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: 10205443
• 负责人: Lauren K Whiteside
• 金额: $ 79.31万
• 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/10205443
• 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; Education; 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; patient oriented; population health; pragmatic trial; prescription opioid; 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，包括阿片类药物过量、阿片类药物使用障碍（OUD）和 与阿片类药物相关的急诊室 (ED) 就诊人数呈上升趋势。急诊室处于公共卫生领域的最前沿 紧急情况下，通常是 OUD 患者来治疗医疗问题的地方，两者都相关 与阿片类药物的使用无关。 OUD 药物 (MOUD) 以及与急诊室护理的联系是关键部分 在解决这场危机时。急诊科 OUD 患者存在一系列复杂的物质使用情况， 精神和医疗合并症，并且经常经历支离破碎的医疗服务。综合的 疾病管理策略，例如协作护理模式，对于解决这一问题有着巨大的希望 急诊室 OUD 患者的治疗需求。急诊科纵向综合护理 (ED-LINC) 干预源于协作护理模式，是一种多组成部分、纵向的干预措施 对 OUD 和相关合并症患者的干预是在急诊室就诊期间启动的。 ED-LINC 临床试验将随机将 500 名在华盛顿州两个 ED 就诊的 OUD 患者分配到 ED-LINC 干预（n=250）或常规护理控制（n=250）条件。随机接受 ED-LINC 干预的患者 将会收到； 1）服药过量教育； 2) 简短的床边干预，旨在激励患者参与门诊治疗 关心; 3) 使用治疗决策支持工具以患者为中心的 MOUD 方法； 4) 纵向和 积极的护理管理将持续三个月，同时每周对患者进行病例量监督 由心理健康专业人员进行干预，允许针对阿片类药物的使用加强护理， 相关的合并症。 ED-LINC 得到急诊科信息交换 (EDIE) 的支持 平台，这是一种新颖的护理协调工具，可以从 30 多个州的医院收集数据， 将这些信息打包在实时警报通知中，供紧急服务提供者使用。 EDIE 的更多功能 包括制定量身定制的护理计划。该试验纳入了务实的结果评估要素， 包括使用 EDIE 和全州行政数据来评估意向的重要结果： 处理样品。 ED-LINC 试验测试了以下假设：随着时间的推移，患者被随机分配到 ED-LINC 与随机接受常规护理的患者相比，干预将证明：1）显着减少 自我报告非法使用阿片类药物； 2) MOUD 启动和保留显着增加，以及 3) 显着增加 减少 ED 利用率。二次分析将探讨甲基苯丙胺使用合并症的影响 和性别对干预治疗效果的影响。研究小组还计划进行实施过程 使用新颖的混合方法进行评估，以了解可持续实施的潜力 干预元素。从这一形成性评估中获得的数据将用于准备演示 在试验最后一年的政策峰会上收集研究结果，以便快速传播和 与急诊室 OUD 患者护理相关的潜在政策变化。