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Trial registered on ANZCTR


Registration number
ACTRN12618001206213
Ethics application status
Approved
Date submitted
1/03/2018
Date registered
18/07/2018
Date last updated
25/07/2022
Date data sharing statement initially provided
3/03/2020
Date results information initially provided
25/07/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Introducing Best Practice Oxygen therapy for Infants with Bronchiolitis
Scientific title
Nasal High Flow Therapy for Infants less than 12 months with Bronchiolitis – Translating new knowledge into practice
Secondary ID [1] 293469 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Bronchiolitis 305662 0
Condition category
Condition code
Respiratory 304884 304884 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention is a facilitated, structured educational support program dedicated to observing adherence to statewide NHF guidelines for infants admitted to hospital with bronchiolitis over a 3-4 month winter period. Education material such as printed information sheets and power point presentation will be provided to the local Nurse Educator to perform the education as part of their standard education sessions. Three of the six participating hospitals will receive the face-to-face intervention at the start of the study by study nurses to the local Nurse Educator.
Records on hospital education sessions, content and frequency will be obtained. Additionally a questionnaire on current knowledge on bronchiolitis treatment will be distributed to medical and nursing staff. Knowledge will then again be assessed at end of the study.
Education will be delivered face to face and via powerpoint presentation by the Nurse Educator locally. This would be 15-20mins education 1-2 times/nurse over the winter period.
Research Nurses will screen patients during study period every 2 weeks to monitor adherence to educational materials provided. Attendance records, hospital checklists and patient observation charts will be monitored during these site visits.
Intervention code [1] 299718 0
Treatment: Other
Comparator / control treatment
The three participating hospitals in the control group will be provided with a copy of the statewide NHF therapy guideline only, They will receive the structured educational support program at the completion of the study.
Control group
Active

Outcomes
Primary outcome [1] 304076 0
The Composite Primary outcome will measure the knowledge translation in 4 primary domains.

1. Standard outcome parameters of patients (measured as transfer rate to tertiary hospital) measured by review of hospital medical records
2. Clinicians knowledge of bronchiolitis and their management and care for admitted infants measured by surveys using related key fields including Knowledge, Skills, Professional Role and Memory provided by Huijg, J. et al (Implementation Science 2014), 9:33..
3. Consumer satisfaction as routine care in tertiary and regional hospitals is measured using the EQ-5D Quality of Life tool and the Pediatric Quality of Life tool for infants 1-12months with the parent/guardian as a proxy. Cost effectiveness of NHF therapy as routine care in tertiary and regional hospitals is calculated by length of stay and equipment/consumables used, using hospital medical records
Timepoint [1] 304076 0
4-6 months post Australian winter period 2019
Secondary outcome [1] 341851 0
Length of hospital stay as assessed by review of hospital records of admitted infants with bronchiolitis.
Timepoint [1] 341851 0
4-6 months post Australian winter period 2019
Secondary outcome [2] 341852 0
Length of oxygen therapy as assessed by review of hospital records of admitted infants with bronchiolitis.
Timepoint [2] 341852 0
4-6 months post Australian winter period 2019
Secondary outcome [3] 341853 0
Measure the resource use and costs from hospital medical records, patient out-of-pocket costs, economic benefit such as quality adjusted life years (QALYS), and assess the difference between facilitated and non-facilitated sites.
Timepoint [3] 341853 0
4-6 months post Australian winter period 2019

Eligibility
Key inclusion criteria
Inclusion criteria for patients:
Infants less than 12 months old with bronchiolitis who are admitted to hospital and have an oxygen requirement with SpO2<92%

Inclusion criteria for nurses receiving educational support
• Registered or Enrolled nurse
• Current employees of the health care facility
• Nurses permanently on the roster for the participating ward/ED for the duration of the study.

Inclusion criteria for medical staff
• Residents, Registrars, Fellows and Consultants
• Current employees of the Health care facility
• Medical staff who will be on the roster for the participating ward/ED for the duration of the study.
Minimum age
0 Months
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Exclusion criteria for patients
• Critically ill with immediate need for NIV/Intubation
• Apnoeas requiring NIV/ Intubation
• Blocked nasal passages/choanal atresia
• Upper airway obstruction
• Craniofacial malformations
• Trauma/surgery to nasopharynx
• Pneumothorax
• Cyanotic congenital heart disease
• Decreased level of consciousness
• Oncology patients
• Foreign body aspiration- suspected or confirmed
• Any patient with known lung disease or other conditions that have not been discussed with either the Respiratory Consultant or the treating Paediatrician

Exclusion criteria for nursing and medical staff
• Students
• Agency or casual pool nurses
• Locums (medical)

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Central randomisation of hospital centres participating into intervention or control arm.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Factorial
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Data obtained during the recruitment phase of PARIS 1 trial (ACTRN12613000388718) from 1st May 2015 – 31st October 2015 (winter period) gives an indication of numbers of infants who required oxygen therapy and should be placed on NHF therapy. We estimate a total of 214 patients will be observed for this study.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/04/2019
Actual
1/04/2019
Date of last participant enrolment
Anticipated
20/04/2020
Actual
30/03/2020
Date of last data collection
Anticipated
20/07/2020
Actual
30/03/2021
Sample size
Target
214
Accrual to date
Final
235
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 9456 0
The Prince Charles Hospital - Chermside
Recruitment hospital [2] 9457 0
Gold Coast University Hospital - Southport
Recruitment hospital [3] 9458 0
Ipswich Hospital - Ipswich
Recruitment hospital [4] 9459 0
Sunshine Coast University Hospital - Birtinya
Recruitment hospital [5] 9460 0
Redcliffe Hospital - Redcliffe
Recruitment hospital [6] 9461 0
Caboolture Hospital - Caboolture
Recruitment postcode(s) [1] 18186 0
4020 - Redcliffe
Recruitment postcode(s) [2] 18182 0
4032 - Chermside
Recruitment postcode(s) [3] 18183 0
4215 - Southport
Recruitment postcode(s) [4] 18184 0
4305 - Ipswich
Recruitment postcode(s) [5] 18187 0
4510 - Caboolture
Recruitment postcode(s) [6] 18185 0
4575 - Birtinya

Funding & Sponsors
Funding source category [1] 298093 0
University
Name [1] 298093 0
AusHSI - Queensland University of Technology
Country [1] 298093 0
Australia
Primary sponsor type
Hospital
Name
Lady Cilento Children's Hospital
Address
501 Stanley St
South Brisbane
QLD 4101
Country
Australia
Secondary sponsor category [1] 297170 0
Other Collaborative groups
Name [1] 297170 0
Paediatric Critical Care Research Group
Address [1] 297170 0
Paediatric Critical Care Research Group
Level 7, Centre for Children’s Health Research
Lady Cilento Children's Hospital Precinct
62 Graham Street, South Brisbane QLD 4101
Country [1] 297170 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 299113 0
Children's Health Service Human Research Ethics Committee
Ethics committee address [1] 299113 0
Children’s Health Queensland Human Research Ethics Committee
Level 7, Centre for Children’s Health Research
Lady Cilento Children's Hospital Precinct
62 Graham Street, South Brisbane QLD 4101
Ethics committee country [1] 299113 0
Australia
Date submitted for ethics approval [1] 299113 0
15/01/2018
Approval date [1] 299113 0
30/01/2018
Ethics approval number [1] 299113 0
HREC/18/QRCH/3

Summary
Brief summary
This study aims to determine the benefit, effectiveness, and sustainability of a facilitated and structured educational support program versus no facilitation or educational support program in the uptake and adherence to NHF therapy guidelines for infants less than 12 months old admitted with bronchiolitis. The key stakeholders (nursing and medical workforce) have been familiarised with the use of NHF therapy within the boundaries of the completed NHMRC PARIS I trial, 2013-2016. Our study group has developed a comprehensive education program, which includes visual education, paper and signage resources, face to face teaching and online video postings.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 79334 0
A/Prof Andreas Schibler
Address 79334 0
Paediatric Critical Care Research Group
Children's Centre for Health Research
62 Graham Street
South Brisbane
QLD 4101
Country 79334 0
Australia
Phone 79334 0
+61 414869359
Fax 79334 0
Email 79334 0
a.schibler@uq.edu.au
Contact person for public queries
Name 79335 0
A/Prof Andreas Schibler
Address 79335 0
Paediatric Critical Care Research Group
Children's Centre for Health Research
62 Graham Street
South Brisbane
QLD 4101
Country 79335 0
Australia
Phone 79335 0
+61 414869359
Fax 79335 0
Email 79335 0
a.schibler@uq.edu.au
Contact person for scientific queries
Name 79336 0
A/Prof Andreas Schibler
Address 79336 0
Paediatric Critical Care Research Group
Children's Centre for Health Research
62 Graham Street
South Brisbane
QLD 4101
Country 79336 0
Australia
Phone 79336 0
+61 414869359
Fax 79336 0
Email 79336 0
a.schibler@uq.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
The study outcome relates to change in practice and not individual patient data, hence there will be no individual data sharing possible.


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.