Clinical Trials Directory

Trials / Recruiting

RecruitingNCT06872190

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

Status
Recruiting
Phase
N/A
Study type
Interventional
Enrollment
300 (estimated)
Sponsor
University of California, San Francisco · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
OTHERED-Based Clinical Decision Support for Opioid Use DisorderThe 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 DisorderThe 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.

Timeline

Start date
2025-04-20
Primary completion
2027-07-01
Completion
2027-07-01
First posted
2025-03-12
Last updated
2025-05-07

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT06872190. Inclusion in this directory is not an endorsement.