Using Clinical Decision Support to Provide Social Risk-Informed Care for Opioid Use Disorder in the Emergency Department

NCT06872190 | Recruiting

• 2 other identifiers: 24-41722K23DA060993
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

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)

Keywords

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

Outcome Measures

Primary Outcomes (19)

• CDSv1 clinician launch

  Percentage of ED clinicians who launch CDSv1 for patients with OUD

  12 months

• CDSv1 encounter launch

  Percentage of eligible encounters (i.e., encounters including patients with OUD as defined by the EHR-derived phenotype) where CDSv1 was launched by clinician

  12 months

• CDSv2 clinician launch

  Percentage of ED clinicians who launch CDSv2 for patients with OUD

  12 months

• CDSv2 encounter launch

  Percentage of eligible encounters (i.e., encounters including patients with OUD as defined by the EHR-derived phenotype) where CDSv2 was launched by clinician

  12 months

• CDSv1 adherence to OUD treatment recommendations

  For ED visits in which CDSv1 is launched, investigators will assess the percentage of times either buprenorphine, methadone, or naltrexone was prescribed by an ED clinician

  12 months

• CDSv2 adherence to OUD treatment recommendations

  For ED visits in which CDSv2 is launched, investigators will assess the percentage of times either buprenorphine, methadone, or naltrexone was prescribed by an ED clinician

  12 months

• CDSv2 adherence to social care recommendations

  For ED visits in which CDSv2 is launched, investigators will assess the percentage of times social care recommendations (to be determined, based on results from Aim 2) were followed by ED clinicians

  12 months

• CDSv1 acceptability

  Acceptability of Intervention Measure 4-item survey to assess clinician acceptability of CDSv1. Response scales range from "1 = Completely disagree" to "5 = Completely agree", with higher scores indicating greater success.

  During first 6 months of CDSv1 deployment

• CDSv1 appropriateness

  Intervention Appropriateness Measure 4-item survey to assess clinician perception of CDSv1 appropriateness. Response scales range from "1 = Completely disagree" to "5 = Completely agree", with higher scores indicating greater success.

  During first 6 months of CDSv1 deployment

• CDSv2 acceptability

  Acceptability of Intervention Measure 4-item survey to assess clinician acceptability of CDSv2. Response scales range from "1 = Completely disagree" to "5 = Completely agree", with higher scores indicating greater success.

  During first 6 months of CDSv2 deployment

• CDSv2 appropriateness

  Intervention Appropriateness Measure 4-item survey to assess clinician perception of CDSv2 appropriateness. Response scales range from "1 = Completely disagree" to "5 = Completely agree", with higher scores indicating greater success.

  During first 6 months of CDSv2 deployment

• Patient recruitment CDSv1

  Number of patients who receive OUD medication as a result of CDSv1 who are enrolled for primary outcome ascertainment

  12 months

• Patient recruitment CDSv2

  Number of patients who receive OUD medication as a result of CDSv2 who are enrolled for primary outcome ascertainment

  12 months

• ED clinicians' perceptions of CDSv1

  Themes emerging from semi-structured qualitative interviews exploring clinician perceptions of CDSv1

  Within first 8 months of CDSv1 deployment

• ED patients' perceptions of CDSv1

  Themes emerging from semi-structured qualitative interviews exploring patient perceptions of receiving treatment from CDSv1

  Within first 8 months of CDSv1 deployment

• ED clinicians' perceptions of CDSv2

  Themes emerging from semi-structured qualitative interviews exploring clinician perceptions of CDSv2

  Within first 8 months of CDSv2 deployment

• ED patients' perceptions of CDSv2

  Themes emerging from semi-structured qualitative interviews exploring patient perceptions of receiving social risk-informed treatment from CDSv2

  Within first 8 months of CDSv2 deployment

• Feasibility of primary endpoint collection for CDSv1

  Percentage of participants for whom data on OUD medication adherence and follow up are successfully collected at 30 days for CDSv1

  13 months

• Feasibility of primary endpoint collection for CDSv2

  Percentage of participants for whom data on OUD medication adherence and follow up are successfully collected at 30 days for CDSv2

  13 months

Secondary Outcomes (4)

• CDSv1 treatment adherence

  13 months

• CDSv1 follow up

  13 months

• CDSv2 treatment adherence

  13 months

• CDSv2 follow up

  13 months

Study Arms (2)

ED-Based Clinical Decision Support for Opioid Use Disorder

ACTIVE COMPARATOR

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

Other: ED-Based Clinical Decision Support for Opioid Use Disorder

Social Care-Enhanced Clinical Decision Support for Opioid Use Disorder

EXPERIMENTAL

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.

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

Interventions

ED-Based Clinical Decision Support for Opioid Use Disorder OTHER

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.

Also known as: CDSv1

ED-Based Clinical Decision Support for Opioid Use Disorder

Social Care-Enhanced Clinical Decision Support for Opioid Use Disorder OTHER

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.

Also known as: CDSv2

Social Care-Enhanced Clinical Decision Support for Opioid Use Disorder

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• \- 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.

Sponsors & Collaborators

• University of California, San Francisco: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

University of California, San Francisco

San Francisco, California, 94143, United States

RECRUITING

MeSH Terms

Conditions

Opioid-Related Disorders

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Study Officials

• Melanie F Molina, MD, MAS

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Melanie F Molina, MD, MAS

CONTACT

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

Jacob Perez

CONTACT

jacob.perez@ucsf.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The investigators will first deploy CDSv1 and collect outcomes with CDSv1, while they build CDSv2. After a brief wash-in period, they will deploy CDSv2 and collection outcomes on CDSv2.

Study Record Dates

• First Submitted: March 6, 2025
• First Posted: March 12, 2025
• Study Start: April 20, 2025
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): July 1, 2027
• Last Updated: May 7, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)