Improving Diagnostic Safety Through STeatosis Identification, Risk Stratification, and Referral in the ED

Part of paid clinical trials in Chicago, Illinois.

Sponsor
Northwestern University
Study ID
NCT06944353
Status
Enrolling By Invitation

Conditions

  • Metabolic Dysfunction-Associated Steatotic Liver Disease
  • Non-Alcoholic Fatty Liver Disease
  • Steatosis of Liver

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • STIRRED — BEHAVIORAL
    The STIRRED intervention is a behavioral intervention directed at the treating ED clinicians. An Our Practice Advisory (OPA) will alert the clinician to the radiology finding of hepatic steatosis at the time of preparing the discharge materials. The OPA will prompt the clinician to discuss this finding with the patient and will automatically add hepatic steatosis to the discharge diagnoses and insert patient-facing discharge information about hepatic steatosis. It will additionally prompt the clinician to refer the patient for follow-up which will be stratified based on their fibrosis risk level.

Study Details

Hepatic steatosis is a common radiographic "incidental finding" that is overlooked and underreported to patients. The investigators developed a clinical decision support system using machine learning and natural language processing that will prompt reporting to patients and provide ED clinicians risk stratified follow-up care recommendations. Data on both the implementation and effectiveness of our intervention resulting from this trial will inform future use with a goal of ultimately improving diagnostic safety and outcomes for patients with hepatic steatosis.

Key Dates

Start date
Dec 4, 2025
Status verified
May 2026
Primary completion
Jan 31, 2027
Completion
Jul 31, 2028

Study Design

Enrollment
4,704 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH

Arms

  • No Intervention: Usual Care
    Includes any patient notification about steatosis, education and referrals as per the treating clinician's usual and customary practice.
  • Experimental: STIRRED
    Patients with incidentally noted hepatic steatosis who are seen in Emergency Departments after STIRRED intervention has been activated within the local EHR may receive additional notification about steatosis, education or referrals for additional testing and follow-up as prompted by the STIRRED intervention which is directed at their discharging clinician.

Primary Outcome Measure

Effectiveness: New steatotic liver disease-related diagnosis among high-risk patients [ Time Frame: 120 days post-ED discharge ]

Locations (1)

FacilityCityStateZIPSite coordinators
Northwestern Memorial HospitalChicagoIllinois60611-

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By research site
Northwestern Memorial Hospital· Chicago, IL

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