Pilot Intervention to Improve Adherence to Dabigatran for Patients With Atrial Fibillation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- Gaps Days Between Prescription Refills for Dabigatran, Rivaroxaban, and Apixaban
研究概览
简要总结
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
详细描述
Hypotheses and Specific Aims: Atrial fibrillation is common and increases the risk of thromboembolic events. Current national guidelines recommend long-term treatment with warfarin, an oral anti-coagulant, for patients with atrial fibrillation and multiple thromboembolic risk factors. Adherence to warfarin is important because of its narrow therapeutic window, which requires frequent lab monitoring (i.e., INR) 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 medication adherence, and to adjust warfarin dose based on INR values. Sub-therapeutic anti-coagulation increases the risk of thromboembolic events and is most commonly due to poor medication adherence.
Dabigatran is a newly approved oral factor X inhibitor medication that is more efficacious than warfarin for lowering the risk of stroke and systemic embolism in patients with atrial fibrillation. Additional advantages of dabigatran include fewer drug-drug interactions and standard dosing, eliminating the need for dose titration or lab monitoring. However, adherence is an important consideration with dabigatran because it is a twice a day medication and requires monthly refills due to its formulation, both of which are strong risk factors for non-adherence. 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 adherence support provided by these clinics. Non-adherence to chronic cardiovascular medications is common and non-adherence to dabigatran may potentially limit its effectiveness in routine clinical use.
Rivaroxaban is a newly approved, Factor Xa inhibitor, oral medication prescribed to reduce the risk of stroke and systemic embolism among patients with atrial fibrillation. Rivaroxaban is a once daily medication that is recommended to be taken during an evening meal to reduce the potential risk of decreased efficacy of therapy. In a randomized, double-blind study comparing warfarin to Rivaroxaban, Rivaroxaban was found non-inferior to warfarin for the prevention of stroke and systemic embolism in patients with atrial fibrillation, and the risk of major and critically relevant non-major bleeding were similar between the two anticoagulants. In addition, patients taking Rivaroxaban 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 adherence support provided by these clinics. Non-adherence to chronic cardiovascular medications is common and non-adherence to Rivaroxaban may potentially limit its effectiveness in routine clinical use.
Apixaban is a FDA approved anticoagulant, Factor Xa inhibitor, oral medication prescribed to reduce the risk of stroke and blood clots among patients with atrial fibrillation. Apixaban is taken twice daily. In a double-blind, double-dummy, randomized, non-inferior and superior controlled trial, apixaban was found to be superior to warfarin in reducing stroke, systemic embolism, and death. In addition, patients taking apixaban 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 adherence support provided by these clinics. Non-adherence to chronic cardiovascular medications is common and non-adherence to apixaban may potentially limit its effectiveness in routine clinical use.
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. This provides an opportune time to conduct the proposed study focusing on adherence to dabigatran, rivaroxaban, and apixaban. We will first perform qualitative interviews with patients (n~30) and pharmacists (n~20) to better understand barriers and facilitators to dabigatran adherence. Informed by the qualitative findings and the literature on interventions to improve cardiovascular medication adherence, we will develop and pilot test a multi-faceted intervention to improve adherence among patients recently started on dabigatran, rivaroxaban, and apixaban.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Intervention
- 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.
- 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 prescription.
- Pharmacists follow-up: If dabigatran, rivaroxaban, and apixaban has not been refilled, the pharmacy staff will contact the patient to assess reasons that the patient has not refilled the medication.
干预措施: Intervention (Behavioral)
Control
Usual care
干预措施: Control (Other)
结局指标
主要结局
Gaps Days Between Prescription Refills for Dabigatran, Rivaroxaban, and Apixaban
时间窗: 3 and 6 months
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.
次要结局
未报告次要终点