Implementation of DDInteract: A Shared-decision Making Tool for Anticoagulant Drug-Drug INTERACTions

DDInteract 的实施：抗凝药物-药物相互作用的共享决策工具

• 批准号: 10628461
• 负责人: DANIEL C MALONE
• 金额: $ 89.89万
• 依托单位: UNIVERSITY OF UTAH
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-08-15 至 2026-07-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10628461
• 关键词: Implementation; DDInteract; Shared; decision; Making

Project Summary: Both warfarin and direct-acting anti-coagulants (DOACs, i.e. apixaban, dabigatran, edoxaban, and rivaroxaban) are widely used to prevent thrombosis due to atrial fibrillation and other clotting disorders. Individuals receiving anticoagulants often have multiple comorbidities requiring other medications, and exposure to multiple therapies increases the risk of bleeding due to drug-drug interactions (DDIs). Current electronic health records (EHR) systems can provide warnings (i.e. alerts) about potential interactions, but these warnings are text-based, are non-specific beyond stating the interaction is “major” or “contraindicated”; and lack any medication or patient attributes that affect the likelihood of harm. Our team has developed and tested a novel share decision making (SDM) tool called DDInteract, designed to reduce exposure to anticoagulant DDIs. This tool is interoperable within existing EHR systems. Our project uses a practical, implementation science-based approach to promote the sustainable uptake of DDInteract to reduce exposure to clinically important anticoagulant DDIs. Through an implementation science framework, we will enable prescribers and patients to better understand the risk/benefit calculus so they can work together to minimize the risk of harm. Our approach is preferred over standalone web-based SDM tools because 1) DDInteract can be seamlessly launched within the EHR without having to open and authenticate against a separate application; 2) it automatically pulls relevant data (e.g., age, history of bleeding, other medications) from the patient’s record to calculate a patient-specific risk; 3) it writes medication orders back to the EHR; and 4) it automatically produces documentation for clinical notes and tailored patient instructions explaining the risk and shared decisions made during the visit. In essence, this tool is a scalable out-of-the-box solution to the issue of anticoagulant DDIs. The central hypothesis of this project seeks to evaluate whether DDInteract affects exposure to potential DDIs and risk for bleeding among patients receiving an anticoagulant from before to after implementation of DDInteract compared to providers from usual care sites. We will accomplish our objectives and test our hypothesis by pursuing the following aims: Specific Aim 1: Examine contextual factors and define relevant implementation strategies to facilitate integration of DDInteract within 3 University-based healthcare systems; Specific Aim 2: Evaluate DDInteract in production/real-world situations to identify barriers and facilitators to adoption and use of DDInteract and develop solutions to overcome those barriers; and Specific Aim 3: Conduct a cluster randomized, multi-system trial to evaluate the effectiveness of DDInteract to mitigate exposure to drug interactions involving oral anticoagulants. This project will greatly improve SDM for DDIs by implementing this novel tool (DDInteract) in the participating clinics.

项目概要： 华法林和直接作用的抗凝剂（DOAC，即阿哌沙班、达比加群、依度沙班和 利伐沙班）广泛用于预防由于心房纤维性颤动和其它凝血障碍引起的血栓形成。 接受抗凝剂治疗的患者通常有多种合并症，需要其他药物治疗， 暴露于多种疗法会增加由于药物-药物相互作用（DDI）引起的出血风险。电流 电子健康记录（EHR）系统可以提供关于潜在交互的警告（即警报），但 这些警告是基于文本的，除了说明相互作用是“严重”或“禁忌”之外，没有具体说明; 并且缺乏任何影响伤害可能性的药物或患者属性。我们的团队已经开发并 测试了一种名为DDInteract的新型股票决策（SDM）工具，该工具旨在减少 抗凝剂DDI。该工具可在现有的EHR系统中互操作。我们的项目使用了一种实用的， 实施以科学为基础的方法，促进可持续地采用DDInteract，以减少接触 临床上重要的抗凝剂DDI。通过一个实施科学框架，我们将使 处方者和患者更好地了解风险/获益计算，以便他们能够共同努力， 伤害的风险。我们的方法优于独立的基于Web的SDM工具，因为1）DDInteract可以 在EHR中无缝启动，而无需针对单独的 应用程序; 2）它自动拉取相关数据（例如，年龄、出血史、其他药物） 病人的记录，以计算病人的具体风险; 3）它写的药物订单回EHR;和4）它 自动生成临床笔记和定制的患者说明文件，解释风险， 访问期间做出的决定。从本质上讲，这个工具是一个可扩展的开箱即用的解决方案， 抗凝剂DDI。本项目的中心假设旨在评估DDInteract是否影响 接受抗凝剂治疗的患者从治疗前到治疗后的潜在DDI暴露和出血风险 DDInteract的实施与来自普通护理站点的提供者相比。我们会实现我们的目标 并通过追求以下目标来测试我们的假设：具体目标1：检查上下文因素并定义 相关实施策略，以促进DDInteract在3所大学的医疗保健中的整合 具体目标2：在生产/实际情况下评估DDInteract，以识别障碍， 促进采用和使用DDInteract，并制定克服这些障碍的解决方案; 目标3：进行一项集群随机、多系统试验，以评估DDInteract缓解的有效性 暴露于涉及口服抗凝剂的药物相互作用。本项目将通过以下方式大大改进DDI的SDM 在参与的诊所实施这种新工具（DDInteract）。