Management of Direct Oral Anticoagulants to Lower Adverse Events in Atrial Fibrillation (MODL-AF)

项目总结/摘要：直接口服抗凝剂（DOAC）用于卒中预防的研究 在过去5年中，美国房颤（AF）患者显著增加，目前占 2/3口服抗凝剂处方。这种增长部分是由于人们认为DOAC更简单 使用比传统疗法（即，华法林），考虑到其监测便利性。然而，效果监测是 并不是唯一相关的考虑因素。不正确的剂量和不良的依从性都是DOAC的常见问题， 导致不良事件发生率增加，包括出血、中风和死亡。解决 与安全有效的门诊DOAC使用相关的大量临床问题，Kaiser Permanente 科罗拉多最初在抗凝管理服务中招募接受DOAC治疗的患者 用于监测华法林治疗。在这种积极主动的DOAC管理模式中，所有患者都开了一种 DOAC由抗凝专家进行全面评估和纵向监测。虽然 这种方法可以防止不良事件，但它是非常资源密集型的。有可能针对病人 有剂量错误或依从性问题风险的患者可以更经济有效地提供相同的益处。 2016年，Kaiser Permanente Southern加州采用了这样的方法。他们的数据驱动的DOAC 管理模式依赖于管理报告来检测潜在的给药和依从性问题， 将有风险的患者推荐给抗凝专家。在实践中，这种差异在其他方面高度相似， 卫生保健组织提供了一个独特的自然实验，以评估的有效性和效率， 这些管理方法。使用药物流行病学和计算机模拟的稳健方法 方法，并与Kaiser Permanente Northwest合作，后者不提供系统级DOAC 管理服务，作为参考人群，我们建议确定比较（1）安全性，（2） 有效性，以及（3）这些DOAC护理模式的成本效益。初步证据 表明主动和数据驱动的护理模式可能会改善中风和出血的结果相对于通常的 在乎必须在卫生系统一级研究DOAC管理服务，因为卫生系统承担了 DOAC管理的成本负担，并负责制定实施护理的决策 模型我们的建议和环境非常适合进行这种评估。这项研究将提供可靠的 这些护理模式的相对有效性的证据比 可能与随机试验，结果将有更大的普遍性，由于缺乏选择偏见。 我们对这些创新项目的仔细分析结果将回答重要而及时的问题 关于门诊DOAC护理的最佳策略。它们将对临床实践产生直接影响， 从而更安全地使用DOAC并提高效率。它们还将为未来的研究开辟新的途径。

PROJECT SUMMARY/ABSTRACT: The use of direct oral anticoagulants (DOACs) for stroke prophylaxis in patients with atrial fibrillation (AF) has markedly increased in the U.S. over the past 5 years, now accounting for 2 in 3 oral anticoagulant prescriptions. This increase is driven in part by a perception that DOACs are simpler to use than traditional therapy (i.e., warfarin) given their monitoring convenience. However, effect monitoring is not the only relevant consideration. Incorrect dosing and poor adherence are both common with DOACs, contributing to increased rates of adverse events, including bleeding, stroke, and death. To address the substantial clinical concerns associated with safe and effective ambulatory DOAC use, Kaiser Permanente Colorado enrolls patients treated with a DOAC in the anticoagulation management services originally developed to monitor warfarin therapy. In this proactive DOAC management model, all patients prescribed a DOAC are comprehensively evaluated and longitudinally monitored by anticoagulation specialists. Although this approach may prevent adverse events, it is very resource-intensive. It is possible that targeting patients who are at risk of dosage errors or adherence problems could provide the same benefit more cost-effectively. In 2016, Kaiser Permanente Southern California adopted such an approach. Their data-driven DOAC management model relies on administrative reports to detect potential dosing and adherence concerns and refers those at risk to anticoagulant specialists. This difference in practice amongst otherwise highly similar health care organizations provides a unique natural experiment to evaluate the effectiveness and efficiency of these management approaches. Using robust methods from pharmacoepidemiology and computer simulation methodologies, and with Kaiser Permanente Northwest, which does not provide system-level DOAC management services, as a reference population, we propose to determine the comparative (1) safety, (2) effectiveness, and (3) cost-effectiveness of each of these models of DOAC care. Preliminary evidence suggests both proactive and data-driven care models may improve stroke and bleed outcomes relative to usual care. DOAC management services must be studied at the health system level as health systems bear most of the cost burden for DOAC management and are responsible for making decisions about implementing care models. Our proposal and setting are uniquely suited for such an assessment. This study will provide reliable evidence on the comparative effectiveness of these care models more quickly and efficiently than would be possible with a randomized trial, and results will have greater generalizability due to lack of selection bias. Results from our careful analysis of these innovative programs will answer important and timely questions concerning optimal strategies for ambulatory DOAC care. They will have immediate impact on clinical practice, leading to safer use of DOACs and improving efficiency. They will also open new avenues for future research.