Fracture in the Elderly Multidisciplinary Rehabilitation (FEMuR): study protocol for a phase II randomised feasibility study of a multidisciplinary rehabilitation package following hip fracture [ISRCTN22464643].
BACKGROUND
Proximal femoral fracture is a common, major health problem in old age resulting in loss of functional independence and a high-cost burden on society, with estimated health and social care costs of £2.3 billion per year in the UK. Rehabilitation has the potential to maximise functional recovery and maintain independent living, but evidence of effectiveness is lacking. Usual rehabilitation care is delivered by a multi-disciplinary team in the hospital and in the community. An 'enhanced rehabilitation' intervention has been developed consisting of a workbook, goal-setting diary and extra therapy sessions, designed to improve self-efficacy and increase the amount and quality of the practice of physical exercise and activities of daily living.


METHODS/DESIGN
This paper describes the design of a phase II study comprising an anonymous cohort of all proximal femoral fracture patients admitted to the three acute hospitals in Betsi Cadwaladr University Health Board over a 6-month period with a randomised feasibility study comparing the enhanced rehabilitation intervention with usual care. These will assess the feasibility of a future definitive randomised controlled trial and concurrent economic evaluation in terms of recruitment, retention, outcome measure completion, compliance with the intervention and fidelity of delivery, health service use data, willingness to be randomised and effect size for a future sample size calculation. Focus groups will provide qualitative data to contribute to the assessment of the acceptability of the intervention amongst patients, carers and rehabilitation professionals and the feasibility of delivering the planned intervention. The primary outcome measure is function assessed by the Barthel Index. Secondary outcomes measure the ability to perform activities of daily living, anxiety and depression, potential mediators of outcomes such as hip pain, self-efficacy and fear of falling, health utility, health service use, objectively assessed physical function and adverse events. Participants' preference for rehabilitation services will be assessed in a discrete choice experiment.


DISCUSSION
Phase II studies are an opportunity to not only assess the feasibility of trial methods but also to compare different methods of outcome measurement and novel methods of obtaining health service use data from routinely collected patient information.


TRIAL REGISTRATION
Current Controlled Trials ISRCTN22464643, UKCRN16677.
['Williams|Nefyn H|NH|', 'Hawkes|Claire|C|', 'Din|Nafees Ud|NU|', 'Roberts|Jessica L|JL|', 'Charles|Joanna M|JM|', 'Morrison|Val L|VL|', 'Hoare|Zoe|Z|', 'Edwards|Rhiannon T|RT|', 'Andrew|Glynne|G|', 'Alexander|Swapna|S|', 'Lemmey|Andrew B|AB|', 'Woods|Bob|B|', 'Sackley|Catherine|C|', 'Logan|Pip|P|', 'Hunnisett|David|D|', 'Mawdesley|Kevin|K|', 'Wilkinson|Clare|C|']
Rehabilitation Feasibility Proximal femoral fracture Self-efficacy Cohort Randomised controlled trial Economic evaluation Focus group Acceptability Discrete choice experiment