Clinical trial NCT06002243: Non-Expert Acquisition & Remote Expert Review of Screening Echocardiography Images From Child Health & AnteNatal Clinics
Official title: Non-Expert Acquisition and Remote Expert Review of Screening Echocardiography Images From Child Health and AnteNatal Clinics (NEARER SCAN)
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Rheumatic Heart Disease
Keywords: Echocardiography
Task-sharing
Aboriginal and Torres Strait Islander Peoples
Pregnancy
Children
First Nation Peoples
Lead sponsor: Menzies School of Health Research
Sponsor class: OTHER
Collaborators: name: The University of Western Australia
name: Telethon Kids Institute
name: Western Australian Country Health Service
name: Northern Territory Government of Australia
name: Timor-Leste Ministry of Health
name: Miwatj Health Aboriginal Corporation
name: Mala'la Health Service Aboriginal Corporation
name: Pilbara Aboriginal Health Alliance
First posted: 2023-08-21
Enrollment: 1500
Sex: ALL
Minimum age (years): 5
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

Brief 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in proportion receiving secondary antibiotic prophylaxis
timeFrame: 18 months from commencement of study
Secondary outcomes:
measure: Full echocardiogram following screening echocardiogram
timeFrame: 3 months from screening echocardiogram
measure: Proportion of people diagnosed with RHD who are retained in care
timeFrame: 18 months from commencement of study
measure: Secondary antibiotic prophylaxis prescription and adherence
timeFrame: 12 months from time of diagnosis or at end of the study (which ever is longer).
measure: Maternal morbidity and mortality outcomes
timeFrame: Within 6 weeks of the individual's post-partum period
measure: Prevalence of rheumatic heart disease within the screened population
timeFrame: 18 months from commencement of study
measure: Rheumatic valvular heart disease severity (mild, moderate or severe) within the screening population based on echocardiographic diagnosis
timeFrame: 18 months from commencement of study
measure: Neonatal morbidity and mortality outcomes
timeFrame: Within 6 weeks post-partum
Other outcomes:
Locations:
Study officials:
affiliation: Menzies School of Health Research
name: Joshua R Francis, MBBS
role: PRINCIPAL_INVESTIGATOR
References: