Clinical trial NCT03023930: Opioid Use Disorder in the Emergency Department: CTN 0069
Official title: Opioid Use Disorder in the Emergency Department: Clinical Trials Network-0069
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Opioid Use Disorder
Keywords: Opioid Use Disorder
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
name: The Emmes Company, LLC
First posted: 2017-01-18
Enrollment: 1731
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility 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.

Primary outcomes:
measure: Implementation (Considered the Primary Outcome)
timeFrame: 12 months
measure: Effectiveness
timeFrame: 30 Days Post Enrollment
Secondary outcomes:
measure: Implementation: ED Organizational Readiness to Change Assessment (ORCA) Score
timeFrame: Pre IF (Baseline)
Other outcomes:
measure: Implementation: ED Provider Readiness and Preparedness Ruler Score
timeFrame: Pre IF (Baseline)
measure: Implementation: ED Provider Readiness and Preparedness Ruler Score
timeFrame: post IF Evaluation Period (12 months)
measure: Implementation: ED Provider Readiness and Preparedness Ruler Score
timeFrame: Post IF (6 months)
measure: Effectiveness: Illicit Opioid Urine Toxicology
timeFrame: 30 days post enrollment
measure: Effectiveness: Healthcare Service Utilization
timeFrame: 30 days post enrollment
measure: Effectiveness: Overdose Event
timeFrame: 30 days post enrollment
measure: Effectiveness: Opioid Use
timeFrame: 30 days post enrollment
measure: Effectiveness: HIV Risk
timeFrame: 30 days post enrollment
measure: Implementation: Community ORCA Score
timeFrame: Pre IF (Baseline)
measure: Implementation: Community ORCA Score
timeFrame: Post IF (6 months)
measure: Implementation: Community ORCA Score
timeFrame: post IF Evaluation Period (12 months)
measure: Implementation: Community Readiness and Preparedness Ruler Score
timeFrame: Pre IF (Baseline)
measure: Implementation: Community Readiness and Preparedness Ruler Score
timeFrame: Post IF (6 months)
measure: Implementation: Community Readiness and Preparedness Ruler Score
timeFrame: post IF Evaluation Period (12 months)
measure: Implementation: ED Organizational Readiness to Change Assessment (ORCA) Score
timeFrame: Post IF (6 months)
measure: Implementation: ED Organizational Readiness to Change Assessment (ORCA) Score
timeFrame: Post IF Evaluation Period (12 months)
measure: Implementation: Fidelity
timeFrame: Baseline Period (Baseline)
measure: Implementation: Fidelity
timeFrame: IF Evaluation Period (18 months)
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins Hospital
state: Maryland
city: New York
country: United States
facility: The Mount Sinai Hospital
state: New York
city: New York
country: United States
facility: Weill Cornell Medical College
state: New York
city: Cincinnati
country: United States
facility: University of Cincinnati Medical Center
state: Ohio
city: Seattle
country: United States
facility: Harborview Medical Center
state: Washington
Study officials:
affiliation: Department of Emergency Medicine, Yale School of Medicine
name: Gail D'Onofrio, MD, MS
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Internal Medicine, Yale School of Medicine
name: David A Fiellin, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.