Non-Expert Acquisition & Remote Expert Review of Screening Echocardiography Images From Child Health & AnteNatal Clinics

Rheumatic Heart Disease Clinical Trial

— NEARER SCAN  

Official title:

Non-Expert Acquisition and Remote Expert Review of Screening Echocardiography Images From Child Health and AnteNatal Clinics (NEARER SCAN)

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06002243
• Other study ID #: APP2015869
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 2024
• Est. completion date: December 2025

Study information

• Verified date: March 2024
• Source: Menzies School of Health Research
• Contact: Joshua R Francis, MBBS
• Phone: +61423528381
• Email: josh.francis[@]menzies.edu.au
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The Non-Expert Acquisition and Remote Expert Review of Screening echocardiography images from Child health and AnteNatal clinics (NEARER SCAN) study is a co-designed, implementation research project that will improve equitable access to culturally safe, best quality care for Rheumatic Heart Disease (RHD) in high-burden Aboriginal and Torres Strait Islander communities in Australia, and in Timor-Leste. The research addresses an area of unmet need, using novel technologies and embedding them in health practice, to enhance and accelerate diagnosis of RHD outside acute health settings and improve outcomes. The study will be conducted in partnership with community leaders and local partners.

Description:

This study titled 'Non-Expert Acquisition and Remote Expert Review of Screening echocardiography images from Child health and AnteNatal clinics' (NEARER SCAN; "LENO BESIK" in Tetum) aims to co-design, implement and evaluate a task-sharing approach to echocardiographic screening for early detection and management of rheumatic heart disease (RHD) in high-risk settings in Australia and Timor-Leste.

Specific objectives include:

1. To co-design implementation strategies with communities underpinned by local program theories.

2. To implement SPLASH echocardiography training and a task-sharing approach to echocardiographic screening for early detection and management of RHD in communities, based on co-designed implementation strategies.

3. To conduct a realist evaluation to understand what implementation strategies assist in integrating this intervention into routine health service delivery and why.

4. To determine the clinical effectiveness of the intervention in terms of impact on key clinical outcome measures.

5. To conduct cost-of-illness, cost-effectiveness and budget-impact analyses of the task-sharing approach to echocardiographic screening for early detection and management of RHD in Australia and Timor-Leste.

Local primary health clinic staff will be trained to perform focused echocardiography using hand-carried ultrasound (HCU) devices employing the 'Single Parasternal Long Axis view with a Sweep of the Heart' (SPLASH) technique. The acquired images will be interpreted by experts (cardiologists and cardiac sonographers) remotely from the site of acquisition. Approximately 1500 children and pregnant women will be screened across high-risk communities in Australia and Timor Leste, over an 18 month period.

A mixed-methods effectiveness-implementation study design will be used to evaluate the implementation of an intervention designed to achieve early detection and management of RHD in high-risk populations. An implementation strategy will be co-designed at each site with the local community and participating primary healthcare (PHC) service, incorporating non-adaptable elements of the intervention, and mapped onto a Theory of Change framework. Co-design, implementation and evaluation will occur simultaneously, and a Type 2 hybrid design study will be used to evaluate both the implementation strategies and the clinical effectiveness of the intervention. The clinical effectiveness will be assessed as the change in the proportion of the at-risk population that received secondary prophylaxis by the end of the study compared to baseline. Program implementation will be evaluated with a realist evaluation to explain under what circumstances the program is successfully integrated into routine service delivery. Data informing evaluation will include numbers of normal, abnormal, and uninterpretable SPLASH echocardiograms obtained, numbers of participants progressing through the cascade of care, augmented by qualitative data from interviews conducted with staff and participants, and costs.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 1500
• Est. completion date: December 2025
• Est. primary completion date: June 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years and older

Eligibility

Inclusion Criteria in Australia:

• Any child between the age of 5 - 20 years old living in the participating community

• Pregnant women at high risk for RHD undergoing antenatal appointments or a hospital admission will be invited to participate. High risk for RHD will be defined as being from an area where RHD all-age prevalence is >1/1000 RHD or acute rheumatic fever incidence >30/100,000 per year in 5-14-year-olds. For practical purposes, this means Aboriginal women living in urban, rural or remote communities in northern Australia, or immigrants from high-risk settings.

Inclusion criteria for Timor-Leste:

• Any child between the age of 5-20 years old and any pregnant woman.

Exclusion criteria for Australia and Timor-Leste:

• Women who are unable to consent due to physical, mental, or intellectual disability will be excluded. Women and children with known existing cardiac disease will NOT be excluded since evaluation of severity and change in severity during pregnancy will be tracked, and data will inform the calculation of prevalence.

Related Conditions & MeSH terms

• Heart Diseases
• Rheumatic Heart Disease

Intervention

Diagnostic Test:
• SPLASH echocardiography screening
Screening echocardiogram performed by a briefly trained health worker with images reviewed off site by an expert cardiologist or cardiac sonographer to determine screening outcome. Screening outcome may include: screen positive, screen negative or uninterpretable images.

Locations

Country	Name	City	State
n/a

Sponsors (9)

Lead Sponsor	Collaborator
Menzies School of Health Research	Mala'la Health Service Aboriginal Corporation, Miwatj Health Aboriginal Corporation, Northern Territory Government of Australia, Pilbara Aboriginal Health Alliance, Telethon Kids Institute, The University of Western Australia, Timor-Leste Ministry of Health, Western Australian Country Health Service

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in proportion receiving secondary antibiotic prophylaxis	The change in proportion of the at-risk population receiving secondary antibiotic prophylaxis at the end of the study as compared to baseline	18 months from commencement of study
Secondary	Full echocardiogram following screening echocardiogram	Proportion of people with an abnormal or uninterpretable screening echocardiogram who get a full diagnostic echocardiogram within 3 months and receive a diagnosis.	3 months from screening echocardiogram
Secondary	Proportion of people diagnosed with RHD who are retained in care	Proportion of people diagnosed during study period with RHD who receive guideline-based care by local health service	18 months from commencement of study
Secondary	Secondary antibiotic prophylaxis prescription and adherence	Proportion of people prescribed secondary prophylaxis who are achieving >= 80% adherence in a 12 months period from time of diagnosis or the end of the study, whichever is longer.	12 months from time of diagnosis or at end of the study (which ever is longer).
Secondary	Maternal morbidity and mortality outcomes	Description of maternal morbidity and mortality in pregnant women diagnosed with RHD on echocardiographic screening. This will be reported in absolute numbers and percentage of study population. Morbidity will include cardiac complications (heart failure, arrhythmia, aborted sudden cardiac death, acute myocardial infarction), need for obstetric intervention including emergency cesarean section, intensive care admission, other obstetric complications.	Within 6 weeks of the individual's post-partum period
Secondary	Prevalence of rheumatic heart disease within the screened population	Prevalence of RHD in screened population based on echocardiographic diagnosis	18 months from commencement of study
Secondary	Rheumatic valvular heart disease severity (mild, moderate or severe) within the screening population based on echocardiographic diagnosis	Description of severity of RHD in screened population. This will include proportions of mild, moderate and severe valve disease.	18 months from commencement of study
Secondary	Neonatal morbidity and mortality outcomes	Description of neonatal morbidity and mortality outcomes for the pregnant women diagnosed with RHD. This will be reported as absolute numbers and percentage of study population. Morbidity will include need for admission to neonatal intensive care.	Within 6 weeks post-partum