Clinical trial NCT06872190: Using Clinical Decision Support to Provide Social Risk-Informed Care for Opioid Use Disorder in the Emergency Department
Official title: Using Clinical Decision Support to Provide Social Risk-Informed Care for Opioid Use Disorder in the Emergency Department
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Opioid Use Disorder
Social Determinants of Health (SDOH)
Keywords: social risk-informed care
clinical decision support
opioid use disorder
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2025-03-12
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
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.
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: 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.

Primary outcomes:
measure: CDSv1 clinician launch
timeFrame: 12 months
measure: CDSv1 encounter launch
timeFrame: 12 months
measure: CDSv2 clinician launch
timeFrame: 12 months
measure: CDSv2 encounter launch
timeFrame: 12 months
measure: CDSv1 adherence to OUD treatment recommendations
timeFrame: 12 months
measure: CDSv2 adherence to OUD treatment recommendations
timeFrame: 12 months
measure: CDSv2 adherence to social care recommendations
timeFrame: 12 months
measure: CDSv1 acceptability
timeFrame: During first 6 months of CDSv1 deployment
measure: CDSv1 appropriateness
timeFrame: During first 6 months of CDSv1 deployment
measure: CDSv2 acceptability
timeFrame: During first 6 months of CDSv2 deployment
measure: CDSv2 appropriateness
timeFrame: During first 6 months of CDSv2 deployment
measure: Patient recruitment CDSv1
timeFrame: 12 months
measure: Patient recruitment CDSv2
timeFrame: 12 months
measure: ED clinicians' perceptions of CDSv1
timeFrame: Within first 8 months of CDSv1 deployment
measure: ED patients' perceptions of CDSv1
timeFrame: Within first 8 months of CDSv1 deployment
measure: ED clinicians' perceptions of CDSv2
timeFrame: Within first 8 months of CDSv2 deployment
measure: ED patients' perceptions of CDSv2
timeFrame: Within first 8 months of CDSv2 deployment
measure: Feasibility of primary endpoint collection for CDSv1
timeFrame: 13 months
measure: Feasibility of primary endpoint collection for CDSv2
timeFrame: 13 months
Secondary outcomes:
measure: CDSv1 treatment adherence
timeFrame: 13 months
measure: CDSv1 follow up
timeFrame: 13 months
measure: CDSv2 treatment adherence
timeFrame: 13 months
measure: CDSv2 follow up
timeFrame: 13 months
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California, San Francisco
state: California
Study officials:
affiliation: University of California, San Francisco
name: Melanie F Molina, MD, MAS
role: PRINCIPAL_INVESTIGATOR
References: