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NCT Number: NCT07024498

Coordinating Outpatient bupreNorphiNe for Emergency Care and Continuing Treatment

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

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Key information

Conditions

Opioid Use Disorder Chemically-Induced Disorders Disease Attributes Emergencies Mental Disorders Narcotic-Related Disorders Opioid-Related Disorders Pathologic Processes Pathological Conditions, Signs and Symptoms Substance-Related Disorders

Age range

14 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

El Centro Regional Medical Center Emergency Department, El Centro, California, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Treatment and study plan

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.

Primary outcomes

  1. buprenorphine treatment (continuous)

    Time frame: 6 months

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

Secondary outcomes

  1. buprenorphine treatment (continuous)

    Time frame: 3 months, 12 months

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

  2. buprenorphine retention (binary)

    Time frame: 3 months, 6 months, 12 months

    Proportion of patients with active buprenorphine prescriptions after initial ED visit without a gap in buprenorphine coverage of more than 7 days

  3. outpatient buprenorphine initiation

    Time frame: 30 days

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

Other outcomes

  1. quality of care transitions

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

    Handoffs and transitions subscale of AHRQ Survey on Patient Safety Culture

  2. quality of care coordination

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

    Teamwork across units subscale of AHRQ Survey on Patient Safety Culture

Study contacts

Contact information is provided by the study sponsor or research team.

Marykate MIller, MPH

CONTACT

[email protected]

916-734-2877

Stephen G Henry, MD MSc

CONTACT

[email protected]

916-734-7391

Sponsors and collaborators

Lead sponsor

University of California, Davis

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)

Registry information

Acronym: CONNECT

Important dates

Study start
2025
Primary completion
2028
Study completion
2029
First posted
Jun 17, 2025
Registry last updated
Jun 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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