Trial Review

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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] 306393 0
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 325222 0
Chronic viral hepatitis 325223 0
Condition category
Condition code
Cancer 322625 322625 0 0
Liver
Infection 322634 322634 0 0
Other infectious diseases
Public Health 322635 322635 0 0
Health service research
Oral and Gastrointestinal 322700 322700 0 0
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] 322829 0
Early detection / Screening
Intervention code [2] 322830 0
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] 330420 0
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] 330420 0
6 months and 12 months post intervention implementation
Primary outcome [2] 330421 0
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] 330421 0
6 months and 12 months post intervention implementation
Primary outcome [3] 330422 0
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] 330422 0
6 months and 12 months post intervention implementation
Secondary outcome [1] 406141 0
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] 406141 0
6 months and 12 months post intervention implementation
Secondary outcome [2] 406142 0
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] 406142 0
T=0, T=6 months and T=12 months post intervention implementation
Secondary outcome [3] 406143 0
Uptake of Hepatitis B screening in priority groups

*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 tool for general practice
Timepoint [3] 406143 0
T=0, T=6 months and T=12 months post intervention implementation
Secondary outcome [4] 406145 0
Uptake of hepatitis C screening in priority groups

*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 tool for general practice
Timepoint [4] 406145 0
T=0, T=6 months and T=12 months post intervention implementation
Secondary outcome [5] 406455 0
Uptake of clinical management of people living with hepatitis B

*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 tool for general practice
Timepoint [5] 406455 0
T=0, T=6 months and T=12 months post intervention implementation
Secondary outcome [6] 406456 0
Uptake of treatment of people living with hepatitis C

*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 tool for general practice
Timepoint [6] 406456 0
T=0, T=6 months and T=12 months post intervention implementation

Eligibility
Key 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
4. Have over 1,800 active patients, using Royal Australian College of General Practitioners (RACGP) definition (patient has attended the clinic at least three times in the past two years). This minimum patient number threshold was chosen as it represents the lower bound of the interquartile range of active patients per clinic.

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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Locum services

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
This pilot and feasibility study has been designed using the principles of the UK Medical Research Council's Complex Intervention Framework. It is being undertaken under the auspices of the POLAR data-sharing research program 'Aurora', where participating general practices make de-identified clinical data available for approved research. Twenty general practices will be recruited from 3 Primary Health Networks in Victoria to participate in the pilot and feasibility study, via an Expression of Interest process, to test the HepLOGIC intervention.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
As this is a pilot and feasibility study, a sample size calculation has not been undertaken.
There is little published guidance on determining the appropriate sample size for pilot and feasibility studies and general ‘rules of thumb’ indicate a sample of between 12 and 50 participants per group may be appropriate.

Evaluation of the study will involve mixed methods - qualitative analysis of survey and interview data collected from clinician and staff who use the intervention, and quantitative analysis of user engagement metrics collected by the intervention software and through the analysis of de-identified clinical data (collected in the POLAR dataset).

The summarised electronic medical records provided in the POLAR dataset will be analysed to generate a comprehensive assessment of the uptake of testing among those at risk, engagement in care of those affected, and ongoing involvement in treatment and monitoring within the intervention and control cohorts.
Analysis will include:
• Descriptive statistics to summarise practice and patient characteristics and clinical profile
• The completeness of ethnicity/country of birth/Indigenous status
• The uptake of screening for hepatitis B in priority risk groups
• The uptake of screening for hepatitis C in priority risk groups
• The uptake of clinical management for eligible people living with hepatitis B
• The uptake of treatment for people living with hepatitis C
A pre-test/post-test comparison group study will be undertaken in both intervention and control groups for the above outcomes. A linear regression model comparing the intervention and control group will be used to test for whether there is an improvement post implementation for each respective outcome. The estimated difference in proportion for each outcome will be reported with their respective 95% confidence interval and p-value. The linear regression will also be adjusted for potential confounders.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/06/2023
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
60000
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 310746 0
Government body
Name [1] 310746 0
Victorian Cancer Agency
Country [1] 310746 0
Australia
Primary sponsor type
Hospital
Name
Melbourne Health
Address
300 Grattan Street, Melbourne, VIC 3000
Country
Australia
Secondary sponsor category [1] 312008 0
None
Name [1] 312008 0
Address [1] 312008 0
Country [1] 312008 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 310321 0
Melbourne Health
Ethics committee address [1] 310321 0
Ethics committee country [1] 310321 0
Australia
Date submitted for ethics approval [1] 310321 0
29/06/2021
Approval date [1] 310321 0
03/09/2021
Ethics approval number [1] 310321 0
HREC/64745/MH-2021

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 117246 0
Prof Benjamin Cowie
Address 117246 0
Victorian Infectious Diseases Reference Laboratory
The Peter Doherty Institute for Infection and Immunity
792 Elizabeth Street Melbourne Victoria 3000
Country 117246 0
Australia
Phone 117246 0
+613 9342 9377
Fax 117246 0
Email 117246 0
benjamin.cowie@mh.org.au
Contact person for public queries
Name 117247 0
Amelia Savage
Address 117247 0
Victorian Infectious Diseases Reference Laboratory
The Peter Doherty Institute for Infection and Immunity
792 Elizabeth Street Melbourne Victoria 3000
Country 117247 0
Australia
Phone 117247 0
+613 9342 9483
Fax 117247 0
Email 117247 0
amelia.savage@mh.org.au
Contact person for scientific queries
Name 117248 0
Amelia Savage
Address 117248 0
Victorian Infectious Diseases Reference Laboratory
The Peter Doherty Institute for Infection and Immunity
792 Elizabeth Street Melbourne Victoria 3000
Country 117248 0
Australia
Phone 117248 0
+613 9342 9483
Fax 117248 0
Email 117248 0
amelia.savage@mh.org.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
IPD will not be publicly available. In accordance with the conditions of data access and ethical approval for this study, IPD will be only be made available to the study investigators for the purpose of this research. It will be stored in a secure data environment, which is only accessible by the data custodians and the researchers. At the conclusion of the research the data will be destroyed by the data custodians in accordance with their ethically-approved data disposal arrangements.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
15039Study protocol    Not yet publicly available - protocol paper in dev... [More Details]
15040Clinical study report    This will be available at the end of the study and... [More Details]



Results publications and other study-related documents

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No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.