Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000583842
Ethics application status
Approved
Date submitted
9/03/2021
Date registered
17/05/2021
Date last updated
17/05/2021
Date data sharing statement initially provided
17/05/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Implementation of a guideline-based cardiovascular risk assessment and decision aid tool for General Practice (CHAT-GP)
Scientific title
The effectiveness of implementing an auto-populated cardiovascular risk calculator and decision aid tool for General Practice (CHAT-GP) to improve guideline-based risk assessment and management
Secondary ID [1] 303570 0
none
Universal Trial Number (UTN)
Trial acronym
CHAT-GP
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cardiovascular disease
 320943 0
Condition category
Condition code
Cardiovascular 318747 318747 0 0
Other cardiovascular diseases
Public Health 319272 319272 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This study will test implementation strategies (an app that auto-populates decision support tools from medical records, supported by a GP/patient website and training) for evidence-based interventions (risk calculator, decision aid, audit & feedback) to improve guidelines-based assessment of cardiovascular disease risk in general practice.
The intervention will run continuously for 6 months in a stepped wedge trial format. Primary Health Networks will start in the control group, then be randomly allocated to receive the intervention in a specified month. All Primary Health Networks will begin in the control group and then each month 2 Primary Health Networks will begin the intervention. A 1 hour training meeting with the practice manager and interested staff will be conducted at the time of randomisation, using Zoom to demonstrate the intervention via screenshare and answer any questions. It is completely at GP staff discretion whether they choose to attend the training and use the CVD risk calculator and/or decision aid during a consultation with an eligible patient. If they do, a 20 minute consultation is required for a MBS-funded Heart Health Check, but they may choose other billing codes. The study does not require a specific number of consultations to be performed irrespective of whether the general practice is in a PHN in either the control or intervention group. GPs may also choose to do the self-directed audit and feedback interactive activity for CPD points at their discretion, which is recommended by the RACGP to take 6 hours. Patients may choose to use the consumer version of the risk calculator and decision aid in the waiting room or in their own time.

Our team developed and piloted the intervention in 2016-18 including testing:
1. Interactive CVD risk calculator that automatically combines CVD risk assessment and management algorithms to help GPs identify the correct risk category and guidelines, to address GP capability barriers using best practice risk communication principles;
2. Personalised patient decision aid that shows the effect of medication/lifestyle interventions on CVD risk to help GPs discuss the benefits and harms of different options, addressing patient capability barriers based on international shared decision making standards;
3. Self-directed audit & feedback including cases that GPs find challenging for CVD risk assessment and communication, and comparison of management to guidelines, using evidence-based behaviour change techniques to address GP motivation barriers.

Feasibility testing indicated a need to better integrate these tools into the general practice context. This stepped wedge trial will implement the intervention using a Pen CS Topbar app that auto-populates the website tool from a patient’s medical record during the consultation. This will be supported by a website offering: 1) additional guideline information and the self-directed audit and feedback training for GPs and practice nurses, and 2) a consumer version of the risk calculator/decision aid tool with a lifestyle change action plan to facilitate patient engagement in risk assessment and management. Training will be provided to practice managers (including waiting room resources and monthly practice-level audit & feedback reports) and individual staff (including demonstration of the tools and a lifestyle prescription pad to refer patients to the supporting consumer resources).

The development and feasibility testing is detailed in https://implementationscience.biomedcentral.com/articles/10.1186/s13012-019-0927-x.
The intervention content is hosted at www.auscdvrisk.com.au. At the time of randomisation practices will receive access to the Pen CS Topbar app that autopopulates this tool from patient records and log in details for the audit and feedback component.

A process evaluation will be conducted to evaluate intervention use in this study, including recorded use of the Topbar app and associated website, and self-reported uptake of different components via staff interviews. The outcome of complete CVD risk assessment data for eligible patients will involve Pen CS CAT4 auditing medical record software.
Intervention code [1] 319859 0
Behaviour
Intervention code [2] 320247 0
Prevention
Comparator / control treatment
This is a stepped wedge trial. Therefore, all groups commence the study in the control group, providing usual care, then every month thereafter 2 groups are granted access to the intervention tools.

Usual care entails the GP performing care as normal with their patients with no other criteria designated by the study. This may involve an absolute CVD risk assessment using alternative risk calculators (e.g. www.cvdcheck.org.au) but only 17% of eligible patients currently have complete data for this, suggesting uptake is low.
Control group
Active

Outcomes
Primary outcome [1] 326693 0
The primary outcome is complete absolute CVD risk assessment data for eligible (45-74 years, 30-74 if Aboriginal or Torres Strait Islander, old, with no diagnosis of cardiovascular disease) patients seen in the last month, assessed via monthly Pen CS reports from participating GP practices.
Timepoint [1] 326693 0
Monthly assessment for the 6 month duration of the study of all groups in the stepped wedge trial (both control and intervention).
Secondary outcome [1] 392379 0
Secondary outcomes will include guidelines-based management (medication prescribed for high risk and not low risk patients) as indicated in Pen CS reports,

Timepoint [1] 392379 0
End of trial (6 months post-enrolment)
Secondary outcome [2] 393997 0
GP referral to the My Health For Life lifestyle program based on standard data collected by partner organisation the National Heart Foundation (for Queensland sites only).
Timepoint [2] 393997 0
End of trial (6 months post enrolment)

Eligibility
Key inclusion criteria
To be included in the trial, practices must see, on average, at least 5 patients who are eligible (45-74 years old, or 30-74 if Aboriginal or Torres Strait Islander, and with no diagnosis of cardiovascular disease) to receive a cardiovascular disease risk assessment, weekly.

Practices must also have access to the PEN CS suite of tools, including Topbar, and must allow the research team to have access to their data (related to CVD risk assessments) for 6 months.

Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
None

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Practices will be recruited prior to trial commencement, and will be informed of the month in which they will receive access to the intervention after the randomisation sequence is generated.

Allocation will be concealed by central randomisation by computer.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
This is a stepped wedge trial. Therefore, all groups commence the study in the control group, providing usual care, then every month thereafter 2 groups are granted access to the intervention tools.

It is not possible to blind practices or their staff/patients in this implementation study given they require training in the intervention, which will be visibly different than usual care.
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
We will use generalised linear mixed modelling to compare the proportions of eligible patients with a complete absolute CVD risk assessment while within the intervention and control arms. The model will adjust for clustering by PHN, the secular effect of time and practice and patient level covariates. The same approach will be taken to analyse the secondary binary outcomes of guidelines-based management and referral to lifestyle programs.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/07/2021
Actual
Date of last participant enrolment
Anticipated
2/08/2021
Actual
Date of last data collection
Anticipated
1/12/2021
Actual
Sample size
Target
24
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 307993 0
Government body
Name [1] 307993 0
National Health and Medical Research Council
Country [1] 307993 0
Australia
Primary sponsor type
University
Name
University of Sydney
Address
Camperdown NSW 2006
Country
Australia
Secondary sponsor category [1] 308716 0
None
Name [1] 308716 0
Address [1] 308716 0
Country [1] 308716 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 307986 0
University of Sydney Human Research Ethics Committee
Ethics committee address [1] 307986 0
Ethics committee country [1] 307986 0
Australia
Date submitted for ethics approval [1] 307986 0
20/12/2019
Approval date [1] 307986 0
25/09/2020
Ethics approval number [1] 307986 0
10169

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

Contacts
Principal investigator
Name 109138 0
Dr Carissa Bonner
Address 109138 0
Rm 226A, Edward Ford Building A27, The University of Sydney, Camperdown NSW 2006
Country 109138 0
Australia
Phone 109138 0
+61 2 9351 7125
Fax 109138 0
Email 109138 0
[email protected]
Contact person for public queries
Name 109139 0
Carissa Bonner
Address 109139 0
Rm 226A, Edward Ford Building A27, The University of Sydney, Camperdown NSW 2006
Country 109139 0
Australia
Phone 109139 0
+61 2 9351 7125
Fax 109139 0
Email 109139 0
[email protected]
Contact person for scientific queries
Name 109140 0
Carissa Bonner
Address 109140 0
Rm 226A, Edward Ford Building A27, The University of Sydney, Camperdown NSW 2006
Country 109140 0
Australia
Phone 109140 0
+61 2 9351 7125
Fax 109140 0
Email 109140 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
10938Study protocol  [email protected] 381520-(Uploaded-09-03-2021-10-47-55)-Study-related document.docx



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.