Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613000889752
Ethics application status
Approved
Date submitted
6/08/2013
Date registered
9/08/2013
Date last updated
25/07/2019
Date data sharing statement initially provided
25/07/2019
Date results information initially provided
25/07/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Factors Influencing Social and Health Outcomes after Land Transport Injury:cohort study (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 recruitment. Participants will be followed up at baseline, 6, 12 and 24 months. Information will be collected on social, economic, health and quality of life outcomes.
Intervention code [1] 287693 0
Not applicable
Comparator / control treatment
Not applicable
Control group
Uncontrolled

Outcomes
Primary outcome [1] 290205 0
Disability and Functioning tool used WHODASII
Timepoint [1] 290205 0
6, 12, 24 months post crash
Primary outcome [2] 290206 0
Health related quality of life tools using SF12, EQ5D3L
Timepoint [2] 290206 0
6, 12, 24 months post crash
Secondary outcome [1] 304071 0
Social outcome - questions on expectations and satisfaction related to social life
Timepoint [1] 304071 0
6, 12, 24 months follow ups
Secondary outcome [2] 304098 0
Psychological tools used Impact of event scale and Depression, anxiety and stress scale (DASS21)
Timepoint [2] 304098 0
6, 12, 24 months post crash
Secondary outcome [3] 304099 0
Compensation- questions on claims process, outcome and satisfaction
Timepoint [3] 304099 0
6, 12 and 24 months
Secondary outcome [4] 304100 0
Health care utilization- questions on contact with medical professionals and linkage to medicare and pharmaceutical benefit scheme.
Timepoint [4] 304100 0
6, 12, 24 months post crash
Secondary outcome [5] 304101 0
Employment- questions on work history, job satisfaction, return to work, income and job modification
Timepoint [5] 304101 0
6, 12, 24 months post crash
Secondary outcome [6] 304102 0
Pain using numeric pain scale
Timepoint [6] 304102 0
6, 12, 24 months post crash
Secondary outcome [7] 372989 0
Health Literacy was added as an additional secondary outcome to determine the association between health literacy and recovery in the cohort. Health Literacy Questionnaire (HLQ) was developed and extensively tested in Australia by a team led by Professor Richard Osborne in Victoria, Australia. The HLQ is a widely used multi-dimensional health literacy assessment tool for surveys, evaluation and service improvement. It collects information on how people find, understand and use health information, and how they manage their health and interact with healthcare providers.
Timepoint [7] 372989 0
6 and 12 months

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
Completed
Date of first participant enrolment
Anticipated
12/08/2013
Actual
12/08/2013
Date of last participant enrolment
Anticipated
31/01/2015
Actual
18/12/2016
Date of last data collection
Anticipated
Actual
18/01/2019
Sample size
Target
1500
Accrual to date
Final
1220
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
Recruitment hospital [4] 2726 0
Liverpool Hospital - Liverpool
Recruitment hospital [5] 2727 0
Concord Repatriation Hospital - Concord
Recruitment hospital [6] 2728 0
Canterbury Hospital - Campsie
Recruitment hospital [7] 2729 0
John Hunter Hospital Royal Newcastle Centre - New Lambton
Recruitment hospital [8] 14311 0
St George Hospital - Kogarah
Recruitment postcode(s) [1] 27309 0
2217 - Kogarah

Funding & Sponsors
Funding source category [1] 287751 0
Government body
Name [1] 287751 0
State Insurance Regulatory Authority (SIRA)
Country [1] 287751 0
Australia
Primary sponsor type
Individual
Name
Proffesor Ian Cameron
Address
Kolling Institute of Medical Research, Level 13 | Royal North Shore Hospital | St Leonards NSW | 2065
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
Approved
Ethics committee name [1] 289697 0
Sydney Local Health District Human Research Ethics Comittee
Ethics committee address [1] 289697 0
Concord Repatriation General Hospital,
Hospital Road, Concord West 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
Kolling Institute of Medical Research, Level 13 | Royal North Shore Hospital | St Leonards NSW | 2065
Country 42038 0
Australia
Phone 42038 0
+61 02 9809 9041
Fax 42038 0
+61 2 9808 9037
Email 42038 0
ian.cameron@sydney.edu.au
Contact person for public queries
Name 42039 0
Dr Jagnoor Jagnoor
Address 42039 0
Kolling Institute of Medical Research, Level 13 | Royal North Shore Hospital | St Leonards NSW | 2065
Country 42039 0
Australia
Phone 42039 0
+61 2 9809 9043
Fax 42039 0
+61 2 9808 9037
Email 42039 0
jagnoor.jagnoor@sydney.edu.au
Contact person for scientific queries
Name 42040 0
Dr Jagnoor Jagnoor
Address 42040 0
Kolling Institute of Medical Research, Level 13 | Royal North Shore Hospital | St Leonards NSW | 2065
Country 42040 0
Australia
Phone 42040 0
+61 2 9809 9043
Fax 42040 0
+61 2 9808 9037
Email 42040 0
jagnoor.jagnoor@sydney.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
It is undecided, as there are several data linkages involved. There is potential to share survey-based database.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
3370Study protocolJagnoor, J., Blyth, F., Gabbe, B., Derrett, S., Boufous, S., Dinh, M., … Cameron, I. D. (2014). Factors influencing social and health outcomes after motor vehicle crash injury: an inception cohort study protocol. BMC public health, 14, 199. doi:10.1186/1471-2458-14-199https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3936822/jagnoor.jagnoor@sydney.edu.au 364745-(Uploaded-23-07-2019-14-55-07)-Study-related document.pdf



Results publications and other study-related documents

Documents added manually
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Study results articleYes Gopinath, B et al. Describing and comparing the ch... [More Details]
Study results articleYes Gopinath, B et al. Health-related quality of life ... [More Details]
Study results articleYes Gopinath, B et al. Differential Predictors of Pain... [More Details]
Plain language summaryNo So far the study findings highlight the need for b... [More Details]

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseOutcomes after traffic injury: Mental health comorbidity and relationship with pain interference.2020https://dx.doi.org/10.1186/s12888-020-02601-4
EmbaseImpacts of injury severity on long-term outcomes following motor vehicle crashes.2021https://dx.doi.org/10.1186/s12889-021-10638-7
EmbaseFactors influencing social and health outcomes after motor vehicle crash injury: an inception cohort study protocol.2014https://dx.doi.org/10.1186/1471-2458-14-199
N.B. These documents automatically identified may not have been verified by the study sponsor.