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Trial registered on ANZCTR

Registration number

ACTRN12622000356763

Ethics application status

Approved

Date submitted

15/02/2022

Date registered

28/02/2022

Date last updated

6/02/2023

Date data sharing statement initially provided

28/02/2022

Type of registration

Prospectively registered

Titles & IDs

Public title

HepLOGIC pilot and feasibility study to test a decision support tool for general practitioners that is designed to enhance the delivery of care to people living with viral hepatitis and reduce their risk of liver cancer.

Scientific title

Feasibility of a primary care intervention (HepLOGIC) - investigating the effect of an electronic clinical decision support system on the identification and management of people at risk of chronic viral hepatitis and liver cancer.

Secondary ID [1]

Nil known

Universal Trial Number (UTN)

U1111-1274-2170

Trial acronym

Hep-LOGIC

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Liver cancer

Chronic viral hepatitis

Condition category

Condition code

Cancer

Liver

Infection

Other infectious diseases

Public Health

Health service research

Oral and Gastrointestinal

Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

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 use 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 screened; 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 will alert 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.

A point-of-care prompt will also alert reception staff when ethnicity or country of birth data is incomplete for a patient on check-in (ethnicity is an important determinant of viral hepatitis risk).

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), streamlined ethnicity/country of birth data collection forms for patients to complete, 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 research team will discuss the monthly reports and discuss adherence to the intervention with a nominated contact person for the clinic at least once every two months during the study.

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 12 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 (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.

Intervention code [1]

Early detection / Screening

Intervention code [2]

Prevention

Comparator / control treatment

Controls will be used for the evaluation of clinical outcomes, and include primary care practices who operate in the same geographic region as intervention clinics, but did not receive the intervention.

Control group

Active

Outcomes

Primary outcome [1]

Reach to target population will measure the proportion of eligible patients (i.e, those who presented at the clinic with a hepatitis b or hepatitis c testing or management risk that triggered the WALRUS point-of-care intervention) who were acted on due to the intervention. This will be assessed using de-identified electronic medical records and user metric analytics collected by the Population Level Analysis and Reporting (POLAR) tool.

Timepoint [1]

6 months and 12 months post intervention implementation

Primary outcome [2]

Adoption by target settings will measure the uptake/use of the intervention tools by staff within participating practices. It will be assessed using user metric analytics collected by the POLAR tool (e.g. number and type of clinical users who launched and engaged with the intervention) and user surveys surveys using study-specific questionnaires that focus on the design and user interaction with the intervention, to understand factors that influenced uptake and use.

Timepoint [2]

6 months and 12 months post intervention implementation

Primary outcome [3]

Maintenance over time will measure the degree to which the intervention tool becomes routinely used over time. This will be assessed using de-identified electronic medical records and user metric analytics collected by the POLAR tool, and surveys using study-specific questionnaires that have been developed to capture insights from practice staff about the likelihood of future use and potential improvements.

Timepoint [3]

6 months and 12 months post intervention implementation

Secondary outcome [1]

Consistency of implementation will be assessed using clinical data (medical records) and user metric analytics collected by the POLAR tool, and surveys using study-specific questionnaires that have been developed to capture insights from practice staff about issues and experiences in implementation.

Timepoint [1]

6 months and 12 months post intervention implementation

Secondary outcome [2]

Completeness of ethnicity, country of birth and Indigenous status data (composite)

*This data will be assessed through the audit and analysis of de-identified electronic medical records collected from the intervention clinics using the Population Level Analysis and Reporting (POLAR) tool for general practice

Timepoint [2]