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

项目摘要/摘要：使用直接口服抗凝剂 (DOAC) 预防卒中 过去 5 年来，美国心房颤动 (AF) 患者显着增加，目前占 三分之二的口服抗凝药处方。这种增长的部分原因是人们认为 DOAC 更简单 鉴于其监测方便，比传统疗法（即华法林）更适合使用。然而，效果监测 不是唯一相关的考虑因素。 DOAC 剂量不正确和依从性差都很常见， 导致不良事件发生率增加，包括出血、中风和死亡。为了解决 与安全有效的门诊 DOAC 使用相关的重大临床问题，Kaiser Permanente 科罗拉多州最初将接受 DOAC 治疗的患者纳入抗凝管理服务 开发用于监测华法林治疗。在这种主动的 DOAC 管理模式中，所有患者都开出处方 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的发生，但非常耗费资源。有可能针对患者 那些面临剂量错误或依从性问题风险的人可以更经济有效地提供相同的好处。 2016年，南加州凯撒医疗机构就采用了这样的方法。他们的数据驱动的 DOAC 管理模式依赖于行政报告来检测潜在的剂量和依从性问题， 将有风险的人转介给抗凝专家。实践中的这种差异在其他方面高度相似 医疗保健组织提供了独特的自然实验来评估其有效性和效率 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 方法论，以及 Kaiser Permanente Northwest，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以改善中风和出血的结果相对于平常 关心。 DOAC 管理服务必须在卫生系统层面进行研究，因为卫生系统承担着大部分任务 DOAC 管理的成本负担，并负责做出有关实施护理的决策 模型。我们的建议和设置非常适合此类评估。这项研究将提供可靠的 证据表明这些护理模式的相对有效性比现有护理模式更快、更有效 通过随机试验是可能的，并且由于缺乏选择偏差，结果将具有更大的普遍性。 我们对这些创新计划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。他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.