Every year, 70,000 people in the UK break a hip, and the health and social care bill runs to £3 billion. Current guidelines recommend just two hours of rehabilitation per week after surgery, but no one knows if that is enough to get patients back on their feet and home quickly. This trial will test whether giving patients more frequent and longer mobility sessions on the hospital ward increases the number of days they spend alive and at home within the first 30 days after admission. The researchers will recruit 2,310 patients across 22 NHS hospitals, comparing usual care with an enhanced ward-based mobility programme. If the intervention works, it could directly change national rehabilitation guidelines and how the NHS commissions post-surgery care. That would mean fewer patients stuck in hospital beds, lower costs for the health service, and—most importantly—more people recovering in their own homes rather than in a ward.
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Background Each year, there are 70,000 new cases of hip fracture in the UK, with an associated ongoing annual cost of health and social care of £3 billion. National standards recommend two hours of in-patient rehabilitation after surgery per week - we do not know if this is enough. Research Question For patients aged = 60 years, does increasing the frequency and duration of a mobility focussed intervention after hip fracture surgery increase the number of days alive and at home within 30 days of hospital admission compared to usual care? Design Cluster randomised controlled trial (RCT) with process and economic evaluations. PPI The importance of this question was established in a James Lind Alliance priority setting partnership and developed with the UK Musculoskeletal Trauma PPI group. Two PPI co-applicants will be supported by a reference group of 30 PPI members. Cluster Randomisation Clusters (NHS Hospitals) will be allocated in a 1:1 ratio using a computer-generated randomisation sequence. Allocations will be minimised for unit size, NHFD mobility data and NHFD 30-day mortality data. Health Technologies Usual care versus usual care with an additional ward-based mobility focussed intervention. Target Population All people having surgery for a fracture of the hip will be eligible. Those <60 years of age, who have a fracture caused by an area of abnormal bone (e.g. a tumour), have a contraindication to mobilising, were confined to bed prior to injury, or previously randomised will not be eligible. Outcomes The primary outcome is days at home during the first 30 days after hospital admission (DAH30). DAH30 is an integer between 0 and 30 which reflects the total number of days that the participant spends alive and at home. The secondary outcomes are health-related quality of life (EQ-5D-5L), death, mobility on discharge, and place of residence at discharge, 30 and 120 days, complications including falls, health and personal social service resource use and costs, and incremental cost-effectiveness expressed in terms of incremental cost per quality-adjusted life year (QALY) gained. A process evaluation will evaluate the acceptability and fidelity of the intervention and the extent to which the intervention is embedded in usual care to inform its implementation on a wider scale. Sample size We will recruit 2310 participants from 22 clusters. This is based on carrying out simulations, seeking 90% power, 2-sided 5% significance, a minimum clinically important difference of 2 days on the DAH30 and an ICC of 0.025 and average cluster size of 100, and allowing for a small amount of missing data/imbalance in cluster size. Primary Analysis We will use linear regression to compare the mean difference (with 95% confidence interval produced) in the primary outcome (DAH30) between the treatment groups using cluster robust variance estimation. Timelines Recruitment of 8/centre/month across 22 NHS sites. Milestones: 0-9M initial set up; 10-18M site set up; 12-32M recruitment; 12-38M data collection; 39-44M analysis and reporting. Impact and dissemination The results will directly inform future iterations of national guidelines and commissioning to deliver optimum rehabilitation in the acute post-operative period. Results will be presented in high-impact journals, a monograph and at conferences. With our PPI members, we will produce lay summaries, animated results videos and disseminate through patient organisations.
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