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

Northwestern University

Status: Begins enrollment in 3 months

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

Treatments: Behavioral: STIRRED

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT06944353

R01HS029777 (U.S. AHRQ Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 4,704 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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4,704 participants in 2 patient groups

Usual Care

No Intervention group

Description:

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

STIRRED

Experimental group

Description:

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.

Treatment:

Behavioral: STIRRED