Fracture in the Elderly Multidisciplinary Rehabilitation (FEMuR): study protocol for a phase II randomised feasibility study of a multidisciplinary rehabilitation package following hip fracture

Williams, Nefyn H.; Roberts, Jessica L.; Ud Din, Nafees; Totton, Nicola; Charles, Joanna M.; Hawkes, Claire A.; Morrison, Val; Zoe, Hoare; Williams, Michelle; Pritchard, Aaron W.; Alexander, Swapna; Lemmey, Andrew; Woods, Robert T.; Sackley, Catherine Mary; Logan, Phillipa A.; Edwards, Rhiannon T.; Wilkinson, Clare

Abstract

Objective: To conduct a rigorous feasibility study for a future definitive parallel-group randomised controlled trial (RCT) and economic evaluation of an enhanced rehabilitation package for hip fracture.

Setting: Recruitment from 3 acute hospitals in North Wales. Intervention delivery in the community.

Participants: Older adults (aged ≥65) who received surgical treatment for hip fracture, lived independently prior to fracture, had mental capacity (assessed by clinical team) and received rehabilitation in the North Wales area.

Intervention: Remote randomisation to usual care (control) or usual care+enhanced rehabilitation package (intervention), including six additional home-based physiotherapy sessions delivered by a physiotherapist or technical instructor, novel information workbook and goal-setting diary.

Primary and secondary outcome measures: Primary: Barthel Activities of Daily Living (BADL). Secondary measures included Nottingham Extended Activities of Daily Living scale (NEADL), EQ-5D, ICECAP capability, a suite of self-efficacy, psychosocial and service-use measures and costs. Outcome measures were assessed at baseline and 3-month follow-up by blinded researchers.

Results: 62 participants were recruited, 61 randomised (control 32; intervention 29) and 49 (79%) completed 3-month follow-up. Minimal differences occurred between the 2 groups for most outcomes, including BADL (adjusted mean difference 0.5). The intervention group showed a medium-sized improvement in the NEADL relative to the control group, with an adjusted mean difference between groups of 3.0 (Cohen's d 0.63), and a trend for greater improvement in self-efficacy and mental health, but with small effect sizes. The mean cost of delivering the intervention was £231 per patient. There was a small relative improvement in quality-adjusted life year in the intervention group. No serious adverse events relating to the intervention were reported.

Conclusions: The trial methods were feasible in terms of eligibility, recruitment and retention. The effectiveness and cost-effectiveness of the rehabilitation package should be tested in a phase III RCT.

Citation

Williams, N. H., Roberts, J. L., Ud Din, N., Totton, N., Charles, J. M., Hawkes, C. A., …Wilkinson, C. (2016). Fracture in the Elderly Multidisciplinary Rehabilitation (FEMuR): study protocol for a phase II randomised feasibility study of a multidisciplinary rehabilitation package following hip fracture. BMJ Open, 6(10), 1-13. https://doi.org/10.1136/bmjopen-2016-012422

• Journal Article Type: Article
• Acceptance Date: Aug 25, 2016
• Online Publication Date: Oct 5, 2016
• Publication Date: Oct 1, 2016
• Deposit Date: Feb 6, 2017
• Publicly Available Date: Feb 6, 2017
• Journal: BMJ Open
• Electronic ISSN: 2044-6055
• Publisher: BMJ Publishing Group
• Peer Reviewed: Peer Reviewed
• Volume: 6
• Issue: 10
• Article Number: e012422
• Pages: 1-13
• DOI: https://doi.org/10.1136/bmjopen-2016-012422
• Public URL: https://nottingham-repository.worktribe.com/output/808339
• Publisher URL: http://bmjopen.bmj.com/content/6/10/e012422.info