Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617001591347
Ethics application status
Approved
Date submitted
15/11/2017
Date registered
1/12/2017
Date last updated
19/12/2018
Date data sharing statement initially provided
19/12/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
The Australasian Paediatric Head Injury Rules Study: Assessing the gap prior to implementation (APHIRST Gap). A mixed methods study examining the use of CT scanning of the brain in the management of children admitted to the Emergency Department with a head injury.
Scientific title
The Australasian Paediatric Head Injury Rules Study: Assessing the gap prior to implementation (APHIRST Gap). A mixed methods study examining the use, and the related factors influencing the use, of CT scanning of the brain (CTB) in the management of children admitted to Emergency Departments with mild head injury and using this information to inform a knowledge translation strategy.
Secondary ID [1] 293213 0
Nil known
Universal Trial Number (UTN)
U1111-1204-2290
Trial acronym
APHIRST Gap (Australasian Paediatric Head Injury Rules Study: Assessing the gap prior to implementation)
Linked study record
ACTRN12614000463673

Health condition
Health condition(s) or problem(s) studied:
Head Injury 305224 0
Condition category
Condition code
Injuries and Accidents 304527 304527 0 0
Other injuries and accidents

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
This study utilises a mixed method study design.

Quantitative study: Sites will conduct a retrospective medical record audit of children admitted to their Emergency Department (ED) between January 1 and December 31, 2016 with a presenting diagnosis of head injury. Data from the first 100 eligible patients will be collected on the use of CT scanning of the brain (CTB) to confirm their diagnosis at discharge, with the objective of identifying hospital and or patient level factors associated with CTB use. We are specifically looking at the variation of CTB use between tertiary, urban and rural/regional hospitals located in Australia and New Zealand.
Each site will conduct a medical record search for admissions to their ED with a diagnosis of head injury. Each record will be screened for eligibility, with data collected from the first 100 eligible records only. Data will be directly entered into a secure web-based database.

Qualitative study: Interviews will be conducted with clinical staff at participating EDs with various levels of training and expertise to identify and explore the clinician and organisational related factors influencing the use of CTB in children with mild head injuries, We are interested in identifying the resources available and used by clinicians in EDs to inform their management of mild head injuries. Potential participants will be provided with an Information Statement and participation in the interview will be considered as implied consent.
Interviews will be recorded, transcribed and qualitatively analysed using the Theoretical Domains Framework (TDF).
Intervention code [1] 299470 0
Not applicable
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 303768 0
The primary outcome of the medical record audit is whether CTB was performed during the ED visit, as extracted from the documented radiology procedures performed during the patient visit.
Timepoint [1] 303768 0
The primary timepoint is the time of discharge from either the ED or hospital ward, if the patient was admitted.
Primary outcome [2] 303769 0
The primary outcome of the qualitative interviews is the identification of factors at the level of the clinician and organisation, which influence the use of CTB in children who present to the ED with mild head injuries.
Timepoint [2] 303769 0
Interview transcription and thematic analysis.
Secondary outcome [1] 340111 0
A secondary outcome is the identification of hospital and /or patient level factors associated with CTB use.
These factors will be examined at the hospital level according to trauma centre designation or Australasian College for Emergency Medicine (ACEM) ED level - including availability of 24 hour CT, 24 hour radiologist availability, 24 hour neurosurgeon availability and short stay unit, annual paediatric volume, college approval for paediatric emergency training (ACEM accreditations), urban/rural designation and geographical location.
Patient level factors will be assessed by medical record review and include Glasgow coma scale score, patient age, mechanism of injury and presence of relevant co-morbidities such as possible non-accidental injury, ventriculoperitoneal (VP) shunt, known brain tumour, pre-existing neurological condition or bleeding disorder.
Timepoint [1] 340111 0
The secondary timepoint is the time of descriptive statistical analysis of pooled data, when analysis will be conducted to identify factors associated with the use of CTB.
Secondary outcome [2] 340112 0
A secondary outcome of the qualitative study is the determination of the resources available to and used by clinicians in the ED, to inform their management of children presenting with mild head injuries.
Timepoint [2] 340112 0
Secondary timepoint is interview transcription and thematic analysis.

Eligibility
Key inclusion criteria
Quantitative study:
- Any child aged from birth to their 16th birthday
- Presented to the Emergency Department in 2016
- Diagnosis of Head Injury

Qualitative study:
- Doctor (including trainees) or Registered Nurse
- Working in a clinical role (part-time or full-time)
- Working in an Australian or New Zealand Emergency Department
Minimum age
0 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Quantitative study:
- Patients presenting to the ED more than 24 hours after a blunt head trauma
- Patients who have had neuroimaging performed at another hospital prior to presenting
- Patients re-presenting within 24 hours of a CTB at the ED with isolated dental injury as a primary diagnosis

Qualitative study:
- Students and interns
- Clinicians not engaged in clinical practice
- Agency or bank staff (nurses) or locums (medical)

Study design
Purpose
Duration
Selection
Timing
Statistical methods / analysis
Qualitative:
Descriptive statistics will be used to summarise patient, visit and ED demographic data and frequency of imaging. Binary outcomes will be presented as proportions with 95% confidence intervals, Continuous outcomes will be presented as means and standard deviations or medians and interquartile range. Multivariable logistic regression analysis will be used to explore the association between hospital and patient-level characteristics and CTB.

Qualitative:
Thematic analysis of transcribed data using the Theoretical Domains Framework (TDF) using NVivo10 software. Open coded text relating to the key questions and themes will be identified.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
1/04/2017
Date of last participant enrolment
Anticipated
31/03/2018
Actual
11/12/2018
Date of last data collection
Anticipated
31/03/2018
Actual
11/12/2018
Sample size
Target
3200
Accrual to date
Final
3172
Recruitment in Australia
Recruitment state(s)
ACT,NSW,QLD,SA,WA,VIC
Recruitment hospital [1] 9252 0
The Royal Childrens Hospital - Parkville
Recruitment hospital [2] 9253 0
Princess Margaret Hospital - Subiaco
Recruitment hospital [3] 9254 0
Armadale Kelmscott Memorial Hospital - Armadale
Recruitment hospital [4] 9255 0
Lady Cilento Children's Hospital - South Brisbane
Recruitment hospital [5] 9256 0
Caloundra Hospital - Caloundra
Recruitment hospital [6] 9257 0
Nambour General Hospital - Nambour
Recruitment hospital [7] 9258 0
Gold Coast University Hospital - Southport
Recruitment hospital [8] 9259 0
Toowoomba Hospital - Toowoomba
Recruitment hospital [9] 9260 0
Ipswich Hospital - Ipswich
Recruitment hospital [10] 9261 0
Logan Hospital - Meadowbrook
Recruitment hospital [11] 9262 0
The Prince Charles Hospital - Chermside
Recruitment hospital [12] 9263 0
Robina Hospital - Robina
Recruitment hospital [13] 9264 0
Bundaberg Hospital - Bundaberg
Recruitment hospital [14] 9265 0
The Canberra Hospital - Garran
Recruitment hospital [15] 9266 0
The Sutherland Hospital - Caringbah
Recruitment hospital [16] 9267 0
Mount Druitt Hospital - Mount Druitt
Recruitment hospital [17] 9268 0
Tamworth Rural Referral Hospital - Tamworth
Recruitment hospital [18] 9269 0
The Children's Hospital at Westmead - Westmead
Recruitment hospital [19] 9270 0
Sydney Children's Hospital - Randwick
Recruitment hospital [20] 9271 0
Coffs Harbour Base Hospital - Coffs Harbour
Recruitment hospital [21] 9272 0
Womens and Childrens Hospital - North Adelaide
Recruitment hospital [22] 9273 0
Port Augusta Hospital - Port Augusta
Recruitment hospital [23] 9274 0
Box Hill Hospital - Box Hill
Recruitment hospital [24] 9275 0
Monash Medical Centre - Moorabbin campus - East Bentleigh
Recruitment hospital [25] 9276 0
Bendigo Health Care Group - Bendigo Hospital - Bendigo
Recruitment hospital [26] 9277 0
Maroondah Hospital - Ringwood East
Recruitment hospital [27] 9278 0
Angliss Hospital - Upper Ferntree Gully
Recruitment hospital [28] 9279 0
Albany Hospital - Albany
Recruitment hospital [29] 9280 0
Bunbury Hospital - Bunbury
Recruitment postcode(s) [1] 17914 0
3052 - Parkville
Recruitment postcode(s) [2] 17915 0
6008 - Subiaco
Recruitment postcode(s) [3] 17916 0
6112 - Armadale
Recruitment postcode(s) [4] 17917 0
4101 - South Brisbane
Recruitment postcode(s) [5] 17918 0
4551 - Caloundra
Recruitment postcode(s) [6] 17919 0
4560 - Nambour
Recruitment postcode(s) [7] 17920 0
4215 - Southport
Recruitment postcode(s) [8] 17921 0
4350 - Toowoomba
Recruitment postcode(s) [9] 17922 0
4305 - Ipswich
Recruitment postcode(s) [10] 17923 0
4131 - Meadowbrook
Recruitment postcode(s) [11] 17924 0
4032 - Chermside
Recruitment postcode(s) [12] 17925 0
4226 - Robina
Recruitment postcode(s) [13] 17926 0
4670 - Bundaberg
Recruitment postcode(s) [14] 17927 0
2605 - Garran
Recruitment postcode(s) [15] 17928 0
2229 - Caringbah
Recruitment postcode(s) [16] 17929 0
2770 - Mount Druitt
Recruitment postcode(s) [17] 17930 0
2340 - Tamworth
Recruitment postcode(s) [18] 17931 0
2145 - Westmead
Recruitment postcode(s) [19] 17932 0
2031 - Randwick
Recruitment postcode(s) [20] 17933 0
2450 - Coffs Harbour
Recruitment postcode(s) [21] 17934 0
5006 - North Adelaide
Recruitment postcode(s) [22] 17935 0
5700 - Port Augusta
Recruitment postcode(s) [23] 17936 0
3128 - Box Hill
Recruitment postcode(s) [24] 17937 0
3165 - East Bentleigh
Recruitment postcode(s) [25] 17938 0
3550 - Bendigo
Recruitment postcode(s) [26] 17939 0
3135 - Ringwood East
Recruitment postcode(s) [27] 17940 0
3156 - Upper Ferntree Gully
Recruitment postcode(s) [28] 17941 0
6330 - Albany
Recruitment postcode(s) [29] 17942 0
6230 - Bunbury
Recruitment outside Australia
Country [1] 9317 0
New Zealand
State/province [1] 9317 0
Waikato, Auckland, Bay of Plenty

Funding & Sponsors
Funding source category [1] 297841 0
Charities/Societies/Foundations
Name [1] 297841 0
The Angior Family Foundation
Country [1] 297841 0
Australia
Funding source category [2] 297951 0
Government body
Name [2] 297951 0
National Health and Medical Research Council
Country [2] 297951 0
Australia
Funding source category [3] 297952 0
Charities/Societies/Foundations
Name [3] 297952 0
Emergency Medicine Foundation
Country [3] 297952 0
Australia
Primary sponsor type
Individual
Name
Professor Franz Babl
Address
Murdoch Childrens Research Institute
The Royal Children's Hospital
Flemington Road
Parkville, VIC 3052
Country
Australia
Secondary sponsor category [1] 296886 0
Charities/Societies/Foundations
Name [1] 296886 0
Murdoch Childrens Research Institute
Address [1] 296886 0
The Royal Children's Hospital
Flemington Road
Parkville VIC 3052
Country [1] 296886 0
Australia
Other collaborator category [1] 279787 0
Other
Name [1] 279787 0
PREDICT (Paediatric Research in Emergency Departments International Collaborative)
Address [1] 279787 0
Murdoch Childrens Research Institute
The Royal Children's Hospital
Flemington Road
Parkville VIC 3052
Country [1] 279787 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 298888 0
The Royal Children's Hospital, Melbourne
Ethics committee address [1] 298888 0
Ethics committee country [1] 298888 0
Australia
Date submitted for ethics approval [1] 298888 0
20/09/2016
Approval date [1] 298888 0
23/09/2016
Ethics approval number [1] 298888 0
36277
Ethics committee name [2] 298892 0
The Children and Adolescent Health Service
Ethics committee address [2] 298892 0
Ethics committee country [2] 298892 0
Australia
Date submitted for ethics approval [2] 298892 0
19/05/2017
Approval date [2] 298892 0
20/07/2017
Ethics approval number [2] 298892 0
2025EP
Ethics committee name [3] 298893 0
Central Health and Disability
Ethics committee address [3] 298893 0
Ethics committee country [3] 298893 0
New Zealand
Date submitted for ethics approval [3] 298893 0
07/07/2017
Approval date [3] 298893 0
21/09/2017
Ethics approval number [3] 298893 0
17/CEN/156

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

Contacts
Principal investigator
Name 78570 0
A/Prof Franz Babl
Address 78570 0
Royal Children's Hospital
Flemington Rd
Parkville
Victoria 3052; Australia
Country 78570 0
Australia
Phone 78570 0
+613-9345 6592
Fax 78570 0
+613-9345 5938
Email 78570 0
[email protected]
Contact person for public queries
Name 78571 0
Franz Babl
Address 78571 0
Royal Children's Hospital
Flemington Rd
Parkville
Victoria 3052; Australia
Country 78571 0
Australia
Phone 78571 0
+613-9345 6592
Fax 78571 0
+613-9345 5938
Email 78571 0
[email protected]
Contact person for scientific queries
Name 78572 0
Franz Babl
Address 78572 0
Royal Children's Hospital
Flemington Rd
Parkville
Victoria 3052; Australia
Country 78572 0
Australia
Phone 78572 0
+613-9345 6592
Fax 78572 0
+613-9345 5938
Email 78572 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?

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.