RecruitingACTRN12625000256471

An alternative model of care for liver health care for First Nations patients living in remote communities

Assessing adherence of screening and surveillance models of care for liver disease in remote Indigenous Australian communities


Sponsor

Flinders University

Enrollment

40 participants

Start Date

Jul 21, 2025

Study Type

Interventional

Conditions

Summary

Colonisation has, and continues to, negatively impact the health and wellbeing of First Nations peoples, which is further exacerbated by unequal access to health services especially in rural and remote communities. Liver disease and liver cancer are growing concerns for First Nations peoples due to increasing incidence rates. Disparities in liver disease outcomes, especially for those residing in rural and remote communities, are exacerbated by key barriers such as the lack of access to specialist care and the need to travel substantial distances Off-Country to access testing and treatment. This project aims to address these health inequities by exploring new ways of diagnosing and managing liver disease in rural and remote communities using non-invasive technologies On-Country. Who is it for? You may be eligible to participate in the liver check phase of this study if you are an Aboriginal and/or Torres Strait Islander person aged 25 or older and has at least one risk factor for liver disease. You will be eligible to participate in the liver monitoring phase if you have been identified during the screening phase of having compensated advanced chronic liver disease. Study details In the liver check phase, eligible participants will have a liver health assessment alongside their routine annual health check. This phase will include simple fibrosis tests that will help identify anyone at potential risk of liver disease complications. This risk will be confirmed by an On-Country scan (using a FibroScan) that will enable diagnosis of advanced liver disease. Participants identified to be at risk of liver cancer in Phase 2 will be invited to take part in Phase 3, the liver monitoring phase. This phase of the project will be a stepped-wedge randomised trial to compare two models of liver cancer surveillance — the current model of care and the study On-Country model of care. The new model of care will allow participants to have 6 monthly ultrasounds On-Country (performed by an experienced ultrasonographer) in conjunction with serum biomarker tests for liver cancer. Yarning circles will be incorporated at the end of Phase 2 and Phase 3 to explore participant experiences in the study, their knowledge of liver disease and views on the different models of care. It is hoped that the result from this study will help to demonstrate the feasibility of providing quality liver health care On-Country to First Nations peoples living in remote communities.


Eligibility

Sex: Both males and femalesMin Age: 25 Yearss

Plain Language Summary

Simplified for easier understanding

Liver disease and liver cancer are growing health problems in First Nations communities across Australia. Unfortunately, many Aboriginal and Torres Strait Islander people in remote areas have limited access to specialist liver care — and often need to travel long distances away from their Country to get diagnosed and treated. Identifying liver disease early, when it is most treatable, is critically important. This study is bringing liver health testing directly to remote First Nations communities through an On-Country model of care. In the first phase, participants will have non-invasive liver assessments (including a FibroScan) during their routine annual health check. Those identified with advanced liver disease will be invited into a second phase — a randomised trial comparing the standard model of care (travel-based) with regular On-Country liver cancer surveillance using ultrasound scans. You may be eligible for the initial check if you are an Aboriginal and/or Torres Strait Islander person aged 25 or older with at least one known risk factor for liver disease (such as hepatitis B, hepatitis C, alcohol use, or obesity). No exclusion criteria apply to the monitoring phase. This study is grounded in community partnership and cultural respect.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

The study is divided into three parts: (1) the site engagement phase, (2) the liver check (screening) phase and (3) the liver monitoring (surveillance) phase. In Phase 1 (duration: 12mths, concurrentl

The study is divided into three parts: (1) the site engagement phase, (2) the liver check (screening) phase and (3) the liver monitoring (surveillance) phase. In Phase 1 (duration: 12mths, concurrently with Phase 2), the study will focus on engaging with sites about the project, establishing a Community Leadership Group, providing training to the local study team (Principal Investigator and Indigenous Project Officer), and providing community awareness and education. A CLG will be established at each study site and may include local primary healthcare staff, community Elders and local community members, who will be the primary mechanism for community liaison with support from site Principal Investigator (PI) and Indigenous Project Officer (IPO), and project team. The CLG will have up to five members as chosen by the community. The CLG, with the support of the project team, will provide feedback on the project training and resources relevant to their site (including language translation, diagrams and visual representation of service pathways). Training for the local study team will focus on liver disease and the research project and will be provided by two of the study investigators over 2 sessions at 2hrs each within a month of starting Phase 2. Community awareness and education will be an ongoing process, and can vary from one-to-one sessions during a clinic visit to a yarn at the local community centre. This will be determine by each local CLG. In the liver check phase (duration: 12mths, concurrently with Phase 1), members in the community meeting study inclusion criteria will be eligible to have a liver health assessment alongside their routine annual health check. This phase will include simple fibrosis tests that will help identify anyone at potential risk of liver disease complications. This risk will be confirmed by an On-Country scan (using a FibroScan) that will enable diagnosis of advanced liver disease. The liver health check will require one appointment at your local medical health service, and you may need to come in for another appointment for the FibroScan appointment. These appointments will take approximately 20mins each. Participants identified to be at risk of liver cancer in Phase 2 will be invited to take part in Phase 3, the liver monitoring phase (duration: 24mths). This phase of the project will be a stepped-wedge randomised trial to compare two models of liver cancer surveillance — the current model of care and the study On-Country model of care. The new model of care will allow participants to have 6 monthly ultrasounds On-Country (performed by an experienced ultrasonographer) in conjunction with serum biomarker tests for liver cancer. The blood test will take approximately 10-15mins and the liver scan approximately 20mins. Adherence to the intervention will be assessed through collecting information on how many of the 6mthly reviews are attended. Yarning circles will be incorporated at the end of Phase 2 and Phase 3 to explore participant experiences in the study, their knowledge of liver disease and views on the different models of care. Each yarning circle is anticipated to take 1hr.


Locations(1)

SA,WA, Australia

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ACTRN12625000256471


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