Coordinating Outpatient bupreNorphiNe for Emergency Care and Continuing Treatment

NCT07024498 | Not Yet Recruiting

• 2 other identifiers: 2284130R61DA059027
• Study Type: interventional
• Target: 3,492
• Locations: 1 country
• Sites: 4

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• buprenorphine treatment (continuous)

  Cumulative number of days with active buprenorphine prescription after initial ED visit

  6 months

Secondary Outcomes (3)

• buprenorphine treatment (continuous)

  3 months, 12 months

• buprenorphine retention (binary)

  3 months, 6 months, 12 months

• outpatient buprenorphine initiation

  30 days

Other Outcomes (2)

• quality of care transitions

  approximately 3 months after the implementation period at each site, controlling for baseline values

• quality of care coordination

  approximately 3 months after the implementation period at each site, controlling for baseline values

Study Arms (1)

Hospital ED and 2 associated outpatient clinics that provide buprenorphine treatment

OTHER

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.

Other: care coordination implementation strategies

Interventions

care coordination implementation strategies OTHER

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.

Hospital ED and 2 associated outpatient clinics that provide buprenorphine treatment

Eligibility Criteria

• Age: 14 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

Sponsors & Collaborators

• University of California, Davis: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (4)

El Centro Regional Medical Center Emergency Department

El Centro, California, 92243, United States

Location

University of California Irvine Emergency Department

Irvine, California, 92868, United States

Location

Marshall Medical Center Emergency Department

Placerville, California, 95667, United States

Location

University of California Davis Emergency Department

Sacramento, California, 95817, United States

Location

MeSH Terms

Conditions

Opioid-Related Disorders; Emergencies

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Stephen G Henry, MD MSc

  University of California, Davis

  PRINCIPAL INVESTIGATOR

• Aimee K Moulin, MD MAS

  University of California, Davis

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marykate MIller, MPH

CONTACT

916-734-2877; mkemiller@ucdavis.edu

Stephen G Henry, MD MSc

CONTACT

916-734-7391; sghenry@ucdavis.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a stepped wedge design with intervention assignment at the site level and the primary outcome assessed at the patient level. The intervention will be implemented sequentially at the site level. The sequence in which sites will implement the intervention was determined prospectively to alternate between sites that did versus did not participate in the prior study to identify implementation strategies. After a 9 month baseline period, one site will transition to the intervention condition every 3 months until all four have implemented the intervention. Patients will be followed for up to 12 months after their ED visit to assess buprenorphine treatment outcomes.

Study Record Dates

• First Submitted: May 29, 2025
• First Posted: June 17, 2025
• Study Start (Estimated): December 1, 2026
• Primary Completion (Estimated): May 1, 2029
• Study Completion (Estimated): July 31, 2029
• Last Updated: April 15, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Time Frame: expected 12 months after study completion

Locations

US (4)