Trial Review

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Trial registered on ANZCTR


Registration number
Ethics application status
Yes
Date submitted
6/08/2013
Date registered
Date last updated

Titles & IDs
Public title
The FISH Study
Scientific title
Factors Influencing Social and Health Outcomes after Land Transport Injury: inception cohort study
Secondary ID [1] 282981 0
NIL
Universal Trial Number (UTN)
U1111-1146-3934
Trial acronym
FISH
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Injuries due to Motor Vehicle Crash 289806 0
Condition category
Condition code
Injuries and Accidents 290157 290157 0 0
Other injuries and accidents

Intervention/exposure
Study type
Observational
Patient registry
True
Target follow-up duration
2
Target follow-up type
Years
Description of intervention(s) / exposure
Adults ( 17 years and above) injured in road transport crash in New South Wales, Australia in last 28 days from the day of recruitement.
Intervention code [1] 287693 0
Not applicable - Observational study
Comparator / control treatment
Not applicable
Control group
Uncontrolled

Outcomes
Primary outcome [1] 290185 0
Pain ( Numeric Rating Scale), Disability and Functioning ( WHODAS II),
Health related quality od life (SF12, EQ5D3L), Psychological (impact of event scale and Depression, anxiety and stress scale DASS21), Health care utilization, Employment
Timepoint [1] 290185 0
Within 28 days from road transport crash.
Secondary outcome [1] 304071 0
Social outcome and Compensation (claims)
Timepoint [1] 304071 0
6, 12, 24 months follow ups

Eligibility
Key inclusion criteria
Age 17 years and above
Recent ( in last 28 days) injured in road transport crash in NSW
Medicare number
Minimum age
17 Years
Maximum age
100 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Intentional self harm
Dementia or pre-exsisting cognitive impairments affecting ability to consent.
Severe injury like brain, spinal cord, extensive burns etc as defined by NSW lifetime care and support.
Death of family in the land transport crash.
Non english speaking background.

Study design
Purpose
Psychosocial
Duration
Longitudinal
Selection
Random sample
Timing
Prospective
Statistical methods / analysis
Descriptive analysis for variables of interest. Bivariate and multivariate regression analysis for each outcome of interest. Adjustment for confounding and mediators,. Sub-group analysis and assesment of interaction terms.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
12/08/2013
Actual
Date of last participant enrolment
Anticipated
31/01/2015
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
1500
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 1422 0
Royal North Shore Hospital - St Leonards
Recruitment hospital [2] 1423 0
Royal Prince Alfred Hospital - Camperdown
Recruitment hospital [3] 1424 0
Orange Health Service - Orange

Funding & Sponsors
Funding source category [1] 287751 0
Government funding body
Name [1] 287751 0
Motor Accident Authority of NSW
Country [1] 287751 0
Australia
Primary sponsor type
University
Name
Proffesor Ian Cameron
Address
Rehabilitation Studies Unit
University of Sydney
Street address - 59 Charles Street, Ryde.
Postal- PO box 6, Ryde,1680
Country
Australia
Secondary sponsor category [1] 286472 0
None
Name [1] 286472 0
Address [1] 286472 0
Country [1] 286472 0

Ethics approval
Ethics application status
Yes
Ethics committee name [1] 289697 0
Sydney Local Health District Human Research Ethics Comittee
Ethics committee address [1] 289697 0
Concord Repatriation General Hospital,
Concord NSW 2139
Ethics committee country [1] 289697 0
Australia
Date submitted for ethics approval [1] 289697 0
19/03/2013
Approval date [1] 289697 0
20/05/2013
Ethics approval number [1] 289697 0
HREC/13/CRGH/67

Summary
Brief summary
A limited amount is known about the key determinants of the health and social outcomes for people who have
sustained an injury as a result of a land transport crash and, in particular, the extent to which determinants specifically related to the compensation process are relevant.

The proposed investigation will seek to:

1) Identify individual and system factors influencing the health and social outcomes of people who have sustained an injury related to a land transport crash and who seek compensation through a compulsory third party (CTP) compensation scheme;
2) Identify individual and system factors influencing the health and social outcomes of people who have sustained a non­compensable injury in a land transport crash in NSW;
3) Identify the key factors that explain the differences between those who apply for compensation and those who are eligible to apply but do not.

There are a number of domains, which relate to the individual and the system, which will be explored:
­ Characteristics related to the individual that influence the likelihood of applying for compensation
­ Characteristics related to the health service experience process
­ Characteristics related to the claims process
­ Characteristics related to the liability and fault process
­ Characteristics related to the legal representation process

The study will utilise an inception cohort design, with a sample size of 1,500 participants aged 17 years or older, who are injured as a result of a crash involving a motorised vehicle in NSW and who have been diagnosed with an injury within 28 days of the crash. Recruitment will be through metropolitan and rural hospital emergency departments, general practitioners, physiotherapy clinics, police crash records and the Motor Accidents Authority claims database.

People with severe injury, those unable to give consent due to cognitive impairment, those with minor localised soft tissue injury, those with a self harm related injury or those where a family member has died as a result of the crash, will be excluded.

Data about health and social recovery outcomes and variables that potentially influence these outcomes will be
collected by questionnaire administered by telephone or by written questionnaire for people who are deaf or prefer to
complete a written questionnaire. There will be a focus on key variables identified in the literature that are associated with health outcomes. The questionnaire will be no longer than 45 minutes and be conducted at baseline (within 28 days of the motor vehicle crash), 6, 12 and 24 months post­injury. Detailed statistical analyses will explore the associations and interactions between the measured variables and health and social recovery
outcomes.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 42038 0
Prof Ian Cameron
Address 42038 0
59 Charles Street, Ryde, NSW 2112
Country 42038 0
Australia
Phone 42038 0
+61 02 9809 9041
Fax 42038 0
02 9808 9037
Email 42038 0
ian.cameron@sydney.edu.au
Contact person for public queries
Name 42039 0
Jagnoor Jagnoor
Address 42039 0
59 Charles Street, Ryde, NSW 2112
Country 42039 0
Australia
Phone 42039 0
+61 9809 9043
Fax 42039 0
02 9808 9037
Email 42039 0
jagnoor.jagnoor@sydney.edu.au
Contact person for scientific queries
Name 42040 0
Jagnoor Jagnoor
Address 42040 0
59 Charles Street, Ryde, NSW 2112
Country 42040 0
Australia
Phone 42040 0
+61 9809 9043
Fax 42040 0
02 9808 9037
Email 42040 0
jagnoor.jagnoor@sydney.edu.au

No information has been provided regarding IPD availability


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.