Finding advanced liver fibrosis in MASLD patients during primary care visits

Metabolic Dysfunction-associated Steatotic Liver Disease (MASLD) in Primary Care

This project will test an electronic health record alert that helps primary care teams identify MASLD patients at higher risk of advanced liver fibrosis so they can be referred for confirmatory testing.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 225 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Medical University of South Carolina (Academic / other)
• Locations: 1 site (Charleston, South Carolina)
• Trial ID: NCT07159386 on ClinicalTrials.gov

What this trial studies

This stepped-wedge, cluster-randomized intervention implements a non-interruptive EHR alert to prompt FIB-4 calculation and, when indicated, referral for liver stiffness measurement (VCTE) among MASLD patients in primary care. Primary care practices in the MUSC network will sequentially activate the alert, allowing comparison of detection rates, referrals, and clinical actions across periods. Clinicians will be surveyed for usability and workflow impact, and patient-level outcomes will be measured to assess changes in advanced fibrosis detection. The goal is to generate generalizable evidence on integrating non-invasive fibrosis screening into routine primary care.

Who should consider this trial

Good fit: Adults with a diagnosis code for MASLD seen in participating MUSC primary care clinics—especially those with type 2 diabetes—who do not have cirrhosis and are not pregnant.

Not a fit: Patients with established cirrhosis, cirrhosis complications, hepatocellular carcinoma, prior liver transplant, pregnant women, or those not seen in the participating clinics would be unlikely to benefit.

Why it matters

Potential benefit: If successful, more patients with advanced fibrosis would be identified earlier in primary care and referred for timely management, potentially reducing liver-related complications.

How similar studies have performed: Guidelines support sequential FIB-4 followed by VCTE and EHR alerts have improved screening in other conditions, but implementing this specific MASLD EHR alert in primary care is relatively novel.

Eligibility criteria

Patients

Inclusion Criteria:

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

Exclusion Criteria:

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

Clinicians Clinicians will also be study participants, as we will be surveying them for feedback on the MASLD fibrosis risk assessment intervention. The MUSC primary care network at last count employed 122 clinicians across the 27 primary care practices.

Inclusion criteria:

1\. All physicians, physician assistants, and nurse practitioners delivering primary care during the intervention phase of the study.

Exclusion criteria:

None

Where this trial is running

Charleston, South Carolina

• Medical University of South Carolina — Charleston, South Carolina, United States (Recruiting)

Study contacts

• Principal investigator: Andrew Schreiner, MD, MSCR — Medical University of South Carolina
• Study coordinator: Andrew Schreiner, MD, MSCR

Conditions Metabolic Dysfunction-associated Steatotic Liver Disease; Diabetes; Liver; Obesity