A definitive randomised controlled trial (RCT) and economic evaluation of a community-based rehabilitation programme following hip fracture. Fracture in the Elderly Multidisciplinary Rehabilitation - Phase III (FEMuR III)
BackgroundProximal femoral fracture, commonly known as hip fracture, is common, disabling and costly. Rehabilitation has the potential to maximise functional recovery and maintain independent living, but evidence of effectiveness and cost-effectiveness is lacking. So far, we have developed a community-based rehabilitation programme that was designed to enhance usual rehabilitation and have assessed the feasibility for this definitive randomised controlled trial (RCT). ObjectivesWhat is the effectiveness and cost-effectiveness of an enhanced rehabilitation programme following surgical repair of proximal femoral fracture in older people compared with usual care? What are the mechanisms and processes that explain the implementation and impacts of the enhanced rehabilitation programme?
DesignMulti-centre, pragmatic, parallel group, two-armed RCT with 1:1 allocation ratio stratified by gender and site. Blinded outcome assessment and statistical analysis; unblinded patient and carer participants and clinicians. Internal pilot phase, concurrent process and economic evaluations.SettingParticipant recruitment on orthopaedic wards; intervention delivered in the community following hospital discharge. 12 sites in England and Wales.ParticipantsOlder adults (aged ≥60) recovering from surgical treatment following hip fracture, with mental capacity and living independently prior to fracture. InterventionsUsual care versus enhanced rehabilitation (workbook, goal-setting diary, six additional therapy sessions).Outcome measures: Baseline, 4 and 12 months follow-up. Nottingham Extended Activities of Daily Living (NEADL), EuroQol EQ-5D-3L, Hospital Anxiety and Depression Scale (HADS), self-efficacy, hip pain intensity, fear of falling, grip strength, physical performance battery. Carer strain Index and HADS.Sample size446 to detect a difference of 2.4 in NEADL (SD 10), 5% significance, 90% power, 79% retention.Data analysis: Effectiveness analysis will be ANCOVA at 12 months for NEADL, adjusting for baseline score, site and gender. The economic analysis will be a cost-utility analysis with a health service and personal social care perspective. The process evaluation will include qualitative interviews of a purposive sample of patients, carers and therapists. An internal pilot phase will assess recruitment and retention after the first six months.Internal pilotAn internal pilot phase will assess recruitment and retention for the first 6 months in terms of the number of sites open to recruitment, the number of patient participants recruited per open site per month, and the retention rate at the 4 months follow-up assessment.
Trial progress, particularly the site and participant recruitment in the internal pilot.
The enhanced rehabilitation intervention has the potential to influence outcomes for people recovering from hip fracture. The focus in hospital is discharging people home safely; from a primary care perspective, rehabilitation is also about recovering function for everyday independent living. It also has implications for rehabilitation from other serious illnesses, and long-term conditions managed in primary care, which might benefit from a functional assessment, improved self-efficacy, goal setting and self-monitoring.