Trial Review

The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12623000527662
Ethics application status
Approved
Date submitted
9/03/2023
Date registered
19/05/2023
Date last updated
13/10/2024
Date data sharing statement initially provided
19/05/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Optimising Respiratory Support in Rural and Remote Settings for Children
Scientific title
Optimising Respiratory Support in Rural and Remote Settings for Children:
A Paediatric Acute Respiratory Study (PARIS), PARIS on Country
A Multicentre Science Implementation Study
Secondary ID [1] 309152 0
Nil known
Universal Trial Number (UTN)
Trial acronym
PARIS on Country
PARIS -> A Paediatric Acute Respiratory Study,
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Respiratory disease 329269 0
Condition category
Condition code
Respiratory 326221 326221 0 0
Other respiratory disorders / diseases
Respiratory 326222 326222 0 0
Asthma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention is a Respiratory Care Bundle (RCB). The respiratory care bundle is a comprehensive educational bundle that is based on current standard Queensland Health clinical guidelines for bronchiolitis and Acute Respiratory Failure and use of nasal high-flow therapy in infants and children. The bundle incorporates evidence based on the recent randomised controlled trials (RCT’s) in Australia and New Zealand on these cohorts of infants and children and uses existing standard clinical guidelines and practices used by Tertiary/Regional in South East Queensland ACTRN12613000388718, ACTRN1261800021079).

The RCB will be applied to all children aged 0-4 years presenting to hospital with either bronchiolitis, reactive airway disease or pneumonia. The RCB is a care pathway for which nurses and doctors will receive education via face to face or where this is not possible via videoconference by the research team (study educators). Each education session consists of a 1–2-hour tutorial and all nurses and doctors in each hospital attending the study cohort will be trained. The RCB will be integrated into the mandatory education. The education will be provided in the Teaching phase of the study 4 weeks prior to the implementation phase. Each hospital will also have a local champion nurse who will provide on a daily base education and advice when necessary. Adherence to the RCB will be monitored by reviewing the medical records.

For hospitals, which have not yet used Nasal High-Flow (NHF), additional education will be provided for use of NHF. This includes education on equipment, physiology of NHF therapy and patient specific application of NHF. The NHF equipment and consumables for each hospital will be provided as part of the study. The length of NHF therapy is dictated by each patient's condition and will be at the discretion of the attending clinician. The adherence to the NHF guidelines will be reviewed using the patient's medical record.

The RCB will be implemented in a step wedged study design with each step having an interval of 5 months plus one month of education prior. 3-4 hospitals will be randomly allocated to the implementation phase at each of these steps, which allows that after 30 months all hospitals will use the RCB. An additional 12 months of post implementation data for all children admitted to the study sites will be collected to survey the adherence and sustainability of the RCB by reviewing the patient's medical record.

An example of a care procedure that will be implemented as part of the RCB are the following:

Once the patient is commenced on NHF therapy, it is at the discretion (dependent on the patient’s condition) of the referring clinician to nominate which level =/> 4 clinical services capability framework (CSCF) facility consultation will be sought from (Paediatrician in Cairns and/or Paediatric ICU consultant in Townsville - both Tertiary facilities). Retrieval Services Queensland (RSQ) may also be the first port of call if the clinician requires immediate consult as they can trigger consultation with both Cairns and Townsville.
• Local nursing clinical leadership (Director of Nursing/ Nurse Unit Manager/ Clinical Nurse Coordinator/ Shift Team Leader) should be informed of the patient via regular patient status communication processes.
• Consultation with the level =/>4 CSCF facility will be at 2hrs post commencement of NHF therapy or sooner if required. It is expected that consultation with the level =/> CSCF facility will have taken place within 4hrs of the NHF therapy being commenced.
• If it is assessed at 2hrs, or earlier, post commencement of NHFC therapy that the patient may require transfer to a level =/>4 CSCF or higher facility, contact with RSQ will occur to inform the need or potential need of a retrieval.
• If it is assessed at 2hrs post commencement of NHF therapy that the patient does not require transfer to a level =/> CSCF facility, consultation with the level =/>4 CSCF facility is still mandated to ensure the level =/>4 CSCF facility is aware of the patient and the patient’s condition.
Intervention code [1] 325613 0
Treatment: Other
Comparator / control treatment
Current standard practice prior to implementation of the Respiratory Care Bundle.
Control group
Active

Outcomes
Primary outcome [1] 334112 0
The primary outcome is the proportion of yearly hospital transfers of infants and children aged 0-4 years with Acute Respiratory Failure including bronchiolitis cared for with the new Respiratory Care Bundle in comparison to numbers under the existing respiratory pathways. Interhospital transfers will be identified by reviewing the patient's medical record.
Timepoint [1] 334112 0
The primary outcome will be assessed during the duration of the study (30 months).

Pre implementation data on the proportion of interhospital transfers over the period of January 2016 to September 2023 (6.5 years) will be obtained for each participating hospital.

Additionally, data on the proportion of interhospital transfers over a period of 1 year post implementation of the study will be obtained for each participating hospital (February 2026- January 2027).
Secondary outcome [1] 419393 0
Length of hospital stay, measured as per medical records.
Timepoint [1] 419393 0
This secondary outcome will be assessed during the duration of the study (30 months).

Pre implementation data on the length of hospital stay as per medical records over the period of January 2016 to September 2023 (6.5 years) will be obtained for each participating hospital.

Additionally, data on the on the length of hospital stay as per medical records over a period of 1 year post implementation of the study will be obtained for each participating hospital (February 2026- January 2027).
Secondary outcome [2] 419394 0
Length of Oxygen therapy as per medical records
Timepoint [2] 419394 0
The secondary outcome will be assessed during the duration of the study (30 months).

Pre implementation data on the length of oxygen therapy as per medical records over the period of January 2016 to September 2023 (6.5 years) will be obtained for each participating hospital.

Additionally, data on the on the length of oxygen therapy as per medical records over a period of 1 year post implementation of the study will be obtained for each participating hospital (February 2026- January 2027).
Secondary outcome [3] 419395 0
Health Care costs including transport costs and social opportunity costs (including back transfer). Patient/Hospital costs will be calculated based on Queensland Health activity-based funding model, Transport costs will be obtained from Royal Flying Doctors Queensland Ambulance Services, Back transfer costs will be obtained from commercial airline ticketing.
Timepoint [3] 419395 0
This secondary outcome will be assessed during the duration of the study (30 months).

Pre implementation data on the health care costs, transport costs and social opportunity costs over the period of January 2016 to September 2023 (6.5 years) will be obtained for each participating hospital.

Additionally, data on the on the health care costs, transport costs and social opportunity costs over a period of 1 year post implementation of the study will be obtained for each participating hospital (February 2026- January 2027).
Secondary outcome [4] 419396 0
Adherence to the respiratory care bundle beyond the intervention period measured with the Normalisation Process Theory and the Society for Implementation Research Instrument Toolkit (SIRC) with a study-specific online questionnaire which will be distributed to nurses and doctors using RedCap as a portal.
Timepoint [4] 419396 0
Adherence to the respiratory care bundle of nurses and doctors during the 30 months study period and additionally 12 months post implementation.
Secondary outcome [5] 419397 0
Measurement of the proportion of infants and children transferred to a tertiary hospital post implementation as per medical records.
Timepoint [5] 419397 0
This secondary outcome will be assessed during a period of 12 months post implementation.
Secondary outcome [6] 419398 0
Consumer satisfaction - staff and parents/carers as per a study specific questionnaire.
Timepoint [6] 419398 0
This secondary outcome will be assessed during the duration of the study (30 months) and 12 months post implementation.

Eligibility
Key inclusion criteria
Infants with bronchiolitis admitted to hospital, aged <12 months with or without oxygen requirement, defined as acute onset of respiratory disease, presenting with increased respiratory rate, cough, increased work of breathing, rhinorrhoea, increased body temperature, widespread crackles or wheeze and reduced fluid intake.

Children admitted to hospital aged 0-4 years with acute respiratory symptoms, presenting with increased respiratory rate, with or without oxygen requirement, with or without increased work of breathing and wheeze, increased body temperature and reduced fluid intake. Note, there are only few infants <12 months of age that are presenting to hospital with respiratory symptoms other than bronchiolitis.
Minimum age
No limit
Maximum age
4 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
No formal patient exclusion criteria exist, as the intent of the study is to observe and audit all episodes when a child presents with acute respiratory failure, including bronchiolitis to one of the participating hospitals.

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 of the timepoint when each hospital switches from pre implementation to the implementation phase will be concealed to each site prior to the implementation phase.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A central randomisation electronically will occur to allocate the cluster of hospitals (3-4 at a time) for when they commence the Respiratory Care Bundle intervention.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
A stepped wedge cluster-randomised study design will be used to investigate the structured implementation of a respiratory care bundle (the intervention) for paediatric Acute Respiratory Failure including bronchiolitis.
NB: This trial will allocate in random order the implementation of the respiratory care bundle to each hospital. There will be 3-4 hospitals in each clustered randomisation. No individual clinical patient/participant randomisation will be required.
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Generalised linear mixed models (GLMMs) will be used to account for cluster hospital effects with adjustment for the rollout time of the intervention and potential district effect and estimate the change in the proportions of paediatric intensive care transfers (using a logistic link function) as well as the length of stay in acute care settings (using Poisson or negative binomial distributions) under the intervention condition, compared with those under the control condition. Model fit and assumption testing will be conducted as appropriate within the GLMM framework and significance will be set at p<0.05. The GLMM can handle missing data in the outcome variable under the ignorable mechanism (such as missing completely at random).

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/10/2023
Actual
22/03/2024
Date of last participant enrolment
Anticipated
30/09/2027
Actual
Date of last data collection
Anticipated
30/06/2028
Actual
Sample size
Target
1260
Accrual to date
0
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 24230 0
Weipa Hospital - Weipa
Recruitment hospital [2] 24231 0
Thursday Island Hospital - Thursday Island
Recruitment hospital [3] 24232 0
Cooktown Hospital - Cooktown
Recruitment hospital [4] 24233 0
Bamaga Hospital - Bamaga
Recruitment hospital [5] 24234 0
Charters Towers Hospital - Charters Towers
Recruitment hospital [6] 24235 0
Ayr Hospital - Ayr
Recruitment hospital [7] 24236 0
Joyce Palmer Health Service - Palm Island
Recruitment hospital [8] 24237 0
Mount Isa Base Hospital - Mount Isa
Recruitment hospital [9] 24238 0
Cloncurry Hospital - Cloncurry
Recruitment hospital [10] 24239 0
Doomadgee Hospital - Doomadgee
Recruitment hospital [11] 24240 0
Normanton Hospital - Normanton
Recruitment hospital [12] 24241 0
Mornington Island Hospital - Mornington Island
Recruitment hospital [13] 24242 0
Atherton Hospital - Atherton
Recruitment hospital [14] 24243 0
Innisfail Hospital - Innisfail
Recruitment hospital [15] 24244 0
Mareeba Hospital - Mareeba
Recruitment hospital [16] 24245 0
Mossman Hospital (Douglas Shire Multi Purpose Health Service) - Mossman
Recruitment hospital [17] 24246 0
Tully Hospital - Tully
Recruitment postcode(s) [1] 39768 0
4874 - Weipa
Recruitment postcode(s) [2] 39769 0
4875 - Thursday Island
Recruitment postcode(s) [3] 39770 0
4895 - Cooktown
Recruitment postcode(s) [4] 39771 0
4876 - Bamaga
Recruitment postcode(s) [5] 39775 0
4825 - Mount Isa
Recruitment postcode(s) [6] 39776 0
4824 - Cloncurry
Recruitment postcode(s) [7] 39777 0
4830 - Doomadgee
Recruitment postcode(s) [8] 39778 0
4890 - Normanton
Recruitment postcode(s) [9] 39779 0
4871 - Mornington Island
Recruitment postcode(s) [10] 39780 0
4883 - Atherton
Recruitment postcode(s) [11] 39781 0
4860 - Innisfail
Recruitment postcode(s) [12] 39782 0
4880 - Mareeba
Recruitment postcode(s) [13] 39783 0
4873 - Mossman
Recruitment postcode(s) [14] 39784 0
4854 - Tully

Funding & Sponsors
Funding source category [1] 313353 0
Government body
Name [1] 313353 0
Medical Research Future Fund
Country [1] 313353 0
Australia
Funding source category [2] 313367 0
Commercial sector/Industry
Name [2] 313367 0
Fisher and Paykel Healthcare New Zealand - Inkind funding for equipment
Country [2] 313367 0
New Zealand
Funding source category [3] 317622 0
Charities/Societies/Foundations
Name [3] 317622 0
Emergency Medicine Foundation
Country [3] 317622 0
Australia
Primary sponsor type
University
Name
Griffith University
Address
Griffith University,
Nathan Campus,
170 Kessels Rd,
Nathan, Qld, 4111
Country
Australia
Secondary sponsor category [1] 315127 0
None
Name [1] 315127 0
Address [1] 315127 0
Country [1] 315127 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 312575 0
Townsville Human Research Ethics Committee
Ethics committee address [1] 312575 0
Ethics committee country [1] 312575 0
Australia
Date submitted for ethics approval [1] 312575 0
26/09/2022
Approval date [1] 312575 0
24/11/2022
Ethics approval number [1] 312575 0
HREC/QTHS/89412
Ethics committee name [2] 315198 0
Far North Queensland Human Research Ethics Committee
Ethics committee address [2] 315198 0
Ethics committee country [2] 315198 0
Australia
Date submitted for ethics approval [2] 315198 0
31/03/2023
Approval date [2] 315198 0
24/11/2022
Ethics approval number [2] 315198 0
HREC/2023/QCH/94401

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

Contacts
Principal investigator
Name 125146 0
A/Prof Donna Franklin
Address 125146 0
C/O
Gold Coast University Hospital (GCUH) - Children's Critical Care Unit
Hospital Blvd
Southport, Qld, 4215.
Country 125146 0
Australia
Phone 125146 0
+61 432059569
Fax 125146 0
Email 125146 0
[email protected]
Contact person for public queries
Name 125147 0
Donna Franklin
Address 125147 0
C/O
GCUH - Children's Critical Care Unit
Hospital Blvd
Southport, Qld, 4215.
Country 125147 0
Australia
Phone 125147 0
+61 432059569
Fax 125147 0
Email 125147 0
[email protected]
Contact person for scientific queries
Name 125148 0
Donna Franklin
Address 125148 0
C/O
GCUH - Children's Critical Care Unit
Hospital Blvd
Southport, Qld, 4215.
Country 125148 0
Australia
Phone 125148 0
+61 432059569
Fax 125148 0
Email 125148 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?
Deidentified participant data on published outcomes.
When will data be available (start and end dates)?
After publication date of article and within 3 years post the publication date.
Available to whom?
Researchers with an approved proposed use, approved by appropriate institutional review boards and the Trial Steering Committee - with a signed data access agreement in place.
Available for what types of analyses?
An approved specified purpose.
How or where can data be obtained?
Deidentified participant data will be shared upon reasonable request, addressed to the Chief Investigator/corresponding author.
[email protected]


What supporting documents are/will be available?

No Supporting Document Provided



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.