NCT03544112

Brief Summary

The purpose of this study is to learn what resources are needed to improve outcomes for patients with opioid use disorder. The study will look at how patients engage in treatment and the decisions that patients and providers make regarding treatment, specifically buprenorphine treatment, for opioid use disorder. The aims of this study are:

  • 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
390

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2018

Shorter than P25 for all trials

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 21, 2018

Completed
11 days until next milestone

First Posted

Study publicly available on registry

June 1, 2018

Completed
10 days until next milestone

Study Start

First participant enrolled

June 11, 2018

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 29, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 29, 2019

Completed
Last Updated

August 30, 2019

Status Verified

August 1, 2019

Enrollment Period

12 months

First QC Date

May 21, 2018

Last Update Submit

August 28, 2019

Conditions

Opioid-use Disorder

Outcome Measures

Primary Outcomes (1)

  • Receipt of ED-initiated BUP (binary) and will be abstracted from the health record.

    Proportion receiving emergency department BUP amongst patients who have been determined to be eligible for and willing to receive ED-initiated BUP

    12 Months

Secondary Outcomes (1)

  • Proportion of patients who received ED-initiated BUP who are engaged in formal addiction treatment 30 days after the index ED visit.

    12 Months

Study Arms (3)

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.

Behavioral: Employ a multifaceted approach to facilitate clinical protocol implementation

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.

Behavioral: Employ a multifaceted approach to facilitate clinical protocol implementation

Patients

ED patients will be recruited to participate in interviews or focus groups.

Behavioral: Employ a multifaceted approach to facilitate clinical protocol implementationDrug: Initiate BUP (SL-BUP or XR-BUP) in the ED

Interventions

Employ a multifaceted approach to facilitate clinical protocol implementationBEHAVIORAL

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 StakeholdersED and OUD treatment providers and staffPatients
Initiate BUP (SL-BUP or XR-BUP) in the EDDRUG

The study implementation facilitators will assist local champions to identify potential treatment providers and draw on existing resources for training and ongoing support.

Patients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

This will be a three-site study employing a multi-faceted approach to facilitate clinical protocol implementation and to assess feasibility, acceptability, and impact

You may qualify if:

  • ED STAFF: ED/Hospital leadership and staff: Leadership and staff across multiple disciplines (e.g., nurses, social workers, physicians, NPs, PAs, pharmacist, physician and nursing directors) at each ED site will be recruited to participate in the formative evaluation and the IF.
  • 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
  • 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.
  • 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?

You may not qualify if:

  • Unwilling or unable to provide consent
  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Valley Regional Healthcare

Claremont, New Hampshire, 03743, United States

Location

Catholic Medical Center

Manchester, New Hampshire, 03102, United States

Location

Bellevue Hospital Center

New York, New York, 10016, United States

Location

New York University School of Medicine

New York, New York, 10016, United States

Location

Related Publications (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, 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.

    PMID: 37140493DERIVED

  • 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.

    PMID: 33750454DERIVED

MeSH Terms

Conditions

Opioid-Related Disorders

Condition Hierarchy (Ancestors)

Narcotic-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Study Officials

  • Ryan McCormack, MD

    NYU Langone Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 21, 2018

First Posted

June 1, 2018

Study Start

June 11, 2018

Primary Completion

May 29, 2019

Study Completion

May 29, 2019

Last Updated

August 30, 2019

Record last verified: 2019-08

Locations

US(4)