Clinical trial NCT06671886: NAFLD Clinical Care Pathway
Official title: Testing the Effectiveness of NAFLD Clinical Care Pathway in VA Primary Care
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: NAFLD
MASLD
Keywords: NAFLD
Veterans
Primary health care
MASLD
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2024-11-04
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: NAFLD Diagnosis and risk stratification
timeFrame: Baseline, 6 months
Secondary outcomes:
measure: Fibroscan Test
timeFrame: Baseline, 6 & 12 months
measure: Referral to hepatology
timeFrame: Baseline, 6 and 12 months
measure: Hepatology Clinic Visit
timeFrame: Baseline, 6 and 12 months
measure: NAFLD discussion
timeFrame: 6 and 12 months
measure: Referral to weight loss services
timeFrame: Baseline, 6 and 12 months
measure: Enrollment in weight loss services
timeFrame: Baseline, 6 and 12 months
Other outcomes:
Locations:
city: Houston
country: United States
facility: Michael E. DeBakey VA Medical Center, Houston, TX
state: Texas
Study officials:
affiliation: Michael E. DeBakey VA Medical Center, Houston, TX
name: Hashem B. El-Serag, MD MPH
role: PRINCIPAL_INVESTIGATOR
References: