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

Primary Purpose

Otitis Media, Conductive Hearing Loss

Status
Active
Phase
Not Applicable
Locations
Australia
Study Type
Interventional
Intervention
facilitator
Sponsored by
Menzies School of Health Research
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Otitis Media focused on measuring primary health care, workforce, Aboriginal or Torres Strait Islander, facilitator, education

Eligibility Criteria

1 Week - 16 Years (Child)All SexesAccepts Healthy Volunteers

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

Exclusion Criteria: none

Sites / Locations

  • Ali Curung
  • Ampilatwatja
  • Darwin
  • Galiwin'ku
  • Gunbalanya
  • Kalkarindji Primary Health Centre
  • Wurli Wurlinjang Health Service
  • Lajamanu Primary Health Centre
  • Mala'la Health Service
  • Milikapiti Community Health Centre
  • Milingimbi Health Clinic
  • Minjilang Community Health Centre
  • Nauiyu
  • Palumpa Community Health Centre
  • Pirlangimpi Health Clinic
  • Ti Tree Community Health Centre
  • Wadeye Community Health Centre
  • Warruwi Community Health Centre
  • Julanimawu (Nguiu) Community Health centre
  • Yirrkala Clinic

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Facilitator

Control

Arm Description

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 Facilitator. Brief 6-monthly 2 to 3 hour in-service training via zoom for health professionals.

Outcomes

Primary Outcome Measures

Ear assessment
Proportion of children who have had a documented ear assessment

Secondary Outcome Measures

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

Full Information

First Posted
April 12, 2019
Last Updated
April 5, 2022
Sponsor
Menzies School of Health Research
Collaborators
Australian Government Department of Health and Ageing, Northern Territory Government of Australia
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1. Study Identification

Unique Protocol Identification Number
NCT03916029
Brief Title
Hearing for Learning Initiative - a Health Facilitator Model for Otitis Media
Acronym
HfLI
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

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
February 3, 2019 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
June 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Menzies School of Health Research
Collaborators
Australian Government Department of Health and Ageing, Northern Territory Government of Australia

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Otitis Media, Conductive Hearing Loss
Keywords
primary health care, workforce, Aboriginal or Torres Strait Islander, facilitator, education

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Stepped-wedge cluster randomised controlled trial
Masking
Outcomes Assessor
Masking Description
Data analyst will be blinded to the cluster allocation.
Allocation
Randomized
Enrollment
18 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Facilitator
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Control
Arm Type
No Intervention
Arm Description
No Facilitator. Brief 6-monthly 2 to 3 hour in-service training via zoom for health professionals.
Intervention Type
Behavioral
Intervention Name(s)
facilitator
Intervention Description
Training and employment of community members to assist the diagnosis and management of otitis media
Primary Outcome Measure Information:
Title
Ear assessment
Description
Proportion of children who have had a documented ear assessment
Time Frame
6-monthly
Secondary Outcome Measure Information:
Title
Prevalence of otitis media
Description
Proportion of children with any otitis media
Time Frame
6-monthly
Title
Management plan
Description
Proportion of otitis media cases with a management plan
Time Frame
6-monthly
Title
Appropriate management plan
Description
Proportion of management plans that are appropriate
Time Frame
6-monthly
Title
Follow-up
Description
Proportion of cases with follow-up within 10 days
Time Frame
6-monthly
Other Pre-specified Outcome Measures:
Title
Prevalence of hearing loss among school age children
Description
Proportion of school age children with conductive hearing loss
Time Frame
6-monthly

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Week
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Aboriginal or Torres Strait Islander, resident in participating community (cluster) Exclusion Criteria: none
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amanda Leach, PhD
Organizational Affiliation
Menzies School of Health Research
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Kelvin Kong, MBBS
Organizational Affiliation
Newcastle University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Peter S Morris, MBBS, PhD
Organizational Affiliation
Menzies School of Health Research
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Alan Cass, MBBS, PhD
Organizational Affiliation
Menzies School of Health Research
Official's Role
Study Director
Facility Information:
Facility Name
Ali Curung
City
Ali Curung
State/Province
Northern Territory
Country
Australia
Facility Name
Ampilatwatja
City
Ampilatwatja
State/Province
Northern Territory
Country
Australia
Facility Name
Darwin
City
Darwin
State/Province
Northern Territory
ZIP/Postal Code
0800
Country
Australia
Facility Name
Galiwin'ku
City
Galiwin'ku
State/Province
Northern Territory
Country
Australia
Facility Name
Gunbalanya
City
Gunbalanya
State/Province
Northern Territory
Country
Australia
Facility Name
Kalkarindji Primary Health Centre
City
Kalkarindji
State/Province
Northern Territory
ZIP/Postal Code
0852
Country
Australia
Facility Name
Wurli Wurlinjang Health Service
City
Katherine
State/Province
Northern Territory
ZIP/Postal Code
0850
Country
Australia
Facility Name
Lajamanu Primary Health Centre
City
Lajamanu
State/Province
Northern Territory
Country
Australia
Facility Name
Mala'la Health Service
City
Maningrida
State/Province
Northern Territory
ZIP/Postal Code
0820
Country
Australia
Facility Name
Milikapiti Community Health Centre
City
Milikapiti
State/Province
Northern Territory
Country
Australia
Facility Name
Milingimbi Health Clinic
City
Milingimbi
State/Province
Northern Territory
ZIP/Postal Code
0822
Country
Australia
Facility Name
Minjilang Community Health Centre
City
Minjilang
State/Province
Northern Territory
Country
Australia
Facility Name
Nauiyu
City
Nauiyu
State/Province
Northern Territory
Country
Australia
Facility Name
Palumpa Community Health Centre
City
Palumpa
State/Province
Northern Territory
ZIP/Postal Code
0822
Country
Australia
Facility Name
Pirlangimpi Health Clinic
City
Pirlangimpi
State/Province
Northern Territory
ZIP/Postal Code
0822
Country
Australia
Facility Name
Ti Tree Community Health Centre
City
Ti Tree
State/Province
Northern Territory
ZIP/Postal Code
0872
Country
Australia
Facility Name
Wadeye Community Health Centre
City
Wadeye
State/Province
Northern Territory
ZIP/Postal Code
0822
Country
Australia
Facility Name
Warruwi Community Health Centre
City
Warruwi
State/Province
Northern Territory
ZIP/Postal Code
0822
Country
Australia
Facility Name
Julanimawu (Nguiu) Community Health centre
City
Wurrumiyanga
State/Province
Northern Territory
ZIP/Postal Code
0822
Country
Australia
Facility Name
Yirrkala Clinic
City
Yirrkala
State/Province
Northern Territory
ZIP/Postal Code
0880
Country
Australia

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
34134736
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.
Results Reference
derived

Learn more about this trial

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

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