Hearing for Learning Initiative – a Health Facilitator Model for Otitis Media

Overview

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?

Full Title of Study: “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”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Health Services Research
    • Masking: Single (Outcomes Assessor)
  • Study Primary Completion Date: June 30, 2024

Detailed Description

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.

Interventions

  • Behavioral: facilitator
    • Training and employment of community members to assist the diagnosis and management of otitis media

Arms, Groups and Cohorts

  • Active Comparator: Facilitator
    • 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.
  • No Intervention: Control
    • No Facilitator. Brief 6-monthly 2 to 3 hour in-service training via zoom for health professionals.

Clinical Trial Outcome Measures

Primary Measures

  • Ear assessment
    • Time Frame: 6-monthly
    • Proportion of children who have had a documented ear assessment

Secondary Measures

  • Prevalence of otitis media
    • Time Frame: 6-monthly
    • Proportion of children with any otitis media
  • Management plan
    • Time Frame: 6-monthly
    • Proportion of otitis media cases with a management plan
  • Appropriate management plan
    • Time Frame: 6-monthly
    • Proportion of management plans that are appropriate
  • Follow-up
    • Time Frame: 6-monthly
    • Proportion of cases with follow-up within 10 days

Participating in This Clinical Trial

Inclusion Criteria

Aboriginal or Torres Strait Islander, resident in participating community (cluster) Exclusion Criteria:

none

Gender Eligibility: All

Minimum Age: 1 Week

Maximum Age: 16 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Menzies School of Health Research
  • Collaborator
    • Australian Government Department of Health and Ageing
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Amanda Leach, PhD, Principal Investigator, Menzies School of Health Research
    • Kelvin Kong, MBBS, Study Director, Newcastle University
    • Peter S Morris, MBBS, PhD, Study Director, Menzies School of Health Research
    • Alan Cass, MBBS, PhD, Study Director, Menzies School of Health Research

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