Non-alcoholic fatty liver disease (NAFLD) and non-alcoholic steatohepatitis (NASH) Digestive System Other specified inflammatory liver diseases
Conditions
Interventions
Current interventions as of 15/02/2023:
Twelve PC practices (four practices per country) will participate in the model evaluation. Practices will be randomized to intervention and cont
Sponsors
University of Crete
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Current inclusion criteria as of 15/02/2023: 1. Metabolic dysfunction: overweight/obesity OR type 2 diabetes OR metabolic syndrome (MetS) OR 2. Liver dysfunction: raised alanine aminotransferase (ALT) OR raised aspartate aminotransferase (AST) OR 3. NAFLD: an ultrasonographic fatty liver indicator (US-FLI) >60 AND no other causes of liver disease AND no alcohol excess OR 4. Cardiovascular disease (CVD): any diagnosis or medication for CVD Previous 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)
Exclusion criteria
Exclusion criteria: 1. Not registered in the selected GPs practice 2. Unwillingness or inability to provide signed informed consent and complete study procedures due to cognitive impairment, dementia and/or terminal illness
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Current primary outcome measure as of 15/02/2023: The following primary outcome measures will be assessed at 12 weeks: 1. Number of patients screened for NAFLD/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 the specialist using GP report (case report form) Previous primary outcome measure: 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 the specialist using GP report (case report form) | — |
Secondary
| Measure | Time frame |
|---|---|
| Current secondary outcome measure as of 15/02/2023: The following secondary outcome measures will be assessed: 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 a referral to a specialist, measured using a 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 NAFLD/NASH allocated to PC, measured using GP report (case report form) Previous secondary outcome measure: 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 a referral to a specialist, measured using a 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 | — |
Countries
Greece, Spain
Outcome results
None listed