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LEAVE Safe With DOACs

NCT04068727 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 561

Last updated 2024-02-20

No results posted yet for this study

Summary

Given the risks associated with direct oral anticoagulants (DOACs) and the lack of defined pathways for patients prescribed this class of medications, the study intervention has the potential for an enormous impact in preventing medication errors and improving the quality of care transition, patient knowledge, and adherence with DOAC therapy.

Conditions

Interventions

OTHER

Clinical Pharmacist Intervention

After randomization, the pharmacist calls patients to assess drug choice and dose. Staff distribute manufacturer coupons and help patients apply for medication payment assistance. Pharmacist discusses DOAC alternatives with prescribe and provides DOAC education by discussing potential adverse effects, medication interactions, alarm symptoms, and lab work. Staff mail educational materials. Pharmacist documents concerns in the electronic health record and messages prescriber about missing lab work. Patients share medication-related concerns. Patients are provided with a phone number for non-education calls to discuss their medications from 6 AM - 10 PM on any day. The pharmacist offers dose de-escalation instructions based on the DOAC prescription. The pharmacist advises the continuity provider on DOAC duration and monitoring. For follow-up/perioperative support, the pharmacist reviews and recommends lab monitoring and gives DOAC interruption/resumption recommendations.

Sponsors & Collaborators

  • Agency for Healthcare Research and Quality (AHRQ)

    collaborator FED

  • University of Massachusetts, Worcester

    lead OTHER

Principal Investigators

  • Alok Kapoor, MD · UMass Medical School

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-12-02
Primary Completion
2021-12-01
Completion
2022-09-14

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04068727 on ClinicalTrials.gov