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Coordinating Outpatient bupreNorphiNe for Emergency Care and Continuing Treatment

NCT07024498 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 3492

Last updated 2026-04-15

No results posted yet for this study

Summary

The main purpose of this stepped wedge trial will be to test the impact of a bundle of implementation strategies designed to improve ED-outpatient care coordination on long-term buprenorphine retention among adult patients who start buprenorphine for opioid use disorder in a hospital emergency department (ED) and then are referred for continued outpatient buprenorphine treatment after they leave the ED. Our hypothesis is that adopting the bundle of implementation strategies will be associated with subsequent increases in:

A) Cumulative number of days with active buprenorphine prescription at 3, 6, and 12 months after patients' initial ED visit (6 months = primary outcome)

B) Proportion of patients with active buprenorphine prescriptions without gaps in buprenorphine coverage of more than 7 days at 3, 6, and 12 months after patients' initial ED visit

C) Proportion of patients who fill at least 1 outpatient buprenorphine prescription within 30 days of their ED visit

D) Clinician reported quality of ED-outpatient care coordination and care transitions

Conditions

Interventions

OTHER

care coordination implementation strategies

The intervention will be a bundle of implementation strategies developed during a prior study and informed by the multi-team systems framework. Core implementation strategies are expected to include a standardized ED substance use navigator note (with education and billing support), a mechanism for sharing PHI information across ED-clinic pairs that use different electronic health record systems, an improved ability for patients to directly contact EDs and clinics, ensuring ED and outpatient teams mutually understand each other roles, implementing procedures to increase capacity for same-day outpatient buprenorphine refills, and interactive problem solving with an external facilitation team. Strategies will be adapted to local contexts at each site.

Sponsors & Collaborators

  • National Institute on Drug Abuse (NIDA)

    collaborator NIH

  • University of California, Davis

    lead OTHER

Principal Investigators

  • Stephen G Henry, MD MSc · University of California, Davis

  • Aimee K Moulin, MD MAS · University of California, Davis

Study Design

Allocation
NA
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
14 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-12-01
Primary Completion
2029-05-01
Completion
2029-07-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

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 NCT07024498 on ClinicalTrials.gov