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

项目摘要/摘要：#年使用直接口服抗凝剂(DOAC)预防中风 在过去的5年里，美国的房颤患者显著增加，现在占 3种口服抗凝药物处方中有2种。这种增长在一定程度上是因为人们认为DOAC更简单 鉴于其监测的方便性，比传统疗法(即华法林)更适合使用。然而，效果监测是 这不是唯一相关的考虑因素。DOAC的给药不正确和依从性差都很常见， 增加了不良事件的发生率，包括出血、中风和死亡。要解决这个问题 与安全有效的非卧床DOAC使用相关的实质性临床问题，Kaiser Permanente 科罗拉多州最初在抗凝管理服务中登记接受DOAC治疗的患者 开发的目的是监测华法林治疗。在这种积极主动的DOAC管理模式中，所有患者都开出了 DOAC由抗凝专家进行全面评估和纵向监测。虽然 这种方法可能会防止不良事件的发生，它非常耗费资源。有可能以患者为目标 那些有剂量错误或依从性问题风险的人可以更经济高效地提供同样的好处。 2016年，南加州的Kaiser Permanente采取了这样的做法。他们的数据驱动型DOAC 管理模式依赖管理报告来检测潜在的剂量和遵从性问题，并 建议那些有风险的人去看抗凝剂专家。在实践中的这种差异在其他方面非常相似 医疗保健组织提供了一个独特的自然实验来评估 这些管理方法。使用药物流行病学和计算机模拟中的稳健方法 方法，与Kaiser Permanente Northwest合作，后者不提供系统级DOAC 作为参考人群的管理服务，我们建议确定(1)安全性、(2) 有效性，以及(3)每种DOAC护理模式的成本效益。初步证据 建议积极主动和数据驱动的护理模式可能会改善中风和出血的预后 关心。DOAC管理服务必须在卫生系统一级进行研究，因为卫生系统承担着 DOAC管理层的成本负担，并负责做出有关实施护理的决策 模特们。我们的建议和背景非常适合这样的评估。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 随机化试验是可能的，由于没有选择偏差，结果将具有更大的普适性。 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护理的最佳战略。它们将对临床实践产生立竿见影的影响， 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.