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Trial registered on ANZCTR


Registration number
ACTRN12620000887976
Ethics application status
Approved
Date submitted
26/06/2020
Date registered
9/09/2020
Date last updated
9/09/2020
Date data sharing statement initially provided
9/09/2020
Type of registration
Retrospectively registered

Titles & IDs
Public title
Does the use of the Canadian CT Head rule (CCHR) definition of minor head injury in a regional NSW emergency department safely lead to lower utilisation of computer tomography (CT) imaging in patients over 65 when compared to the NSW Closed Head Injury guidelines definition?
Scientific title
Does the use of the Canadian CT Head rule (CCHR) definition of minor head injury in a regional NSW emergency department safely lead to lower utilisation of computer tomography (CT) imaging in patients over 65 when compared to the NSW Closed Head Injury guidelines definition?
Secondary ID [1] 301614 0
None
Universal Trial Number (UTN)
U1111-1253-0105
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Mild head injury 317996 0
mild traumatic brain injury 317998 0
minor head trauma 317999 0
Condition category
Condition code
Emergency medicine 316029 316029 0 0
Other emergency care
Injuries and Accidents 316030 316030 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
The study will combine both a retrospective and prospective arm assessing patients over 65 who present to the Port Macquarie Base Hospital emergency department (PMBH ED) after a blunt head trauma.

The retrospective arm will involve a chart review of patients who presented due to head trauma from January-Decemeber 2019 and received a computerised tomography (CT) scan. Each patient electronic medical record (EMR) will be retrospectively assessed for the following features:
1. The presence of Canadian CT Head Rule (CCHR) inclusion criteria: Glasgow Coma Scale (GCS) of 13-15 with one of the following: witnessed loss of consciousness, definite amnesia or witnessed disorientation post blunt head trauma
2. The presence of CCHR exclusion criteria: anticoagulation, dementia, intoxication, bleeding disorder, penetrating skull injury, depressed skull fracture, acute focal neurological deficit that can’t be ascribed to an extracerebral cause, no history of trauma as the primary event eg. syncope, post-traumatic seizure, unstable vitals due to trauma or reassessment of the same head injury
3. CT results and patient outcome
4. Length time from ordering to reporting of imaging within 24 hours
5. Miscellaneous: antiplatelet medication

It will then be determined whether the patient should have undergone a CT brain according to the CCHR definition of minor head injury (MHI).

Within the prospective arm of the study, all patients over 65 that present to PMBH ED from 13th July- 31st August 2020 post blunt head injury will be prospectively enrolled. Clinicians ordering a CT Brain in this population will be asked to answer questions via a pop up link in EMR that will auto-populate. This data will be cross-checked with the patients electronic medical record and additionally assessed for the above features. After the data is collected it will then be analysed to see if applying the more restrictive CCHR definition of minor head injury can safely decrease the utilisation of CT Brains in this population without missing a clinically significant brain injury.

Clinically significant brain injury is defined according to the CCHR as any acute brain finding on CT which would normally require admission to hospital and neurological follow-up unless the patient is neurologically intact and has one of the following lesions: solitary contusion less than 5 mm in diameter; localised subarachnoid blood less than 1mm thick; smear subdural haematoma less than 4 mm thick; isolated pneumocephaly, or closed depressed skull fracture not through the inner table.
Intervention code [1] 317916 0
Diagnosis / Prognosis
Comparator / control treatment
The comparator is the NSW Closed Head Injury guidelines definition of minor head injury (MHI) which is currently applied as part of standard care to all patients who present to PMBH ED following blunt head trauma. These guidelines define MHI as a patient with an initial Glasgow coma scale (GCS) of 14-15 following acute blunt head trauma, with or without loss of consciousness or post-traumatic amnesia. Both the retrospective and prospective arms are used for the comparator group.

Control group
Active

Outcomes
Primary outcome [1] 324238 0
Sensitivity of the Canadian CT Head Rule definition of minor head injury to detect clinically significant head injury. The true positive rate for MHI will be assessed from the Canadian Ct Head Rule when compared to the reference standard (NSW Closed Head Injury Guidelines).

Timepoint [1] 324238 0
Within 2 months post data-collection completion
Primary outcome [2] 324588 0
Specificity of the CCHR definition of minor head injury to detect clinically significant head injury. The true negative rate for MHI will be assessed for the Canadian CT Head Rule when compared to the reference standard (NSW Closed Head injury Guidelines).
Timepoint [2] 324588 0
Within 2 months post-data collection completion
Secondary outcome [1] 384126 0
Any change in the number of CT brain scans conducted through application of the CCHR definition of minor head injury (MHI). The number of CT brain scans will be determined for each cohort using radiology request records for CT brains.
Timepoint [1] 384126 0
Within 2 months post-data collection completion
Secondary outcome [2] 384127 0
Cost to the health care system calculated using the potential reduction in CT brain scans

Timepoint [2] 384127 0
Within 2 months post-data collection completion
Secondary outcome [3] 384128 0
Patient time spent in the emergency department, measured in time from CT brain ordering to reporting using patient electronic medical records.
Timepoint [3] 384128 0
Within 2 months post-data collection completion

Eligibility
Key inclusion criteria
Patients over 65 who received at CT brain due to head injury with a Glasgow coma scale of 13-15.
Minimum age
65 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Age <65 years
Glasgow coma scale <13
Alzheimer’s disease
Intoxication at time of CT
Anticoagulation medication
Bleeding disorder
Post-traumatic seizure
Penetrating skull injury
Depressed skull fracture
Acute focal neurological deficit that cannot be ascribed to an extracerebral cause
No history of trauma as the primary event eg. syncope, seizure
Unstable vital signs due to trauma
Reassessment of the same head injury

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Defined population
Timing
Both
Statistical methods / analysis
We aim to analyse all patients who received a CT brain at PMBH ED due to blunt head trauma in 2019. There were a total of 2971 CT brains conducted during 2019. Patients under the age of 65 (n=893) were removed from this dataset, resulting in a total of 2078 CT brains conducted in over 65 year olds in 2019. We conducted a pilot study on 100 random patients and determined that 52% of patients underwent a CT brain due to minor head trauma. When this data is extrapolated to the entire data set, we estimate that 1080 patients will be included for analysis in our study.

We plan to conduct a sensitivity and specificity analysis in addition to a cost-benefit analysis using IBM SPSS. We will also calculate the percentage reduction in the number of CT brains due to the application of the CCHR definition of MHI.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
13/07/2020
Date of last participant enrolment
Anticipated
31/12/2020
Actual
Date of last data collection
Anticipated
14/01/2021
Actual
Sample size
Target
1080
Accrual to date
259
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 16974 0
Port Macquarie Base Hospital - Port Macquarie
Recruitment postcode(s) [1] 30636 0
2444 - Port Macquarie

Funding & Sponsors
Funding source category [1] 306045 0
University
Name [1] 306045 0
University of New South Wales
Country [1] 306045 0
Australia
Primary sponsor type
University
Name
University of New South Wales
Address
Sydney NSW 2052
Country
Australia
Secondary sponsor category [1] 306507 0
None
Name [1] 306507 0
Address [1] 306507 0
Country [1] 306507 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 306272 0
The North Coast NSW Human Research Ethics Committee
Ethics committee address [1] 306272 0
NCNSW Human Research Ethics Committee
PO Box 821 Murwillumbah NSW 2484
Ethics committee country [1] 306272 0
Australia
Date submitted for ethics approval [1] 306272 0
19/11/2019
Approval date [1] 306272 0
08/03/2020
Ethics approval number [1] 306272 0
(HREA270) 2019/ETH13659

Summary
Brief summary
Mild head injury (MHI) in the elderly population is a very common presenting complaint to the emergency department. After assessment, the main decision health providers need to make is whether or not the patient requires a CT Brain to assess for significant intra-cranial injury such as intracranial haemorrhage. Current NSW Health Head Injury guidelines define a minor head injury as “a patient with an initial Glasgow Coma Score (GCS) of 14-15 on arrival at hospital following acute blunt head trauma with or without a definite history of loss of consciousness or post traumatic amnesia”. As a result of this broad definition, almost all patients in NSW who present to the emergency department after blunt head trauma undergo a CT scan. In comparison, the “Canadian CT Head Rule (CCHR)”, which is the most commonly used and validated clinical decision rule around head injury, defines MHI as a patient with a GCS of 13-15 and who has one of the following; sustains a period of loss of consciousness, post- traumatic amnesia or disorientation post head impact. Using this inclusion criteria, the CCHR definition and rule was shown to be 100% sensitive and 69% specific for the need for detecting need for neuro-surgical interventions post head injury. It was also 98% sensitive and 50% specific for detecting clinically significant brain injury. Our study will aim to assess whether the use of this more restrictive imaging strategy can safely reduce the number of CT Brains ordered post MHI in a regional NSW emergency department.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 103318 0
Dr David Thomson
Address 103318 0
Port Macquarie Base Hospital Emergency Department. Wrights Road Port Macquarie NSW 2444
Country 103318 0
Australia
Phone 103318 0
+61435153774
Fax 103318 0
Email 103318 0
[email protected]
Contact person for public queries
Name 103319 0
David Thomson
Address 103319 0
Port Macquarie Base Hospital Emergency Department. Wrights Road Port Macquarie NSW 2444
Country 103319 0
Australia
Phone 103319 0
+61435153774
Fax 103319 0
Email 103319 0
[email protected]
Contact person for scientific queries
Name 103320 0
David Thomson
Address 103320 0
Port Macquarie Base Hospital Emergency Department. Wrights Road Port Macquarie NSW 2444
Country 103320 0
Australia
Phone 103320 0
+61435153774
Fax 103320 0
Email 103320 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
We do not have ethics approval for this.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
8324Study protocol  [email protected]
8325Ethical approval  [email protected]
8326Other    Data extraction sheet 380065-(Uploaded-24-06-2020-13-06-31)-Study-related document.pdf



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.