LEAVE Safe With DOACs

University of Massachusetts, Worcester

Status: Completed

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

Treatments: Other: Clinical Pharmacist Intervention

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT04068727

1R18HS02592401 (Other Grant/Funding Number)

H00017891

Details and patient eligibility

About

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.

Full 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.

Enrollment: 561 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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561 participants in 2 patient groups

Control

No Intervention group

Clinical Pharmacist Intervention

Experimental group

Treatment:

Other: Clinical Pharmacist Intervention