Screening, Motivational Assessment, Referral, and Treatment in Emergency Departments
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,285
- 试验地点
- 8
- 主要终点
- days of use of the primary drug of abuse
研究概览
简要总结
Misuse of drugs and alcohol has a tremendous impact on individual health and on society, in terms of both human suffering and economic cost. Most substance abusers never seek specialty addiction treatment, but a large percentage of them receives some form of medical care, frequently in emergency room settings. There is considerable evidence showing that Screening, Brief Intervention, Referral, and Treatment (SBIRT) interventions in medical settings result in decreased drinking and alcohol-related problems among those with alcohol abuse or dependence. However, there are few studies using these models focusing on drug users. Although drug users are seen in large numbers in emergency departments, there have been no randomized controlled trials of SBIRT models for drug users presenting in Emergency Departments (EDs).
This study is designed to assess the effects of Assessment, Referral, and a Brief Intervention on substance use of individuals screening positive for drug use during a medical ED visit. The Southwest Node of the NIDA Clinical Trials Network, located at UNM CASAA, is taking the lead on this study. Six sites across the country will participate in this study, including the ED of UNM Hospital. A total of 1285 ED patients who screen positive for current drug use problems will be randomly assigned to receive 1) minimal screening only, 2) assessment of substance use and referral to treatment, or 3) assessment and referral combined with a 30-minute counseling session (Brief Intervention) and two follow-up telephone counseling sessions. Outcomes will be assessed at 3, 6, and 12 months after the ED visit. We hypothesize that those who receive the Brief Intervention will have the least drug use at follow-up, that those who receive minimal screening only (the usual current practice) will have the most drug use, and that those receiving assessment and referral without the Brief intervention will have intermediate outcomes.
详细描述
- STUDY SYNPOSIS AND SCHEMA
STUDY OBJECTIVES:
The study will contrast substance use and substance-related outcomes among patients endorsing problematic drug use during an emergency department (ED) visit who are randomly assigned to one of three treatment conditions: 1) minimal screening only (MSO); 2) screening, assessment, and referral to treatment (if indicated) (SAR); and 3) screening, assessment, and referral plus a brief intervention (BI) with two telephone follow-up booster sessions (BI-B).
STUDY DESIGN:
The proposed project is a 3-group randomized, prospective trial with blinded assessments. Individuals presenting in the ED endorsing problematic drug use on screening will be randomized in 1:1:1 ratio to MSO vs. SAR vs. BI-B. Randomization will occur after screening, and those randomized to MSO will not receive further assessment until follow-up. The other two groups will receive baseline assessment, and assignment to SAR vs. BI-B will not be revealed until after the baseline assessment is complete. Those in the SAR group will then receive referral if indicated or requested, and those assigned to the BI-B group will be receive a brief intervention consisting of motivational enhancement therapy (MET) adapted for use in the ED, followed by referral if indicated or requested. The BI-B group will also receive two booster telephone calls, ideally within one week of the ED visit. Follow-up assessments of all three groups will be conducted face-to-face at 3 months, 6 months, and 12 months post-enrollment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Registration as patient in the ED during study screening hours
- •Positive screen (≥3) for problematic use of a non-alcohol, non-nicotine drug based on the Drug Abuse Screening Test (DAST)
- •At least one day of problematic drug use (excluding alcohol and nicotine) in the past 30 days
- •Age 18 years or older
- •Adequate English proficiency
- •Ability to provide informed consent
- •Access to phone (for booster sessions)
排除标准
- •Inability to participate due to emergency treatment
- •Significant impairment of cognition or judgment rendering the person incapable of informed consent. (e.g., traumatic brain injury, delirium, intoxication)
- •Status as a prisoner or in police custody at the time of treatment.
- •Current engagement in addiction treatment
- •Residence more than 50 miles from the location of follow-up visits
- •Inability to provide sufficient contact information (must provide at least 2 reliable locators).
- •Prior participation in the current study.
结局指标
主要结局
days of use of the primary drug of abuse
时间窗: 30 days preceding 3-month follow-up
Assessed by Time-line Follow-back method
次要结局
- Days of use of the primary drug of abuse(6 months, 12 months)
- number days abstinent from all drugs(3, 6, 12 months)
- days of heavy drinking(3, 6, 12 months)
- total quantity of drug use(3, 6, 12 months)
- objective change in drug use based on analysis of hair samples(3, 6, 12 months)
- self-reported consequences of drug and alcohol use(3, 6, 12 months)
- percent entering treatment among those classified as having probable dependence(3, 6, 12 months)
- ED and other health care utilization(3, 6, 12 months)
研究者
Michael Bogenschutz
PI
University of New Mexico