Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619000040167
Ethics application status
Approved
Date submitted
9/01/2019
Date registered
14/01/2019
Date last updated
3/12/2020
Date data sharing statement initially provided
14/01/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Cockburn Ear Portal: An Ears, Nose and Throat (ENT) and Audiology referral portal for improving access to ear health services for Aboriginal children in metropolitan areas using telehealth
Scientific title
Cockburn Ear Portal: An ENT and Audiology referral portal to reduce time to assessment for ear health services for Aboriginal children in metropolitan areas using telehealth
Secondary ID [1] 297011 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Otitis Media 310992 0
Condition category
Condition code
Ear 309645 309645 0 0
Other ear disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Screening ear health assessments including medical history, otoscopy, tympanometry, audiometry and otoacoustics emissions testing appropriate for the child's age will be collected by the research assistant in the community during a single face to face visit. If the child has otitis media requiring assessment by ENT/Audiology at Perth Children's Hospital (PCH), a referral and the results will be transfered electronically to the PCH multidisciplinary team (MDT) consisting of an ENT doctor, audiologist, paediatrician and ENT clinical nurse specialist. If the child does not have otitis media requiring MDT assessment, they will be screenfailed from the study and appropriate further follow up arranged (e.g. discharge from care, follow up with GP etc.).

The MDT will look at the results and develop an ear health care plan for the participant. The care plan may include further follow up ear health assessments (watching and waiting), prescribing antibiotics, referral for surgery etc. The ear health care plan will be sent back to the research assistant in the community for implementation with the participant as soon as possible. The participant has the option of a live video consultation with the MDT if they wish.
All participating children will be receive the Ear Portal telehealth service. The time until assessment will be calculated from initial referral until Ear Portal telehealth assessment.
Intervention code [1] 313287 0
Diagnosis / Prognosis
Intervention code [2] 313288 0
Early detection / Screening
Intervention code [3] 313289 0
Prevention
Comparator / control treatment
In addition to the Ear Portal telehealth referral, each participant will have a standard referral sent to PCH to be triaged via the standard referral pathway. The ENT consultant triaging the referral will provide an estimated waiting time until outpatient appointment for the participant. This estimate will be the comparator for time until assessment.
Control group
Active

Outcomes
Primary outcome [1] 318603 0
Time to assessment based on date of initial referral and date of Ear Portal care plan implementation or estimated date of outpatient appointment, collected from medical and research records.
Timepoint [1] 318603 0
Time to assessment will be measured starting from the date of the initial referral to PCH. For each participant, the time will be measured until the date of care plan implementation for Ear Portal and the estimated date of outpatient appointment provided by the triaging ENT consultant.
Secondary outcome [1] 365502 0
Total cost of service provision. Prior to the start of the study, the costs associated with the current referral pathway will be calculated, to reflect resource use for the status quo. These costs will be estimated based on reports from the staff undertaking duties via the current pathway e.g. administrative staff, ENTs, ENT CNS, audiologists as well as information collected from a clinical audit of the waitlist. Resource use will be collected as part of the study data, enabling calculation of total costs associated with the Ear Portal service. Cost of the service will be compared with costs of the current standard referral pathway (the baseline) at the end of the study, to assess the net incremental cost.
Estimation of cost effectiveness will subsequently be modelled based on extrapolated outcomes drawn from the literature. Results will be presented as cost per quality adjusted life year gained.
Timepoint [1] 365502 0
Costs will be measured from the screening visit until the 3 month follow up visit.
Secondary outcome [2] 365503 0
Family satisfaction with care according to a questionnaire designed specifically for the research program.
Timepoint [2] 365503 0
Questionnaire completed at 3 month follow up

Eligibility
Key inclusion criteria
1. Aged between 0 and 6 years old.
2. Are of Aboriginal descent
3. Live within the greater metropolitan region of Perth (within a 60km radius)
4. Have been screened and identified as having ear disease requiring referral as defined by; evidence of OM with effusion (OME) for >3 months; a history of 3 episodes of OM in the past 6 months; 4 episodes of OM in the past 12 months; or significant parental concerns regarding their child’s hearing or speech development.
Minimum age
0 Years
Maximum age
6 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Are a CAT 1 (urgent) referral. Treatment will be sought immediately for these children.
2. The child’s legal representative (parent/guardian) is unwilling or unable to provide informed consent to participate.

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)
Not applicable
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Not applicable
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Not applicable
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
For the primary endpoint (time-to-assessment) a sample size of 104 children will have over 90% power to detect a difference of at least 6 months in waiting times, assuming a 5% type I error rate. Factoring in a 15% dropout rate a total sample size of 120 children is required.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/10/2019
Actual
26/02/2020
Date of last participant enrolment
Anticipated
31/12/2020
Actual
Date of last data collection
Anticipated
31/03/2021
Actual
Sample size
Target
120
Accrual to date
10
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 12843 0
Perth Children's Hospital - Nedlands
Recruitment postcode(s) [1] 25318 0
6009 - Nedlands

Funding & Sponsors
Funding source category [1] 301582 0
Government body
Name [1] 301582 0
National Health and Medical Research Councril (NHMRC) Centre of Research Excellence in Ear and Hearing Health of Indigenous Children (CRE_ICHEAR)
Country [1] 301582 0
Australia
Funding source category [2] 301583 0
Charities/Societies/Foundations
Name [2] 301583 0
Perth Children's Hospital Foundation
Country [2] 301583 0
Australia
Primary sponsor type
Other
Name
Telethon Kids Institute
Address
Northern Entrance, Perth Children's Hospital,
15 Hospital Avenue, Nedlands, WA, 6009
Country
Australia
Secondary sponsor category [1] 301280 0
None
Name [1] 301280 0
Address [1] 301280 0
Country [1] 301280 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 302311 0
Child and Adolescent Health Service HREC
Ethics committee address [1] 302311 0
Ethics committee country [1] 302311 0
Australia
Date submitted for ethics approval [1] 302311 0
22/01/2019
Approval date [1] 302311 0
06/03/2019
Ethics approval number [1] 302311 0
Ethics committee name [2] 302312 0
Western Australian Aboriginal Health Ethics Committee (WAAHEC)
Ethics committee address [2] 302312 0
Ethics committee country [2] 302312 0
Australia
Date submitted for ethics approval [2] 302312 0
01/02/2019
Approval date [2] 302312 0
23/07/2019
Ethics approval number [2] 302312 0

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

Contacts
Principal investigator
Name 89782 0
Dr Chris Brennan-Jones
Address 89782 0
Northern Entrance, Perth Children's Hospital
15 Hospital Avenue, Nedlands, Western Australia, 6009

PO Box 855, West Perth, Western Australia, 6872
Country 89782 0
Australia
Phone 89782 0
+61 863191520
Fax 89782 0
Email 89782 0
[email protected]
Contact person for public queries
Name 89783 0
Kathryn Jajko
Address 89783 0
Northern Entrance, Perth Children's Hospital
15 Hospital Avenue, Nedlands, Western Australia, 6009

PO Box 855, West Perth, Western Australia, 6872
Country 89783 0
Australia
Phone 89783 0
+61 863191010
Fax 89783 0
Email 89783 0
[email protected]
Contact person for scientific queries
Name 89784 0
Chris Brennan-Jones
Address 89784 0
Northern Entrance, Perth Children's Hospital
15 Hospital Avenue, Nedlands, Western Australia, 6009

PO Box 855, West Perth, Western Australia, 6872
Country 89784 0
Australia
Phone 89784 0
+61 863191520
Fax 89784 0
Email 89784 0
[email protected]

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?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
4462Study protocol  [email protected]
4463Statistical analysis plan  [email protected]
4464Informed consent form  [email protected]
4465Ethical approval  [email protected]



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.