跳至主要内容
临床试验/NCT06002243
NCT06002243尚未招募不适用

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

Menzies School of Health Research0 个研究点目标入组 1,500 人开始时间: 2024年4月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
1,500
主要终点
Change in proportion receiving secondary antibiotic prophylaxis

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Screening
盲法
None

入排标准

年龄范围
5 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

研究组 & 干预措施

Intervention

Experimental

Participant receiving echocardiography screening.

干预措施: SPLASH echocardiography screening (Diagnostic Test)

结局指标

主要结局

Change in proportion receiving secondary antibiotic prophylaxis

时间窗: 18 months from commencement of study

The change in proportion of the at-risk population receiving secondary antibiotic prophylaxis at the end of the study as compared to baseline

次要结局

  • Maternal morbidity and mortality outcomes(Within 6 weeks of the individual's post-partum period)
  • Full echocardiogram following screening echocardiogram(3 months from screening echocardiogram)
  • Rheumatic valvular heart disease severity (mild, moderate or severe) within the screening population based on echocardiographic diagnosis(18 months from commencement of study)
  • Secondary antibiotic prophylaxis prescription and adherence(12 months from time of diagnosis or at end of the study (which ever is longer).)
  • Neonatal morbidity and mortality outcomes(Within 6 weeks post-partum)
  • Proportion of people diagnosed with RHD who are retained in care(18 months from commencement of study)
  • Prevalence of rheumatic heart disease within the screened population(18 months from commencement of study)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Joshua Francis

Senior Research Fellow

Menzies School of Health Research

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