Clinical effectiveness and cost-effectiveness of a multifaceted podiatry intervention for falls prevention in older people: a multicentre cohort randomised controlled trial (the REducing Falls with ORthoses and a Multifaceted podiatry intervention trial)

Abstract

BackgroundFalls are a serious cause of morbidity and cost to individuals and society. Evidence suggests that foot problems and inappropriate footwear may increase the risk of falling. Podiatric interventions could help reduce falls; however, there is limited evidence regarding their clinical effectiveness and cost-effectiveness.ObjectivesTo determine the clinical effectiveness and cost-effectiveness of a multifaceted podiatry intervention for preventing falls in community-dwelling older people at risk of falling, relative to usual care.DesignA pragmatic, multicentred, cohort randomised controlled trial with an economic evaluation and qualitative study.SettingNine NHS trusts in the UK and one site in Ireland.ParticipantsIn total, 1010 participants aged ≥ 65 years were randomised (intervention,n = 493; usual care,n = 517) via a secure, remote service. Blinding was not possible.InterventionsAll participants received a falls prevention leaflet and routine care from their podiatrist and general practitioner. The intervention also consisted of footwear advice, footwear provision if required, foot orthoses and foot- and ankle-strengthening exercises.Main outcome measuresThe primary outcome was the incidence rate of falls per participant in the 12 months following randomisation. The secondary outcomes included the proportion of fallers and multiple fallers, time to first fall, fear of falling, fracture rate, health-related quality of life (HRQoL) and cost-effectiveness.ResultsThe primary analysis consisted of 484 (98.2%) intervention and 507 (98.1%) usual-care participants. There was a non-statistically significant reduction in the incidence rate of falls in the intervention group [adjusted incidence rate ratio 0.88, 95% confidence interval (CI) 0.73 to 1.05;p = 0.16]. The proportion of participants experiencing a fall was lower (50% vs. 55%, adjusted odds ratio 0.78, 95% CI 0.60 to 1.00;p = 0.05). No differences were observed in key secondary outcomes. No serious, unexpected and related adverse events were reported. The intervention costs £252.17 more per participant (95% CI –£69.48 to £589.38) than usual care, was marginally more beneficial in terms of HRQoL measured via the EuroQoL-5 Dimensions [mean quality-adjusted life-year (QALY) difference 0.0129, 95% CI –0.0050 to 0.0314 QALYs] and had a 65% probability of being cost-effective at the National Institute for Health and Care Excellence threshold of £30,000 per QALY gained. The intervention was generally acceptable to podiatrists and trial participants.LimitationsOwing to the difficulty in calculating a sample size for a count outcome, the sample size was based on detecting a difference in the proportion of participants experiencing at least one fall, and not the primary outcome. We are therefore unable to confirm if the trial was sufficiently powered for the primary outcome. The findings are not generalisable to patients who are not receiving podiatry care.ConclusionsThe intervention was safe and potentially effective. Although the primary outcome measure did not reach significance, a lower fall rate was observed in the intervention group. The reduction in the proportion of older adults who experienced a fall was of borderline statistical significance. The economic evaluation suggests that the intervention could be cost-effective.Future workFurther research could examine whether or not the intervention could be delivered in group sessions, by physiotherapists, or in high-risk patients.Trial registrationCurrent Controlled Trials ISRCTN68240461.FundingThis project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full inHealth Technology Assessment; Vol. 21, No. 24. See the NIHR Journals Library website for further project information.

Construção e validação de conteúdo de cartilha educativa para prevenção de quedas no hospital

“…In the United Kingdom, a study on the use of a booklet for preventing falls in the elderly in the community also demonstrated good patient acceptability and practical applicability of the material. (25) Furthermore, it is important that studies involving new educational technologies assess their applicability in the context in which they will be used. (26) It is worth noting that the educational manual was not designed to replace the verbal guidance provided by the nurse during nursing care, but rather to reinforce the guidelines and solve doubts, since the patient can consult the material whenever they are interested.…”

“…(26) It is worth noting that the educational manual was not designed to replace the verbal guidance provided by the nurse during nursing care, but rather to reinforce the guidelines and solve doubts, since the patient can consult the material whenever they are interested. (25) It is suggested that nurses use the booklet during educational strategies and that, at that moment, this technology facilitates the construction of knowledge between nurse-patient-family, besides favoring clarification of doubts.…”

A study update newsletter or Post-it® note did not increase postal questionnaire response rates in a falls prevention trial: an embedded randomised factorial trial

“…This trial was embedded within the National Institute for Health Research Health Technology Assessment (NIHR HTA) programme funded REFORM (REducing Falls with ORthoses and a Multifaceted podiatry intervention) study (registration number ISRCTN68240461; registration date, 1 st July 2011; http://www.isrctn.com/ISRCTN68240461) 10 , which aimed to evaluate the clinical and cost effectiveness of a podiatry intervention for the prevention of falls in older people. Ethical approval for the REFORM study and this embedded sub-study was given by National Research Ethics Service East of England – Cambridge East Research Ethics Committee (REC reference 11/EE/0379) and the University of York, Department of Health Sciences Research Governance Committee.…”

Qualitative research to inform hypothesis testing for fidelity-based sub-group analysis in clinical trials: Lessons learnt from the process evaluation of a multifaceted podiatry intervention for falls prevention

“…Further details of the REFORM trial are provided in table 2 and the study has been published elsewhere. (10,11) In this paper we present findings of a qualitative process evaluation, which was conducted alongside the REFORM trial. Through interviews with podiatrists who delivered the REFORM intervention and trial participants we aim to explore some of the factors which affected the fidelity of the REFORM intervention.…”