Coordinating Outpatient bupreNorphiNe for Emergency Care and Continuing Treatment

Part of paid clinical trials in El Centro, California.

Sponsor
University of California, Davis
Study ID
NCT07024498
Status
Recruiting
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Conditions

  • Opioid Use Disorder

Eligibility Criteria

Sex
ALL
Age
14 Years - N/A
Healthy Volunteers
Not accepted

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.

Study Details

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

Key Dates

Start date
Nov 1, 2025
Status verified
Jun 2026
Primary completion
May 1, 2029
Completion
Jul 31, 2029

Study Design

Enrollment
3,492 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER

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.

Primary Outcome Measure

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

Central Contacts

Locations (4)

FacilityCityStateZIPSite coordinators
El Centro Regional Medical Center Emergency DepartmentEl CentroCalifornia92243
Rahul Nene, MD PhD
[email protected]
760-339-7100
University of California Irvine Emergency DepartmentIrvineCalifornia92868
Bharath Chakravarthy, MD
[email protected]
714-456-7890
Marshall Medical Center Emergency DepartmentPlacervilleCalifornia95667
Arianna Campbell, PA-C
[email protected]
530-409-7890
University of California Davis Emergency DepartmentSacramentoCalifornia95817
Marykate Miller, MPH
[email protected]
916-734-2877

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