None listed
Conditions
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.
Interventions
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.
Sponsors
Study design
Eligibility
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.
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