Emergency Department-Initiated Medications for Alcohol Use Disorder

急诊科启动的酒精使用障碍药物

• 批准号: 10567250
• 负责人: Kathryn Hawk
• 金额: $ 75.26万
• 依托单位: YALE UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-07-01 至 2028-06-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10567250
• 关键词: Accident and Emergency department; Acute; Address; Alcohol consumption; Alcohol withdrawal syndrome; Alcohols; American; Assessment tool; Automobile Driving; Behavior Therapy; Caring; Categories; Cause of Death; Characteristics; Chronic Disease; Client satisfaction; Clinical; Combination Drug Therapy; Complication; Documentation; Drug usage; Effectiveness; Electronics; Emergency Department patient; Emergency Department-based Intervention; Emergency Medicine; Emergency department visit; Enrollment; Environment; Ethnic Origin; Evaluation; Family; Gender; Goals; Guidelines; Health; Health Personnel; Healthcare Systems; Heart Diseases; Heavy Drinking; Individual; Infection; Injury; Inpatients; Insurance; Intervention; Interview; Life; Malignant Neoplasms; Mediation; Medical; Modeling; Morbidity - disease rate; Motivation; Naltrexone; Oral; Outcome; Outcome Measure; Outcome Study; Outpatients; Participant; Patient Care; Patient Self-Report; Patients; Pharmaceutical Preparations; Pharmacotherapy; Prospective Studies; Protocols documentation; Race; Randomized; Recommendation; Records; Reporting; Respondent; Sampling Studies; Societies; Socioeconomic Status; Stroke; Surveys; Testing; Tobacco; Tobacco use; Treatment outcome; Withdrawal; Withdrawal Symptom; addiction; alcohol abuse therapy; alcohol craving; alcohol intervention; alcohol use disorder; analytical method; arm; binge drinking; buprenorphine treatment; clinically relevant; college; cost effective; craving; design; drinking; effective therapy; experience; follow up assessment; gabapentin; hazardous drinking; housing instability; improved outcome; medical specialties; medication compliance; mortality; novel; open label; opioid use; opioid use disorder; participant enrollment; patient engagement; pharmacologic; primary care setting; primary outcome; programs; psychosocial; randomized, clinical trials; screening, brief intervention, referral, and treatment; sociodemographics

Project Summary/Abstract Excessive alcohol consumption is the third leading preventable cause of death in the U.S. and responsible for 2.7 million years of potential life lost annually. Emergency departments (EDs) provide care for patients with AUD experiencing a variety of alcohol related and unrelated health problems, including illness and injury. Thus, the ED encounter presents a unique opportunity to screen, enhance motivation, initiate medication treatment, and refer to continuation care patients who both seek and do not seek AUD treatment. While combined pharmacological and behavioral therapies for alcohol use disorder (AUD) have demonstrated efficacy in specialty and primary care settings, their effectiveness in the ED setting is unknown, and EDs do not routinely provide comprehensive interventions for AUD. The proposed open label randomized clinical trial (RCT) will evaluate two ED-based intervention models to increase AUD treatment provision and patient engagement. ED patients with moderate to severe AUD (N=240) will be randomly assigned to: (1) Screening, Brief Intervention and Referral to Treatment (SBIRT) (n=120); or (2) SBIRT with ED-initiated medications for AUD (SBIRT+ED- MAUD) (n=120). Gabapentin and extended release or oral naltrexone will be offered as a combination pharmacotherapy in the ED-MAUD component. SBIRT intervention in both study arms will utilize a facilitated referral with direct linkage to continuation AUD treatment following the ED visit. The primary outcome measure will be the rate of AUD treatment engagement assessed on day 30 post randomization in each of the two study groups (Aim 1). The study will also evaluate the between-group difference in the reductions of heavy drinking days from 30 days prior to 30 days post randomization (Aim 2). A statistically significant effect on the primary outcome and a clinically meaningful effect on the reductions of heavy drinking days favoring the SBIRT+ED- MAUD are hypothesized. All enrolled patients will be followed daily on days 1-7 using a brief electronic survey to assess their alcohol cravings, withdrawal symptoms and medication adherence, and with comprehensive follow-up assessments at 30- and 90-days post randomization. The primary outcome, AUD treatment engagement on day 30 post the ED visit, will be based on clinical records documentation obtained from the AUD treatment provider. Alcohol consumption outcomes, medication adherence, the intensity of alcohol cravings and withdrawal symptoms, and other important study outcomes will be based on patient self-report using validated assessment instruments. The planned study sample and the proposed analytical methods will allow for additional meaningful exploratory evaluations of potential differential effects of gender, race, ethnicity, insurance types, and housing instability on the evaluated outcomes. No prospective studies of ED-initiated MAUD interventions have been reported. If successful, the proposed study will provide critically important evidence needed to support a broader dissemination of ED-based interventions for AUD, including MAUD.

项目总结/摘要 过量饮酒是美国第三大可预防的死亡原因， 2.7每年损失百万年的潜在生命。急诊科（ED）为患有以下疾病的患者提供护理 AUD经历各种与酒精相关和不相关的健康问题，包括疾病和伤害。因此，在本发明中， 遇到艾德提供了一个独特的机会来筛选，增强动机，开始药物治疗， 并指寻求和不寻求AUD治疗的继续护理患者。虽然结合 酒精使用障碍（AUD）的药理学和行为疗法已被证明有效， 专科和初级保健机构，他们的有效性在艾德设置是未知的，和ED不定期 为AUD提供全面的干预。拟议的开放标签随机临床试验（RCT）将 评估两种基于ED的干预模式，以增加AUD治疗提供和患者参与。艾德 中度至重度AUD患者（N=240）将被随机分配至：（1）筛选，短暂干预 和转诊治疗（SBIRT）（n=120）;或（2）SBIRT + ED启动药物治疗AUD（SBIRT+艾德- MAUD）（n=120）。加巴喷丁和缓释或口服纳洛酮将作为组合提供 ED-MAUD组件中的药物治疗。两个研究组中的SBIRT干预将利用便利的 转诊与艾德访视后继续AUD治疗直接相关。主要结局指标 是两项研究中随机化后第30天评估的AUD治疗参与率 目标1）。这项研究还将评估两组在减少大量饮酒方面的差异 从随机化前30天至随机化后30天（目标2）。对原发性高血压有统计学显著影响， SBIRT+艾德对减少重度饮酒天数的结果和有临床意义的影响， 毛泽东是假设的。所有入组患者将在第1-7天使用简短的电子调查进行每日随访 评估他们的酒精渴望，戒断症状和药物依从性，并与全面的 随机化后30天和90天的随访评估。主要结局，AUD治疗 艾德访视后第30天的参与，将基于从 AUD治疗提供者。饮酒结果、药物依从性、酒精浓度 渴望和戒断症状以及其他重要的研究结果将基于患者的自我报告 使用经过验证的评估工具。计划的研究样品和拟定的分析方法将 允许对性别、人种、种族的潜在差异效应进行额外有意义的探索性评价， 保险类型和住房不稳定性对评估结果的影响。无ED启动的前瞻性研究 已报告了MAUD干预措施。如果成功，拟议的研究将提供至关重要的 需要证据来支持更广泛地传播基于ED的AUD干预措施，包括MAUD。