Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000388415
Ethics application status
Approved
Date submitted
3/04/2025
Date registered
1/05/2025
Date last updated
1/05/2025
Date data sharing statement initially provided
1/05/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
Pathways for Aboriginal & Torres Strait Islander hearing health: The PATHWAY Project
Scientific title
Pathways for Aboriginal & Torres Strait Islander hearing health: The PATHWAY Project assessing how Aboriginal and/or Torres Strait Islander families navigate the hearing healthcare system and costs involved
Secondary ID [1] 313198 0
None
Universal Trial Number (UTN)
U1111-1314-6106
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Otitis media 335492 0
Hearing impairment 335502 0
Condition category
Condition code
Ear 332053 332053 0 0
Other ear disorders

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
The objective of this study is to integrate Aboriginal research methodologies with Western methods to co-design a comprehensive strategy aimed at improving the ear health patient pathway—from surveillance to management and follow-up—for Aboriginal children living in the far west region of South Australia.

Participants will include Aboriginal families with young children aged 0 to 8 years who have a history of ear disease. Data will be collected from medical records to provide a detailed description of the time it takes for children in the study location to move through the ear and hearing health pathway. Additionally, a questionnaire on out-of-pocket health care expenditure (OOPHE) will be administered to determine the impact of ear and hearing-related OOPHE on the children, their families, and themselves.

The data collected from medical records will be retrospective information and include the child's name, date of birth, parent/caregiver's name, residential location, gender, clinic name, date of visit, MBS code allocated, fee charged, appointment attendance, healthcare professional seen, tests completed, outcome, and recommendations. Identifying information will be removed from the final dataset prior to analysis.

Face-to-face yarning sessions, facilitated by an Aboriginal Research Officer, will be conducted. These sessions will begin with 'social yarning' to build rapport and relationships with participants, followed by 'research yarning' to explore various aspects such as the experience of caring for children with otitis media and its impact on the children, their families, and the community. Other factors to be explored include influences on the patient journey (surveillance, management, follow-up), accessibility of ear health care, and local implementation factors (health priorities, capacity, resources). There will be one yarning session (social and research yarning in one session) per participant conducted one-on-one on the same day as enrolment into the study with a duration of approximately 40 minutes and will be audio recorded and transcribed verbatim, by a professional transcription agency.

Data collection for the OOPHE and yarning sessions will occur at the time of enrolment into the study and retrospective data from medical records will occur over different visits to the participating sites following a participant’s enrolment into the study.

The anticipated time frame for the completion of this work is one (1) year.
Intervention code [1] 329775 0
Early Detection / Screening
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 339656 0
Understanding the time taken for Aboriginal and/or Torres Strait Islander families to move through the ear and hearing health pathway.
Timepoint [1] 339656 0
Data will be collected at a single timepoint following enrolment.
Primary outcome [2] 339663 0
Out-of-pocket healthcare expenditure (OOPHE) for Aboriginal and/or Torres Strait Islander families accessing the hearing healthcare system
Timepoint [2] 339663 0
Data will be collected at a single timepoint following enrolment.
Secondary outcome [1] 446635 0
None
Timepoint [1] 446635 0
N/a

Eligibility
Key inclusion criteria
Parents/caregivers of Aboriginal and/or Torres Strait Islander children aged 0 to 8 years with a history of ear disease residing in the far west region of South Australia.
Minimum age
0 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Parents/caregivers of non-Aboriginal and/or Torres Strait Islander children
- Parents/caregivers of Aboriginal and/or Torres Strait Islander children aged 9 years and over
- Parents/caregivers of Aboriginal and/or Torres Strait Islander children aged 0 to 8 years without a history of ear disease
- Parents/caregivers of Aboriginal and/or Torres Strait Islander children who do not reside in the far west region of South Australia

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Defined population
Timing
Both
Statistical methods / analysis
Out-of-pocket healthcare expenditure survey
Response options for the survey are reported on a 5 point Likert scale from strongly disagree to strongly agree. Descriptive statistics will be used to calculate the proportion of responses for each response option for each item.

Clinic records
We will produce epidemiological curves of the data to graphically represent the time taken to move from first visit through to resolution of the health condition. Non-parametric tests, such as Pearson’s chi-square, will be performed for proportional data and parametric tests, such as Student’s T-test, for continuous data. Significance will be when p<0.05.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/05/2025
Actual
Date of last participant enrolment
Anticipated
3/11/2025
Actual
Date of last data collection
Anticipated
1/05/2026
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA

Funding & Sponsors
Funding source category [1] 317644 0
Government body
Name [1] 317644 0
National Health and Medical Research Council
Country [1] 317644 0
Australia
Primary sponsor type
University
Name
Flinders University
Address
Country
Australia
Secondary sponsor category [1] 319959 0
None
Name [1] 319959 0
Address [1] 319959 0
Country [1] 319959 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 316343 0
Aboriginal Health Research Ethics Committee
Ethics committee address [1] 316343 0
Ethics committee country [1] 316343 0
Australia
Date submitted for ethics approval [1] 316343 0
31/07/2023
Approval date [1] 316343 0
17/07/2024
Ethics approval number [1] 316343 0
04-23-1076
Ethics committee name [2] 316352 0
SA Department for Health and Wellbeing Human Research Ethics Committee
Ethics committee address [2] 316352 0
Ethics committee country [2] 316352 0
Australia
Date submitted for ethics approval [2] 316352 0
26/06/2024
Approval date [2] 316352 0
14/10/2024
Ethics approval number [2] 316352 0
2024/HRE00194
Ethics committee name [3] 316353 0
Flinders University Human Research Ethics Committee
Ethics committee address [3] 316353 0
Ethics committee country [3] 316353 0
Australia
Date submitted for ethics approval [3] 316353 0
17/07/2024
Approval date [3] 316353 0
17/07/2024
Ethics approval number [3] 316353 0
7633
Ethics committee name [4] 316354 0
SA Department for Education
Ethics committee address [4] 316354 0
Ethics committee country [4] 316354 0
Australia
Date submitted for ethics approval [4] 316354 0
01/08/2024
Approval date [4] 316354 0
26/08/2024
Ethics approval number [4] 316354 0
2024-0022

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

Contacts
Principal investigator
Name 137590 0
A/Prof Jacqueline Stephens
Address 137590 0
Flinders University, College of Medicine and Public Health, Sturt Rd, Bedford Park SA 5042
Country 137590 0
Australia
Phone 137590 0
+61 8 8201 3972
Fax 137590 0
Email 137590 0
[email protected]
Contact person for public queries
Name 137591 0
Jacqueline Stephens
Address 137591 0
Flinders University, College of Medicine and Public Health, Sturt Rd, Bedford Park SA 5042
Country 137591 0
Australia
Phone 137591 0
+61 8 8201 3972
Fax 137591 0
Email 137591 0
[email protected]
Contact person for scientific queries
Name 137592 0
Jacqueline Stephens
Address 137592 0
Flinders University, College of Medicine and Public Health, Sturt Rd, Bedford Park SA 5042
Country 137592 0
Australia
Phone 137592 0
+61 8 8201 3972
Fax 137592 0
Email 137592 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No
No IPD sharing reason/comment: The data that support the findings of this study are unavailable due to restrictions applied by the research ethics committees, and so are not publicly available.



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.