Clinical trial NCT06944353: Improving Diagnostic Safety Through STeatosis Identification, Risk Stratification, and Referral in the ED
Official title: Improving Diagnostic Safety Through STeatosis Identification, Risk Stratification, and Referral in the ED (STIRRED)
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Non-Alcoholic Fatty Liver Disease
Steatosis of Liver
Keywords: Metabolic Associated Steatotic Liver Disease
Incidental Radiology finding
Emergency Medicine
Lead sponsor: Northwestern University
Sponsor class: OTHER
Collaborators: name: Agency for Healthcare Research and Quality (AHRQ)
name: University of Texas, Southwestern Medical Center at Dallas
First posted: 2025-04-25
Enrollment: 4704
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: 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

Primary outcomes:
measure: Effectiveness: New steatotic liver disease-related diagnosis among high-risk patients
timeFrame: 120 days post-ED discharge
measure: Implementation: Intervention fidelity
timeFrame: Baseline at time of intervention delivery
Secondary outcomes:
Other outcomes:
measure: Effectiveness: New steatotic liver disease-related diagnosis among all patients
timeFrame: 120 days post-ED discharge, 1 year post-ED discharge
measure: Effectiveness: Non-invasive testing (NIT) completion
timeFrame: 1 year post-ED discharge
measure: Effectiveness: new liver lab test completion
timeFrame: 1 year post-ED discharge
measure: Effectiveness: new medication initiation
timeFrame: 1 year post-ED discharge
measure: Effectiveness: new referrals
timeFrame: 1 year post-ED discharge
measure: Effectiveness: weight change
timeFrame: 1 year post-ED discharge
measure: Implementation: Acceptability of Intervention Measure (AIM)
timeFrame: 2 months after STIRRED implementation; 4 months after final site STIRRED implementation
measure: Implementation: Intervention Appropriateness Measure (IAM)
timeFrame: 2 months after STIRRED implementation; 4 months after final site STIRRED implementation
measure: Implementation: Feasibility of Intervention Measure (FIM)
timeFrame: 2 months after STIRRED implementation; 4 months after final site STIRRED implementation
measure: Implementation: Clinical Sustainability
timeFrame: 2 months after STIRRED implementation; 4 months after final site STIRRED implementation
measure: Implementation: Cognitive Load of Intervention
timeFrame: 2 months after STIRRED implementation; 4 months after final site STIRRED implementation
Locations:
city: Chicago
country: United States
facility: Northwestern Memorial Hospital
state: Illinois
Study officials:
affiliation: Northwestern University
name: Amy V Kontrick, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Northwestern University
name: Danielle M McCarthy, MD
role: PRINCIPAL_INVESTIGATOR
References: