LEAVE Safe With DOACs

NCT ID: NCT04068727

Last Updated: 2024-02-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 561 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-12-02
• Study Completion Date: 2022-09-14

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.

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: SINGLE

Study Groups

Control

Group Type: NO_INTERVENTION

No interventions assigned to this group

Clinical Pharmacist Intervention

Group Type: EXPERIMENTAL

Clinical Pharmacist Intervention

Intervention Type: 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.

Interventions

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.

Intervention Type: OTHER

Other Intervention Names

Clinical Pharmacist Intervention Based on Checklist Endorsed by the AC Forum

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Agency for Healthcare Research and Quality (AHRQ)

FED

Sponsor Role: collaborator

University of Massachusetts, Worcester

OTHER

Sponsor Role: lead

Responsible Party

Alok Kapoor

Associate Professor of Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Alok Kapoor, MD

Role: PRINCIPAL_INVESTIGATOR

UMass Medical School

Locations

UMass Memorial Medical Center

Worcester, Massachusetts, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 37758967 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 36510110 (View on PubMed)

Other Identifiers

1R18HS02592401

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

H00017891

Identifier Type: -

Identifier Source: org_study_id