NAFLD Clinical Care Pathway

Part of paid clinical trials in Houston, Texas.

Sponsor
VA Office of Research and Development
Study ID
NCT06671886
Status
Recruiting
Apply to this trial

Conditions

  • MASLD
  • NAFLD

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • E-trigger — BEHAVIORAL
    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.

Study Details

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.

Key Dates

Start date
Feb 2, 2024
Status verified
Nov 2025
Primary completion
Jan 31, 2028
Completion
Nov 13, 2028

Study Design

Enrollment
32 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH

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.

Primary Outcome Measure

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

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Michael E. DeBakey VA Medical Center, Houston, TXHoustonTexas77030-4211
Hashem B El-Serag, MD MPH
[email protected]
713-794-8640
Kyler Godwin, PhD MPH BS
[email protected]
(713) 440-4672
Hashem B. El-Serag, MD MPH (PRINCIPAL_INVESTIGATOR)
Kyler Godwin, PhD MPH BS (SUB_INVESTIGATOR)

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By research site
Michael E. DeBakey VA Medical Center, Houston, TX· Houston, TX

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