The Emergency Department Longitudinal Integrated Care (ED-LINC) Effectiveness Randomized Trial Targeting Opioid Use and Related Comorbidity from the ED

急诊科纵向综合护理 (ED-LINC) 有效性随机试验针对急诊室的阿片类药物使用和相关合并症

• 批准号: 10441622
• 负责人: Lauren K Whiteside
• 金额: $ 76.75万
• 依托单位: UNIVERSITY OF WASHINGTON
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-08-01 至 2026-06-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10441622
• 关键词: Accident and Emergency department; Address; Adult; Alcohols; Ambulatory Care; American; Anxiety; Buprenorphine; COVID-19 pandemic; Caring; Case Manager; Clinical; Clinical Trials; Complex; Computerized Medical Record; Data; Disease Management; Effectiveness; Elements; Emergency Care; Emergency Department Physician; Emergency Situation; Emergency department visit; Goals; Health; Health Professional; Health system; Healthcare; Home; Hospitals; Individual; Intervention; Location; Medical; Mental Depression; Mental Health; Methamphetamine; Methods; Modeling; Motivation; Naloxone; Notification; Opioid; Outcome; Outcome Assessment; Overdose; Patient Care; Patient Self-Report; Patients; Penetrance; Pharmaceutical Preparations; Policies; Population; Primary Health Care; Process Assessment; Provider; Public Health; Randomized; Risk Behaviors; Sampling; Supervision; Testing; Time; Washington; acute care; base; care coordination; care seeking; clinical care; clinically relevant; collaborative care; college; comorbidity; comparative effectiveness trial; effectiveness testing; evidence base; experience; follow-up; formative assessment; health care delivery; health management; heroin use; high risk; illicit opioid; implementation intervention; implementation process; member; methamphetamine use; multi-component intervention; multidisciplinary; novel; opioid epidemic; opioid overdose; opioid use; opioid use disorder; overdose education; patient oriented; population health; pragmatic trial; programs; public health emergency; randomized effectiveness trial; randomized trial; response; scale up; secondary analysis; sex; sharing platform; substance use; substance use treatment; support tools; symposium; tool; treatment as usual; treatment effect; trial design

The US is currently experiencing an opioid epidemic with opioid overdose, opioid use disorder (OUD) and Emergency Department (ED) visits related to opioids on the rise. The ED is at the forefront of this public health emergency and often a place where patients with OUD come for treatment of medical problems, both related and unrelated to opioid use. Medications for OUD (MOUD) and linkage to care from the ED are a critical piece in addressing this crisis. Patients in the ED with OUD present with a complex constellation of substance use, psychiatric and medical comorbidity, and often experience fragmented healthcare delivery. Comprehensive disease management strategies, such as the Collaborative Care model, hold great promise for addressing the treatment needs of patients with OUD in the ED. The Emergency Department Longitudinal Integrated Care (ED-LINC) intervention derives from the Collaborative Care model and is a multi-component, longitudinal intervention for patients with OUD and related comorbidity that is initiated during an ED visit. The ED-LINC clinical trial will randomize 500 patients with OUD seeking care at two Washington State EDs to the ED-LINC intervention (n=250) or usual care control (n=250) conditions. Patients randomized to the ED-LINC intervention will receive; 1) overdose education; 2) brief bedside intervention targeting motivation to engage in outpatient care; 3) a patient-centered approach to MOUD using a treatment decision support tool; 4) longitudinal and proactive care management which will proceed for three months along with weekly caseload supervision of the interventionist by a mental health professional allowing for stepped-up care targeting opioid use and associated comorbidity. ED-LINC is supported by the Emergency Department Information Exchange (EDIE) platform, which is a novel care coordination tool that collects data from hospitals in over 30 states and packages this information for emergency providers in real-time alert notifications. Further features of EDIE include creation of tailored care plans. The trial incorporates pragmatic outcome assessment elements, including the use of EDIE and statewide administrative data to assess important outcomes on the intent-to- treat sample. The ED-LINC trial tests the hypotheses that over time, patients randomized to the ED-LINC intervention, when compared to patients randomized to usual care, will demonstrate: 1) significant reductions in self-report illicit opioid use; 2) significant increases in MOUD initiation and retention, and 3) significant reductions in ED utilization. Secondary analyses will explore the impact of methamphetamine use comorbidity and sex on intervention treatment effects. The study team also plans to conduct an implementation process assessment using novel mixed methods to understand the potential for sustainable implementation of intervention elements. Data derived from this formative evaluation will be used to prepare for the presentation of study results at a policy summit in the final year of the trial which will allow for rapid dissemination and potential policy changes related to care for patients with OUD from the ED.

美国目前正在经历阿片类药物流行病，阿片类药物过量，阿片类药物使用障碍（OUD）和 与阿片类药物相关的急诊科（艾德）就诊人数正在上升。艾德站在公共卫生的最前沿 急诊室，通常是OUD患者前来治疗医疗问题的地方，两者都与 与阿片类药物无关治疗OUD（MOUD）的药物以及与艾德护理的联系是关键 解决这场危机。艾德的OUD患者存在复杂的物质使用， 精神和医疗并发症，并经常经历支离破碎的医疗保健服务。全面 疾病管理策略，如协作护理模式，为解决 急诊室纵向整合照护 （ED-LINC）干预源自协作护理模式，是一种多组分、纵向 在艾德访视期间开始的OUD和相关合并症患者的干预。关于ED-LINC 一项临床试验将随机抽取500名在华盛顿州两个急诊科就诊的OUD患者， 干预（n=250）或常规护理对照（n=250）条件。随机分配至ED-LINC干预组的患者 将接受; 1）过量教育; 2）针对从事门诊治疗动机的简短床边干预 护理; 3）使用治疗决策支持工具的以患者为中心的MOUD方法; 4）纵向和 积极主动的护理管理，将持续沿着三个月，每周对 由心理健康专业人员进行干预，允许针对阿片类药物使用的加强护理， 科摩罗联合国。ED-LINC由紧急部门信息交换（EDIE）支持 平台，这是一种新型的护理协调工具，从30多个州的医院收集数据， 在实时警报通知中为紧急提供者打包此信息。EDIE的更多功能 包括制定有针对性护理计划。该试验纳入了务实的结果评估要素， 包括使用EDIE和全州范围的行政数据来评估意图的重要结果， 处理样品。ED-LINC试验检验了以下假设：随着时间的推移，随机分配至ED-LINC的患者 与随机接受常规治疗的患者相比，干预将证明：1）显著降低 在自我报告的非法阿片类药物使用中; 2）MOUD启动和保留的显着增加，以及3）显着 降低艾德利用率。二次分析将探讨甲基苯丙胺使用的影响 性别对干预治疗效果的影响。研究小组还计划开展一项实施进程 使用新的混合方法进行评估，以了解可持续实施 干预因素。从形成性评估中获得的数据将用于准备演示文稿 在试验最后一年的政策首脑会议上公布研究结果，以便迅速传播， ED与OUD患者护理相关的潜在政策变化。