Home environmental assessments and modification delivered by occupational therapists to reduce falls in people aged 65 years and over : the OTIS RCT

Background: Falls and fall-related fractures in older people are highly prevalent and a major contributor to morbidity and cost to individuals and society. There is only one small pilot trial evaluating the effectiveness of a home hazard assessment and environmental modification in the UK. This trial reported a reduction in falls as a secondary outcome; no economic evaluation was undertaken. The results therefore need confirming and a cost-effectiveness analysis undertaking. Objectives: To determine the clinical and cost-effectiveness of a home hazard assessment and environmental modification delivered by occupational therapists for preventing falls in community-dwelling people aged over 65 at risk of falling, relative to usual care. Design: A pragmatic, multicentre, modified cohort randomised controlled trial with an economic evaluation and qualitative study. Setting: Eight NHS trusts in primary and secondary care in England. Participants: In total, 1331 participants were randomised (intervention, n=430; usual care group, n=901) via a secure, remote service. Blinding was not possible. Interventions: All participants received a falls prevention leaflet and routine care from their General Practitioner. The intervention group were additionally offered one home environmental assessment and modifications recommended or provided to identify and manage personal fall-related hazards, delivered by an occupational therapist. Main outcome measures: The primary outcome was the number of falls per participant over the 12 months from randomisation. The secondary outcomes were the proportion of fallers and multiple fallers, time to fall, fear of falling, fracture rate, health-related quality of life and cost-effectiveness. Results: The primary analysis included all 1331 randomised participants and indicated weak evidence of a difference in fall rate between the two groups, with an increase in the intervention group relative to usual care (adjusted incidence rate ratio 1.17, 95% CI 0.99 to 1.38; p=0.07). A similar proportion of participants in the intervention group (57.0%) and the usual care group (56.2%) reported at least one fall over 12 months. There were no differences in any of the secondary outcomes. The base case cost-effectiveness analysis from an NHS and personal social services perspective found that, on average per participant, the intervention was associated with additional costs (£18.78, 95% CI £16.33 to £21.24), but was less effective (mean QALY loss -0.0042, 95% CI -0.0041 to -0.0043). Sensitivity analyses demonstrated uncertainty in these findings. No serious, related adverse events were reported. The intervention was largely delivered as intended but recommendations were followed to a varying degree. Limitations: Outcome data were participant self-reported, which may have led to inaccuracies in the reported falls data. Conclusions: We found no evidence that an occupational therapist-delivered home assessment and modification reduced falls in this population of over 65 year old, community-dwelling participants deemed at risk of falling. The intervention was more expensive and less effective than usual care, therefore does not provide a cost-effective alternative. Future work: Evaluation of falls prevention advice in a higher risk population, perhaps those previously hospitalised for a fall, or given by other professional staff could be justified. Trial registration: ISRCTN22202133