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

利用基于证据的实践让门诊 VTE 患者能够安全地使用直接口服抗凝剂：使用 DOAC 保持安全

• 批准号: 10165790
• 负责人: Alok Kapoor
• 金额: $ 50万
• 依托单位: UNIV OF MASSACHUSETTS MED SCH WORCESTER
• 依托单位国家: 美国
• 财政年份: 2019
• 资助国家: 美国
• 起止时间: 2019-08-01 至 2023-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10165790
• 关键词: Leveraging; Evidence; based; practices; Ambulatory

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.

项目摘要/摘要 静脉血栓栓塞（VTE）的新发作的患者患不良毒品事件的风险较高 （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 非试验环境提出了剂量和其他药物适当性标准的问题（给药，药物 - 在全60％的患者处方DOAC中，药物相互作用，持续时间等）。这尤其令人担忧 诊断出没有住院的静脉血栓栓塞（VTE）的患者，即卧床 VTE人口，并处方直接口服抗凝剂。门诊VTE人口包括大多数患者 具有深静脉血栓形成（DVT）和许多肺栓塞患者。与心房患者不同 纤颤，通常会接受心脏病专家或参加华法林诊所的患者的随访 开处方DOAC的患者没有建立随访的途径。他们通常也没有 临床药剂师作为住院患者的咨询经常会这样做。 最近，抗凝论坛，一个跨学科的非营利组织，专注于抗凝问题， 发布了DOAC清单以进行最佳护理过渡（DOAC清单），以详细说明 确保在开处方的DOAC治疗VTE的患者中安全过渡。这些步骤包括评估 DOAC适当性，确认DOAC处方的可承受性和访问权限 教育，电话获得抗凝专业知识，合并的文档和通信 初级保健提供者以及肾功能和肝功能监测。我们建议操作 DOAC清单以创建临床药剂师和药房提供的全面干预措施 技术人员的目标是防止与DOAC相关的临床上重要的药物错误，其中包括 可预防的AD，可改善AD（可能已减少严重性或持续时间的ADE），并且 潜在的ADE（可能造成伤害的药物错误）。 我们的建议包括以下具体目的：（1）将交流论坛DOAC清单的项目运行到 创建由临床药剂师为卧床VTE患者提供的全面，标准化的干预措施 规定的DOAC； （2）测量500例DOAC临床上重要的药物错误的差异 随机进行干预和控制臂； （3）进行评估的过程评估，以评估忠诚度，适应性， 影响机制和上下文因素对我们干预的实施的影响； （4）创建 传播研究结果的计划。 鉴于处方DOAC的卧床VTE人口的增长，此类的风险 药物以及这些患者缺乏定义的途径，我们的护理过渡干预具有潜力 为了防止临床上重要的药物错误和改善护理质量过渡的巨大影响， 患者知识和药物依从性。

项目成果

Impact of a pharmacist intervention on DOAC knowledge and satisfaction in ambulatory patients.

药剂师干预对门诊患者 DOAC 知识和满意度的影响。

• DOI: 10.1007/s11239-022-02743-0
• 发表时间: 2023
• 期刊: Journal of thrombosis and thrombolysis
• 影响因子: 4
• 作者: Pham,Thu;Patel,Parth;Mbusa,Daniel;Kapoor,Alok;Crawford,Sybil;Sadiq,Hammad;Rampam,Sanjeev;Wagner,Joann;Gurwitz,JerryH;Mazor,KathleenM
• 通讯作者: Mazor,KathleenM