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Advanced Fibrosis Detection for MASLD in Primary Care

This study is looking at a new way to help doctors in primary care find advanced fibrosis (scarring) in patients with Metabolic Dysfunction-associated Steatotic Liver Disease (MASLD), also known as fatty liver disease. It tests an electronic health record (EHR) alert that reminds doctors to use a tool called FIB-4 to assess fibrosis risk. The study aims to see if this alert helps doctors detect advanced fibrosis earlier. You could join if you are an adult with a MASLD diagnosis and Type 2 diabetes. The study will measure how well advanced fibrosis is detected over up to five years. The current status of this study is unclear.

Study design
This is an interventional study planning to enroll 225 participants. It uses a stepped-wedge, cluster randomized design to evaluate the EHR alert.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The primary goal is to detect advanced fibrosis up to five years after the intervention is put in place.

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NCT07159386

Advanced Fibrosis Detection for MASLD in Primary Care

Recruiting
NAAges 18+InterventionalHealth services
Medical University of South Carolina
~225 participants
Updated 2026-03-31 on ClinicalTrials.gov
What's tested:EHR alert

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Detection of advanced fibrosis
Measured over Up to five years after implementation of the intervention.

Conditions

Metabolic Dysfunction-associated Steatotic Liver Disease

Explore related trials

Nonalcoholic Fatty Liver DiseaseObesityType 2 Diabetes Mellitus

Where it's being run

1 sites across 1 states
South Carolina1

Study leadership

  • Andrew Schreiner, MD, MSCR · PRINCIPAL_INVESTIGATOR · Medical University of South Carolina

Who to contact

Andrew Schreiner, MD, MSCR
[email protected]
(843) 876-0888
Email the study team

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Eligibility criteria

Inclusion

Patients with a diagnosis code for MASLD
Type 2 diabetes mellitus will

Exclusion

All patients with cirrhosis, complications of cirrhosis (e.g. portal hypertension, hepatic encephalopathy), hepatocellular carcinoma, or previous liver transplant will be excluded.
pregnant women.

What this trial measures

  • Detection of advanced fibrosisUp to five years after implementation of the intervention.

    The primary clinical outcome of interest is the detection of advanced fibrosis. This outcome will be determined by reviewing US with elastography results from the medical record. Advanced fibrosis will be categorized by LSM \>8 kPa (no advanced fibrosis is LSM \<8 kPa)