NAFLD Clinical Care Pathway

NCT06671886 | Recruiting

• 2 other identifiers: IIR 22-071HX003655-01A2
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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

Keywords

NAFLD; Veterans; Primary health care; MASLD

Outcome Measures

Primary Outcomes (1)

• NAFLD Diagnosis and risk stratification

  The investigators will use chart reviews to extract unstructured data regarding the primary outcome measure: existence of EHR progress note documenting a new NAFLD diagnosis AND complete risk stratification of NAFLD (i.e., fibrosis). The investigators will use our validated process to guide uniform abstraction and classification.

  Baseline, 6 months

Secondary Outcomes (6)

• Fibroscan Test

  Baseline, 6 & 12 months

• Referral to hepatology

  Baseline, 6 and 12 months

• Hepatology Clinic Visit

  Baseline, 6 and 12 months

• NAFLD discussion

  6 and 12 months

• Referral to weight loss services

  Baseline, 6 and 12 months

Study Arms (2)

E-trigger

EXPERIMENTAL

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.

Behavioral: E-trigger

Usual care

NO INTERVENTION

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

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.

E-trigger

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

Michael E. DeBakey VA Medical Center, Houston, TX

Houston, Texas, 77030-4211, United States

RECRUITING

Related Publications (1)

• Godwin KM, Grigoryan L, Thrift AP, Duong H, Kanwal F, Giardina T, Kadiyala H, Zimolzak A, Patidar KR, El-Serag HB. A cluster randomized trial of a Multicomponent Clinical Care Pathway (MCCP) to improve MASLD diagnosis and management in primary care: study protocol. BMC Health Serv Res. 2025 May 6;25(1):645. doi: 10.1186/s12913-025-12737-2.

  PMID: 40325466 DERIVED

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease

Interventions

trigger factor, E coli

Condition Hierarchy (Ancestors)

Fatty Liver; Liver Diseases; Digestive System Diseases

Study Officials

• Hashem B. El-Serag, MD MPH

  Michael E. DeBakey VA Medical Center, Houston, TX

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hashem B El-Serag, MD MPH

CONTACT

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

Kyler Godwin, PhD MPH BS

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: PACT teams will be randomized to the intervention or control arms of the study. Patients will not be individually recruited or randomized for the cluster-randomized trial.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: The study is a cluster-randomized trial to test the effectiveness of the NCCP intervention relative to Usual Care on patient-level clinical process outcomes. The unit of randomization will be the PACT team enrolled into the NCCP or usual care. Outcome assessments will be conducted at 6 and 12 months.

Study Record Dates

• First Submitted: October 30, 2024
• First Posted: November 4, 2024
• Study Start: February 2, 2024
• Primary Completion (Estimated): January 31, 2028
• Study Completion (Estimated): November 13, 2028
• Last Updated: November 14, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)