Opioid Use Disorder in the Emergency Department: CTN 0069

Not Applicable

Completed

• Conditions: Opioid Use Disorder
• Interventions: Other: Standard Dissemination Practice; Other: Implementation Facilitation (IF)

• Registration Number: NCT03023930
• Lead Sponsor: Yale University

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2017-01-10
• Study First Submitted QC: 2017-01-13
• Study First Posted: 2017-01-18
• Study Start: 2017-04-03
• Primary Completion: 2021-07-16
• Study Completion: 2022-04-23
• Results First Submitted: 2022-07-15
• Results First Submitted QC: 2023-02-16
• Results First Posted: 2023-02-21
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-27
• Last Update Posted: 2023-12-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1731

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

Read More

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.

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Evidenced-based Practice Dissemination	Implementation Facilitation (IF)	Evaluating standard dissemination practice compared with implementation facilitation
Evidenced-based Practice Dissemination	Standard Dissemination Practice	Evaluating standard dissemination practice compared with implementation facilitation

Primary Outcome Measures

Name	Time	Method
Implementation (Considered the Primary Outcome)	12 months	The primary implementation outcome will be evaluated assessing the rate of ED-initiated BUP therapy with referral for ongoing MAT
Effectiveness	30 Days Post Enrollment	The primary effectiveness outcome is defined as the rates of patient engagement in formal addiction treatment on the 30th day post enrollment.

Secondary Outcome Measures

Name	Time	Method
Implementation: ED Organizational Readiness to Change Assessment (ORCA) Score	Pre IF (Baseline)	ED ORCA score relating to ED-initiated BUP with referral for ongoing MAT. Scores are dichotomized as less ready (scores 0-6) or most ready (scores 7-10).

Trial Locations

Locations (5)

Harborview Medical Center; 🇺🇸 Seattle, Washington, United States

Weill Cornell Medical College; 🇺🇸 New York, New York, United States

University of Cincinnati Medical Center; 🇺🇸 Cincinnati, Ohio, United States

The Mount Sinai Hospital; 🇺🇸 New York, New York, United States

Johns Hopkins Hospital; 🇺🇸 Baltimore, Maryland, United States