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

Not Applicable

Recruiting

• Conditions: Opioid Use Disorder; Social Determinants of Health (SDOH)

• Registration Number: NCT06872190
• Lead Sponsor: University of California, San Francisco

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.

Study Timeline

• Study First Submitted: 2025-03-06
• Study First Submitted QC: 2025-03-06
• Study First Posted: 2025-03-12
• Study Start: 2025-04-20
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-05
• Last Update Posted: 2025-05-07
• Primary Completion: 2027-07
• Study Completion: 2027-07

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Primary Outcome Measures

Name	Time	Method
CDSv1 clinician launch	12 months	Percentage of ED clinicians who launch CDSv1 for patients with OUD
CDSv1 encounter launch	12 months	Percentage 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 launch	12 months	Percentage of ED clinicians who launch CDSv2 for patients with OUD
CDSv2 encounter launch	12 months	Percentage 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 recommendations	12 months	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
CDSv2 adherence to OUD treatment recommendations	12 months	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
CDSv2 adherence to social care recommendations	12 months	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
ED clinicians' perceptions of CDSv2	Within first 8 months of CDSv2 deployment	Themes emerging from semi-structured qualitative interviews exploring clinician perceptions of CDSv2
ED patients' perceptions of CDSv2	Within first 8 months of CDSv2 deployment	Themes emerging from semi-structured qualitative interviews exploring patient perceptions of receiving social risk-informed treatment from CDSv2
CDSv1 acceptability	During first 6 months of CDSv1 deployment	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.
CDSv1 appropriateness	During first 6 months of CDSv1 deployment	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.
CDSv2 acceptability	During first 6 months of CDSv2 deployment	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.
CDSv2 appropriateness	During first 6 months of CDSv2 deployment	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.
Patient recruitment CDSv1	12 months	Number of patients who receive OUD medication as a result of CDSv1 who are enrolled for primary outcome ascertainment
Patient recruitment CDSv2	12 months	Number of patients who receive OUD medication as a result of CDSv2 who are enrolled for primary outcome ascertainment
ED clinicians' perceptions of CDSv1	Within first 8 months of CDSv1 deployment	Themes emerging from semi-structured qualitative interviews exploring clinician perceptions of CDSv1
ED patients' perceptions of CDSv1	Within first 8 months of CDSv1 deployment	Themes emerging from semi-structured qualitative interviews exploring patient perceptions of receiving treatment from CDSv1
Feasibility of primary endpoint collection for CDSv1	13 months	Percentage 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 CDSv2	13 months	Percentage of participants for whom data on OUD medication adherence and follow up are successfully collected at 30 days for CDSv2

Secondary Outcome Measures

Name	Time	Method
CDSv1 treatment adherence	13 months	Proportion of participants adherent to the same OUD medication prescribed using CDSv1 at 30 days post-ED visit
CDSv1 follow up	13 months	Proportion of participants receiving formal inpatient, outpatient, or ED-based addiction treatment services at 30 days post-ED visit for CDSv1
CDSv2 treatment adherence	13 months	Proportion of participants adherent to the same OUD medication prescribed using CDSv2 at 30 days post-ED visit
CDSv2 follow up	13 months	Proportion of participants receiving formal inpatient, outpatient, or ED-based addiction treatment services at 30 days post-ED visit for CDSv2

Trial Locations

Locations (1)

University of California, San Francisco; 🇺🇸 San Francisco, California, United States