Dabigatran Adherence Pilot Intervention for Patients With Atrial Fibrillation
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:
- 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
- Conduct interviews with pharmacists (n=20) in anti-coagulation clinics in order to understand their opinions why patients do or don't take medications
- Informed by interviews, develop and test an intervention targeting patients/pharmacists to improve adherence to dabigatran/rivaroxaban/apixaban
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Health Services Research
|Official Title:||Pilot Intervention to Improve Adherence to Dabigatran for Patients With Atrial Fibillation|
- Gaps Days Between Prescription Refills for Dabigatran, Rivaroxaban, and Apixaban [ Time Frame: 3 and 6 months ] [ Designated as safety issue: No ]The investigators will calculate the # of gap days between refills for dabigatran/rivaroxaban/apixaban for each3 and 6 months of the pilot intervention. This will be based on pharmacy refill data and calculated using the date dabigatran/rivaroxaban/apixaban was dispensed and the # of days supplied for that prescription. We will add the # of gap days for each 3 and 6 months of the pilot for each patient, and compare the total # of gaps days between intervention and usual care patients. The gap days between refills is a validated measure of adherence and identifies patients with sub-optimal adherence.A negative gap day value indicates that participants received the refill prior to completion of the previous prescription.
|Study Start Date:||January 2012|
|Study Completion Date:||June 2014|
|Primary Completion Date:||June 2014 (Final data collection date for primary outcome measure)|
Placebo Comparator: Control
Show Detailed Description
Please refer to this study by its ClinicalTrials.gov identifier: NCT01578044
|United States, Colorado|
|VA Eastern Colorado Health Care System, Denver, CO|
|Denver, Colorado, United States, 80220|
|Principal Investigator:||Michael Ho, MD PhD||VA Eastern Colorado Health Care System, Denver, CO|