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Trial registered on ANZCTR


Registration number
ACTRN12619000039189
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
PCH Ear Portal: An urban-based Ears, Nose and Throat (ENT) and Audiology referral telehealth portal to provide equitable access to specialist ear health services for children
Scientific title
PCH Ear Portal: An urban-based ENT and Audiology referral telehealth portal to reduce time to assessment for specialist ear health services for children
Secondary ID [1] 297040 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Otitis Media 310993 0
Condition category
Condition code
Ear 309648 309648 0 0
Other ear disorders
Public Health 309671 309671 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Eligible participants will be identified by ENT staff from the outpatient waitlist and triage of referrals. Children will be recruited in cohorts from the start of the waitlist (Cohort 1), the middle of the waitlist (Cohort 2) and the end of the waitlist (Cohort 3).

Once informed consent obtained, 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 research clinic at PCH during a single face to face visit. If the child has otitis media requiring assessment by ENT/Audiology, 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 for implementation with the participant via phone as soon as possible. The participant also has the option of phone or video call directly with the MDT if they wish, according to their needs. If further consultation is required, more than one session may be arranged. The time until assessment will be calculated from initial referral until Ear Portal telehealth assessment.

Intervention code [1] 313291 0
Diagnosis / Prognosis
Intervention code [2] 313294 0
Early detection / Screening
Intervention code [3] 313295 0
Prevention
Comparator / control treatment
Cohort 3 will consist of children recruited who are receiving their first outpatient appointment via the standard care pathway. They will complete the study assessments on the day of outpatient appointment and receive care via the standard outpatient pathway. Their outcomes will be compared to Cohorts 1 and 2.
Control group
Active

Outcomes
Primary outcome [1] 318605 0
Time to assessment based on date of initial referral and date of Ear Portal care plan implementation or attendance of outpatient appointment, collected from medical and research records.
Timepoint [1] 318605 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 participants) or the date of outpatient appointment (for control participants).
Secondary outcome [1] 365513 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] 365513 0
The costs of resources will be measured from the initial ear screening visit through to the 12 month follow up visit for the Ear Portal service.
Secondary outcome [2] 365514 0
Family satisfaction with care according to a questionnaire designed specifically for the research program.
Timepoint [2] 365514 0
Questionnaire completed at outpatient appointment or 12 month follow up visit
Secondary outcome [3] 374344 0
Difference in hearing outcomes between cohorts as measured at study entry and at 12 month follow up.
Timepoint [3] 374344 0
Comparison of hearing outcomes between cohorts measured at study entry and again at 12-month follow up.

Secondary outcome [4] 374345 0
Change in wait time for standard care pathway following implementation of Ear Portal in the hospital.
Timepoint [4] 374345 0
An audit of the ENT outpatient waitlist will be completed following conclusion of the study to assess waiting time for children who receive standard care following introduction of Ear Portal. This will be compared to the waiting time for the standard care pathway at the start of the study (pre-Ear Portal). This will provide some preliminary information to see whether children receiving care also benefit from Ear Portal via reduced waiting times.
Secondary outcome [5] 374346 0
Successful establishment of the EarBase database to track long term health, educational and developmental outcomes of participants.
Timepoint [5] 374346 0
EarBase will be designed during this study and tested to ensure it is able to collect necessary information for future probabilistic linkage for the WA Data Linkage branch, as well can be used as a successful tool to identify children for future research studies such as clinical trials.. The study team will evaluate the pilot of EarBase at the end of the study to determine its effectiveness for achieving these outcomes
Secondary outcome [6] 374347 0
Successful establishment of the EarBase database to track long term health, educational and developmental outcomes of participants.
Timepoint [6] 374347 0
EarBase will be designed during this study and tested to ensure it is able to collect necessary information for future probabilistic linkage for the WA Data Linkage branch, as well can be used as a successful tool to identify children for future research studies such as clinical trials.. The study team will evaluate the pilot of EarBase at the end of the study to determine its effectiveness for achieving these outcomes
Secondary outcome [7] 374348 0
Determination of microbiological, immunological and metabolomic profiles associated with poorer outcomes of otitis media.
Timepoint [7] 374348 0
Optional samples collected at each study visit and if applicable at the time of ear surgery. To be analysed by laboratory collaborators.

Eligibility
Key inclusion criteria
Children will be eligible for the study to be enrolled in the appropriate cohort if they meet all of the following criteria:
1. Aged between 6 months and 6 years old.
2. Live within the greater metropolitan region of Perth (within a 60km radius)
3. Identified during triage of initial referral to PCH for hearing or ear related issue
4. Have been screened and identified as having ear disease 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.

At least 20% of the study population must be of Aboriginal descent to ensure that there is adequate representation in the sample given the prevalence of OM in Aboriginal children. Therefore, there will be a cap of 96 non-Aboriginal children to be recruited to each cohort.. Once this cap is met, only Aboriginal children will be eligible to be recruited until the total target of 120 is reached for that cohort.
Minimum age
6 Months
Maximum age
6 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
All participants:
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
Parallel
Other design features
This is a prospective, three cohort study in which eligible participants across the ENT outpatient waitlist will be enrolled to receive Ear Portal. Children will be recruited in cohorts from the start of the waitlist (Cohort 1), the middle of the waitlist (Cohort 2) and the end of the waitlist (Cohort 3).
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
19/06/2020
Date of last participant enrolment
Anticipated
30/06/2021
Actual
Date of last data collection
Anticipated
30/06/2022
Actual
Sample size
Target
360
Accrual to date
3
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 12844 0
Perth Children's Hospital - Nedlands
Recruitment postcode(s) [1] 25319 0
6009 - Nedlands

Funding & Sponsors
Funding source category [1] 301585 0
Hospital
Name [1] 301585 0
Telethon-Perth Children's Hospital Research Fund
Country [1] 301585 0
Australia
Primary sponsor type
Other
Name
Telethon Kids Institute
Address
Northern Entrance, Perth Children's Hospital, 15 Hospital Avenue, Nedlands, Western Australia, 6009
PO Box 855, West Perth, Western Australia, 6872
Country
Australia
Secondary sponsor category [1] 301282 0
None
Name [1] 301282 0
Address [1] 301282 0
Country [1] 301282 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 302314 0
Child and Adolescent Health Service HREC
Ethics committee address [1] 302314 0
Ethics committee country [1] 302314 0
Australia
Date submitted for ethics approval [1] 302314 0
22/01/2019
Approval date [1] 302314 0
02/05/2019
Ethics approval number [1] 302314 0
Ethics committee name [2] 302316 0
Western Australian Aboriginal Health Ethics Committee (WAAHEC)
Ethics committee address [2] 302316 0
Ethics committee country [2] 302316 0
Australia
Date submitted for ethics approval [2] 302316 0
01/02/2019
Approval date [2] 302316 0
23/07/2019
Ethics approval number [2] 302316 0

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

Contacts
Principal investigator
Name 89790 0
Dr Chris Brennan-Jones
Address 89790 0
Northern Entrance, Perth Children's Hospital
15 Hospital Avenue, Nedlands, Western Australia, 6009

PO Box 855, West Perth, Western Australia, 6872
Country 89790 0
Australia
Phone 89790 0
+61 863191520
Fax 89790 0
Email 89790 0
[email protected]
Contact person for public queries
Name 89791 0
Kathryn Jajko
Address 89791 0

Northern Entrance, Perth Children's Hospital
15 Hospital Avenue, Nedlands, Western Australia, 6009

PO Box 855, West Perth, Western Australia, 6872
Country 89791 0
Australia
Phone 89791 0
+61 863191010
Fax 89791 0
Email 89791 0
[email protected]
Contact person for scientific queries
Name 89792 0
Chris Brennan-Jones
Address 89792 0
Northern Entrance, Perth Children's Hospital
15 Hospital Avenue, Nedlands, Western Australia, 6009

PO Box 855, West Perth, Western Australia, 6872
Country 89792 0
Australia
Phone 89792 0
+61 863191520
Fax 89792 0
Email 89792 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
4422Study protocol  [email protected]
4423Statistical analysis plan  [email protected]
4424Informed consent form  [email protected]
4425Ethical approval  [email protected]



Results publications and other study-related documents

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No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.