STIRRED System for Fatty Liver

(STIRRED Trial)

Overseen By Danielle M McCarthy, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Northwestern University

Disqualifiers: Liver disease, Multiple findings, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new system called STIRRED to help manage fatty liver (hepatic steatosis) identified during emergency room visits. The goal is to inform patients about their condition and ensure they receive proper follow-up care, potentially improving health outcomes. Participants will receive either the usual care or the enhanced STIRRED treatment, which includes notifications and recommendations for follow-up tests. The trial seeks individuals discharged from a Northwestern Medicine emergency department after a first visit revealed fatty liver. As an unphased trial, it offers participants the chance to contribute to innovative research that could enhance future care for fatty liver patients.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that the STIRRED system is safe for use in patients with hepatic steatosis?

Research has shown that the STIRRED system offers a new method for doctors to better identify and manage fatty liver disease. It involves no drugs or physical treatments. Instead, it is a computer program that aids doctors in providing improved advice and follow-up care.

Since STIRRED supports doctors' decisions rather than acting as a drug or procedure, it poses no direct safety risk to patients. The primary goal is to enhance how doctors inform and guide patients regarding their liver health, meaning participants should not expect any side effects from using the system.

In summary, STIRRED ensures patients receive accurate information and care for fatty liver disease. There is no evidence of safety concerns, as it serves as a tool to guide doctors, not as a medical treatment. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the STIRRED system for fatty liver because it offers a novel approach by using the power of electronic health records (EHR) to enhance patient care. Unlike traditional methods that rely solely on clinician discretion for notifying and educating patients about liver steatosis, the STIRRED system actively prompts clinicians with additional notifications, educational resources, and referrals for further testing. This proactive intervention could lead to more timely and effective management of fatty liver, potentially improving patient outcomes by catching issues early and ensuring comprehensive follow-up care.

What evidence suggests that the STIRRED system is effective for improving outcomes in patients with hepatic steatosis?

Research has shown that the STIRRED system, which participants in this trial may experience, is designed to improve the detection and reporting of fatty liver disease using advanced technology like machine learning and natural language processing. These tools quickly identify fatty liver from medical records. Early results suggest that the system can diagnose liver disease in more patients within 120 days. This enables high-risk patients to receive faster follow-up care, potentially improving their health. The goal of this approach is to make diagnosing safer and enhance patient care in emergency situations. ^{1 2 3 4 5}

Who Is on the Research Team?

Amy V Kontrick, MD

Principal Investigator

Northwestern University

Danielle M McCarthy, MD

Principal Investigator

Northwestern University

Are You a Good Fit for This Trial?

This trial is for individuals who have been identified with fatty liver conditions such as Non-alcoholic Fatty Liver Disease (NAFLD) during a radiographic exam. The study aims to include those where this finding might typically be overlooked.

Inclusion Criteria

Imaging finding of hepatic steatosis on ED imaging study

I was sent home after my emergency department visit.

My first visit to Northwestern Medicine ED showed fatty liver.

Exclusion Criteria

I am currently admitted to a hospital.

I am under 18 years old.

Multiple incidental findings on ED imaging study

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Implementation

Implementation of the STIRRED CDSS intervention in the ED to identify hepatic steatosis and provide follow-up care recommendations

6 months

Ongoing ED visits

Follow-up

Participants are monitored for new steatotic liver disease-related diagnoses and completion of follow-up care

1 year

Evaluation

Evaluation of the effectiveness and fidelity of the STIRRED intervention

4 months

What Are the Treatments Tested in This Trial?

Interventions

• STIRRED

Trial Overview The STIRRED intervention, which uses machine learning and natural language processing, is being tested. It prompts doctors to report hepatic steatosis findings to patients and provides follow-up care recommendations based on risk levels.

How Is the Trial Designed?

Group I: STIRRED Experimental Treatment 1 Intervention

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.

Group II: Usual Care Active Control 1 Intervention

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

Who Is Running the Clinical Trial?

Northwestern University

Lead Sponsor

Trials

1,674

Recruited

989,000+

University of Texas, Southwestern Medical Center at Dallas

Collaborator

Trials

18

Recruited

21,200+

Agency for Healthcare Research and Quality (AHRQ)

Collaborator

Trials

415

Recruited

6,777,000+

Published Research Related to This Trial

Current treatments for nonalcoholic fatty liver disease (NAFLD) are still not very effective, but weight loss remains a key target for therapy despite being difficult to achieve.

Several investigational drugs show promise for treating NASH, but concerns about long-term safety exist, particularly with vitamin E and other medications like pioglitazone and obeticholic acid, which have notable side effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment options for nonalcoholic steatohepatitis - a safety evaluation. Issa, D., Wattacheril, J., Sanyal, AJ.[2017]

In a review of 15 randomized controlled trials involving both adults and children, metformin showed a significant effect on normalizing alanine transaminase levels compared to vitamin E, indicating its potential efficacy in treating nonalcoholic fatty liver disease (NAFLD).

While some treatments like pioglitazone showed reduced liver necrosis and inflammation, the overall limited data and methodological issues in the studies prevent definitive conclusions about the efficacy of various pharmacological and dietary interventions for NAFLD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pharmacological interventions for nonalcoholic fatty liver disease in adults and in children: a systematic review. Socha, P., Horvath, A., Vajro, P., et al.[2022]

A systematic review of 37 studies involving 1107 patients indicates that fibrates, particularly fenofibrate and bezafibrate, are generally safe and well tolerated for treating primary biliary cholangitis (PBC), with low rates of adverse events.

While fibrates can improve biochemical parameters and reduce pruritus in cholestatic liver diseases, there is limited safety data for their use in primary sclerosing cholangitis (PSC), highlighting a need for further research in this area.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of fibrates in cholestatic liver diseases. Carrion, AF., Lindor, KD., Levy, C.[2021]

In a meta-analysis of 41 randomized controlled trials involving 2,944 participants with non-alcoholic steatohepatitis (NASH), 68% of those on placebo experienced at least one adverse event (AE), highlighting the need for careful safety evaluations in this largely asymptomatic condition.

Serious adverse events were reported in 7.8% of placebo participants, with a notably higher incidence in phase 3 trials and those funded by pharmaceutical companies, indicating that the context of the study may influence safety outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Placebo Adverse Events in Non-alcoholic Steatohepatitis Clinical Trials: A Pooled Analysis of 2,944 Participants. Tay, PWL., Ng, CH., Lin, SY., et al.[2023]

Citations

1. papers.ssrn.com papers.ssrn.com/sol3/papers.cfm?abstract_id=5639915

Improving Diagnostic Safety through STeatosis ... The primary effectiveness outcome will be receipt of a new steatotic liver disease-related diagnosis among high-risk patients within 120 days ...

2. withpower.com withpower.com/trial/phase-non-alcoholic-fatty-liver-disease-8-2025-1f980

STIRRED System for Fatty Liver · Info for Participants Data on both the implementation and effectiveness of our intervention resulting from this trial will inform future use with a goal of ultimately improving ...

3. reporter.nih.gov reporter.nih.gov/project-details/10828499

Project Details To date, we have developed the building blocks for the STIRRED CDSS by employing natural language processing and machine learning to identify hepatic steatosis ...

4. ctv.veeva.com ctv.veeva.com/study/improving-diagnostic-safety-through-steatosis-identification-risk-stratification-and-referral-in-t

Improving Diagnostic Safety Through STeatosis Identification ... The STIRRED CDSS intervention employs natural language processing and machine learning to identify hepatic steatosis in written emergency ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT06944353?term=AREA%5BConditionSearch%5D(%22Fatty%20Liver%22)%20AND%20AREA%5BOverallStatus%5D(NOT_YET_RECRUITING%20OR%20RECRUITING%20OR%20AVAILABLE)&rank=1

Improving Diagnostic Safety Through STeatosis ... A group of independent scientists who monitor the safety and scientific integrity of a clinical trial. The DMC can recommend to the sponsor that the trial be ...