Recruiting

Observational Study

Sponsor:

UCLA

Code:

NCT06872190

Conditions

Opioid Use Disorder

Social Determinants of Health (SDOH)

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

ED-Based Clinical Decision Support for Opioid Use Disorder

Social Care-Enhanced Clinical Decision Support for Opioid Use Disorder

Study Details

Brief summary:

The overarching goal of this proposal is to integrate patient social risk information into an existing electronic health record (EHR)-based clinical decision support (CDS) tool (CDSv1) to facilitate emergency department (ED)-initiated, social risk-informed opioid use disorder (OUD) medication treatment and ultimately improve treatment adherence and follow up. The investigators will evaluate the feasibility and acceptability of the social care-enhanced CDS tool, CDSv2, (compared to CDSv1) at a single study site (UCSF) as an intervention to increase medication treatment adherence and follow up for adult ED patients experiencing opioid use disorder using a mixed-methods, before-after approach.

Conditions

Opioid Use Disorder

Social Determinants of Health (SDOH)

Study ID

NCT06872190

Start date

Apr 20, 2025

Status verified date

Jun, 2026

Completion date

Jul, 2027

Anticipated

Primary completion date

Jul, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion criteria:

  • All University of California, San Francisco ED providers (residents, attendings, advanced practice providers) who have used either CDSv1 or CDSv2 will be eligible to participate in surveys and interviews regarding feasibility and acceptability.
  • English-speaking patients ≥18 years of age presenting to the UCSF ED with opioid use disorder who receive medication treatment (as a result of CDSv1 or CDSv2) will be eligible to participate.

Exclusion criteria:

\- Participants will be excluded if:

  • they have a medical or psychiatric condition requiring hospitalization at the index ED visit,
  • are actively suicidal, are cognitively impaired,
  • present from an extended care facility, or
  • require opioids for a pain condition.

Study Design

Enrollment

300 participants

Anticipated

Allocation

Non randomized

Intervention Model

Sequential

Primary purpose

Health Services Research

Interventions and Outcome Measures

Arms

active comparator: ED-Based Clinical Decision Support for Opioid Use Disorder

Emergency providers will have access to the basic ED-based clinical decision support tool for opioid use disorder.

experimental: Social Care-Enhanced Clinical Decision Support for Opioid Use Disorder

Emergency providers will no longer have access to the basic ED-based clinical decision support tool for opioid use disorder, but will instead have access to the social care-enhanced clinical decision support tool for opioid use disorder.

Interventions

ED-Based Clinical Decision Support for Opioid Use Disorder

The original clinical decision support (CDS) tool, EMergency department initiated BuprenorphinE for opioid use Disorder or EMBED, was designed by researchers at Yale to support emergency department (ED) clinicians with varying levels of experience prescribing buprenorphine for patients with opioid use disorder (OUD). The tool alerts ED providers of a patient who is potentially eligible for MOUD using Epic's storyboard. The provider must then click on the notification to open the OUD evaluation tool, which has multiple components: OUD assessment, OUD diagnosis, withdrawal assessment, and readiness for treatment. These components are then paired with an orderset, "ED Opioid Use Disorder Treatment" that includes nursing orders, prescriptions for buprenorphine and ancillary medications, and substance use disorder discharge resources.

Social Care-Enhanced Clinical Decision Support for Opioid Use Disorder

The investigators will use human-centered design to adapt the basic CDS tool to incorporate patient social needs, involving patients, staff, and end-user ED clinicians in the iterative design process. This tool is being actively developed.

Primary outcome measure

  • CDSv1 clinician launch [ Time Frame: 12 months ]
  • CDSv1 encounter launch [ Time Frame: 12 months ]
  • CDSv2 clinician launch [ Time Frame: 12 months ]
  • CDSv2 encounter launch [ Time Frame: 12 months ]
  • CDSv1 adherence to OUD treatment recommendations [ Time Frame: 12 months ]
  • CDSv2 adherence to OUD treatment recommendations [ Time Frame: 12 months ]
  • CDSv2 adherence to social care recommendations [ Time Frame: 12 months ]
  • CDSv1 acceptability [ Time Frame: During first 6 months of CDSv1 deployment ]
  • CDSv1 appropriateness [ Time Frame: During first 6 months of CDSv1 deployment ]
  • CDSv2 acceptability [ Time Frame: During first 6 months of CDSv2 deployment ]
  • CDSv2 appropriateness [ Time Frame: During first 6 months of CDSv2 deployment ]
  • Patient recruitment CDSv1 [ Time Frame: 12 months ]
  • Patient recruitment CDSv2 [ Time Frame: 12 months ]
  • ED clinicians' perceptions of CDSv1 [ Time Frame: Within first 8 months of CDSv1 deployment ]
  • ED patients' perceptions of CDSv1 [ Time Frame: Within first 8 months of CDSv1 deployment ]
  • ED clinicians' perceptions of CDSv2 [ Time Frame: Within first 8 months of CDSv2 deployment ]
  • ED patients' perceptions of CDSv2 [ Time Frame: Within first 8 months of CDSv2 deployment ]
  • Feasibility of primary endpoint collection for CDSv1 [ Time Frame: 13 months ]
  • Feasibility of primary endpoint collection for CDSv2 [ Time Frame: 13 months ]

Central Contacts and Locations

Central contacts

Melanie F Molina, MD, MAS

415-353-1156melanie.molina@ucsf.edu

Jacob Perez

jacob.perez@ucsf.edu

Locations

University of California, San Francisco

Recruiting

San Francisco, California, United States, 94143

More Information

Sponsor

University of California, San Francisco

Last update posted

Jun 29, 2026

Last verified

Jun, 2026

Keywords

  • social risk-informed care
  • clinical decision support
  • opioid use disorder

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of California, San Francisco on 2026-06-29.