Recruitment

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