Developing a multidisciplinary rehabilitation package following hip fracture and testing in a randomised feasibility study: Fracture in the Elderly Multidisciplinary Rehabilitation (FEMuR)
Background: Proximal femoral fracture is a major health problem in old age, with annual UK health and social care costs of £2.3B. Rehabilitation has the potential to maximise functional recovery and maintain independent living, but evidence of clinical effectiveness and cost-effectiveness is lacking...
| Main Authors: | , , , , , , , , , , , , , , , , , , |
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| Format: | Article |
| Language: | English |
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NIHR Journals Library
2017-08-01
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| Series: | Health Technology Assessment |
| Subjects: | |
| Online Access: | https://doi.org/10.3310/hta21440 |
| _version_ | 1828472650818650112 |
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| author | Nefyn H Williams Jessica L Roberts Nafees Ud Din Joanna M Charles Nicola Totton Michelle Williams Kevin Mawdesley Claire A Hawkes Val Morrison Andrew Lemmey Rhiannon T Edwards Zoe Hoare Aaron W Pritchard Robert T Woods Swapna Alexander Catherine Sackley Pip Logan Clare Wilkinson Jo Rycroft-Malone |
| author_facet | Nefyn H Williams Jessica L Roberts Nafees Ud Din Joanna M Charles Nicola Totton Michelle Williams Kevin Mawdesley Claire A Hawkes Val Morrison Andrew Lemmey Rhiannon T Edwards Zoe Hoare Aaron W Pritchard Robert T Woods Swapna Alexander Catherine Sackley Pip Logan Clare Wilkinson Jo Rycroft-Malone |
| author_sort | Nefyn H Williams |
| collection | DOAJ |
| description | Background: Proximal femoral fracture is a major health problem in old age, with annual UK health and social care costs of £2.3B. Rehabilitation has the potential to maximise functional recovery and maintain independent living, but evidence of clinical effectiveness and cost-effectiveness is lacking. Objectives: To develop an enhanced community-based rehabilitation package following surgical treatment for proximal femoral fracture and to assess acceptability and feasibility for a future definitive randomised controlled trial (RCT) and economic evaluation. Design: Phase I – realist review, survey and focus groups to develop the rehabilitation package. Phase II – parallel-group, randomised (using a dynamic adaptive algorithm) feasibility study with focus groups and an anonymised cohort study. Setting: Recruitment was from orthopaedic wards of three acute hospitals in the Betsi Cadwaladr University Health Board, North Wales. The intervention was delivered in the community following hospital discharge. Participants: Older adults (aged ≥ 65 years) who had received surgical treatment for hip fracture, lived independently prior to fracture, had mental capacity (assessed by the clinical team) and received rehabilitation in the North Wales area. Interventions: Participants received usual care (control) or usual care plus an enhanced rehabilitation package (intervention). Usual care was variable and consisted of multidisciplinary rehabilitation delivered by the acute hospital, community hospital and community services depending on need and availability. The intervention was designed to enhance rehabilitation by improving patients’ self-efficacy and increasing the amount and quality of patients’ practice of physical exercise and activities of daily living. It consisted of a patient-held information workbook, a goal-setting diary and six additional therapy sessions. Main outcome measures: The primary outcome measure was the Barthel Activities of Daily Living (BADL) index. The secondary outcome measures included the Nottingham Extended Activities of Daily Living (NEADL) scale, EuroQol-5 Dimensions, ICEpop CAPability measure for Older people, General Self-Efficacy Scale, Falls Efficacy Scale – International (FES-I), Self-Efficacy for Exercise scale, Hospital Anxiety and Depression Scale (HADS) and service use measures. Outcome measures were assessed at baseline and at 3-month follow-up by blinded researchers. Results: Sixty-two participants were recruited (23% of those who were eligible), 61 were randomised (control, n = 32; intervention, n = 29) and 49 (79%) were followed up at 3 months. Compared with the cohort study, a younger, healthier subpopulation was recruited. There were minimal differences in most outcomes between the two groups, including the BADL index, with an adjusted mean difference of 0.5 (Cohen’s d = 0.29). The intervention group showed a medium-sized improvement on the NEADL scale relative to the control group, with an adjusted mean difference between groups of 3.0 (Cohen’s d = 0.63). There was a trend for greater improvement in FES-I and HADS in the intervention group, but with small effect sizes, with an adjusted mean difference of 4.2 (Cohen’s d = 0.31) and 1.3 (Cohen’s d = 0.20), respectively. The cost of delivering the intervention was £231 per patient. There was a possible small relative increase in quality-adjusted life-years in the intervention group. No serious adverse events relating to the intervention were reported. Conclusions: Trial methods were feasible in terms of eligibility, recruitment and retention, although recruitment was challenging. The NEADL scale was more responsive than the BADL index, suggesting that the intervention could enable participants to regain better levels of independence compared with usual care. This should be tested in a definitive Phase III RCT. There were two main limitations of the study: the feasibility study lacked power to test for differences between the groups and a ceiling effect was observed in the primary measure. Trial registration: Current Controlled Trials ISRCTN22464643. Funding: This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 21, No. 44. See the NIHR Journals Library for further project information. |
| first_indexed | 2024-12-11T05:32:52Z |
| format | Article |
| id | doaj.art-e6ff68ce73aa4f8d80463404571e8f39 |
| institution | Directory Open Access Journal |
| issn | 1366-5278 2046-4924 |
| language | English |
| last_indexed | 2024-12-11T05:32:52Z |
| publishDate | 2017-08-01 |
| publisher | NIHR Journals Library |
| record_format | Article |
| series | Health Technology Assessment |
| spelling | doaj.art-e6ff68ce73aa4f8d80463404571e8f392022-12-22T01:19:23ZengNIHR Journals LibraryHealth Technology Assessment1366-52782046-49242017-08-01214410.3310/hta2144011/33/03Developing a multidisciplinary rehabilitation package following hip fracture and testing in a randomised feasibility study: Fracture in the Elderly Multidisciplinary Rehabilitation (FEMuR)Nefyn H Williams0Jessica L Roberts1Nafees Ud Din2Joanna M Charles3Nicola Totton4Michelle Williams5Kevin Mawdesley6Claire A Hawkes7Val Morrison8Andrew Lemmey9Rhiannon T Edwards10Zoe Hoare11Aaron W Pritchard12Robert T Woods13Swapna Alexander14Catherine Sackley15Pip Logan16Clare Wilkinson17Jo Rycroft-Malone18School of Healthcare Sciences, Bangor University, Bangor, UKSchool of Healthcare Sciences, Bangor University, Bangor, UKSchool of Healthcare Sciences, Bangor University, Bangor, UKSchool of Healthcare Sciences, Bangor University, Bangor, UKSchool of Healthcare Sciences, Bangor University, Bangor, UKSchool of Healthcare Sciences, Bangor University, Bangor, UKSchool of Healthcare Sciences, Bangor University, Bangor, UKWarwick Clinical Trials Unit, University of Warwick, Coventry, UKSchool of Psychology, Bangor University, Bangor, UKSchool of Sports, Health and Exercise Science, Bangor University, Bangor, UKSchool of Healthcare Sciences, Bangor University, Bangor, UKSchool of Healthcare Sciences, Bangor University, Bangor, UKSchool of Healthcare Sciences, Bangor University, Bangor, UKSchool of Healthcare Sciences, Bangor University, Bangor, UKBetsi Cadwaladr University Health Board, St Asaph, UKSchool of Health and Social Care Research, King’s College London, London, UKSchool of Medicine, University of Nottingham, Nottingham, UKSchool of Healthcare Sciences, Bangor University, Bangor, UKSchool of Healthcare Sciences, Bangor University, Bangor, UKBackground: Proximal femoral fracture is a major health problem in old age, with annual UK health and social care costs of £2.3B. Rehabilitation has the potential to maximise functional recovery and maintain independent living, but evidence of clinical effectiveness and cost-effectiveness is lacking. Objectives: To develop an enhanced community-based rehabilitation package following surgical treatment for proximal femoral fracture and to assess acceptability and feasibility for a future definitive randomised controlled trial (RCT) and economic evaluation. Design: Phase I – realist review, survey and focus groups to develop the rehabilitation package. Phase II – parallel-group, randomised (using a dynamic adaptive algorithm) feasibility study with focus groups and an anonymised cohort study. Setting: Recruitment was from orthopaedic wards of three acute hospitals in the Betsi Cadwaladr University Health Board, North Wales. The intervention was delivered in the community following hospital discharge. Participants: Older adults (aged ≥ 65 years) who had received surgical treatment for hip fracture, lived independently prior to fracture, had mental capacity (assessed by the clinical team) and received rehabilitation in the North Wales area. Interventions: Participants received usual care (control) or usual care plus an enhanced rehabilitation package (intervention). Usual care was variable and consisted of multidisciplinary rehabilitation delivered by the acute hospital, community hospital and community services depending on need and availability. The intervention was designed to enhance rehabilitation by improving patients’ self-efficacy and increasing the amount and quality of patients’ practice of physical exercise and activities of daily living. It consisted of a patient-held information workbook, a goal-setting diary and six additional therapy sessions. Main outcome measures: The primary outcome measure was the Barthel Activities of Daily Living (BADL) index. The secondary outcome measures included the Nottingham Extended Activities of Daily Living (NEADL) scale, EuroQol-5 Dimensions, ICEpop CAPability measure for Older people, General Self-Efficacy Scale, Falls Efficacy Scale – International (FES-I), Self-Efficacy for Exercise scale, Hospital Anxiety and Depression Scale (HADS) and service use measures. Outcome measures were assessed at baseline and at 3-month follow-up by blinded researchers. Results: Sixty-two participants were recruited (23% of those who were eligible), 61 were randomised (control, n = 32; intervention, n = 29) and 49 (79%) were followed up at 3 months. Compared with the cohort study, a younger, healthier subpopulation was recruited. There were minimal differences in most outcomes between the two groups, including the BADL index, with an adjusted mean difference of 0.5 (Cohen’s d = 0.29). The intervention group showed a medium-sized improvement on the NEADL scale relative to the control group, with an adjusted mean difference between groups of 3.0 (Cohen’s d = 0.63). There was a trend for greater improvement in FES-I and HADS in the intervention group, but with small effect sizes, with an adjusted mean difference of 4.2 (Cohen’s d = 0.31) and 1.3 (Cohen’s d = 0.20), respectively. The cost of delivering the intervention was £231 per patient. There was a possible small relative increase in quality-adjusted life-years in the intervention group. No serious adverse events relating to the intervention were reported. Conclusions: Trial methods were feasible in terms of eligibility, recruitment and retention, although recruitment was challenging. The NEADL scale was more responsive than the BADL index, suggesting that the intervention could enable participants to regain better levels of independence compared with usual care. This should be tested in a definitive Phase III RCT. There were two main limitations of the study: the feasibility study lacked power to test for differences between the groups and a ceiling effect was observed in the primary measure. Trial registration: Current Controlled Trials ISRCTN22464643. Funding: This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 21, No. 44. See the NIHR Journals Library for further project information.https://doi.org/10.3310/hta21440feasibility studyrealist revieweconomic evaluationproximal femoral fracturerehabilitationcommunityactivities of daily livingself-efficacy |
| spellingShingle | Nefyn H Williams Jessica L Roberts Nafees Ud Din Joanna M Charles Nicola Totton Michelle Williams Kevin Mawdesley Claire A Hawkes Val Morrison Andrew Lemmey Rhiannon T Edwards Zoe Hoare Aaron W Pritchard Robert T Woods Swapna Alexander Catherine Sackley Pip Logan Clare Wilkinson Jo Rycroft-Malone Developing a multidisciplinary rehabilitation package following hip fracture and testing in a randomised feasibility study: Fracture in the Elderly Multidisciplinary Rehabilitation (FEMuR) Health Technology Assessment feasibility study realist review economic evaluation proximal femoral fracture rehabilitation community activities of daily living self-efficacy |
| title | Developing a multidisciplinary rehabilitation package following hip fracture and testing in a randomised feasibility study: Fracture in the Elderly Multidisciplinary Rehabilitation (FEMuR) |
| title_full | Developing a multidisciplinary rehabilitation package following hip fracture and testing in a randomised feasibility study: Fracture in the Elderly Multidisciplinary Rehabilitation (FEMuR) |
| title_fullStr | Developing a multidisciplinary rehabilitation package following hip fracture and testing in a randomised feasibility study: Fracture in the Elderly Multidisciplinary Rehabilitation (FEMuR) |
| title_full_unstemmed | Developing a multidisciplinary rehabilitation package following hip fracture and testing in a randomised feasibility study: Fracture in the Elderly Multidisciplinary Rehabilitation (FEMuR) |
| title_short | Developing a multidisciplinary rehabilitation package following hip fracture and testing in a randomised feasibility study: Fracture in the Elderly Multidisciplinary Rehabilitation (FEMuR) |
| title_sort | developing a multidisciplinary rehabilitation package following hip fracture and testing in a randomised feasibility study fracture in the elderly multidisciplinary rehabilitation femur |
| topic | feasibility study realist review economic evaluation proximal femoral fracture rehabilitation community activities of daily living self-efficacy |
| url | https://doi.org/10.3310/hta21440 |
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