LOCal Assessment and Triage Evaluation of Non-Alcoholic Fatty Liver Disease (LOCATE-NAFLD)

The starting point for patients is when they visit a GP. If the GP has sufficient concerns about the patient’s liver health, they will write a referral letter requesting a specialist hepatology clinic. The GP may also request blood tests, or have already performed those tests. Referral letters will be screened by a hepatologist at the Sunshine Coast and Princess Alexandra Hospitals to identify patients eligible for the study. The details of potential patients will be recorded for potential recruitment into the study. After participants consent to participation, they will complete 3 short questionnaires - a short (5 question) demographics questionnaire, a quality of life questionnaire, and a questionnaire detailing their alcohol consumption. Based on the results of this third questionnaire, if their alcohol consumption is low enough for their liver damage to be considered not related to alcohol consumption (as per the exclusion criteria), they will be enrolled into the study, where they will be randomised to the new model of care (LOCATE) or usual care. Study participants randomised to the new model of care will be invited to attend a local clinic to have their suspected NAFLD assessed using mobile transient elastography (TE), using a Fibroscan machine. Participants will be asked to lie on their back with their right arm raised above their head. A gel will be applied to their skin on the right-hand side. A small hand held sensor is then pressed on the surface of the skin. The gel is wiped off at the end of the procedure. The invitation and assessment will be made by a specialist study nurse trained in the use of the machine. A nurse will call the participants who need to be scheduled for a scan to organise a appointment time, and a follow-up text will be sent as an appointment reminder 48 hours before the scan is due to take place. Those who do not attend will be given the option to reschedule once, and we will record the reason for 'did not attends' if practical (i.e. they can be contacted and provide a reason). The intervention screening appointment will last approximately 30 minutes, with the actual screening process taking between 2-20 minutes to perform (participants will be told in advance that it can take 20 minutes to perform the scan). This will only need to occur once for the intervention. After the assessment the study nurse will write a report on the results and send it to the hepatologist for triage. The triage to low or high risk will depend on the assessment of liver scarring. Participants with low Fibroscan scores (TE under 8.0 kPa) will be classified as ‘Low Risk’. A letter will be sent to participants and their GPs about their test results and proposed management. Patients will be asked to make an appointment with their GP for review of the scan results and for GP advice on NAFLD management. They will then attend their planned hospital hepatology appointment. Participants with clinically significant fibrosis (TE over 8.0 kPa) will be classified as ‘High Risk’ and will be sent a letter summarising their test results and asking them to call the hepatology clinic to arrange a clinic appointment. They may also be enrolled in HCC and variceal surveillance programs, as indicated. GPs will be sent a letter informing them of the results and proposed management by the hepatologist. For those participants randomised to usual care, their referral letters will be dealt with in the usual way, and the patients wait to see a hepatologist as originally planned. The Fibroscan service will enable participants to undergo reliable assessment of the degree of liver fibrosis (scarring) and to identify those with advanced fibrosis and cirrhosis who need both secondary care input and surveillance for liver cancer. The mobile clinics will occur on a rotational basis in the two regions using the GP clinics and primary care centres. This will make it easier for participants to keep their appointments, particularly those in rural areas.