ANZCTR - Registration

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers

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 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]

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

Condition category

Condition code

Injuries and Accidents

Other injuries and accidents

Intervention/exposure

Study type

Observational

Patient registry

True

Target follow-up duration

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]

Not applicable

Comparator / control treatment

Not applicable

Control group

Uncontrolled

Outcomes

Primary outcome [1]

Disability and Functioning tool used WHODASII

Timepoint [1]

6, 12, 24 months post crash

Primary outcome [2]

Health related quality of life tools using SF12, EQ5D3L

Timepoint [2]

6, 12, 24 months post crash

Secondary outcome [1]

Social outcome - questions on expectations and satisfaction related to social life

Timepoint [1]

6, 12, 24 months follow ups

Secondary outcome [2]

Psychological tools used Impact of event scale and Depression, anxiety and stress scale (DASS21)

Timepoint [2]

6, 12, 24 months post crash

Secondary outcome [3]

Compensation- questions on claims process, outcome and satisfaction

Timepoint [3]

6, 12 and 24 months

Secondary outcome [4]

Health care utilization- questions on contact with medical professionals and linkage to medicare and pharmaceutical benefit scheme.

Timepoint [4]

6, 12, 24 months post crash

Secondary outcome [5]

Employment- questions on work history, job satisfaction, return to work, income and job modification

Timepoint [5]

6, 12, 24 months post crash

Secondary outcome [6]

Pain using numeric pain scale

Timepoint [6]

6, 12, 24 months post crash

Secondary outcome [7]

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]

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?

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]

Royal North Shore Hospital - St Leonards

Recruitment hospital [2]

Royal Prince Alfred Hospital - Camperdown

Recruitment hospital [3]

Orange Health Service - Orange

Recruitment hospital [4]

Liverpool Hospital - Liverpool

Recruitment hospital [5]

Concord Repatriation Hospital - Concord

Recruitment hospital [6]

Canterbury Hospital - Campsie

Recruitment hospital [7]

John Hunter Hospital Royal Newcastle Centre - New Lambton

Recruitment hospital [8]

St George Hospital - Kogarah

Recruitment postcode(s) [1]

2217 - Kogarah

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

State Insurance Regulatory Authority (SIRA)

Address [1]

2-24 Rawson Pl, Haymarket NSW 2000

Country [1]

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]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Sydney Local Health District Human Research Ethics Comittee

Ethics committee address [1]

Concord Repatriation General Hospital,
Hospital Road, Concord West NSW 2139

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

19/03/2013

Approval date [1]

20/05/2013

Ethics approval number [1]

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

Prof Ian Cameron

Address

Kolling Institute of Medical Research, Level 13 | Royal North Shore Hospital | St Leonards NSW | 2065

Country

Australia

Phone

+61 02 9809 9041

Fax

+61 2 9808 9037

[email protected]

Contact person for public queries

Name

Jagnoor Jagnoor

Address

Kolling Institute of Medical Research, Level 13 | Royal North Shore Hospital | St Leonards NSW | 2065

Country

Australia

Phone

+61 2 9809 9043

Fax

+61 2 9808 9037

[email protected]

Contact person for scientific queries

Name

Jagnoor Jagnoor

Address

Kolling Institute of Medical Research, Level 13 | Royal North Shore Hospital | St Leonards NSW | 2065

Country

Australia

Phone

+61 2 9809 9043

Fax

+61 2 9808 9037

[email protected]

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

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.	Type	Citation	Link	Email	Other Details	Attachment
3370	Study protocol	Jagnoor, 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:10.1186/1471-2458-14-199	https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3936822/	[email protected]		364745-(Uploaded-23-07-2019-14-55-07)-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

Source	Title	Year of Publication	DOI
Embase	Factors influencing social and health outcomes after motor vehicle crash injury: an inception cohort study protocol.	2014	https://dx.doi.org/10.1186/1471-2458-14-199
Embase	Outcomes after traffic injury: Mental health comorbidity and relationship with pain interference.	2020	https://dx.doi.org/10.1186/s12888-020-02601-4
Embase	Impacts of injury severity on long-term outcomes following motor vehicle crashes.	2021	https://dx.doi.org/10.1186/s12889-021-10638-7

N.B. These documents automatically identified may not have been verified by the study sponsor.

Trial Review

Registering a new trial?

Documents added manually

Documents added automatically