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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

19/08/2022

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]

Nil known

Universal Trial Number (UTN)

Trial acronym

ACCESS

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Otitis media

Hearing loss

Condition category

Condition code

Ear

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]

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]

Proportion of recommended child health appointments attended determined by review of medical records

Timepoint [1]

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]

The proportion of Child Health Navigator appointments attended by review of medical records

Timepoint [2]

Twelve month intervention period

Secondary outcome [1]

A comparison of Paediatric Quality of Life health outcomes

Timepoint [1]