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

Not Applicable

Not yet recruiting

• Conditions: Non-Alcoholic Fatty Liver Disease; Steatosis of Liver

• Registration Number: NCT06944353
• Lead Sponsor: Northwestern University

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.

Detailed Description

Metabolic associated steatotic liver disease 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 and co-morbidities in the electronic health record to create an individualized risk profile and follow up recommendations for patients with suspected metabolic associated steatotic liver disease. 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 Timeline

• Status Verified: 2025-04
• Study First Submitted: 2025-04-16
• Study First Submitted QC: 2025-04-23
• Last Update Submitted: 2025-04-23
• Study First Posted: 2025-04-25
• Last Update Posted: 2025-04-25
• Study Start: 2025-09
• Primary Completion: 2027-01
• Study Completion: 2028-07

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 4704

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)
• multiple incidental findings on ED imaging study

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Effectiveness: New steatotic liver disease-related diagnosis among high-risk patients	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.
Implementation: Intervention fidelity	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: 1. hepatic steatosis added to the ED discharge diagnoses; 2. hepatic steatosis patient education provided; 3. ED adoption of confirming that they 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 6 months prior to implementation to 6 months after implementation.

Trial Locations

Locations (1)

Northwestern Memorial Hospital; 🇺🇸 Chicago, Illinois, United States