Coordinating Outpatient bupreNorphiNe for Emergency Care and Continuing Treatment

NCT ID: NCT07024498

Last Updated: 2025-12-24

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 3492 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-01-01
• Study Completion Date: 2029-07-31

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.

Conditions

Opioid Use Disorder

Keywords

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

Study Design

• Allocation Method: NA
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

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.

Group Type: OTHER

care coordination implementation strategies

Intervention Type: 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.

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

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

• Minimum Eligible Age: 14 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role: collaborator

University of California, Davis

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Stephen G Henry, MD MSc

Role: PRINCIPAL_INVESTIGATOR

University of California, Davis

Aimee K Moulin, MD MAS

Role: PRINCIPAL_INVESTIGATOR

University of California, Davis

Locations

El Centro Regional Medical Center Emergency Department

El Centro, California, United States

University of California Irvine Emergency Department

Irvine, California, United States

Marshall Medical Center Emergency Department

Placerville, California, United States

University of California Davis Emergency Department

Sacramento, California, United States

Countries

United States

Central Contacts

Marykate MIller, MPH

Role: CONTACT

Phone: 916-734-2877

Email: mkemiller@ucdavis.edu

Stephen G Henry, MD MSc

Role: CONTACT

Phone: 916-734-7391

Email: sghenry@ucdavis.edu

Facility Contacts

Rahul Nene, MD PhD

Role: primary

Bharath Chakravarthy, MD

Role: primary

Arianna Campbell, PA-C

Role: primary

Marykate Miller, MPH

Role: primary

Other Identifiers

R61DA059027

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2284130

Identifier Type: -

Identifier Source: org_study_id