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Trial registered on ANZCTR


Registration number
ACTRN12622000769785
Ethics application status
Approved
Date submitted
14/02/2022
Date registered
30/05/2022
Date last updated
30/05/2022
Date data sharing statement initially provided
30/05/2022
Date results provided
30/05/2022
Type of registration
Retrospectively registered

Titles & IDs
Public title
Is the Vocational Intervention Program (VIP) effective at enhancing return to work following severe acquired brain injury (ABI)?
Scientific title
Efficacy of the Vocational Intervention Program (VIP) in improving return to competitive employment following severe acquired brain injury (ABI): a controlled trial
Secondary ID [1] 306412 0
nil
Universal Trial Number (UTN)
U1111-1272-7552
Trial acronym
VIP1.0
Linked study record
N/A

Health condition
Health condition(s) or problem(s) studied:
Acquired brain injury 325248 0
Condition category
Condition code
Neurological 322646 322646 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A three-armed non-randomized controlled trial comparing the efficacy of the VIP to facilitate return to competitive employment following severe acquired brain injury (ABI) when delivered by local vocational rehabilitation (VR) providers (VIP-VR; Arm 1), compared to the existing direct service model delivered by a specialist VR unit (VIP-DS; Arm 2), and treatment-as-usual controls (TAU; Arm 3).
The VIP-VR Fast Track and New Track pathways are individually tailored to the specific needs of the client and the workplace, but comprise of the service actions of intake, information gathering, assessment, stakeholder engagement, goal setting, intervention, and evaluation/review. Intervention includes education, training, emotional/motivational support, as well as coordination, navigating, advocating, and collaboration among stakeholders.

The VIP is a model of service integration program, tailored according to the needs of the participant, co-ordinated and delivered by a team of providers working across organisations and levels of care. Processes for co-ordination will be arranged between providers at each site and varied as the participant progresses through the program.

The VIP will target individuals who have sustained a severe ABI and will be provided on an individual basis to participants and their employers. It consists of two return to work (RTW) pathways, with participants receiving the VIP (Arms 1 & 2) allocated to one of these intervention pathways depending on their specific employment circumstances:

Fast-Track pathway = targeting those with opportunity and capacity to resume work with their pre-injury employer.

RTW programs will follow a graduated approach, tailored to the needs of each participant and employer and include strategies to manage physical and cognitive effects of injury. Participants may be working suitable duties within their pre-injury position or an alternate position.

The VR provider will receive the referral from the local adult NSW Brain Injury Rehabilitation Program (BIRP) site. They will then contact the participant’s employer to confirm their support to proceed with RTW planning. Once a RTW plan has been established, the participant will commence working. There will then be a phase of monitoring and upgrading the RTW program lasting up to 6 months.

Individualised services provided as part of the Fast-Track pathway include:
• Functional and workplace assessment: Undertaken by the VR provider with the client with the employer as a workplace visit taking up to 3 hours in length
• Employer education: The VR provider will provide employer education by a phone call lasting 30 minutes
• RTW Plan development: The VR provider will meet with the client and employer for up to 1 hour 15 minutes to develop the RTW plan
• Implement graduated RTW program, including monitoring and upgrades: The VR provider will deliver monitoring and upgrades through a series of phone-based meetings with the client and employer up to 3 hours
• On-site reviews and support to client and employer: The VR provider will undertake up to 3 on-site visits to review progress and support the client and employer
• Confirm stability of placement, close file and handover for further monitoring if required: The VR provider will organize a final meeting (on-site or remote) with the client and employer, taking up to 30 minutes.


New Track pathway = a ‘pre-vocational’ intervention targeting individuals with extremely severe injury and without opportunity to resume pre-injury employment or unable secure available positions in mainstream employment., though a ‘place and train’ approach.

Specifically, participation in an unpaid work training placement will allow for practical assessment, development of work fitness and skills, and potentially opportunities to transition to paid employment or other work opportunities.

The VR provider will receive the referral from the local adult NSW Brain Injury Rehabilitation Program (BIRP) site. The participant and VR provider will identify suitable options for the work training placement through a vocational assessment, with input from their BIRP case manager, family, and other stakeholders. The VR provider will then source a host employer and conduct workplace assessments to confirm suitability. Unpaid work training placements of up to 12 weeks will be negotiated with host employers.

Individualised services provided as part of the New Track pathway include:
• Vocational assessment to establish goals: Undertaken by the VR provider with the client in the clinic taking up to 2 hours in length
• Canvassing employers for work training placements: Undertaken by the VR provider by phone up to 7 hours
• Workplace assessment: Undertaken by the VR provider and client in consultation with the employer as part of an on-site visit up to 1 hour
• Negotiate conditions of the placement: Undertaken by the VR provider and client in consultation with the employer as part of an on-site visit up to 1 hour
• On-site training and support (including travel training, etc): Undertaken by the VR provider and client on site for up to 2 hours
• Considering the need for equipment and/or training courses: Undertaken by the VR provider in a phone consultation with the client and the employer lasting up to 30 minutes
• Employer education and support: Undertaken by the VR provider in phone consultation with the employer up to 5 hours
• Monitor and upgrade work training placement (as required): Undertaken by the VR provider in phone consultation with the client and the employer up to 9 hours
• Finalise placement outcome and plan for onward vocational program: The VR provider will organize a final meeting (on-site or remote) with the client and employer, taking up to 30 minutes.

Arm 1 (VIP-VR), the VIP will be delivered across 3 regions (encompassing 8 Local Health Districts) of NSW. The primary service providers will be the local adult NSW Brain Injury Rehabilitation Program (BIRP) team partnered with a private VR provider. Staff involved in delivering the VIP will be appropriately qualified (i.e., tertiary qualification in an Allied Health discipline) and experienced in delivering VR.

In Arm 2 (VIP-DS), the same VIP program as listed above for Fast Track and New Track will be delivered by members of a specialist VR unit contained within a single BIRP service (Head2Work service at Liverpool Hospital) where VIP has already been established through a direct service model. Staff involved with delivering the VIP will be experienced Occupational Therapists at Head2Work and other Liverpool Hospital BIRP staff already familiar with the VIP model.
Intervention code [1] 322849 0
Rehabilitation
Intervention code [2] 322850 0
Treatment: Other
Comparator / control treatment
Specialist delivery of the VIP (VIP-DS – participants will complete the VIP through the existing direct service model at a specialist VR unit)
Treatment-as-usual control (TAU – participants with TBI from one of five non-participating NSW BIRP sites, matched to TBI cases in Arm 1 (VIP-VR) for age, sex, injury severity, time post-injury, education level, and pre-injury work status). These participants will not complete the VIP, but will have primary and secondary outcome measures collected.
Treatment as usual is not standardised and each of the control study sites have differences in their clinical practice. Typical actions would include referral of some clients with vocational potential to a local VR provider and in some units, in-house VR might be provided for a small number of high functioning clients returning to their previous employment.
Control group
Active

Outcomes
Primary outcome [1] 330450 0
Change in competitive employment status (defined as full-time or part-time work taking place within the integrated, mainstream labour market for which the participant was compensated). These data were collected from the treating VR provider, who would record in the outcome in their case closure report..
Timepoint [1] 330450 0
Treatment group: Baseline, at completion of VIP, and three months following completion of VIP

TAU group: Baseline, at completion of VIP, and three months following completion of VIP at the same timepoints as the client they were matched to in the treatment arm progressed through the study.
Secondary outcome [1] 406256 0
Change in clinician ratings of dysexecutive behaviour, as measured using the validated Dysexecutive Questionnaire (DEX), completed by the client's primary clinician at the Brain Injury Rehabilitation Unit, and forwarded by that clinician to the research team.
Timepoint [1] 406256 0
Treatment group: Baseline, at completion of VIP, and three months following completion of VIP

TAU group: Baseline, at completion of VIP, and three months following completion of VIP at the same timepoints as the client they were matched to in the treatment arm progressed through the study.
Secondary outcome [2] 406257 0
Change in clinician ratings of disability, as measured using the validated Disability Rating Scale (DRS)
Timepoint [2] 406257 0
Treatment group: Baseline, at completion of VIP, and three months following completion of VIP

TAU group: Baseline, at completion of VIP, and three months following completion of VIP at the same timepoints as the client they were matched to in the treatment arm progressed through the study.
Secondary outcome [3] 406258 0
Change in clinician ratings of community participation, as measured using the validated Sydney Psychosocial Reintegration Scale-2 (SPRS-2)
Timepoint [3] 406258 0
Treatment group: Baseline, at completion of VIP, and three months following completion of VIP

TAU group: Baseline, at completion of VIP, and three months following completion of VIP at the same timepoints as the client they were matched to in the treatment arm progressed through the study.
Secondary outcome [4] 406259 0
Change in participant ratings of health-related quality of life, as measured using the validated 12 Item Short-Form Health Survey (SF-12)
Timepoint [4] 406259 0
Baseline, at completion of VIP, and three months following completion of VIP
Secondary outcome [5] 406260 0
Change in participant ratings of psychological distress, as measured using the validated Depression, Anxiety, and Stress Scale-21 Item version (DASS-21)
Timepoint [5] 406260 0
Baseline, at completion of VIP, and three months following completion of VIP
Secondary outcome [6] 406261 0
Change in participant ratings of health-related quality of life, as measured using the validated Quality of Life After Brain Injury – Overall Score (QoLIBRI-OS)
Timepoint [6] 406261 0
Baseline, at completion of VIP, and three months following completion of VIP
Secondary outcome [7] 406262 0
Change in participant ratings of self-efficacy, as measured using the validated General Self-Efficacy Scale (GSE)
Timepoint [7] 406262 0
Baseline, at completion of VIP, and three months following completion of VIP
Secondary outcome [8] 410069 0
Change in participant ratings of self-efficacy, as measured using the validated TBI Self-Efficacy Scale (TBI-SE)
Timepoint [8] 410069 0
Baseline, at completion of VIP, and three months following completion of VIP

Eligibility
Key inclusion criteria
A. Diagnosis (all participants)
• Primary diagnosis of severe ABI:
o Severe to extremely severe TBI (PTA duration > 24 hours); or
o Severe non-traumatic (acquired) brain injury (e.g., resulting from an injury to the brain following a medical event such as stroke, brain infection, loss of oxygen from heart attack or drowning)

B. Currently engaged with the referring BIRP in a rehabilitation program (all participants)

C. Employment circumstances (VIP-VR and VIP-DS only)
• Fast-Track participants:
o Employed at time of injury
o Has indicated a willingness to return to work (RTW) with pre-injury employer
o Pre-injury employer able to provide a graded RTW program (Fast-Track pathway)
• New-Track participants:
o No currently identified employer or marketable skills to secure paid work
o Has an active rehabilitation goal to participate in employment
o Agreeable to undertake an unpaid work training placement for up to 12 weeks

D. Readiness for RTW (VIP-VR and VIP-DS only)
• Accommodation is stable and enables the client to reliably engage in community activities
• Sufficient cognitive capacity to apply new information in everyday situations, or the ability to learn to do this, such that the level of support can be reduced over time
• Attends to personal care needs in a community setting either independently or with support
• Mobilizes independently in the community and workplace with or without aids
• Shows appropriate behaviour (or behaviour can be managed) within a workplace or training environment
Minimum age
16 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
All participants:
• Requires significant support in the community that makes them unsuitable for mainstream work settings (e.g., 24 hours supervision/physical assistance)
• Current alcohol or substance use disorder that could compromise program engagement

Additional criteria for New-Track participants:
• Does not have capacity or not amenable to attend a work training placement at least 8 hours per week and potential to work towards paid work at completion of the program (may utilise supported wage system, wage subsidies etc.)
• Has a vocational goal and marketable skills suitable for obtaining new employment without VIP services
• Requires formal qualifications/certificates to secure new employment

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)
Allocation is not concealed
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
Not applicable
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The sample size was determined primarily based on funding allocation for the project rather than statistical considerations. Specifically, estimates of available funding for VR services led to a recruitment target of n=75 for the VIP-VR arm. Sample size for the VIP-DS and TAU arms will be contingent on the size and characteristics of the VIP-VR participants, as well as the study duration. Participants in the VIP-DS arm will be consecutive referrals to the Head2Work service undertaking the VIP over the study timeframe that meet the study eligibility criteria. The size of the TAU arm will depend on the number of TBI participants eventually enrolled in the VIP-VR arm (we estimate that around n=55 TBI participants will be enrolled in the VIP-VR arm, each of which will trigger enrolment of a matched TBI participant in TAU).

All analyses will be implemented on an intention-to-treat (ITT) basis. Baseline socio-demographic and injury-related characteristics of the three intervention arms will be compared using one-way analysis of variance (ANOVA) for normally distributed continuous data, Kruskal-Wallis tests for non-normally distributed continuous data, or chi-square tests of independence for categorical data.

The effects of the three intervention arms on the primary and secondary outcomes over time will be assessed using generalized and linear mixed effects modelling. Repeated measurements (i.e., three timepoints) will be nested at level 1 within each participant at level 2, such that variability between participants can be modelled using random effects. Fixed effects for each model will include: time (represented as two piecewise variables representing: (1) baseline to VIP completion, (2) VIP completion to 3 month follow-up), intervention arm (at level 2) and arm*time cross-level interactions. Any baseline characteristics identified as being statistically significant across intervention arms from univariate comparisons will also be considered as fixed effects. Each model will include a random intercept; random slopes corresponding to the piecewise time variables will also be considered. Alternate R-sided covariance structures (e.g., autoregressive(1)) will also be tested.

In each model, two simple effects contrasts will be defined to evaluate baseline differences between the intervention arms: (1) VIP-VR & VIP-DS vs. TAU, (2) VIP-VR vs. VIP-DS. Significant overall tests of arm*time interactions will be followed-up with up to four contrasts evaluating how the 2 between-group comparisons defined for the simple effect contrasts change (1) from baseline to VIP completion; and (2) from VIP completion to 3 month follow-up.

Overall model goodness-of-fit will be assessed using likelihood ratio tests, AIC and BIC statistics as appropriate. Fixed effects will be evaluated with Wald-type tests. Random effects will be evaluated via likelihood ratio tests.

A secondary analysis will evaluate whether the two VIP pathways (i.e., Fast-Track vs. New-Track) have differential effects on the study primary and secondary outcomes. To achieve this, participants in the VIP-VR and VIP-DS arms will be aggregated and re-categorized according to the VIP pathway undertaken. The same generalized and linear mixed effects modelling approach will then be repeated, with the intervention arm factor replaced by a VIP pathway factor.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
22/07/2015
Date of last participant enrolment
Anticipated
Actual
6/09/2017
Date of last data collection
Anticipated
Actual
5/09/2018
Sample size
Target
180
Accrual to date
Final
148
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 21716 0
Royal Rehab - Ryde - Ryde
Recruitment hospital [2] 21717 0
Westmead Hospital - Westmead
Recruitment hospital [3] 21718 0
Ballina District Hospital - Ballina
Recruitment hospital [4] 21719 0
Coffs Harbour Base Hospital - Coffs Harbour
Recruitment hospital [5] 21720 0
Lourdes Hospital & Community Services - Dubbo
Recruitment hospital [6] 21721 0
Bathurst Base Hospital - Bathurst
Recruitment postcode(s) [1] 36766 0
2112 - Ryde
Recruitment postcode(s) [2] 36767 0
2145 - Westmead
Recruitment postcode(s) [3] 36768 0
2478 - Ballina
Recruitment postcode(s) [4] 36769 0
2450 - Coffs Harbour
Recruitment postcode(s) [5] 36770 0
2830 - Dubbo
Recruitment postcode(s) [6] 36771 0
2795 - Bathurst

Funding & Sponsors
Funding source category [1] 310764 0
Government body
Name [1] 310764 0
iCare NSW
Country [1] 310764 0
Australia
Primary sponsor type
Hospital
Name
Agency for Clinical Innovation (ACI)
Address
1 Reserve Rd, St Leonards NSW 2065
Country
Australia
Secondary sponsor category [1] 312001 0
Government body
Name [1] 312001 0
State Insurance Regulatory Authority (SIRA)
Address [1] 312001 0
Level 14/15, 231 Elizabeth St, Sydney NSW 2000
Country [1] 312001 0
Australia
Other collaborator category [1] 282158 0
University
Name [1] 282158 0
University of Sydney- John Walsh Rehabilitation Research
Address [1] 282158 0
– Kolling Institute of Medical Research, Royal North Shore Hospital, St Leonards NSW 2065
Country [1] 282158 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 310340 0
Northern Sydney Local health District HREC
Ethics committee address [1] 310340 0
Ethics committee country [1] 310340 0
Australia
Date submitted for ethics approval [1] 310340 0
06/07/2015
Approval date [1] 310340 0
22/07/2015
Ethics approval number [1] 310340 0
RESP/15/161

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 117298 0
A/Prof Grahame Simpson
Address 117298 0
Brain Injury Rehabilitation Research Group, Ingham Institute for Applied Medical Research, 1 Campbell St, Liverpool 2170, NSW
Country 117298 0
Australia
Phone 117298 0
+61 2 8738 5495
Fax 117298 0
Email 117298 0
[email protected]
Contact person for public queries
Name 117299 0
Grahame Simpson
Address 117299 0
Brain Injury Rehabilitation Research Group, Ingham Institute for Applied Medical Research, 1 Campbell St, Liverpool 2170, NSW
Country 117299 0
Australia
Phone 117299 0
+61 2 8738 5495
Fax 117299 0
Email 117299 0
[email protected]
Contact person for scientific queries
Name 117300 0
Grahame Simpson
Address 117300 0
Brain Injury Rehabilitation Research Group, Ingham Institute for Applied Medical Research, 1 Campbell St, Liverpool 2170, NSW
Country 117300 0
Australia
Phone 117300 0
+61 2 8738 5495
Fax 117300 0
Email 117300 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Permission to deposit participant data in a public repository was not sought at the time of consenting.


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
SourceTitleYear of PublicationDOI
EmbaseA vocational intervention that enhances return to work after severe acquired brain injury: A pragmatic trial.2023https://dx.doi.org/10.1016/j.rehab.2023.101787
N.B. These documents automatically identified may not have been verified by the study sponsor.