Skip to content

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

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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06872190
Enrollment
300
Registered
2025-03-12
Start date
2025-04-20
Completion date
2027-07-01
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Opioid Use Disorder, Social Determinants of Health (SDOH)

Keywords

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

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.

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.

Interventions

OTHERED-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.

OTHERSocial 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.

Sponsors

University of California, San Francisco
Lead SponsorOTHER
National Institute on Drug Abuse (NIDA)
CollaboratorNIH

Study design

Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Subject)

Intervention 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.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
CDSv1 clinician launch12 monthsPercentage of ED clinicians who launch CDSv1 for patients with OUD
CDSv1 encounter launch12 monthsPercentage of eligible encounters (i.e., encounters including patients with OUD as defined by the EHR-derived phenotype) where CDSv1 was launched by clinician
CDSv2 clinician launch12 monthsPercentage of ED clinicians who launch CDSv2 for patients with OUD
CDSv2 encounter launch12 monthsPercentage of eligible encounters (i.e., encounters including patients with OUD as defined by the EHR-derived phenotype) where CDSv2 was launched by clinician
CDSv1 adherence to OUD treatment recommendations12 monthsFor 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
CDSv2 adherence to OUD treatment recommendations12 monthsFor 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
CDSv2 adherence to social care recommendations12 monthsFor 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
CDSv1 acceptabilityDuring first 6 months of CDSv1 deploymentAcceptability 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.
CDSv1 appropriatenessDuring first 6 months of CDSv1 deploymentIntervention 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.
CDSv2 acceptabilityDuring first 6 months of CDSv2 deploymentAcceptability 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.
CDSv2 appropriatenessDuring first 6 months of CDSv2 deploymentIntervention 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.
Patient recruitment CDSv112 monthsNumber of patients who receive OUD medication as a result of CDSv1 who are enrolled for primary outcome ascertainment
Patient recruitment CDSv212 monthsNumber of patients who receive OUD medication as a result of CDSv2 who are enrolled for primary outcome ascertainment
ED clinicians' perceptions of CDSv1Within first 8 months of CDSv1 deploymentThemes emerging from semi-structured qualitative interviews exploring clinician perceptions of CDSv1
ED patients' perceptions of CDSv1Within first 8 months of CDSv1 deploymentThemes emerging from semi-structured qualitative interviews exploring patient perceptions of receiving treatment from CDSv1
ED clinicians' perceptions of CDSv2Within first 8 months of CDSv2 deploymentThemes emerging from semi-structured qualitative interviews exploring clinician perceptions of CDSv2
ED patients' perceptions of CDSv2Within first 8 months of CDSv2 deploymentThemes emerging from semi-structured qualitative interviews exploring patient perceptions of receiving social risk-informed treatment from CDSv2
Feasibility of primary endpoint collection for CDSv113 monthsPercentage of participants for whom data on OUD medication adherence and follow up are successfully collected at 30 days for CDSv1
Feasibility of primary endpoint collection for CDSv213 monthsPercentage of participants for whom data on OUD medication adherence and follow up are successfully collected at 30 days for CDSv2

Secondary

MeasureTime frameDescription
CDSv1 treatment adherence13 monthsProportion of participants adherent to the same OUD medication prescribed using CDSv1 at 30 days post-ED visit
CDSv1 follow up13 monthsProportion of participants receiving formal inpatient, outpatient, or ED-based addiction treatment services at 30 days post-ED visit for CDSv1
CDSv2 treatment adherence13 monthsProportion of participants adherent to the same OUD medication prescribed using CDSv2 at 30 days post-ED visit
CDSv2 follow up13 monthsProportion of participants receiving formal inpatient, outpatient, or ED-based addiction treatment services at 30 days post-ED visit for CDSv2

Countries

United States

Contacts

CONTACTMelanie F Molina, MD, MAS
melanie.molina@ucsf.edu415-353-1156
CONTACTJacob Perez
jacob.perez@ucsf.edu
PRINCIPAL_INVESTIGATORMelanie F Molina, MD, MAS

University of California, San Francisco

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 30, 2026