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Trial registered on ANZCTR


Registration number
ACTRN12619000521123
Ethics application status
Approved
Date submitted
22/02/2019
Date registered
2/04/2019
Date last updated
5/11/2020
Date data sharing statement initially provided
2/04/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Early vocational intervention for people who have experienced trauma
Scientific title
The impact of early vocational intervention on return to work outcomes for people who have experienced traumatic brain injury, spinal and musculoskeletal trauma
Secondary ID [1] 297499 0
None
Universal Trial Number (UTN)
U1111-1229-0725
Trial acronym
EIVRS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
traumatic brain injury 311687 0
spinal cord injury 311688 0
orthopaedic injury 311689 0
Condition category
Condition code
Physical Medicine / Rehabilitation 310316 310316 0 0
Occupational therapy
Injuries and Accidents 310353 310353 0 0
Fractures
Neurological 310354 310354 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Currently most vocational rehabilitation services do not commence until after the injured individual has been discharged from inpatient treatment (i.e., for traumatic brain injuries(TBI), spinal cord injuries (SCI) or orthopaedic injuries). We will be recruiting participants to the study early in their inpatient hospital stay, but only after they are medically stable and, in the case of patients with TBI, have emerged from post-traumatic amnesia and are cognitively competent to give consent to participate in the study. If they are randomised to receive the early intervention vocational (EIVR) therapy, discussions will commence immediately after they have given consent to participate in the study, regarding the nature of their pre-injury employment, duties and hours, motivation to return to or engage in work. There will be discussion of current barriers and potential timelines for return to work. These first interactions will focus on establishing rapport, providing an opportunity for the worker role to be acknowledged and understood, introducing the EIVR service, and normalising return to work as an expectation and a goal that can be part of inpatient rehabilitation.

When appropriate, permission will be sought from the participant for the EIVRS therapist to contact the employer. The EIVRS service or the participant (where appropriate) will contact the employer to open communication lines and explain the nature of the participant’s injuries, process for return to work and possible timelines for return to the workplace, as well as potential barriers. Options for work adaptations including alternative or modified duties, hours or roles will also be discussed. The timing of this contact with the employer will be a distinguishing feature from treatment as usual as this does not commonly occur until a later stage of vocational rehabilitation.

Following early interactions, tailored interventions are customized to the unique circumstances of the individual by the vocational consultant and discussed with the treating therapists. A vocational rehabilitation plan will be prepared to address these issues and motivational interviewing provided to the participant. If deemed necessary, referral will be made for cognitive behavioural therapy to address psychological issues that may impede return to work, such as PTSD, anxiety or depression. The EIVRS clinician will continue to liaise with the treating therapists through attendance at case conferences to review progress towards these goals up to the time of discharge. With the participant’s permission they will also maintain contact with the employer during the rehabilitation process to keep them informed. If the participant is assessed as work ready during the in-patient stay and the employer is agreeable, a graded RTW program may be facilitated by the EIVRS clinician.

The EIVRS will be an allied health professional (likely to be an OT) with experience in or knowledge of inpatient trauma rehabilitation, vocational rehabilitation and/or rehabilitation counselling. The EIVRS is planned to be delivered as an in-patient service. On discharge, participants will then have access to the usual vocational services either provided by the facility or a community based specialised vocational services. Access to this service is usually available until a return to work outcome is achieved and is not time limited.

The number of EIVRS sessions cannot be specified as this will depend on what is clinically relevant for each individual. It will most likely range, on average, between 5 and 10 sessions over the course of the program. The number of sessions will be documented. Sessions will be face to face however employer contact is likely to be over the phone. Session duration will depend on what is clinically relevant for that individual at that particular time and may vary according to what the patient can tolerate, how complex the work situation is and what the goal of the session is (to establish rapport, obtain a detailed description of the pre-injury role etc). They will most likely range between 20 minutes and 90 minutes, on average. Session timing and duration will be documented.

The therapist will contact the employer as early as possible in the inpatient rehabilitation process. However, they will not contact the employer until permission is provided by the patient. The timing of this will vary from one individual to another, but can depend on whether the employer has been asking the patient for information, whether the patient is anxious about their job and the therapist to contact the employer. It will be up to the patient to decide whether they are comfortable with the therapist talking to the employer of whether they prefer to make contact themselves. The time of initiating employer contact will be documented.

To monitor fidelity to the intervention, the therapist will keep a record of each session using the EIVRS – session record form. In addition fidelity of the intervention will be monitored using the EVIR therapist activities – monitoring form.

The tailored interventions are not part of usual care in most sites as they are not normally provided whilst the patient is an inpatient.

The tailored intervention includes contacting patients early while they are inpatients (rather than waiting until they are outpatients). These are the phases of the intervention: i) relationship building, education and information; ii) liaising with employer, family and treating team; iii) establishing and monitoring the return to work program; iv) follow-up

Please note, the graded RTW program is part of standard clinical care.
Intervention code [1] 313741 0
Rehabilitation
Comparator / control treatment
There will be a control group, which receive treatment as usual. At the time of providing formal consent to participate they will be made aware that they may receive the early intervention or usual vocational intervention. Should a control participant be actively seeking to pursue return to work whilst still an inpatient, they will be supported in pursing this goal by their treating occupational therapist and given access to available vocational services. Treatment as usual will vary between settings and also according to the individual's compensation status. Given this, therapeutic input will be recorded for both groups, including the nature of therapy received, hours of vocational rehabilitation input, from the EIVRS service or other therapist.

At Epworth sites and Royal Talbot TBI – no inpatient vocational support is provided as ‘treatment as usual’. As noted above, treatment is usual is provided as an out-patient service. For Austin Spinal patients, a more limited vocational service is provided to inpatients, but doesn’t include the paid peer support.
Control group
Active

Outcomes
Primary outcome [1] 319203 0
Employment outcome, specifically hours per week in paid employment. There will be an independent member of the research team performing follow-up at one year post-injury and s/he will document this, along with other outcome measures
Timepoint [1] 319203 0
1 year post-injury
Secondary outcome [1] 367268 0
Work roles and duties (skill levels) relative to pre-injury

A detailed description of the pre-injury roles and duties will be obtained during phase 1 and assigned an ANZSCO classification for occupation type and skill level. At one year follow-up this same information will be recorded.

ANZCO occupation classification: 1=managers, 2=professionals, 3=technicians and trade workers, 4=community and personal service workers, 5=clerical and admin workers, 6=sales workers, 7=machinery operators and drivers, 8=labourers.
ANZCO skill level classification: 1 to 5 (with higher score indicating lower skill level)
Timepoint [1] 367268 0
1 year post-injury
Secondary outcome [2] 367269 0
Number of hours working relative to pre-injury

The average number of hours at one-year post-injury will be recorded and compared to pre-injury average hours.
Timepoint [2] 367269 0
1 year post-injury
Secondary outcome [3] 367276 0
Work modifications relative to pre-injury

Any type of work modifications (e.g., alternative/modified duties) will be noted at one-year post-injury.
Timepoint [3] 367276 0
1 year post-injury
Secondary outcome [4] 367278 0
Engagement in study

This is assessed by a question asking if they are engaged in any study.
Timepoint [4] 367278 0
1 year post-injury
Secondary outcome [5] 367279 0
Engagement in re-training

This is assessed by a question asking if they are engaged in re-training.
Timepoint [5] 367279 0
1 year post-injury
Secondary outcome [6] 367280 0
Engagement in voluntary work

This is assessed by a question asking if they are engaged in voluntary work.


Timepoint [6] 367280 0
1 year post-injury
Secondary outcome [7] 367285 0
Sustainability of employment 6 months following return to employment - hours worked per week

We will measure sustainability of employment 6 months following RTW for all enrolled individuals. This will be recorded as average hours worked per week.
Timepoint [7] 367285 0
1 year post-injury
Secondary outcome [8] 368258 0
Sustainability of employment 6 months following return to employment - roles and duties

ANZCO occupation and skill level will be recorded as follows:.

ANZCO occupation classification: 1=managers, 2=professionals, 3=technicians and trade workers, 4=community and personal service workers, 5=clerical and admin workers, 6=sales workers, 7=machinery operators and drivers, 8=labourers.

ANZCO skill level classification: 1 to 5 (with higher score indicating lower skill level)

Timepoint [8] 368258 0
1 year post-injury
Secondary outcome [9] 368260 0
Sustainability of employment 6 months following return to employment – work modifications

Any type of work modifications (e.g., alternative/modified duties) will be noted.

Timepoint [9] 368260 0
1 year post-injury
Secondary outcome [10] 368263 0
Community/social participation

This is not a composite. Rather, community and social participation is measured by the PART-O. The PART-O is a questionnaire that allows you to generate the following scores: productivity score, social relations score, out-and-about score, a total average score and a total balanced score.
Timepoint [10] 368263 0
1 year post-injury
Secondary outcome [11] 368690 0
Quality of Life – Physical Health .This information is collected by the SF-12 v2 health survey, which provides two scores, one of which is for physical health.
Timepoint [11] 368690 0
1. Recruitment
2. Hospital Discharge
3. 1 year post-injury
Secondary outcome [12] 368691 0
Quality of Life – Mental Health This information is collected by the SF-12 v2 health survey, which provides two scores, one of which is for mental health.
Timepoint [12] 368691 0
1. Recruitment
2. Hospital Discharge
3. 1 year post-injury
Secondary outcome [13] 368692 0
Satisfaction ratings and feedback are measured by a satisfaction questionnaire, where participants rate on a scale of 1-5 (very satisfied to very unsatisfied) on a number of different areas about the EIVRS service. This is to measure satisfaction ratings and feedback of the intervention. Open-text questions allow for the provision of any other feedback regarding satisfaction of the EIVRS service. Participants in the intervention group and their employers (where relevant) and their insurance claim coordinators will complete the satisfaction ratings at participant discharge from the study intervention. All participants, all employers (where relevant), and rehabilitation team members of participants in the intervention group will complete the ratings at one year post injury.
Timepoint [13] 368692 0
1. At discharge from the study intervention for participants in the intervention group and their employers (if relevant) and insurance claim coordinators.
2. At one year post-injury for all participants, all employers (if relevant), rehabilitation team members of participants in the intervention group and EIVRS therapists.
Secondary outcome [14] 368693 0
Quality ratings and feedback are measured by a satisfaction questionnaire, where participants rate on a scale of 1-5 (very good quality to very poor quality) on a number of different areas about the EIVRS service. This is to measure quality ratings and feedback of the intervention. Open-text questions allow for the provision of any other feedback regarding quality of the EIVRS service. Participants in the intervention group and their employers (where relevant) and their insurance claim coordinators will complete the quality ratings at participant discharge from the study intervention. All participants, all employers (where relevant), rehabilitation team members of participants in the intervention group will complete the ratings at one year post injury.
Timepoint [14] 368693 0
1. At discharge from the study intervention for participants in the intervention group and their employers (if relevant) and insurance claim coordinators.
2. At one year post-injury for all participants, all employers (if relevant), rehabilitation team members of participants in the intervention group and EIVRS therapists.
Secondary outcome [15] 368694 0
Barriers and facilitators to delivery of effective EIVRS intervention - Qualitative interviews This is not a composite. Qualitative interviews will take approximately 1 hour and occur face-to-face. Interviews will be audio-recorded and follow a semi-structured interview schedule. Interviews will be coded to either barriers or facilitators using qualitative analysis software. Qualitative interviews will be completed with 20 participants in the intervention group, 20 employers of participants in the intervention group, 15 rehabilitation team members of participants in the intervention group and the three EIVRS therapists who have delivered the study intervention.
Timepoint [15] 368694 0
1. Discharge from the study intervention for participants and employers.
2. 1 year post-injury for rehab team members and EIVRS therapists.
Secondary outcome [16] 368826 0
Quality-adjusted Life Years (QALYs) - Cost benefit analysis SF6D scores will be derived from SF-12 v2 response data using Australian weights. SF6D scores will then be multiplied by duration assuming linear time trend between time-points.
This outcome differs to others in the study. QALYs is a measure of disease burden (counting for the quality and the quantity of life lived) which will be used in a cost benefit analysis along with productivity gains/losses, use and cost of vocational rehabilitation services and health service utilization. QALYs is also separate to assessing the opinion of the quality of the intervention from the perspectives of participants, insurance claims coordinators, employers and rehabilitation team members.
Timepoint [16] 368826 0
1. Recruitment
2. Hospital discharge
3. 1 year post-injury
Secondary outcome [17] 368827 0
Productivity gains / losses - Cost benefit analysis Calculated based on pre-/post-injury difference in paid and unpaid work hours multiplied by hourly wage rate for duties in paid and unpaid work hours. Pre-injury employment hours and duties will be taken from the recruitment questionnaire. Post-injury hours and duties in paid work will be taken from Employment Status items in the hospital discharge and one year follow up questionnaires. Post-injury hours and duties in unpaid work taken from PART-O-17 items.
Timepoint [17] 368827 0
1. Recruitment
2. Hospital discharge
3. 1 year post-injury
Secondary outcome [18] 368828 0
Health service utilisation - Cost benefit analysis will be calculated based on obtaining a health service utilization questionnaire from participants which captures information on medications taken, services used and hospital admissions that occurred since hospital discharge for traumatic injury.
Timepoint [18] 368828 0
1. 6 months post hospital discharge
2. 1 year post injury
Secondary outcome [19] 368829 0
Use and cost of vocational rehabilitation services - Cost benefit analysis

Calculated based on administrative data regarding number, duration and nature of vocational rehabilitation sessions.
Timepoint [19] 368829 0
At point of service use from baseline to 1 year post injury.

Eligibility
Key inclusion criteria
1. Individuals must have a traumatic brain injury, spina cord injury, or multi-trauma orthopaedic injury, defined as an Injury Severity Score >12, urgent surgery, or admission to the ICU for >24 hours.
2. Individuals are admitted to Epworth HealthCare or Royal Talbot for rehabilitation.
3. Individuals are employed at the time of their injury.
Minimum age
16 Years
Maximum age
70 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Failure to regain consciousness or emerge from post-traumatic amnesia.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint(s)
Statistical methods / analysis
Following appropriate exploratory analysis of the data, comparison of the two groups, EIVRS service, and treatment as usual, on the primary outcome of mean weekly hours in paid employment at 12 months will be performed using linear regression (which in the case of no other variables included in the model is equal to an independent samples t-test).

Secondary outcomes such as PART-O and SF-12v2 physical and mental health summary scores (or number of hours in paid employment if found to be skewed) will be compared using linear regression, or if found to be skewed, appropriate methods for skewed data such as quantile regression (McKenzie et al, 2015) or negative binomial regression, appropriate for the analysis of counts, including number of hours worked. Sustainability of employment at 6 months (i.e. confined to those who returned to work) will be assessed using binary logistic regression. A small number of clinically relevant variables, such as age, gender, number of hours worked prior to injury, education, injury type and severity, will be included in the regression models as potential predictors and confounders.

Qualitative interviews for each data source (i.e. participants, employers, clinicians, EIVRS therapists) will be transcribed and then analysed thematically following the six-step process recommended by Braun & Clarke (2006). We will involve the lived experience advisory panel in developing an understanding of the data and identifying themes both within and across the four data sources.

A cost-befit analysis will also be conducted. The primary outcome for the cost-benefit analysis will be quality-adjusted life-years (QALYs) to 12-month follow-up calculated based on baseline and 12-month data using SF12v2-based SF6D scores derived using recently published Australian weights (Norman et al, 2014). Secondary outcomes for will be return to work (RTW) and the PARTO-17. Treatment effects with respect to RTW and the PARTO-17 will be estimated as for the main analysis. Treatment effects with respect to total QALYs to 12-month follow-up will be estimated using one-part generalized linear models (GLM); controlling for SF6D index scores at baseline and specifying appropriate variance and link functions (Glick et al, 2010). Patient-level data on health service utilisation to 12-months post injury period will be obtained from the health service utilisation questionniare, productivity gains to 12-months post-injury will be estimated based on responses to the RTW, the ratio of pre/post hours in work and PARTO-17 data. Patient-level data regarding health service utilisation and productivity gains will be combined with patient-level data regarding direct costs of the EIVRS service and treatment as usual to calculate per patient total cost for treatment and control arms. Given the likely structure of our data and the advice of Buntin and Zaslavsky (2004), treatment effects with respect to total cost will estimated using a one-part GLM models with gamma variance function and a log link (rather than transformed OLS or two-part models); controlling for patient characteristics at baseline. Results will be expressed as (i) cost per QALY gained, and (ii) net monetary benefits (NMB).

Recruitment
Recruitment status
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)
VIC
Recruitment hospital [1] 13229 0
Austin Health - Austin Hospital - Heidelberg
Recruitment hospital [2] 13230 0
Epworth Richmond - Richmond
Recruitment hospital [3] 13231 0
Epworth Rehabilitation Camberwell - Camberwell
Recruitment hospital [4] 13232 0
Epworth Rehabilitation Brighton - Brighton
Recruitment hospital [5] 13254 0
Epworth Hawthorn - Hawthorn
Recruitment postcode(s) [1] 25786 0
3084 - Heidelberg
Recruitment postcode(s) [2] 25787 0
3121 - Richmond
Recruitment postcode(s) [3] 25788 0
3124 - Camberwell
Recruitment postcode(s) [4] 25789 0
3186 - Brighton
Recruitment postcode(s) [5] 25791 0
3122 - Hawthorn

Funding & Sponsors
Funding source category [1] 302061 0
Government body
Name [1] 302061 0
Transport Accident Commission (TAC)
Address [1] 302061 0
60 Brougham St, Geelong VIC 3220
Country [1] 302061 0
Australia
Primary sponsor type
University
Name
Monash University
Address
Simon Barret
Monash University
Wellington Rd, Clayton, VIC 3168
Country
Australia
Secondary sponsor category [1] 301877 0
None
Name [1] 301877 0
None
Address [1] 301877 0
None
Country [1] 301877 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 302742 0
Austin Health Human Research Ethics Committee
Ethics committee address [1] 302742 0
Austin Hospital
145 Studley road
PO Box 5555 Heidelberg
Victoria, 3084
Ethics committee country [1] 302742 0
Australia
Date submitted for ethics approval [1] 302742 0
28/11/2018
Approval date [1] 302742 0
29/04/2019
Ethics approval number [1] 302742 0

Summary
Brief summary
There is a need to support individuals to maximise their potential for return to employment following major trauma. The current study will evaluate an early vocational intervention service provided to individuals experiencing major trauma to determine whether it positively impacts employment outcome one year post-injury as well as study, community and social participation, and quality of life, as compared with delivery of 'usual care' access to vocational rehabilitation. It is hypothesizes that participants receiving the early vocational intervention will show better employment outcomes and social participation at one year post-injury than control participants receiving usual care. Qualitative interviews with injured individuals, their employers and the therapists involved will also be conducted to identify the factors associated with successful RTW, as well as barriers, and satisfaction and quality ratings will be completed with participants, their employers, therapists and insurance claims coordinators to identify key learnings from the early vocational intervention program
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 91238 0
Dr Pamela Ross
Address 91238 0
Epworth HealthCare
89 Bridge Rd, Richmond, VIC, 3121
Country 91238 0
Australia
Phone 91238 0
+61 0418 303 174
Fax 91238 0
Email 91238 0
pam.ross@epworth.org.au
Contact person for public queries
Name 91239 0
Dr Pamela Ross
Address 91239 0
Epworth HealthCare
89 Bridge Rd, Richmond, VIC, 3121
Country 91239 0
Australia
Phone 91239 0
+61 0418 303 174
Fax 91239 0
Email 91239 0
pam.ross@epworth.org.au
Contact person for scientific queries
Name 91240 0
Prof Jennie Ponsford
Address 91240 0
Monash Epworth Rehabilitation Research Centre
Ground Floor, 185-187 Hoddle Street, Richmond, VIC, 3121
Country 91240 0
Australia
Phone 91240 0
+61 0419320671
Fax 91240 0
Email 91240 0
jennie.ponsford@monash.edu

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
This has not been included in the ethics request.
What supporting documents are/will be available?
No other documents available
Summary results
No Results