Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000478718
Ethics application status
Approved
Date submitted
14/03/2022
Date registered
25/03/2022
Date last updated
24/04/2024
Date data sharing statement initially provided
25/03/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
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
Scientific title
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
Secondary ID [1] 305186 0
APP1184032
Universal Trial Number (UTN)
U1111-1269-1369
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
severe otitis media 323461 0
Condition category
Condition code
Ear 321010 321010 0 0
Other ear disorders
Infection 323074 323074 0 0
Other infectious diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 321584 0
Diagnosis / Prognosis
Intervention code [2] 321585 0
Early detection / Screening
Intervention code [3] 323128 0
Prevention
Comparator / control treatment
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 in the control arm will receive the usual standard care from the treating hospital medical team. It is expected that standard care would include a discussion about the proposed discharge plan with the family. The treating medical team will determine how this discussion occurs (ie. whether Aboriginal staff are involved or not) consistent with their normal practice. Any ear health discharge planning included in this will be dependent on the routine clinical examinations conducted by hospital staff plus information obtained from the basic diagnosis in the sticker placed in the hospital notes.
Families in both the intervention and control groups will receive printed educational material regarding the most appropriate 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.
Control group
Active

Outcomes
Primary outcome [1] 328792 0
The difference in proportion of children with clinical failure. Participants will be categorised by a blinded clinical outcome assessment of the electronic medical records documenting a visit to the child's local community clinic as follows:
1. Clinically Inactive: no supporative or severe otitis media, or unilateral otitis media with effusion and no recommendation of any treatment, hearing support or clinical review
2. Clinically Active on Appropriate Treatment: current suppurative or severe otitis media but currently following appropriate treatment plan
3. Clinically Active and Needs Treatment: current suppurative or severe otitis media which requires treatment, but not currently following appropriate treatment plan
4. Clinically Active and Failed Treatment: current suppurative or severe otitis media, currently following appropriate treatment plan but condition worsening or not responding to treatment
Categories 3 and 4 would be deemed “clinical failure”.
Timepoint [1] 328792 0
4-8 months post hospital discharge
Secondary outcome [1] 400362 0
Proportions of children with adherence to what would be the "2020 Otitis Media Guidelines" recommended management of ear disease between the two groups. Adherence success is defined as attending >80% recommended clinic reviews and taking >80% prescribed medications and will be assessed by a blinded review of the electronic medical records,
Timepoint [1] 400362 0
up to 4-8 months post hospital discharge (exact end timepoint would be date of follow-up ear examination)
Secondary outcome [2] 400363 0
Proportions of children with clinical complications, as assessed by a blinded review of the electronic medical records, Clinical complications include extracranial complications (for example mastoiditis and cholesteatoma) and intracranial complications (for example meningitis, brain abscess and sigmoid sinus thrombosis).
Timepoint [2] 400363 0
up to 4-8 months post hospital discharge (exact end timepoint would be date of follow-up ear examination)
Secondary outcome [3] 400364 0
Proportions of children with serious adverse events (SAEs). Due to the nature of the intervention we anticipate that SAEs will be rare. A serious adverse events (SAE) is an undesirable experience occurring during the intervention period that:
o Results in death
o Is life-threatening
o Results in hospitalisation (initial or prolongation)
o Results in disability or permanent damage
Assessment will be by blinded assessment of the electronic medical records,
Timepoint [3] 400364 0
up to 4-8 months post hospital discharge (exact end timepoint would be date of follow-up ear examination)
Secondary outcome [4] 400365 0
Family satisfaction with discharge planning score using a questionnaire designed specifically for this study. Questions are adapted from the AHRQ Child Hospital Survey https://www.ahrq.gov/cahps/surveys-guidance/hospital/about/child_hp_survey.html and the BHI Aboriginal Patient Experience Question Set https://www.bhi.nsw.gov.au/nsw_patient_survey_program/Aboriginal-patient-experience
Timepoint [4] 400365 0
between 0 and 6 weeks post hospital discharge
Secondary outcome [5] 400366 0
Family satisfaction with overall care in hospital score using a questionnaire designed specifically for this study. Questions are adapted from the AHRQ Child Hospital Survey https://www.ahrq.gov/cahps/surveys-guidance/hospital/about/child_hp_survey.html and the BHI Aboriginal Patient Experience Question Set https://www.bhi.nsw.gov.au/nsw_patient_survey_program/Aboriginal-patient-experience
Timepoint [5] 400366 0
between 0 and 6 weeks post hospital discharge
Secondary outcome [6] 400367 0
The sensitivity and specificity of both the routine clinical ear assessment (where available) and the AEHP's ear health examination. An expert in the field will provide an independent assessment of the videos and photos obtained by the AEHP's ear health examination to act as the 'gold standard'. Both the AEHP's ear health examination assessment and the information in the hospital notes regarding the routine clinical ear assessment will be compared to this 'gold standard'.
Timepoint [6] 400367 0
At hospital discharge

Eligibility
Key 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.
Minimum age
29 Days
Maximum age
17 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key 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)

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation involves contacting the holder of the allocation schedule who is off-site. Eligibility will be determined by person on-site at the Royal Darwin Hospital and allocation will be carried out after study enrollment by another person at the Menzies School of Health Research.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (RedCap). Randomisation will be stratified by ear diagnosis from screening ear examination:
i) wet perforation in either ear
ii) bulging ear drum in either ear, but no wet perforations
iii) all others
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The primary clinical outcome analysis will report the difference in proportion (and 95% confidence interval) of children with clinical failure at 3 months post hospital discharge. Unadjusted differences in clinical failure will be assessed by the Chi-squared test. An adjusted model will include stratification factors using a binomial regression model. Risk difference and relative risk estimates will be reported.

We will follow the “intention to treat” principle but only use the available data (ie. there will be no imputation for missing values). The number of children with completely missing primary outcome data (ie. where there is no medical record available for review) will be described. This number is expected to be small (<5% of randomised children) and the same in each arm. Sensitivity analyses will involve a “per protocol” approach based on successful AEHW-led discharge and adjustment for potential confounders.

Secondary outcome assessment of proportions of children with:
i) adherence to recommended recommended management of ear disease between the two groups;
ii) clinical complications and
iii) serious adverse events (SAEs)
will be compared between the two groups using Chi-square test (reported as absolute risk difference and 95% CI).

Secondary outcomes of family satisfaction with both discharge planning and overall hospital care will be compared between the two groups using Student’s t-test (reported as difference in mean and SD, 95% CI). Pre-specified subgroup analyses will be conducted according to whether the family speak English as a first language or not.

The sample size is calculated to allow detection of a difference of 13% in clinical failure. This assumes that clinical failure will be reduced from 33% to 20%. A difference of 13% in clinical outcomes is modest but would be clinically important. Assuming we have data on more than 512 children available for analysis, the power of the study will be >90% (at the 5% significance level). A total sample of 600 (300 per group) children will allow for an attrition rate up to 15%.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
2/05/2022
Actual
8/12/2022
Date of last participant enrolment
Anticipated
22/12/2025
Actual
Date of last data collection
Anticipated
30/06/2026
Actual
Sample size
Target
600
Accrual to date
52
Final
Recruitment in Australia
Recruitment state(s)
NT
Recruitment hospital [1] 20439 0
Royal Darwin Hospital - Tiwi
Recruitment postcode(s) [1] 35208 0
0810 - Tiwi

Funding & Sponsors
Funding source category [1] 309570 0
Government body
Name [1] 309570 0
NHMRC
Country [1] 309570 0
Australia
Primary sponsor type
University
Name
Menzies School of Health Research
Address
PO Box 41096, Casuarina NT 0811, Australia
John Mathews Building, Royal Darwin Hospital Campus, Rocklands Drive, Casuarina NT 0810
Country
Australia
Secondary sponsor category [1] 312323 0
None
Name [1] 312323 0
Address [1] 312323 0
Country [1] 312323 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 309348 0
Human Research Ethics Committee of Northern Territory Department of Health and Menzies School of Health Research
Ethics committee address [1] 309348 0
Ethics committee country [1] 309348 0
Australia
Date submitted for ethics approval [1] 309348 0
10/11/2021
Approval date [1] 309348 0
01/03/2022
Ethics approval number [1] 309348 0
2021-4200

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

Contacts
Principal investigator
Name 113858 0
Prof Peter Morris
Address 113858 0
Menzies School of Health Research, John Mathews Building, Royal Darwin Hospital Campus, Rocklands Drive, Casuarina NT 0810
Country 113858 0
Australia
Phone 113858 0
+61 428910254
Fax 113858 0
Email 113858 0
[email protected]
Contact person for public queries
Name 113859 0
Joanne Howes
Address 113859 0
Menzies School of Health Research, John Mathews Building, Royal Darwin Hospital Campus, Rocklands Drive, Casuarina NT 0810
Country 113859 0
Australia
Phone 113859 0
+61 8 89467947
Fax 113859 0
Email 113859 0
[email protected]
Contact person for scientific queries
Name 113860 0
Joanne Howes
Address 113860 0
Menzies School of Health Research, John Mathews Building, Royal Darwin Hospital Campus, Rocklands Drive, Casuarina NT 0810
Country 113860 0
Australia
Phone 113860 0
+61 8 89467947
Fax 113860 0
Email 113860 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
all of the individual participant data collected during the trial, after de-identification
When will data be available (start and end dates)?
Immediately following publication, no end date determined
Available to whom?
any citizen or group that has both a reasonable scientific question and the expertise to answer that question as determined on a case-by-case basis
Available for what types of analyses?
any purpose that is deemed a reasonable scientific question as determined on a case-by-case basis
How or where can data be obtained?
access subject to approvals by Principal Investigator via email [email protected]


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
15412Study protocol    To be published



Results publications and other study-related documents

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