Improving Liver Fibrosis Diagnosis in Primary Care Using FibroX AI

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorYale University

About this trial

The goal of this clinical trial is to learn whether an artificial intelligence (AI) tool called FibroX can help primary care providers better diagnose significant liver fibrosis (≥F2) and clinically significant portal hypertension in adults with metabolic dysfunction-associated steatotic liver disease (MASLD).

The main questions it aims to answer are:

* Can FibroX improve the accuracy of diagnosing significant liver fibrosis (≥F2) and clinically significant portal hypertension compared to usual care? * Is FibroX easy to use and acceptable to primary care providers in simulated clinical settings? * Do providers trust FibroX as a decision-support tool?

Researchers will compare FibroX-assisted care to usual care to see if FibroX improves diagnostic accuracy, provider trust, and supports better decision-making.

Participants will:

* Be primary care providers (MDs, DOs, NPs, PAs) from diverse clinics * Review simulated patient cases with MASLD risk factors * Use either usual care tools (standard labs and optional FIB-4 calculator) or FibroX (AI-generated risk score, triage band, and explainability panel) * Make diagnostic and referral decisions for each case * Complete surveys on usability, trust in AI, confidence, and cognitive workload

This study will help determine whether FibroX can be integrated into real-world primary care workflows to support earlier and more accurate detection of liver fibrosis and portal hypertension, potentially reducing missed diagnoses, unnecessary referrals, and improving patient outcomes.

Eligibility criteria

Qualifiers

Licensed primary care providers (MD, DO, NP, or PA)

Currently practicing in adult primary care (≥0.5 Full-Time Equivalent)

Affiliated with one of the participating clinics (academic, community, or Federally Qualified Health Center)

Willing and able to participate in simulated electronic health record (EHR)-based case reviews

Disqualifiers

Providers not actively practicing in adult primary care

Providers with less than 0.5 FTE in clinical practice

Prior involvement in the development or validation of the FibroX tool

Inability to complete both simulation periods due to scheduling or other constraints

Trial design

Treatments tested in this trial

  • FibroX
  • Usual Care

Treatment groups

40 Participants
are divided into 2 treatment groups

Locations

This trial has no locations

Sponsors and collaborators

Yale University

Lead sponsor