Non-Alcoholic Fatty Liver DiseaseSTIRREDNCT06944353
Improving Diagnostic Safety Through STeatosis Identification, Risk Stratification, and Referral in the ED
A study testing STIRRED in people with Non-Alcoholic Fatty Liver Disease and Steatosis of Liver, run by Northwestern University at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-Alcoholic Fatty Liver Disease, Steatosis of Liver, Metabolic Dysfunction-Associated Steatotic Liver Disease
- What is being tested?
- STIRRED
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4,704 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Dec 2025to Jul 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Northwestern Memorial Hospital
Chicago, Illinois, 60611
About this study
Official title: Improving Diagnostic Safety Through STeatosis Identification, Risk Stratification, and Referral in the ED (STIRRED)
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.
Read the 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.
- Conditions
- Non-Alcoholic Fatty Liver Disease, Steatosis of Liver, Metabolic Dysfunction-Associated Steatotic Liver Disease
- Being tested
- STIRRED
- Keywords
- Metabolic Associated Steatotic Liver Disease, Incidental Radiology finding, Emergency Medicine
- Medical subject headings
- Non-alcoholic Fatty Liver Disease, Fatty Liver
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
STIRREDBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Usual Care | No intervention | Includes any patient notification about steatosis, education and referrals as per the treating clinician's usual and customary practice. |
| STIRRED | Experimental | 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. Receives: Behavioral: STIRRED |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effectiveness: New steatotic liver disease-related diagnosis among high-risk patients
For patients at high risk for liver fibrosis, The investigators will evaluate for new steatotic liver disease related ICD codes.
Measured: 120 days post-ED discharge
Implementation: Intervention fidelity
Fidelity is the degree to which the STIRRED CDSS was delivered as intended.
Fidelity will be evaluated across four components:
- hepatic steatosis added to the ED discharge diagnoses;
- hepatic steatosis patient education provided;
- ED adoption of confirming that the clinicians have informed the patient of the new finding; and
- 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.
Measured: Baseline at time of intervention delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2025
- Study start4 Dec 2025
- Primary completionJan 2027 (estimated)
- Study completionJul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Non-Alcoholic Fatty Liver DiseaseStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 4,704 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Collaborators
- Agency for Healthcare Research and Quality (AHRQ), University of Texas, Southwestern Medical Center at Dallas
- Responsible party
- Principal investigator, Amy Kontrick, Northwestern University
- Investigators
- Amy V Kontrick, MD, Principal investigator, Northwestern UniversityDanielle M McCarthy, MD, Principal investigator, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06944353
- Sponsor's protocol ID
- R01HS029777
- Other IDs
- R01HS029777
- Acronym
- STIRRED
- Status last verified
- May 2026
- First submitted
- 16 Apr 2025
- Last updated
- 29 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified IPD used in the analysis of the hybrid implementation effectiveness trial will be shared. All published data will be formatted according to the principals of Common Data Elements (CDE) as defined by the NIH. Clinical and survey response data will contain raw item responses as well as any aggregate scores for participants. To facilitate future use and interoperability of our data, we will employ standard processing and documentation protocols adopted by the Inter-university Consortium for Political and Social Research (ICPSR) for data formats and dictionaries as well as for variable names, descriptions, and labels. Data will be made available through a data repository (still to be determined) following the completion of the grant period and final publication of the trial manuscript.
Publications
McCarthy DM, VanWagner LB, Rafferty MR, Cameron KA, Lee J, Dong S, Fellner A, Kontrick AV. Improving diagnostic safety through STeatosis Identification, Risk stratification, and Referral pathway in the ED (STIRRED): Protocol for an effectiveness implementation trial. Contemp Clin Trials. 2026 Feb;161:108187. doi: 10.1016/j.cct.2025.108187. Epub 2025 Dec 15.
PubMed 41407098
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Diagnostic Safety Through STeatosis Identification, Risk Stratification, and Referral in the ED (STIRRED)
- ClinicalTrials.gov ID
- NCT06944353
- Acronym / sponsor ID
- STIRRED / R01HS029777
- Conditions
- Non-Alcoholic Fatty Liver Disease, Steatosis of Liver, Metabolic Dysfunction-Associated Steatotic Liver Disease
- Keywords
- Metabolic Associated Steatotic Liver Disease, Incidental Radiology finding, Emergency Medicine
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 4,704 participants (estimated)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Collaborators
- Agency for Healthcare Research and Quality (AHRQ), University of Texas, Southwestern Medical Center at Dallas
- Study start
- 4 Dec 2025 (actual)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Jul 2028 (estimated)
- First posted
- 25 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Usual Care | No intervention | –Includes any patient notification about steatosis, education and referrals as per the treating clinician's usual and customary practice. |
| STIRRED | Experimental | Behavioral: STIRREDPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| STIRREDThe 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. | Behavioural | STIRRED |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2026.
- Derived from this study: PubMed 41407098McCarthy DM, VanWagner LB, Rafferty MR, Cameron KA, Lee J, Dong S, Fellner A, Kontrick AV. Improving diagnostic safety through STeatosis Identification, Risk stratification, and Referral pathway in the ED (STIRRED): Protocol for an effectiveness implementation trial. Contemp Clin Trials. 2026 Feb;161:108187. doi: 10.1016/j.cct.2025.108187. Epub 2025 Dec 15.
- Individual participant dataSharing planned: Yes. De-identified IPD used in the analysis of the hybrid implementation effectiveness trial will be shared. All published data will be formatted according to the principals of Common Data Elements (CDE) as defined by the NIH. Clinical and survey response data will contain raw item responses as well as any aggregate scores for participants. To facilitate future use and interoperability of our data, we will employ standard processing and documentation protocols adopted by the Inter-university Consortium for Political and Social Research (ICPSR) for data formats and dictionaries as well as for variable names, descriptions, and labels. Data will be made available through a data repository (still to be determined) following the completion of the grant period and final publication of the trial manuscript.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Amy V Kontrick, MD principal investigator
Northwestern University
Danielle M McCarthy, MD principal investigator
Northwestern University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing STIRRED in people with Non-Alcoholic Fatty Liver Disease and Steatosis of Liver, run by Northwestern University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 29 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effectiveness: New steatotic liver disease-related diagnosis among high-risk patients (time frame: 120 days post-ED discharge). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06944353, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 May 2026.