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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]

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

Condition category

Condition code

Neurological

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]

Rehabilitation

Intervention code [2]

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]

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]

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]

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]

Secondary outcome [2]

Change in clinician ratings of disability, as measured using the validated Disability Rating Scale (DRS)

Timepoint [2]

Secondary outcome [3]

Change in clinician ratings of community participation, as measured using the validated Sydney Psychosocial Reintegration Scale-2 (SPRS-2)

Timepoint [3]

Secondary outcome [4]

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]