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

NCT06944353 | Not Yet Recruiting

• 1 other identifier: R01HS029777
• Study Type: interventional
• Target: 4,704
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

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

Keywords

Metabolic Associated Steatotic Liver Disease; Incidental Radiology finding; Emergency Medicine

Outcome Measures

Primary Outcomes (2)

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

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

  120 days post-ED discharge

• Implementation: Intervention fidelity

  Fidelity is the degree to which the STIRRED CDSS was delivered as intended. Fidelity will be evaluated across four components: 1. hepatic steatosis added to the ED discharge diagnoses; 2. hepatic steatosis patient education provided; 3. ED adoption of confirming that the clinicians have informed the patient of the new finding; and 4. 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.

  Baseline at time of intervention delivery

Other Outcomes (11)

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

  120 days post-ED discharge, 1 year post-ED discharge

• Effectiveness: Non-invasive testing (NIT) completion

  1 year post-ED discharge

• Effectiveness: new liver lab test completion

  1 year post-ED discharge

Study Arms (2)

Usual Care

NO INTERVENTION

Includes any patient notification about steatosis, education and referrals as per the treating clinician's usual and customary practice.

STIRRED

EXPERIMENTAL

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.

Behavioral: STIRRED

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.

STIRRED

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

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

Study Sites (1)

Northwestern Memorial Hospital

Chicago, Illinois, 60611, United States

Location

Related Publications (1)

• McCarthy DM, VanWagner LB, Rafferty MR, Cameron KA, Lee J, Dong S, Fellner A, Kontrick AV. Improving diagnostic safety through STeatosis Identification, Risk stratification, and Referral pathway in the ED (STIRRED): Protocol for an effectiveness implementation trial. Contemp Clin Trials. 2026 Feb;161:108187. doi: 10.1016/j.cct.2025.108187. Epub 2025 Dec 15.

  PMID: 41407098 DERIVED

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease; Fatty Liver

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases

Study Officials

• Amy V Kontrick, MD

  Northwestern University

  PRINCIPAL INVESTIGATOR

• Danielle M McCarthy, MD

  Northwestern University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Amy V Kontrick, MD

CONTACT

312-694-7000; a-kontrick@northwestern.edu

Danielle M McCarthy, MD

CONTACT

312-926-7532; d-mccarthy2@northwestern.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: April 16, 2025
• First Posted: April 25, 2025
• Study Start: December 1, 2025
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): July 1, 2028
• Last Updated: December 10, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share

Locations

US (1)