Early, specialist vocational rehabilitation to facilitate return to work after traumatic brain injury: the FRESH feasibility RCT
Background Up to 160,000 people incur traumatic brain injury (TBI) each year in the UK. TBI can have profound effects on many areas of human functioning, including participation in work. There is limited evidence of the clinical effectiveness and cost-effectiveness of vocational rehabilitation (V...
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| Format: | Article |
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NIHR Journals Library
2018
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| Online Access: | https://eprints.nottingham.ac.uk/52258/ |
| _version_ | 1848798685093167104 |
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| author | Radford, Kathryn A. Sutton, Chris Sach, Tracey Holmes, Jain Watkins, Caroline L. Forshaw, Denise Jones, Trevor Hoffman, Karen O’Connor, Rory C. Tyerman, Ruth Merchán-Baeza, Jose Antonio Morris, Richard McManus, Emma Drummond, Avril Walker, Marion Duley, Lelia Shakespeare, David Hammond, Alison Phillips, Julie |
| author_facet | Radford, Kathryn A. Sutton, Chris Sach, Tracey Holmes, Jain Watkins, Caroline L. Forshaw, Denise Jones, Trevor Hoffman, Karen O’Connor, Rory C. Tyerman, Ruth Merchán-Baeza, Jose Antonio Morris, Richard McManus, Emma Drummond, Avril Walker, Marion Duley, Lelia Shakespeare, David Hammond, Alison Phillips, Julie |
| author_sort | Radford, Kathryn A. |
| building | Nottingham Research Data Repository |
| collection | Online Access |
| description | Background
Up to 160,000 people incur traumatic brain injury (TBI) each year in the UK. TBI can have profound effects on many areas of human functioning, including participation in work. There is limited evidence of the clinical effectiveness and cost-effectiveness of vocational rehabilitation (VR) after injury to promote early return to work (RTW) following TBI.
Objective
To assess the feasibility of a definitive, multicentre, randomised controlled trial (RCT) of the clinical effectiveness and cost-effectiveness of early, specialist VR plus usual care (UC) compared with UC alone on work retention 12 months post TBI.
Design
A multicentre, feasibility, parallel-group RCT with a feasibility economic evaluation and an embedded mixed-methods process evaluation. Randomisation was by remote computer-generated allocation.
Setting
Three NHS major trauma centres (MTCs) in England.
Participants
Adults with TBI admitted for > 48 hours and working or studying prior to injury.
Interventions
Early specialist TBI VR delivered by occupational therapists (OTs) in the community using a case co-ordination model.
Main outcome measures
Self-reported RTW 12 months post randomisation, mood, functional ability, participation, work self-efficacy, quality of life and work ability. Feasibility outcomes included recruitment and retention rates. Follow-up was by postal questionnaires in two centres and face to face in one centre. Those collecting data were blind to treatment allocation.
Results
Out of 102 target participants, 78 were recruited (39 randomised to each arm), representing 39% of those eligible and 5% of those screened. Approximately 2.2 patients were recruited per site per month. Of those, 56% had mild injuries, 18% had moderate injuries and 26% had severe injuries. A total of 32 out of 45 nominated carers were recruited. A total of 52 out of 78 (67%) TBI participants responded at 12 months (UC, n = 23; intervention, n = 29), completing 90% of the work questions; 21 out of 23 (91%) UC respondents and 20 out of 29 (69%) intervention participants returned to work at 12 months. Two participants disengaged from the intervention. Face-to-face follow-up was no more effective than postal follow-up. RTW was most strongly related to social participation and work self-efficacy. It is feasible to assess the cost-effectiveness of VR. Intervention was delivered as intended and valued by participants. Factors likely to affect a definitive trial include deploying experienced OTs, no clear TBI definition or TBI registers, and repatriation of more severe TBI from MTCs, affecting recruitment of those most likely to benefit/least likely to drop out.
Limitations
Target recruitment was not reached, but mechanisms to achieve this in future studies were identified. Retention was lower than expected, particularly in UC, potentially biasing estimates of the 12-month RTW rate.
Conclusions
This study met most feasibility objectives. The intervention was delivered with high fidelity. When objectives were not met, strategies to ensure feasibility of a full trial were identified. Future work should test two-stage recruitment and include resources to recruit from ‘spokes’. A broader measure covering work ability, self-efficacy and participation may be a more sensitive outcome. |
| first_indexed | 2025-11-14T20:23:42Z |
| format | Article |
| id | nottingham-52258 |
| institution | University of Nottingham Malaysia Campus |
| institution_category | Local University |
| last_indexed | 2025-11-14T20:23:42Z |
| publishDate | 2018 |
| publisher | NIHR Journals Library |
| recordtype | eprints |
| repository_type | Digital Repository |
| spelling | nottingham-522582020-05-04T19:38:50Z https://eprints.nottingham.ac.uk/52258/ Early, specialist vocational rehabilitation to facilitate return to work after traumatic brain injury: the FRESH feasibility RCT Radford, Kathryn A. Sutton, Chris Sach, Tracey Holmes, Jain Watkins, Caroline L. Forshaw, Denise Jones, Trevor Hoffman, Karen O’Connor, Rory C. Tyerman, Ruth Merchán-Baeza, Jose Antonio Morris, Richard McManus, Emma Drummond, Avril Walker, Marion Duley, Lelia Shakespeare, David Hammond, Alison Phillips, Julie Background Up to 160,000 people incur traumatic brain injury (TBI) each year in the UK. TBI can have profound effects on many areas of human functioning, including participation in work. There is limited evidence of the clinical effectiveness and cost-effectiveness of vocational rehabilitation (VR) after injury to promote early return to work (RTW) following TBI. Objective To assess the feasibility of a definitive, multicentre, randomised controlled trial (RCT) of the clinical effectiveness and cost-effectiveness of early, specialist VR plus usual care (UC) compared with UC alone on work retention 12 months post TBI. Design A multicentre, feasibility, parallel-group RCT with a feasibility economic evaluation and an embedded mixed-methods process evaluation. Randomisation was by remote computer-generated allocation. Setting Three NHS major trauma centres (MTCs) in England. Participants Adults with TBI admitted for > 48 hours and working or studying prior to injury. Interventions Early specialist TBI VR delivered by occupational therapists (OTs) in the community using a case co-ordination model. Main outcome measures Self-reported RTW 12 months post randomisation, mood, functional ability, participation, work self-efficacy, quality of life and work ability. Feasibility outcomes included recruitment and retention rates. Follow-up was by postal questionnaires in two centres and face to face in one centre. Those collecting data were blind to treatment allocation. Results Out of 102 target participants, 78 were recruited (39 randomised to each arm), representing 39% of those eligible and 5% of those screened. Approximately 2.2 patients were recruited per site per month. Of those, 56% had mild injuries, 18% had moderate injuries and 26% had severe injuries. A total of 32 out of 45 nominated carers were recruited. A total of 52 out of 78 (67%) TBI participants responded at 12 months (UC, n = 23; intervention, n = 29), completing 90% of the work questions; 21 out of 23 (91%) UC respondents and 20 out of 29 (69%) intervention participants returned to work at 12 months. Two participants disengaged from the intervention. Face-to-face follow-up was no more effective than postal follow-up. RTW was most strongly related to social participation and work self-efficacy. It is feasible to assess the cost-effectiveness of VR. Intervention was delivered as intended and valued by participants. Factors likely to affect a definitive trial include deploying experienced OTs, no clear TBI definition or TBI registers, and repatriation of more severe TBI from MTCs, affecting recruitment of those most likely to benefit/least likely to drop out. Limitations Target recruitment was not reached, but mechanisms to achieve this in future studies were identified. Retention was lower than expected, particularly in UC, potentially biasing estimates of the 12-month RTW rate. Conclusions This study met most feasibility objectives. The intervention was delivered with high fidelity. When objectives were not met, strategies to ensure feasibility of a full trial were identified. Future work should test two-stage recruitment and include resources to recruit from ‘spokes’. A broader measure covering work ability, self-efficacy and participation may be a more sensitive outcome. NIHR Journals Library 2018-06-01 Article PeerReviewed Radford, Kathryn A., Sutton, Chris, Sach, Tracey, Holmes, Jain, Watkins, Caroline L., Forshaw, Denise, Jones, Trevor, Hoffman, Karen, O’Connor, Rory C., Tyerman, Ruth, Merchán-Baeza, Jose Antonio, Morris, Richard, McManus, Emma, Drummond, Avril, Walker, Marion, Duley, Lelia, Shakespeare, David, Hammond, Alison and Phillips, Julie (2018) Early, specialist vocational rehabilitation to facilitate return to work after traumatic brain injury: the FRESH feasibility RCT. Health Technology Assessment, 22 (33). pp. 1-124. ISSN 1366-5278 https://www.journalslibrary.nihr.ac.uk/hta/hta22330#/abstract doi:10.3310/hta22330 doi:10.3310/hta22330 |
| spellingShingle | Radford, Kathryn A. Sutton, Chris Sach, Tracey Holmes, Jain Watkins, Caroline L. Forshaw, Denise Jones, Trevor Hoffman, Karen O’Connor, Rory C. Tyerman, Ruth Merchán-Baeza, Jose Antonio Morris, Richard McManus, Emma Drummond, Avril Walker, Marion Duley, Lelia Shakespeare, David Hammond, Alison Phillips, Julie Early, specialist vocational rehabilitation to facilitate return to work after traumatic brain injury: the FRESH feasibility RCT |
| title | Early, specialist vocational rehabilitation to facilitate return to work after traumatic brain injury: the FRESH feasibility RCT |
| title_full | Early, specialist vocational rehabilitation to facilitate return to work after traumatic brain injury: the FRESH feasibility RCT |
| title_fullStr | Early, specialist vocational rehabilitation to facilitate return to work after traumatic brain injury: the FRESH feasibility RCT |
| title_full_unstemmed | Early, specialist vocational rehabilitation to facilitate return to work after traumatic brain injury: the FRESH feasibility RCT |
| title_short | Early, specialist vocational rehabilitation to facilitate return to work after traumatic brain injury: the FRESH feasibility RCT |
| title_sort | early, specialist vocational rehabilitation to facilitate return to work after traumatic brain injury: the fresh feasibility rct |
| url | https://eprints.nottingham.ac.uk/52258/ https://eprints.nottingham.ac.uk/52258/ https://eprints.nottingham.ac.uk/52258/ |