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.

项目概要/摘要 过量饮酒是美国第三大可预防的死亡原因，也是导致 每年损失 270 万年的潜在寿命。急诊科 (ED) 为患有以下疾病的患者提供护理 AUD 经历了各种与酒精相关和无关的健康问题，包括疾病和受伤。因此， 急诊科的遭遇提供了一个独特的机会来筛查、增强动力、开始药物治疗、 并指寻求和不寻求 AUD 治疗的持续护理患者。合并时 酒精使用障碍（AUD）的药物和行为疗法已被证明有效 专科和初级保健机构，其在急诊科的有效性尚不清楚，并且急诊科通常不会 为澳元提供全面的干预措施。拟议的开放标签随机临床试验（RCT）将 评估两种基于 ED 的干预模型，以增加 AUD 治疗的提供和患者的参与。急诊科 中度至重度 AUD 患者 (N=240) 将被随机分配至： (1) 筛查、简短干预 转诊治疗 (SBIRT) (n=120)； (2) SBIRT 联合 ED 启动药物治疗 AUD（SBIRT+ED- MAUD) (n=120)。加巴喷丁和缓释或口服纳曲酮将作为组合提供 ED-MAUD 成分中的药物治疗。两个研究组中的 SBIRT 干预将利用便利的 转诊与急诊就诊后继续 AUD 治疗直接相关。主要结果指标 将是两项研究中随机化后第 30 天评估的 AUD 治疗参与率 组（目标 1）。该研究还将评估酗酒减少的组间差异 从随机分组前 30 天到随机分组后 30 天的天数（目标 2）。对初级的统计显着影响 结果以及对减少酗酒天数有临床意义的影响有利于 SBIRT+ED- MAUD 是假设的。所有入组患者将在第 1-7 天每天使用简短的电子调查进行随访 评估他们的酒精渴望、戒断症状和药物依从性，并进行全面的评估 随机化后 30 天和 90 天的后续评估。主要结局，AUD 治疗 急诊室就诊后第 30 天的参与将基于从急诊室获得的临床记录文件 AUD 治疗提供者。饮酒结果、药物依从性、酒精强度 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。计划的研究样本和建议的分析方法将 允许对性别、种族、族裔的潜在差异影响进行额外有意义的探索性评估， 保险类型和住房不稳定对评估结果的影响。没有 ED 发起的前瞻性研究 MAUD 干预措施已有报道。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。