Developing a multidisciplinary rehabilitation package following hip fracture and testing in a randomised feasibility study: Fracture in the Elderly Multidisciplinary Rehabilitation (FEMuR)

Abstract

BackgroundProximal 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.ObjectivesTo 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.DesignPhase 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.SettingRecruitment 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.ParticipantsOlder 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.InterventionsParticipants 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 measuresThe 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.ResultsSixty-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’sd = 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’sd = 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’sd = 0.31) and 1.3 (Cohen’sd = 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.ConclusionsTrial 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 registrationCurrent Controlled Trials ISRCTN22464643.FundingThis project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full inHealth Technology Assessment; Vol. 21, No. 44. See the NIHR Journals Library for further project information.

Development of an evidence-based complex intervention for community rehabilitation of patients with hip fracture using realist review, survey and focus groups

“…Further detail can be found in the final report to the funder. 18 The literature review, survey results and qualitative data were used to develop the following overarching working theory:…”

“…We therefore undertook a realist review of the available evidence for hip fracture rehabilitation to develop theory on the context, mechanism and outcomes of existing rehabilitation programmes, with this forming the basis for the development of our own evidence-based intervention for subsequent testing in a feasibility study. 18 The development of these theory areas was performed in conjunction with a survey of current practice by UK rehabilitation health professionals and focus groups with patients, carers and multidisciplinary rehabilitation team. While the Medical Research Council (MRC) framework for complex interventions provides general guidelines for intervention development and supports the use of theoretical underpinning, 12 detailed guidance on how this framework is practically applied to intervention development is lacking.…”

Postacute Management of Older Adults Suffering an Osteoporotic Hip Fracture: A Consensus Statement From the International Geriatric Fracture Society

“…Most falls occur at home, and safety improvements such as removing clutter, providing enough lighting, and installing grab bars in bathrooms might be needed prior to discharge. 144 It is important to schedule follow-up appointments after discharge with the patient's primary care provider and with the orthopedic surgeon. 145 Home health services should be involved, not only to continue improving mobility 146 but also to assess the status of chronic or newly acquired medical conditions such as heart failure, chronic obstructive pulmonary disease, infections, pressure injuries, and depression.…”

“…Referral to fall prevention programs also should be part of the care plan at the time of discharge as well as providing services necessary after returning home, either temporarily or permanently. 144…”

Mixed methods process evaluation of an enhanced community-based rehabilitation intervention for elderly patients with hip fracture

“…A study funded by the Health Technology Assesment programme 7 completed the first two phases of the MRC framework for complex interventions. 8 The first phase developed an enhanced rehabilitation intervention from the following working theory 9 :…”