Opioid Use Disorder in the Emergency Department: CTN 0069
NCT ID: NCT03023930
Last Updated: 2023-12-18
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
NA
1731 participants
INTERVENTIONAL
2017-04-03
2022-04-23
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
HEALTH_SERVICES_RESEARCH
NONE
Study Groups
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Evidenced-based Practice Dissemination
Evaluating standard dissemination practice compared with implementation facilitation
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.
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.
Interventions
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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.
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.
Eligibility Criteria
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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.
Exclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
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National Institute on Drug Abuse (NIDA)
NIH
The Emmes Company, LLC
INDUSTRY
Yale University
OTHER
Responsible Party
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Principal Investigators
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Gail D'Onofrio, MD, MS
Role: PRINCIPAL_INVESTIGATOR
Department of Emergency Medicine, Yale School of Medicine
David A Fiellin, MD
Role: PRINCIPAL_INVESTIGATOR
Department of Internal Medicine, Yale School of Medicine
Locations
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Johns Hopkins Hospital
Baltimore, Maryland, United States
The Mount Sinai Hospital
New York, New York, United States
Weill Cornell Medical College
New York, New York, United States
University of Cincinnati Medical Center
Cincinnati, Ohio, United States
Harborview Medical Center
Seattle, Washington, United States
Countries
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References
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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.
D'Onofrio G, Edelman EJ, Hawk KF, Chawarski MC, Pantalon MV, Owens PH, Martel SH, Rothman R, Saheed M, Schwartz RP, Cowan E, Richardson L, Salsitz E, Lyons MS, Freiermuth C, Wilder C, Whiteside L, Tsui JI, Klein JW, Coupet E, O'Connor PG, Matthews AG, Murphy SM, Huntley K, Fiellin DA. Implementation Facilitation to Promote Emergency Department-Initiated Buprenorphine for Opioid Use Disorder. JAMA Netw Open. 2023 Apr 3;6(4):e235439. doi: 10.1001/jamanetworkopen.2023.5439.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
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1611018631
Identifier Type: -
Identifier Source: org_study_id