Opioid Use Disorder in the Emergency Department: CTN 0069

• ClinicalTrials.gov Identifier: NCT03023930
• Recruitment Status: Completed
• First Posted: January 18, 2017
• Results First Posted: February 21, 2023
• Last Update Posted: February 21, 2023
• Sponsor: Yale University
• Collaborators: National Institute on Drug Abuse (NIDA); The Emmes Company, LLC
• Information provided by (Responsible Party): Yale University

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Opioid Use Disorder	Other: Standard Dissemination Practice; Other: Implementation Facilitation (IF)	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 1731 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Masking Description: Note: Care Providers and Research Associates are masked during Baseline Evaluation Period
• Primary Purpose: Health Services Research
• Official Title: Opioid Use Disorder in the Emergency Department: Clinical Trials Network-0069
• Actual Study Start Date: April 3, 2017
• Actual Primary Completion Date: July 16, 2021
• Actual Study Completion Date: April 23, 2022

Arms and Interventions

Arm

Intervention/treatment

Experimental: Evidenced-based Practice Dissemination; Evaluating standard dissemination practice compared with implementation facilitation

Other: Standard Dissemination Practice; Emergency department provider education using a grand rounds format. The content of the lecture will cover the scope of the opioid problem, ED specific facts related to the epidemic, potential models of intervention including the results of publications outlining the efficacy of ED-initiated BUP.; Other: Implementation Facilitation (IF); IF involves a "formative evaluation" to identify the specific and dynamic needs of stakeholders and the context for implementation of evidence-based practices. This evaluation informs the initial tailoring and refinement of the IF, which includes a bundle of services tailored to meet site-specific needs, such as identifying and engaging local stakeholders, providing extensive ongoing education, tailoring program to the site and monitoring performance and offering feedback.

Outcome Measures

Primary Outcome Measures :

1. Implementation (Considered the Primary Outcome) [ Time Frame: 12 months ]
   The primary implementation outcome will be evaluated assessing the rate of ED-initiated BUP therapy with referral for ongoing MAT
2. Effectiveness [ Time Frame: 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 :

1. Implementation: Fidelity [ Time Frame: Baseline Period (Baseline) ]
   Fidelity will be measured using a critical action checklist relating to the provision of ED-initiated BUP with referral for ongoing MAT in eligible patients.
2. Implementation: Fidelity [ Time Frame: IF Evaluation Period (18 months) ]
   Fidelity will be measured using a critical action checklist relating to the provision of ED-initiated BUP with referral for ongoing MAT in eligible patients.
3. Implementation: ED Provider Readiness and Preparedness Ruler Score [ Time Frame: Pre IF (Baseline) ]
   ED provider readiness and preparedness ruler score to initiate BUP and provide referral for ongoing MAT
4. Implementation: ED Provider Readiness and Preparedness Ruler Score [ Time Frame: Post IF (6 months) ]
   ED provider readiness and preparedness ruler score to initiate BUP and provide referral for ongoing MAT
5. Implementation: ED Provider Readiness and Preparedness Ruler Score [ Time Frame: post IF Evaluation Period (12 months) ]
   ED provider readiness and preparedness ruler score to initiate BUP and provide referral for ongoing MAT
6. Implementation: ED Organizational Readiness to Change Assessment (ORCA) Score [ Time Frame: Pre IF (Baseline) ]
   ED ORCA score relating to ED-initiated BUP with referral for ongoing MAT
7. Implementation: ED Organizational Readiness to Change Assessment (ORCA) Score [ Time Frame: Post IF (6 months) ]
   ED ORCA score relating to ED-initiated BUP with referral for ongoing MAT
8. Implementation: ED Organizational Readiness to Change Assessment (ORCA) Score [ Time Frame: Post IF Evaluation Period (12 months) ]
   ED ORCA score relating to ED-initiated BUP with referral for ongoing MAT
9. Implementation: Community Readiness and Preparedness Ruler Score [ Time Frame: Pre IF (Baseline) ]
   Community opioid treatment provider/program readiness and preparedness ruler score to continue MAT for patients with OUD who have received ED-initiated BUP
10. Implementation: Community Readiness and Preparedness Ruler Score [ Time Frame: Post IF (6 months) ]
    Community opioid treatment provider/program readiness and preparedness ruler score to continue MAT for patients with OUD who have received ED-initiated BUP
11. Implementation: Community Readiness and Preparedness Ruler Score [ Time Frame: post IF Evaluation Period (12 months) ]
    Community opioid treatment provider/program readiness and preparedness ruler score to continue MAT for patients with OUD who have received ED-initiated BUP
12. Implementation: Community ORCA Score [ Time Frame: Pre IF (Baseline) ]
    Community opioid treatment provider/program ORCA score relating to receiving patients with OUD who have received ED-initiated BUP
13. Implementation: Community ORCA Score [ Time Frame: Post IF (6 months) ]
    Community opioid treatment provider/program ORCA score relating to receiving patients with OUD who have received ED-initiated BUP
14. Implementation: Community ORCA Score [ Time Frame: post IF Evaluation Period (12 months) ]
    Community opioid treatment provider/program ORCA score relating to receiving patients with OUD who have received ED-initiated BUP
15. Effectiveness: Opioid Use [ Time Frame: 30 days post enrollment ]
    Self-reported days of illicit opioid use (past 7 days) as measured by Time-Line Follow-Back methods at 30 days
16. Effectiveness: Overdose Event [ Time Frame: 30 days post enrollment ]
    Overdose event (past 30 days) captured by participant self-report, state medical examiner records, National Death Index and review of medical records
17. Effectiveness: HIV Risk [ Time Frame: 30 days post enrollment ]
    HIV risk taking behaviors (past 30 days) as measured by HIV Risk Taking Behavior Scale
18. Effectiveness: Healthcare Service Utilization [ Time Frame: 30 days post enrollment ]
    All Healthcare Service Utilization Inpatient and Outpatient
19. Effectiveness: Illicit Opioid Urine Toxicology [ Time Frame: 30 days post enrollment ]
    Rates of illicit opioid negative urines

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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.

Contacts and Locations

Locations

United States, Maryland

Johns Hopkins Hospital

Baltimore, Maryland, United States, 21287

United States, New York

The Mount Sinai Hospital

New York, New York, United States, 10029

Weill Cornell Medical College

New York, New York, United States, 10065

United States, Ohio

University of Cincinnati Medical Center

Cincinnati, Ohio, United States, 45219

United States, Washington

Harborview Medical Center

Seattle, Washington, United States, 98104

Sponsors and Collaborators

Yale University

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

  Study Documents (Full-Text)

Documents provided by Yale University:

Study Protocol  [PDF] May 22, 2018

Statistical Analysis Plan  [PDF] September 20, 2021

Informed Consent Form  [PDF] October 18, 2016

More Information

Publications:

D'Onofrio G, O'Connor PG, Pantalon MV, Chawarski MC, Busch SH, Owens PH, Bernstein SL, Fiellin DA. Emergency department-initiated buprenorphine/naloxone treatment for opioid dependence: a randomized clinical trial. JAMA. 2015 Apr 28;313(16):1636-44. doi: 10.1001/jama.2015.3474.

Coupet E Jr, D'Onofrio G, Chawarski M, Edelman EJ, O'Connor PG, Owens P, Martel S, Fiellin DA, Cowan E, Richardson L, Huntley K, Whiteside LK, Lyons MS, Rothman RE, Pantalon M, Hawk K. Emergency department patients with untreated opioid use disorder: A comparison of those seeking versus not seeking referral to substance use treatment. Drug Alcohol Depend. 2021 Feb 1;219:108428. doi: 10.1016/j.drugalcdep.2020.108428. Epub 2020 Nov 26.

Chawarski MC, Hawk K, Edelman EJ, O'Connor P, Owens P, Martel S, Coupet E Jr, Whiteside L, Tsui JI, Rothman R, Cowan E, Richardson L, Lyons MS, Fiellin DA, D'Onofrio G. Use of Amphetamine-Type Stimulants Among Emergency Department Patients With Untreated Opioid Use Disorder. Ann Emerg Med. 2020 Dec;76(6):782-787. doi: 10.1016/j.annemergmed.2020.06.046. Epub 2020 Aug 8.

Hawk KF, D'Onofrio G, Chawarski MC, O'Connor PG, Cowan E, Lyons MS, Richardson L, Rothman RE, Whiteside LK, Owens PH, Martel SH, Coupet E Jr, Pantalon M, Curry L, Fiellin DA, Edelman EJ. Barriers and Facilitators to Clinician Readiness to Provide Emergency Department-Initiated Buprenorphine. JAMA Netw Open. 2020 May 1;3(5):e204561. doi: 10.1001/jamanetworkopen.2020.4561.

D'Onofrio G, Edelman EJ, Hawk KF, Pantalon MV, Chawarski MC, Owens PH, Martel SH, VanVeldhuisen P, Oden N, Murphy SM, Huntley K, O'Connor PG, Fiellin DA. Implementation facilitation to promote emergency department-initiated buprenorphine for opioid use disorder: protocol for a hybrid type III effectiveness-implementation study (Project ED HEALTH). Implement Sci. 2019 May 7;14(1):48. doi: 10.1186/s13012-019-0891-5.

• Responsible Party: Yale University
• ClinicalTrials.gov Identifier: NCT03023930
• Other Study ID Numbers: 1611018631; 5UG1DA015831-15 ( U.S. NIH Grant/Contract )
• First Posted: January 18, 2017
• Results First Posted: February 21, 2023
• Last Update Posted: February 21, 2023
• Last Verified: February 2023

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Yale University:

Opioid Use Disorder

Additional relevant MeSH terms:

Disease; Emergencies; Opioid-Related Disorders; Substance-Related Disorders; Pathologic Processes; Disease Attributes; Narcotic-Related Disorders; Chemically-Induced Disorders; Mental Disorders