Recruiting

Buprenorphine

Sponsor:

UCLA

Code:

NCT07024498

Conditions

Opioid Use Disorder

Eligibility Criteria

Sex: All

Age: 14+

Healthy Volunteers: Not accepted

Interventions

care coordination implementation strategies

Study Details

Brief 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

Opioid Use Disorder

Study ID

NCT07024498

Start date

Nov 1, 2025

Status verified date

Jun, 2026

Completion date

Aug 1, 2029

Anticipated

Primary completion date

Aug 1, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 14+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • patients who start buprenorphine for opioid use disorder at a participating ED

Study Design

Enrollment

3492 participants

Anticipated

Allocation

Non randomized

Intervention Model

Sequential

Primary purpose

Other

Interventions and Outcome Measures

Arms

other: Hospital ED and 2 associated outpatient clinics that provide buprenorphine treatment

Each arm will receive the intervention at a different time point and will provide data for both the pre- and post-intervention conditions. During the pre-intervention periods, ED teams will use their existing workflows/procedures for referring patients to and coordinating with outpatient clinics that provide buprenorphine. During the post-implementation period, the ED and outpatient teams will use workflows/procedures that have incorporated the intervention.

Interventions

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.

Primary outcome measure

  • buprenorphine treatment (continuous) [ Time Frame: 6 months ]

Central Contacts and Locations

Central contacts

Marykate MIller, MPH

916-734-2877mkemiller@health.ucdavis.edu

Stephen G Henry, MD MSc

916-734-7391sghenry@health.ucdavis.edu

Locations

Marshall Medical Center Emergency Department

Recruiting

Placerville, California, United States, 95667

Contacts

Arianna Campbell, PA-C

530-409-7890asampson@marshallmedical.org

University of California Davis Emergency Department

Recruiting

Sacramento, California, United States, 95817

Contacts

Marykate Miller, MPH

916-734-2877mkemiller@health.ucdavis.edu

More Information

Sponsor

University of California, Davis

Last update posted

Jun 12, 2026

Last verified

Jun, 2026

Keywords

  • emergency department
  • opioid use disorder
  • care coordination
  • implementation science
  • hybrid effectiveness-implementation
  • multiteam systems
  • buprenorphine
  • stepped wedge

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of California, Davis on 2026-06-12.