Emergency Department Connection to Care With Buprenorphine for Opioid Use Disorder

Status:	Recruiting
Conditions:	Hospital
Therapuetic Areas:	Other
Healthy:	No
Age Range:	18 - Any
Updated:	7/14/2018
Start Date:	June 11, 2018
End Date:	May 2019
Contact:	Phoebe Gauthier, MPH
Email:	phoebe.r.gauthier@dartmouth.edu
Phone:	603-646-7021

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

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.

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)

We found this trial at

sites

Bellevue Hospital Center

New York, New York 10016

Principal Investigator: Ryan McCormack, MD

Phone: 646-831-5161

from

New York, NY