NCT04068727

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 561 (actual)
• Sponsor: University of Massachusetts, Worcester · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2019-12-02
• Primary completion: 2021-12-01
• Completion: 2022-09-14
• First posted: 2019-08-28
• Last updated: 2024-02-20

Locations

1 site across 1 country: United States