Journal Article

Protocol for a definitive randomised controlled trial and economic evaluation of a community-based rehabilitation programme following hip fracture: fracture in the elderly multidisciplinary rehabilitation—phase III (FEMuR III)

Dodd, Susanna, Busse, Monica, Smith, Toby O, Hardwick, Ben, Lewis, Ruth, Clayton, Dannii, Masterson-Algar, Patricia, Sackley, Catherine, Edwards, Rhiannon Tudor, Charles, Joanna Mary, Lemmey, Andrew, Howard, Lola, Dobson, Susan, Logan, Phillipa, Dorkenoo, Shanaz, Hennessy, Sophie, Soady, Claire, Williams, Nefyn, Morrison, Val, Ralph, Penelope

2020

Overview

IntroductionProximal femoral (hip) fracture is common, serious and costly. Rehabilitation may improve functional recovery but evidence of effectiveness and cost-effectiveness are lacking. An enhanced rehabilitation intervention was previously developed and a feasibility study tested the methods used for this randomised controlled trial (RCT). The objectives are to compare the effectiveness and cost-effectiveness of the enhanced rehabilitation programme following surgical repair of proximal femoral fracture in older people compared with usual care.Methods and analysisProtocol for phase III, parallel-group, two-armed, superiority, pragmatic RCT with 1:1 allocation ratio; allocation sequence by minimisation programme with a built-in random element; secure web-based allocation concealment. The two treatments will be usual care (control) and usual care plus an enhanced rehabilitation programme (intervention). The enhanced rehabilitation will consist of a patient-held information workbook, goal setting diary and up to six additional therapy sessions. Outcome assessment and statistical analysis will be performed blind; patient and carer participants will be unblinded. Outcomes will be measured at baseline, 17 and 52 weeks’ follow-up. Primary outcome at 52 weeks will be the Nottingham Extended Activities of Daily Living scale. Secondary outcomes will measure anxiety and depression, health utility, cognitive status, hip pain intensity, falls self-efficacy, fear of falling, grip strength and physical function. Carer strain, anxiety and depression will be measured in carers. All safety events will be recorded, and serious adverse events will be assessed to determine whether they are related to the intervention and expected. Concurrent economic evaluation will be a cost-utility analysis from a health service and personal social care perspective. An embedded process evaluation will determine the mechanisms and processes that explain the implementation and impacts of the enhanced rehabilitation programme.Ethics and disseminationNational Health Service research ethics approval reference 18/NE/0300. Results will be disseminated by peer-reviewed publication.Trial registration numberISRCTN28376407; Pre-results registered on 23 November 2018.

• Publisher: British Medical Journal Publishing Group,BMJ Publishing Group LTD,BMJ Publishing Group
• Subject: Accidental Falls / Activities of Daily Living / Aged / Aged, 80 and over / Anxiety / Caregivers / clinical trials / Cost analysis / Cost-Benefit Analysis / Dementia / Equivalence Trials as Topic / Feasibility studies / Femur / Fractures / Goal setting / health economics / Health services / hip / Hip Fractures - surgery / Hospitals / Humans / Intervention / Mortality / Older people / Patients / Pragmatic Clinical Trials as Topic / Qualitative research / Randomized Controlled Trials as Topic / Rehabilitation / Rehabilitation Medicine