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Trial registered on ANZCTR


Registration number
ACTRN12623000497606p
Ethics application status
Submitted, not yet approved
Date submitted
5/05/2023
Date registered
15/05/2023
Date last updated
15/05/2023
Date data sharing statement initially provided
15/05/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
The impact of the Victorian Virutal Emergency Department on the use of healthcare for children and their families
Scientific title
A randomised controlled trial measuring the impact of a paediatric virtual emergency department on healthcare utilisation for Victorian children and their families
Secondary ID [1] 309576 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Paediatric Healthcare 329879 0
Condition category
Condition code
Public Health 326784 326784 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention is advice from the virtual Nurse on Call portal to attend the Victorian Virtual ED (VVED). The VVED is a novel telehealth resource, initially launching in 2020, the VVED allows patients to remotely consult with an emergency nurse or doctor using video technology. In this trial, eligible patients who seek urgent medical care from the Victorian Nurse on Call (NOC) telephone service will be randomly allocated to be advised to seek care from the VVED or receive the standard advice to attend a physical ED at a 1:1 ratio. The nurses will provide this advice over the phone using scripting. The scripting ensures that families know that VVED is an option, but they can still attend a physical ED if required.

Compliance with the advised allocation will be assessed via linked medical records.
Intervention code [1] 325997 0
Treatment: Other
Comparator / control treatment
The comparator represents the current standard of care which is referral to the physical ED by NOC. In this trial, half of the study participants will be randomly allocated to receive this control intervention. The nurses will provide this advice over the phone using scripting as the current standard Nurse on Call scripting when urgent physical assessment is required
Control group
Active

Outcomes
Primary outcome [1] 334633 0
The Number and proportion of participating patients (0-18 years) presenting to physical ED or being admitted to hospital in the 7 days post randomisation
Timepoint [1] 334633 0
Data will be collected from the Victorian Admitted Episodes Dataset and the Victorian Emergency Minimum Dataset, patient presentations within 7 days of contacting NOC will be recorded as they occur.
Secondary outcome [1] 421464 0
Cost of implementing the VVED model based on workforce requirements as provided by the VVED investigator team
Timepoint [1] 421464 0
4 months after trial start
Secondary outcome [2] 421465 0
Direct hospital costs associated with the VVED referral approach compared to traditional physical ED referral approach. This will be sourced via the CVDL data linkage
Timepoint [2] 421465 0
7 days after randomisation
Secondary outcome [3] 421466 0
Costs to families, estimated based on time implications observed for families along with estimates of average distance travelled if applicable. This will be sourced via the CVDL data linkage and patient postcode
Timepoint [3] 421466 0
7 days after randomisation

Eligibility
Key inclusion criteria
Participants need to meet the following criteria to be included in the study:
- Point of contact to NOC must be a parent/guardian of a child aged 0-18 years old
- Currently located in Victoria at the time of call
- Patients presenting with non-life-threatening conditions AND are deemed by NOC protocols as requiring ED review.
Minimum age
No limit
Maximum age
18 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Participants meeting any of the following criteria will be excluded from this study:
• Patients who present to NOC with life-threatening conditions (ie. altered conscious state, severe work of breathing)
• Currently located outside of Victoria
• Children or young people who present to NOC without a parent/caregiver.
• Primary complaint relating to pregnancy, suicide or drug/alcohol misuse


Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computerised sequence generation
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Not all patients who are directed to go to the ED by NOC actually attend an ED. In a 2008 evaluation report (the only publicly available evaluation of NOC we could find), approx. 60% of all patients advised to go to the ED by NOC did so. We therefore conservatively estimate that 50% of patients directed to go to the ED via NOC will do so. In consultation with The Clinical Epidemiology and Biostatistics Unit (CEBU), at Murdoch Children’s Research Institute, to detect a minimum 10% reduction in physical ED utilisation with the VVED model (from 50% to 40%), an estimated sample size of 1142 paediatric patients (571 in each group) is required to have 90% power to detect a difference of 10% at a two sided 5% significance level with an additional 10% buffer incorporated to account for potential missing data and/or failure to data link patients. This equates to a minimum volume of 4,230 paediatric callers to NOC, based on the referral rate of 27% to ED. This volume of patients can easily be achieved based on the average rate of 11,000 paediatric callers to NOC per month in Victoria. However, given seasonal variability in call volumes to NOC, we aim to conduct the study over a four-month period (June 2023 - September 2023) to ensure we meet the calculated sample size.

Data analysis will be conducted using Stata version 17. The primary outcome will be measured as the proportion of children who attended ED or were admitted to hospital, logistic regression models will be used to estimate odds ratios and 95% confidence intervals to compare the differences in utilisation between the intervention and comparator groups. An adjusted logistic regression model will include covariates such as age, gender, SEIFA index (derived by postcode), rurality (derived by postcode), preferred language, interpreter required.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
5/06/2023
Actual
Date of last participant enrolment
Anticipated
30/09/2023
Actual
Date of last data collection
Anticipated
7/10/2023
Actual
Sample size
Target
1142
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 313761 0
Other Collaborative groups
Name [1] 313761 0
Murdoch Children's Research Institute (MCRI)
Country [1] 313761 0
Australia
Primary sponsor type
Other Collaborative groups
Name
Murdoch Children's Research Institute (MCRI)
Address
50 Flemington Rd, Parkville VIC 3052
Country
Australia
Secondary sponsor category [1] 315588 0
Hospital
Name [1] 315588 0
VVED, Northern Health
Address [1] 315588 0
Northern Health, 1885 Cooper Street, Epping VIC 3076
Country [1] 315588 0
Australia
Other collaborator category [1] 282659 0
Government body
Name [1] 282659 0
Healthdirect Australia
Address [1] 282659 0
PO Box K411, Haymarket, NSW 1240
Country [1] 282659 0
Australia

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 312932 0
Human Research Ethics Committee, Royal Children’s Hospital
Ethics committee address [1] 312932 0
Royal Children’s Hospital, Flemington Road, Parkville VIC 3052
Ethics committee country [1] 312932 0
Australia
Date submitted for ethics approval [1] 312932 0
14/11/2022
Approval date [1] 312932 0
Ethics approval number [1] 312932 0

Summary
Brief summary
This study is a randomised controlled trial (RCT) utilising a single virtual site, the virtual Nurse on Call (NOC) platform. Participants will be recruited by contacting NOC and following the ascertainment of their eligibility by the nurse from NOC, eligible patients will be randomised to either receive advice to attend a physical emergency department or to contact the VVED. 1,142 participants will be included with 571 in each trial arm. Follow-up will continue for one week to observe participants’ health service use but the trial itself will take place over the course of several months until the last patients have been recruited and follow-up is completed. The outcome is patient’s use of either the VVED, physical ED, or admission to hospital and will be used to reflect the acceptability of NOC advice by patients.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 126386 0
Dr Joanna Lawrence
Address 126386 0
Royal Childrens Hospital,
Flemington rd
Parkville VIC 3052
Australia
Country 126386 0
Australia
Phone 126386 0
+61 481679578
Fax 126386 0
Email 126386 0
joanna.lawrence@rch.org.au
Contact person for public queries
Name 126387 0
Dr Joanna Lawrence
Address 126387 0
Royal Childrens Hospital,
Flemington rd
Parkville VIC 3052
Australia
Country 126387 0
Australia
Phone 126387 0
+61 481679578
Fax 126387 0
Email 126387 0
joanna.lawrence@rch.org.au
Contact person for scientific queries
Name 126388 0
Dr Joanna Lawrence
Address 126388 0
Royal Childrens Hospital,
Flemington rd
Parkville VIC 3052
Australia
Country 126388 0
Australia
Phone 126388 0
+61 481679578
Fax 126388 0
Email 126388 0
joanna.lawrence@rch.org.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Due to privacy restrictions of health data and the potentially sensitive and identifiable nature of this data no IPD will be publicly available.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
19103Study protocol    385832-(Uploaded-05-05-2023-12-17-59)-Study-related document.doc



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.