Trial Review

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Trial registered on ANZCTR


Registration number
Help: Registration number
ACTRN12625001168448
Ethics application status
Help: Ethics application status
Approved
Date submitted
Help: Date submitted
7/10/2025
Date registered
Help: Date registered
27/10/2025
Date last updated
Help: Date last updated
27/10/2025
Date data sharing statement initially provided
Help: Data sharing statement date
27/10/2025
Type of registration
Help: Type of registration
Retrospectively registered

Titles & IDs
Public title
Evaluating the impact of Artificial Intelligence (AI) assistance in cardiovascular disease risk assessment for resource-constrained settings: a randomised controlled study with general practitioners in Indonesia
Scientific title
Evaluating the impact of Artificial Intelligence (AI) assistance in cardiovascular disease risk assessment for resource-constrained settings: a randomised controlled study with general practitioners in Indonesia
Additional trial identifiers [1] 315520 0
None
Universal Trial Number (UTN)
Trial acronym
Related trial records

Health condition
Health condition(s) studied:
atherosclerotic cardiovascular disease 339112 0
Condition category
Condition code
Cardiovascular 335400 335400 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of the intervention or exposure
We perform a three-way within-subject randomised design, where doctors as participants completed clinical vignettes or patient cases. For each patient case, participants asses 10-year atherosclerotic cardiovascular disease (ASCVD) risk and made management decisions using either a conceptual prototype of AI-based clinical decision support (CDS), automated CDS, or no decision support. This online study may take approximately 1 hour.

Participants are presented with nine hypothetical patient cases in an outpatient setting. each case present a brief patient history, physical examination, and simple laboratory results that are commonly available in resource-constrained clinical settings. The trial set up and the CDS interface was designed to emulate access on a mobile device which is a likely real-world implementation of such tools in resource-constrained setting

The study is simulated using Gorilla.sc, a platform for conducting online experiments, which is customised to display patient cases and the CDS interventions. Allocation of cases to the different conditions of CDS quality, and the order of presentation are randomised. All randomisations are set equal (1:1) and performed by the Gorilla software. Participants self-enrolled in the online experiment. The study URL is provided in the invitation and participants are asked to access the study from a laptop or desktop computer with an internet connection at a convenient time and place. Participants are instructed to complete all cases to the best of their clinical judgment in a single, uninterrupted session and no time limits were imposed. Participant ID and time are automatically monitored by the software.

This is a within-subject cross-over trial. While participants could distinguish between the control (no decision support) and intervention conditions, they were blinded to the nature of the intervention. The Automated CDS and AI-based CDS are presented as “Risk Calculator 1” and “Risk Calculator 2” respectively, without disclosure of which system incorporated AI. This approach is designed to minimise placebo effects that could influence clinician performance. No formal washout period was required, as the interventions are software-based and delivered in a blinded, counterbalanced sequence to mitigate carryover effects.
Intervention code [1] 332141 0
Early detection / Screening
Description of the comparator or control
The control group is cases with No decision support i.e. the current approach to risk assessment served as the control condition. Each case present a brief patient history, physical examination, and simple laboratory results that are commonly available in resource-constrained clinical settings

Risk factors, risk assessment, and patient management in each case are coded by a GP and reviewed by a cardiologist consultant; disagreements were resolved by consensus. The gold standard for risk assessment was determined prior to the study based on the clinical guidelines. Cases and gold standard responses for correct risk assessment and patient management were independently reviewed by an expert panel of two other senior cardiology consultants to ensure clinical relevance.
Control group
Active

Outcomes
Primary outcome [1] 342975 0
Risk assessment
Timepoint [1] 342975 0
Asses at the conclusion of the study
Primary outcome [2] 342976 0
Aspirin prescription
Timepoint [2] 342976 0
Asses at the conclusion of the study
Primary outcome [3] 342977 0
Statin prescription
Timepoint [3] 342977 0
Asses at the conclusion of the study
Secondary outcome [1] 452983 0
Technology Acceptance
Timepoint [1] 452983 0
Immediately after assessing all the patient cases
Secondary outcome [2] 453364 0
Decision-making time
Timepoint [2] 453364 0
Immediately after assesing the patient case, automatically measured by the platform
Secondary outcome [3] 453365 0
Anti-hypertensive prescription (Primary Outcome)
Timepoint [3] 453365 0
Assess at the conclusion of the study
Secondary outcome [4] 453366 0
Advanced examination referral (Primary Outcome)
Timepoint [4] 453366 0
Asses at the conclusion of the study

Eligibility
Key inclusion criteria
Indonesian doctors who are working in general practice or enrolled in a cardiology training program are eligible to participate.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Healthy volunteers
No
Key exclusion criteria
Did not complete consent
Did not finish instructions and all study tasks
Did not complete pre-study and post-study consent

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)
Participants are allocated to sequences at the time of enrolment using balanced randomisation, with sequences presented in random order by Gorilla platform.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The allocation of patient cases to CDS type is according to 9 pre-generated sequences, created so that cases are allocated evenly across each of the three conditions.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
effects of CDS are tested using Friedman’s test comparing three-way multiple repeated measures of cases correctly assessed and managed across interventions.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
1/11/2024
Date of last participant enrolment
Anticipated
Actual
31/12/2024
Date of last data collection
Anticipated
Actual
31/12/2024
Sample size
Target
61
Accrual to date
Final
102
Recruitment outside Australia
Country [1] 27421 0
Indonesia
State/province [1] 27421 0

Funding & Sponsors
Funding source category [1] 320117 0
University
Name [1] 320117 0
Macquarie University
Country [1] 320117 0
Australia
Funding source category [2] 320118 0
Government body
Name [2] 320118 0
NHMRC
Country [2] 320118 0
Australia
Primary sponsor type
University
Name
Macquarie University
Address
Country
Australia
Secondary sponsor category [1] 322677 0
None
Name [1] 322677 0
Address [1] 322677 0
Country [1] 322677 0
Other collaborator category [1] 283703 0
University
Name [1] 283703 0
Universitas Indonesia
Address [1] 283703 0
Country [1] 283703 0
Indonesia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 318666 0
Macquarie University Human Research Ethics Committee Medical Sciences
Ethics committee address [1] 318666 0
Ethics committee country [1] 318666 0
Australia
Date submitted for ethics approval [1] 318666 0
11/11/2021
Approval date [1] 318666 0
02/05/2022
Ethics approval number [1] 318666 0
10328
Ethics committee name [2] 318667 0
Fakultas Kedokteran Universitas Indonesia
Ethics committee address [2] 318667 0
Ethics committee country [2] 318667 0
Indonesia
Date submitted for ethics approval [2] 318667 0
14/06/2022
Approval date [2] 318667 0
20/06/2022
Ethics approval number [2] 318667 0
22-06-0746

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

Contacts
Principal investigator
Name 144862 0
Prof Farah Magrabi
Address 144862 0
Macquarie University, Australian Institute of Health Innovation, LEVEL 6, 75 TALAVERA RD, NSW 2113
Country 144862 0
Australia
Phone 144862 0
+61 2 9850 2429
Fax 144862 0
Email 144862 0
[email protected]
Contact person for public queries
Name 144863 0
Anindya Susanto
Address 144863 0
Macquarie University, Australian Institute of Health Innovation, LEVEL 6, 75 TALAVERA RD, NSW 2113
Country 144863 0
Australia
Phone 144863 0
+61423309268
Fax 144863 0
Email 144863 0
[email protected]
Contact person for scientific queries
Name 144864 0
Anindya Susanto
Address 144864 0
Macquarie University, Australian Institute of Health Innovation, LEVEL 6, 75 TALAVERA RD, NSW 2113
Country 144864 0
Australia
Phone 144864 0
+61423309268
Fax 144864 0
Email 144864 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
Yes
Will there be any conditions when requesting access to individual participant data?
Persons/groups eligible to request access:
• Researchers
Conditions for requesting access:
• Yes, conditions apply:
• Requires review on a case-by-case basis by the trial custodian, sponsor or data sharing committee
• Requires approval by an ethics committee
What individual participant data might be shared?
• De-identified individual participant data:
• Published results
• Primary outcome(s)
What types of analyses could be done with individual participant data?
• Any type of analysis (i.e. no restrictions on data re-use)
When can requests for individual participant data be made (start and end dates)?
From:
At the end of the study
To:
A finite period of: 5 years
Where can requests to access individual participant data be made, or data be obtained directly?
• Email of trial custodian, sponsor or committee: contact [email protected] (corresponding) or [email protected] (Principal investigator)

Are there extra considerations when requesting access to individual participant data?
No


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

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

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseAI-Assisted Cardiovascular Risk Assessment by General Practitioners in Resource-Constrained Indonesian Settings Using a Conceptual Prototype: Randomized Controlled Study.2025https://dx.doi.org/10.2196/73131
N.B. These documents automatically identified may not have been verified by the study sponsor.