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

Primary Purpose

Rheumatic Heart Disease

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
SPLASH echocardiography screening
Sponsored by
Menzies School of Health Research
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Rheumatic Heart Disease focused on measuring Echocardiography, Task-sharing, Aboriginal and Torres Strait Islander Peoples, Pregnancy, Children, First Nation Peoples

Eligibility Criteria

5 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Intervention

    Arm Description

    Participant receiving echocardiography screening.

    Outcomes

    Primary Outcome Measures

    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

    Secondary Outcome Measures

    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.
    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
    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.
    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.
    Prevalence of rheumatic heart disease within the screened population
    Prevalence of RHD in screened population based on echocardiographic diagnosis
    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.
    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.

    Full Information

    First Posted
    June 13, 2023
    Last Updated
    August 12, 2023
    Sponsor
    Menzies School of Health Research
    Collaborators
    The University of Western Australia, Telethon Kids Institute, Western Australian Country Health Service, Northern Territory Government of Australia, Timor-Leste Ministry of Health, Miwatj Health Aboriginal Corporation, Mala'la Health Service Aboriginal Corporation, Pilbara Aboriginal Health Alliance
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    1. Study Identification

    Unique Protocol Identification Number
    NCT06002243
    Brief Title
    Non-Expert Acquisition & Remote Expert Review of Screening Echocardiography Images From Child Health & AnteNatal Clinics
    Acronym
    NEARER SCAN
    Official Title
    Non-Expert Acquisition and Remote Expert Review of Screening Echocardiography Images From Child Health and AnteNatal Clinics (NEARER SCAN)
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    August 2023 (Anticipated)
    Primary Completion Date
    June 2025 (Anticipated)
    Study Completion Date
    December 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Menzies School of Health Research
    Collaborators
    The University of Western Australia, Telethon Kids Institute, Western Australian Country Health Service, Northern Territory Government of Australia, Timor-Leste Ministry of Health, Miwatj Health Aboriginal Corporation, Mala'la Health Service Aboriginal Corporation, Pilbara Aboriginal Health Alliance

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    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: To co-design implementation strategies with communities underpinned by local program theories. 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. To conduct a realist evaluation to understand what implementation strategies assist in integrating this intervention into routine health service delivery and why. To determine the clinical effectiveness of the intervention in terms of impact on key clinical outcome measures. 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Rheumatic Heart Disease
    Keywords
    Echocardiography, Task-sharing, Aboriginal and Torres Strait Islander Peoples, Pregnancy, Children, First Nation Peoples

    7. Study Design

    Primary Purpose
    Screening
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    1500 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Intervention
    Arm Type
    Experimental
    Arm Description
    Participant receiving echocardiography screening.
    Intervention Type
    Diagnostic Test
    Intervention Name(s)
    SPLASH echocardiography screening
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Change in proportion receiving secondary antibiotic prophylaxis
    Description
    The change in proportion of the at-risk population receiving secondary antibiotic prophylaxis at the end of the study as compared to baseline
    Time Frame
    18 months from commencement of study
    Secondary Outcome Measure Information:
    Title
    Full echocardiogram following screening echocardiogram
    Description
    Proportion of people with an abnormal or uninterpretable screening echocardiogram who get a full diagnostic echocardiogram within 3 months and receive a diagnosis.
    Time Frame
    3 months from screening echocardiogram
    Title
    Proportion of people diagnosed with RHD who are retained in care
    Description
    Proportion of people diagnosed during study period with RHD who receive guideline-based care by local health service
    Time Frame
    18 months from commencement of study
    Title
    Secondary antibiotic prophylaxis prescription and adherence
    Description
    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.
    Time Frame
    12 months from time of diagnosis or at end of the study (which ever is longer).
    Title
    Maternal morbidity and mortality outcomes
    Description
    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.
    Time Frame
    Within 6 weeks of the individual's post-partum period
    Title
    Prevalence of rheumatic heart disease within the screened population
    Description
    Prevalence of RHD in screened population based on echocardiographic diagnosis
    Time Frame
    18 months from commencement of study
    Title
    Rheumatic valvular heart disease severity (mild, moderate or severe) within the screening population based on echocardiographic diagnosis
    Description
    Description of severity of RHD in screened population. This will include proportions of mild, moderate and severe valve disease.
    Time Frame
    18 months from commencement of study
    Title
    Neonatal morbidity and mortality outcomes
    Description
    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.
    Time Frame
    Within 6 weeks post-partum

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    5 Years
    Accepts Healthy Volunteers
    No
    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.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Joshua R Francis, MBBS
    Phone
    +61423528381
    Email
    josh.francis@menzies.edu.au
    First Name & Middle Initial & Last Name or Official Title & Degree
    James A Marangou, MBBS
    Phone
    +61412277527
    Email
    james.marangou@menzies.edu.au
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Joshua R Francis, MBBS
    Organizational Affiliation
    Menzies School of Health Research
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

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

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