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Trial registered on ANZCTR


Registration number
ACTRN12614001006639
Ethics application status
Approved
Date submitted
24/06/2014
Date registered
17/09/2014
Date last updated
24/04/2015
Type of registration
Retrospectively registered

Titles & IDs
Public title
Early access to Vocational Rehabilitation Services for People with Spinal Cord Injury
Scientific title
An evaluation of early access to vocational rehabilitation services for people with recent spinal cord injury admitted to spinal injury units compared to usual care in improving vocational and psychosocial outcomes
Secondary ID [1] 284556 0
Nil
Universal Trial Number (UTN)
U1111-1156-4842
Trial acronym
In-Voc
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Spinal Cord Injury 291822 0
Vocational rehabilitation 291823 0
Condition category
Condition code
Injuries and Accidents 292185 292185 0 0
Other injuries and accidents
Physical Medicine / Rehabilitation 292186 292186 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Early access to vocational rehabilitation (VR) services in the three spinal cord injury units in New South Wales, Australia will be provided by trained vocational consultants.

The duration of the intervention is individualised according to the needs and goals of the participants, anywhere around 3 weeks to 3 months.

Contact will be made as early as one week post injury if possible considering medical/psychological stability but may be up to 6 months post injury based on the consultation with the treating health professionals, when the rehabilitation team were in agreement that the person is well enough to be offered the intervention.

The rehabilitation vocational consultants will engage in a variety of tasks with each client - the frequency and nature of which will be individually tailored to the client's needs, they include;
1. Engagement in a series of conversations regarding return to work expectations
2. Assisting the inpatient to commence conversations with the pre-injury employer to explore return to work possibilities including conducting work place visits, job analysis and workplace assessments
3. Assisting the inpatient to explore return to work options including providing vocational counseling, job seeking skills training
4. Assisting the in-patient to develop an individual return to work plan
5. Establishing relationships and processes with key stakeholders that will support and facilitate return to work
6. Ensuring the continuity of appropriate vocational rehabilitation post discharge

Intervention code [1] 289324 0
Rehabilitation
Intervention code [2] 289787 0
Behaviour
Comparator / control treatment
People with spinal cord injury in similar settings but in different states, Western and South Australia, where VR services are not available during acute and sub acute care will be used as comparators.
VR services in these states are generally delivered after the patient is discharged from the hospital in the community setting.

This trial essentially compares early provision of VR services vs usual/traditional care.

An additional strategy due to anticipated difficulty in recruiting controls is to form a historical comparison group using data already available from a previous project, the Spinal Cord Injury Community Participation Project.
Control group
Active

Outcomes
Primary outcome [1] 292063 0
Return to work rates (assessed per Australian Bureau of Statistics definition)
Timepoint [1] 292063 0
12, 24 & 30 months after injury
Secondary outcome [1] 308114 0
General Health and well being measured using SF-36 (The Medical Outcomes Survey Short Form 36)
Timepoint [1] 308114 0
12, 24 months after injury
Secondary outcome [2] 308148 0
Disability measured using FIM (Functional Independence Measure (TM))
Timepoint [2] 308148 0
12 and 24 months after injury
Secondary outcome [3] 308150 0
The level of handicap using CHART (The Craig Handicap Assessment and Reporting Technique)
Timepoint [3] 308150 0
12 and 24 months after injury
Secondary outcome [4] 308151 0
The Moorong Self Efficacy Scale to measure self efficacy across a wide range of life domains.
Timepoint [4] 308151 0
12 and 24 months after injury
Secondary outcome [5] 309087 0
Qualitative experiences of (purposively) selected participants and rehabilitation team members involved in the early intervention program to explore issues such as acceptance, timeliness, appropriateness, role conflict etc .

Assessed by focus group discussions of rehabilitation team members at all 3 sites, key informant interviews of all the vocational consultants and in-depth semi-structured interviews of purposively selected participants.
Timepoint [5] 309087 0
12 months from the time of completion of the early intervention program
Secondary outcome [6] 309088 0
Cost effectiveness analysis of the early intervention program using Incremental Cost Effectiveness Ratio (ICER)
Timepoint [6] 309088 0
12 and 24 months

Eligibility
Key inclusion criteria
1. Recent spinal cord injury (defined as spinal cord injury in previous 6 months that results in permanent disability)
2. Gives informed consent to participate in the evaluation
Minimum age
16 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Spinal injuries attributable to progressive or degenerative diseases, congenital conditions, or metastatic lesions

2. No return to work goal as indicated by a total lack of interest in and/or desire to return to work on the part of the participant. Work may be either in a paid or unpaid capacity. Note that students yet to obtain work are included as are participants who wish to return to or commence non paid work eg volunteer work, or as a carer, or to commence or continue a course of study or training that may lead to improved vocational prospects

3. Considered by the rehabilitation treatment team to be unable to participate due to any medical or psychological reasons, e.g. requiring permanent mechanical ventilation, severe depression or adjustment disorder



Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
All eligible persons admitted to the three spinal units in New South Wales, Australia during the study period will be offered the intervention while a similar group of people with spinal cord injury in Western and South Australia where the intervention is not available will be used as control.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Not applicable
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Prospective cohort study
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
The number of participants needed to achieve this study's primary objective was determined based on these assumptions that were based on literature review and clinical reasoning of minimally worthwhile treatment effect:
1. The anticipated return to work rate in the intervention group is around 50% at 12 months
2. The anticipated return to work rate in the control group is around 20% at 12 months
and assuming two-sided significance level(1-alpha) of 95 and 80% Power with the ratio of sample size, Unexposed/Exposed of 0.5, giving the total sample size of 105 (70 intervention and 35 control).
However given the anticipated 60% rate of participation (20% declining and 20% with no return to work expectation), the final estimated sample size is around 150 (100 intervention and 50 control).

Primary outcome will be compared at 12, 24 and 30 months post-injury. Descriptive statistics will be used to identify differences between InVoc and usual care groups’ scores on secondary outcomes. For nominal data, percentage differences, odds ratios with 95% confidence intervals and Chi-squared will be used to determine statistical significance. For parametric data, paired t-tests will be used for normally distributed and Mann-Whitney-U tests for non-normal and non-parametric data.


Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,SA,WA
Recruitment hospital [1] 2427 0
Royal North Shore Hospital - St Leonards
Recruitment hospital [2] 2428 0
Prince of Wales Private Hospital - Randwick
Recruitment hospital [3] 2429 0
Royal Rehabilitation Hospital - Coorabel/Moorong - Ryde
Recruitment hospital [4] 2430 0
Hampstead Rehabilitation Centre - Northfield
Recruitment hospital [5] 2431 0
Royal Perth Hospital - Perth

Funding & Sponsors
Funding source category [1] 289184 0
Government body
Name [1] 289184 0
NSW Lifetime Care and Support Authority
Address [1] 289184 0
24/580 George St, Sydney NSW 2000

Country [1] 289184 0
Australia
Primary sponsor type
University
Name
Rehabilitation Studies Unit (RSU), University of Sydney
Address
Sydney Medical School/Northern

THE UNIVERSITY OF SYDNEY
Kolling Institute, Royal North Shore Hospital, St Leonards, NSW 2065
Country
Australia
Secondary sponsor category [1] 287855 0
None
Name [1] 287855 0
Address [1] 287855 0
Country [1] 287855 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290964 0
Northern Sydney Central Coast Human Research Ethics Committee
Ethics committee address [1] 290964 0
Level 2, Building 51
Royal North Shore Hospital
St Leonards, NSW 2065
Ethics committee country [1] 290964 0
Australia
Date submitted for ethics approval [1] 290964 0
Approval date [1] 290964 0
26/05/2011
Ethics approval number [1] 290964 0
HREC/11/HAWKE/91

Summary
Brief summary
This project's hypotheses are that early access to vocational rehabilitation services for in-patients in NSW spinal units will increase return to work rates and have a positive impact on general health and well being of the participants.

This study will also have other components to complement the quantitative aspect namely a qualitative sub-evaluation (investigating the perspective of the participants and rehabilitation staff), a process sub-evaluation (with reference to the implementation of the intervention), and a cost sub-evaluation.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 48158 0
Prof Ian Cameron
Address 48158 0
Rehabilitation Studies Unit, Sydney Medical School/Northern

THE UNIVERSITY OF SYDNEY
Kolling Institute, Royal North Shore Hospital, St Leonards NSW 2065
Country 48158 0
Australia
Phone 48158 0
+61299264962
Fax 48158 0
+61299264045
Email 48158 0
ian.cameron@sydney.edu.au
Contact person for public queries
Name 48159 0
Prof Ian Cameron
Address 48159 0
Rehabilitation Studies Unit, Sydney Medical School/Northern

THE UNIVERSITY OF SYDNEY
Kolling Institute, Royal North Shore Hospital, St Leonards, NSW 2065
Country 48159 0
Australia
Phone 48159 0
+61299264962
Fax 48159 0
+61299264045
Email 48159 0
ian.cameron@sydney.edu.au
Contact person for scientific queries
Name 48160 0
Prof Ian Cameron
Address 48160 0
Rehabilitation Studies Unit, Sydney Medical School/Northern

THE UNIVERSITY OF SYDNEY
Kolling Institute, Royal North Shore Hospital, St Leonards
NSW 2065
Country 48160 0
Australia
Phone 48160 0
+61299264962
Fax 48160 0
+61299264045
Email 48160 0
ian.cameron@sydney.edu.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary