Early, specialist vocational rehabilitation to facilitate return to work after traumatic brain injury: the FRESH feasibility RCT

Article history

The research reported in this issue of the journal was funded by the HTA programme as project number 11/66/02. The contractual start date was in March 2013. The draft report began editorial review in February 2017 and was accepted for publication in September 2017. The authors have been wholly responsible for all data collection, analysis and interpretation, and for writing up their work. The HTA editors and publisher have tried to ensure the accuracy of the authors’ report and would like to thank the reviewers for their constructive comments on the draft document. However, they do not accept liability for damages or losses arising from material published in this report.

Declared competing interests of authors

Jain Holmes received consultancy fees as an employee of Obair Associates to train and mentor FRESH therapists and was subsequently granted PhD Studentship funding from the University of Nottingham and UK Occupational Therapy Research Foundation to work on this study. She was a paid employee of Obair Associates Ltd during the conduct of the study. Tracey Sach was a member of the Health Technology Assessment Efficient Study Designs Board during the conduct of the trial.

Copyright statement

© Queen’s Printer and Controller of HMSO 2018. This work was produced by Radford et al. under the terms of a commissioning contract issued by the Secretary of State for Health and Social Care. This issue may be freely reproduced for the purposes of private research and study and extracts (or indeed, the full report) may be included in professional journals provided that suitable acknowledgement is made and the reproduction is not associated with any form of advertising. Applications for commercial reproduction should be addressed to: NIHR Journals Library, National Institute for Health Research, Evaluation, Trials and Studies Coordinating Centre, Alpha House, University of Southampton Science Park, Southampton SO16 7NS, UK.

2018 Queen’s Printer and Controller of HMSO

Traumatic brain injury

Traumatic brain injury is defined as an injury to the brain caused by a trauma to the head. 1 It is a leading cause of death and a major cause of long-term disability in working-age adults. 2–4 More than 1 million people attend UK emergency departments for head injuries annually, with over 160,000 admitted to hospital. 5,6 Approximately 1.3 million people in the UK live with the consequences of TBI. 6 The economic and societal impact is considerable,7–9 costing the economy an estimated £15B per year. 10 This includes premature death, health and social care costs and lost productivity. TBI is also a known cause of personal bankruptcy. 11 However, the human cost far outweighs the economic impact. People who survive TBI are more likely to suffer from depression12 and have poor quality of life (QoL). 13,14 Even those without prior history of mental illness are twice as likely to suffer from mental health problems later in life. 10

Traumatic brain injury resulting from a blow to the head, blast waves from an explosion, swift acceleration or deceleration, or a foreign object penetrating the brain2,15 causes damage to brain tissues. In closed head injuries, it is the shearing movement and swelling of the brain within the skull following impact that causes damage. Open head injuries are caused by an object penetrating the skull and entering the brain16 or by skull fractures resulting from road traffic accidents (RTAs), falls and sports injuries. Although closed head injuries are more common than open head injuries, they are often more difficult to treat17 as they tend to result in diffuse damage affecting different areas of the brain.

The severity of TBI ranges from mild to severe and is usually determined by measures such as the duration of coma or post-traumatic amnesia (PTA), Glasgow Coma Scale (GCS) scores and the nature and extent of functional impairments following the injury. 18 A minor or mild TBI is usually defined by a GCS score of 13–15. Moderate TBI is usually defined as resulting in PTA lasting < 24 hours, a GCS score of 9–12 or a loss of consciousness lasting between 15 minutes and 6 hours. Severe TBI is usually diagnosed if the patient has a GCS score of 3–8, has been unconscious for ≥ 6 hours or has been in PTA ≥ 24 hours. 19,20 However, definitions of TBI severity vary widely across studies.

Traumatic brain injury symptoms may be physical, cognitive, perceptual, behavioural or emotional21,22 and include movement problems, seizures, impaired speech, fatigue, memory loss, decision-making difficulties, inattention, difficulty in planning or initiating tasks, inability to express thoughts, and visual and sensory problems. 22 It is often the hidden cognitive, psychological and emotional sequelae that present some of the greatest problems for people with TBI. They include reduced awareness, anxiety, anger, depression and apathy,21 and may affect social participation, independence and self-confidence, which, ultimately, have an impact on QoL.

The long-term outcomes of TBI depend on a number of factors, such as the location and severity of the injury,22 and are difficult to predict as they do not necessarily correlate with the amount of observable damage to the brain. 18,23,24 Restricted activity and social participation are common consequences. Although 70% of people who incur moderate or severe TBI are likely to sustain permanent neurological damage, resulting in long-term physical, cognitive, emotional and behavioural problems that interfere with work,25–27 many people who incur milder injuries also experience long-term impairments that limit participation in daily life activities, including work. 28,29 Doctor et al. 30 studied all consecutive patients with TBI at a level I trauma centre in the USA. Participants had to have positive evidence of TBI [e.g. any period of loss of consciousness, PTA of at least 1 hour and computerised tomography (CT) evidence of a brain lesion]. They stratified mild TBI from other severity levels using the GCS and found that workers with mild TBI were almost 3.5 times more likely to be unemployed at 1 year post injury than the general population, after controlling for age, sex and education [relative risk 3.46; confidence interval (CI) 2.87 to 4.28]. 30 Whatever the extent of the damage, TBI may be further complicated by the distressing nature of the injury and the survivor’s and family’s psychological response to it.

Return to work following traumatic brain injury

Returning to work is a primary rehabilitation goal following a TBI. Data on the reported employment rates of people with TBI vary widely between studies. Methodological differences such as sampling methods, definitions of work, length of follow-up and loss to follow-up make drawing comparison between studies difficult. 3 A systematic review31 identified that only 41% (range 30–65%) of people who were in work prior to their TBI were working at 1 and 2 years post injury. Those who do not return to work within 2 years post injury are unlikely to ever return. 31,32 For those who do, retaining work is also problematic. Many TBI survivors return prematurely but drop out once the impact of the brain injury on their job is realised. 33 Longer-term follow-up studies suggest a downwards trend in job type and earning potential as TBI survivors return to, but fail to retain, work, spiralling into more menial and poorly paid employment. 34 Although some people with mild TBI may successfully return to work without external support,35 a significant proportion (24%, range 5–56%) encounter difficulties,28,36,37 and approximately 35% are able to find only part-time work. 38 The challenge is in identifying who needs help. 35

Traumatic brain injury sequelae, including physical, sensory, communication, cognitive, behavioural, emotional, financial and social difficulties, can all have an impact on a person’s ability to work. 2,39,40 Cognitive problems especially may present considerable problems in the workplace40 and, unless the TBI survivor and employer are aware of them, they can be misinterpreted. For example, reduced ability to initiate activities may be misconstrued as laziness, yawning when losing attention as a sign of boredom and increased irritability due to fatigue as rudeness. In addition, reduced insight, which affects the ability to accurately self-monitor and adjust performance, is regarded as a poor indicator for RTW success even in people who are otherwise independent in activities of daily living (ADL). 41–44

Emotional difficulties such as anxiety and depression, which are common following TBI,44,45 have also been associated with lower levels of post-injury employment. 41,46–48 Even in those with mild TBI, post-concussive symptoms, fatigue and mild balance problems may be predictive of employment outcomes. 44,49–52 Moreover, the increased risk of seizures can preclude people from driving and doing certain jobs. 44,53–55 Ensuring that timely mechanisms are in place to identify and address these problems, irrespective of TBI severity, would seem important.

Therefore, although study heterogeneity and the known difficulty in following up people with TBI over time56 may explain some of the difference in reported outcomes, inadequate VR is also a plausible explanation for poor rates of return and job retention difficulties.

Vocational rehabilitation

Vocational rehabilitation is defined as whatever helps someone with a health problem to return to, or remain in, work. 57 It involves helping people find work, helping those who are in work but having difficulty, and supporting career progression in spite of illness or disability. The primary aim is to optimise work participation. 58

Early Specialist Traumatic brain injury Vocational Rehabilitation (ESTVR) is an adaptive form of rehabilitation that depends on identifying problems that the person with TBI has. ESTVR therapists then advise that person and their employer on how to adapt their behaviour and activities so that the problems can be managed by the patient and accommodated in the workplace. The person with TBI can then continue to be involved in work. The need for such an intervention was based on the reported prevalence of employment difficulties for people with TBI38 and findings from our previous pilot study,59 which suggested that for people with more moderate and severe injuries, continued involvement in work was unlikely to happen without support beyond 3 months, and that 10% fewer people with mild injuries would be in work at 12 months post injury without VR.

Vocational rehabilitation targets not only the brain-injured person but also their family, the work environment and the employer; crossing boundaries between health, employment, social care and welfare services. Therefore, it is a complex intervention,60 and one that needs to be individually tailored to the person and the local context, which makes it difficult to standardise.

Enabling people who have capacity to work to do so is a UK Government priority. 61 Clinical guidelines and professional recommendations62–64 state that VR should be provided for people with TBI. Ensuring people who develop long-term health conditions can return to, and remain in, work is both a government health outcome priority65 and a recognised role for health-care professionals (HCPs). 66 Despite this, NHS provision does not typically extend to VR for TBI survivors. 67 Health-based services supporting people with TBI in returning to work are rare in the UK and estimated to meet < 10% of the need. 68

Evidence for vocational rehabilitation for people with traumatic brain injury

There is a lack of evidence to support the clinical effectiveness or cost-effectiveness of VR for people with TBI. Two systematic reviews3,69 of RTW following TBI have concluded that there is a need for well-conducted experimental and observational studies. Saltychev et al. ,3 in a systematic review of pre- and post-injury predictors of vocational outcome, identified 80 studies, comprising 12 controlled (eight RCTs, two controlled clinical trials and two observational reports) and 68 uncontrolled observational reports. They found no strong evidence that vocational outcomes after TBI could be predicted or improved. However, most of the studies included in the review were generic studies of neurorehabilitation rather than trials evaluating the effectiveness of a VR intervention.

In a systematic review examining the effectiveness of VR in TBI, Graham et al. 69 identified three small RCTs: two of military populations in the USA37,70 and one of civilians in Hong Kong. 71

Salazar et al. 70 compared an intensive in-hospital cognitive rehabilitation intervention and integrated work programmes delivered by a neuropsychologist, occupational therapist (OT) and speech pathologist (n = 67) with an in-home rehabilitation programme including TBI education and individual counselling from a psychiatric nurse (n = 53). Participants were active US military personnel with moderate to severe TBI within 90 days of injury. At 1 year, there were no significant differences between groups in fitness for military duty, RTW rate, cognition, physical or verbal aggression, or QoL. However, among those who were unconscious for > 1 hour (n = 75), the proportion who returned to work was 7% higher in the cognitive rehabilitation and VR group, although the difference was not significant (95% CI –10% to 24%; p = 0.43).

Twamley et al. 37 compared a 1-year supported employment programme with the same programme plus CogSMART (for the first 3 months). Participants were US military veterans with mild to moderate TBI (n = 50). The authors hypothesised that augmenting work rehabilitation with compensatory cognitive training may improve functional outcomes because compensatory interventions can be individually tailored to each person’s job search process and job duties. CogSMART sessions were delivered by an employment specialist and included strategies to improve sleep, fatigue, headaches and tension, and compensatory cognitive strategies for prospective memory, attention, learning and memory, and executive functioning. At 12 months, there was no difference in employment between the groups. However, those also receiving CogSMART had significant reductions in post-concussive symptoms, improvements in prospective memory functioning, less severe post-traumatic stress disorder and less depression, which suggested that adding CogSMART to supported employment might improve post-concussive symptoms and prospective memory.

Man et al. 71 compared 12 sessions of three-dimensional artificial intelligence (AI), virtual reality-based VR with 12 sessions of psychoeducational VR with a vocational trainer. People with mild to moderate TBI were recruited from rehabilitation facilities in Hong Kong (n = 50). The programmes included similar problem-solving tasks, instructions and provided time to practise skills. Of the 40 participants self-reporting employment outcomes at 6 months, 8 out of 20 in the AI-VR group were employed compared with only 4 out of 20 in the psychoeducational VR group [odds ratio (OR) 2.20, 95% CI 0.46 to 10.57].

Graham et al. 69 concluded that VR for people with TBI may improve employment status but no programme was more effective than its comparator. No studies compared VR with UC or a non-VR attention control group, or reported secondary employment outcomes such as hours worked, wages earned, absenteeism, presenteeism or self-efficacy.

Since this review,69 two further VR in TBI trials72,73 have been published. O’Connor et al. 72 compared VR enhanced by cognitive rehabilitation and a computer-based homework programme with supportive client-centred therapy in a small pilot trial in US veterans with mild TBI and mental illness (n = 18). At 12 months, they identified small to moderate effects in the VR group on employment outcomes (more people competitively employed and more days worked). The 12-session VR programme, led by therapists and psychologists, included strategies to manage cognitive difficulties in the workplace, enhance skills to recognise and control unhelpful behaviours at work, deal with negative emotions, and foster positive relationships among coworkers and employers. There was also a computer-based homework programme, in addition to support, from a VR specialist. This feasibility study was small and hampered by poor adherence with therapeutic strategies in both groups, although programme attendance was similar, and high withdrawal rates. Of the 25 participants randomised, six withdrew or were withdrawn in the first two study sessions owing to mental health destabilisation (n = 3), an unexpected move out of the area (n = 2) and dissatisfaction with the control group assignment (n = 1).

Trexler et al. 73 examined the effectiveness of resource facilitation (RF) (i.e. a partnership that supports people to make informed choices and achieve rehabilitation goals, involving active engagement with a previous employer) in 44 people with mild to moderate acquired brain injury (ABI) who were working pre injury (n = 22, 13 with TBI) and a UC control group (n = 22, 10 with TBI). At 15 months, 17 out of 22 participants in the RF group with a goal of returning to work, volunteering or returning to education were successful (11 had returned to paid employment, three became volunteers and three returned to education), compared with 12 out of 22 participants in the UC control group meeting return-to-work/volunteering/education goals (10 remained employed and two returned to education). RF participants with a work-related goal had seven times higher odds of returning to productive activity than the control participants (95% CI 1.25 to 39.15).

However, although this case-co-ordinated approach in ABI seems positive, the trial73 took place in a single centre, numbers were small and there were only 23 participants with TBI (mostly mild). The intervention was staff resource intensive, requiring three more staff than UC, and lasting for 15 months. Both intervention and UC participants had access to acute and outpatient rehabilitation services, neuropsychological services and specialised day treatment programmes. However, the total amount of RF and outpatient therapies provided to the VR and UC groups was not reported, meaning that it is difficult to identify if both groups received similar levels of outpatient therapy and if differences are attributable to RF VR. Data specific to people with TBI were not reported. Interestingly, more participants in the RF group than in the UC group were employed in professional and executive positions to which they returned, which may also have contributed to the favourable outcome. Therefore, this study requires replication on a larger scale elsewhere.

Overall, current evidence for effectiveness of VR in TBI is limited and inconclusive. Of the five VR trials37,70–73 published to date, three37,70,72 have been with US military personnel or veterans. Military studies differ from those in civilian populations as participants present with different challenges (e.g. post-traumatic stress disorder) but also opportunities (e.g. better motivation, adherence and greater opportunities for redeployment within the military).

The effectiveness of neurological rehabilitation in traumatic brain injury on work outcomes

Other trials have compared various neurological rehabilitation interventions (e.g. cognitive rehabilitation,74,75 multidisciplinary rehabilitation programmes,76,77 individually tailored intervention78 and telephone-based motivational interviewing79) for people with TBI and reported work outcomes. These interventions did not include VR and no significant differences in work outcomes were identified.

In the only two large trials35,36 of early intervention following head injury, Wade et al. 36 offered intervention following routine review of all patients (n = 314) presenting to accident and emergency (A&E) with TBI. Eligible patients were prospectively randomised to a TBI specialist rehabilitation team (n = 184) or a group receiving existing standard services (n = 130). Intervention group participants were assessed 7–10 days post TBI to identify their rehabilitation needs and offered interventions as appropriate, for example information, signposting, telephone support or further outpatient intervention (46%) from different TBI specialist HCPs, including, but not specific to, advice and support with aspects of work. 80 At 6 months post TBI, 132 trial and 86 control participants were followed up (attrition: 32% intervention, 34% control) and assessed on a social disability measure. Severity of TBI was estimated from duration of PTA as mild (n = 79, 40%), moderate (n = 62, 32%) or severe (n = 55, 28%). Intervention group participants had significantly less social disability (p = 0.01) than the control group, suggesting that early intervention by a TBI specialist service can significantly reduce social morbidity post TBI. The amount of intervention increased with length of PTA. However, most participants receiving extensive services had mild to moderate TBI, suggesting that persistent TBI problems may not be severity related. In a similar trial35 (n = 1156), 71% of the 478 participants followed up at 6 months (41% response rate) had returned to some form of work or education, with no differences in work outcomes between groups (i.e. both 71%). However, in a subgroup analysis of participants with PTA lasting > 1 hour and admitted to hospital (n = 71), those in the intervention group were significantly less likely to report problems in work, relationships and social and leisure activities as measured by the Rivermead Head Injury Follow-up questionnaire (p = 0.04), suggesting that this could be a group that might benefit most from this support.

Limitations of previous studies

There are very few RCTs of VR in TBI and no cost-effectiveness evaluations of VR.

Previous trials of VR in TBI are typically small, military-based and of low methodological quality, with limitations in blinding, incomplete data, high attrition and selective outcome reporting. The definitions used for employment are wide-ranging (e.g. from homemaker to competitive employment) and time points at which employment outcomes are measured (3, 6 or 12 months) vary between studies, making trial comparisons difficult. Studies included mixed samples including TBI, stroke and other cerebral pathologies, or a range of different TBI severities.

Randomised controlled trials of general neurological rehabilitation in TBI including work outcomes and VR as part of a neurorehabilitation programme have not described the VR provided in sufficient detail for replication or implementation into clinical services. None of the trials included economic evaluation. Observational studies contribute to the evidence base but cannot provide robust, reliable evidence of clinical effectiveness that generalises to the target clinical population.

Justification for the current study

A single-centre cohort comparison study of ESTVR developed in the NHS and delivered by an OT supported by a TBI case manager (CM) was compared with usual NHS rehabilitation in people with TBI of all severities (n = 94). 59 The primary focus of the ESTVR was to prevent job loss by identifying people early after injury and optimising the opportunity to return to work with an existing employer. The findings suggested that better work outcomes (job retention at 12 months post TBI) may be achieved through early occupational therapy targeted at job retention,59 particularly for those with moderate or severe injury, although a clinically meaningful 10% difference was also observed in people with mild TBI at 12 months post injury.

However, as ESTVR was already part of a specialist TBI service and it was delivered by one therapist in a single centre, it is unclear whether or not the successful outcomes were attributable to ESTVR and whether or not it is deliverable by OTs elsewhere.

The lack of RCTs of VR and of rehabilitation in people with TBI and the known difficulty in conducting RCTs of complex health interventions,81 mean that a feasibility study is needed prior to a definitive RCT. The aims are to test the feasibility of conducting a multicentre RCT comparing ESTVR delivered by NHS OTs in addition to usual NHS rehabilitation (i.e. UC) with UC alone on work outcomes at 12 months post TBI. The feasibility study should also explore factors related to the trial process and outcomes, intervention delivery, training provided and factors likely to affect its clinical implementation in the NHS.

Structure of the Health Technology Assessment monograph

The FRESH (Facilitating Return to work through Early Specialist Health-based interventions) study consisted of a feasibility RCT, a feasibility health economic evaluation and an embedded mixed-methods process evaluation. Chapter 2 describes the design of ESTVR, the development and delivery of ESTVR training package for OTs (training, manual and mentoring) and its evaluation. Chapter 3 reports the aims, methods and findings of the feasibility RCT. Chapter 4 describes the feasibility economic evaluation and Chapter 5 summarises the aims, methods and findings of the process evaluation. The study’s key findings are discussed in Chapter 6 and the study conclusion is in Chapter 7. The appendix and supplementary material files contain details of the study components.

Aims and objectives

The aim of this chapter is to describe the ESTVR intervention and the development of the ESTVR training package.

The development of a programme theory and logic model

The starting point for the trial and subsequent process evaluation was a clear description of the intervention and its underlying theory (i.e. assumptions about how it would work in context). These assumptions included theories based on evidence from the literature and those based on experience or ‘common sense’ (see Appendix 1 for a summary of ESTVR).

The ‘theory of change’ underpinning ESTVR

For people who survive TBI and who are employed or studying at the time of injury, advice not to return to work too soon or make a premature decision about the ability to return to work is an important pre-discharge need. However, hospitals do not routinely identify and record whether or not people who have a TBI are employed pre injury. Information and advice about work is not routinely provided by HCPs for people who survive TBI, and work ability is rarely assessed early after injury. When advice is given, it can sometimes be unhelpful. For example, HCPs sometimes advise a person that they will be unable to return to work, based on an assumption that this involves returning to the same job with the same roles and responsibilities and the same working hours. However, a RTW can involve returning to the same employer but doing a modified or entirely different job. Or it might mean returning to work for a new employer, or doing the same, doing a modified or doing a different job than pre injury. Moreover, disability discrimination law requires employers to make reasonable adjustments to accommodate the injured person in the workplace. Adjustments can include more breaks, reductions in working hours, reduced responsibilities, increased supervision, flexitime working, working from home and receiving help from other people or agencies, including rehabilitation. They can also include modifications to the work environment.

Therefore, health-based support for returning to work after TBI has typically been deficient in meeting TBI survivors’ work needs. ESTVR was designed to bridge the gap between existing TBI rehabilitation services and employers and the voluntary sector in supporting survivors in a RTW. Tested in a single-centre cohort comparison, we found that the intervention may be effective in supporting job retention at 12 months post TBI.

The implicit theory of change on which ESTVR is based can be expressed as follows:

Traumatic brain injury results in physical, psychological, behavioural and emotional changes that are likely to have an impact on the capacity to return to, and remain in, work. The ability to early identify work needs after TBI is missing from TBI rehabilitation services and there is a VR knowledge and skills gap.

Implementing mechanisms for identifying TBI survivors who are employed at the time of injury, educating TBI care teams about ‘return to work’, and teaching OTs with TBI knowledge, basic skills in VR, disability discrimination, how to evaluate jobs and assess work capability, and how to match TBI survivor’s abilities to job demand, engage with employers and other employment sector stakeholders, go into the workplace and how to negotiate reasonable adjustments and a phased RTW, will enable TBI rehabilitation services to support stroke survivors in a RTW. This should result in a higher proportion of TBI survivors returning to, and remaining in, work in the first 12 months post TBI.

Logic model

A logic model was generated based on the programme theory and the intervention manual to visually depict how the intervention works and describe the resources needed, the intended activities, the hypothesised mechanisms underpinning the intervention and intended outcomes82 (Table 1).

Logic models provide stakeholders with a road map describing a sequence of events that connect the health intervention with its desired results and impact (improvement in patient outcomes and retaining work). 83 The process of mapping the intervention helped identify the resources and activities (core inputs) required to achieve the goals (outputs and outcomes) and overall sustained improvements (impact).

The logic model was informed by the meaningfulness (personal opinions, values, thoughts, beliefs, positive or negative experiences and perceptions of TBI service users) and the appropriateness of the intervention (i.e. how ESTVR meets expectations and the extent to which ESTVR fits with what is considered state of the art) from the perspective of researchers and TBI service users. 82

To develop the model, three of the authors (KR, JP, JH) experienced in delivering VR for people with an ABI analysed the component parts of the ESTVR intervention described in the training manual to identify:

• core activities/processes leading to the desired outcomes

• necessary resources (considered essential to intervention delivery and outcome success, e.g. the knowledge and expertise of the therapist, supportive policies and legal frameworks that facilitate workplace accommodations and prevent disability discrimination)

• immediate impacts (influence on patient and stakeholder decisions and awareness that facilitate longer-term outcomes, e.g. patient’s increased awareness of problems, employer awareness of injury impact)

• longer-term impacts (resulting from immediate outcomes, e.g. RTW, sustained work)

• health outcomes (benefits of the intervention at a person, employer, health organisation and societal level, e.g. prevention of long-term work disability, cost savings).

The logic model was then used to design and develop an intervention fidelity checklist for use during monitoring visits (see Report Supplementary Material 1), an intervention content pro forma for recording the intervention delivered (see Report Supplementary Material 2) and to inform the interview topic guides (see Report Supplementary Material 3).

ESTVR

ESTVR was based on an intervention initially delivered by the Nottingham Traumatic Brain Injury Service (NTBIS), and described and evaluated by Radford et al.,59 Phillips84 and Phillips et al. 85 It is an early, specialist, health-based, case co-ordination model. People with TBI who are employed or studying full-time are identified early (within 8 weeks) following injury and the intervention is aimed at preventing job loss and optimising employment and education outcomes by ensuring the person can return to work/study. It is delivered by HCPs with specialist knowledge of TBI and VR-specific knowledge working in the NHS. The VR is based on best practice recommendations64 and is either delivered by an OT, supported by a health-based TBI specialist CM, or by an OT adopting a case-co-ordination role. 86 Its aim is to prevent job loss in people who are employed or studying at injury onset.

The intervention is based on the premise that a RTW need not involve a return to the same job with the same roles and responsibilities but could include a return to some form of work or an adapted or modified job with different roles and responsibilities with an existing employer, and that these adaptations could be negotiated as part of the employer’s requirement to make reasonable adjustments to support their employee in a RTW.

The ESTVR intervention seeks to lessen the impact of TBI by assessing the person’s role as a worker and finding acceptable strategies to overcome problems (e.g. assessing and addressing new physical, cognitive or psychological disabilities which might have a direct impact on work activities in relation to job demands). In the ESTVR model, it is intended that the OT provides pre-work training to prepare the person for work by establishing structured routines with gradually increasing activity levels, provides opportunities to practise work skills (e.g. computer use to increase concentration, cooking to practise multitasking), liaises with employers/tutors and disability employment advisors (DEAs) to advise about the effects of the brain injury and to plan and monitor graded work return, conducts worksite visits and job evaluations, identifies the need for workplace or job adaptations and serves as the link between health and Department for Work and Pensions (DWP) services to access additional support.

The TBI CM co-ordinates the overall TBI care package, provides support, education and advice to the person with TBI, family and others (e.g. NHS staff, social services, Headway and solicitors) and remaining in contact while there are achievable rehabilitation goals.

The intervention involves eight core processes as depicted in the logic model:

1. early intervention from a TBI team [i.e. within 8 weeks (ideally 4 weeks) of injury to provide information and advice about the impact of TBI and RTW (e.g. maintaining contact with employer/tutor)] to prevent job loss

2. assessment of the impact of TBI on the individual and the job, and analysis of the impact of TBI on the person’s work ability

3. provision of individually tailored education and rehabilitation to support a RTW

or, when return to the pre-existing employer is not feasible or sustainable, exploration of alternatives to pre-injury employment/learning:

1. optimisation of the employment/learning environment (the OT negotiates a graded RTW and any necessary accommodations to the job role, responsibilities, coworker or supervisory support and environmental adaptations needed for reintegration, and provides feedback on performance)

2. monitoring of the RTW to ensure that the person can maintain employment

The CM/VR therapist:

1. provides ongoing education, advice and emotional support to the person with TBI and their family throughout the VR process

2. co-ordinates the return to work/education rehabilitation across all sectors

3. communicates openly in writing with stakeholders about work performance at all stages of the return to work/education process.

Early intervention

The purpose of intervening early is to ensure advice (1) not to make premature decisions about relinquishing work and (2) to maintain contact with the employer is given to patients, family members and other key NHS service providers involved in the person’s care.

The assessment involves:

• asking questions about occupational status and vocational aspirations and needs

• responding to the person with TBI’s questions and concerns about return to work, education or training. It sometimes involves input from other relevant stakeholders who form part of a wider multidisciplinary team co-ordinated by the VR therapist or CM including NHS HCPs such as medical consultant, clinical psychologists and physiotherapists and external agencies (e.g. Jobcentre Plus, occupational health).

The rehabilitation involves:

• providing interventions (directly related to the person’s work or study) that promote optimal recovery and management of difficulties, including one or more of the following –

  • developing skills or behaviours necessary for work or study

  • restoring work-related routines

  • activities to improve attention, work/study tolerance and stamina

  • extending coping strategies (e.g. fatigue management) for use in the workplace or for study.

• planning a return to work/study with relevant agreed accommodations, such as equipment, graded return, voluntary trial, restricted hours/duties, advice/support in the workplace, job coaching, support from work colleagues, off-site support (e.g. from the OT or other relevant agencies). In the case of study return, these may include adjustments to course, learning-support equipment, individual learning support, examination support and personal support (e.g. personal tutor). These plans take account of family and personal circumstances and the required motor sensory and cognitive–behavioural and emotional skills necessary to a return to work/education.

Education involves:

• advising the person with TBI not to return to work too soon (i.e. until the impact of the TBI is understood and coping strategies formulated)

• educating the person, family and employer about difficulties likely to affect work/study (e.g. functional ability, insight and ability to work or return to work/study)

• developing strategies for the person to explain the effects of their TBI to others

• providing written information for participants and employers (e.g. about managing fatigue, job accommodations and informing the Driver and Vehicle Licensing Agency about driving) (see Report Supplementary Material 4).

Communication and co-ordination includes:

• establishing which other community services [e.g. ABI team, speech and language therapy (SALT)] are involved and communicating with them

• supporting the person prior to, and during, meetings with employers and other stakeholders (including clarifying what was said and agreed in meetings)

• seeking the person’s consent to contact the employer, education provider and/or training provider to discuss needs

• establishing and maintaining communication with employer and informing them of rehabilitation goals

• consulting with occupational health, DEA, Jobcentre Plus occupational psychologist or other VR service providers to discuss relevant action if there is doubt about a client’s ability to cope with a supervised and graded RTW

• providing clear written and verbal advice about appropriate timing, and gradual increases in hours and responsibilities

• liaison with the relevant occupational health department for advice or, when unavailable, consulting the NHSPlus website

• agreeing and discussing the disclosure of information to an employer or occupational health provider (providing clients with draft submissions for comment prior to disclosure)

• agreeing and discussing the RTW plans with the client and a family member (when possible)

• negotiating and agreeing workplace accommodations, such as equipment, graded return, voluntary trial, restricted hours/duties, advice/support in the workplace, job coaching, support from work colleagues, off-site support (e.g. from the OT or other relevant agencies) with the employer. In the case of study return, these may include adjustments to course, learning-support equipment, individual learning support, examination support and personal support (e.g. personal tutor).

Monitoring involves:

• reviewing progress with ongoing advice, support and feedback for person and employer (supervisor and work colleagues, as appropriate) and obtaining feedback from family members about the impact of work on personal life, family life and relationships

• liaising with DEAs when long-term adjustment and support are needed (e.g. major adjustments to work duties, specialist equipment or help with travel to work).

The intervention is individually tailored and delivered in the community, clinic or workplace over weeks or months based on participants’ individual needs. In our earlier cohort comparison,85 participants had a mean of 6.5 sessions of occupational therapy and 4.7 1-hour-long sessions of case management over the 12-month intervention period. Half of the sessions were delivered in person and half by telephone or e-mail. This ‘direct’ contact with the person accounts for about two-thirds of the therapist’s overall time. The rest is spent in administration and travel.

In the single-centre cohort study, ESTVR was delivered by a single experienced OT trained in VR. ESTVR was developed based on best practice recommendations64 over a number of years and evaluated pragmatically in the context in which it was developed. What remained unclear was whether or not OTs in other contexts could be trained to deliver it so that its effectiveness could be tested in a RCT. The intervention needed to be described such that the key intervention components were clear before an intervention training manual could be developed. Therefore, the starting point for this study was to manualise the intervention and train OTs in the three sites to deliver it.

Development, delivery and evaluation of the ESTVR training package

The OTs employed on FRESH needed to learn how to deliver the ESTVR intervention over the 12-month duration.

Methods

Summary of design and methods of randomised controlled trial

Figure 1 summarises the study method in line with the recommendations93 for individually randomised controlled trials of non-pharmacological interventions.

FIGURE 1.

Study method CONSORT flow chart. CONSORT, Consolidated Standards of Reporting Trials.

Demographics and baseline characteristics

Demographic and baseline characteristics were summarised using:

• mean [standard deviation (SD)] or median [interquartile range (IQR)], as appropriate, if quantitative (continuous or count)

• median (IQR) or frequency (%), as appropriate, if ordinal

• frequency (%) if nominal (dichotomous or polychotomous)

• both overall and within intervention groups.

Recruitment characteristics

Monthly trends in recruitment across sites were graphed to assess patterns in recruitment rate over time. This was intended to help evaluate potential barriers to recruitment, inform strategies to maximise recruitment and determine the potential duration of recruitment in any subsequent trial.

Site-specific and overall eligibility and recruitment rates were estimated as point estimate with 95% CI. CIs were calculated using exact (binomial) methods.

Participant attrition

Traumatic brain injury and carer participant attrition rates at each follow-up time point were estimated overall, by site and by follow-up mode; each rate estimate has been provided as point estimate with 95% CI. CIs were calculated using exact (binomial) methods. Numbers of TBI and carer participants dropping out for various reasons have also been presented.

In addition, baseline characteristics (including intervention arm allocation) affecting TBI participant attrition were investigated using logistic regression. Baseline characteristics [site, age, sex, severity of TBI, education level, marital status, ethnic group, living alone, occupational group, length of inpatient stay, cause of injury, PTA (as either a continuous or categorical variable), post-traumatic unconsciousness (as either a continuous or categorical variable), pre-injury work status, baseline ADL, baseline anxiety, baseline depression, baseline work self-efficacy, baseline percentage work time missed owing to health, baseline percentage activity impairment owing to health and intervention arm] were added individually. Any term significant at the 20% significance level was considered for inclusion in a multiple logistic regression model. However, selection of terms for this model was restricted by the small sample size. To investigate the joint effect of terms significant (p < 0.2) at the first stage of the modelling, terms were included in the model based on a forward stepwise selection procedure using a 5% significance level (for inclusion and exclusion); categories were merged as necessary to limit sparseness of categories and, when non-linear effects were deemed possible (e.g. when scale scores are skewed), scales were categorised. Statistical significance of variables was assessed using the likelihood ratio test.

Outcome measures

All outcome measures were summarised at each time point overall, by intervention group and by site using:

• mean (SD), or median (IQR), as appropriate, if quantitative (continuous)

• median (IQR) or frequency (%), as appropriate, if ordinal

• frequency (%) if nominal (dichotomous or polychotomous).

Summaries have been within intervention groups, within sites and within site by intervention groups. Descriptive analysis of work status data over time was performed to investigate within-individual trends in work status to aid selection of the primary work status-related outcome for a subsequent effectiveness trial, should this trial demonstrate feasibility.

Generalised linear models for continuous, ordinal and dichotomous outcomes were used to compare the two intervention groups (defined according to the intention-to-treat population, but with no imputation) on outcome data. Baseline measures of the outcomes variables were included as covariates (or factors) in the models for outcome data. Measures of effectiveness and relative effectiveness (differences between means or ORs, presented as ‘ESTVR relative to UC’ as appropriate) were estimated and 95% CIs presented; no p-values have been presented.

Exploratory logistic modelling was used to investigate factors previously found to be related to work return and estimates of intervention effectiveness will be adjusted for baseline factors which were found (i.e. significant at the 5% level using a likelihood ratio test) or deemed likely to affect the work status at 12 months post randomisation. A decision for inclusion of terms was also dictated by model convergence, which was not achievable for some potential models owing to the small sample and sparseness of the data.

Investigation of the distribution of responses for health outcome measures and of patterns in work status over time was performed to inrefers to imputationform the design (primary outcome, follow-up duration, analysis, sample size, etc.) of a future trial. Key parameters (e.g. percentage in work at 12 months in control arm) were also estimated (with CIs) to inform the design of the potential future trial.

Statistics (frequency, percentage) describing the nature and extent of missing data were produced for each outcome, summarised by (1) planned mode of data collection method (face to face and postal) and (2) treatment arm. No imputation of missing data was performed.

Adverse outcomes

Adverse events were presented as frequencies (%), overall and by intervention group.

Results

This section reports on the process of recruiting and conducting the 3-, 6- and 12-month outcome assessments with participants (patients and carers) in the feasibility RCT, before presenting the outcome data relating to clinical effectiveness. Particular emphasis is given to 12-month outcomes as these reflect the time point at which effectiveness would be evaluated in a RCT.

The results are organised around the first 10 objectives listed at the start of this chapter (see Methods, Objectives), although objective 1 will be addressed primarily in the summary of the results.

Randomised controlled trial process

Following delays, two sites opened for recruitment in December 2013 and one site (site 3) opened in February 2014. After lower than anticipated recruitment during the early stages, a 3-month extension was granted by the funder following agreement from all participating sites to continue in the trial. Recruitment took place over the full 12 months planned in the trial protocol in two sites and 11 months in the third. However, the RA did not commence until 1 March 2013 in site 2, with the site relying on the OT to attempt recruitment during the first month following its opening. The trial closed to recruitment after 14 January 2015, having allowed a 2-week window for consent for those with injuries sustained up until 31 December 2014. A total of 78 participants were recruited and randomised in equal numbers to the ESTVR and UC arms. The overall screening, recruitment, randomisation, treatment and follow-up process data are presented in the CONSORT (Consolidated Standards of Reporting Trials) diagram (Figure 2).

FIGURE 2.

Study CONSORT diagram.

Screening and recruitment

Objective 2: to estimate the proportion of potentially eligible traumatic brain injury patients recruited and identify reasons for non-recruitment (missed, medical, logistic, other)

In total, 1446 patients were screened, with 200 (14%) eligible for recruitment, 1167 (81%) ineligible and 79 (5%) with unknown eligibility, mainly owing to being ‘discharged prior to screening’. Once patients were identified as eligible for the study, they were approached by a RA or research nurse for consent. Of the 200 who were eligible, 78 (39%, 95% CI 32% to 46%) (5% of those screened) were recruited to the trial. The majority of those ineligible (779, 67%) were either unemployed (216, 19%) or retired (563, 48%). Other common reasons were remaining in hospital < 48 hours (95, 8%), living approximately > 1 hour away (105, 9%) and not competent to provide consent (79, 7%). Fifty-seven (5%) of those screened were recorded as not having had a TBI, 39 (3%) had died and small numbers were not planning to return to work (n = 7), were aged < 16 years (n = 5) or were enrolled in a competing trial (n = 1).

Objective 3: to estimate the recruitment rate (by centre)

Participant recruitment

The estimated recruitment rate (overall 39%, 95% CI 32% to 46%) varied somewhat by site, from 32% (95% CI 21% to 44%) in site 1 to 35% (95% CI 24% to 49%) in site 2 and 49% (95% CI 37% to 62%) in site 3. Site 3 met its recruitment target of 34 in 11 months. Sites 1 and 2 each recruited 22 participants in 12 months, albeit with differing patterns of recruitment across the trial, with site 2 recruiting to target for the first 6 months of the trial (n = 17) and recruitment at site 1 improving towards the end of the recruitment period (Figure 3).

FIGURE 3.

Recruitment by site against target (two sites technically opened in late December 2013 but did not recruit anyone until January 2014).

A total of 76 (38% of those eligible) patients declined to participate, 29 (15%) did not respond to a letter inviting them to take part following discharge (lost to follow-up) and 17 (9%) did not participate for other reasons [seven (4%) were not approached owing to behavioural safety issues highlighted by the clinical team, six (3%) gave incorrect personal information and four (2%) were erroneously excluded].

Some of the 76 people who declined volunteered a reason. The most common set of reasons was that they believed that they did not require help or that the intervention would be of no benefit, in some cases owing to them being back at work, although 16 patients reported that it was ‘too much’ for them to participate in the trial (see Report Supplementary Material 12, Table 4).

Carers

Carers of TBI patients were nominated by recruited patients. In total, 52 carers were nominated by 78 patients and 32 (62%, 95% CI 47% to 75% of those nominated) were recruited.

Recruitment process measurements

The ESTVR intervention was intended to be delivered early (within 8 weeks) after TBI. The mean time from injury to first face-to-face contact with a FRESH therapist was 35.3 working days (range 7–97 working days) indicating that most participants’ intervention commenced within 8 weeks (56 days) of TBI. Further statistics relating to times between injury onset and recruitment and between injury and intervention commencing are provided in Report Supplementary Material 12, Table 5. The success of randomising participants and delivering the intervention within the early recovery/post-acute phase is discussed further in Chapter 5.

External validity (generalisability)

Those who consented were similar to those who declined in the characteristics collected (mean age 38.9 years and 39.1 years respectively; percentage male 85% and 80% respectively).

Objective 4: to determine the spectrum of traumatic brain injury severity among recruits

Participant baseline characteristics

Overall, 41 (56%) of those recruited had a minor TBI (GCS score of 13–15). Of those who responded to specific questions about amnesia or unconsciousness, 61 (79%) reported having experienced PTA and 59 (79%) reported having been unconscious.

The most common causes of injury were falls (n = 30, 39%) and RTAs (n = 31, 40%), although 19 of those who had fallen were randomised to the intervention arm and 19 of those who had suffered a RTA were randomised to the control arm (Table 3).

TABLE 3 - Demographics for TBI participants, by intervention arm and overall; frequency (%) unless otherwise stated

A level, Advanced level; GCE, General Certificate of Education; GCSE, General Certificate of Secondary Education; n₁, control; n₂, intervention.

Other causes of injury (football, hit on the head by a hockey ball, has no idea but thinks he fell – aneurysm, struck on the head by a tree branch).

Using the values only of those who experienced PTA.

Characteristic	Intervention arm		Overall (n = 78)
	UC (n1 = 39)	VR (n2 = 39)
Sex
Male	32 (82)	34 (87)	66 (85)
Female	7 (18)	5 (13)	12 (15)
Age (years), mean (SD)	38.0 (13.8)	40.6 (13)	39.3 (13.4)
Marital status
Married or living with a partner	19 (49)	22 (56)	41 (53)
In a long-term relationship but not cohabiting	6 (15)	5 (13)	11 (14)
Single	12 (31)	10 (26)	22 (28)
Divorced or separated	2 (5)	2 (5)	4 (5)
Lives alone or with others
Lives alone	5 (13)	8 (21)	13 (17)
Lives with family/spouse or significant other	34 (87)	31 (80)	65 (83)
Highest education level
Degree, higher degree or equivalent qualification	13 (33)	14 (36)	27 (35)
Higher education qualification	8 (21)	5 (13)	13 (17)
GCE, A level or equivalent qualification	3 (8)	4 (10)	7 (9)
GCSE grades A*–C or equivalent	8 (21)	9 (23)	17 (22)
Other qualifications	1 (3)	3 (8)	4 (5)
No qualifications	6 (15)	4 (10)	10 (13)
Ethnic group
White	35 (90)	34 (87)	69 (88)
Black Caribbean	2 (5)	1 (3)	3 (4)
Asian	2 (5)	2 (5)	4 (5)
Other	0 (0)	2 (5)	2 (3)
Occupational grouping (n1 = 32, n2 = 36, n = 68)
Managers, directors and senior officials	4 (13)	4 (11)	8 (12)
Professional occupations	5 (16)	6 (17)	11 (16)
Associate professional and technical occupations	6 (19)	2 (6)	8 (12)
Administrative and secretarial occupations	2 (6)	4 (11)	6 (9)
Skilled trades occupations	8 (25)	8 (22)	16 (24)
Caring, leisure and other service occupations	0 (0)	1 (3)	1 (2)
Sales and customer service occupations	1 (3)	1 (3)	2 (3)
Process, plant and machine operatives	2 (6)	4 (11)	6 (9)
Elementary occupations	4 (13)	6 (17)	10 (15)
Number of days in hospital, median (IQR)	7 (4–11)	10 (5–18)	9 (4–14.3)
Cause of injury
Fall	11 (28)	19 (49)	30 (39)
RTA	19 (49)	12 (31)	31 (40)
Assault	7 (18)	6 (15)	13 (17)
Othera	2 (5)	2 (5)	4 (5)
Categorised lowest GCS (n1 = 36, n2 = 37, n = 73)
Severe (≤ 8)	8 (22)	11 (30)	19 (26)
Moderate (9–12)	7 (19)	6 (16)	13 (18)
Minor (13–15)	21 (58)	20 (54)	41 (56)
Experienced PTA (n1 = 39, n2 = 38, n = 77)
Yes	31 (80)	30 (79)	61 (79)
Duration of PTA (hours), median (IQR) [range] (n1 = 27, n2 = 28, n = 55)b	24 (3–96) [0.1–240]	60 (24–168) [0.3–336]	48 (5–120) [0.1–336]
Unconscious after injury (n1 = 37, n2 = 38, n = 75)
Yes	27 (73)	32 (84)	59 (79)
Time unconscious after injury (hours), median (IQR) [range] (n1 = 17, n2 = 24, n = 41)b	1 (0.2–48) [0.02–840]	1 (0.5–21) [0.02–336]	1 (0.4–36) [0.02–840]
Injury date to baseline questionnaire completion (days), median (IQR)	21 (8–34)	22 (10–39)	22 (8–36.3)
Site
1	11 (28.2)	11 (28.2)	22 (28.2)
2	11 (28.2)	11 (28.2)	22 (28.2)
3	17 (43.6)	17 (43.6)	34 (43.6)

The mean age of participants was 39.3 years and most (n = 66, 85%) were male. A total of 88% described themselves as white. Forty-one (53%) participants were married and 40 (51%) had a higher education qualification (degree or other). Most (n = 63, 81%) participants reported that their health was worse than 12 months previously, with a mean NEADL score of 9.5 points. Other demographic and health characteristics are summarised in Table 7.

Stratification achieved balance by site (see Table 3) and differences between arms on other demographic measures were generally small (see Table 3). Differences between arms on self-reported measures of health were generally small, although, on average, the UC group was slightly less severely impaired (in ADL, community integration and anxiety levels) and reported being more able to work effectively (higher work self-efficacy, lower percentage work time missed due to health impairment while working and overall work impairment) (Table 4).

TABLE 4 - Traumatic brain injury participants’ validated measures scores at baseline, by intervention arm and overall; frequency (%) unless otherwise stated

n₁, control; n₂, intervention; VAS, visual analogue scale.

Measure	Intervention arm		Overall (n = 78)
	UC (n1 = 39)	VR (n2 = 39)
EQ-5D-3L VAS, mean (SD)	56.2 (25.7)	53.4 (22.1)	54.8 (23.9)
NEADL, mean (SD), higher scores indicate greater independence
Mobility (valid range 0–6 points)	2.7 (2.3)	2.3 (2.4)	2.5 (2.4)
Kitchen (valid range 0–5 points)	2.9 (1.8)	2.7 (1.7)	2.8 (1.8)
Domestic (valid range 0–5 points)	1.5 (2.0)	1.5 (2.2)	1.5 (2.1)
Leisure (valid range 0–6 points)	2.7 (1.3)	2.5 (1.3)	2.6 (1.3)
Total score (valid range 0–22 points)	9.9 (6.4)	9 (6.7)	9.5 (6.5)
CIQ, mean (SD)
Home integration (valid range 0–10)	4.4 (2.9)	4.5 (2.9)	4.5 (2.9)
Social integration (valid range 0–12)	7.5 (2.5)	6.3 (2.7)	6.9 (2.7)
Social productivity (valid range 0–7) (n1 = 39, n2 = 37, n = 76)	4.8 (1.6)	5 (1.7)	4.9 (1.6)
Total score (valid range 0–29) (n1 = 39, n2 = 37, n = 76)	16.6 (4.8)	16.0 (5.0)	16.3 (4.9)
HADS
Anxiety
Normal (0–7)	26 (67%)	24 (62%)	50 (64%)
Borderline abnormal (8–10)	7 (18%)	8 (21%)	15 (19%)
Abnormal (11–21)	6 (15%)	7 (18%)	13 (17%)
Depression (n1 = 38, n2 = 39, n = 77)
Normal (0–7)	23 (61%)	25 (64%)	48 (62%)
Borderline abnormal (8–10)	9 (24%)	9 (23%)	18 (23%)
Abnormal (11–21)	6 (16%)	5 (13%)	11 (14%)
Self-efficacy single question from WAI, mean (SD) (valid range 0–10)	5.2 (3.1)	4.6 (3.2)	4.9 (3.2)
WPAI v2, mean (SD)
Per cent work time missed due to health (n1 = 8, n2 = 7, n = 15)	52.2 (44.0)	65.0 (47.0)	58.2 (44.2)
Per cent impairment while working due to health (n1 = 6, n2 = 6, n = 12)	36.7 (34.4)	81.7 (24.0)	59.2 (36.8)
Per cent overall work impairment due to health (n1 = 8, n2 = 7, n = 15)	63.6 (34.9)	87.1 (23.6)	74.6 (31.5)
Per cent activity impairment due to health	52.3 (33.9)	60.5 (29.5)	56.4 (31.8)
EQ-5D-3L
Mobility
No problems	16 (41)	17 (44)	33 (42)
Some problems	18 (46)	19 (49)	37 (47)
Confined to bed	5 (13)	3 (8)	8 (10)
Self-care
No problems	27 (69)	26 (67)	53 (68)
Some problems	9 (23)	12 (31)	21 (27)
Unable to wash or dress	3 (8)	1 (3)	4 (5)
Usual activities
No problems	7 (18)	2 (5)	9 (12)
Some problems	15 (39)	18 (46)	33 (42)
Unable to do usual activities	17 (44)	19 (49)	36 (46)
Pain/discomfort
No pain or discomfort	12 (31)	9 (23)	21 (27)
Moderate pain or discomfort	25 (64)	26 (67)	51 (65)
Extreme pain or discomfort	2 (5)	4 (10)	6 (8)
Anxiety/depression
Not anxious or depressed	25 (64)	23 (59)	48 (62)
Moderately anxious or depressed	10 (26)	14 (36)	24 (31)
Extremely anxious or depressed	4 (10)	2 (5)	6 (8)
Health compared to previous 12 months
Better	1 (3)	0 (0)	1 (1)
Much the same	10 (26)	4 (10)	14 (18)
Worse	28 (72)	35 (90)	63 (81)

Two consenting carers did not return the baseline questionnaire; one of those returned the 3-month questionnaire. Most carers were female and were the spouse or partner of the TBI participant. More control group carer participants were a parent of the TBI participant (47% vs. 7%) (Table 5).

TABLE 5 - Traumatic brain injury carers’ demographics and validated measures scores at baseline, by intervention arm and overall; data are frequency (%) unless otherwise stated

n₁, control; n₂, intervention.

Data extracted from participant questionnaire for two carers who were consented but did not return their baseline questionnaire.

TBI carer demographic and carer strain measures	Intervention arm		Overall (n = 30)
	UC (n1 = 16)	VC (n2 = 14)
Sexa
Male	2 (12)	2 (13)	4 (13)
Female	15 (88)	13 (87)	28 (88)
Age (years), mean (SD)	48.6 (11.4)	44.9 (17.2)	46.9 (14.3)
Relationship to participanta
Spouse	7 (41)	8 (53)	15 (47)
Partner	2 (12)	6 (40)	8 (25)
Parent	8 (47)	1 (7)	9 (28)
Sibling	0 (0)	0 (0)	0 (0)
Friend	0 (0)	0 (0)	0 (0)
Other	0 (0)	0 (0)	0 (0)
CSI, mean (SD)	6.0 (4.1)	5.4 (3.1)	5.7 (3.6)
CSI – categorised
All item responses are negative	3 (19)	1 (7)	4 (13)
1–6 item responses are positive	5 (31)	7 (50)	12 (40)
≥ 7 item responses are positive	8 (50)	6 (43)	14 (47)

Sample size calculation based on the Community Integration Questionnaire

If the CIQ, rather than the ‘in-work’ rate, is chosen as the primary outcome measure for a full trial, then the parameters required for the sample size calculation would be the SD and the minimally important difference in means. The minimal important difference is not established in the literature, but the research team believes it to be in the range of 1–2 points, possibly towards the middle or lower end of this range: a difference of 1.5 points is almost 10% of the mean baseline CIQ score (16.3 points). The point estimate of the CIQ residual SD from the 12-month inferential analysis (linear model) was 5.02. Based on this, and using a linear model (adjusted for baseline CIQ) to achieve 90% power using a 5% significance level, to detect a minimal important difference on the CIQ of:

• 1 point – 1062 participants (531 per arm) would need to provide outcome data at 12 months, equating to randomising 1416 participants if 12-month attrition is 25%

• 1.5 points – 474 participants (237 per arm) would need to provide outcome data at 12 months, equating to randomising 632 participants if 12-month attrition is 25%

• 2 points – 268 participants (134 per arm) would need to provide outcome data at 12 months, equating to randomising 358 participants if 12-month attrition is 25%.

Specific feasibility criteria for progression to the main trial

Feasibility will be shown if at least two TBI patients per month are recruited on average and, if the average number of patients recruited monthly is less than two, strategies to achieve this target are identified:

• Met in one site (site 3) and on average overall (2.2 per month); however, two sites recruited at slightly under two patients per month (22 each in 12 months, 1.8 per month). A number of different intrinsic and extrinsic factors influenced recruitment in each site. These included the deployment of network support, patient repatriation, the lack of a designated trauma unit in one centre, lack of access to A&E records, construction of a helipad near one centre, which affected admissions (trauma admissions triaged to another local major trauma centre), and the characteristics of the local population in one centre (most at, or near, retirement age). Recruitment was most successful (3.1 per month) in the site with a RA dedicated to the project, supervised by the local PI.

Feasibility will be demonstrated if no fewer than 5% of TBI patients screened are recruited:

• A total of 78 out of 1446 screened (5.4%, 95% CI 4.3% to 6.7%) were recruited.

Feasibility will be demonstrated if ≥ 25% of eligible TBI patients are recruited and, when < 25%, strategies are identified to achieve this:

• A total of 78 out of 200 (39.0%, 95% CI 32.2% to 46.1%) of eligible participants were recruited.

Feasibility will be demonstrated if the proportions of recruited participants with mild TBI and moderate or severe TBI are equal or if recruitment strategies to address any observed imbalance are identified:

• The proportion of participants recruited who had incurred a mild TBI (56%) was higher than the proportion with moderate or severe TBI (44%), as categorised by the GCS score. The imbalance is thought to have been due to repatriation of a higher proportion of more severely injured patients requiring ongoing rehabilitation as part of the newly configured major trauma pathways.

• As part of this study, estimates based on the consent rate and the number of patients fitting the inclusion criteria who were repatriated in a given time period in one site suggested that the recruitment targets and injury severity balance would have been achieved by extending the recruitment window to 12 weeks and with the necessary resource for recruiting repatriated patients.

Feasibility will be shown if at least 30% of eligible carers are recruited:

• The 78 TBI participants nominated 45 carers and 32 (61.5%, 95% CI 47.0% to 74.7%) were recruited. Carers were typically female and either a spouse/partner (72%) or parent (28%) of the TBI participant.

Feasibility will be demonstrated if < 40% withdraw or are lost to follow-up or, when > 40%, if strategies to overcome identified barriers are identified:

• In total, 52 out of 78 (67%) questionnaires were available for analysis at 12 months, from 23 and 29 participants in the UC and ESTVR intervention groups, respectively. Follow-up of the primary end point at 12 months was also 67%. Therefore, at 12 months, 33.3% (95% CI 23.1% to 44.9%) of TBI participants did not provide RTW outcome data (22 non-response and four withdrawals). Additional strategies to reduce loss to follow-up in a future trial were identified. These included text messages and telephone calls from an identified number (having asked participants at recruitment to accept the trial telephone number as an identified number) and text messages with a link to an online questionnaire to facilitate response in smartphone users and people who return to work.

Feasibility will be shown if < 30% withdraw from the intervention or if > 30% withdraw but strategies to reduce this rate are identified:

• Two participants (5%) disengaged from the intervention. One declined further support having being advised that he was not legally permitted to drive, one lost his job, transferred to long-term benefits and declined further help, and a further two could not be contacted (one moved to a new care home) after minimal intervention.

Feasibility will be demonstrated if bespoke work questions are answered in >90% of returned questionnaires or, if answered in < 90% of questionnaires, strategies to improve completion are identified:

• Overall, all bespoke RTW questions were answered at all time points by ≥ 90% of participants, except for ‘Reason left work/education or changed job/course (Q23)’, which just failed to meet this criterion at the 6-month follow-up time point. However, the completion rate was 100% at the other time points, and this apparently lower rate was due to a single non-respondent out of nine (as this question was often not applicable). Hence, we concluded that this feasibility criterion had been met.

Feasibility will be demonstrated by < 30% loss to follow-up of the primary end point at 12 months with strategies identified to reduce this rate to 20%:

• Attrition was estimated to be 33.3%. Despite the follow-up protocol implemented by the CTU and efforts by the RA at site 3, no RTW information was collected for those who failed to complete the full questionnaire. It will be important to consider the use of technology to increase both the ongoing contact with trial participants and to collect RTW information. This may also help reduce the differential attrition between the control and intervention arms.

Feasibility will be demonstrated if most participants interviewed state that the intervention is acceptable:

• Almost all of the participants interviewed stated that the intervention was acceptable and useful. Participants liked knowing that the FRESH OT was there if needed. However, two reported feeling fraudulent because they did not feel that the TBI had left them in need of rehabilitation. They valued particular elements, including letters to the participant and employer, specific support to prepare for work, negotiating a RTW and support once back at work. Participants thought that FRESH should be available in the future to them and their employer and that it should be driven by the health professional.

Feasibility will be demonstrated if most participants interviewed indicate that randomisation is acceptable:

• None of the participants interviewed indicated that randomisation was unacceptable or declined participation because they wanted to ensure randomisation to the intervention group.

Feasibility will be demonstrated if most of the therapists interviewed consider the training to be useful and acceptable and, if this was not the case, if strategies for improvement are identified:

• All of the therapists interviewed considered the training to be useful and considered that all three elements of the training package (training, manual and mentoring) were essential. Training increased therapists’ confidence to deliver ESTVR. However, they wanted training to converge with the start of recruitment and to include more detail about the study and delivering interventions within a trial context. They requested more opportunities for knowledge sharing around cases. The most valued aspects of the training package were case discussions and mentoring to support individual tailoring of the intervention and its local implementation.

The findings indicate that training packages should include detailed intervention descriptions in order to facilitate implementation.

Summary

We set out to assess the integrity of the study protocol (e.g. inclusion/exclusion criteria, staff training, adherence to the intervention, and to identify reasons for non-adherence). This study found the protocol to be robust. The feasibility objectives were achieved or, when not achieved, strategies for achieving targets were identified. Therefore, overall feasibility has been demonstrated so this key feasibility objective was met.

The trial achieved 76% of its target recruitment. The recruitment rate overall was 6.5 per month. However, this varied by centre. Site 1 recruited 22 patients (32% of those eligible), site 2 recruited 22 patients (35% of those eligible) and site 3 recruited 34 patients (49% of those eligible), with site 3 achieving the 12-month target of 34 patients in 11 months (a rate of 3.1 per month) and the other centres fluctuating and achieving rates of 1.8 per month. However, site 3 had a dedicated RA for face-to-face follow-up and who could deploy time flexibly for recruitment. The reasons for the fluctuations and mechanisms to improve recruitment are well understood.

More people with a mild TBI (56% of participants) were recruited than those with moderate or severe TBI. The imbalance is thought to have occurred owing to repatriation following the establishment of MTCs with new care pathways.

As part of this study, estimates based on the consent rate and the number of patients fitting the inclusion criteria who were repatriated in a given time period in one site suggested that the recruitment targets and injury severity balance would have been achieved by extending the recruitment window to 12 weeks and with the necessary resource for recruiting repatriated patients.

The impact of patients displaced or repatriated, and the option of extending the recruitment window from 8 to 12 weeks, was explored using data from a single centre (site 3). This suggested that an extension from 8 to 12 weeks would have meant that we would have achieved the recruitment target. However, as more severe cases are often transferred to other sites, additional resources and approvals would need to be in place to support recruitment across a wider geographical area.

Although the overall recruitment target of 102 was not met, the reasons for this are well understood and this knowledge will inform the design of the definitive trial. The ideal model for recruitment in a future trial is to have a RA embedded in the research team and supervised by the local PI, with support and training from the CTU.

Identifying people who had sustained a TBI was, in some cases, problematic. Not everyone who sustains a head injury is scanned for the presence of brain injury and not all injuries to the brain are present on a scan. Because of this, it was not a requirement of FRESH that participants’ TBI was confirmed by CT. Instead, we relied on local clinical procedures for the identification of patients with TBI. This lack of a clear definition of TBI may have affected eligibility and inflated the proportion of patients screened. Moreover, the establishment of MTCs contributed to difficulties in identifying people who sustain mild TBI, as this was sometimes missed or poorly recorded in patients admitted with other severe injuries.

In one site, there was no designated trauma ward and, therefore, no simple mechanism for identifying potential participants [Trauma Audit and Research Network (TARN) registers are often retrospectively completed and capture patients admitted for only ≥ 72 hours]. All patients admitted to A&E with a suspected ‘head injury’ were screened in an attempt to identify those who had sustained a TBI. As all of these patients were entered onto the screening log, the proportion of participants recruited in relation to the number screened was low.

A total of 39% of potentially eligible patients and 5.5% of TBI patients screened were recruited. The most common reasons for non-recruitment were that participants were discharged before being seen and did not respond to recruitment materials by post or that participants had already returned to work or did not feel that they needed support to return to work. In total, 76 (38% of eligible) refused consent.

The findings suggest that TBI patients are willing to be randomised to either receive support with RTW or not.

A total of 56% of participants had incurred a mild TBI, 18% a moderate TBI and 26% a severe TBI. When compared with the pilot study, more people with mild TBI were included in FRESH. This can be explained, in part, by the institution of MTCs operating a ‘hub and spoke’ model, with organised pathways of care, which resulted in the repatriation of potential participants with moderate or severe TBI to referring hospitals or rehabilitation units, which were geographically dispersed and for which additional approvals and resources were required for recruitment.

The higher proportion of people with mild TBI in this study will have had an impact on the 12-month rate of RTW; if this is high in the control arm then it may be deemed that an effectiveness trial is not required given the limited gains in this population. Therefore, it is important that a more balanced sample including more people with moderate or severe injuries can be recruited to demonstrate gains within the 12-month follow-up period.

Carers of TBI patients were nominated by recruited patients. In total, 45 carers were nominated by 78 patients and 31 (69%) were recruited. Proportionately fewer eligible carers were recruited in site 3 than in other centres.

At baseline, across all three centres, the return rate was 78 out of 78 (100%). At 3 months, the return rate was 65 out of 78 (83%); at 6 months, 62 out of 78 (79%); and at 12 months, 52 out of 78 (67%). Only four of the 26 ‘lost to follow-up’ at 12 months formally withdrew, so reasons for non-response are generally not known. However, those who did not respond at 12 months were significantly more likely to be younger, not live alone, be more anxious and have lower mean percentage health-related activity impairment at baseline. Furthermore, at least in the control group, they appeared more likely to have been out of work at 6 months.

Carers’ response rates were similar to, or slightly lower than, those of the TBI participants. At baseline, 30 out of 32 (94%) questionnaires were returned; at 3 months, 26 out of 32 (81%) were returned; at 6 months, 23 out of 32 (72%) were returned; and at 12 months, there were 22 out of 32 (69%) returns. Four carers formally withdrew because the nominated carer was a partner and the relationship ended.

Follow-up in TBI participants is known to be difficult and we have shown that it can be achieved using postal follow-up with text message prompts and telephone assistance. The Lancashire CTU’s success in securing excellent return rates resulted from a team of well-trained staff, who followed a well-considered and robust protocol to enhance response. The team also developed rapport with trial participants. However, the different response rates observed between groups suggests that those in the control group, in particular, may require an incentive to remain in the trial and contact should be made between the 6- and 12-month follow-up points. The possibility of the 12-month work status affecting non-response (a ‘not missing at random’ missing data mechanism) should be considered when designing and analysing a full trial.

Postal follow-up appears to be comparable to face-to-face follow-up and is less resource intensive.

Other than non-return of questionnaires, there were few problems with incomplete (or invalid) responses to primary and secondary health outcome related questions.

Measuring RTW was possible in people with TBI but complicated by several factors:

• The interchangeable use of the terms ‘work’ and ‘employment’ by participants. A person can be technically employed but ‘off sick’, but may still refer to their work status as being ‘in work’.

• The interplay between benefit eligibility, insurance claims and work status. Some participants may intend to stay ‘off sick’ to remain eligible for sickness benefits or insurance payouts.

Future studies should give clear definitions within the questionnaire and offer reassurance that there is no communication between the researchers and the DWP or insurance companies. It proved difficult to obtain an unbiased estimate of the RTW rate in the control arm, which is the key parameter required for a sample size calculation for an effectiveness trial. Attrition appeared to be dependent on work status and also intervention group. So, although > 90% of the control arm respondents were working or studying at 12 months, it is likely that those out of work were less likely to respond than those in work, particularly control group participants, who may have felt dissatisfied with the trial as a result of having been allocated to that arm. However, unless this can be overcome, it would appear that an effectiveness trial of ESTVR using a work status variable at 12 months would not provide convincing evidence of effectiveness, due to a combination of the high control group attrition rate and the inherent bias in the intervention effect estimate.

Return to work was found to be most strongly related to social participation (community integration) and work self-efficacy, with a weaker relationship with impairment and, for competitive work or full-time study, with depression.

Introduction

Traumatic brain injury is a major event in a person’s life that can have long-term consequences in terms of reduced health, independence and employability. Together this equates to reduced QoL and increased costs for the individual, their family and society. A recent review7 of research on the economic burden of TBI included 10 studies, of which only two were from the UK. The authors concluded that:

Further research is needed to estimate the economic burden of these participants on healthcare providers and social services and how this can impact current health policies and practices.

Humphreys et al. 7

One paper10 estimates, based on data from the USA, Australia and Europe, that the annual cost of TBI in developed countries is 0.8% of yearly GDP, with the annual cost of TBI in the UK being £15B. If VR is found to be effective at helping people retain, or return to, work while at the same time being cost-effective, this could help to substantially reduce this economic burden.

Economic evaluations are an essential component of the health technology assessment process to ensure that the interventions evaluated offer value for money as well as clinical benefit. Definitive trials are expensive to conduct; therefore, it is important to assess the feasibility of running a definitive trial before it is funded to ensure that funds are not wasted on trials that are unlikely to be feasible to run. The FRESH trial assesses the feasibility of designing a definitive trial of VR after TBI and this chapter contributes to this endeavour by assessing the feasibility of undertaking a concurrent economic evaluation of VR following TBI.

Aims and perspective

A definitive study of clinical effectiveness and cost-effectiveness can be successful only if appropriate methods of measurement are employed. This component of the study aimed to assess the feasibility of conducting a definitive economic evaluation of the cost-effectiveness of VR after TBI and undertake an early-stage cost-effectiveness analysis of VR after TBI in order to inform a definitive study.

The objectives of the economic component of this study were to:

• identify relevant resources and outcomes likely to change as a result of VR

• assess the feasibility of collecting resource use and outcome data for a cost-effectiveness analysis within a fully powered trial by evaluating completion rates

• consider how data collection instruments should be designed for a definitive study

• demonstrate the feasibility of conducting a within-trial cost-effectiveness analysis, reporting early-stage estimates of incremental costs and effects, in a complete-case analysis.

Although the National Institute for Health and Care Excellence (NICE)106 recommends a NHS and Personal Social Services (PSS) perspective in the reference case, it is recognised that, for certain conditions, a broader perspective may be important when interventions are likely to have an impact on the costs and benefits felt by other government sectors. These resources and outcomes are recommended as being presented separately from the reference case. It should be noted that the NICE guidance106 does not permit the inclusion of productivity costs in either the reference case or non-reference case. This reflects the methodological challenge of measuring such costs. In this study, the aim of the intervention is to help people back into work or to retain work after TBI; therefore, changes in productivity are central to any economic analysis. Given the methodological challenges of measuring productivity costs,107,108 this report presents the resource use (in units of time) and costs separately.

Methods

Early-stage cost–utility analysis

As above, the difference in mean cost per participant was –£1030.64 (95% CI –£3840.45 to £1779.17) when adjusting for centre and baseline costs, meaning that the VR intervention was, on average, cheaper than UC. The incremental mean QALYs per participant was –0.0506 (95% CI –0.1715 to 0.0702) with adjustment for baseline and centre. Figure 4 illustrates the cost-effectiveness plane comparing incremental costs and QALYs for the VR intervention with UC in the base-case analysis.

FIGURE 4.

Cost-effectiveness plane for the comparison of the VR intervention and UC, based on 10,000 bootstrapped cost–effect pairs, using QALYs for the base-case analysis.

The NMB of the intervention was calculated, assuming a WTP of £20,000 and £30,000 per QALY generated, in line with NICE guidance. 106 The NMB for the VR intervention group, when considering the intervention costs in the analysis, was £18.64 (95% CI –£3355.00 to £3032.98) when using a £20,000 WTP per QALY threshold and –£487.36 (95% CI –£4655.34 to £3159.67) at the WTP threshold of £30,000 per QALY. At a WTP threshold of £20,000, the NMB is above zero, which indicates that TBI may be cost-effective at currently accepted thresholds. It should be noted this is based on only the limited data within this feasibility study, although it does demonstrate the uncertainty that currently exists.

The probability of VR being cost-effective at a WTP threshold of £20,000 (£30,000) per QALY was 47.00% (39.03%) (Figure 5).

FIGURE 5.

Cost-effectiveness acceptability curve showing the probability that VR intervention is cost-effective compared with UC for different values of WTP per QALY.

The EVPI was £3077.17 (£3741.49) per participant at a threshold ICER of £20,000 (£30,000). This can be seen in Figure 6.

FIGURE 6.

Expected value of perfect information in the base-case analysis.

The population EVPI was estimated as £69,024,213.37 (£83,925,662.63) over a 1-year time horizon with a WTP per QALY of £20,000 (£30,000) (Figure 7). These figures indicate that the cost of future research is likely to be less than the value to be gained in terms of reducing the uncertainty surrounding the decision about whether or not to adopt VR for TBI, and, thus, proceeding to a definitive trial would be of value.

FIGURE 7.

Population EVPI in the base-case analysis.

Summary

This chapter has explored the feasibility of identifying and collecting resource use and outcome data for use in a health economic evaluation. It has also demonstrated the feasibility of conducting a within-trial cost–utility analysis and estimated the potential value of undertaking future research on VR following TBI.

Although data completeness was largely good for those participants actually completing the questionnaires, dropout (higher in the control group) and missing resource use data for those still in the study at 12 months (higher in the VR intervention group) meant that only 37 (47.4%) out of 78 participants (47.4%) could be included in the complete-case analysis in the base case. Overall, complete resource use data were available for 38 out of 78 (48.7%) participants, compared with 51 out of 78 (65.4%) participants for QoL. Therefore, while it has been shown that it is feasible to collect health economic data to assess the cost-effectiveness of VR following TBI in a subsequent definitive study, this is not without potential challenges that would need to be overcome.

A relatively small number of participants (n = 32, 41.0%) had a carer complete the carer questionnaires and, thus, it would seem important to try and capture information on carer time and cost inputs via the participant questionnaires in a definitive study.

Given the percentage of total cost accounted for by broader costs, taking such a perspective would be important in a definitive study. The bespoke method of collecting information on productivity changes seemed the easiest to value. The WPAI v2, while collecting information on presenteeism, considers only those in work and so involved an additional step to cost changes to productivity for those not in work. WPAI v2 was difficult to use in terms of estimating and valuing the costs of changes to productivity. Using the mean hourly wage as reported in ASHE113 was more straightforward than asking participants to report which income band they fell within. Using published wage rates would mean that a future study could ask one less question (i.e. drop the income question from participant questionnaires).

A definitive trial will need to re-evaluate how best to capture the intervention costs distinct from other wider NHS resource use. It is unclear if participants are able to differentiate between VR intervention OT visits and community OT visits that were not part of the intervention. The moderate agreement found between therapist- and participant-recorded OT visits seems to suggest that participants probably included intervention visits in their response to questionnaires. As they were not asked to exclude them, we cannot be sure if they would be able to do this in practice. We dealt with this in the analysis by undertaking SAs including and excluding the sessions recorded by the intervention OTs themselves in order to provide a range on the possible estimates of costs and early stage cost-effectiveness.

From the value-of-information analysis conducted, it is likely that the cost of future research is lower than the potential value of undertaking the research (in terms of level of uncertainty around the decision to adopt or not VR for TBI) and, thus, proceeding to a definitive trial might be of value.

Aims and objectives of the process evaluation

Process evaluations are recommended alongside trials of complex interventions to help understand and interpret outcomes and inform future implementation. 128 We conducted a parallel process evaluation, nested within the feasibility trial to (1) identify VR outcomes important to TBI survivors, (2) assess fidelity of implementation (e.g. enablers of, and barriers to, intervention deployment), (3) understand UC and (4) explore factors affecting the running of a definitive trial.

The process evaluation was to address the following questions:

1. Was the training seen as acceptable and useful by therapists who received it?

2. What changes are needed for a future trial?

3. Did therapists deliver the ESTVR intervention as intended?

4. What, and how much, was delivered (when, where and how often)?

5. What factors affected intervention deployment in each group?

6. Was the ESTVR intervention perceived as useful and acceptable by those (patients and employers) who received it and was UC considered acceptable by control participants?

7. To what extent was ESTVR already being delivered in UC?

8. What additional resources (NHS/social care/other) were used by intervention and control group participants?

9. What factors will influence the use of ESTVR in the context of usual NHS rehabilitation?

10. What factors will affect running a definitive trial?

11. What were the practical clinical issues for the screening, recruitment and consent of participants?

12. What were the practical difficulties, comprehensibility and emotional load required to complete outcome measures?

To inform the choice of primary outcome for a definitive trial an embedded study set out to identify:

1. What are the most important primary outcomes of VR for people with TBI from the perspective of newly injured and long-term survivors of TBI, service providers and employers?

Methodology

The extent to which ESTVR occurred in usual care (the routine rehabilitation of people with traumatic brain injury)

To describe the extent to which ESTVR occurred in UC, we mapped local service provision before and after the trial intervention period using a self-administered postal questionnaire (see Report Supplementary Material 15) previously developed for an England-wide survey67 of VR for people with long-term neurological conditions (LTNCs) and adapted for TBI. The questionnaire was based on the best practice guidelines for VR for people with LTNCs. 63 The questionnaire included 44 items in two parts (A and B):

• Part A explored funding sources, referral numbers and waiting times, black and minority ethic groups served, time established, vocational needs addressed and interventions provided, cross-partnership working, training, professionals involved in delivery, timing and nature of intervention delivered, audit, evaluation and factors influencing service development. Both general and specialist VR services for people with TBI completed this section.

• Part B explored the components of the specialist VR in more depth, including assessment and intervention, relationships with other agencies and people involved in service delivery.

Most questions were closed or semi-closed. However, questions probing perceptions about resources and barriers to, and enablers of, service development required free-text responses and were analysed separately. Details of known VR services for people with TBI in the FRESH catchment (within 1 hour’s drive from each recruitment centre) were requested.

All respondents completed part A and only those identifying themselves as a ‘specialist VR TBI service’ in accordance to fit with a working definition completed part B:

A specialist VR service for people following a traumatic brain injury is characterised by, a multi-disciplinary team with expertise in TBI and expertise in VR who through shared education and learning and by working with employees and employers in the work-place can meet the needs of the majority of their patients/clients.

Reproduced with permission from Playford et al. 67

Reproduced with permission from Playford et al. 67

We used data from an earlier mapping study67 to identify VR providers in health services in each recruitment centre. We also used the knowledge of PIs and local therapists to identify UC providers. Questionnaires were sent in three tranches to services most likely to be involved in health-based TBI VR service delivery within 1 hour’s drive of each FRESH recruitment site. The three tranches were:

Tranche 1 – FRESH-trained therapists and PIs in FRESH sites.

Tranche 2 – services identified by FRESH therapists and PIs.

Tranche 3 – additional services in FRESH catchment identified by respondents to tranche 2.

To optimise response, services with no named recipient were contacted by telephone to identify a recipient. In services for which the respondents’ contact details were already known, questionnaires were sent by e-mail. A description of the mailing strategy is given below and illustrated in Figure 8:

1. questionnaire sent by e-mail and hard copy posted with personalised covering letter and stamped-addressed envelope (see Report Supplementary Material 15)

2. for questionnaires not returned within 2 weeks, reminder e-mail and questionnaire sent

3. subsequent reminder sent 2 weeks after the first

4. personalised e-mail thanking respondents on receipt of completed questionnaire

5. respondents asked to identify other local service(s) delivering VR for people with TBI. Questionnaires sent to services not previously identified, followed by steps a–d.

FIGURE 8.

Vocational rehabilitation service mapping. A4E, Action for Employment; DP, Diane Playford.

The e-mail address, covering letters and reminders were drafted in accordance with Dillman. 129 In London, additional services were identified in partnership with co-applicant Dr Diane Playford, who was conducting an online survey of VR services for people with all LTNCs in London. Questionnaires from respondents to that survey within the FRESH site 2 study catchment and who had identified themselves as providing VR services for people with sudden-onset neurological conditions (including TBI and stroke) were forwarded to the project team and data were extracted on those provided TBI services.

The project team identified services providing VR for people with TBI and, when doubt existed, contacted respondents for clarification. Only those providing VR services for people with TBI were included in this mapping survey. Identified services and respondents were asked to complete the questionnaire at study outset and at the end.

Data from questionnaires were entered into Microsoft Excel and descriptive analysis undertaken to identify service delivery patterns, service features and types of interventions offered.

The questionnaire enabled us to identify and describe components of VR service delivery in UC, differences between UC and ESTVR in each centre at study outset, and to describe changes in UC during the study’s course.

Results

How did FRESH therapists spend their time?

Overall, 60% per cent of therapists’ time was spent in patient-facing and patient-related activity, 16% on administration and 24% on travel (Figure 9).

FIGURE 9.

Overall time spent by all the therapists per participant.

The proportion of time spent in patient-facing and patient-related activity was similar for each therapist (therapist A = 65%, therapist B = 58%, therapist C = 54% and therapist D = 59%). There was a difference in the amount of time therapists spent travelling. This ranged from 14% to 34%. London-based therapists spent almost 15% more time in travel. Injury severity did not appear to influence intervention time. The combined amount of face-to-face and non-face-to-face time was similar, ranging from 60% to 64%.

What intervention was delivered? (content)

Therapists’ activity was measured against the core components ESTVR identified in the logic model. One ’core component’ involved working with employers in supporting the TBI participants’ RTW. However, FRESH therapists had direct contact with only 14 (37%) of participants’ employers, non-direct contact (when the participant acts as a conduit of information between the therapist and employer) with 20 (53%) employers and gave ‘advice only’ (when the patient is advised on how to broker their own RTW with an employer) to four (10%) participants. The extent to which the therapists engaged directly with employers differed between therapists.

The main focus of the intervention received by trial participants was help in preparing for a RTW and assisting in the RTW (Figure 10). Very little therapy time was spent on personal or domestic ADL or non-work-related physical activities. Time spent dealing with current issues, goal setting and providing psychological support varied between therapists. However, this may be related to differences in the way therapists classified their activity.

FIGURE 10.

Components of occupational therapy face-to-face sessions.

Overall, therapists spent most of their non-direct contact time dealing with participants, families and employers, followed by occupational health and human resources (Figure 11). They also liaised with other health professionals, specifically other OTs and psychologists. Nobody reported having contact with DEAs or other DWP services. There was little liaison with solicitors or other private providers. Other liaison included alcohol services and the school of a parent with a TBI.

FIGURE 11.

Non face-to-face time. Other health professionals refers to CM, physiotherapist, psychologist and cognitive–behavioural therapist. HR, human resources; OH, occupational health.

Did the intervention meet patients’ and employers’ expectations?

Acceptability was measured by interviewing 30 trial participants, six employers and the four FRESH therapists to seek their views on the interventions (ESTVR and UC) and, in the case of patients and staff only, their views on recruitment and the acceptability of randomisation. We sought to understand what service interventions were most valued in practice by an employee with TBI and which by an employer.

What were the practical difficulties, comprehensibility and emotional load required to complete outcome measures?

None of the participants interviewed indicated that randomisation was unacceptable or declined participation because they wanted to ensure randomisation to the intervention group:

Yes, she has, yeah. Before we got into the HR element of coming back to work and seeing the [work] doctor – she’s been present at all those meetings – we met before and we discussed about what’s actually possible and how to approach the meetings and what to put on the table, basically, and say this is what I can do. Yeah, she’s been there and she’s supported me and, like I said, just coming along to the meetings and things.

3002

The main problems reported by participants regarding the practical difficulties, comprehensibility and emotional load required to complete outcome measures were concerned with participants’ memory problems. Many of the patients asked could not recall receiving or completing questionnaires, or said that they forgot to complete it because they were too busy. Two reported needing help to interpret questions or complete questionnaires.

In several cases, responses were complicated by the fact that the brain injury was only one of a number of serious injuries incurred at the same time and participants were not sure how to respond to the questions when factors other than the brain injury limited their abilities.

Research assistants who completed baseline measures with participants found questions to be repetitive and reported that participants provided different responses to similar questions.

What factors will affect the running of the definitive trial?

What factors will affect the use of ESTVR in the context of usual NHS rehabilitation?

Interviews were held with 15 NHS staff with a role in delivering, managing or commissioning TBI rehabilitation (five in each site).

Macro-level societal gaps were identified in rehabilitation pathways for people with TBI and this was echoed by the UC participants interviewed.

Community neurological rehabilitation experience was seen as essential for therapists delivering ESTVR; even FRESH OTs with community experience initially found it challenging to work outside their normal geographical boundaries.

A communication gap between occupational therapy services and commissioners poses a threat to the future delivery of VR for people with TBI.

Occupational therapists and their managers felt that the intervention was worthwhile but believed that commissioners needed to be convinced. They felt that they had little influence over commissioning. Commissioners agreed that VR was likely to be beneficial, but were unlikely to commission services that were both specialised and highly specific. Some commissioners believed VR was already being provided under general rehabilitation service level agreements. However, NHS therapists were unclear whether or not they were permitted to deliver VR.

To what extent was ESTVR already being delivered in usual care?

What are the most important primary outcomes of vocational rehabilitation?

Trial participants with a new TBI (n = 78) were interviewed at approximately 3 weeks post injury. Responses were available for 72 people. In total, 48 long-term survivors of TBI volunteered, 23 were excluded because they did not have a TBI (n = 16), lived too far away (n = 4) or said that they felt unable to cope in group situations (n = 3). A total of 25 people with TBI were invited and 14 responded, but one person did not turn up. Therefore, 13 people with long-term TBI took part. The severity of their injuries was unknown. Two people were accompanied to the group as they could not travel independently (Table 29). Eighteen employers were identified and invited, four did not respond and two were excluded as they had no experience of TBI. Therefore, 12 employers participated. Participants in each group came from a wide geographical area and represented a variety of post-TBI experience.

People with a new diagnosis of TBI prioritised RTW and symptom management. People with long-term TBI rated self-confidence and ‘assessment of brain function’ as their top two most important outcomes. People with long-term TBI differentiated between self-confidence and self-esteem, defining self-confidence as having task-specific confidence and self-esteem as how they felt about themselves more generally (Table 30).

Service providers prioritised quality of work–life balance and insight into the impact of the injury on the person with TBI. For employers, the most important outcomes were communication between the employer, employee and the therapist, and understanding the impact of the injury on the person with TBI (Table 31).

Summary

In people with TBI, outcome priorities differed according to time since injury. Newly injured people said that a RTW and symptom management were the most important outcomes. Employers prioritised communication between employer, employee and NHS VR services, and understanding the TBI impact on workability; service providers said QoL and insight were more important than work outcomes. People late after injury, nine of whom were employed, prioritised self-confidence and having a comprehensive assessment of their brain function to understand the impact of TBI on all daily life activities, not just work.

The long-term survivors did not prioritise returning to work. This may be because early after injury, and particularly while still in hospital, participants have limited knowledge of the consequences of their injury or may have reduced insight into its effects due to either impaired awareness or lack of opportunity to test out their abilities. They may not initially recognise the full impact of their injury on their ability to work or acknowledge any potential long-term consequences. 135 It is only over time that people realise the full impact. 136 Moreover, for participants late after injury who are employed, a RTW may no longer be a goal. Finding ways of coping with the effects of their TBI across a broad range of daily life activities and having work–life balance was seen as more important than a RTW itself. This could be because they are no longer faced with financial concerns and fears for the future that motivate the newly injured person to return ‘to normal’ and retain financial independence.

For all TBI survivors, the second most important outcome was the need for all relevant parties to understand the effects of TBI on the individual. Newly injured participants called this ‘knowing what to expect’ and those with long-term TBI referred to ‘education about TBI’ and understanding their ‘brain function’. Therapists referred to the need for ‘self-awareness’ and ‘insight’ into a person’s ability, while employers said that they wanted to understand the TBI impact on the employees’ work ability. These findings are similar to others that have highlighted that understanding TBI and its impact on the individual is an important outcome of rehabilitation. 135,137,138 All stakeholders felt that, without this understanding, it would be difficult to facilitate a successful RTW or any other activity. Therefore, some means of measuring a person’s understanding of the TBI impact on their ability to work may be an important measure of TBI VR.

All except newly injured participants differentiated between understanding their brain injury and coping with it. Long-term TBI survivors made specific suggestions for coping outcomes including measures of confidence, self-esteem and the ability to manage fatigue.

The employers we interviewed ranked communication as their primary outcome. Those with some experience of employing a person with TBI highlighted understanding the effects of the brain injury and doing the right thing for their employee. Although they felt that RTW was important, they also highlighted the need for good QoL, irrespective of whether or not this involved work.

Service providers rated the opportunity to explore a person’s own goals and achieve a good work–life balance. Interestingly, service providers struggled to identify discrete ‘outcomes’ of VR. They emphasised the importance of the rehabilitation process and the need for the person with TBI to understand how their brain injury had affected them. Inherent in their suggestions were that measuring aspects of process was more important than the outcome, and that having better measures of the intervention process was the only way to link the intervention with its outcomes.

Both service providers’ and employers’ responses were more aligned with people living long term with TBI than with the more recently injured. This may reflect their experiences of working with people with more severe TBI problems later after injury and over time. Both service providers and employers acknowledged that returning to employment following TBI was difficult and not always possible.

Key findings

The FRESH study demonstrated feasibility across the majority of its objectives and, when these were not met, strategies for addressing these in a definitive trial were identified. However, two main challenges remain, namely how to:

1. recruit those people with TBI most likely to benefit from the intervention

2. reduce attrition, particularly in the UC group.

Recruitment

At 12 months post randomisation, 91% of UC respondents reported that they had returned to some form of work, suggesting that their problems did not affect their ability to return to work within the first year. However, in contrast, qualitative data indicated that most of those treated in the intervention arm, and many of the UC participants interviewed, had considerable problems that had an impact on their ability to work. Those receiving ESTVR greatly valued this intervention.

This dichotomy may have been influenced by two factors, which will impact any definitive trial:

1. problems with recruitment, resulting in a sample with a disproportionately large number of participants with mild TBI

2. non-response at 12 months observed to be higher in the UC group than the intervention group, impacting on the potential validity of RTW data between the ESTVR and UC arms.

Recruitment of people with moderate and/or severe TBIs was affected by the establishment of ‘hub and spoke’ MTCs when the study was funded. New care pathways for ‘major trauma’ meant that people with moderate or severe injuries requiring ongoing rehabilitation were rapidly repatriated to designated rehabilitation units or local referring hospitals before they could be recruited, or lived further away and, therefore, no longer met the inclusion criteria. Any future trial would need to include resources necessary to identify, recruit and treat repatriated patients.

Recruitment was also affected by the study design, which assumed that patients could be recruited for VR early after TBI. However, persuading people with TBI, still in hospital, that they might later encounter difficulties in the workplace was problematic. Of those who declined and offered a reason, 34 (45%) said that they could not think about work at this time, did not think they needed help or felt that ESTVR would not be beneficial. Perhaps offering a more generic form of rehabilitation might have had greater appeal. Alternative recruitment mechanisms including timing of recruitment need to be explored in future studies. For example, offering all potential participants a set follow-up appointment post discharge (e.g. 2–4 weeks) to assess progress may have been more appropriate and have facilitated recruitment.

Recruitment was further compromised by the lack of a clear definition of TBI. Not everyone who sustains a head injury is scanned for brain injury and not all brain injuries are detectable on a scan. For this reason, it was not a requirement of FRESH that TBI was confirmed by CT and, instead, diagnosis relied on local clinical procedures. This lack of a clear definition may have affected eligibility and inflated the proportion screened. In one site, there was no designated trauma ward and, therefore, no simple mechanism for identifying potential participants (TARN registers are often retrospectively completed and capture only patients admitted for ≥ 72 hours). All patients admitted to A&E with a suspected ‘head injury’ were screened to identify those with TBI. As all these patients were entered onto the screening log, the proportion recruited in relation to the number screened was low. Screening was further complicated by head injuries missed when patients were being treated for other serious injuries simultaneously.

Problems in defining and recording TBI in medical records are not new36 and difficulties identifying injury severity are well documented in studies of TBI rehabilitation. 2,140 Presence and duration of PTA are often poorly recorded in medical notes and are difficult to assess retrospectively. While this is possible using standardised interview methods, such as the Rivermead PTA protocol, it requires skilled clinicians experienced in TBI assessment. 19 These difficulties are further exacerbated by the non-linear relation between injury severity (measured by the GCS) and functional and vocational outcome. 24,141 Future studies could combine data from case notes with self-report or follow standardised protocols to obtain more reliable estimates of PTA.

Although the recruitment rate was satisfactory, actual recruitment from the total of eligible patients was low; 61% of eligible patients were not recruited, and some are likely to have had significant problems. Even if the target recruitment rate of 34 participants per year (slightly exceeded at one site) could be achieved across a larger number of sites in an effectiveness trial, recruitment overall would be difficult. For example, if RTW were retained as the primary outcome measure and attrition at 12 months reduced to 25%, a total of 1352 participants would need to be recruited to give 90% power to detect a 7.5% increase in the 12-month RTW rate; this would require recruitment from 20 sites for 24 months.

However, as reported by potential participants during recruitment and TBI participants during the study, there may be more important outcomes of VR than RTW itself. This was the perspective of TBI survivors late after injury, who prioritised improved self-efficacy and social interaction among their top six outcomes (along with assessment of brain function, education on TBI impact, improved self-esteem and fatigue management). Therapists also prioritised work–life balance, gaining insight into TBI impact and enabling individuals to explore their own goals above return to paid work. These findings suggest that adjusting to TBI is an important rehabilitation outcome even if the focus of the intervention is work. This is further supported by the finding that, at 12 months, a measure of social participation (the CIQ) and a measure of work self-efficacy (a single question from the WAI) were quite strongly related to who was working or studying at 12 months. Therefore, it is possible that a broader outcome measure, relating to ability to work, confidence in working or a broader ability to participate in work or other activities might be a better and potentially more sensitive outcome. This suggestion is supported by other TBI rehabilitation studies indicating positive effects of TBI rehabilitation on participation outcomes. 36,73,74 However, future studies would need to be designed to isolate the effects of the VR over and above a comparator. 69,142

On this basis, if the CIQ was the primary outcome for a definitive trial then, based on a linear model (adjusted for baseline CIQ), to achieve 90% power with 5% significance to achieve a minimal important difference of 1.5 points (i.e. the difference between the means at 12 months), would require 474 participants (237 per arm). This would equate to randomising 632 participants if 12-month attrition was 25%. This could be achieved by recruiting from 12 sites for a little over 18 months at the rate of 34 participants per year.

Attrition

Poor response to follow-up at 12 months in the UC group and the injury severity imbalance is likely to have inflated the estimate of people with TBI who return to, and remain in, work without support at 12 months post injury. People with milder TBI in the UC group who were not in work at 6 months were also less likely to respond at 12 months than those who were in work at 6 months. The observed figure of 91% of UC respondents in work or study at 12 months is higher than published elsewhere. Systematic reviews and other prospective follow-up studies have indicated this to be in the region of 71–76% in people with milder injuries,28,35 which is closer to the rate we observed at 6 months. As people with more severe injuries are less likely to drop out, providing they can be recruited, there remains potential for research on a group who are more likely to benefit from the intervention and in whom the potential for attrition is reduced.

High attrition rates in studies of TBI populations is a well documented problem. 35,56,143–145 Incentivisation might be key; a recent trial73 (n = 44) of RF, a vocational intervention in the USA, followed and retained 100% of participants (23 with TBI) to 15 months by incentivising them with a US$100 fee on completion.

Given the high RTW rates in control participants, it could be argued that interventions should be offered only to people with TBI who report work problems or require help accessing work because they are unemployed. However, our inclusion criteria limited recruitment to people employed at the time of injury because we tested the feasibility of delivering and measuring a job retention intervention. This was because little, if any, advice or information about work is routinely provided prior to discharge following TBI. In addition, the disparate and limited VR services for people with ABIs in England67,146 means that problems often go undetected or inappropriate advice about work is given by HCPs, resulting in job loss.

The ESTVR model differs from those used for people who have no job to return to or who cannot return to an existing role and who, therefore, require retraining and job brokerage to find suitable work, both of which services are more resource intensive. ESTVR aimed to prevent job loss by offering early advice to participants, family, employers and other HCPs. It maintains that a RTW does not necessarily involve returning to the same job with the same roles and responsibilities or working hours as previously, rather it can involve an adapted form of work with an existing employer. The danger is that without early intervention to prevent job loss, therapists’ time will be consumed in delivering resource-intensive job finding and retraining interventions later to those who have unfortunately lost their job. However, it remains to be understood how best to identify those that will benefit most from this support.

Process evaluation

Participants interviewed included people with TBI of all severities who reported significant problems following TBI and valued the intervention received. About 20% interviewed from each arm, and in each site, reported having received an intervention similar to ESTVR. Therefore, it is possible that such rehabilitation is already being delivered as part of UC. In five cases, another ABI service intervened before ESTVR and so, although it is not known whether or not a work-related intervention was offered, this does suggest that early intervention is happening, albeit to a limited extent, in UC.

Work return following TBI needs to be both safe and sustainable in the longer term. It is plausible that attrition in UC was biased towards those who were no longer working and that long-term work sustainability in people with mild TBI needs to be better understood. 28

We have demonstrated that ESTVR delivery was feasible. OTs familiar with working in the community may be more amenable to training and mentoring. Therefore, upskilling community OTs with specialist VR experience was considered the best way of delivering the intervention. Mentoring was an essential mechanism for supporting intervention fidelity. Similar findings have been reported elsewhere. 147,148 Mentoring also acted as a window on the trial, highlighting local issues with screening and recruitment that enabled timely intervention.

Economic evaluation

The feasibility of identifying and collecting resource use data for use in a health economic evaluation was explored. Although data completeness was good (> 80%) for participants completing the questionnaires, dropout and missing data for those still in the study at 12 months meant that only 37 out of the original 78 participants (47.4%) could be included in the early-stage complete-case, base-case analysis. Therefore, although it is feasible to measure and value health economic data to assess cost-effectiveness of VR following TBI, a subsequent definitive study would not be without potential challenges, particularly around retention.

The feasibility findings also suggest that, in a definitive trial, it would be important to take a broader perspective when measuring and valuing costs, and re-evaluate how best to capture intervention costs distinct from other wider NHS resource use. Despite the challenges in undertaking a definitive study of VR following TBI in those in work or education at the time of injury, the estimates in the value-of-information analysis suggest that the cost of future research is likely to be lower than the potential value of undertaking the research.

Organisational issues

The study was compromised by a number of organisational problems including failure of CLRN nurses to recruit any patients; the variable way in which head injury is managed in different centres, which affected the identification of people with TBI; and difficulties in recruiting or deploying experienced OTs on the trial (despite securing Excess Treatment Costs). There were limited options for backfilling clinical caseloads of staff deployed to the trial, which led to team frustration. Line managers suggested that this could be solved by increasing the number of hours allocated to the FRESH OT role, which would not only be more attractive to OTs but might force senior managers to ensure adequate cover for existing demands. As the total amount of time allocated to FRESH approximated to 1 day per week, some believed that existing OT services were expected to absorb this commitment within existing resources.

Research in the context of other studies

There have been four small TBI-specific randomised controlled pilot or feasibility trials of vocational interventions in TBI. Although all showed positive gains in employment status following TBI rehabilitation, none was more effective than its comparator intervention. 6 Yet, as three37,70,72,149 were US military based and one71 was a civilian study in China comparing a virtual reality training programme with standard VR, they are not directly relevant to this study.

In a recent systematic review of rehabilitation for people with ABIs, Turner-Stokes et al. 150 identified 19 studies involving 3480 participants, comparing multidisciplinary rehabilitation with routinely available local services or lower levels of intervention. Within the subgroup of five studies for mild TBI (1180 patients), they found ‘strong evidence’ that most individuals make a good recovery when appropriate information is provided, without the need for additional specific interventions, whereas those with moderate to severe injury require intervention. They also found some evidence that rehabilitation early after injury results in better outcomes and ‘strong evidence’ that more intensive programmes are associated with earlier functional gains in moderate to severe injury, and ‘moderate evidence’ to suggest that continuing outpatient therapy might sustain this. 150

Five trials35,36,70,78,151 (1180 patients) that were targeted primarily at increasing participation (social integration, RTW, etc.) and reducing post-concussion symptoms included patients in the milder ambulatory category. Four35,36,78,151 compared a programme of treatment as needed (which consisted largely of community-based rehabilitation) with a lesser intervention (Paniak et al. 151: information only; Wade et al. 35,36: standard follow-up, which usually meant that no further input). All were rated as high-quality RCTs. The authors summated that an intervention provided to a totally unselected group of patients with mild TBI was not effective (both treatment and control intervention groups made substantial gains in terms of enhanced participation, including RTW, and it was concluded that ‘strong evidence’ suggests that most patients with mild TBI make a good recovery and those with PTA of < 1 hour, usually not admitted to hospital, need no specific intervention; patients with PTA of > 1 hour do benefit from routine follow-up contact to receive information and advice; and a subgroup of patients with moderate to severe injury benefit from a higher level of intervention but may not present themselves unless routine follow-up is provided).

These findings are supported by a systematic review of mild TBI involving four studies (1309 participants), two from Canada,152,153 one from the USA30 and one from the Netherlands154 that found that most workers with mild TBI returned to work within 3–6 months after injury, 76% (152 out of 201) of the patients reported full RTW at 6 months post injury, suggesting that mild TBI is not a significant risk factor for long-term work disability. 28 However, one study153 reported that only 44% of people with mild TBI had returned to work within 6–9 months of injury.

In a trial36 of early intervention following head injury, in which TBI specialist team rehabilitation was offered following routine review of all patients presenting to A&E with head injury, at 7–10 days, participants (n = 184) who received the specialist input, which was decided on the basis of presenting problems and ranged from signposting to further rehabilitation, had significantly less social disability (p = 0.01) 6 months after injury than controls (n = 130). The findings suggest that early intervention by a TBI specialist service significantly reduced social morbidity at 6 months after head injury. Although the amount of service provided increased with length of PTA, most people who received extensive rehabilitation services had incurred mild to moderate injuries, suggesting that persistent problems may not be severity related. In a similar trial35 of 1156 patients in the preceding year, 71% of 478 participants who were followed up at 6 months (41%) had returned to some form of work or education at 6 months. Although there were no differences in work outcomes between the intervention and control groups (both 71%), a subgroup analysis of 71 patients with PTA lasting > 1 hour who were admitted to hospital found that those who received the specialist rehabilitation were significantly less likely to report problems in work, relationships, and social and leisure activities at 6 months as measured by the Rivermead head injury follow-up questionnaire (Mann–Whitney U-test: z = –2.07; p = 0 04), suggesting a group who might benefit most from the support.

The findings from these two trials35,36 might imply that, in an unselected group of people with TBI, it may be possible to triage people to receive greater or lesser amounts of specialist intervention on the basis of symptom severity and need. Such a triage-based hierarchical model is not dissimilar to that proposed by Eva et al. 155 for supporting cancer survivors in a RTW and to that proposed by Frank and Thurgood. 156

The only VR-specific study with which we can directly compare the results is the single-centre cohort comparison study59,85 on which this multicentre feasibility trial was based. The current intervention provided was similar in dose and intensity but slightly shorter in duration than that in the single-centre study,85 which was pragmatic. However, the two studies did differ, first, in that the single-centre study was not a randomised study and, second, in the fact that the initial study took place before the establishment of MTCs and recruited more participants with moderate or severe TBI (17% moderate, 40% severe).

Strengths and limitations

Research implications

• People with TBI can be recruited and randomised to a feasibility trial of a VR intervention but the timing of recruitment needs further testing. A two-stage recruitment process that enables potential participants to return home and live with their injury before recruitment is recommended.

• The intervention was no more expensive than UC and the estimates found in the value-of-information analysis suggest that the cost of future research is likely to be lower than the potential value of undertaking the research.

• People with TBI can successfully complete outcome assessments but further strategies are needed to improve retention to 12 months.

• Return to work was most strongly related to social participation (community integration) and work self-efficacy. These findings support those of our primary outcome interview study and suggest that an outcome measure relating to a broader ability to participate in work or other activities, such as the Community Integration Questionnaire, might potentially be more sensitive.

• NHS OTs in different geographical locations can be trained to deliver early VR for people with TBI, with mentoring support to ensure intervention fidelity. Training should cover research processes and allow more time for discussing cases and addressing therapists’ concerns about delivering the intervention as part of a trial.

• A future study should include a working definition of TBI and explore optimal methods for identifying and screening potential participants in each site, including access to NHS registers and systems.

• Early engagement with NHS commissioners, therapy services, research networks and local R&D to explore options for deploying NHS therapists to research and network support for recruitment may reduce delays and recruitment problems. Additional training may be needed for research and network staff in recruiting people with TBI to a complex rehabilitation intervention.

Therefore, a multicentre trial of VR is feasible and warranted, but further work is needed to test the suggested strategies for optimising recruitment of people with moderate and severe TBI (recruiting from referring ‘spokes’ for up to 12 weeks post injury), and identifying people with mild TBI with problems that might threaten work stability or affect RTW success (by seeking initial consent to follow-up and screening for problems after discharge from hospital) to ensure that intervention is delivered to those that most need it. In any definitive trial, additional stratification factors for randomisation, including TBI severity and age, should be considered, and subgroup analysis conducted to determine whether intervention effectiveness differs between those with mild and moderate/severe TBI. Although optimising recruitment may have a positive impact on retention and follow-up rates, implementation and evaluation of additional strategies (e.g. incentivisation, mini text surveys, cross-referencing with DWP data) to reduce the amount of missing primary outcome data, particularly in UC, remains important. Given the likelihood that outcome data are not missing at random, SAs should also be performed.

Implications for clinical practice

The FRESH study was a feasibility trial; therefore, no conclusions about the effectiveness of early VR for people with TBI can be drawn.

A mismatch in understanding between NHS therapists and local commissioners about VR delivery may determine whether or not the vocational needs of people with TBI are met.

Research partnerships: service users

Trevor Jones suffered a TBI in 2004. He was a co-applicant who had worked with us on a previous bid and assisted in the development of this proposal. Trevor was a member of the Trial Management Group and an observer on the SSC. He assisted in focus groups with other TBI survivors, contributed to the development and delivery of the VR training, assisted in a recruitment workshop for research staff and commented on drafts of all patient-facing documents. Trevor also helped in analysing anonymised interviews. Trevor talks about his role in a podcast, which can be accessed via www.nottingham.ac.uk/go/fresh (accessed 19 December 2017).

Richard Morris, representing Headway, was a member of the SSC until becoming RA to the study in 2015. Richard supported us in publicising a call for focus group participants via Headway’s Facebook (Facebook, Inc., Menlo Park, CA, USA) page and assisted in qualitative interview data analysis. Both Trevor and Richard have helped prepare papers for publication, outputs for the lay public and this report.

Two additional service users, Johnathan Franchi and Stephanie Parvin assisted in training delivery, and Jonathan, an IT specialist, assisted in recording the training.

Contributions of authors

Kate Radford (Associate Professor in Rehabilitation Research) was chief investigator, responsible for the design and conduct of the study and drafting the report, except Chapter 4.

Chris Sutton (Trial Statistician) managed the input from the Lancashire CTU, led the data collection and analysis and assisted in writing Chapter 3.

Tracey Sach (Professor of Health Economics) led the economic evaluation, wrote Chapter 4 and was a member of the TSC.

Jain Holmes (RA) assisted in developing and delivering the training package, mentoring the therapists and analysing the process evaluation data. She contributed to drafting Chapter 5.

Caroline Watkins (Lancashire CTU Lead) led the input from the Lancashire CTU, chaired the operational group and was a member of the TMG. She commented on drafts of the report.

Denise Forshaw (Senior Trial Manager) was responsible for trial management and contributed to drafts of Chapter 3.

Trevor Jones (PPI Lead) assisted in bid development, supported data analysis and wrote the Plain English summary.

Karen Hoffman (PI) assisted in identifying and recruiting the trial therapists, assisted in study setup and recruitment training and was a member of the TMG.

Rory O’Connor (PI) assisted in the study setup, the choice of outcome measures, supervised the RA in face-to-face follow-up in site 3, was a member of the TMG and wrote the Abstract.

Ruth Tyerman (VR expert trainer and mentor) assisted in developing the training manual, trained and mentored the fresh OTs and contributed to drafts of Chapter 5.

Jose Antonio Merchán-Baeza (RA) analysed the content and fidelity data and contributed to drafts of Chapter 5.

Richard Morris (RA) analysed the qualitative data, assisted in conducting interviews, and proofread, compiled and formatted the report.

Emma McManus (Health Economics RA) conducted the economic analysis evaluation and drafted Chapter 4.

Avril Drummond contributed to the TMG and assisted in proofreading the report.

Marion Walker was a member of the SSC and assisted in writing the executive summary.

Lelia Duley advised on study setup, trial management and contributed to the TMG.

David Shakespeare (PI) assisted in the study setup and recruitment.

Alison Hammond contributed to the project design, advised on the report structure and assisted in revisions.

Julie Phillips (Research OT) assisted in developing and delivering the training package, mentoring therapists, interviewing participants and analysing the content of intervention and process evaluation data. She contributed to writing the report.

Data sharing statement

All available data from this report can be obtained by contacting the corresponding author. Please e-mail Kate.Radford@nottingham.ac.uk.

Patient data

This work uses data provided by patients and collected by the NHS as part of their care and support. Using patient data is vital to improve health and care for everyone. There is huge potential to make better use of information from people’s patient records, to understand more about disease, develop new treatments, monitor safety, and plan NHS services. Patient data should be kept safe and secure, to protect everyone's privacy, and it’s important that there are safeguards to make sure that it is stored and used responsibly. Everyone should be able to find out about how patient data are used. #datasaveslives You can find out more about the background to this citation here: https://understandingpatientdata.org.uk/data-citation.

Disclaimers

This report presents independent research funded by the National Institute for Health Research (NIHR). The views and opinions expressed by authors in this publication are those of the authors and do not necessarily reflect those of the NHS, the NIHR, NETSCC, the HTA programme or the Department of Health and Social Care. If there are verbatim quotations included in this publication the views and opinions expressed by the interviewees are those of the interviewees and do not necessarily reflect those of the authors, those of the NHS, the NIHR, NETSCC, the HTA programme or the Department of Health and Social Care.

Purpose of this document

This document aims to provide a non-specialist summary of the intervention to be evaluated, providing core information on when, where, how often and by whom the intervention is delivered to those participants randomised to this arm of the trial. It also summarises the ESTVR process and core activities of the intervention, emphasising ‘minimum standards’.

Aims of the intervention

ESTVR aims to prevent job loss in people who were employed prior to their TBI by adopting a case co-ordination model that involves identifying employed people within 8 weeks of injury, assessing the TBI on the person and its impact on work activities, roles and responsibilities and finding acceptable ways of overcoming problems. This includes the use of strategies to cope with TBI-related problems (e.g. fatigue management); liaison with employers and other statutory and voluntary service providers involved in the person’s care including health and social care, employment-related and voluntary services (e.g. Headway) planning; preparing for, and negotiating, a phased RTW and supporting adjustment to disability over time; and by adapting the work environment by making recommendations to modify or to overcome problems (e.g. physical adaptations, additional breaks, changes to working hours, roles and responsibilities and supernumerary support). Family members and employers receive support to promote their understanding of the TBI impact on the person and their work ability.

When, where and how often

• Intervention starts about 5 weeks after admission to hospital.

• It lasts a maximum of 52 weeks with one or two contacts per month, but a variable number of contacts dependent on individual participant need.

• Early sessions take place in inpatient facilities, often a specialist trauma or rehabilitation unit when possible and include family and carers when possible.

• Many people will be discharged from inpatient care after the first few days or weeks when the intervention will continue in the community, including the patient’s home or workplace or another mutually agreed venue.

By whom

The intervention is designed, implemented and monitored by qualified OTs registered with the Health Professionals Council and (ideally) employed by NHS trusts. Participating OTs will be trained in the intervention. OTs deliver all of the face-to-face contacts with patients.

Content of the intervention

The intervention is multifaceted and must be tailored to individual needs and abilities.

However, the ESTVR process involves the following core activities.