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OpenTrials
Completed

NCT Number: NCT04068727

LEAVE Safe With DOACs

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.

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Key information

Conditions

Cardiovascular Diseases Arrhythmias, Cardiac Atrial Fibrillation Bleeding Brain Diseases Central Nervous System Diseases Cerebrovascular Disorders Embolism and Thrombosis Heart Diseases Hemorrhage Nervous System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Stroke Thromboembolism Vascular Diseases Venous Thromboembolism

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UMass Memorial Medical Center

Worcester, Massachusetts, 01605, United States

About this study

Patients first treated with direct oral anticoagulants (DOACs) in an ambulatory setting are at an elevated risk for adverse drug events (ADEs) or potential ADEs from medication errors. An intervention that integrates clinical pharmacists, a pharmacy technician, and follows a checklist published by experts at the Anticoagulation Forum can prevent adverse outcomes. The Investigators propose research on the effectiveness, implementation, and dissemination for a care transition intervention that follows the checklist which includes evaluation for appropriateness of DOAC use, assistance with drug procurement, telephone access to an anticoagulation expert, and other best practice recommendations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age ≥ 18
  • New prescription of DOAC within 4 days of consent OR continued DOAC use for a patient with new episode of worsening thromboembolic or bleeding event within 4 days of consent or discharged from the hospital with DOAC prescription within 4 days of consent
  • Fluency in English, Portuguese, or Spanish

Exclusion criteria

  • Currently hospitalized with inpatient status (as opposed to observation status)
  • Age < 18
  • Prisoners
  • Pregnant patients (medications are contraindicated)

Treatment and study plan

Clinical Pharmacist Intervention

Other

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.

Other names: Clinical Pharmacist Intervention Based on Checklist Endorsed by the AC Forum

Primary outcomes

  1. Number of Direct Oral Anticoagulant (DOAC)-Related Clinically Important Medication Errors

    Time frame: 90 Days Post Enrollment

    The number of preventable, ameliorable and potential Adverse Drug Events (ADEs) that physician reviewers attribute to Direct Oral Anticoagulant (DOAC) medication. Each DOAC related clinically important medication error is counted as a separate event, enabling patients to have multiple events consistent with the literature.

Secondary outcomes

  1. Patient Knowledge regarding Anticoagulation and Venus Thromboembolism (VTE) using the Anticoagulation and Venus Thromboembolism (VTE) knowledge questionnaire

    Time frame: 90 Days Post Enrollment

    Patient knowledge regarding Anticoagulation and Venus Thromboembolism (VTE) will be evaluated using a modified version of a 22-item instrument previously developed and tested by the institution. This instrument assesses patients' knowledge of warning signs of bleeding and new VTE, interactions with other medications, and complications of VTE. A low score indicate a low level of knowledge and a high score indicates a high level of knowledge regarding anticoagulation and VTE.

  2. Number of missed or extra doses to assess medication adherence

    Time frame: 90 Days Post Enrollment

    Patients are asked to to count out the number of remaining pills from the last filled prescription and provide the fill date, number of pills dispensed, the schedule prescribed (either once or twice a day depending on DOAC), and skipped doses for deliberate interruption to determine medication adherence with the number of missed or extra doses.

  3. Medication Possession Ratio (MPR) to assess medication adherence

    Time frame: 90 Days Post Enrollment

    Medication adherence is measured with Medication Possession Ratio (MPR) which is the ratio between the time a patient had medication on hand, the time that a patient is eligible to have a medication on hand, and the time that a patient is covered by the medication. The MPR ratio will be calculated by using available pharmacy data.

  4. Proportion of days covered (PDC) to assess medication adherence

    Time frame: 90 Days Post Enrollment

    Proportion of Days Covered (PDC) is the ratio between the time that a patient has a medication on hand, the time that a patient is eligible to have a medication on hand, and the time that a patient is covered by the medication. Medication adherence will be evaluated using the mean PDC using available pharmacy data.

Sponsors and collaborators

Lead sponsor

University of Massachusetts, Worcester

Other

Collaborators

  • Agency for Healthcare Research and Quality (AHRQ)

Registry information

Official study title

Leveraging Evidence-based Practices for Ambulatory VTE and Other Patients to be Safe With Direct Oral Anticoagulants: LEAVE Safe With DOACs

Important dates

Study start
2019
Primary completion
2021
Study completion
2022
First posted
Aug 28, 2019
Registry last updated
Feb 20, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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