Clinical trial NCT03544112: Emergency Department Connection to Care With Buprenorphine for Opioid Use Disorder
Official title: NIDA CTN-0079: Emergency Department Connection to Care With Buprenorphine for Opioid Use Disorder
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Opioid-use Disorder
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2018-06-01
Enrollment: 390
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_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

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:

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.


Eligibility criteria: Inclusion Criteria:

* 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.

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

  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?
  3. 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

Exclusion Criteria:

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
* 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)

Primary outcomes:
measure: Receipt of ED-initiated BUP (binary) and will be abstracted from the health record.
timeFrame: 12 Months
Secondary outcomes:
measure: Proportion of patients who received ED-initiated BUP who are engaged in formal addiction treatment 30 days after the index ED visit.
timeFrame: 12 Months
Other outcomes:
Locations:
city: Claremont
country: United States
facility: Valley Regional Healthcare
state: New Hampshire
city: Manchester
country: United States
facility: Catholic Medical Center
state: New Hampshire
city: New York
country: United States
facility: Bellevue Hospital Center
state: New York
city: New York
country: United States
facility: New York University School of Medicine
state: New York
Study officials:
affiliation: NYU Langone Health
name: Ryan McCormack, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.