Authors' objectives: Proximal femoral (hip) fracture is common, serious and costly. An enhanced community rehabilitation intervention (Fracture in the Elderly Multidisciplinary Rehabilitation) was codeveloped with patients, carers and therapists. Trial methods have been tested previously in a feasibility study. To determine the effectiveness and cost-effectiveness of the Fracture in the Elderly Multidisciplinary Rehabilitation intervention compared with usual NHS rehabilitation care. To determine the mechanisms and processes that explain the implementation and impacts of the Fracture in the Elderly Multidisciplinary Rehabilitation intervention. Hip fracture is common, serious and costly. Usual rehabilitation care was enhanced by a workbook, goal-setting diary and six extra therapy sessions delivered in people’s homes to increase their practice of exercises and activities of daily living. This was called the Fracture in the Elderly Multidisciplinary Rehabilitation intervention. The aim of the trial was to test whether it was better than usual care and better value for money.

Authors' results and conclusions: In total, 205 participants were randomised (n = 104 experimental; n = 101 control). Trial processes were adversely affected by the coronavirus disease discovered in 2019 pandemic and the target sample of 446 was not met. By 52 weeks, the intervention group had worse Nottingham Extended Activities of Daily Living scores than the control group (mean difference: −1.9; 95% confidence interval: −3.7 to −0.1), which was not clinically important. Joint modelling analysis testing for difference in longitudinal outcome adjusted for missing values, removed the apparent inferiority of the Fracture in the Elderly Multidisciplinary Rehabilitation intervention with a mean difference of 0.1 (95% confidence interval: −1.1 to 1.3). There was no statistical or clinically significant difference in secondary outcomes between groups. A median of 4.5 extra rehabilitation sessions were delivered to the intervention group, with a median of two sessions delivered in-person. Instrumental variable regression did not find any effect of the amount of rehabilitation on the main outcome. There were 53 unrelated serious adverse events including 11 deaths in the control group: 41 serious adverse events including nine deaths in the intervention group. The mean cost of delivering the Fracture in the Elderly Multidisciplinary Rehabilitation intervention was £444 per participant. The intervention group gained 0.02 (95% confidence interval: −0.036 to 0.076) more quality-adjusted life-years than the control group. This was not clinically or statistically significant. Mean health service use costs were higher in the intervention group. The Fracture in the Elderly Multidisciplinary Rehabilitation intervention was not more effective and had higher costs than usual rehabilitation care. Two hundred and five people agreed to take part. The trial was disrupted by the COVID-19 pandemic. We had to stop recruiting people before the target sample of 446 was met. We could not visit them in their home to give the Fracture in the Elderly Multidisciplinary Rehabilitation intervention, or to fill out questionnaires or test physical function. Because there were fewer people in the trial than planned, and fewer people completing questionnaires, the results were more uncertain. However, the results showed that after 12 months people in the Fracture in the Elderly Multidisciplinary Rehabilitation intervention group did not perform more activities of daily living than the usual care group. Neither was there any difference in their mental health, confidence, fear of falling, hip pain, nor quality of life. When we could measure physical function, this was not better either. The Fracture in the Elderly Multidisciplinary Rehabilitation intervention group had higher costs, which were due to factors unrelated to the intervention. On average, the Fracture in the Elderly Multidisciplinary Rehabilitation intervention group received only 4–5 extra therapy sessions, only two of which were delivered in-person.

Authors' methods: Definitive, pragmatic, multisite, parallel-group, two-armed, superiority randomised controlled trial with 1 : 1 allocation ratio. Concurrent economic and process evaluations. Participant recruitment in 13 hospitals across England and Wales, with the Fracture in the Elderly Multidisciplinary Rehabilitation intervention delivered in the community. Patients aged over 60 years, with mental capacity, recovering from surgical treatment for proximal femoral fracture, and living in their own home prior to fracture. Usual rehabilitation care (control) was compared with usual rehabilitation care plus the Fracture in the Elderly Multidisciplinary Rehabilitation intervention, which comprised a patient-held workbook and goal-setting diary aimed at improving self-efficacy, and six additional therapy sessions delivered in the community (intervention), to increase the practice of exercise and activities of daily living. The trial was severely impacted by coronavirus disease discovered in 2019. Possible reasons for lack of detected effect included limited intervention fidelity (number and remote mode of delivery), lack of usual levels of support from health professionals and families, and change in recovery beliefs and behaviours during the pandemic. We recruited people aged over 60 years, who were recovering from repair of their hip fracture. They were divided by chance into two groups and given usual care or the Fracture in the Elderly Multidisciplinary Rehabilitation intervention. We asked people how well they could perform activities of daily living, whether they were anxious, depressed, confident in their own abilities, frightened of falling and had hip pain. We tested their grip strength, balance, walking speed and ability to stand from sitting.

Project Status: Completed

URL for project: https://www.journalslibrary.nihr.ac.uk/programmes/hta/NIHR135972

Year Published: 2025

URL for published report: https://www.journalslibrary.nihr.ac.uk/hta/RBGD4741

URL for additional information: English

English language abstract: An English language summary is available

Publication Type: Full HTA

Country: England, United Kingdom

DOI: 10.3310/RBGD4741

Organisation Name: NIHR Health Technology Assessment programme

Contact Address: NIHR Journals Library, National Institute for Health and Care Research, Evaluation, Trials and Studies Coordinating Centre, Alpha House, University of Southampton Science Park, Southampton SO16 7NS, UK

Contact Name: journals.library@nihr.ac.uk

Contact Email: journals.library@nihr.ac.uk