Emergency Department-Initiated Medications for Alcohol Use Disorder

急诊科启动的酒精使用障碍药物

基本信息

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
项目类别：
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

项目摘要

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.

项目摘要/摘要过度饮酒是美国第三大可预防的死亡原因，并负责每年有270万年的潜在生命损失。急诊科（EDS）为患者提供护理 AUD经历各种酒精相关和无关的健康问题，包括疾病和伤害。因此， ED相遇提供了一个独特的机会，可以筛选，增强动力，启动药物治疗，并参考均寻求和不寻求AUD治疗的延续护理患者。同时组合酒精使用障碍（AUD）的药理和行为疗法已证明有效专业和初级保健环境，它们在ED环境中的有效性尚不清楚，并且ED不会定期为AUD提供全面的干预措施。拟议的开放标签随机临床试验（RCT）将评估两个基于ED的干预模型，以增加AUD治疗的提供和患者参与。 ed 中度至重度AUD（n = 240）的患者将随机分配给：（1）筛查，简短干预并转介治疗（sbirt）（n = 120）;或（2）使用AUD的介绍药物的SBIRT（SBIRT+ED- 莫德）（n = 120）。 Gabapentin和扩展释放或口服Naltrexone将作为组合提供 Ed-Maud成分中的药物治疗。两个研究武器的SBIRT干预将利用促进的 ED访问后，转介与连续AUD治疗直接连接。主要结果度量将是在两项研究中的每个研究中在随机分组后第30天评估的AUD治疗率率组（目标1）。该研究还将评估大量饮酒减少的组间差异从随机分组后30天之前的30天开始（AIM 2）。对主要的统计学意义影响结果和临床意义对减少大量饮酒的日期有意义的影响，有利于SBIRT+ED- 假设莫德。所有注册的患者将在第1-7天使用简短的电子调查进行每天遵循评估他们的酒精渴望，戒断症状和药物依从性，并全面随机分组后30天和90天的后续评估。主要结果，AUD处理 ED访问后第30天的参与度将基于从临床记录文档中获得的 AUD治疗提供商。饮酒结果，药物依从性，酒精的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自我报告使用经过验证的评估工具。计划的研究样本和提议的分析方法将允许对性别，种族，种族的潜在差异影响进行其他有意义的探索性评估保险类型和对评估结果的住房不稳定。没有前瞻性研究据报道了MAUD干预措施。如果成功，拟议的研究将非常重要支持包括Maud在内的AUD的更广泛传播基于ED的干预措施所需的证据。