A randomized trial of interventions to improve warfarin adherence

描述(由申请人提供)：数百万患有房颤和深静脉血栓等疾病的美国人使用华法林来降低血栓事件(例如中风或肺血栓)的风险。尽管华法林在正确使用时非常有效，但它也与高不良事件发生率和由于抗凝水平控制不佳而失去疗效有关。即使在专门监测服用华法林的患者的专门抗凝诊所，32%至68%的患者时间也超出了目标治疗国际标准化比率(INR)范围，这增加了患者因抗凝不足而患血栓栓塞症(TE)的风险，以及因抗凝过度而出血的风险。抗凝控制不佳的主要、可改变的因素之一是不坚持使用华法林。这项拟议的研究将评估两种旨在通过增加华法林依从性来改善抗凝控制的新方法的有效性和成本效益，这两种方法的信息来自最近完成的两项由美国国立卫生研究院资助的研究。财政奖励和电子药丸提醒/反馈系统已被成功地用于改变各种健康背景下的健康行为。这项应用是一项四臂随机对照试验(RCT)，参与者可以获得基于彩票的每日经济奖励；在家中获得定制的电话电子提醒和反馈系统；彩票和电子提醒和反馈系统；或常规护理(电子药箱仅用作记录设备，禁用所有提醒和反馈)。主要的具体目标将是：1)评估基于彩票的财政奖励的有效性--参与者在服用药物的每一天都符合条件--相对于对照组在6个月内进行抗凝控制；2)相对于对照组评估定制的抗凝控制电子提醒和反馈系统在6个月内的有效性；以及3)评估基于彩票的财政奖励和电子提醒系统在6个月内相对于其他组在抗凝控制方面的联合有效性。次要目标包括评估上述每种方法的成本效益，以及评估对遵守措施和其他结果的影响。拟议的干预措施借鉴了行为经济学研究的见解，旨在通过使用易于应用的技术来实现成本效益和可伸缩性。如果成功，这种方法每年可以将美国人中华法林的死亡、严重血栓栓塞事件和药物不良反应减少数万人。与公共卫生相关：华法林是一种血液稀释剂，如果使用得当，可以显著降低美国数百万患者中风和其他凝血事件的可能性。然而，许多患者难以正确服用华法林，因此中风、其他凝血事件和出血的风险很高。在这项研究中，我们正在测试两种提高华法林依从性的创新方法的有效性和成本效益，这两种方法有可能大幅降低数百万美国人的死亡或重大疾病风险，对他们来说，华法林是一种至关重要的药物。

DESCRIPTION (provided by applicant): Warfarin is used by millions of Americans with conditions such as atrial fibrillation and deep venous thrombosis to lower their risk of thromboembolic events (e.g., stroke or pulmonary embolism). Although warfarin is highly efficacious when used correctly, it is also associated with high adverse event rates and lost efficacy due to poor control of anticoaguation levels. Even in specialized anticoagulation clinics that are devoted to monitoring patients on warfarin, 32% to 68% of patient time is spent out of the target therapeutic international normalized ratio (INR) range, putting patients at increased risk for thromboembolism (TE) from under-anticoagulation and bleeding from over-anticoagulation. One of the primary, modifiable contributors to poor anticoaguation control is non-adherence to warfarin. The proposed study will evaluate the effectiveness and cost-effectiveness of two novel approaches that aim to improve anticoaguation control by increasing warfarin adherence, informed by two recently completed NIH-funded studies. Both financial incentives and electronic pill reminder/feedback systems have been used successfully to modify health behaviors in a variety of health contexts. This application is for a 4-arm randomized controlled trial (RCT) in which participants receive either a lottery-based daily financial incentive; a customized, transtelephonic electronic pillbox reminder and feedback system at home; both the lottery and the electronic reminder and feedback system; or usual care (the electronic pillbox used only as a recording device with all reminders and feedback disabled). The primary specific aims will be to: 1) assess the effectiveness of a lottery-based financial incentive -- with participants eligible each day they take their medication -- on anticoagulation control relative to the control group over 6 months; 2) assess the effectiveness of a customized electronic reminder and feedback system on anticoagulation control relative to the control group over 6 months; and 3) assess the joint effectiveness of the lottery-based financial incentives and electronic reminder system on anticoagulation control relative to the other groups over 6 months. Secondary aims include assessment of the cost-effectiveness of each of the above approaches, and evaluation of the impact on adherence measures and other outcomes. The proposed interventions draw on insights from behavioral economic research and are designed to be cost-effective and scalable through the use of easily applied technology. If successful, this approach could reduce the number of deaths, serious thromboembolic events, and adverse drug effects from warfarin by tens of thousands among Americans each year. PUBLIC HEALTH RELEVANCE: Warfarin is a blood thinner that, when properly used, significantly reduces the likelihood of strokes and other clotting events in millions of patients in the United States. However, many patients have difficulty taking their warfarin correctly and therefore are at high risk of strokes, other clotting events, and bleeding. In this study, we are testing the effectiveness and cost-effectiveness of two innovative approaches to improving adherence to warfarin which have the potential to reduce substantially the risk of death or significant illness for the millions of Americans for whom warfarin is a critically important medication.