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Trial registered on ANZCTR


Registration number
ACTRN12622000824763
Ethics application status
Approved
Date submitted
20/05/2022
Date registered
10/06/2022
Date last updated
8/12/2024
Date data sharing statement initially provided
10/06/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
ACCESS: Aboriginal Community Controlled Ear-health Support System: developing, embedding and evaluating best practice models of care
Scientific title
ACCESS: Aboriginal Community Controlled Ear-health Support System: developing, embedding and evaluating best practice models of care
Secondary ID [1] 307177 0
Nil known
Universal Trial Number (UTN)
Trial acronym
ACCESS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Otitis media 326403 0
Hearing loss 326443 0
Condition category
Condition code
Ear 323690 323690 0 0
Other ear disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
ACCESS will investigate a novel Aboriginal Child Health Navigator.

Stream 1. Community consultation:
We will determine what is needed from the Aboriginal Child Health Navigator model of care and how it can be integrated into enhanced service models through community yarning sessions and health worker semi-structured interviews with key informants such as parents, healthcare staff and service managers.
The community consultation period will occur pre-, during and post intervention.
The expected duration of the yarning circles will be approximately 60 minutes, although will not be limited if participants wish to continue with further discussion.
The yarning topics will be developed by the research team and informed by the literature and relevant theoretical frameworks. The questions will then be reviewed by ACCHS staff and the local research team member, and amendments will be made following feedback.
The interview guide for the health worker interviews will be developed by the investigators and informed by empirical evidence and theoretical frameworks. The interview guide will be reviewed by ACCHS staff, including the local research team member and amendments will be made following their feedback. The expected duration of the interview is 30-60 minutes.

Stream 2. Evaluation and comparison:
The second stream of ACCESS involves evaluating the Child Health Navigator, comparing a 12-month period prior to the Child Health Navigator and 12-months with the Child Health Navigator. From the 12-month Child Health Navigator period and the 12-month pre-Child Health Navigator period a 6-month analysis period will be determined. ACCESS will track appointment information of children to compare attendance to ear health-related services. The Child Health Navigator will use Aboriginal co-designed screening tools such as the Parent-evaluated Listening & Understanding Measure (PLUM) and the Talking and Listening Scale (HATS), in conjunction with the 715-health check to identify children who require the support of health and other relevant services. We will evaluate these tools during the follow-up consultations mentioned above (Stream 1).
The PLUM and HATS are basic checklists. They assist early childhood workers to ask families the right questions in order to find out how a child’s listening skills are developing. Parents/carers will be asked about their child’s day-to-day hearing and speech. Examples include, can the child hear people calling them, talking or singing? Can they communicate, like pointing, cooing, babbling, copying sounds or saying words. The response options include ‘not yet or a little’, ‘sometimes’ or ‘a lot’. The responses are tallied and will indicate whether the child is ‘on track’ with their listening and talking skills.
The 715 is a specific health check that is available for Aboriginal and Torres Strait Islander people. It helps to identify risk factors for chronic disease to manage the good health of the patient. The health check will include an assessment of the patient’s physical, psychological and social wellbeing. A Practice Nurse, Aboriginal Health Worker or Aboriginal Health Practitioner may assist with initial tests and medical history. A General Practitioner delivers the final assessment and recommends appropriate follow up care.
The Aboriginal Child Health Navigator commencement will be staggered across Tharawal Aboriginal Corporation, Riverina Medical and Dental Aboriginal Corporation and Orange Aboriginal Medical Service ACCHS. We plan a four-month wash-in phase where we work with Navigators and the local ACCHSs to develop the role to be locally relevant and to specifically address the determinants and consequences of ear health and hearing problems.
The Aboriginal Child Health Navigator will not replace the General Practitioner or other medical appointments rather coordinate, including supporting family identified priorities, the reason for any referrals, helping them to make the appointments, if needed, and assisting actual attendance by addressing any barriers (systems and social determinants) faced and promotion of family strengths and resilience. The Child Health Navigator will collaborate with ACCHS staff to ensure local processes are applied to invite participation to the Aboriginal Child Health Checks, ensure the conduct of these checks and the management plans arising from these checks. The Navigator will also be responsible for the education of families and services (including schools) to understand Otitis Media and hearing loss and the impact of these conditions.
The anticipated duration of a Child Health Navigator session is dependent on the family’s needs and priorities. Appointments could vary from 30 to 60 minutes and session attendance will be documented on the study’s reporting system.

Intervention code [1] 323634 0
Early detection / Screening
Comparator / control treatment
Pre-Child Health Navigator period
- The comparator period will be the 6-month period prior to the Child Health Navigator’s involvement that has the largest number of consultations, but it must fall within the 12-month ‘pre-Child Health Navigator period’
- During the comparator period, patients may receive medical consultations, specialist consultations, allied health assessments and other appointments for health related concerns.
- Data source: Orange Aboriginal Medical Service, Tharawal Aboriginal Corporation and Riverina Aboriginal Medical and Dental Corporation patient information management systems
Control group
Active

Outcomes
Primary outcome [1] 331440 0
Proportion of recommended child health appointments attended determined by review of medical records
Timepoint [1] 331440 0
The unit of analysis will be the consultations within the specified time windows for the 12-month Child Health Navigator period and 12-month pre-Child Health Navigator period. The specific Child Health Navigator analysis period will be the 6-month period of the Child Health Navigator’s involvement with the child that has the largest number of consultations. The comparator period will be the 6-month period prior to the Child Health Navigator’s involvement that has the largest number of consultations, but it must fall within the 12-month ‘pre-Child Health Navigator period’
Primary outcome [2] 331596 0
The proportion of Child Health Navigator appointments attended by review of medical records
Timepoint [2] 331596 0
Twelve month intervention period
Secondary outcome [1] 410071 0
A comparison of Paediatric Quality of Life health outcomes
Timepoint [1] 410071 0
Start of the Navigator’s engagement with the family; and 6 to 12 months into that engagement.
Secondary outcome [2] 410072 0
A comparison of Parent-evaluated Listening and Understanding Measure (PLUM)
Timepoint [2] 410072 0
Start of the Navigator’s engagement with the family; and 6 to 12 months into that engagement.
Secondary outcome [3] 410393 0
A comparison of Kessler-5 outcomes
Timepoint [3] 410393 0
Start of the Navigator’s engagement with the family; and 6 to 12 months into that engagement.
Secondary outcome [4] 410394 0
A comparison of the Hearing and Talking Scale (HATS)
Timepoint [4] 410394 0
Start of the Navigator’s engagement with the family; and 6 to 12 months into that engagement.
Secondary outcome [5] 410395 0
A comparison in the Paediatric Integrated Care Survey (PICS)
Timepoint [5] 410395 0
Start of the Navigator’s engagement with the family; and 6 to 12 months into that engagement.

Eligibility
Key inclusion criteria
Urban Aboriginal children younger than 18 years, who receive support from the Child Health Navigator
Minimum age
0 Years
Maximum age
18 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Nil

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
12/09/2022
Actual
28/03/2023
Date of last participant enrolment
Anticipated
20/11/2023
Actual
9/04/2024
Date of last data collection
Anticipated
30/05/2025
Actual
Sample size
Target
105
Accrual to date
Final
105
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 311479 0
Government body
Name [1] 311479 0
National Health and Medical Research Council (Medical Research Futures Fund)
Country [1] 311479 0
Australia
Funding source category [2] 311488 0
Government body
Name [2] 311488 0
National Health and Medical Research Council (Centre for Research Excellence Partnership Pathways to better care AND Outcomes for Aboriginal young people)
Country [2] 311488 0
Australia
Primary sponsor type
University
Name
University of Sydney
Address
Westmead Children's Hospital Clinical School
Corner Hawkesbury Road and, Hainsworth St,
Westmead NSW 2145
Country
Australia
Secondary sponsor category [1] 312887 0
None
Name [1] 312887 0
Address [1] 312887 0
Country [1] 312887 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 310943 0
Aboriginal Health and Medical Research Council of New South Wales - Human Ethics Research Committee
Ethics committee address [1] 310943 0
Ethics committee country [1] 310943 0
Australia
Date submitted for ethics approval [1] 310943 0
Approval date [1] 310943 0
13/04/2022
Ethics approval number [1] 310943 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 119442 0
Prof Hasantha Gunasekera
Address 119442 0
The University of Sydney
Children's Hospital Westmead Clinical School
Westmead Hospital
Corner Hawkesbury Road and Hainsworth Street
Westmead NSW 2145
Country 119442 0
Australia
Phone 119442 0
+61298453399
Fax 119442 0
Email 119442 0
hasantha.gunasekera@health.nsw.gov.au
Contact person for public queries
Name 119443 0
Samantha Rattos
Address 119443 0
C/o Hasantha Gunasekera
The University of Sydney
Children's Hospital Westmead Clinical School
Westmead Hospital
Corner Hawkesbury Road and Hainsworth Street
Westmead NSW 2145
Country 119443 0
Australia
Phone 119443 0
+61286273097
Fax 119443 0
Email 119443 0
samantha.rattos@sydney.edu.au
Contact person for scientific queries
Name 119444 0
Hasantha Gunasekera
Address 119444 0
The University of Sydney
Children's Hospital Westmead Clinical School
Westmead Hospital
Corner Hawkesbury Road and Hainsworth Street
Westmead NSW 2145
Country 119444 0
Australia
Phone 119444 0
+61298453399
Fax 119444 0
Email 119444 0
hasantha.gunasekera@health.nsw.gov.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.