Opioid Use Disorder in the Emergency Department: CTN 0069

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.

Study Overview

• Status: Completed
• Conditions: Opioid Use Disorder
• Intervention / Treatment: Other: Standard Dissemination Practice; Other: Implementation Facilitation (IF)

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 Type: Interventional
• Enrollment (Actual): 1731
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21287
      • Johns Hopkins Hospital
  • New York
    • New York, New York, United States, 10065
      • Weill Cornell Medical College
    • New York, New York, United States, 10029
      • The Mount Sinai Hospital
  • Ohio
    • Cincinnati, Ohio, United States, 45219
      • University of Cincinnati Medical Center
  • Washington
    • Seattle, Washington, United States, 98104
      • Harborview Medical Center

Participation Criteria

Eligibility Criteria

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

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Implementation: ED Organizational Readiness to Change Assessment (ORCA) Score	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).	Pre IF (Baseline)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Implementation: Fidelity	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.	Baseline Period (Baseline)
Implementation: Fidelity	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.	IF Evaluation Period (18 months)
Implementation: ED Provider Readiness and Preparedness Ruler Score	ED provider readiness and preparedness ruler score to initiate BUP and provide referral for ongoing MAT	Post IF (6 months)
Implementation: ED Provider Readiness and Preparedness Ruler Score	ED provider readiness and preparedness ruler score to initiate BUP and provide referral for ongoing MAT	post IF Evaluation Period (12 months)
Implementation: ED Organizational Readiness to Change Assessment (ORCA) Score	ED ORCA score relating to ED-initiated BUP with referral for ongoing MAT	Post IF (6 months)
Implementation: ED Organizational Readiness to Change Assessment (ORCA) Score	ED ORCA score relating to ED-initiated BUP with referral for ongoing MAT	Post IF Evaluation Period (12 months)
Implementation: Community Readiness and Preparedness Ruler Score	Community opioid treatment provider/program readiness and preparedness ruler score to continue MAT for patients with OUD who have received ED-initiated BUP	Pre IF (Baseline)
Implementation: Community Readiness and Preparedness Ruler Score	Community opioid treatment provider/program readiness and preparedness ruler score to continue MAT for patients with OUD who have received ED-initiated BUP	Post IF (6 months)
Implementation: Community Readiness and Preparedness Ruler Score	Community opioid treatment provider/program readiness and preparedness ruler score to continue MAT for patients with OUD who have received ED-initiated BUP	post IF Evaluation Period (12 months)
Implementation: Community ORCA Score	Community opioid treatment provider/program ORCA score relating to receiving patients with OUD who have received ED-initiated BUP	Pre IF (Baseline)
Implementation: Community ORCA Score	Community opioid treatment provider/program ORCA score relating to receiving patients with OUD who have received ED-initiated BUP	Post IF (6 months)
Implementation: Community ORCA Score	Community opioid treatment provider/program ORCA score relating to receiving patients with OUD who have received ED-initiated BUP	post IF Evaluation Period (12 months)
Effectiveness: Opioid Use	Self-reported days of illicit opioid use (past 7 days) as measured by Time-Line Follow-Back methods at 30 days	30 days post enrollment
Effectiveness: Overdose Event	Overdose event (past 30 days) captured by participant self-report, state medical examiner records, National Death Index and review of medical records	30 days post enrollment
Effectiveness: HIV Risk	HIV risk taking behaviors (past 30 days) as measured by HIV Risk Taking Behavior Scale	30 days post enrollment
Effectiveness: Healthcare Service Utilization	All Healthcare Service Utilization Inpatient and Outpatient	30 days post enrollment
Effectiveness: Illicit Opioid Urine Toxicology	Rates of illicit opioid negative urines	30 days post enrollment
Implementation: ED Provider Readiness and Preparedness Ruler Score	ED provider readiness and preparedness ruler score to initiate BUP and provide referral for ongoing MAT.	Pre IF (Baseline)

Collaborators and Investigators

• Sponsor: Yale University
• 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

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): April 3, 2017
• Primary Completion (Actual): July 16, 2021
• Study Completion (Actual): April 23, 2022

Study Registration Dates

• First Submitted: January 10, 2017
• First Submitted That Met QC Criteria: January 13, 2017
• First Posted (Estimated): January 18, 2017

Study Record Updates

• Last Update Posted (Estimated): December 18, 2023
• Last Update Submitted That Met QC Criteria: November 27, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: Opioid Use Disorder
• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Pathologic Processes; Disease Attributes; Narcotic-Related Disorders; Substance-Related Disorders; Emergencies; Opioid-Related Disorders
• Other Study ID Numbers: 1611018631; 5UG1DA015831-15 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No