Executive summary
Background: Patient health literacy, illness perception and awareness are key factors driving health behaviour with important implications for doctor-patient interaction, risk communication and, subsequently, care provision.
Objectives:
Methods: In a descriptive study, a total of 840 patients with age ≥50 years and obesity or Metabolic Syndrome or Type 2 Diabetes Melitus, consecutively visiting Primary Care practices, will be selected to complete CRF assessing socio-demographic characteristics, health habits and biomedical indexes. Health Literacy, illness perception and NAFLD/NASH awareness will be assessed using the European Health Literacy Survey Questionnaire, the Brief Illness Perception Questionnaire and the Public Awareness of NAFLD Questionnaire respectively.
Executive summary
Background: Despite the increasing prevalence of NAFLD, there is limited knowledge and practice regarding its staging, diagnosis and management in primary care.
Objectives:
Methods: Using information generated from WP1 and the latest clinical knowledge, an expert panel of primary care professionals and specialists will develop module key messages, learning objectives and content, including the following topics: what is NAFLD/NASH and what is its natural history? Why is NASH an important issue for Primary Care? Who is at risk and who will be screened?. The module will be designed for delivery primarily via e-learning.
Executive summary
Evaluation is important for examining the impact of training on clinician’s knowledge, attitudes, skills, confidence and practice and can be used for training refinement.
Objectives:
To pilot test in a sample of primary care professionals the:
Methods:
A before-and-after, cross-sectional pilot study will be conducted. A random sample of primary care professionals (n=50) per country (total n=150), stratified by years of experience, geographic setting and work on private/public domain, will be selected. Outcome measures will be: change in key knowledge related to NAFLD, NAFLD screening, NAFLD risk perception, self-efficacy and self-reported changes to five clinical practice areas. We will also evaluate trainee satisfaction and perceived training added value. Measurement will occur pre, post and one month following the training. Qualitative research will be used to assess intervention practicability and acceptability (five primary care professionals per country will be selected for a semi-structured telephone interview). Country-level differences will be examined.
Executive summary
Background: Guidance on NASH screening based on availability of diagnostic tests within primary care systems is currently lacking. NASH Best-practice criteria can help with addressing bottle necks. In this WP, a Model of Care will be developed for use in PC to enhance NASH screening, diagnosis and linkage to specialty care.
Objectives:
Methods: Model development will follow the Plan-Do-Study-Act framework and knowledge of previous WPs. The model will include a standardized care pathway where different tasks will be defined, optimized and sequenced. This will systematically identify and follow patients at risk for NASH, beginning from Primary Care, aiming to improve care quality and efficiency, health professionals coordination/cooperation and patient satisfaction. The following MoC elements be addressed: evidence-base; risk assessment; model objectives and prioritization criteria; patient journey mapping; pathway algorithm implementation tools and supportive materials; patient education and self-management. Two Primary Care Health Professionals in each country will be trained to pilot test the draft MoC (n=20 patients per country) to address content, feasibility and adherence.
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:
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.
Executive summary
Background: The joint EASL-EASD-EASO Clinical Practice Guidelines on NAFLD management proposed recommendations for patient diagnosis, treatment and follow-up. This WP will involve the update of the existing guidelines tailored with specific recommendations for NASH management in PC.
Objectives:
Methods: This will be a consensus-based approach. The process will involve multidisciplinary teams, expert meetings, literature review, quality assessment and drafting, grading and consolidating recommendations (consensus reports). Existing guidelines, the results of previous project WPs and expert opinion will be the three main sources of information for guideline adaptation. Expert panels with representatives from EASD, EASO and ESPCG will be conducted. The guidelines will offer a hierarchy of recommendations and evidence for screening and diagnosis to allow for selection based on local resources. A refined NASH pathway will also be presented with the guideline recommendations to assist with the operationalization into real world practice settings.