MedTrace Logo

Emergency Department Connection to Care With Buprenorphine for Opioid Use Disorder

NCT03544112 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 390

Last updated 2019-08-30

No results posted yet for this study

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.

Conditions

  • Opioid-use Disorder

Interventions

BEHAVIORAL

Employ 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.

DRUG

Initiate 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 & Collaborators

Principal Investigators

  • Ryan McCormack, MD · NYU Langone Health

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-06-11
Primary Completion
2019-05-29
Completion
2019-05-29

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03544112 on ClinicalTrials.gov