Clinical trial NCT03916029: Hearing for Learning Initiative - a Health Facilitator Model for Otitis Media
Official title: 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: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Otitis Media
Conductive Hearing Loss
Keywords: primary health care
workforce
Aboriginal or Torres Strait Islander
facilitator
education
Lead sponsor: Menzies School of Health Research
Sponsor class: OTHER
Collaborators: name: Australian Government Department of Health and Ageing
name: Northern Territory Government of Australia
First posted: 2019-04-16
Enrollment: 18
Sex: ALL
Minimum age (years): 1
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Stepped-wedge cluster randomised controlled trial
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: Inclusion Criteria: Aboriginal or Torres Strait Islander, resident in participating community (cluster)

Exclusion Criteria: none

Primary outcomes:
measure: Ear assessment
timeFrame: 6-monthly
Secondary outcomes:
measure: Prevalence of otitis media
timeFrame: 6-monthly
measure: Management plan
timeFrame: 6-monthly
measure: Appropriate management plan
timeFrame: 6-monthly
measure: Follow-up
timeFrame: 6-monthly
Other outcomes:
measure: Prevalence of hearing loss among school age children
timeFrame: 6-monthly
Locations:
city: Ali Curung
country: Australia
facility: Ali Curung
state: Northern Territory
city: Ampilatwatja
country: Australia
facility: Ampilatwatja
state: Northern Territory
city: Darwin
country: Australia
facility: Darwin
state: Northern Territory
city: Galiwin'ku
country: Australia
facility: Galiwin'ku
state: Northern Territory
city: Gunbalanya
country: Australia
facility: Gunbalanya
state: Northern Territory
city: Kalkarindji
country: Australia
facility: Kalkarindji Primary Health Centre
state: Northern Territory
city: Katherine
country: Australia
facility: Wurli Wurlinjang Health Service
state: Northern Territory
city: Lajamanu
country: Australia
facility: Lajamanu Primary Health Centre
state: Northern Territory
city: Maningrida
country: Australia
facility: Mala'la Health Service
state: Northern Territory
city: Milikapiti
country: Australia
facility: Milikapiti Community Health Centre
state: Northern Territory
city: Milingimbi
country: Australia
facility: Milingimbi Health Clinic
state: Northern Territory
city: Minjilang
country: Australia
facility: Minjilang Community Health Centre
state: Northern Territory
city: Nauiyu
country: Australia
facility: Nauiyu
state: Northern Territory
city: Palumpa
country: Australia
facility: Palumpa Community Health Centre
state: Northern Territory
city: Pirlangimpi
country: Australia
facility: Pirlangimpi Health Clinic
state: Northern Territory
city: Ti Tree
country: Australia
facility: Ti Tree Community Health Centre
state: Northern Territory
city: Wadeye
country: Australia
facility: Wadeye Community Health Centre
state: Northern Territory
city: Warruwi
country: Australia
facility: Warruwi Community Health Centre
state: Northern Territory
city: Wurrumiyanga
country: Australia
facility: Julanimawu (Nguiu) Community Health centre
state: Northern Territory
city: Yirrkala
country: Australia
facility: Yirrkala Clinic
state: Northern Territory
Study officials:
affiliation: Menzies School of Health Research
name: Amanda Leach, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Newcastle University
name: Kelvin Kong, MBBS
role: STUDY_DIRECTOR
affiliation: Menzies School of Health Research
name: Peter S Morris, MBBS, PhD
role: STUDY_DIRECTOR
affiliation: Menzies School of Health Research
name: Alan Cass, MBBS, PhD
role: STUDY_DIRECTOR
References:
citation: Kong K, Cass A, Leach AJ, Morris PS, Kimber A, Su JY, Oguoma VM. A community-based service enhancement model of training and employing Ear Health Facilitators to address the crisis in ear and hearing health of Aboriginal children in the Northern Territory, the Hearing for Learning Initiative (the HfLI): study protocol for a stepped-wedge cluster randomised trial. Trials. 2021 Jun 16;22(1):403. doi: 10.1186/s13063-021-05215-7.