LEAVE Safe With DOACs

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

Study Overview

• Status: Completed
• Conditions: Cardiovascular Diseases; Stroke; Atrial Fibrillation; Bleeding; Venous Thromboembolism
• Intervention / Treatment: Other: Clinical Pharmacist Intervention

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 561
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Worcester, Massachusetts, United States, 01605
      • UMASS Memorial Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control
Experimental: Clinical Pharmacist Intervention	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.; Other Names: Clinical Pharmacist Intervention Based on Checklist Endorsed by the AC Forum

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Direct Oral Anticoagulant (DOAC)-Related Clinically Important Medication Errors	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.	90 Days Post Enrollment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient Knowledge regarding Anticoagulation and Venus Thromboembolism (VTE) using the Anticoagulation and Venus Thromboembolism (VTE) knowledge questionnaire	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.	90 Days Post Enrollment
Number of missed or extra doses to assess medication adherence	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.	90 Days Post Enrollment
Medication Possession Ratio (MPR) to assess medication adherence	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.	90 Days Post Enrollment
Proportion of days covered (PDC) to assess medication adherence	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.	90 Days Post Enrollment

Collaborators and Investigators

• Sponsor: University of Massachusetts, Worcester
• Collaborators: Agency for Healthcare Research and Quality (AHRQ)
• Investigators: Principal Investigator: Alok Kapoor, MD, UMass Medical School

Study record dates

Study Major Dates

• Study Start (Actual): December 2, 2019
• Primary Completion (Actual): December 1, 2021
• Study Completion (Actual): September 14, 2022

Study Registration Dates

• First Submitted: August 22, 2019
• First Submitted That Met QC Criteria: August 22, 2019
• First Posted (Actual): August 28, 2019

Study Record Updates

• Last Update Posted (Actual): February 20, 2024
• Last Update Submitted That Met QC Criteria: February 15, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Vascular Diseases; Embolism and Thrombosis; Arrhythmias, Cardiac; Cardiovascular Diseases; Atrial Fibrillation; Thromboembolism; Venous Thromboembolism
• Other Study ID Numbers: H00017891; 1R18HS02592401 (Other Grant/Funding Number: Agency for Healthcare Research and Quality (AHRQ))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No