Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000771853
Ethics application status
Approved
Date submitted
25/03/2021
Date registered
21/06/2021
Date last updated
21/06/2021
Date data sharing statement initially provided
21/06/2021
Type of registration
Retrospectively registered

Titles & IDs
Public title
Characteristics of patients with a head injury that present to a single Australian tertiary emergency department.
Scientific title
Characteristics, patterns and functional outcomes of head injury patients presenting to a single Australian tertiary emergency department.
Secondary ID [1] 303781 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Head Injury 321282 0
Concussion 321708 0
Traumatic Brain Injury 321709 0
Condition category
Condition code
Emergency medicine 319065 319065 0 0
Other emergency care
Injuries and Accidents 319066 319066 0 0
Other injuries and accidents
Neurological 319067 319067 0 0
Other neurological disorders

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Data that will be collated from eMR review, patient demographics, information about presentation (i.e. mechanism of injury, triage Category, observations - Glasgow Coma Score, Loss Of Consciousness, document any signs/symptoms at presentation)

Telephone interview will be completed by ED research volunteers, lead researcher and associate researchers. The two follow up phone call interviews will occur at 10-14 days and four weeks from day of discharge. Interview will take approximately 7-10 minutes.

Topics discussed during interview - signs/symptoms post discharge, return to usual activity (i.e sport, work, school), any further medical follow up post discharge and opportunity to discuss discharge process from ED.

Phase 1: eMR retrospective data audit will commence from 1st January 2019 until 31st December 2021.

Phase 2: Patient recruited for telephone interviews will commence April 2021 the last patient recruited will be 31st December 2021.
Intervention code [1] 320088 0
Diagnosis / Prognosis
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 326959 0
Determine the number of head injury presentations to one major tertiary referral hospital emergency department.
Timepoint [1] 326959 0
Cumulative data through retrospective eMR data and will be evaluated at the conclusion of the study 31st December 2021.
Primary outcome [2] 327788 0
Management of patients with head injury who present to one major tertiary referral hospital emergency department.
Timepoint [2] 327788 0
Cumulative data through retrospective eMR data and will be evaluated at the conclusion of the study 31st December 2021.
Secondary outcome [1] 394601 0
Qualitative outcome assessing the discharge instructions as collected by the telephone interview.
Timepoint [1] 394601 0
4 weeks post conclusion of the study, 31st January 2022
Secondary outcome [2] 394602 0
The types of services patients were referred to in the community as collected by the telephone interview.
Timepoint [2] 394602 0
4 weeks post conclusion of the study, 31st January 2022

Eligibility
Key inclusion criteria
Phase 1 medical record audit: All patients (up to 30 years of age) presenting to ED at RNSH from 1st January 2019 - 31st December 2021 (36 months) will be reviewed for evidence of head injuries.
Phase 2 telephone interview: Patients (up to 30 years of age) who present to ED with a head injury will be included in the study and who are discharged home or admitted to the ward.
Minimum age
No limit
Maximum age
30 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients older than 31 years, patients given a triage category 1, and patients allocated to the resuscitation area, children identified as a child at risk at time of treatment or children transferred to a tertiary paediatric hospital.

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Defined population
Timing
Both
Statistical methods / analysis
Mainly descriptive exploratory data will be presented and summarised using frequencies and percentages. Basic inferential statistics will be used for group comparisons to be undertaken depending on data distribution. Normally distributed data will be analysed using t test and anova. Non normally distributed data will use parametric testing Mann Whitney, Kruskall Wallis, Chi Square and Fischer exact depending on data type and coding.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
19/05/2021
Date of last participant enrolment
Anticipated
31/12/2021
Actual
Date of last data collection
Anticipated
31/01/2022
Actual
Sample size
Target
280
Accrual to date
1
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 19000 0
Royal North Shore Hospital - St Leonards
Recruitment postcode(s) [1] 33542 0
2065 - St Leonards

Funding & Sponsors
Funding source category [1] 308182 0
Hospital
Name [1] 308182 0
Royal North Shore Hospital
Country [1] 308182 0
Australia
Primary sponsor type
Hospital
Name
Royal North Shore Hospital
Address
Royal North Shore Hospital
Emergency Department
Reserve Road, St Leonards,
NSW 2065
Country
Australia
Secondary sponsor category [1] 308962 0
None
Name [1] 308962 0
Address [1] 308962 0
Country [1] 308962 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 308167 0
Northern Sydney Local Health District Human Research Ethics Committee
Ethics committee address [1] 308167 0
Ethics committee country [1] 308167 0
Australia
Date submitted for ethics approval [1] 308167 0
Approval date [1] 308167 0
17/02/2021
Ethics approval number [1] 308167 0
2020/ETH00587: Head Injury Study

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

Contacts
Principal investigator
Name 109774 0
Ms Danielle Coates
Address 109774 0
Royal North Shore Hospital
Emergency Department
Reserve Road, St Leonards
NSW 2065
Country 109774 0
Australia
Phone 109774 0
+61 0410400780
Fax 109774 0
Email 109774 0
[email protected]
Contact person for public queries
Name 109775 0
Danielle Coates
Address 109775 0
Royal North Shore Hospital
Emergency Department
Reserve Road, St Leonards
NSW 2065
Country 109775 0
Australia
Phone 109775 0
+61 0410400780
Fax 109775 0
Email 109775 0
[email protected]
Contact person for scientific queries
Name 109776 0
Margaret Fry
Address 109776 0
Nursing and Midwifery Directorate NSLHD
Level 7 Kolling Building,
Royal North Shore Hospital,
St Leonards, NSW 2065
Country 109776 0
Australia
Phone 109776 0
+61 0417985214
Fax 109776 0
Email 109776 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?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
11658Study protocol    381679-(Uploaded-12-05-2021-17-01-41)-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.