Background: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. Objective: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. Design and methods:Definitive, pragmatic, multisite, parallel-group, two-armed, superiority randomised controlled trial with 1 : 1 allocation ratio. Concurrent economic and process evaluations. Setting:Participant recruitment in 13 hospitals across England and Wales, with the Fracture in the Elderly Multidisciplinary Rehabilitation intervention delivered in the community. Participants: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. Interventions: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. Primary and secondary outcome measures:Primary effectiveness outcome was the Nottingham Extended Activities of Daily Living scale at 12 months. Secondary outcomes included: Hospital Anxiety and Depression Scale, Falls Self-Efficacy - International scale, hip pain intensity, fear of falling, grip strength and Short Physical Performance Battery. Economic outcomes were EuroQol EQ-5D-3L and Client Service Receipt Inventory. Results: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. Limitations: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. Conclusion:The Fracture in the Elderly Multidisciplinary Rehabilitation intervention was not more effective and had higher costs than usual rehabilitation care. Funding:This synopsis presents independent research funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme as award number 16/167/09.
更多
原文链接
分享
引用
