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NAFLD Clinical Care Pathway

NCT06671886 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2025-11-14

No results posted yet for this study

Summary

Non-alcoholic fatty liver disease (NAFLD) is a new condition that has become the most common chronic liver disease in the world and a main cause of liver cirrhosis, liver failure and liver cancer. Obesity and diabetes, conditions that are very common among Veterans are the main risk factors for NAFLD. Therefore, the burden of NAFLD and its complications among Veterans is substantial. However, most VA patients with NAFLD are undiagnosed and untreated, and their care is not consistent with practice guidelines. The NAFLD Clinical Care Pathway (NCCP) intervention seeks to close this major gap in the care of Veterans by automatically identifying patients at risk of NAFLD, calculating their risk scores of having severe NAFLD, and educating the primary care providers on the diagnosis and treatment of NAFLD. This clinical trial will test the benefit of this NCCP intervention against usual care in increasing the rates of NAFLD diagnosis as well as referral to and enrollment in appropriate treatment. The study will also identify barriers and promotors of future NCCP implementation.

Conditions

  • NAFLD
  • MASLD

Interventions

BEHAVIORAL

E-trigger

The NCCP Intervention is multicomponent. First, the investigators will apply the e-trigger and calculate FIB-4, and second, will educate and train PACT personnel on how to deal with trigger positive patients as well as make treatment recommendations within an inter-professional team. The e-trigger will be generated every 3 months. The effectiveness of the trigger will be assessed using the outcomes previously mentioned.

Sponsors & Collaborators

  • VA Office of Research and Development

    lead FED

Principal Investigators

  • Hashem B. El-Serag, MD MPH · Michael E. DeBakey VA Medical Center, Houston, TX

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-02-02
Primary Completion
2028-01-31
Completion
2028-11-13

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06671886 on ClinicalTrials.gov