Traumatic brain injury (TBI) Injury, Occupational Diseases, Poisoning Brain injury
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Adults (aged 16 and above) living in the London, Preston and Leeds health communities and admitted for 48 hours or more with a new Traumatic Brain Injury 2. Were in work or intending to work or in full-time education (paid or unpaid) prior to their injury
Exclusion criteria
Exclusion criteria: People will be excluded if they: 1. Do not want to take part 2. Do not intend to work/study 3. Are unable to consent for themselves 4. Live more than 1 hours travelling distance from the recruiting centre
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint is study completion Secondary endpoints: 1. Identification of the primary outcome of importance 2. Successful delivery of Early Specialist TBI Vocational Rehabilitation (ESTVR) in three NHS TBI referral centres 3. Measurement of the effectiveness and cost effectiveness of ESTVR vs TAU on work return and job retention The likely primary measure of effectiveness for the main trial is work status at 12 months defined as competitive employment (full or part time paid work in an ordinary work setting, paid at the market rate [Crowther 2004], although exploration of this is a key component of this study [see 1. above]). The corresponding primary success criteria for the intervention at 12 months post randomisation will be the proportion of: 3.1 Persons returned to work in the same role with an existing employer 3.2 Persons returned to a different role with an existing employer 3.4. Persons returned to self-employed work | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary measures of effectiveness to be collected at 3, 6 and 12 months post randomisation will be: 1. Hospital Anxiety and Depression scale (mood) 2. Extended Activities of Daily Living (functional ability) 3. Community Integration Questionnaire (participation) 4. EuroQol EQ-5D-3L (health-related quality of life) 5. Work Productivity and Activity Impairment Questionnaire (productivity) 6. Use of health and social care resources 7. Carer-Strain Index (carer strain) 8. Single question from work ability index (work self-efficacy) | — |
Countries
England, United Kingdom