Clinical trial NCT04068727: LEAVE Safe With DOACs
Official title: Leveraging Evidence-based Practices for Ambulatory VTE and Other Patients to be Safe With Direct Oral Anticoagulants: LEAVE Safe With DOACs
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiovascular Diseases
Venous Thromboembolism
Atrial Fibrillation
Bleeding
Stroke
Lead sponsor: University of Massachusetts, Worcester
Sponsor class: OTHER
Collaborators: name: Agency for Healthcare Research and Quality (AHRQ)
First posted: 2019-08-28
Enrollment: 561
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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)

Primary outcomes:
measure: Number of Direct Oral Anticoagulant (DOAC)-Related Clinically Important Medication Errors
timeFrame: 90 Days Post Enrollment
Secondary outcomes:
measure: Patient Knowledge regarding Anticoagulation and Venus Thromboembolism (VTE) using the Anticoagulation and Venus Thromboembolism (VTE) knowledge questionnaire
timeFrame: 90 Days Post Enrollment
measure: Number of missed or extra doses to assess medication adherence
timeFrame: 90 Days Post Enrollment
measure: Medication Possession Ratio (MPR) to assess medication adherence
timeFrame: 90 Days Post Enrollment
measure: Proportion of days covered (PDC) to assess medication adherence
timeFrame: 90 Days Post Enrollment
Other outcomes:
Locations:
city: Worcester
country: United States
facility: UMass Memorial Medical Center
state: Massachusetts
Study officials:
affiliation: UMass Medical School
name: Alok Kapoor, MD
role: PRINCIPAL_INVESTIGATOR
References: