Title: A definitive multi-centre randomised controlled trial and economic evaluation of a community-based rehabilitation package following hip fracture. Acronym: Fracture in the Elderly Multidisciplinary Rehabilitation - Phase III (FEMuR III)
Funder: Department of Health and Social Care

Abstract: Study Design Multi-centre, pragmatic, parallel-group, 12-month superiority phase III randomised controlled trial (RCT), 1:1 allocation ratio, stratified by gender and site. The RCT will compare the effectiveness and cost-effectiveness of an enhanced rehabilitation package for older people recovering from surgical repair of proximal hip fracture with usual care. There will be concurrent process and economic evaluations, and an internal pilot phase. Economic evaluation will be a cost-utility analysis from a health service and personal social care perspective. Setting Participants recruited on orthopaedic and rehabilitation wards in 12 acute hospital sites; intervention delivered in the community following hospital discharge. Target population Patients recovering from surgical treatment for proximal femoral fracture and their informal and primary (familial) carers. Inclusion criteria: age 60 years or older; recent proximal hip fracture; surgical repair by replacement arthroplasty or internal fixation; living and receiving rehabilitation from the NHS in the area covered by trial sites. Exclusion criteria: living in residential or nursing homes prior to hip fracture; lacking mental capacity to give informed consent. Health technology being assessed An enhanced community-based rehabilitation intervention designed to improve patients’ self-efficacy with a workbook, and increase the amount and quality of patients’ practice of physical exercise and activities of daily living with a goal-setting diary and six additional therapy sessions. Measurement of costs and outcomes Outcome measurement at baseline, 4 and 12 months follow-up. Primary effectiveness outcome measure is the NEADL scale [1]. Primary economic outcome measure is EuroQol EQ-5D-3L [2]. Secondary outcome measure is HADS [3]. Process measures (potential mediators of outcomes): Visual Analogue Scale (VAS) for hip pain intensity [4], Falls Efficacy Scale – International [5,6], VAS for Fear of Falling [7], Abbreviated Mental Test Score [8]. Objective measurement of physical function will be assessed by the researcher at baseline using the grip strength test [9-11], and at 4 and 12 months using the short physical performance battery of tests in the patient's home [12-13]. Carers will complete the Caregiver Strain Index [14] and HADS [3]. Economic evaluation has a public sector multi-agency perspective. Participant service use obtained from Client Service Receipt Inventory (CSRI) [15]. Quality Adjusted Life Years calculated from EuroQol EQ-5D(3L) [2]. Sample size In order to detect a difference of 2.4 in NEADL [16] using ANCOVA, if the SD is 10, R squared of co-variate 0.52, with 5% significance, 90% power and 79% retention rate, the sample size would need to be 446. Project timetable including recruitment rate Permissions (Month -4 to 1); study set up (Month 1 to 3); site training (Month 4 to 8); internal pilot (Month 9 to 14); main trial recruitment (Month 15 to 22); trial follow-up (Month 20 to 34); outcome measurement (Months 9 to 36); data analysis (Month 20 to 40); writing report (Month 41 to 42). Over 12 months we will screen 4309 patients, and if 1939 (45%) are eligible we plan to recruit recruit 446 (23%). Expertise in team Statistics (SD); health economics (RE), trial management (JR); primary care (NW), physiotherapy (CS, MB, TS); occupational therapy (PL); patient and public involvement (SD); health psychology (VM), exercise physiology (AL).

Lay abstract: Aims of the research To determine whether an enhanced community-based rehabilitation programme, following surgical repair of a broken hip, is more effective than usual rehabilitation care. Also, whether the new programme is better value for money for the health service and for personal social care. Background to the research Broken hips are a major health problem in the frail elderly. They cost the UK economy £2.3 billion per year. Rehabilitation has the potential to improve recovery and preserve independence, but more evidence is needed. We have developed a new rehabilitation programme following the surgical repair of a broken hip. This new programme is designed to enhance usual care by improving patients’ self-belief and by increasing the amount and quality of patients’ practice of physical exercise and activities of daily living. It consists of a workbook and goal-setting diary held by the patient, and six additional therapy sessions available to patients once they have returned home. We have completed a feasibility study which found that the methods for performing the trial worked well. The number of participants in the study was too small to say for certain, but there was a medium sized improvement in the ability to perform the activities of daily living. We are now ready to run a larger trial to see if this is true, and is good value for money. Design and methods used We will test which type of rehabilitation is more effective by dividing patients at random into two groups. One group will receive usual care; the other group will receive the new programme. We will measure outcomes at the beginning and after a period of three and 12 months. The main outcome will be how well patients can perform activities of daily living. A two point improvement in this outcome is like improving from only being able to move around the home to being able to use public transport or get in and out of a car. We will also measure mental functioning, anxiety and depression, hip pain intensity, self-belief, fear of falling, tests of physical functioning, overall health and costs. We will also measure carer strain and anxiety and depresson in carers. Differences between the two groups will be compared using statistical tests. The costs of health and social care services and of the enhanced rehabilitation programme will be measured and combined with the measures of overall health to see whether the new programme is good value for money. Patient and Public Involvement The rehabilitation intervention was developed in a previous study funded by the HTA using focus groups of hip fracture patients and their carers. There was also active patient and public involvement (PPI) in study design and conduct and representation on the study steering committee. We have recruited two PPI representatives for this proposal, one of whom is a co-applicant, using the services of the Health and Care Research Wales Cynnwys Pobl/Involving People organisation. Dissemination Results from the study will be presented at scientific meetings where interested doctors, therapists, nurses and health service commissioners will be present. We will write a final report and papers to international journals. The results will be distributed to policy makers, advisory groups, professional bodies and patient support groups. Timetable (months) Set up (1-3); site training (4-8); trial recruitment (9-22); follow-up (11-36); data analysis (15-40); writing report (41-42).

Research activity codes: 6.7 PHYSICAL
Health categories: INJURIES AND ACCIDENTS