Skip to content

Coordinating Outpatient bupreNorphiNe for Emergency Care and Continuing Treatment

Coordinating Outpatient bupreNorphiNe for Emergency Care and Continuing Treatment

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07024498
Acronym
CONNECT
Enrollment
3492
Registered
2025-06-17
Start date
2025-11-01
Completion date
2029-08-01
Last updated
2026-06-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Opioid Use Disorder

Keywords

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

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

Detailed description

Buprenorphine is a highly effective but underused medication for opioid use disorder that reduces cravings and decreases overdose risk. Starting buprenorphine for opioid use disorder in emergency departments (EDs) is recognized as a best clinical practice in the US. However, effective strategies to help patients sustain buprenorphine treatment after they leave the ED are urgently needed. To increase access to buprenorphine treatment, California established California Bridge, a state-funded program that offers same-day buprenorphine initiation plus referral to outpatient opioid use disorder treatment for patients. However, suboptimal ED-outpatient care coordination is a common barrier to buprenorphine retention. During a prior study, we identified a bundle of implementation strategies designed to improve ED-outpatient care coordination for patients who start buprenorphine for opioid use disorder in the ED. In this hybrid effectiveness-implementation study, the research team will work with core clinical teams at 12 sites (4 EDs and 8 outpatient clinics \[2 clinics per ED\]) to implement a bundle of implementation strategies at each site. Implementation will occur over a 12 month period (\ 3 months per site). Patient cohorts will be identified through electronic health record query reports. Data from eligible patients will then be abstracted from the electronic health record at each hospital. Changes in care coordination will be assessed using clinician surveys. Treatment outcomes will be assessed using buprenorphine prescription records obtained from California's prescription drug monitoring program linked to electronic health record data at the patient level. Study results will be used to develop an implementation blueprint that hospitals in California and across the US can use to improve opioid use disorder treatment outcomes for patients who start buprenorphine in hospital EDs.

Interventions

OTHERcare 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

University of California, Davis
Lead SponsorOTHER
National Institute on Drug Abuse (NIDA)
CollaboratorNIH

Study design

Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
OTHER
Masking
NONE

Intervention model description

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.

Eligibility

Sex/Gender
ALL
Age
14 Years to No maximum
Healthy volunteers
No

Inclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
buprenorphine treatment (continuous)6 monthsCumulative number of days with active buprenorphine prescription after initial ED visit

Secondary

MeasureTime frameDescription
buprenorphine treatment (continuous)3 months, 12 monthsCumulative number of days with active buprenorphine prescription after initial ED visit
buprenorphine retention (binary)3 months, 6 months, 12 monthsProportion of patients with active buprenorphine prescriptions after initial ED visit without a gap in buprenorphine coverage of more than 7 days
outpatient buprenorphine initiation30 daysProportion of patients who fill at least 1 outpatient buprenorphine prescription within 30 days of their ED visit

Countries

United States

Contacts

CONTACTMarykate MIller, MPH
mkemiller@health.ucdavis.edu916-734-2877
CONTACTStephen G Henry, MD MSc
sghenry@health.ucdavis.edu916-734-7391
PRINCIPAL_INVESTIGATORStephen G Henry, MD MSc

University of California, Davis

PRINCIPAL_INVESTIGATORAimee K Moulin, MD MAS

University of California, Davis

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 13, 2026