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.

项目摘要 阿片类药物使用障碍（OUD），依赖处方阿片类药物和海洛因，是一个主要的公共卫生问题 对美国人，他们的家人和社区造成毁灭性的损失。有300万美国人有或 有Oud。自1999年以来，阿片类药物过量的死亡人数已在美联航（2015年为33,000）。 丁丙诺啡/纳洛酮（BUP）是一种局部阿片类动力学，与拮抗剂相结合，是一个公认的 OUD的门诊治疗只能由经过适当培训的医生开处方。患者 未经处理的Oud经常在紧急部门（EDS）寻求医疗服务。杂音发射的bup使速率翻了一番 ED OUD患者参与成瘾治疗。但是，在 Ed尚未实施ED护理。健康信息技术（HIT）可用性不佳是主要的 对实施循证医学的挑战。提高热门用户体验和吸收 循证医学，应使用以用户为中心的设计制定命中干预措施。我们提出了一个 多中心，务实的阶梯楔实施试验，以评估以用户为中心的效果 ED患者的计算机化临床决策支持（CD），以递送发射的BUP和 推荐用于正在进行的药物辅助治疗（MAT）。 UG3计划阶段的目的（第1年）是： （1）开发一种以用户为中心的CD，用于发射的bup，并在ED患者中为MAT推荐 OUD将自动识别并促进潜在符合条件的患者的管理和（2） 建立拟议试验的基础设施。在UH3阶段（2 - 5年），我们将与 具体目的是：将以用户为中心的CD对BUP的有效性与ED中的结果进行治疗 OUD患者。我们将测试主要实施假设，即递入的BUP的速率是 以用户为中心的CD较高。该审判将是务实的，并提供比更积极收集的优势 和远端结果：（1）在通常条件下评估干预措施的影响 使用可以被动收集的EHR的结构化数据应用，（2），（3）不需要 临床医生的具体专业知识或培训。形成过程评估，逐步成本效益和 将进行投资分析回报率，以优化实施用户的上下文 - 将CD集中在常规练习中并评估其价值。考虑到BUP对参与的戏剧性影响 在治疗中，该试验将回答Oud Care中的关键实施问题：“什么是最好的方法 最大化接种发射的BUP的采用率并转介到MAT？”我们的发现将立即和 对OUD个人的持久影响。我们在耶鲁大学，梅奥诊所和UNC之间的协作网络 被中毒以有效地进行此设计和幅度的试验。这项研究将由领导者带头 在物质滥用，以用户为中心的健康IT和数据管理方面进行杂交治疗的专家。