Article Text
Abstract
Objectives To describe the implementation of an enhanced rehabilitation programme for elderly hip fracture patients with mental capacity, in a randomised feasibility study compared with usual rehabilitation. To compare processes between the two and to collect the views of patients, carers and therapy staff about trial participation.
Design Mixed methods process evaluation in a randomised feasibility study.
Setting Patient participants were recruited on orthopaedic and rehabilitation wards; the intervention was delivered in the community following hospital discharge.
Participants Sixty-one older adults (aged ≥65 years) recovering from surgical treatment (replacement arthroplasty or internal fixation) following hip fracture, who were living independently prior to fracture and had mental capacity and 31 of their carers.
Interventions Usual care (control) or usual care plus an enhanced rehabilitation package (intervention). The enhanced rehabilitation consisted of a patient-held information workbook, goal-setting diary and up to six additional therapy sessions.
Process evaluation components Recruitment of sites and rehabilitation teams, response of rehabilitation teams, recruitment and reach in patient and carer participants, intervention delivery, delivery to individuals, response of individual patients to the enhanced intervention or usual rehabilitation, response of carer participants, unintended consequences and testing intervention theory and context.
Results Usual rehabilitation care was very variable. The enhanced rehabilitation group received a mean of five additional therapy sessions. All of the returned goal-setting diaries had inputs from the therapy team, and half had written comments by the patients and carers. Focus group themes: variation of usual care and its impact on delivering the intervention; the importance of goal setting; the role of the therapist in providing reassurance about safe physical activities; and acceptability of the extra therapy sessions.
Conclusions Lessons learnt for a future definitive RCT include how to enhance recruitment and improve training materials, the workbook, delivery of the extra therapy sessions and recording of usual rehabilitation care.
Trial registration number ISRCTN22464643; Post- results.
- process evaluation
- feasibility study
- hip fracture
- proximal femoral fracture
- rehabilitation medicine
- self-efficacy
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Footnotes
Contributors NHW was the chief investigator and grant holder, was responsible for study design, conduct and analysis and had overall responsibility for the study and acts as guarantor. JLR was the study manager overseeing day-to-day conduct, participant recruitment and methodological input and conducted qualitative analysis for the focus groups. NUD was involved in participant recruitment, acquisition of quantitative and qualitative data and analysis. NT conducted the statistical analysis for the feasibility study. Her institution affiliation changed from Bangor University to the University of Sheffield during the study. VM was a coinvestigator responsible for study design, provided health psychology expertise and methodological oversight throughout the study. MW was involved in the conduct of the study including maintenance of study documentation and acquisition of data and provided administrative support. AWP contributed to qualitative analysis of the focus groups. All authors were involved in drafting, revising and approving this manuscript.
Funding This work was supported by the National Institute for Health Research’s Health Technology Assessment Programme, grant number 11/33/03.
Disclaimer The views and opinions expressed therein are those of the authors and do not necessarily reflect those of the HTA, NIHR, NHS or the Department of Health.
Competing interests NHW, JLR, NUD, MW, NT and VM report a grant from NIHR HTA programme, for the conduct of the study. NHW reports additional grants from Public Health Wales, NIHR HTA and BCUHB, outside the submitted work.
Patient consent Not required.
Ethics approval The study received ethical approval from the UK NHS North Wales West Research Ethics Committee—West. Ref 13/WA/0402 and NHS Research and Development approval from the Betsi Cadwaladr University Health Board Internal Review Panel.
Provenance and peer review Not commissioned; externally peer reviewed.
Data sharing statement The datasets used during the current study are available from the corresponding author on reasonable request.