Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID07159386

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

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Implementation of EHR Alert Intervention

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

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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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