Finding advanced liver fibrosis in MASLD patients during primary care visits
Official title: Metabolic Dysfunction-associated Steatotic Liver Disease (MASLD) in Primary Care
Run by Medical University of South Carolina · NCT07159386 · Data updated 2026-11-12
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
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 225 (estimated) |
| Sponsor | Medical University of South Carolina Academic / other |
| Locations | 1 site (Charleston, South Carolina) |
| Status | Recruiting |
| Started | March 16, 2026 |
| Main results expected | September 2030 |
| Study ends | September 2030 |
| Registry record updated | March 31, 2026 |
| Trial ID | NCT07159386 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
Show full inclusion / exclusion 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 it's running
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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
- Email: schrein@musc.edu
- Phone: (843) 876-0888
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.