Ignite Creation Date:
2024-05-06 @ 7:25 PM
Last Modification Date:
2024-10-26 @ 3:06 PM
Study NCT ID:
NCT06002243
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-03-18
First Post:
2023-06-13
Brief Title:
Non-Expert Acquisition Remote Expert Review of Screening Echocardiography Images From Child Health AnteNatal Clinics
Sponsor:
Menzies School of Health Research
Organization:
Menzies School of Health Research
Study Overview
Official Title:
Non-Expert Acquisition and Remote Expert Review of Screening Echocardiography Images From Child Health and AnteNatal Clinics NEARER SCAN
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
NEARER SCAN
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None