A randomized trial of interventions to improve warfarin adherence

一项提高华法林依从性的干预措施的随机试验

• 批准号: 8110710
• 负责人: Stephen E. Kimmel
• 金额: $ 76.33万
• 依托单位: UNIVERSITY OF PENNSYLVANIA
• 依托单位国家: 美国
• 财政年份: 2008
• 资助国家: 美国
• 起止时间: 2008-09-01 至 2013-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8110710
• 关键词: Adherence; Adverse drug effect; Adverse event; American; Anticoagulants; Anticoagulation; Atrial Fibrillation; Behavioral; Caring; Cessation of life; Clinic; Clinical Trials; Coagulation Process; Control Groups; Deep Vein Thrombosis; Devices; Disabled Persons; Economics; Effectiveness; Electronics; Event; Failure; Feedback; Funding; Health; Health behavior; Hemorrhage; Home environment; Hospitalization; Hospitals; Impact evaluation; Incentives; International Normalized Ratio; Intervention; Joints; Lead; Measures; Outcome; Participant; Patient Monitoring; Patient Noncompliance; Patients; Pharmaceutical Preparations; Provider; Pulmonary Embolism; Randomized; Randomized Controlled Trials; Relative (related person); Reminder Systems; Research Design; Risk; Stroke; System; Technology; Testing; Thromboembolism; Time; United States; United States National Institutes of Health; Warfarin; arm; base; computerized; cost; cost effective; cost effectiveness; eligible participant; financial incentive; health economics; high risk; improved; indicated prevention; innovation; insight; mortality; novel; novel strategies; pill; prevent; randomized trial; therapeutic target; treatment as usual

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.

描述（由申请人提供）：数百万患有心房颤动和深静脉血栓等疾病的美国人使用华法林来降低血栓栓塞事件（例如中风或肺栓塞）的风险。尽管华法林在正确使用的情况下非常有效，但它也与高不良事件发生率相关，并且由于抗凝水平控制不佳而导致疗效丧失。即使在专门监测华法林患者的抗凝专科诊所中，也有 32% 至 68% 的患者时间花费在目标治疗国际标准化比值 (INR) 范围之外，从而使患者因治疗不足而面临更高的血栓栓塞 (TE) 风险。抗凝和过度抗凝导致的出血。抗凝控制不良的主要、可改变的因素之一是不坚持使用华法林。拟议的研究将评估两种新方法的有效性和成本效益，这些新方法旨在通过增加华法林的依从性来改善抗凝控制，并以最近完成的两项美国国立卫生研究院资助的研究为基础。经济激励和电子药丸提醒/反馈系统都已成功用于改变各种健康环境中的健康行为。该应用程序适用于一项 4 组随机对照试验 (RCT)，其中参与者获得基于抽奖的每日经济激励；家庭定制的电话转电子药盒提醒和反馈系统；抽奖和电子提醒和反馈系统；或常规护理（电子药盒仅用作记录设备，所有提醒和反馈均被禁用）。主要的具体目标是：1）评估基于抽签的经济激励措施（参与者每天服药都有资格）相对于对照组超过 6 个月的抗凝控制的有效性； 2) 评估定制的抗凝控制电子提醒和反馈系统相对于对照组6个月以上的有效性； 3) 评估基于抽奖的经济激励和电子提醒系统相对于其他组在 6 个月内抗凝控制的联合有效性。次要目标包括评估上述每种方法的成本效益，以及评估对依从性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扩展性。如果成功，这种方法每年可以减少数以万计的美国人因华法林而死亡、严重血栓栓塞事件和药物不良反应的人数。公共卫生相关性：华法林是一种血液稀释剂，如果使用得当，可以显着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以百万计的华法林是至关重要的药物的美国人的死亡或重大疾病的风险。

项目成果

A randomized trial of lottery-based incentives and reminders to improve warfarin adherence: the Warfarin Incentives (WIN2) Trial.

• DOI: 10.1002/pds.4094
• 发表时间: 2016-11
• 期刊: PHARMACOEPIDEMIOLOGY AND DRUG SAFETY
• 影响因子: 2.6
• 作者: Kimmel, Stephen E.;Troxel, Andrea B.;French, Benjamin;Loewenstein, George;Doshi, Jalpa A.;Hecht, Todd E. H.;Laskin, Mitchell;Brensinger, Colleen M.;Meussner, Chris;Volpp, Kevin
• 通讯作者: Volpp, Kevin

Randomized trial of lottery-based incentives to improve warfarin adherence.

• DOI: 10.1016/j.ahj.2012.05.005
• 发表时间: 2012-08
• 期刊: American heart journal
• 影响因子: 4.8
• 作者: Kimmel SE;Troxel AB;Loewenstein G;Brensinger CM;Jaskowiak J;Doshi JA;Laskin M;Volpp K
• 通讯作者: Volpp K