Opioid Use Disorder in the Emergency Department: CTN 0069

Opioid Use Disorder Clinical Trial

Official title: Opioid Use Disorder in the Emergency Department: Clinical Trials Network-0069

Status Completed

Clinical Trial Summary

The purpose of this study is to evaluate the impact of (1) Implementation Facilitation (IF) on rates of provision of Emergency Department (ED)-initiated buprenorphine/naloxone (BUP) treatment with referral for ongoing medication-assisted treatment (MAT) and the (2) effectiveness of IF on patient engagement in formal addiction treatment at 30 days.

Clinical Trial Description

The study was originally proposed to use a Hybrid Type 3 Effectiveness-Implementation framework and a modified stepped wedge design.

Original protocol registration language: 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.

Upon results entry, changes were made to reflect that the study design originally was described as a "modified step wedge" but ultimately was not designed or implemented as such, as there was no substantial overlap of the baseline evaluation and IF evaluation periods. Thus, the statistical plan was adjusted accordingly. ;

Related Conditions & MeSH terms

• Emergencies
• Opioid Use Disorder
• Opioid-Related Disorders
• Substance-Related Disorders

• NCT number: NCT03023930
• Study type: Interventional
• Source: Yale University
• Status: Completed
• Phase: N/A
• Start date: April 3, 2017
• Completion date: April 23, 2022