NCT07159386RecruitingNot Applicable

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

Medical University of South Carolina1 site in 1 country225 target enrollmentStarted: March 16, 2026Last updated: March 31, 2026

Conditions

Interventions

Trial Snapshot

Phase: Not Applicable
Status: Recruiting
Sponsor: Medical University of South Carolina
Enrollment: 225
Locations: 1
Primary Endpoint: Detection of advanced fibrosis

Study Overview Study Design Eligibility Criteria Arms & Interventions Outcomes Investigators Sites Records & Identifiers Similar Trials

Study Overview

Brief 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.

Detailed Description

Metabolic dysfunction-associated steatotic liver disease (MASLD, formerly nonalcoholic fatty liver disease [NAFLD]) affects an estimated 1in 3 persons in the U.S., a prevalence expected to increase over the next decade. MASLD's rising prevalence and its association with diabetes and obesity make it a chronic disease well-suited for initial management by primary care providers (PCPs). PCPs can impact MASLD care by first detecting advanced fibrosis, which is the best predictor of cirrhosis, hepatocellular carcinoma, and liver-related mortality in affected patients. Recently issued guidelines from the American Association for the Study of Liver Diseases recommend the sequential use of non-invasive liver tests, the Fibrosis-4 Index (FIB-4) followed by confirmatory liver stiffness measurement (LSM) with vibration-controlled elastography (VCTE), to detect advanced fibrosis in patients with MASLD. FIB-4 is attractive in primary care due to the low-cost and broad availability of its inputs, but PCPs have little experience with FIB-4 calculation, limited comfort with its interpretation, and infrequent access to confirmatory liver stiffness testing. The guidelines provide a clinical threshold for hepatology engagement, recommending referral for patients with advanced fibrosis, while those with low-risk MASLD remain in primary care. Incorporating advanced fibrosis detection into the already overwhelming workload of PCPs requires thoughtful application of electronic health record (EHR)technologies to avoid contributing to PCP alert fatigue and burnout. In this work, investigators aim to evaluate the adoption, penetration, fidelity, sustainability, and performance of a novel, non-interruptive EHR alert for MASLD fibrosis risk assessment in a primary care network by performing a stepped wedge, cluster randomized trial in patients with known or suspected MASLD (Aim 1). This proposal aligns with NIDDK's scientific goal to disseminate, implement, and evaluate evidence-based care strategies in community care settings where the burden of MASLD hides in plain sight.

Study Design

Study Type: Interventional
Allocation: Randomized
Intervention Model: Single Group
Primary Purpose: Health Services Research
Masking: Single (Outcomes Assessor)

Eligibility Criteria

Ages: 18 Years to — (Adult, Older Adult)
Sex: All
Accepts Healthy Volunteers: No

Inclusion Criteria

•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:

Arms & Interventions

Month 12

Experimental

All clinics will begin the study in the control phase. The intervention will be introduced in 5 steps with 5-6 clinics per step at intervals of 6 months. The transition phase from the control period to the intervention period will last 1 month and provide time for rolling out educational content and access to the MASLD fibrosis risk assessment EHR alert. A computer-generated randomization program will assign clinics to one of the 5 pre-defined transition steps (months 6, 12, 18, 24, and 30).