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临床试验/NCT03916029
NCT03916029已完成不适用

The Hearing for Learning Initiative - a Service-enhancement Model of Ear Health Facilitators to Address the Crisis in Ear and Hearing Health of Aboriginal Children in the Northern Territory: a Stepped-wedge Cluster Randomised Trial

Menzies School of Health Research32 个研究点 分布在 1 个国家目标入组 18 人开始时间: 2019年2月3日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
18
试验地点
32
主要终点
Ear assessment

研究概览

简要总结

The Hearing for Learning Initiative is a stepped-wedge cluster randomised controlled trial. The HfLI will implement and rigorously evaluate an innovative community-based service-enhancement model of ear and hearing health, in partnership with participating communities and health and education services.

This initiative will address the following research question: In urban, rural and remote Aboriginal communities in the Northern Territory, does employment, training and integration of local Ear and Hearing Clinical and Education Support Officers into health and education services (the Hearing for Learning initiative), compared to current practice, increase the proportion of children who receive an ear assessment, reduce the prevalence of ear and hearing problems and improve education outcomes of Aboriginal and Torres Strait Islander children, during a four year trial period?

详细描述

Background: Australian Indigenous children achieve lower scores in school readiness and education outcomes than their non-Indigenous peers. Chronic otitis media and hearing loss during early childhood are associated with lower scores for these outcomes. Local problem: Failure to meet child health program schedules and evidence based practice in ear and hearing health is linked to high turnover of the health workforce, inadequate clinical skills and poor knowledge of ear and hearing health needs of children.

This Hearing for Learning Initiative aims to improve health care and education services.

Interventions: The intervention involves training and employing non-professional community members to facilitate busy primary health care services to deliver evidence-based ear and hearing health assessments in children 0 to 16 years of age, and to facilitate the teaching and home learning of hearing impaired children (the intervention).

Trial design: A stepped-wedge community (n=18) cluster-randomised trial will compare the proportion of children receiving an ear assessment (primary outcomes) in the HfLI (intervention) periods with no HfLI (control) periods. Participating communities will be randomly assigned in 6-monthly steps to shift from control to intervention on pre-specified start dates.

Outcomes: the primary outcome is the change in the proportion of Aboriginal and Torres Strait Islander children who receive an ear assessment, between intervention and control periods.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
Single (Outcomes Assessor)

盲法说明

Data analyst will be blinded to the cluster allocation.

入排标准

年龄范围
1 Week 至 16 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Aboriginal or Torres Strait Islander, resident in participating community (cluster)

排除标准

  • 未提供

研究组 & 干预措施

Facilitator

Active Comparator

120 hours training for local community members delivered on-country face-to-face during 6 4-day weeks and over a 3-6 month period. Certificate II modules in Aboriginal Primary Health Care, ear and hearing health skills development (otoscopy, tympanometry, and hearScreen) and employment as Ear Health Facilitators to the end of the trial.

干预措施: facilitator (Behavioral)

Control

No Intervention

No Facilitator. Brief 6-monthly 2 to 3 hour in-service training via zoom for health professionals.

结局指标

主要结局

Ear assessment

时间窗: 6-monthly

Proportion of children who have had a documented ear assessment

Ear assessment

时间窗: 3-monthly

Proportion of children who have had a documented ear assessment

次要结局

  • Prevalence of otitis media(6-monthly)
  • Appropriate management plan(6-monthly)
  • Management plan(6-monthly)
  • Follow-up(6-monthly)
  • Prevalence of otitis media(3-monthly)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (32)

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