LEAVE Safe With DOACs

NCT04068727 | Completed

• 2 other identifiers: H000178911R18HS02592401
• Study Type: interventional
• Target: 561
• Locations: 1 country
• Sites: 1

Brief 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

Cardiovascular Diseases; Venous Thromboembolism; Atrial Fibrillation; Bleeding; Stroke

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

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

  90 Days Post Enrollment

• Number of missed or extra doses to assess medication adherence

  90 Days Post Enrollment

• Medication Possession Ratio (MPR) to assess medication adherence

  90 Days Post Enrollment

• Proportion of days covered (PDC) to assess medication adherence

  90 Days Post Enrollment

Study Arms (2)

Control

NO INTERVENTION

Clinical Pharmacist Intervention

EXPERIMENTAL

Other: Clinical Pharmacist Intervention

Interventions

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.

Also known as: Clinical Pharmacist Intervention Based on Checklist Endorsed by the AC Forum

Clinical Pharmacist Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of Massachusetts, Worcester: lead
• Agency for Healthcare Research and Quality (AHRQ): collaborator

Study Sites (1)

UMass Memorial Medical Center

Worcester, Massachusetts, 01605, United States

Location

Related Publications (2)

• Kapoor A, Patel P, Mbusa D, Pham T, Cicirale C, Tran W, Beavers C, Javed S, Wagner J, Swain D, Crawford S, Darling C, ItoFuKunaga M, McManus D, Mazor K, Gurwitz J. Multicomponent Pharmacist Intervention Did Not Reduce Clinically Important Medication Errors for Ambulatory Patients Initiating Direct Oral Anticoagulants. J Gen Intern Med. 2023 Dec;38(16):3526-3534. doi: 10.1007/s11606-023-08315-z. Epub 2023 Sep 27.

  PMID: 37758967 DERIVED

• Pham T, Patel P, Mbusa D, Kapoor A, Crawford S, Sadiq H, Rampam S, Wagner J, Gurwitz JH, Mazor KM. Impact of a pharmacist intervention on DOAC knowledge and satisfaction in ambulatory patients. J Thromb Thrombolysis. 2023 Feb;55(2):346-354. doi: 10.1007/s11239-022-02743-0. Epub 2022 Dec 12.

  PMID: 36510110 DERIVED

MeSH Terms

Conditions

Cardiovascular Diseases; Venous Thromboembolism; Atrial Fibrillation; Hemorrhage; Stroke

Condition Hierarchy (Ancestors)

Thromboembolism; Embolism and Thrombosis; Vascular Diseases; Arrhythmias, Cardiac; Heart Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Alok Kapoor, MD

  UMass Medical School

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Medicine

Study Record Dates

• First Submitted: August 22, 2019
• First Posted: August 28, 2019
• Study Start: December 2, 2019
• Primary Completion: December 1, 2021
• Study Completion: September 14, 2022
• Last Updated: February 20, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)