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 对美国人、他们的家庭和社区造成毁灭性的损失。300万美国人 我有OUD。自1999年以来，美国阿片类药物过量死亡人数翻了两番（2015年为33，000人）。 丁丙诺啡/纳洛酮（BUP）是一种与拮抗剂组合的部分阿片类激动剂，是一种公认的 OUD的门诊治疗，只能由经过适当培训的医生开具处方。患者 未经治疗的OUD经常在急诊科（ED）寻求医疗护理。ED启动的BUP使速率加倍 艾德患者参与成瘾治疗。然而，在联合国系统内启动BUP的做法是不可取的。 艾德尚未实施到艾德护理中。健康信息技术（HIT）可用性差是一个主要问题。 对循证医学实施的挑战。为了改善HIT用户体验， 根据循证医学，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，阶梯楔形实施试验，以评估以用户为中心的效果 根据ED引发的BUP的发生率，为患有OUD的艾德患者提供计算机化临床决策支持（CDS）， 推荐进行药物辅助治疗（MAT）。UG 3规划阶段（第1年）的目标是： (1)为ED启动的BUP和艾德患者的MAT转诊开发一个实用的、以用户为中心的CDS， OUD将自动识别并促进潜在合格患者的管理，以及（2） 为拟议试验建立基础设施。在UH 3阶段（第2-5年），我们将执行试验， 具体目的：比较以用户为中心的CDS用于BUP与常规护理对艾德结局的有效性 OUD患者我们将检验主要的实施假设，即ED引发的BUP的发生率是 以用户为中心的CDS。这项试验将是务实的，并提供优势，更积极地收集 和远端结果：（1）在通常情况下评估干预的效果， （2）利用可以被动收集的EHR结构化数据，以及（3）不需要 临床医生的专业知识或培训。形成性过程评估、增量成本效益和 将进行投资回报分析，以优化实施用户- 将CDS纳入常规艾德实践并评估其价值。鉴于BUP对参与度的巨大影响， 在治疗中，这项试验将回答OUD护理中的关键实施问题：“什么是 最大限度地提高ED发起的BUP和MAT转诊的采用率？“我们的调查结果将立即 对OUD患者的持续影响。我们的合作网络耶鲁大学，马约诊所， 准备有效地进行这种设计和规模的试验。这项研究将由领导带头， ED发起的药物滥用治疗，以用户为中心的健康IT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.