Clinical trial NCT07024498: Coordinating Outpatient bupreNorphiNe for Emergency Care and Continuing Treatment
Official title: Coordinating Outpatient bupreNorphiNe for Emergency Care and Continuing Treatment
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Opioid Use Disorder
Keywords: emergency department
opioid use disorder
care coordination
implementation science
hybrid effectiveness-implementation
multiteam systems
buprenorphine
stepped wedge
Lead sponsor: University of California, Davis
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2025-06-17
Enrollment: 3492
Sex: ALL
Minimum age (years): 14
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SEQUENTIAL
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.
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* patients with an active buprenorphine prescription coverage within 2 days of their index ED visit

Primary outcomes:
measure: buprenorphine treatment (continuous)
timeFrame: 6 months
Secondary outcomes:
measure: buprenorphine treatment (continuous)
timeFrame: 3 months, 12 months
measure: buprenorphine retention (binary)
timeFrame: 3 months, 6 months, 12 months
measure: outpatient buprenorphine initiation
timeFrame: 30 days
Other outcomes:
measure: quality of care transitions
timeFrame: approximately 3 months after the implementation period at each site, controlling for baseline values
measure: quality of care coordination
timeFrame: approximately 3 months after the implementation period at each site, controlling for baseline values
Locations:
city: El Centro
country: United States
facility: El Centro Regional Medical Center Emergency Department
state: California
city: Irvine
country: United States
facility: University of California Irvine Emergency Department
state: California
city: Placerville
country: United States
facility: Marshall Medical Center Emergency Department
state: California
city: Sacramento
country: United States
facility: University of California Davis Emergency Department
state: California
Study officials:
affiliation: University of California, Davis
name: Stephen G Henry, MD MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: University of California, Davis
name: Aimee K Moulin, MD MAS
role: PRINCIPAL_INVESTIGATOR
References: