Metabolic Dysfunction-Associated Steatotic Liver Disease, Non-Alcoholic Fatty Liver Disease, Steatosis of Liver
Conditions
Keywords
Metabolic Associated Steatotic Liver Disease, Incidental Radiology finding, Emergency Medicine
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 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.
Interventions
BEHAVIORALSTIRRED
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.
Sponsors
Northwestern University
Agency for Healthcare Research and Quality (AHRQ)
University of Texas, Southwestern Medical Center at Dallas
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORAmy V Kontrick, MD
Northwestern University
PRINCIPAL_INVESTIGATORDanielle M McCarthy, MD
Northwestern University
Outcome results
None listed