Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000428662
Ethics application status
Approved
Date submitted
28/03/2023
Date registered
28/04/2023
Date last updated
17/04/2024
Date data sharing statement initially provided
28/04/2023
Type of registration
Retrospectively registered

Titles & IDs
Public title
Characteristics, patterns and outcomes of bicycle injuries that present to one tertiary emergency department.
Scientific title
A prospective, quantitative and qualitative case-linked study on bicycle injuries that present to the Emergency Department.
Secondary ID [1] 309324 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
bicycle injury 329513 0
Condition category
Condition code
Injuries and Accidents 326448 326448 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 prospective study is designed to examine the details of the crash circumstances, injuries and treatment of patients who come to the Emergency Department (ED) of Royal North Shore Hospital (RNSH), who have suffered either major or minor injuries as a result of an accident involving a bicycle.
Patients who present to the ED that fit the inclusion criteria and are not excluded as per the exclusion criteria will be approached by a member of the ED research team for consent to participate in the study. This include permission to access their medical records to examine the characteristics, patterns and outcomes of their bicycle injury and for permission to be contacted three-months following their discharge from the hospital to participate in a short 10-minute telephone interview/survey. Patient's who do not want to participant in the telephone interview but give permission for investigators to access their medical records related to this bicycle injury can indicate so on their consent form.
The data will be collected relating to the circumstances of the accident, injuries suffered and treatment received. This will be entered on the Bicycle Injury Study (BIS) Excel data file. This electronic file will be stored electronically on the RNSH system, governed by RNSH electronic security codes.
The telephone interview/survey will be conducted by a trained member of the ED department research team. The participant’s best contact number will be confirmed upon consent to the study. The survey will ask the participant questions to review their recovery from injuries and the short and long term impacts of their injuries.
Intervention code [1] 325756 0
Diagnosis / Prognosis
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 334294 0
The primary outcome is characteristic and patterns of patients that present with bicycle injury to the emergency department, determined by a review of medical records. The characteristic and patterns and outcomes of patients will be analysed as a composite outcome.
Timepoint [1] 334294 0
Identified at the time of Emergency Department presentation
Primary outcome [2] 334538 0
The primary outcome is the outcome of patients that present with bicycle injury to the emergency department, determined by a review of medical records.
Timepoint [2] 334538 0
Identified at the time of discharge from the Emergency Department
Secondary outcome [1] 420167 0
The secondary objectives is the type of analgesia prescribed in the ED, determined by a review of medical records.
Timepoint [1] 420167 0
Identified at time of Emergency Department presentation.
Secondary outcome [2] 420170 0
Assessment of the degree of recovery after three months including the impact of injuries on daily living activities, via telephone interview of patients presenting to ED RNS with the bicycle injuries. The secondary outcome of degree of recovery after three months and impact of injuries on daily living activities will be analysed as a composite outcome.
Timepoint [2] 420170 0
3 months post-discharge from the Emergency Department
Secondary outcome [3] 421027 0
Understanding of individual's attitudes to more protective gear when bike riding three months following discharge from the Emergency Department, assessed via telephone interview of patients presenting to ED RNS with the bicycle injuries.
Timepoint [3] 421027 0
3 months post-discharge from the Emergency Department

Eligibility
Key inclusion criteria
Inclusion criteria: all patient be 18 years or over presenting to ED, RNSH who have been involved in accident, involving injuries caused by a bicycle, as either a rider or pedestrian, whose treating doctor has assessed them as being fit to participate in the study and give informed consent, and that the patient voluntarily agrees to participate in the study.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria: patients who require emergency surgery and transfer to the operating room, patients who are admitted to the emergency department resuscitation room for management of immediate life threatening injuries.

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Random sample
Timing
Retrospective
Statistical methods / analysis
As this project will focus upon presenting relatively simple numerical picture basic statistics with respect to cause, severity and gross typology of injury only will be undertaken. The anticipated sample size precludes higher statistical analysis.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
7/05/2017
Date of last participant enrolment
Anticipated
12/04/2027
Actual
Date of last data collection
Anticipated
12/07/2027
Actual
Sample size
Target
620
Accrual to date
283
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 24368 0
Royal North Shore Hospital - St Leonards
Recruitment postcode(s) [1] 39952 0
2065 - St Leonards

Funding & Sponsors
Funding source category [1] 313518 0
Hospital
Name [1] 313518 0
Emergency Department, Royal North Shore Hospital
Country [1] 313518 0
Australia
Funding source category [2] 313640 0
Other
Name [2] 313640 0
In-kind support Emergency Department Research Team
Country [2] 313640 0
Australia
Primary sponsor type
Hospital
Name
Emergency Department, Royal North Shore Hospital
Address
Reserve Rd, St Leonards NSW 2065
Country
Australia
Secondary sponsor category [1] 315295 0
None
Name [1] 315295 0
Address [1] 315295 0
Country [1] 315295 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 312705 0
Northern Sydney Local Health District Research Office
Ethics committee address [1] 312705 0
Ethics committee country [1] 312705 0
Australia
Date submitted for ethics approval [1] 312705 0
31/03/2017
Approval date [1] 312705 0
12/04/2017
Ethics approval number [1] 312705 0
2019/ETH08583

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

Contacts
Principal investigator
Name 125618 0
Dr Mark Gillet
Address 125618 0
Emergency Department, Royal North Shore Hospital, Reserve Rd., St. Leonards, NSW 2065
Country 125618 0
Australia
Phone 125618 0
+61 294632228
Fax 125618 0
Email 125618 0
[email protected]
Contact person for public queries
Name 125619 0
Jennifer McGready
Address 125619 0
Emergency Department, Royal North Shore Hospital, Reserve Rd., St. Leonards, NSW 2065
Country 125619 0
Australia
Phone 125619 0
+61 423731431
Fax 125619 0
Email 125619 0
[email protected]
Contact person for scientific queries
Name 125620 0
Mark Gillet
Address 125620 0
Emergency Department, Royal North Shore Hospital, Reserve Rd., St. Leonards, NSW 2065
Country 125620 0
Australia
Phone 125620 0
+61 294632228
Fax 125620 0
Email 125620 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
Patient data will need to be de-identified. Additionally, participant responses to interviews will need to be de-identified to ensure confidentiality.


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.