Advanced Fibrosis Detection for MASLD in Primary Care

NANot yet recruitingINTERVENTIONAL
Enrollment

225

Participants

Timeline

Start Date

December 31, 2025

Primary Completion Date

September 30, 2030

Study Completion Date

September 30, 2030

Conditions
Metabolic Dysfunction-associated Steatotic Liver Disease
Interventions
OTHER

EHR 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.

All Listed Sponsors
collaborator

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

NIH

collaborator

National Institutes of Health (NIH)

NIH

lead

Medical University of South Carolina

OTHER

NCT07159386 - Advanced Fibrosis Detection for MASLD in Primary Care | Biotech Hunter | Biotech Hunter