Recruiting

NAFLD

Sponsor:

VA Office of Research and Development

Code:

NCT06671886

Conditions

NAFLD

MASLD

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

E-trigger

Study Details

Brief 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

Study ID

NCT06671886

Start date

Feb 2, 2024

Status verified date

Nov, 2025

Completion date

Nov 13, 2028

Anticipated

Primary completion date

Jan 31, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Inclusion Criteria:

Patient Aligned Care Teams (PACT) at the Michael E. DeBakey VA Medical Center

Exclusion Criteria:

  • The investigators will exclude PACTs with unstable leadership (i.e., pending departure, vacancy) at time of randomization.
  • PACTs participating in the focus groups in Aim 1 will be excluded in Aim 2 to avoid cross contamination.
  • PACTs meeting the following criteria will be excluded from randomization in Aim 2:

  • PACTs who do not treat NAFLD,
  • PACTs not located at the main hospital,
  • PACTs with less than 100 visits within 3 months.

Study Design

Enrollment

32 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Health Services Research

Interventions and Outcome Measures

Arms

experimental: E-trigger

The NCCP Intervention is made up of multiple components. The investigators will start by applying the e-trigger and assessing the FIB-4 score, and then will train and educate PACT personnel on managing patients with positive triggers, including making treatment recommendations in collaboration with an inter-professional team. The e-trigger will be generated every three months.

no intervention: Usual care

The control group will receive no additional training or education. PACTs will provide usual care.

Interventions

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.

Primary outcome measure

  • NAFLD Diagnosis and risk stratification [ Time Frame: Baseline, 6 months ]

Central Contacts and Locations

Central contacts

Hashem B El-Serag, MD MPH

(713) 794-8640Hashem.El-Serag@va.gov

Kyler Godwin, PhD MPH BS

(713) 440-4672kyler.godwin@va.gov

Locations

Michael E. DeBakey VA Medical Center, Houston, TX

Recruiting

Houston, Texas, United States, 77030-4211

Contacts

Hashem B El-Serag, MD MPH

713-794-8640Hashem.El-Serag@va.gov

Kyler Godwin, PhD MPH BS

(713) 440-4672kyler.godwin@va.gov

Principal Investigator:

Hashem B. El-Serag, MD MPH

More Information

Sponsor

VA Office of Research and Development

Last update posted

Nov 14, 2025

Last verified

Nov, 2025

Keywords

  • NAFLD
  • Veterans
  • Primary health care
  • MASLD

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by VA Office of Research and Development on 2025-11-14.