N/A
N=12
Dabigatran Adherence Pilot Intervention for Patients With Atrial Fibrillation
Atrial Fibrillation
Bottom Line
View on ClinicalTrials.gov: NCT01578044 ↗Enrolled (actual)
12
Serious AEs
0.0%
Results posted
Jun 2015
Primary outcome: Primary: Gaps Days Between Prescription Refills for Dabigatran, Rivaroxaban, and Apixaban — 43; 51; 41; -5 days
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Intervention (Behavioral); Control (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- VA Office of Research and Development
- Primary completion
- Jun 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Gaps Days Between Prescription Refills for Dabigatran, Rivaroxaban, and Apixaban |
43; 51; 41; -5 | — |
Summary
Atrial fibrillation is common and increases the risk of clotting especially in patients with multiple clotting risk factors. Patients treated with warfarin, an oral anti-coagulant, require frequent lab monitoring and dose adjustments and are managed in pharmacy staffed anti-coagulation clinics that routinely contact them to remind them about blood draws, re-enforce medication adherence, and adjust dosing based on labs.
Dabigatran, a newly approved medication that may be better for some with atrial fibrillation to lower risk of stroke and clotting, has been found to have fewer drug problems and eliminates lab monitoring need. Following instructions for taking dabigatran is important because it is a twice daily medication requiring monthly refills. Rivaroxaban is a once daily, newly approved Factor Xa inhibitor oral medication, prescribed to reduce risk of stroke and systemic embolism among patients with atrial fibrillation. Apixaban is a twice daily, FDA approved Factor Xa inhibitor oral anticoagulant, prescribed to reduce the risk of stroke and blood clots among patients with atrial fibrillation. In a double-blind RCT, apixaban was found to be superior to warfarin in reducing stroke, systemic embolism, and death. Patients on dabigatran, rivaroxaban, and apixaban will not be followed in anti-coagulation clinics, therefore will not benefit from the support provided by these clinics.
It's anticipated many patients will be switched to dabigatran, rivaroxaban, or apixaban following recent publication of criteria for dabigatran use from the VA National Pharmacy Benefits Management Program, providing an opportune time to conduct the proposed adherence study. We will conduct qualitative interviews with patients(n~30) and pharmacists(n~20) to understand barriers/facilitators to oral anticoagulant adherence. Informed by the findings, we will develop and pilot test a multi faceted intervention to improve adherence among patients recently started on dabigatran/rivaroxaban/apixaban.
Specific study aims:
1. Conduct interviews with a sample of patients (n=30) recently started on dabigatran for atrial fibrillation to determine why patients do or don't take medications
2. Conduct interviews with pharmacists (n=20) in anti-coagulation clinics in order to understand their opinions why patients do or don't take medications
3. Informed by interviews, develop and test an intervention targeting patients/pharmacists to improve adherence to dabigatran/rivaroxaban/apixaban
Eligibility Criteria
Inclusion Criteria
- Patients who have transitioned from warfarin to dabigatran, rivaroxaban, or apixaban or are recently started on anti-coagulation for atrial fibrillation with dabigatran, rivaroxaban, or apixaban will be eligible to be interviewed and partake in the intervention.
- Pharmacists from the Denver VA Medical Center and who work in the anti-coagulation clinics will be eligible to be interviewed.
Exclusion Criteria
- Patients who prefer a telephone interview but do not have a telephone or cell phone will be excluded.
- Patients for whom the VA is not the primary source of care will also be excluded.
- Pregnant patients will be excluded.
Data sourced from ClinicalTrials.gov (NCT01578044). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.