataset](/datasets/nih-grants) · CC0 1.0*