Opioid-use DisorderED-CONNECTNCT03544112

Emergency Department Connection to Care With Buprenorphine for Opioid Use Disorder

An observational study of Opioid-use Disorder, run by NYU Langone Health at 4 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Opioid-use Disorder
What is being tested?: Employ a multifaceted approach to facilitate clinical protocol implementation and Initiate BUP (SL-BUP or XR-BUP) in the ED
Type of treatment: Lifestyle or therapy programme
How many people: 390 participants
Where: 4 sitesUnited States
Study dates: 11 Jun 2018to 29 May 2019
Phase: Observational
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

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

Who may be able to join

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.

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Stakeholder-Participant Inclusion Criteria
A member of one of the stakeholder groups (1-4 above)
Patient-Participant Inclusion Criteria
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?
NOTE: Patients meeting these criteria, and not meeting exclusion criteria below, may be included as study participants regardless of whether they receive or do not receive ED-initiated BUP

Who cannot join

Stakeholder-Participant Exclusion Criteria
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
Patient-Participant Exclusion Criteria
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

Show all 10Show fewer

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)

Trial locations and contacts

4 sites in 1 country.

United States4 sites

Valley Regional Healthcare
Claremont, New Hampshire, 03743
Catholic Medical Center
Manchester, New Hampshire, 03102
Bellevue Hospital Center
New York, New York, 10016
New York University School of Medicine
New York, New York, 10016

Other trials in United States

About this study

Official title: NIDA CTN-0079: Emergency Department Connection to Care With Buprenorphine for Opioid Use Disorder

The aims of this study are:

To evaluate using mixed methods the feasibility and acceptability of OUD screening, ED-initiated BUP, and referral.
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.

Conditions: Opioid-use Disorder
Being tested: Employ a multifaceted approach to facilitate clinical protocol implementation, Initiate BUP (SL-BUP or XR-BUP) in the ED
Medical subject headings: Opioid-Related Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Employ a multifaceted approach to facilitate clinical protocol implementationBehavioural
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 EDDrug
The study implementation facilitators will assist local champions to identify potential treatment providers and draw on existing resources for training and ongoing support.

Study groups in NCT03544112
Study group	Role	What they receive
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. Receives: 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. Receives: Behavioral: Employ a multifaceted approach to facilitate clinical protocol implementation
Patients		ED patients will be recruited to participate in interviews or focus groups. Receives: Behavioral: Employ a multifaceted approach to facilitate clinical protocol implementation; Drug: Initiate BUP (SL-BUP or XR-BUP) in the ED

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Measured: 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.
Measured: 12 Months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

11 Jun 201829 May 2019

First posted1 Jun 2018
Study start11 Jun 2018
Primary completion29 May 2019
Study completion29 May 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Opioid-use DisorderStudies of the same condition, open and under way.
More trials run by NYU Langone HealthThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 390 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03544112
Sponsor's protocol ID: 17-01513
Acronym: ED-CONNECT
Status last verified: Aug 2019
First submitted: 21 May 2018
Last updated: 30 Aug 2019
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Publications

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.
PubMed 37140493
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.
PubMed 33750454

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Opioid-use Disorder trials

Study at a glance

From the registry record, last updated by the sponsor on 30 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: NIDA CTN-0079: Emergency Department Connection to Care With Buprenorphine for Opioid Use Disorder
ClinicalTrials.gov ID: NCT03544112
Acronym / sponsor ID: ED-CONNECT / 17-01513
Conditions: Opioid-use Disorder
Study type: Observational
Recruitment status: Completed
Enrolment: 390 participants (actual)
Lead sponsor: NYU Langone HealthUniversity, hospital or other
Collaborators: National Institute on Drug Abuse (NIDA)
Study start: 11 Jun 2018 (actual)
Primary completion: 29 May 2019 (actual)
Study completion: 29 May 2019 (actual)
First posted: 1 Jun 2018 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The aims of this study are:

To evaluate using mixed methods the feasibility and acceptability of OUD screening, ED-initiated BUP, and referral.
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.

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 3

Arm	Type	Receives
ED and OUD treatment providers and staff	–	Behavioral: Employ a multifaceted approach to facilitate clinical protocol implementation* 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.
Community Stakeholders	–	Behavioral: Employ a multifaceted approach to facilitate clinical protocol implementation* 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.
Patients	–	Behavioral: Employ a multifaceted approach to facilitate clinical protocol implementation, Drug: Initiate BUP (SL-BUP or XR-BUP) in the EDED patients will be recruited to participate in interviews or focus groups.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
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

Key inclusion criteria (13 listed)

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.

Key exclusion criteria (10 listed)

Stakeholder-Participant Exclusion Criteria
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
Patient-Participant Exclusion Criteria
Not able to speak English sufficiently to understand study procedures and provide written informed consent

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Employ a multifaceted approach to facilitate clinical protocol implementationImplementation 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.	Behavioural	Community Stakeholders, ED and OUD treatment providers and staff, Patients
Initiate BUP (SL-BUP or XR-BUP) in the EDThe study implementation facilitators will assist local champions to identify potential treatment providers and draw on existing resources for training and ongoing support.	Drug	Patients

Primary outcome

Receipt of ED-initiated BUP (binary) and will be abstracted from the health record.
Time frame: 12 Months
Proportion receiving emergency department BUP amongst patients who have been determined to be eligible for and willing to receive ED-initiated BUP

1 secondary outcome

Proportion of patients who received ED-initiated BUP who are engaged in formal addiction treatment 30 days after the index ED visit.
Time frame: 12 Months

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2019.
Derived from this study: PubMed 37140493McCormack 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.
Derived from this study: PubMed 33750454McCormack 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.

Related trials for Opioid-use Disorder

Not yet recruiting
Prescribe to Prevent HIV: A Hybrid Trial Helping Addiction Clinics Prevent HIV & Infections Through Safer Drug Use Support
People Who Use Opioids/People With Opioid Use Disorder (OUD)
Enrolling by invitationObservational study
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Recruiting
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Ryan McCormack, MD principal investigator

NYU Langone Health

4 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Opioid-use Disorder, run by NYU Langone Health at 4 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Receipt of ED-initiated BUP (binary) and will be abstracted from the health record. (time frame: 12 Months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03544112, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Aug 2019.