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

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

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Non-Alcoholic Fatty Liver Disease; Steatosis of Liver; Metabolic Dysfunction-Associated Steatotic Liver Disease
• Intervention / Treatment: Behavioral: STIRRED

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 4704
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Northwestern Memorial Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Behavioral: STIRRED; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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: 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.	Baseline at time of intervention delivery

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Effectiveness: New steatotic liver disease-related diagnosis among all patients	For all patients with incidentally discovered hepatic steatosis, the investigators will evaluate for new steatotic liver disease related ICD codes.	120 days post-ED discharge, 1 year post-ED discharge
Effectiveness: Non-invasive testing (NIT) completion	completion of a fibroscan, liver ultrasound, liver elastography, MRI abdomen, MR Elastography or Enhanced Liver Fibrosis(ELF) that indicate ongoing diagnostic process	1 year post-ED discharge
Effectiveness: new liver lab test completion	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;	1 year post-ED discharge
Effectiveness: new medication initiation	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.	1 year post-ED discharge
Effectiveness: new referrals	Receipt of referral to lifestyle medicine (nutrition) or bariatric surgery as an indicator of engagement in lifestyle changes and weight loss interventions.	1 year post-ED discharge
Effectiveness: weight change	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.	1 year post-ED discharge
Implementation: Acceptability of Intervention Measure (AIM)	Acceptability is the perception that STIRRED is satisfactory or agreeable to ED clinicians	2 months after STIRRED implementation; 4 months after final site STIRRED implementation
Implementation: Intervention Appropriateness Measure (IAM)	Appropriateness is the perceived fit or compatibility of STIRRED for the ED and ED patients	2 months after STIRRED implementation; 4 months after final site STIRRED implementation
Implementation: Feasibility of Intervention Measure (FIM)	feasibility is the extent to which STIRRED can be used within the course of an ED clinical encounter	2 months after STIRRED implementation; 4 months after final site STIRRED implementation
Implementation: Clinical Sustainability	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.	2 months after STIRRED implementation; 4 months after final site STIRRED implementation
Implementation: Cognitive Load of Intervention	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.	2 months after STIRRED implementation; 4 months after final site STIRRED implementation

Collaborators and Investigators

• Sponsor: Northwestern University
• Collaborators: Agency for Healthcare Research and Quality (AHRQ); University of Texas, Southwestern Medical Center at Dallas
• Investigators: Principal Investigator: Amy V Kontrick, MD, Northwestern University; Principal Investigator: Danielle M McCarthy, MD, Northwestern University

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): December 4, 2025
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): July 1, 2028

Study Registration Dates

• First Submitted: April 16, 2025
• First Submitted That Met QC Criteria: April 23, 2025
• First Posted (Actual): April 25, 2025

Study Record Updates

• Last Update Posted (Actual): May 29, 2026
• Last Update Submitted That Met QC Criteria: May 26, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Emergency Medicine; Metabolic Associated Steatotic Liver Disease; Incidental Radiology finding
• Additional Relevant MeSH Terms: Digestive System Diseases; Liver Diseases; Fatty Liver; Non-alcoholic Fatty Liver Disease
• Other Study ID Numbers: R01HS029777 (U.S. AHRQ Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

De-identified IPD used in the analysis of the hybrid implementation effectiveness trial will be shared. All published data will be formatted according to the principals of Common Data Elements (CDE) as defined by the NIH. Clinical and survey response data will contain raw item responses as well as any aggregate scores for participants. To facilitate future use and interoperability of our data, we will employ standard processing and documentation protocols adopted by the Inter-university Consortium for Political and Social Research (ICPSR) for data formats and dictionaries as well as for variable names, descriptions, and labels.

Data will be made available through a data repository (still to be determined) following the completion of the grant period and final publication of the trial manuscript.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No