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Enrolling by Invitation

NCT Number: NCT06944353

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

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.

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Key information

Conditions

Non-Alcoholic Fatty Liver Disease Digestive System Diseases Fatty Liver Liver Diseases Metabolic Dysfunction-Associated Steatotic Liver Disease Steatosis of Liver

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Northwestern Memorial Hospital

Chicago, Illinois, 60611, United States

About this study

Metabolic dysfunction-associated steatotic liver disease (MASLD) is a public health crisis affecting one third of the US adult population. Steatotic liver disease is an obesity related disease with serious health and quality of life consequences. Hepatic steatosis is reported on ~10% of written radiology reports. Unfortunately, lack of awareness often leads to hepatic steatosis being overlooked by providers and unreported to patients leading to delays in diagnosis and referral to specialty care.

This project, Improving Diagnostic Safety through STeatosis Identification, Risk stratification, and Referral pathway in the ED (STIRRED), proposes to improve diagnostic safety by ensuring that patients receive timely notification of the new finding and referral to follow up care. The STIRRED CDSS intervention employs natural language processing and machine learning to identify hepatic steatosis in written emergency department (ED) radiology reports and combine it with common clinical data in the electronic health record to create an individualized risk profile and follow up recommendations for patients with suspected MASLD. This recommendation is communicated to the ED clinician during the ED discharge process via an OurPractice Advisory (OPA) and triggering outpatient referral for follow-up care stratified by risk level.

This trial will evaluate STIRRED across a large health system using a type 2 implementation-effectiveness stepped wedge cluster randomized trial across 11 Emergency Departments in a single health system. Effectiveness of providing risk-based care linkage and implementation outcomes will be evaluated.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • imaging finding of hepatic steatosis on ED imaging study
  • discharged from the ED to home
  • first Northwestern Medicine ED visit in the study period with a hepatic steatosis finding

Exclusion criteria

  • admitted to the hospital
  • age < 18
  • pre-existing Liver Disease diagnosis (Liver Cancer, HCV, HBV, Cirrhosis, NAFLD/MASLD/NASH/MASH, Alcohol Liver Disease, PSC, PBC and autoimmune hepatitis)

Treatment and study plan

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.

Primary outcomes

  1. Effectiveness: New steatotic liver disease-related diagnosis among high-risk patients

    Time frame: 120 days post-ED discharge

    For patients at high risk for liver fibrosis, The investigators will evaluate for new steatotic liver disease related ICD codes.

  2. Implementation: Intervention fidelity

    Time frame: Baseline at time of intervention delivery

    Fidelity is the degree to which the STIRRED CDSS was delivered as intended.

    Fidelity will be evaluated across four components:

    • hepatic steatosis added to the ED discharge diagnoses;
    • hepatic steatosis patient education provided;
    • ED adoption of confirming that the clinicians have informed the patient of the new finding; and
    • ED adoption of placing referral and/or recommendation for follow-up (distinct from routing the message to PCP).

    The Investigators will analyze individual components and a composite score of 0-4 that combines these outcomes. The fidelity components and their composite score (0-4) will be audited monthly from 3 months prior to implementation to 3 months after implementation.

Other outcomes

  1. Effectiveness: New steatotic liver disease-related diagnosis among all patients

    Time frame: 120 days post-ED discharge, 1 year post-ED discharge

    For all patients with incidentally discovered hepatic steatosis, the investigators will evaluate for new steatotic liver disease related ICD codes.

  2. Effectiveness: Non-invasive testing (NIT) completion

    Time frame: 1 year post-ED discharge

    completion of a fibroscan, liver ultrasound, liver elastography, MRI abdomen, MR Elastography or Enhanced Liver Fibrosis(ELF) that indicate ongoing diagnostic process

  3. Effectiveness: new liver lab test completion

    Time frame: 1 year post-ED discharge

    Completion of three key liver disease related lab tests (Liver Function tests, Hepatitis serologies [Hepatitis C Antibody, Hepatitis B surface antigen, Hepatitis B Core antibody, Hepatitis B surface antibody] and INR level) that indicate ongoing diagnostic process;

  4. Effectiveness: new medication initiation

    Time frame: 1 year post-ED discharge

    Receipt of a new prescription for a medication known to impact steatotic liver disease outcomes (e.g., pioglitazone, vitamin E, GLP1 agonist, SGLT2 inhibitor) as an indicator of engagement in lifestyle changes and weight loss interventions.

  5. Effectiveness: new referrals

    Time frame: 1 year post-ED discharge

    Receipt of referral to lifestyle medicine (nutrition) or bariatric surgery as an indicator of engagement in lifestyle changes and weight loss interventions.

  6. Effectiveness: weight change

    Time frame: 1 year post-ED discharge

    Weight values for patients will be evaluated when available to assess for weight loss over time as an indicator of engagement in lifestyle changes and weight loss interventions.

  7. Implementation: Acceptability of Intervention Measure (AIM)

    Time frame: 2 months after STIRRED implementation; 4 months after final site STIRRED implementation

    Acceptability is the perception that STIRRED is satisfactory or agreeable to ED clinicians

  8. Implementation: Intervention Appropriateness Measure (IAM)

    Time frame: 2 months after STIRRED implementation; 4 months after final site STIRRED implementation

    Appropriateness is the perceived fit or compatibility of STIRRED for the ED and ED patients

  9. Implementation: Feasibility of Intervention Measure (FIM)

    Time frame: 2 months after STIRRED implementation; 4 months after final site STIRRED implementation

    feasibility is the extent to which STIRRED can be used within the course of an ED clinical encounter

  10. Implementation: Clinical Sustainability

    Time frame: 2 months after STIRRED implementation; 4 months after final site STIRRED implementation

    The Clinical Sustainability Assessment Tool (CSAT) will be used to understand factors that contribute to sustainability of the STIRRED model in practice over time from the perspective of the ED clinicians.

  11. Implementation: Cognitive Load of Intervention

    Time frame: 2 months after STIRRED implementation; 4 months after final site STIRRED implementation

    NASA task load index (TLX) will assess cognitive load of STIRRED for the ED clinicians. The NASA TLX is a 6-item instrument that has been used to measure the workload of a system.

Sponsors and collaborators

Lead sponsor

Northwestern University

Other

Collaborators

  • Agency for Healthcare Research and Quality (AHRQ)
  • University of Texas, Southwestern Medical Center at Dallas

Registry information

Official study title

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

Acronym: STIRRED

Important dates

Study start
2025
Primary completion
2027
Study completion
2028
First posted
Apr 25, 2025
Registry last updated
May 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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