Optimized Interventions to Prevent Opioid Use Disorder Among Adolescents and Young Adults in the Emergency Department
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,155
- 试验地点
- 1
- 主要终点
- Change in opioid misuse
研究概览
简要总结
The purpose of the study is to develop and test innovative interventions to prevent the development of opioid misuse and opioid use disorders among older adolescents and young adults (AYA; ages 16-30) who use opioids, which will be initiated from a health care visit in the emergency department and extended post discharge via a telehealth approach. This study will have significant impact by identifying optimal, cost-effective opioid prevention strategies to sustain outcomes among AYAs.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Prevention
- 盲法
- Single (Care Provider)
入排标准
- 年龄范围
- 16 Years 至 30 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 16-30 years
- •Seeking care in Michigan Medicine emergency department (ED)
- •Ability to read/comprehend and communicate in English
- •Medically & cognitively able to provide consent or assent
- •Prescription opioid use plus >=1 other risk factor (misuse positive for marijuana, other illicit drugs, other prescription drug misuse; binge drinking; depression or suicidality) or opioid misuse [prescription opioid misuse or illicit opioid use (e.g., heroin, fentanyl)]
排除标准
- •Presenting with acute sexual assault, acute suicidality or a current cancer diagnosis/are currently receiving cancer treatment
- •Current pregnancy at baseline
- •History of injection drug use within last 12 months
- •High risk for opioid use disorder
- •Enrolled in Aim 1
研究组 & 干预措施
Enhanced Usual Care (EUC) then Portal
EUC will be delivered at intake and the portal will occur for 4 weeks starting at intake. All participants receive an opioid disposal bag at enrollment (in-person or mailed).
干预措施: Portal (Behavioral)
Enhanced Usual Care (EUC) then Portal
EUC will be delivered at intake and the portal will occur for 4 weeks starting at intake. All participants receive an opioid disposal bag at enrollment (in-person or mailed).
干预措施: Enhanced Usual Care (EUC) (Behavioral)
Brief intervention (BI) then Portal
The BI will be delivered at intake and the portal will occur for 4 weeks starting at intake. All participants receive an opioid disposal bag at enrollment (in-person or mailed).
干预措施: Brief intervention (BI) (Behavioral)
Brief intervention (BI) then Portal
The BI will be delivered at intake and the portal will occur for 4 weeks starting at intake. All participants receive an opioid disposal bag at enrollment (in-person or mailed).
干预措施: Portal (Behavioral)
Brief intervention (BI) then Enhanced Usual Care (EUC)
The BI will be delivered at intake and EUC will be added 4 weeks later. All participants receive an opioid disposal bag at enrollment (in-person or mailed).
干预措施: Brief intervention (BI) (Behavioral)
Brief intervention (BI) then Enhanced Usual Care (EUC)
The BI will be delivered at intake and EUC will be added 4 weeks later. All participants receive an opioid disposal bag at enrollment (in-person or mailed).
干预措施: Enhanced Usual Care (EUC) (Behavioral)
Enhanced Usual Care (EUC) then EUC
EUC will be delivered at intake and delivered again 4 weeks later. All participants receive an opioid disposal bag at enrollment (in-person or mailed).
干预措施: Enhanced Usual Care (EUC) (Behavioral)
结局指标
主要结局
Change in opioid misuse
时间窗: 3, 6, and 12 months
Alcohol Smoking and Substance Involvement Screening Test severity score (prescription opioids/heroin, scores range 0-27 per subscale, higher score indicates worse outcomes)
Opioid Misuse
时间窗: 3, 6, and 12 months
Alcohol Smoking and Substance Involvement Screening Test severity score (severity of prescription opioids/heroin, scores range 0-27 per subscale; the prescription opioid and heroin subscales are summed such that total possible range on this measure is 0-54, higher score indicates worse outcomes/more severity). Note: missing data was imputed.
Opioid Misuse Severity Score (Past 3-month)
时间窗: 3, 6, and 12 months
Alcohol Smoking and Substance Involvement Screening Test severity risk score (severity of prescription opioids/heroin consumption and consequences, scores range 0-27 per subscale; the prescription opioid and heroin subscales are summed such that total possible range on this measure is 0-54, higher score indicates worse outcomes/more severity). Note: missing data was imputed and median scores are presented.
次要结局
- Change in overdose risk behaviors(3, 6, and 12 months)
- Change in substance use consequences(3, 6, and 12 months)
- Change in other drug and alcohol use(3, 6, and 12 months)
- Change in impaired driving(3, 6, and 12 months)
- Overdose Risk Behaviors(3, 6, and 12 months)
- Past 30-day Opioid Misuse (Dichotomized: 1+ Day vs. 0 Days)(3, 6, and 12 months)
- Other Drug and Alcohol Use Severity(3, 6, and 12 months)
- Substance Use Consequences(3, 6, and 12 months)
- Impaired Driving(3, 6, and 12 months)
- Change in days of opioid misuse(3, 6, and 12 months)
研究者
Maureen A Walton
Professor of Psychiatry
University of Michigan