A trial of Pharmacist management of Oral anticoagulation THerapy versus Enhanced usual CARe in the communitY for AF (APOTHECARY AF)

项目摘要 心房颤动（AF）是老年人最常见的心律失常，也是导致中风的主要原因。 与AF相关的卒中远比与AF无关的卒中严重，口服抗凝治疗（OAC）至关重要 然而，尽管OAC的广泛可用性和可获得性， 用于识别能够从OAC中获益的AF患者的临床指南和工具， 持续提供适当的OAC治疗-使大部分AF患者处于卒中风险中， 其潜在的毁灭性后果。在提供OAC治疗方面报告最多的差距类型包括： 处方，（ii）不适当的药物，或（iii）次优剂量。迫切需要新的解决方案， 解决AF患者在适当提供OAC治疗方面持续存在的差距。 有证据表明，以药剂师为基础的慢性病管理干预措施可能非常有效， 持续，具有很大的可扩展性潜力，并导致更好地遵守指导方针的目标， 改善成果。房颤治疗的潜在疗效尤其有希望，因为药剂师主导的华法林 抗凝临床已被证明可以改善治疗目标、患者满意度和生活质量。 OAC治疗的最新进展现在允许更安全，更容易的有效药物选择 服用华法林，无需频繁监测。因此，药剂师领导的干预措施现在 代表了一种更易于处理的方法，可有效缩小OAC治疗中风的差距 在这种情况下，我们的第一个目标是确定潜在的药剂师处方障碍。 患者、处方者、药剂师和社区层面的OAC，并评估药剂师对以下方面的知识 通过管理调查工具，我们将评估AF的OAC治疗适应症和类型;其次，我们将评估 在一项随机分组的临床试验中，药剂师主导的干预与加强常规护理对 为患有未经治疗的AF和高卒中风险的老年人提供指南一致的OAC治疗 向社区药房介绍。在二次分析中，我们将检查干预对患者的影响 满意度，OAC共享决策，以及OAC依从性，医疗保健利用率和临床事件， 1年我们将利用我们的新随机试验人群，从以下方面确定AF治疗不足的原因： 从患者的角度，探讨这些因素对干预和OAC疗效的影响 坚持。这项拟议的研究将通过创新和 潜在的可持续的中风预防策略制定的药剂师在点的药物输送。 最终，这些数据可用于制定关于药剂师领导的慢性病管理的政策 提供急需的随机试验数据，以支持这些活动的疗效和报销。

PROJECT SUMMARY Atrial fibrillation (AF) is the most common heart rhythm disorder and a leading cause of stroke in the elderly. Stroke related to AF is far more severe than stroke unrelated to AF. Oral anticoagulation (OAC) therapy is critical for stroke prevention and improved survival in AF. However, despite wide availability of OAC and accessible clinical guidelines and tools for identifying individuals with AF who stand to benefit from OAC, major gaps in the delivery of appropriate OAC therapy persist – leaving a large proportion of persons with AF at risk for stroke and its potentially devastating sequalae. The most reported types of gaps in delivery of OAC therapy include: (i) non- prescription, (ii) inappropriate medication, or (iii) sub-optimal dosing. Novel solutions are urgently needed to address the persistent gaps in the appropriate delivery of OAC therapy for persons with AF. Accumulating evidence suggests that pharmacist-based interventions for managing chronic diseases can be highly effective, sustained, with high potential for scalability and lead to greater adherence to guideline-directed targets and improved outcomes. The potential for efficacy around AF care is especially promising, as pharmacist-led warfarin anticoagulation clinics have been shown to improve therapeutic goals, patient satisfaction, and quality-of-life. Recent advances in OAC therapeutics now allow for effective drug choices that are safer and more easily administered than warfarin without the need for frequent monitoring. Thus, pharmacist-led interventions now represent an even more tractable approach to effectively closing gaps in OAC therapy delivery for stroke prevention in patients with AF. In this context, our first aim will identify potential pharmacist barriers to prescribing OAC at the patient, prescriber, pharmacist, and community levels and assess pharmacist knowledge regarding indications and type of OAC therapy in AF through administration of a survey instrument; second, we will evaluate in a cluster randomized clinical trial, the efficacy of a pharmacist-led intervention versus enhanced usual care on the delivery of guideline concordant OAC therapy for older individuals with untreated AF and high stroke risk presenting to community pharmacies. In secondary analyses, we will examine the effect of intervention on patient satisfaction, OAC shared decision-making, and on OAC adherence, health care utilization, and clinical events at 1 year. We will leverage our novel randomized trial population to also identify reasons for undertreated AF from a patient perspective and explore the impact of these factors on the efficacy of the intervention and OAC adherence. This proposed research will generate clinically actionable knowledge through an innovative and potentially sustainable stroke prevention strategy enacted by pharmacists at the point of medication delivery. Ultimately, these data may be used to shape policy regarding pharmacist-led management of chronic disease providing much needed randomized trial data to support efficacy and reimbursement for these activities.