Hearing for Learning Initiative - a Health Facilitator Model for Otitis Media (HfLI)

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

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?

Study Overview

• Status: Active, not recruiting
• Conditions: Otitis Media; Conductive Hearing Loss
• Intervention / Treatment: Behavioral: facilitator

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.

• Study Type: Interventional
• Enrollment (Actual): 18
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Australia
  • Northern Territory
    • Ali Curung, Northern Territory, Australia
      • Ali Curung
    • Ampilatwatja, Northern Territory, Australia
      • Ampilatwatja
    • Darwin, Northern Territory, Australia, 0800
      • Darwin
    • Galiwin'ku, Northern Territory, Australia
      • Galiwin'ku
    • Gunbalanya, Northern Territory, Australia
      • Gunbalanya
    • Kalkarindji, Northern Territory, Australia, 0852
      • Kalkarindji Primary Health Centre
    • Katherine, Northern Territory, Australia, 0850
      • Wurli Wurlinjang Health Service
    • Lajamanu, Northern Territory, Australia
      • Lajamanu Primary Health Centre
    • Maningrida, Northern Territory, Australia, 0820
      • Mala'la Health Service
    • Milikapiti, Northern Territory, Australia
      • Milikapiti Community Health Centre
    • Milingimbi, Northern Territory, Australia, 0822
      • Milingimbi Health Clinic
    • Minjilang, Northern Territory, Australia
      • Minjilang Community Health Centre
    • Nauiyu, Northern Territory, Australia
      • Nauiyu
    • Palumpa, Northern Territory, Australia, 0822
      • Palumpa Community Health Centre
    • Pirlangimpi, Northern Territory, Australia, 0822
      • Pirlangimpi Health Clinic
    • Ti Tree, Northern Territory, Australia, 0872
      • Ti Tree Community Health Centre
    • Wadeye, Northern Territory, Australia, 0822
      • Wadeye Community Health Centre
    • Warruwi, Northern Territory, Australia, 0822
      • Warruwi Community Health Centre
    • Wurrumiyanga, Northern Territory, Australia, 0822
      • Julanimawu (Nguiu) Community Health centre
    • Yirrkala, Northern Territory, Australia, 0880
      • Yirrkala Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 week to 16 years (Child)
• Accepts Healthy Volunteers: Yes

Description

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

Exclusion Criteria: none

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Behavioral: facilitator; Training and employment of community members to assist the diagnosis and management of otitis media
No Intervention: Control; No Facilitator. Brief 6-monthly 2 to 3 hour in-service training via zoom for health professionals.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ear assessment	Proportion of children who have had a documented ear assessment	6-monthly

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Prevalence of hearing loss among school age children	Proportion of school age children with conductive hearing loss	6-monthly

Collaborators and Investigators

• Sponsor: Menzies School of Health Research
• Collaborators: Northern Territory Government of Australia; Australian Government Department of Health and Ageing
• Investigators: Principal Investigator: Amanda Leach, PhD, Menzies School of Health Research; Study Director: Kelvin Kong, MBBS, Newcastle University; Study Director: Peter S Morris, MBBS, PhD, Menzies School of Health Research; Study Director: Alan Cass, MBBS, PhD, Menzies School of Health Research

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): February 3, 2019
• Primary Completion (Estimated): June 30, 2024
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: April 12, 2019
• First Submitted That Met QC Criteria: April 12, 2019
• First Posted (Actual): April 16, 2019

Study Record Updates

• Last Update Posted (Actual): March 15, 2024
• Last Update Submitted That Met QC Criteria: March 12, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: education; primary health care; workforce; facilitator; Aboriginal or Torres Strait Islander
• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Otorhinolaryngologic Diseases; Ear Diseases; Sensation Disorders; Hearing Disorders; Otitis; Hearing Loss; Otitis Media; Hearing Loss, Conductive
• Other Study ID Numbers: R813; TEHREC -18-3264 (Other Identifier: Ethics Committee); CAHREC - 19-330 (Other Identifier: Ethics Committee)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No