Opioid Use Disorder in the Emergency Department: CTN 0069



Status:Recruiting
Conditions:Hospital
Therapuetic Areas:Other
Healthy:No
Age Range:18 - Any
Updated:5/19/2018
Start Date:April 3, 2017
End Date:January 2021
Contact:Gail D'Onofrio, MD, MS
Email:gail.donofrio@yale.edu
Phone:203-785-4404

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

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.

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.

Patient Inclusion Criteria:

- Patients who are treated in the ED during study screening hours with Diagnostic and
Statistical Manual (DSM)-5 criteria for moderate to severe OUD and provide an opioid
positive urine sample will be eligible to participate.

Patient Exclusion Criteria:

- Patients who test positive for fentanyl only are not eligible due to lack of uniformly
available rapid urine tests.

- Patients will be excluded if they have a medical or psychiatric condition requiring
hospitalization at the index ED visit, are acutely suicidal or severely cognitively
impaired precluding informed consent, present from an extended care facility, require
continued prescription opioids for a pain condition, are a prisoner or in police
custody at time of index ED visit, are currently (past 30 days) enrolled in formal
addiction treatment including by court order, are unable to provide 2 contact numbers,
are unwilling to follow study procedures, have been previously enrolled in the current
study or do not speak English.

ED and Community Participants Inclusion Criteria:

- ED and community providers and administrators (i.e. physicians, residents, fellows,
nursing, nurse practitioners, physician assistants, pharmacists, social workers,
counselors, administrative directors, office-based physicians and opioid treatment
program representatives) as well as ED patients with OUD.
We found this trial at
4
sites
New York, New York 10029
Principal Investigator: Lynne Richardson, MD
Phone: 212-824-8066
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234 Goodman Dr
Cincinnati, Ohio 45229
(513) 584-1000
Principal Investigator: Michael Lyons, MD, MPH
Phone: 513-558-0890
University of Cincinnati Medical Center Opening in 1823 as the country
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1800 Orleans St.
Baltimore, Maryland 21287
410-955-5000
Principal Investigator: Richard Rothman, MD, PhD
Phone: 410-735-6428
Johns Hopkins Hospital Patients are the focus of everything we do at The Johns Hopkins...
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325 9th Ave
Seattle, Washington 98104
(206) 744-3300
Principal Investigator: Lauren Whiteside, MD
Phone: 203-744-8464
Harborview Medical Center Harborview Medical Center is the only designated Level 1 adult and pediatric...
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