Evaluating a clinical care pathway for the screening, diagnosis and treatment of fatty liver disease among primary care patients

INTERVENTION: Twelve PC practices (four practices per country) will participate in the model evaluation. Practices will be randomized to intervention and control groups in a 1:1 ratio. The randomization is computer generated by a faculty not involved in the study. From all intervention and control practices, the researchers will recruit a representative sample of patients at high risk for NASH (age >50 years, obesity, type 2 diabetes or metabolic syndrome). Intervention group: Primary care providers will be asked to implement the NASH model of care which includes a standardized care pathway which involves a protocol defining different HP tasks for the screening, diagnosis, referral and management of patients at high risk for NASH. All GPs in practices randomized to the intervention group will be exposed to NASH training intervention and supported with implementing the Model of Care. The NASH Model of Care includes Screening algorithms will include serum biomarkers and calculation of FIB‐4 (next‐to‐patient). Patient auto‐calculation will be promoted. Patients with FIB‐4 < 1.30 will be considered as having no sufficient evidence of liver fibrosis, thus not requiring referral to specialists. However, they will be advised to modify their diet and lifestyle and repeat FIB‐4 every 2 years. For indeterminate FIB‐4 values, patients will be referred to hospital care for transient elastography. Hospital specialists will interpret elastography results jointly with serum markers. Control group: In the control group, GPs will follow their usual care procedures, tools and tests. CONDITION: Non‐alcoholic steatohepatitis (NASH) ; Digestive System ; Other specified inflammatory liver diseases PRIMARY OUTCOME: ; The following primary outcome measures will be assessed at 12 weeks:; 1. Number of patients screened for NASH measured using prospective tracking of eligible patients; 2. Number of patients diagnosed with advanced fibrosis measured using diagnostic criteria (case report form); 3. Number of patients referred to specialist using GP report (case report form); INCLUSION CRITERIA: 1. Registered as a patient in the practice of the participating GP 2. Age >=50 years 3. One or more of the following conditions: 3.1. Obesity (BMI>30) 3.2. Type 2 diabetes (T2DM) 3.3. Metabolic syndrome (MetS) SECONDARY OUTCOME: ; The following secondary outcome measures will be assessed at 12 weeks:; 1. Proportion of patients accepting assessment at PC, measured by GP report (case report form); 2. Proportion of patients accepting referral to specialists, measured by GP report (case report form); 3. Number of patients without advanced fibrosis (F1/F2) who did not need referral to a specialist, measured using GP report (case report form); 4. Number of patients with advanced fibrosis (F3/F4) receiving comprehensive care, measured using standardized criteria (case report form); 5. Number of high‐risk patients screened for NASH allocated to PC, measured using GP report (case report form); 6. Direct/indirect costs of model implementation, measured by cost tracking of medical and non‐medical expenses;