None listed
Conditions
Brief summary
Most cases of liver cancer are preventable, with chronic viral hepatitis causing the majority. If people who are living with hepatitis B or hepatitis C can access increased testing, appropriate treatment and follow-up from their GP, their risk of getting liver cancer later in life may be significantly reduced. The HepLOGIC intervention includes a range of clinical decision support system (CDSS) tools that are integrated with clinical information systems in primary care. The current study aims to assess the feasibility and acceptability of using these tools to optimise liver cancer risk screening and care for patients with hepatitis B or hepatitis C. Who is it for? This study is for general practice clinics in Eastern Melbourne, South Eastern Melbourne, or Gippsland Primary Health Network (Victoria, Australia), who participate in the POLAR data-sharing program. By default all patients attending recruited practices will participate in the study. Study details The HepLOGIC intervention will be implemented at 20 general practice clinics. The intervention will involve a series of electronic health tools including prompts for doctors to screen patients for liver cancer risk factors. Participants may be asked to provide further details regarding their medical history and ethnicity, and may undergo additional testing. It is anticipated that these procedures will take up to 10 minutes to complete in addition to a scheduled appointment. Patient will only interact with their general practice clinic in this study and will not be contacted or identified by the researchers in any way. It is hoped this research will demonstrate the feasibility and acceptability of targeted health practice tools for integration in standard care for patients with hepatitis B and hepatitis C. Future larger studies will aim to determine the efficacy of these tools in reducing liver cancer risk in hepatitis patients.
Interventions
The HepLOGIC intervention to be tested in this pilot and feasibility study comprises a suite of clinical decision support system (CDSS) tools that are integrated with clinical information systems in primary care. Comprising point-of-care prompts and practice-level audit and recall components, the intervention aims to support the delivery of guideline-based care to people living with hepatitis B or hepatitis C and reduce their risk of developing liver cancer. This is a 'practice-facing' rather than 'patient-facing' intervention. Patients will not necessarily be aware that the intervention is in use as it is embedded in workflows to target practice staff. It does not require patient consent as the intervention promotes and does not deviate from guideline-based care. The guidelines will be from the following sources: 1. Australian recommendations for the management of hepatitis C virus infection: A consensus statement (June 2020) [hepcguidelines.org.au] and 2. B positive guide - A guide for primary care providers [hepatitisb.org.au] The National Hepatitis B Testing Policy and the National Hepatitis C Testing Policy provide standardised currently available information to inform health providers, government and industry on specific matters concerning hepatitis B and hepatitis C testing. These are not strictly defined as guidelines but are essential best practice documents in the cascade of care for hepatitis B and hepatitis C and so are treated as guidelines in the context of this study. Point-of-care component of the HepLOGIC intervention Electronic point-of-care prompts will electronic medical record data to alert a clinician during a patient consultation (in real time) and provide recommended actions, if: 1. The person has indications for risk of hepatitis B or hepatitis C and should be tested; OR 2. The person has been diagnosed with hepatitis B and requires follow up or management; OR 3. The person has been diagnosed with hepatitis C but has no evidence of treatment. The point-of-care tool alerts the clinician when a patient who has presented for consultation meets one or more of the above risk groups and provide recommended actions and a link to best practice guidelines. The point-of-care prompts will be active for the duration of the study. Practice staff will be offered training in their use during the implementation phase of the study. Practice-level audit component of the HepLOGIC intervention A practice level audit workflow and reporting tool will enable prioritisation of patients at risk of liver cancer and streamline processes for identifying patients for further investigation or management. The audit tool will be targeted for use by an appropriate staff member, as identified by the practice, who may be a clinician, nurse or practice manager. The staff member using the tool may change throughout the study as deemed appropriate by the practice. The audit tool will interrogate the practice's electronic medical records and group patients who are at risk of liver cancer, based on indications in their medical record. This will enable staged recall of patients for further assessment in tranches that are manageable to the practice (estimated to be in the range of 5-20 patients per week). The practice level audit tool will be available for clinic use for the duration of the study, noting that it must be manually run by practice staff. Relevant practice staff will be trained in its use during the implementation phase and provided with guidance and recommendations regarding its incorporation and use in practice workflows. It will be recommended that it is used at least fortnightly but this may be modified by the practice, depending on practice capacity. Adherence to this and how the tool was ultimately used by the practice will be evaluated in the study to determine the feasibility of the tool. Supporting tools The CDSS intervention will be supported by a number of tools including information and training resources (an online training video for use of the intervention, quick reference guides; and audit tool guidance and recommendations), resources to promote ethnicity data collection, and monthly practice monitoring and benchmarking reports. These tools will be developed specifically for this study, noting that ethnicity data collection tools will be aligned with the best practice guidance from the Royal Australian College of General Practitioners. Monthly reports will be automatically generated using data collected by the intervention software and Population Level Analysis and Reporting (POLAR) tool that underpins this project. They will collate data on user (GP) engagement with the point-of-care tool and summaries of data that relate to the clinical outcomes of the project (including number of patients for whom ethnicity data was added, number of patients offered testing, number of patients engaged in management or treatment for chronic viral hepatitis) The intervention will be implemented in the clinical information systems and workflow of 20 primary care practices, and tested within 'usual business' for a period of 13 months. Recruitment of practices will be limited to those who participate in the POLAR data-sharing research program within the Gippsland, Eastern Melbourne and South Eastern Melbourne Primary Health Network (PHN) regions. Primary care practices will be invited to participate in the study via an Expression of Interest promoted through newsletters and targeted communications with their respective PHN. At the conclusion of the Expression of Interest period, clinics that have registered interest in the study and meet the inclusion criteria will be stratified by PHN and a total of 20 clinics will recruited to test the intervention (aim 4 from Gippsland, 8 from Eastern Melbourne and 8 from South Eastern Melbourne). If more than the allocated number of clinics per PHN express interest in participating in the study and meet the inclusion criteria, then clinics will be randomly recruited from within that group. That randomisation will be carried out by an independent statistician.
Sponsors
Study design
Eligibility
Inclusion criteria
Inclusion criteria for recruitment to the study are primary care clinics that are: 1. Located in the Eastern Melbourne, South Eastern Melbourne, or Gippsland Primary Health Network (Victoria, Australia); and 2. Participate in the POLAR data-sharing research program; and 3. Use either Best Practice or Medical Director (Clinical) for electronic medical record collection and management; and Recruiting a clinic to the project will also effectively recruit all adult patients who have an electronic medical record at that clinic, as this study is underpinned by the use of electronic medical records to drive the intervention.
Exclusion criteria
Locum services