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Opioid Use DisorderNCT06872190

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

A study testing ED-Based Clinical Decision Support for Opioid Use Disorder and Social Care-Enhanced Clinical Decision Support for Opioid Use Disorder in people with Opioid Use Disorder and Social Determinants of Health (SDOH), run by University of California, San Francisco at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
ED-Based Clinical Decision Support for Opioid Use Disorder and Social Care-Enhanced Clinical Decision Support for Opioid Use Disorder
Could I receive a placebo?
No, everyone receives an active treatment
How many people
300 participants
Where
1 siteUnited States
Study dates
20 Apr 2025to Jul 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Melanie F Molina, MD, MAS contact

415-353-1156

melanie.molina@ucsf.edu

Jacob Perez contact

jacob.perez@ucsf.edu

United States1 site, 1 recruiting
  • University of California, San Francisco

    San Francisco, California, 94143

    Recruiting

Other trials in United States

About this study

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.

Read the detailed description

Over 2.7 million people suffer from opioid use disorder (OUD) in the United States (US), resulting in more than 80,000 opioid overdose deaths in 2021. Medications for opioid use disorder are underused disproportionately in patients living in poverty, whose unmet food, housing, and transportation needs impede access to medications and routine healthcare. Emergency departments (EDs) are the primary (and often only) healthcare access points for vulnerable populations with social needs, including people with OUD. In response, healthcare professional organizations have increasingly called for ED-initiated medications for OUD (MOUD), which has been shown to lead to better adherence compared to referrals to treatment alone.

Clinical decision support (CDS) tools in electronic health records (EHRs) can be used to support ED-initiated MOUD. They enhance care quality by providing actionable information to clinicians in real time; a study of a CDS tool for MOUD showed that it significantly increased the number of MOUD prescribers. A major risk of ED-initiated MOUD, however, is that it could lead to inequitable outcomes unless closely paired with efforts to connect patients to services that also address social needs. For instance, patients with food or housing insecurity are unlikely to prioritize adherence to MOUD over meeting their basic material needs; patients with MOUD who lack reliable transportation may be unable to access follow up care for MOUD. Linking social interventions to MOUD initiation may improve the likelihood of adherence to treatment and follow-up care. Though CDS tools that use patients' social risk data have been developed to improve care for other chronic diseases, e.g., hypertension and diabetes, to date, the CDS tools that facilitate ED-initiated MOUD have not been designed to harness social risk information to improve MOUD care planning. There is an urgent need to design and test a CDS tool that simultaneously facilitates MOUD initiation and helps identify and intervene on patients' social needs.

The overarching goal of this project is to evaluate the feasibility and acceptability of a social care-enhanced CDS tool (CDSv2) designed to facilitate ED-based, social risk-informed MOUD compared to an existing CDS tool for ED-based MOUD (CDSv1), with the ultimate goal of improving treatment adherence and follow up for ED patients experiencing OUD.

Specific Aim: Assess the feasibility and acceptability of the social care-enhanced CDS tool (CDSv2, compared to CDSv1) at the UCSF ED as an intervention to improve medication treatment adherence and follow up for adult ED patients experiencing OUD. The investigators will perform a mixed-methods, before-after pilot study evaluating the basic CDS tool (CDSv1) and the social care-enhanced CDS tool (CDSv2) over 28 months. To assess feasibility of patient recruitment and primary endpoint collection (e.g, adherence, follow up), the investigators will perform chart review and outreach to patients. To measure clinician utilization and acceptability, the investigators will collect EHR-based audit log and survey data. The investigators will also conduct semi-structured interviews with a purposive sample of ED clinicians and patients to further capture their experiences (acceptability) with the social care-enhanced CDS tool and the basic CDS tool.

The expected sample size of 300 will include 240 providers and 60 patients.

Being tested
ED-Based Clinical Decision Support for Opioid Use Disorder, Social Care-Enhanced Clinical Decision Support for Opioid Use Disorder
Keywords
social risk-informed care, clinical decision support, opioid use disorder
Medical subject headings
Opioid-Related Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ED-Based Clinical Decision Support for Opioid Use DisorderOther

    Also called CDSv1

    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 DisorderOther

    Also called CDSv2

    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.

Study groups in NCT06872190
Study groupRoleWhat they receive
ED-Based Clinical Decision Support for Opioid Use DisorderActive comparatorEmergency providers will have access to the basic ED-based clinical decision support tool for opioid use disorder.
Receives: Other: ED-Based Clinical Decision Support for Opioid Use Disorder
Social Care-Enhanced Clinical Decision Support for Opioid Use DisorderExperimentalEmergency 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.
Receives: Other: Social Care-Enhanced Clinical Decision Support for Opioid Use Disorder

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. CDSv1 clinician launch

    Percentage of ED clinicians who launch CDSv1 for patients with OUD

    Measured: 12 months

  2. 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

    Measured: 12 months

  3. CDSv2 clinician launch

    Percentage of ED clinicians who launch CDSv2 for patients with OUD

    Measured: 12 months

  4. 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

    Measured: 12 months

  5. 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

    Measured: 12 months

  6. 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

    Measured: 12 months

  7. 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

    Measured: 12 months

  8. 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.

    Measured: During first 6 months of CDSv1 deployment

  9. 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.

    Measured: During first 6 months of CDSv1 deployment

  10. 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.

    Measured: During first 6 months of CDSv2 deployment

  11. 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.

    Measured: During first 6 months of CDSv2 deployment

  12. Patient recruitment CDSv1

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

    Measured: 12 months

  13. Patient recruitment CDSv2

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

    Measured: 12 months

  14. ED clinicians' perceptions of CDSv1

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

    Measured: Within first 8 months of CDSv1 deployment

  15. ED patients' perceptions of CDSv1

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

    Measured: Within first 8 months of CDSv1 deployment

  16. ED clinicians' perceptions of CDSv2

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

    Measured: Within first 8 months of CDSv2 deployment

  17. ED patients' perceptions of CDSv2

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

    Measured: Within first 8 months of CDSv2 deployment

  18. 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

    Measured: 13 months

  19. 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

    Measured: 13 months

Secondary outcomes (4)
  1. CDSv1 treatment adherence

    Proportion of participants adherent to the same OUD medication prescribed using CDSv1 at 30 days post-ED visit

    Measured: 13 months

  2. CDSv1 follow up

    Proportion of participants receiving formal inpatient, outpatient, or ED-based addiction treatment services at 30 days post-ED visit for CDSv1

    Measured: 13 months

  3. CDSv2 treatment adherence

    Proportion of participants adherent to the same OUD medication prescribed using CDSv2 at 30 days post-ED visit

    Measured: 13 months

  4. CDSv2 follow up

    Proportion of participants receiving formal inpatient, outpatient, or ED-based addiction treatment services at 30 days post-ED visit for CDSv2

    Measured: 13 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Mar 2025
  2. Study start20 Apr 2025
  3. Primary completionJul 2027 (estimated)
  4. Study completionJul 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Non-randomised
Intervention model
Sequential
Model description
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.
Masking
Single blind
Who is masked
Participant
Enrolment
300 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06872190
Sponsor's protocol ID
24-41722
Other IDs
K23DA060993
Status last verified
Jun 2026
First submitted
6 Mar 2025
Last updated
29 Jun 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing ED-Based Clinical Decision Support for Opioid Use Disorder and Social Care-Enhanced Clinical Decision Support for Opioid Use Disorder in people with Opioid Use Disorder and Social Determinants of Health (SDOH), run by University of California, San Francisco at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 29 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Melanie F Molina, MD, MAS (415-353-1156, melanie.molina@ucsf.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

CDSv1 clinician launch (time frame: 12 months). The study lists 19 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2026.

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