Opioid-use Disorder
Conditions
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.
Interventions
BEHAVIORALEmploy 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.
DRUGInitiate 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.
Sponsors
National Institute on Drug Abuse (NIDA)
NYU Langone Health
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Receipt of ED-initiated BUP (binary) and will be abstracted from the health record. | 12 Months | Proportion receiving emergency department BUP amongst patients who have been determined to be eligible for and willing to receive ED-initiated BUP |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of patients who received ED-initiated BUP who are engaged in formal addiction treatment 30 days after the index ED visit. | 12 Months |
Countries
United States
Outcome results
None listed