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Trial registered on ANZCTR


Registration number
ACTRN12625000144415p
Ethics application status
Submitted, not yet approved
Date submitted
10/12/2024
Date registered
7/02/2025
Date last updated
7/02/2025
Date data sharing statement initially provided
7/02/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
Rheumatic Heart Disease (RHD) echo screening study in school vs school and community settings in year 7 and 8 students.
Scientific title
A cluster randomised control trial comparing the effectiveness and cost effectiveness of school vs school and community-based settings in echo screening for undetected Rheumatic Heart Disease (RHD) for year 7 and 8 students
Secondary ID [1] 313403 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Rheumatic Heart Disease 335779 0
Condition category
Condition code
Cardiovascular 332352 332352 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention for this trial is an echocardiogram (echo). An echocardiogram is a non-invasive ultrasound scan of the heart. For this trial, the echo will be an abbreviated screening scan conducted specifically to detect rheumatic heart disease (RHD). The echo will be conducted according to a specific protocol known as single parasternal-long-axis view with a sweep of the heart (SPLASH +). This protocol has been used in other RHD screening studies internationally. Students will be screened in private lying down on plinths.The SPLASH+ protocol does not require the use of ECG, and in most cases will not require rangatahi/ fanau/young person to change into gowns. This echo screen can be completed while the rangatahi/ fanau/young person is wearing their usual clothes, by pulling their collar down a little, or unbuttoning the top button of their blouse. This will be conducted in a private area. An ultrasound probe covered in gel (usually warm gel, removed with a tissue afterwards) is moved over the upper chest area (near the collarbone) to obtain images of the heart and surrounding blood vessels. Images of the heart will be captured from several different angles. Rangatahi/ fanau/young person will feel mild pressure from the probe but shouldn’t feel any discomfort / pain.

The screening echo will be delivered by non-expert heart scanners. The heart scanners are health professionals such as nurses or radiographers who have completed training specifically to complete SPLASH + screening echos. The heart scanners will be supervised by expert cardiac sonographers. The training requirements and timeframes for the briefly trained heart scanners are:
1. Online modules x 12 (own time). This is the WiRED International Rheumatic Heart Disease e-Learning modules which cover the following modules: what is rheumatic heart disease, and rationale for screening, cardiac anatomy and physiology, RHD pathophysiology, How echocardiography works, views of the heart in echocardiography, adjusting the 2D images, ColourDoppler imaging, RHD findings on an echocardiogram, measuring regurgitation and using ECG with echocardiography.

This is intensive training that is delivered over 14 days through tutorials, hands-on practice and logbook - 100 training scans.

2. Anatomy of the heart, diastole, systole, valves, blood flow etc for 3-4 days via zoom.
The trainers are a cardiac sonographer) and a paediatrician.
3. Starship Simulator for 1.5 days (3 half days). The simulator is a machine based at Starship that allows for practising the views while beginning learning, great to practise on this before a "real" patient. It is not portable outside of Starship.

4.Skills lab for 1 half day. This is preparation before patient contact for the new training non-experts. It involves teaching on the cardiac cycle, flow through the heart, ergonomics, screening protocol views, discussion of colour Doppler. And then lining up 100 pre-scans as part of the curriculum.

Quizzes are administered throughout, and they must pass at 80% before they are released into the community.

The screening echo will be conducted once and in person. The SPLASH + protocol takes approximately 8-10 minutes to complete. If an abnormality (evidence of RHD or other cardiac abnormality such as a congenital defect) is suspected on the abbreviated echo, the participant will proceed to having a full, confirmatory echo. This will be done by the expert cardiac sonographers and will take up to one hour. The aim in this study is to have the confirmatory echo completed on the same day, or as soon as possible after the screening echo.

Study participants and their caregivers will be provided with written material outlining what an echo is and how the procedure will be conducted. A link to a video demonstrating how an echo is conducted will also be provided. Study participants will have the opportunity to watch a short 3-minute 30 seconds video designed for this study and ask questions on the day of their echo with trained kaiawhina/workers at the screening locations. Caregivers are welcome to be present during the echo. The screening echo requires minimal exposure and study participants will remain dressed in their usual school uniforms/clothing.

The echo will be conducted either at intermediate schools or at community venues such as marae, churches, or primary health care setting. At some community venues, healthcare van used primarily for immunisations, will be converted and used for echo screening.

The intervention group are communities randomised to receive the echo at schools only.
Intervention code [1] 330006 0
Early detection / Screening
Intervention code [2] 330178 0
Treatment: Devices
Comparator / control treatment
Comparator/control
This is a cluster randomised control trial. The intervention (screening echo) does not change according to the control/ comparator groups; instead, the location of the intervention changes.
The comparator/control group in this trial are school clusters randomised to have the intervention (screening echo) at school or a community venue. The choice of screening location will be made by the caregivers and study participants themselves.
Control group
Active

Outcomes
Primary outcome [1] 339955 0
To determine the effectiveness of echo screening for undetected RHD in school-based settings alone versus school and community-based settings in Aotearoa New Zealand.
Effectiveness will include assessing as the logistical and operational aspects of delivering echo screening, as well as workforce implications and model of care preferences of parents/guardians and clinicians.
Timepoint [1] 339955 0
Participation will be assessed at the end of the enrolment period for the trial.
Consent rate and completion rate will be assessed post all echo screening is completed.
Patient and whanau/ aiga/ kainga/family preferences and experiences survey results will be collected post echo screening.
Screening staff experiences survey results will be collected post echo screening.
Proportion of patients with screen detected RHD or non-RHD abnormalities will be collected post echo screening.
Attendance rate at follow up and rate of adherence to recommended management pathway will be collected post echo screening.
Number of participating schools will be collected pre screening
Characteristics of participating schools will be collected pre screening
Number and % of heart screeners undertaking the screening will be collected pre screening
Implementation issues identified by the screening staff and participants will be collected post screening
Proportion of screens that were not of ‘good quality' will be collected post screening
Recommendations for a workforce model will be collected post screening
Mitigations to manage capacity will be collected post screening
Determining a base line for stage shift will be collected post screening.
Primary outcome [2] 340091 0

Cost-effectiveness variables of echo screening for undetected RHD in school-based settings alone versus school and community-based settings in Aotearoa New Zealand will be assessed as composite outcome.
Timepoint [2] 340091 0
Cost-effectiveness variables survey results will be collected post echo screening.
Secondary outcome [1] 442057 0
Availability of the workforce, training levels, and diagnostic capacity assessed as a composite outcome.
Timepoint [1] 442057 0
All staff involved in RHD screening (including heart screeners, kaiawhina/workers, sonographers and relevant members of the study team) will be invited to korero together as a group at the completion of a site screening clinic.
Secondary outcome [2] 442566 0
Maori whanau and Pacific aiga/ kainga/family experience for those whose rangatahi/ fanau/young person are diagnosed with RHD through echo screening programme assessed as composite outcome.
Timepoint [2] 442566 0
Talanoa/hui and interviews will be conducted once echo results have been provided to Maori whanau and Pacific aiga/ kainga/family.
Secondary outcome [3] 442592 0
The perspectives of parents/caregivers on the use of Artificial Intelligence (AI) in their child’s healthcare, as well as perspectives of the workforce involved in RHD screening.
Timepoint [3] 442592 0
Parents and caregivers whose children participate in the study will be invited to complete an electronic survey following the screening of their rangatahi/ fanau.
Perspectives of the workforce will be invited to complete an electronic survey post screening at each site.
Secondary outcome [4] 442593 0
Validity of the Lot Quality Assurance Sampling (LQAS) methodology is back tested, and cutoff values are refined for classifying school risk.
Timepoint [4] 442593 0
Data collected in REDCap will be reviewed at the end of the study.

Eligibility
Key inclusion criteria
A universal approach to echo screening will be taken in the schools selected, therefore all students, attending a selected school, within the years 7 and 8 will be invited to participate in this study via their parents/guardians.
Minimum age
10 Years
Maximum age
13 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
The key exclusion criteria for this trial are:
- Students without parental consent
- Students that do not assent to an echo screen on the day
- Students that are unwilling or unable to complete a screen on the day

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Not concealed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
In this trial, each school acts as a cluster and randomisation will occur at individual cluster level. Prior to randomisation block stratification will occur. Schools will be stratified according to roll size into one of three categories- small, medium or large schools. What determines a small, medium or large school will be defined once participating schools are confirmed. Once stratified, randomisation to the control (school screening only) or comparator (school+ community screening) groups will occur via simple randomisation using a randomisation table created by Microsoft excel’s randomisation function”.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
This trial is a cluster RCT where individual schools act as a cluster. The intervention (screening echo) is the same across the clusters. The clusters are randomised to receive the intervention at school (control) or school plus community (comparator).
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The data collected during this trial will be used to operationalise the study, to manage the screening of participants and their clinical care. It will also be used to meet the research objectives/answer the study questions, largely retrospectively. Interim data analysis may be undertaken during the study to monitor progress and identify any issues with the study protocol. Ethnicity will be an important variable within this analysis.
Analysis components:
1. Capturing all necessary data: identifying all data variables to be captured during the
study and linking to any additional data required (eg. test results) will create a
comprehensive dataset that includes all the necessary information and that uses a
common identifier ie. the participant study number.
2. Data cleaning and pre-processing: Once all data is collated, data will be cleaned and
pre-processed to ensure that it is ready for analysis. This involves removing duplicates,
missing values, and outliers, and transforming the data as necessary. Data quality
(including overall quality of the datasets and the quality of variables of interest) will be
taken into account when the analysis is undertaken and when the results are
interpreted. Data cleaning may result in identification of quality issues that may require
contacting the study participant/their whanau post screening to rectify.
3. Statistical analysis: To assess the differences or associations between the two
intervention models, several statistical approaches will be considered. The choice of
method will depend on the nature of the data and the specific outcomes being
evaluated, ensuring the most appropriate analytical techniques are applied.
Descriptive Statistics
1.Continuous Variables: Calculate means, medians, standard deviations, and ranges.
2.Categorical Variables: Calculate frequencies and percentages.
Univariate Analysis:
1.Chi-square Test: To test for significant differences in screening uptake between
different hospitals, regions, and ethnic groups.
2.T-test or ANOVA: To compare means of continuous variables between groups.
Multivariate Analysis
Logistic Regression:
1.Outcome Variable: Screening status (binary: screened vs. not screened).
2.Outcome Variable: Screening status (binary: screened school based vs. Screened School + Community)
3.Predictor Variables: school, ethnic group, age, gender, etc.
4.Adjust for potential confounders
5.Association with the Outcome: Use univariate analysis to identify variables significantly
associated with the outcome.
6.Association with the Predictor: Check if the potential confounder is associated with the
predictor variables.
7.Expert Knowledge: Use expert knowledge including literature reviews to identify
variables that could influence both the predictors and the outcome.
Linear Regression:
1.Outcome Variable: Continuous outcomes related to screening.
2.Predictor Variables: Same as above.
Cost-effectiveness Analysis
a..Outcome Variable: Net Benefits
b.Outcome Variable: Net Costs
c.Outcome Variable: Incremental Cost-effectiveness Ratios
4. Robust standard errors will be used to account for potential intra-cluster correlation
within schools. By using robust variance estimation (VCE), the model will adjust for the
clustering effect, ensuring valid statistical inferences and mitigating the risk of biased
standard errors that may arise from the lack of independence between students within
the same school. Reporting: to report the findings and conclusions based on the
analysis, we may use visualisations such as graphs and charts to help illustrate our
findings and make them more accessible to stakeholders. It is also important to
provide clear and concise explanations of the statistical tests used and the results
obtained.
Focus will be on both the statistical as well as the clinical and practical significance of
the findings. Some analysis may not be undertaken if the total number available for
analysis is small.
5. Software use:
a.Excel: Microsoft Corporate. (2016)
b.Python: python Software Foundation (2022). Python (version 3.9)
c.Stata: StataCorp LLC. (2021)
d.R: R Core Team. (2023). R (version 4.3.0)
e. SAS: SAS Institute Inc. (2022). SAS (version 9.4)
f. TreeAge Pro Healthcare: TreeAge Software, LLC . (2024). TreeAge Pro Healthcare 2024
R2.
Quantitative Analysis
The following measures will be calculated from the collected data:
Consent/Assent
1,Number and percentage of consents (parents/guardians) by ethnicity, school (including
type of school eg. intermediate) and mode (initial approach, via school’s digital platform,
via SMS link or other)
2.Number and percentage of declines (parents/guardians) by ethnicity and school
3.Number and percentage of declines (students - assent) by ethnicity and school
4.Number and percentage of e-consents vs paper based consents by ethnicity and school
5.Timeliness of consents – comparison of contact dates vs consent dates
Screening
1.Number and percentage of positive cases by ethnicity and age via SPLASH + screen
2.Number and percentage of positive cases by ethnicity, age and stage via cardiac
sonographer screen
3.Number and percentage of those with normal screen by ethnicity and age
4.Number and percentage of those with incidental findings (including by individual finding)
by ethnicity and age
5.Analysis of ‘other observations’ will be undertaken to determine any patterns
Note: a detailed analysis of the clinical findings from the screens will also be undertaken based on the data collected.
Coverage by model
1.Uptake (actual screens undertaken) of school based only model by age, ethnicity and
school
2. Uptake (actual screens undertaken) of school plus community option model by age,
ethnicity – including specific uptake analysis by school and community option
3.Comparison of above.
Cost Effectiveness
Analysis of the costs and benefits, compared by setting and perspective
Settings
1.Baseline: Current Practice
2.Intervention 1: Screening School-based Only
3.Intervention 2: Screening School + Community
Perspectives
1.Societal (Reference Case 1)
2.Healthcare Sector (Reference Case 2)
3.Patient/Household
Decision Tree Analysis including Markov Model of Disease Progression
Outcomes
1.Expected patient counts and costs of disease stages
2.Expected net benefits of interventions
3.Expected net costs of interventions
4.Expected incremental cost-effectiveness ratios for interventions
Sensitivity Analyses
1.Variable selection depends on results and uncertainty surrounding parameters
2.Single- and multi-variate
Subgroup analyses will be conducted as needed and when feasible
1.Ethnic profile
2.Age structure
3.Deprivation profile
4.Household characteristics (eg., area of domicile)
Descriptive Analysis of student baseline characteristics
Ethnic profile comparing total response ethnicity with prioritised – particularly to ascertain impact of prioritising Maori where more than one ethnicity is recorded.
Description of the cohort of students – compared by prioritised ethnicity:
1.Ethnic profile
2.Age structure
3.Area of domicile
4.Deprivation profile
Other potential analysis
1.Pathway variation for positive cases
2.Timeliness of follow up pathways
Qualitative Analysis
Survey Analysis of students, parents/whanau
1.Acceptability of model option, including cultural acceptability
2.Experience of approach, consent, screen, information given etc
3.Costs incurred eg. transport, out-of-pocket treatment
4.Quality of life measures
5.Whether they would find AI reading of scans acceptable – in the future (not for this
screen)
6.Other impacts
Survey Analysis of Workforce
There are a range of different roles within the workforce who will be surveyed, including;
1.Clinicians – sonographers, doctors and nurses
2.Other non-expert screeners
3.Kaiawhina/worker
4.Other research staff
Analysis will cover:
1.Acceptability of screening by venue (school vs community setting)
2.Rating of process
3.Elements of best set-up eg. bus for screening vs school facility
4.System impacts (gathered from a range of workforce stakeholders beyond the actual
screen)
5.Specific issues
Survey Analysis of School
1.Acceptability of pilot at your school
2.Time commitment
3.Staff commitment
4.Specific issues
Survey Analysis of Community setting/venue
1.Acceptability of pilot in your setting/venue
2.Time commitment
3.Staff commitment
4.Specific issues

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
28/04/2025
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
3000
Accrual to date
Final
Recruitment outside Australia
Country [1] 26752 0
New Zealand
State/province [1] 26752 0

Funding & Sponsors
Funding source category [1] 317844 0
Government body
Name [1] 317844 0
Health New Zealand | Te Whatu Ora
Country [1] 317844 0
New Zealand
Primary sponsor type
Individual
Name
Dr Dale Bramley Health New Zealand | Te Whatu Ora
Address
Country
New Zealand
Secondary sponsor category [1] 320174 0
None
Name [1] 320174 0
Address [1] 320174 0
Country [1] 320174 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 316526 0
Health and Disability Ethics Committees
Ethics committee address [1] 316526 0
Ministry of Health, Health and Disability Ethics Committees PO Box 5013 Wellington 6140
Ethics committee country [1] 316526 0
New Zealand
Date submitted for ethics approval [1] 316526 0
26/11/2024
Approval date [1] 316526 0
Ethics approval number [1] 316526 0

Summary
Brief summary
The overall aim of the study is to provide high quality data and evidence-based recommendations to inform a case for an equitable national RHD echo screening programme in Aotearoa New Zealand.
The primary objective of this RCT study is to determine the effectiveness and cost-effectiveness of echo screening for undetected RHD in school-based settings alone versus school and community-based settings in Aotearoa New Zealand.
It is hypothesised that a school plus community-based programme will achieve a 10% additional uptake rate compared to a school-based only programme.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 138162 0
Dr Karen Bartholomew
Address 138162 0
Health New Zealand | Te Whatu Ora Level 2, Q4 Smales Farm, Takapuna Auckland 0720
Country 138162 0
New Zealand
Phone 138162 0
+64 212115629
Fax 138162 0
Email 138162 0
[email protected]
Contact person for public queries
Name 138163 0
Karen Bartholomew
Address 138163 0
Health New Zealand | Te Whatu Ora Level 2, Q4 Smales Farm, Takapuna Auckland 0720
Country 138163 0
New Zealand
Phone 138163 0
+64 212115629
Fax 138163 0
Email 138163 0
[email protected]
Contact person for scientific queries
Name 138164 0
Karen Bartholomew
Address 138164 0
Health New Zealand | Te Whatu Ora Level 2, Q4 Smales Farm, Takapuna Auckland 0720
Country 138164 0
New Zealand
Phone 138164 0
+64 212115629
Fax 138164 0
Email 138164 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
All data gathering, collection and access processes for this study are designed to actively protect the privacy and confidentiality of data. Sharing IPD could potentially lead to the identification of participants especially in Maori and Pacific communities who are disproportionately affected by RHD.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
24442Statistical analysis plan    388776-(Uploaded-13-01-2025-09-01-01)-STATISTICAL ANALYSIS PLAN1.pdf
24443Informed consent form    388776-(Uploaded-13-01-2025-09-02-04)-PISCF_Workforce Substudy_Final.pdf



Results publications and other study-related documents

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