Evaluating a clinical care pathway for the screening, diagnosis and treatment of fatty liver disease among primary care patients.
Executive summary
Background: Model evaluation is necessary for establishing model effectiveness, including factors related to process, outcomes and feasibility. Model evaluation will guide necessary adjustments for achieving optimal adaptation, impact and integration.
Objectives:
- To evaluate Model of Care (MoC) impact on NASH screening, diagnosis and linkage to specialty care.
- To evaluate MoC process effectiveness.
- To assess MoC acceptability and practicability.
Methods: A pre-post randomized controlled study design will be conducted. Twelve Primary Care practices (4 practices per country) will be selected to participate in model evaluation. Practices will be randomized to ‘intervention’ and ‘control’ groups in a 1:1 ratio. From each practice 50 patients at high risk for NASH (age >50 years, obesity, T2 Diabetes Mellitus or Metabolic Syndrome) will be recruited. Screening algorithms will include serum biomarkers and calculation of FIB-4.
In the active group, participants will be exposed to the MoC developed in WP4. In the control group, participants will receive usual care. Outcomes will be assessed in both arms. Primary outcomes include the numbers of patients screened, diagnosed with advanced fibrosis and referred to specialists. Secondary outcomes include proportions of patients accepting assessment at PC (process evaluation), accepting referral to specialists (process evaluation), without advanced fibrosis (F1/F2) not needing referral, with advanced fibrosis (F3/F4) receiving comprehensive care, numbers of high-risk patients screened for NASH allocated to Primary Care and costs of model implementation. Additional patient data include: socio-demographics, health habits, biomedical indexes, personal and family history, laboratory tests and hepatic testing. Electronic medical records will be used to track patient outcomes. Semi-structured interviews and focus groups will also be conducted with purposively selected patients (n=10 per country) and stakeholders to explore communication pathways, integrated care provision, patient and provider satisfaction. Patient-level characteristics and Model of Care delivery rates will be compared between pre/post assessments and between active and control groups. Qualitative outcomes will be analyzed using Thematic Content Analysis.
