Actively Recruiting
Metabolic Dysfunction-associated Steatotic Liver Disease (MASLD) Fibrosis Risk Assessment Using an Electronic Health Record Alert in Primary Care
Led by Medical University of South Carolina · Updated on 2026-03-31
225
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
M
Medical University of South Carolina
Lead Sponsor
N
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating a new electronic health record (EHR) alert designed to help primary care providers assess the risk of advanced fibrosis in patients with metabolic dysfunction-associated steatotic liver disease (MASLD). This chronic liver condition affects about one in three people in the U.S. and is linked to diabetes and obesity. The study uses a stepped wedge, cluster randomized design to test how well this alert works in improving MASLD management in primary care settings. The study introduces a non-interruptive EHR alert that appears when MASLD is diagnosed or suspected in a patient's record. This alert prompts clinicians to use an integrated tool to calculate the Fibrosis-4 Index (FIB-4), a low-cost test indicating fibrosis risk. If the risk is high, the alert recommends ordering a liver stiffness measurement (LSM) via ultrasound elastography to confirm fibrosis status. Clinics start in a control phase and transition to using the alert in five steps at six-month intervals, with a one-month transition period to provide education and system access. Participants include patients with MASLD and primary care clinicians. The study tracks the detection of advanced fibrosis up to five years after alert implementation. Researchers will also measure how often eligible patients receive liver stiffness tests, how many clinicians order these tests, patient completion rates of testing, and whether clinics continue using the alert over time. This ongoing monitoring aims to understand the alert's adoption, accuracy, and sustainability in real-world care.
CONDITIONS
Brief Title
Advanced Fibrosis Detection for MASLD in Primary Care
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with a diagnosis code for metabolic dysfunction-associated steatotic liver disease (MASLD)
- Type 2 diabetes mellitus diagnosis
- Primary care physicians, physician assistants, and nurse practitioners delivering care during the intervention phase
You will not qualify if you...
- Patients with cirrhosis or complications such as portal hypertension or hepatic encephalopathy
- Patients with hepatocellular carcinoma
- Patients with previous liver transplant
- Pregnant women
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Up to 5 years after intervention implementation
Participants receive care in primary care clinics where a non-interruptive electronic health record (EHR) alert prompts clinicians to assess MASLD fibrosis risk using an integrated tool. This includes calculation of the FIB-4 index and recommendations for liver stiffness measurement (LSM) if indicated, along with guidance for disease management and specialist referral for advanced fibrosis.
Care is delivered through routine primary care visits, with assessments prompted by EHR alerts as appropriate.
Trial Site Locations
Total: 1 location
1
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
Actively Recruiting
Research Team
A
Andrew Schreiner, MD, MSCR
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
HEALTH_SERVICES_RESEARCH
Number of Arms
5
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