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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03916029
Acronym
HfLI
Enrollment
18
Registered
2019-04-16
Start date
2019-02-03
Completion date
2024-12-31
Last updated
2025-05-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Otitis Media, Conductive Hearing Loss

Keywords

primary health care, workforce, Aboriginal or Torres Strait Islander, facilitator, education

Brief summary

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?

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

BEHAVIORALfacilitator

Training and employment of community members to assist the diagnosis and management of otitis media

Sponsors

Australian Government Department of Health and Ageing
CollaboratorOTHER_GOV
Northern Territory Government of Australia
CollaboratorOTHER_GOV
Menzies School of Health Research
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Outcomes Assessor)

Masking description

Data analyst will be blinded to the cluster allocation.

Intervention model description

Stepped-wedge cluster randomised controlled trial

Eligibility

Sex/Gender
ALL
Age
1 Weeks to 16 Years
Healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

none

Design outcomes

Primary

MeasureTime frameDescription
Ear assessment6-monthlyProportion of children who have had a documented ear assessment

Secondary

MeasureTime frameDescription
Prevalence of otitis media6-monthlyProportion of children with any otitis media
Management plan6-monthlyProportion of otitis media cases with a management plan
Appropriate management plan6-monthlyProportion of management plans that are appropriate
Follow-up6-monthlyProportion of cases with follow-up within 10 days

Other

MeasureTime frameDescription
Prevalence of hearing loss among school age children6-monthlyProportion of school age children with conductive hearing loss

Countries

Australia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 22, 2026