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Deadly Ears in Deadly Hands: Aboriginal Health Professional-led ear and hearing assessment and discharge planning for Aboriginal children at risk of severe ear infection

Effect of a hospital-based randomised controlled trial of the creation of a personalised ear health management plan based on the "2020 Otitis Media Guidelines" to inform discharge planning by a trained Aboriginal Ear Health Professional (Aboriginal Health Practitioner or Aboriginal Registered Nurse) on the rate of clinical failure in Aboriginal children at risk of severe otitis media

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12622000478718
Enrollment
52
Registered
2022-03-25
Start date
2022-12-08
Completion date
2025-12-22
Last updated
2024-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

This study will investigate whether personalised ear health discharge planning by an Aboriginal Ear Health Professional (either Aboriginal Health Practitioner, Aboriginal Health Worker or Aboriginal Registered Nurse) for in-patient Aboriginal children at Royal Darwin Hospital will improve the ear health problems of those children over the next 4 to 8 months. The Aboriginal Ear Health Professional will also spend time with the children's families whilst they are in hospital, providing them with ear and other more general health education and supporting them through the hospital experience.

Interventions

At screening, all children will receive an ear examination from the clinical trial team. This ear examination will take place at the participant's bedside and involve video otoscopy and tympanometry. It is anticipated that this ear examination would take approximately 10 minutes. A sticker indicating the diagnosis of the child's ear health condition (e.g. acute otitis media, bilateral otitis media with effusion) will be placed in the child's hospital notes. This will not include any management r

At screening, all children will receive an ear examination from the clinical trial team. This ear examination will take place at the participant's bedside and involve video otoscopy and tympanometry. It is anticipated that this ear examination would take approximately 10 minutes. A sticker indicating the diagnosis of the child's ear health condition (e.g. acute otitis media, bilateral otitis media with effusion) will be placed in the child's hospital notes. This will not include any management recommendations. Children randomised to the intervention group will receive standard care (as the control group) plus additional support from an Aboriginal Ear Health Professional (AEHP), who could be either an Aboriginal Health Practitioner (AHP), Aboriginal Health Worker (AHW) or Aboriginal Registered Nurse (ARN). The AEHP will conduct a hearing, talking and understanding assessment of the child (using PLUM and HATS https://plumandhats.nal.gov.au/) if age-appropriate. This assessment takes approximately 10 minutes. They will also a basic hearing screen when possible (approx. 4 years and over) performed using an automated hearing test via a tablet/mobile phone and noise cancelling headphones, which will take approximately 5 minutes to perform. All assessments will take place at the bedside in the ward, unless the family indicate that they would prefer this be conducted elsewhere (for example, outside or in the cafeteria). Based on these findings, the screening ear examination and a review of the child's medical ear health history, the AEHP will create a personalised recommended ear health management plan for the child. This management plan will be guided by the "2020 Otitis Media Guidelines for Aboriginal and Torres Strait Islander Children" and details given to the treating medical team. Required follow-up medical visits and referrals to specialists will be arranged and the primary health centre will be notified. Adherence to this intervention will be via audit of the electronic medical records up to 8 months after hospital discharge. The AEHP will spend time with the family of the child regularly (approximately daily) until the child is discharged from hospital. This time will be used to educate the family about ear health management, as well as offering more general health advice and support in the hospital environment. Time spent with each family will vary depending on the family's needs. Families in both the intervention and control groups will receive printed educational material regarding the most relevant to them of the five most important chronic conditions affecting children in Royal Darwin Hospital: severe otitis media; early childhood malnutrition; iron deficiency anaemia; chronic suppurative lung disease; and acute rheumatic fever. These materials are from readily available resources, such as RHD Australia, Bronchiectasis Toolbox, Department of Health etc.

Sponsors

Menzies School of Health Research
Lead SponsorUniversity

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Blinded (masking used) (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
All
Age
29 Days to 17 Years
Healthy volunteers
Yes

Inclusion criteria

1) Age: greater than 28 days post-term (corrected for premature infants) to 17 years old 2) Aboriginal and/or Torres Strait Islander 3) Inpatient at Royal Darwin Hospital 4) At risk of severe otitis media defined as either: a) Worst ear diagnosis upon ear examination of either: i) Acute otitis media without perforation (AOMwoP) ii) Acute otitis media with perforation (AOPwiP) iii) Chronic suppurative otitis media (CSOM) iv) Dry perforation v) Grommets b) Bilateral otitis media with effusion (bOME) c) Age less than 3 years and living outside of Darwin and Palmerston local council areas, without a current ear examination showing one or both ears are normal NB Ear examination conducted by study team at time of screening. using video otoscopy and tympanometry. Ear examination takes approximately 10-15 minutes to complete.

Exclusion criteria

1) Previously participation on the trial 2) Sibling living in the same household randomised within 6 weeks 3) Lack of access to primary health care provider in the NT 4) Not planning to remain resident in the NT for 4 months 5) Attending Royal Darwin Hospital for “day surgery” 6) Participant’s primary clinician unwilling to enrol patient 7) Transferred directly to 5a/5b from maternity ward (i.e. never been out of hospital)

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026