Improving Diagnostic Safety Through STeatosis Identification, Risk Stratification, and Referral in the ED (STIRRED)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Enrolling By Invitation
- Sponsor
- Northwestern University
- Enrollment
- 4,704
- Locations
- 2
- Primary Endpoint
- Effectiveness: New steatotic liver disease-related diagnosis among high-risk patients
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Health Services Research
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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)
Arms & Interventions
Usual Care
Includes any patient notification about steatosis, education and referrals as per the treating clinician's usual and customary practice.
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.
Intervention: STIRRED (Behavioral)
Outcomes
Primary Outcomes
Effectiveness: New steatotic liver disease-related diagnosis among high-risk patients
Time Frame: 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
Time Frame: 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.
Effectiveness: New steatotic liver disease-related diagnosis among high-risk patients
Time Frame: 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
Time Frame: 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.
Secondary Outcomes
No secondary outcomes reported
Investigators
Amy Kontrick
Associate Professor
Northwestern University