Background:
Proximal femoral fracture is a major health problem in old age with annual UK health and social care costs of £2.3 billion. Rehabilitation has the potential to maximise functional recovery and maintain independent living, but evidence of effectiveness and cost-effectiveness is lacking.
Objectives:
To develop an enhanced community based rehabilitation package following surgical treatment for proximal femoral fracture and to assess acceptability and feasibility for a future definitive randomised controlled trial (RCT) and economic evaluation.
Design:
Phase I - realist review, survey and focus groups to develop rehabilitation package.
Phase II –parallel-group, randomised (using dynamic adaptive algorithm) feasibility study with focus groups and anonymised cohort.
Setting:
Recruitment from orthopaedic wards of three acute hospitals in Betsi Cadwaladr University Health Board in North Wales. Intervention delivered in the community following hospital discharge.
Participants:
Older adults (aged ≥65) who received surgical treatment for hip fracture, lived independently prior to fracture, had mental capacity (assessed by clinical team) and received rehabilitation in the North Wales area.
Interventions:
Usual care (control) or usual care plus enhanced rehabilitation package (intervention). Usual care was variable and consisted of multi-disciplinary rehabilitation delivered by the acute hospital, community hospital and community services depending on need and availability. The intervention was designed to enhance rehabilitation by improving patients’ self-efficacy and increasing the amount and quality of patients’ practice of physical exercise and activities of daily living. It consisted of a patient-held information workbook, goal-setting diary and six additional therapy sessions.
Main outcome measures:
Primary outcome measure: Barthel Activities of Daily Living (BADL). Secondary outcomes Nottingham Extended Activities of Daily Living (NEADL), EQ-5D, ICECAP capability, self-efficacy, psychosocial and service-use measures and costs. Outcome measures were assessed at baseline and three-month follow up by blinded researchers.
Results:
Sixty two participants were recruited (23%), 61 randomised (Control: 32; Intervention: 29), and 49 (79%) followed up at three months. Comparedwith the cohort a younger, healthier sub-population was recruited. There were minimal differences in most outcomes between the two groups, including the BADL. The intervention group showed a medium sized improvement in the NEADL relative to the control group, with an adjusted mean difference between groups of 3.0, Cohen’s d 0.63). There was a trend for a greater improvement in self-efficacy and mental health, but with small effect sizes. The cost of delivering the intervention was £231 per patient. There was a possible small relative improvement in QALY in the intervention group. No serious adverse events relating to the intervention were reported.
Limitations:
The feasibility study lacked power to test for differences between the groups. A ceiling effect was observed in the primary measure.
Conclusion:
Trial methods were feasible in terms of eligibility, recruitment and retention, though recruitment was challenging. The NEADL was more responsive than the BADL and suggested the intervention could enable participants to regain better levels of independence compared with usual care. This should be tested in a definitive Phase III RCT.