Dabigatran Adherence Pilot Intervention for Patients With Atrial Fibrillation

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

Conditions

• Atrial Fibrillation

Interventions

BEHAVIORAL

Intervention

1. Patient education: Patients will receive information on dabigatran, including risks, benefits and potential side effects. This information will be re-enforced during the study on a monthly basis during the IVR calls and during the pharmacy service calls to patients. 2. Tele-monitoring: We will use IVR technology to send patients an automated reminder to refill their dabigatran, rivaroxaban, and apixaban prescriptions. This call will be delivered on day 20 following each dabigatran, rivaroxaban, and apixaban prescriptions. 3. Pharmacists follow-up: If dabigatran, rivaroxaban, and apixaban have not been refilled, the pharmacy staff will contact the patient to assess reasons that the patient has not refilled the medication.

OTHER

Control

Usual care

Sponsors & Collaborators

• VA Office of Research and Development

  lead FED

Principal Investigators

• Michael Ho, MD PhD · VA Eastern Colorado Health Care System, Denver, CO

Study Design

Allocation

RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

90 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2012-01-31

Primary Completion

2014-06-30

Completion

2014-06-30

Countries

• United States

Study Locations