RecruitingNot ApplicableNCT07159386

Advanced Fibrosis Detection for MASLD in Primary Care

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

Sponsor

Medical University of South Carolina

Enrollment

225 participants

Start Date

Mar 16, 2026

Study Type

INTERVENTIONAL

Conditions

Metabolic Dysfunction-Associated Steatotic Liver Disease

Summary

This proposal evaluates the implementation of a novel, non-interruptive, electronic health record alert for metabolic dysfunction-associated steatotic liver disease (MASLD) fibrosis risk assessment in primary care patients with MASLD using a stepped wedge, cluster randomized design. This work will generate generalizable data to dramatically enhance MASLD management in primary care.

Eligibility

Min Age: 18 Years

Inclusion Criteria4

Patients
Patients with a diagnosis code for MASLD
Type 2 diabetes mellitus will
\. All physicians, physician assistants, and nurse practitioners delivering primary care during the intervention phase of the study.

Exclusion Criteria4

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.
None

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Interventions

OTHEREHR alert

Diagnoses of MASLD (based on ICD 9/10 code) in a patient's EHR history, visit, or problem list, will cue a non-interruptive alert to appear and prompt clinicians to use the integrated EPIC© FIB-4 calculation SmartPhrase. The tool displays the FIB-4 risk score, the advanced fibrosis risk, and the clinical guidance. LSM by ultrasound with elastography will be recommended for patients with FIB-4 \>1.3 (FIB-4 \>2.0 if age \>65) and the decision support will urge clinicians to order US with elastography through the SmartSet. LSM results will be documented in the EHR and categorized as low-risk MASLD (LSM \<8 kPa) or advanced fibrosis (LSM \>8 kPa). Results will be disseminated to the ordering PCPs and the patients. PCPs will receive information on patient counseling for MASLD, and the expanding roles of weight loss, reduced alcohol use, and exercise on disease management. PCPs will be encouraged to refer patients with advanced fibrosis to a hepatology specialist, in accordance with guidelines.