Coordinating Outpatient bupreNorphiNe for Emergency Care and Continuing Treatment

ConditionOpioid Use Disorder

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age14+

SponsorUniversity of California, Davis

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

None

Trial design

Design model

Sequential

Treatments tested in this trial

care coordination implementation strategies
Other intervention
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.

Treatment groups

3,492 Participants

are divided into 1 treatment group

Group A: Hospital ED and 2 associated outpatient clinics that provide buprenorphine treatmentOther 1 intervention

Trial outcomes

Primary outcomes

buprenorphine treatment (continuous)

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

Time frame

6 months

Secondary outcomes

buprenorphine treatment (continuous)

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

Time frame

3 months, 12 months

buprenorphine retention (binary)

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

Time frame

3 months, 6 months, 12 months

outpatient buprenorphine initiation

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

Time frame

30 days

Other outcomes

quality of care transitions

Handoffs and transitions subscale of AHRQ Survey on Patient Safety Culture

Time frame

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

quality of care coordination

Teamwork across units subscale of AHRQ Survey on Patient Safety Culture

Time frame

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

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of California, Davis

Lead sponsor

National Institute on Drug Abuse (NIDA)

Collaborator

Source ClinicalTrials.gov

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