EMBED: Pragmatic trial of user-centered clinical decision support to implement EMergency department-initiated BuprenorphinE for opioid use Disorder

项目摘要 阿片类药物使用障碍(OUD)，即对处方阿片类药物和海洛因的依赖，是一个主要的公共卫生问题 给美国人、他们的家人和他们的社区带来了毁灭性的损失。300万美国人拥有或 已经吃过了。自1999年以来，美国阿片类药物过量死亡人数增加了四倍(2015年为3.3万人)。 丁丙诺啡/纳洛酮(buprennoine/naloxone，BUP)是一种部分阿片激动剂，与拮抗剂联合使用，是一种成熟的 OUD的门诊治疗只能由受过适当培训的医生开出。患有疾病的患者 未经治疗的OUD经常到急诊室寻求医疗护理。ED发起的BUP使比率翻了一番 勃起功能障碍患者对成瘾治疗的参与度。然而，启动BUP的做法在 ED尚未落实到急诊护理中。健康信息技术(HIT)可用性差是一个主要原因 对循证医学实施的挑战。改善热门用户体验和对 循证医学，HIT干预措施应采用以用户为中心的设计。我们提出了一个 多中心、务实、阶梯式楔形实施试验，评估以用户为中心的效果 计算机化临床决策支持(CDS)对ED患者BUP和BUD发生率的影响 转诊为正在进行的药物辅助治疗(MAT)。UG3规划阶段(第1年)的目标是： (1)开发实用的、以用户为中心的CDS，用于ED发起的BUP和转诊，用于ED患者的MAT OUD将自动识别和方便潜在符合条件的患者的管理，以及(2) 为拟议的试验建立基础设施。在UH3阶段(2-5年)，我们将通过以下方式执行试验 具体目的是：比较以用户为中心的BUP CDS与常规护理对急诊预后的影响 OUD患者。我们将测试主要实施假设，即ED发起的BUP比率为 以用户为中心的CDS更高。这项试验将是务实的，并提供比更积极收集的优势 和远期结果：(1)在通常情况下评估干预的效果 应用，(2)利用来自EHR的可被动收集的结构化数据，以及(3)不需要 临床医生的特定专业知识或培训。形成性过程评估、增量成本效益，以及 将进行投资回报分析，以优化实施用户- 将CDS纳入常规急救实践，并评价其价值。鉴于BUP对参与度的戏剧性影响 在治疗方面，这项试验将回答在OUD护理中实施的关键问题：“什么是最好的方法 最大限度地提高ED发起的BUP的采用率并转诊到MAT？？我们的调查结果将立即和 对患有OUD的个人的持久影响。我们在耶鲁大学、梅奥诊所和北卡罗来纳大学之间的协作网络 准备有效地进行这种设计和规模的试验。这项研究将由领先的 ED发起的药物滥用治疗、以用户为中心的健康信息技术和数据管理方面的专家。

Project Summary Opioid use disorder (OUD), dependence on prescription opioids and heroin, is a major public health problem taking a devastating toll on Americans, their families, and their communities. Three million Americans have or have had OUD. Opioid overdose deaths have quadrupled in the United Sates since 1999 (33,000 in 2015). Buprenorphine/naloxone (BUP), a partial opioid agonist combined with an antagonist, is a well-established outpatient treatment for OUD that can only be prescribed by appropriately trained physicians. Patients with untreated OUD often seek medical care in emergency departments (EDs). ED-initiated BUP doubles the rate of engagement in addiction treatment in ED patients with OUD. However, the practice of initiating BUP in the ED has not been implemented into ED care. Poor health information technology (HIT) usability is a major challenge to implementation of evidence-based medicine. To improve the HIT user experience and uptake of evidence-based medicine, HIT interventions should be developed using user-centered design. We propose a multicenter, pragmatic, stepped wedge implementation trial to evaluate the effect of user-centered computerized clinical decision support (CDS) for ED patients with OUD upon rates of ED-initiated BUP and referral for ongoing medication assisted treatment (MAT). The aims for the UG3 Planning Phase (Year 1) are: (1) Develop a pragmatic, user-centered CDS for ED-initiated BUP and referral for MAT in ED patients with OUD which will automatically identify and facilitate management of potentially eligible patients and (2) Establish the infrastructure for the proposed trial. In the UH3 Phase (Years 2-5) we will execute the trial with the specific aim to: Compare the effectiveness of user-centered CDS for BUP to usual care on outcomes in ED patients with OUD. We will test the primary implementation hypothesis that rates of ED-initiated BUP are higher with user-centered CDS. This trial will be pragmatic and offer advantages over more actively collected and distal outcomes by: (1) evaluating the effects of an intervention under the usual conditions in which it will be applied, (2) utilizing structured data from the EHR that can be passively collected, and (3) requiring no specific expertise or training of clinicians. Formative process evaluation, incremental cost effectiveness, and return on investment analyses will be performed to optimize the context for implementation of the user- centered CDS into routine ED practice and to evaluate its value. Given BUP's dramatic effect on engagement in treatment, this trial will answer the critical implementation question in OUD care: “What is the best way to maximize the rate of adoption of ED-initiated BUP and referral to MAT?" Our findings will have immediate and lasting impact upon individuals with OUD. Our collaborative network between Yale, the Mayo Clinic, and UNC is poised to efficiently carry out a trial of this design and magnitude. The study will be spearheaded by leading experts in ED-initiated treatment in substance abuse, user-centered health IT, and data management.