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

EMBED：以用户为中心的临床决策支持的实用试验，以实施急诊部门发起的丁丙诺啡E治疗阿片类药物使用障碍

• 批准号: 10379284
• 负责人: Gail D'Onofrio
• 金额: $ 181.52万
• 依托单位: YALE UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2018
• 资助国家: 美国
• 起止时间: 2018-04-01 至 2024-09-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10379284
• 关键词: Accident and Emergency department; Adoption; Ambulatory Care; American; Appointment; Award; Buprenorphine; Caring; Clinic; Clinical; Clinical Decision Support Systems; Clinical Trials; Communities; Data Collection; Data Coordinating Center; Distal; Eligibility Determination; Emergency Care; Emergency Department patient; Emergency department visit; Evidence Based Medicine; Family; Goals; Health; Health Services Accessibility; Healthcare Systems; Heroin; Individual; Infrastructure; Institutional Review Boards; Intervention; Intervention Studies; Investments; Medical; Medical Informatics; Medical center; North Carolina; Opioid agonist; Outcome; Outcome Measure; Patients; Phase; Physicians; Population; Pragmatic clinical trial; Process; Public Health; Science; Suboxone; Substance Use Disorder; Substance abuse problem; Testing; Training; United States National Institutes of Health; Universities; Withdrawal; addiction; antagonist; capsule; clinical center; clinical decision support; cohort; collaboratory; compare effectiveness; computerized; craving; data management; effective therapy; experience; health information technology; implementation barriers; implementation context; implementation outcomes; implementation questions; implementation trial; improved; incremental cost-effectiveness; innovation; intervention effect; medication-assisted treatment; opioid epidemic; opioid mortality; opioid use; opioid use disorder; pragmatic implementation; pragmatic trial; prescription opioid addiction; process evaluation; prospective; protocol development; response; routine practice; screening; structured data; systems research; tool; treatment as usual; treatment strategy; treatment trial; trial design; uptake; usability; user centered design

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.

项目概要 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，是一个重大的公共卫生问题 给美国人、他们的家庭和社区带来毁灭性的损失。三百万美国人拥有或 喝过沉香精油。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 33,000 人）。 丁丙诺啡/纳洛酮 (BUP) 是一种部分阿片类激动剂与拮抗剂的组合，是一种成熟的药物 OUD 的门诊治疗只能由经过适当培训的医生开处方。患者患有 未经治疗的 OUD 经常到急诊科 (ED) 寻求医疗护理。 ED 启动的 BUP 使速率加倍 患有 OUD 的 ED 患者参与成瘾治疗的研究。然而，启动 BUP 的实践 ED 尚未实施到 ED 护理中。健康信息技术 (HIT) 可用性差是一个主要问题 实施循证医学面临的挑战。改善 HIT 用户体验和吸收率 循证医学认为，HIT 干预措施应采用以用户为中心的设计来制定。我们提出一个 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 针对 ED 患者 OUD 的计算机化临床决策支持 (CDS)，根据 ED 启动的 BUP 率和 转诊进行持续药物辅助治疗 (MAT)。 UG3 规划阶段（第一年）的目标是： (1) 为 ED 发起的 BUP 开发实用的、以用户为中心的 CDS，并为患有以下疾病的 ED 患者转诊 MAT： OUD 将自动识别并促进潜在合格患者的管理，以及 (2) 为拟议的试验建立基础设施。在 UH3 阶段（第 2-5 年），我们将执行试验 具体目标是： 比较以用户为中心的 BUP CDS 与常规护理对 ED 结果的有效性 OUD 患者。我们将测试主要的实施假设，即 ED 发起的 BUP 的比率为 以用户为中心的 CDS 更高。该试验将是务实的，并且比更积极地收集数据具有优势 和远端结果：（1）在通常条件下评估干预措施的效果 应用，(2) 利用可以被动收集的 EHR 结构化数据，以及 (3) 不需要 临床医生的特定专业知识或培训。形成过程评估、增量成本效益，以及 将进行投资回报分析，以优化实施用户的环境 将 CDS 纳入常规 ED 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：“什么是最好的方法？ 最大限度地提高 ED 发起的 BUP 的采用率并转介至 MAT？”我们的研究结果将立即产生影响 对 OUD 个体产生持久影响。我们在耶鲁大学、梅奥诊所和北卡罗来纳大学之间的合作网络 准备有效地进行这种设计和规模的试验。该研究将由领先的 急诊科发起的药物滥用治疗、以用户为中心的健康 IT 和数据管理领域的专家。