Opioid Use Disorder in the Emergency Department: CTN 0069
Last updated on July 2021Recruitment
- Recruitment Status
- Active, not recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Opioid Use Disorder
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Masking Description: Note: Care Providers and Research Associates are masked during Baseline Evaluation PeriodPrimary Purpose: Health Services Research
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
The study uses a Hybrid Type 3 Effectiveness-Implementation framework and a modified stepped wedge design. The study will be conducted at four EDs with a high prevalence of patients with untreated opioid use disorder (OUD). The four sites will receive the same sequence of evaluations and interventio...
The study uses a Hybrid Type 3 Effectiveness-Implementation framework and a modified stepped wedge design. The study will be conducted at four EDs with a high prevalence of patients with untreated opioid use disorder (OUD). The four sites will receive the same sequence of evaluations and interventions: the baseline evaluation period after the standard dissemination practice, the IF phase, and continuation of facilitation into the IF evaluation period. The timing of initiation of the study activities at each site will be randomly offset by ~ 3 month increments to accommodate logistical constraints of simultaneous implementation at all sites. The study populations will include (1) ED providers and staff involved in the treatment of patients with OUD; (2) Community opioid treatment provider and program staff involved in providing care for patients with OUD referred from the ED; and (3) ED patients with moderate to severe OUD. Exploratory analyses have been added to assess the impact of COVID-19 and social distancing guidance on drug use and drug supply; access to medications for opioid use disorder; and COVID19 disease from the perspectives of patient participants and ED leadership.
Tracking Information
- NCT #
- NCT03023930
- Collaborators
- National Institute on Drug Abuse (NIDA)
- The Emmes Company, LLC
- Investigators
- Principal Investigator: Gail D'Onofrio, MD, MS Department of Emergency Medicine, Yale School of Medicine Principal Investigator: David A Fiellin, MD Department of Internal Medicine, Yale School of Medicine