Leveraging Evidence-based practices for Ambulatory VTE Patients to be Safe with Direct Oral Anticoagulants: LEAVE Safe with DOACs

项目摘要/摘要 新发静脉血栓栓塞症(VTE)的患者发生药物不良事件的风险较高 (ADES)。尽管试验数据表明直接口服抗凝剂(DOAC)比华法林更安全，但来自 非试验设置表明剂量和其他药物适当性标准存在问题(给药、药物- 药物相互作用、持续时间等)总共有60%的患者开了DOAC。这一点尤其令人担忧 静脉血栓栓塞症(VTE)确诊后无需住院即可出院的患者，即门诊 VTE人群，并开出直接口服抗凝剂。动态静脉血栓栓塞组包括大多数患者。 有深静脉血栓形成(DVT)和许多肺栓塞患者。与房颤患者不同的是 纤颤，通常接受心脏病专家的随访，或去华法林诊所就诊的患者，非卧床VTE 服用DOAC的患者没有既定的随访途径。他们通常也不会有 临床药剂师的咨询，就像住院病人经常做的那样。 最近，专注于抗凝问题的多学科非营利性组织抗凝论坛， 发布DOAC最佳护理过渡核对表(DOAC核对表)，以详细说明 确保使用DOAC治疗静脉血栓栓塞症的患者能够安全过渡护理。这些步骤包括评估 DOAC的适当性，DOAC处方的可负担性和可获得性的确认，患者 教育，电话获取抗凝专业知识，合并文件和沟通 初级保健提供者，以及肾和肝功能监测。我们建议将 DOAC检查表将创建由临床药剂师和药房提供的全面干预 技术人员，目标是防止与DOAC相关的临床重要用药错误，包括 可预防的不良反应、可改善的不良反应(严重程度或持续时间本可降低的不良反应)，以及 潜在的不良反应(可能造成伤害的用药错误)。 我们的建议包括以下具体目标：(1)将AC论坛DOAC检查表的项目付诸实施 创建由临床药师为门诊VTE患者提供的全面、标准化的干预 处方DOAC；(2)测量500名患者使用DOAC时临床重要用药差错的差异 随机到干预和控制组；(3)进行过程评估，评估保真度、适应性、 影响机制和背景因素对我们干预实施的影响；以及(4)创造 传播研究结果的计划。 鉴于门诊VTE人口的增长，开出DOAC的这类患者的相关风险 药物治疗，以及这些患者缺乏明确的治疗途径，我们的护理过渡干预具有潜力 对于预防临床重要用药差错和提高护理过渡质量的巨大影响， 患者知识和服药依从性。

PROJECT SUMMARY/ABSTRACT Patients with new episodes of venous thromboembolism (VTE) are at an elevated risk for adverse drug events (ADEs). Although trial data suggest that direct oral anticoagulants (DOACs) are safer than warfarin, data from non-trial setting suggests problems with dosing and other medication appropriateness criteria (administration, drug- drug interactions, duration, etc.) in a full 60% of patients prescribed DOACs. This is particularly concerning for patients with venous thromboembolism (VTE) diagnosed and discharged without hospitalization, i.e. the ambulatory VTE population, and prescribed direct oral anticoagulants. The ambulatory VTE population includes most patients with deep vein thrombosis (DVT) and many patients with pulmonary embolism. Unlike patients with atrial fibrillation, who typically receive follow-up with a cardiologist, or patients attending warfarin clinics, ambulatory VTE patients prescribed DOACs do not have established pathways for follow-up. They also do not typically have consultation by a clinical pharmacist as a hospitalized patient often does. Recently the Anticoagulation Forum, a multidisciplinary nonprofit organization focused on anticoagulation issues, published the DOAC Checklist for Optimal Care Transitions (DOAC Checklist) to elaborate the steps required to ensure a safe transition of care in patients prescribed DOACs for treatment of VTE. These steps include evaluation of the appropriateness of DOAC, confirmation of the affordability and access of DOAC prescribed, patient education, telephone access to anticoagulation expertise, consolidated documentation and communication to primary care provider, and renal and hepatic function monitoring. We propose operationalizing the items of the DOAC Checklist to create a comprehensive intervention delivered by clinical pharmacists and a pharmacy technician with the goal of preventing DOAC-related clinically important medication errors which includes preventable ADEs, ameliorable ADEs (ADEs in which the severity or duration could have been reduced), and potential ADEs (medication errors with the potential to cause harm). Our proposal includes the following specific aims: (1) operationalize the items of the AC Forum's DOAC checklist to create a comprehensive, standardized intervention delivered by clinical pharmacists for ambulatory VTE patients prescribed DOACs; (2) measure the difference in clinically important medication errors with DOAC for 500 patients randomized to intervention and control arms; (3) conduct a process evaluation assessing fidelity, adaptation, mechanisms of impact and the influence of contextual factors on implementation of our intervention; and (4) create a plan for disseminating study findings. Given the growth of the ambulatory VTE population prescribed DOACs, the associated risks with this class of medications, and the lack of defined pathways for these patients, our care transition intervention has the potential for enormous impact in preventing clinically important medication errors and improving the quality of care transition, patient knowledge, and medication adherence.