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

项目总结/摘要 新发静脉血栓栓塞（VTE）的患者发生药物不良事件的风险升高 （ADE）。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 非试验环境表明剂量和其他药物适当性标准（给药，药物- 药物相互作用、持续时间等）有60%的病人开了口服抗抑郁药这一点尤其令人担忧， 诊断为静脉血栓栓塞（VTE）且出院后未住院的患者，即门诊患者 VTE人群，并处方直接口服抗凝剂。非卧床VTE人群包括大多数患者 深静脉血栓形成（DVT）和许多肺栓塞患者。与心房肌萎缩症患者不同， 房颤，通常接受心脏病专家随访的患者，或参加华法林诊所的患者，门诊VTE 开DOAC的患者没有既定的随访途径。他们通常也没有 临床药剂师的咨询就像住院病人经常做的那样。 最近，抗凝论坛，一个多学科的非营利组织，专注于抗凝问题， 发布了DOAC最佳护理过渡清单（DOAC清单），详细说明了 确保为治疗VTE而开具DOAC的患者的护理安全过渡。这些步骤包括评估 DOAC的适当性，确认DOAC的可负担性和可获得性，患者 教育、电话咨询抗凝专业知识、合并文件和沟通， 初级保健提供者，以及肾和肝功能监测。我们建议将大会议程项目付诸实施， DOAC清单，以创建由临床药师和药房提供的综合干预措施 技术人员，目的是防止DOAC相关的临床重要用药错误，包括 可预防的ADE、可改善的ADE（严重程度或持续时间可以降低的ADE），以及 潜在ADE（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论坛的DOAC清单项目付诸实施， 为非卧床VTE患者创建由临床药师提供的全面、标准化干预 处方DOAC;（2）测量500例患者使用DOAC时临床重要用药错误的差异 随机分为干预组和对照组;（3）进行过程评估，评估保真度，适应性， 影响机制和环境因素对我们干预实施的影响;（4）创造 传播研究结果的计划。 考虑到门诊静脉血栓栓塞人群的增长，使用DOAC的相关风险 药物治疗，以及这些患者缺乏明确的途径，我们的护理过渡干预有可能 对于预防临床上重要的用药错误和提高护理过渡质量的巨大影响， 患者知识和药物依从性。

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.