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

口服抗凝治疗与社区 AF 强化常规护理的药剂师管理试验（APOTHECARY AF）

• 批准号: 10687502
• 负责人: Roopinder Sandhu
• 金额: $ 84.37万
• 依托单位: CEDARS-SINAI MEDICAL CENTER
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-09-30 至 2024-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10687502
• 关键词: Address; Adherence; Agreement; Anticoagulation; Atrial Fibrillation; Awareness; California; Canada; Cardiovascular Diseases; Caring; Characteristics; Chronic Disease; Client satisfaction; Clinic; Clinic Visits; Clinical; Cluster randomized trial; Communities; Community Pharmacy; Complex; Country; County; Data; Disease; Dose; Drug Interactions; Elderly; Enrollment; Event; Goals; Guidelines; Healthcare Systems; Individual; Infrastructure; Intervention; Knowledge; Lead; Monitor; Notification; Oral; Outcome; Patients; Persons; Pharmaceutical Preparations; Pharmacists; Pharmacy facility; Physicians; Policies; Population; Prevention strategy; Prevention therapy; Quality of life; Questionnaires; Randomized; Randomized Clinical Trials; Reporting; Research; Research Personnel; Risk; Shapes; Stroke; Stroke prevention; Surveys; Therapeutic; Treatment Efficacy; Warfarin; Woman; aging population; arm; base; care delivery; clinically actionable; cost effectiveness; efficacy evaluation; health care service utilization; health literacy; heart rhythm; improved; improved outcome; innovation; intervention effect; men; novel; open label; patient-level barriers; primary outcome; programs; prospective; randomized trial; response; secondary analysis; shared decision making; standard of care; stroke risk; stroke therapy; tool; treatment arm; treatment as usual; usual care arm

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.

项目总结 心房颤动(房颤)是老年人最常见的心律失常和中风的主要原因。 与房颤相关的中风比与房颤无关的中风严重得多。口服抗凝(OAC)治疗至关重要 用于预防中风和提高房颤患者的存活率。然而，尽管OAC和可访问 临床指南和工具，以确定谁将受益于房颤患者的OAC，主要差距 继续提供适当的OAC治疗-使很大比例的房颤患者面临中风和 其潜在的毁灭性后遗症。报告最多的提供OAC治疗的差距类型包括：(I)非 处方，(Ii)不适当的用药，或(Iii)次最佳剂量。迫切需要新的解决方案来 解决房颤患者在适当提供OAC治疗方面的持续空白。积累 有证据表明，以药剂师为基础的慢性病干预措施可以非常有效， 持续，具有很高的可扩展性，并导致更多地遵守指导方针的目标，以及 改善了结果。房颤护理周围的疗效潜力特别有希望，因为药剂师领导的华法林 抗凝诊所已被证明可以提高治疗目标、患者满意度和生活质量。 OAC疗法的最新进展现在允许更安全和更容易的有效药物选择 比华法林更有效，不需要经常监测。因此，现在由药剂师领导的干预 代表了一种更容易处理的方法，可以有效地弥合中风OAC治疗的差距 房颤患者的预防。在这种情况下，我们的第一个目标是确定潜在的药剂师开处方的障碍 患者、处方医生、药剂师和社区层面的OAC，并评估药剂师对以下方面的知识 房颤患者应用OAC治疗的适应证和类型；第二，我们将评估 在一项整群随机临床试验中，药剂师领导的干预与加强常规护理的疗效 对患有未经治疗的房颤和高卒中风险的老年患者实施指南一致的OAC治疗 向社区药房展示。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遵守、医疗保健利用和临床事件，请访问 1年。我们将利用我们的新的随机试验人群来确定房颤治疗不足的原因 从患者的角度探讨这些因素对干预效果和OAC的影响 坚持不懈。这项拟议的研究将通过创新和 潜在可持续的中风预防策略，由药剂师在给药时制定。 最终，这些数据可能被用来制定药剂师领导的慢性病管理政策。 提供急需的随机试验数据，以支持这些活动的有效性和报销。