Dabigatran Adherence Study
Atrial fibrillation is a common cardiac problem and it increases the risk of clotting events especially in patients with multiple clotting risk factors. Therefore, patients are treated with warfarin, an oral anti-coagulant, which requires frequent lab monitoring and dose adjustment. The majority of veterans on warfarin are managed in anti-coagulation clinics staffed by pharmacists who routinely contact patients to remind them to get blood draws, to re-enforce taking of their medication, and to adjust warfarin dose based on lab test values. Not having adequate anti-coagulation increases the risk of clotting and is most commonly due to not taking medications as prescribed.
Dabigatran is a newly approved medication that may be better for some patients than warfarin for lowering the risk of stroke and clotting in patients with atrial fibrillation. Additional advantages of dabigatran include fewer drug problems, and eliminating the need lab monitoring. However, following the doctors instructions for taking the medication is an important consideration with dabigatran because it is a twice a day medication and requires monthly refills, both of which are strong risk factors for not following the prescribed instructions. In addition, patients taking dabigatran will not be followed in anti-coagulation clinics because there is no lab value to monitor, and therefore, they will no longer benefit from the support provided by these clinics.
It is anticipated that many patients will be switched to dabigatran following recent publication of criteria for dabigatran use from the VA National Pharmacy Benefits Management Program. For our study, we will first perform interviews with patients (n~30) and pharmacists (n~20) to better understand reasons why people take or don't take the medicine. Informed by the interviews and the literature on interventions to improve people taking their medicine, we will develop and test an intervention to improve taking dabigatran among patients recently started on dabigatran.
The Specific aims of this study are:
- Aim 1 - Conduct interviews with a sample of patients (n=30) recently started on dabigatran for atrial fibrillation to determine why patients take and don't take their medications.
- Aim 2 - Conduct interviews with pharmacists (n=20) in anti-coagulation clinics in order to understand their opinions why patients take and don't take their medications.
- Aim 3 - Informed by the interviews, develop and test an intervention targeting patients and pharmacists to improve patients taking their dabigatran.
|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 Dabigatran Adherence|
- Gaps between prescription refills for dabigatran [ Time Frame: 6 months ] [ Designated as safety issue: No ]The investigators will calculate the number of gap days between refills for dabigatran for each of the 3 months of the pilot intervention This will be based on pharmacy refill data and calculated using the date dabigatran was dispensed and the number of days supplied for that prescription. We will add the number of gap days for each of the 3 months of the pilot for each patient, and compare the total number 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.
|Study Start Date:||January 2012|
|Estimated Study Completion Date:||December 2013|
|Estimated Primary Completion Date:||June 2013 (Final data collection date for primary outcome measure)|
Experimental: Facilitator to Dabigatran Adherence
Placebo Comparator: Arm 2
Show Detailed Description
|Contact: Michael Ho, MD PhD||(720) email@example.com|
|Contact: Paul D Varosy, MD||(415) 221-4710 ext 3178||Paul.Varosy@va.gov|
|United States, Colorado|
|VA Eastern Colorado Health Care System, Denver||Recruiting|
|Denver, Colorado, United States, 80220|
|Contact: Robert L Keith, MD 303-399-8020 ext 3182 firstname.lastname@example.org|
|Contact: Pamela Rice, PhD (303) 399-8020 ext 3846 Pamela.Rice@va.gov|
|Principal Investigator: Michael Ho, MD PhD|
|Principal Investigator:||Michael Ho, MD PhD||VA Eastern Colorado Health Care System, Denver|