Background: In the United States, non-alcoholic fatty liver disease (NAFLD) affects
25-30% of adults and has become a leading cause of chronic liver disease including
cirrhosis and liver cancer. The burden of NAFLD and its complications among patients in
the Department of Veterans Affairs (VA) is increasing. Most complications occur among
patients with advanced hepatic fibrosis. Treatment (e.g., weight loss) improves patients'
outcomes.
Significance: The investigator's data indicate that most VA patients with NAFLD are
undiagnosed and untreated. There is an urgent need to address this major gap in care.
Most people with NAFLD are seen in primary care settings. The NAFLD Clinical Care Pathway
(NCCP) is a multistep, algorithmic process that entails identification of patients at
risk through an e-trigger (Step 1), targeted history and lab testing (Step 2),
noninvasive testing for hepatic fibrosis using FIB-4 (Step 3), elective additional
fibrosis testing with Fibroscan for those with indeterminate FIB-4 (Step 4), and
subsequent recommended management. The NCCP has face and content validity based on
consensus of multiple stakeholders including VA clinicians, and high efficacy in the
investigator's preliminary data. The investigators propose to adapt the multicomponent
NCCP intervention for use in VA primary care and prospectively test its effectiveness for
identification and severity stratification of patients with NAFLD. The investigator's
approach is consistent with VA strategic priorities to implement a more
"Veteran-centered" approach that improves access to care.
Innovation & Impact: This is the first study to examine the effectiveness of any NAFLD
clinical care pathway in a VA primary care practice. The design is a cluster-randomized
controlled trial with randomization at the level of Patient Aligned Care Teams (PACTs) in
primary care, and a state-of-the-art technique to diagnose NAFLD and stage the severity
of hepatic fibrosis. The investigator's formative and summative evaluation will provide
key information about the feasibility, acceptability and determinants of implementation.
The NCCP intervention is a paradigm shift in NAFLD care from haphazard and sporadic care
into a systematic, equitable, and evidence-based approach.
Specific Aims: Aim 1. Conduct a formative evaluation to assess feasibility and
acceptability of the NCCP among patients and providers; adapt the NCCP for prospective
testing based on feedback. Aim 2. Examine the effectiveness of the NCCP intervention
compared to usual care in improving NAFLD care processes and patient outcomes. Aim 3.
Conduct a summative evaluation to identify patient and provider characteristics
associated with effectiveness of NCCP and to assess future implementation. The
investigator's hypothesis is that NCCP when adapted to Patient Aligned Care Teams (PACTs)
in VA primary care considerably increases the identification of patients with NAFLD and
those with high-risk NAFLD, and results in an increase in guideline-concordant
management.
Methodology: The study will be conducted in primary care settings in a single large VA
Medical Center. The investigators will conduct patient interviews and focus groups with
PACTs to inform adaption of the NCCP. The investigators will then conduct a
cluster-randomized trial of 16 PACTs in primary care to compare the effectiveness of NCCP
to usual care in improving NAFLD care, with PACTs as unit of randomization and patients
as the unit of analysis. The multicomponent intervention includes an e-trigger to
identify patients eligible for NAFLD screening and calculate fibrosis scores, a
structured provider education on NAFLD management and treatment recommendations, and
coordination by an inter-professional team. The primary outcome will be a composite
binary variable consisting of NAFLD diagnosis and risk stratification. Secondary outcomes
include referral to a weight loss program, referral of patients with advanced fibrosis to
hepatology specialty care, and enrollment among those referred to weight loss and
hepatology specialty care. Summative evaluation will inform future implementation.
Next Steps/Implementation: The investigators study will provide information needed to
support future projects to implement the NCCP in VA primary care settings. The study will
also lay the foundation for a subsequent project to examine the adopted intervention's
effect on weight loss and NAFLD biomarkers in patients with high-risk NAFLD.