Emergency Department Connection to Care With Buprenorphine for Opioid Use Disorder
NCT ID: NCT03544112
Last Updated: 2019-08-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
390 participants
OBSERVATIONAL
2018-06-11
2019-05-29
Brief Summary
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The aims of this study are:
1. To evaluate using mixed methods the feasibility and acceptability of OUD screening, ED-initiated BUP, and referral.
2. Over the course of the study and as XR-BUP is added to hospital formularies, to estimate the percentage and confidence intervals of patients assessed, treated, and engaged in treatment at Day 30. This will be a three-site study employing a multi-faceted approach to facilitate clinical protocol implementation and to assess feasibility, acceptability, and impact. Investigators will develop, introduce and update site-specific ED clinical protocols and implementation plans for OUD screening, ED-initiated BUP, and referral for treatment. A participatory action research approach will be utilized along with mixed methods incorporating data derived from:
* Medical record and administrative data abstraction,
* Research assessments involving patients who are eligible for and willing to receive ED-initiated BUP (including both those who do, and do not, receive BUP); these assessments will document the index ED visit and the 30th day after the index ED visit,
* Qualitative interviews, focus groups, and quantitative assessments involving providers and staff, patients, and other stakeholders.
Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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ED and OUD treatment providers and staff
* ED patients will be recruited to participate in interviews or focus groups.
* ED patients who are eligible for and willing to receive ED-initiated BUP will be recruited to participate in two research visits.
* Administrative and health record data will be examined to assess rates of screening, assessment, eligibility determination, etc.
Employ a multifaceted approach to facilitate clinical protocol implementation
Implementation will include developing clinical protocols containing core components of the intervention to which fidelity is expected, along with aspects that may be adapted by local sites to aid implementation. In partnership with multidisciplinary teams at each site, we will adapt clinical practices from other contexts and available information about SL-BUP and XR-BUP to site-specific clinical protocols and implementation strategies. The study implementation facilitators will assist local champions to identify potential treatment providers and draw on existing resources for training and ongoing support.
Community Stakeholders
* Community treatment providers/OTP leadership and program staff: Providers, leadership and staff involved in the provision of office-based BUP, community treatment, and/or at opioid treatment programs (OTPs) will be recruited to participate in the formative evaluation and the Implementation Facilitation.
* Other Stakeholders: Other community leaders and members (e.g., EMS, fire department, police, local government leadership, community advocacy groups, etc.) may be recruited to participate in qualitative interviews or focus groups.
Employ a multifaceted approach to facilitate clinical protocol implementation
Implementation will include developing clinical protocols containing core components of the intervention to which fidelity is expected, along with aspects that may be adapted by local sites to aid implementation. In partnership with multidisciplinary teams at each site, we will adapt clinical practices from other contexts and available information about SL-BUP and XR-BUP to site-specific clinical protocols and implementation strategies. The study implementation facilitators will assist local champions to identify potential treatment providers and draw on existing resources for training and ongoing support.
Patients
ED patients will be recruited to participate in interviews or focus groups.
Employ a multifaceted approach to facilitate clinical protocol implementation
Implementation will include developing clinical protocols containing core components of the intervention to which fidelity is expected, along with aspects that may be adapted by local sites to aid implementation. In partnership with multidisciplinary teams at each site, we will adapt clinical practices from other contexts and available information about SL-BUP and XR-BUP to site-specific clinical protocols and implementation strategies. The study implementation facilitators will assist local champions to identify potential treatment providers and draw on existing resources for training and ongoing support.
Initiate BUP (SL-BUP or XR-BUP) in the ED
The study implementation facilitators will assist local champions to identify potential treatment providers and draw on existing resources for training and ongoing support.
Interventions
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Employ a multifaceted approach to facilitate clinical protocol implementation
Implementation will include developing clinical protocols containing core components of the intervention to which fidelity is expected, along with aspects that may be adapted by local sites to aid implementation. In partnership with multidisciplinary teams at each site, we will adapt clinical practices from other contexts and available information about SL-BUP and XR-BUP to site-specific clinical protocols and implementation strategies. The study implementation facilitators will assist local champions to identify potential treatment providers and draw on existing resources for training and ongoing support.
Initiate BUP (SL-BUP or XR-BUP) in the ED
The study implementation facilitators will assist local champions to identify potential treatment providers and draw on existing resources for training and ongoing support.
Eligibility Criteria
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Inclusion Criteria
* PROVIDERS: Community treatment providers/OTP leadership and program staff: Providers, leadership and staff involved in the provision of office-based BUP, community treatment, and/or at opioid treatment programs (OTPs) will be recruited to participate in the formative evaluation and the Implementation Facilitation.
* COMMUNITY: Other Stakeholders: Other community leaders and members (e.g., EMS, fire department, police, local government leadership, community advocacy groups, etc.) may be recruited to participate in qualitative interviews or focus groups.
* PATIENTS: ED patients will be recruited to participate in interviews or focus groups.
* PATIENT-PARTICIPANTS: ED patients who are eligible for and willing to receive ED-initiated BUP will be recruited to participate in two research visits.
* ALL ED PATIENTS: Administrative and health record data will be examined to assess rates of screening, assessment, eligibility determination, etc.
* A member of one of the stakeholder groups (1-4 above)
* Eligible for and willing to receive ED-initiated BUP
1. Eligibility for ED-initiated BUP is operationally defined as meeting site clinical protocol criteria determined and documented by site clinical staff. See Section 9.2 Clinical Protocol.
2. Willing to receive ED-initiated BUP is operationally defined as providing an affirmative answer to the following question, which will be embedded in each site's clinical protocol: Would you like to receive buprenorphine today?
Exclusion Criteria
* Currently in jail, prison or any inpatient overnight facility as required by court of law or have pending legal action or that could prevent participation in the study
* Not able to speak English sufficiently to understand study procedures and provide written informed consent
* Unable or unwilling to provide written informed consent or to participate in study procedures
* Currently receiving any medication treatment for OUD at the time of index ED visit
* Current research participant in a substance use intervention study or previous participation in the current study
* Are currently in jail, prison or any inpatient overnight facility as required by court of law or have pending legal action or that could prevent participation in the study
* Inadequate locator information (unable to provide 2 unique means of contact)
18 Years
ALL
No
Sponsors
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National Institute on Drug Abuse (NIDA)
NIH
NYU Langone Health
OTHER
Responsible Party
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Principal Investigators
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Ryan McCormack, MD
Role: PRINCIPAL_INVESTIGATOR
NYU Langone Health
Locations
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Valley Regional Healthcare
Claremont, New Hampshire, United States
Catholic Medical Center
Manchester, New Hampshire, United States
Bellevue Hospital Center
New York, New York, United States
New York University School of Medicine
New York, New York, United States
Countries
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References
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McCormack RP, Rotrosen J, Gauthier P, D'Onofrio G, Fiellin DA, Marsch LA, Novo P, Liu D, Edelman EJ, Farkas S, Matthews AG, Mulatya C, Salazar D, Wolff J, Knight R, Goodman W, Williams J, Hawk K. Implementing Programs to Initiate Buprenorphine for Opioid Use Disorder Treatment in High-Need, Low-Resource Emergency Departments: A Nonrandomized Controlled Trial. Ann Emerg Med. 2023 Sep;82(3):272-287. doi: 10.1016/j.annemergmed.2023.02.013. Epub 2023 May 2.
McCormack RP, Rotrosen J, Gauthier P, D'Onofrio G, Fiellin DA, Marsch LA, Novo P, Liu D, Edelman EJ, Farkas S, Matthews AG, Mulatya C, Salazar D, Wolff J, Knight R, Goodman W, Hawk K. Implementation facilitation to introduce and support emergency department-initiated buprenorphine for opioid use disorder in high need, low resource settings: protocol for multi-site implementation-feasibility study. Addict Sci Clin Pract. 2021 Mar 9;16(1):16. doi: 10.1186/s13722-021-00224-y.
Other Identifiers
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17-01513
Identifier Type: -
Identifier Source: org_study_id