Title: Does Occupational Therapist led environmental assessment and modification reduce falls among high risk older people?
Funder: Department of Health and Social Care

Abstract: Design: A large pragmatic individually randomised controlled trial using unequal randomisation. Setting: Patients homes. Strategy for reviewing literature: Four key documents informed this study design: first, the most recent NICE guidelines on preventing falls in the community; second, the most recent Cochrane review on community falls prevention, third, the recently published UK College of Occupational Therapists falls prevention guideline (College of Occupational Therapists, 2015), and fourth, a pilot RCT undertaken in a primary care UK setting. Target population: Men and women aged 65 years and over who have at least one risk factor for a fall in the next 12 months and who have been recruited either from the cohort of the NIHR funded REFORM trial, of a podiatry intervention to prevent falls, from the CASPER trial, from primary care, or the Yorkshire Health Study Cohort. Inclusion criteria: Increased risk of falling (defined as: “an unexpected event in which the participants come to rest on the ground, floor, or lower level”Lamb et al, 2005), through a history of falls or fear of falling; living in their own home. Exclusion criteria: Chair or bed bound; unable to give informed consent. Living in residential or nursing care. Health technologies being assessed: Environmental assessment and modification and intervention delivered by Occupational Therapists. Primary outcome: Reduction in the number of falls per person over 12 months as measured by a monthly falls calendar. Secondary outcomes: Quality of life (EQ5D); time to fall; number of falls; fear of falling; fall related injuries and costs. Measurement of costs and outcomes: An economic analysis will be undertaken taking both the NHS and societal perspective of the cost utility of preventing falls. As well as a within trial analysis a modelling extrapolation beyond the trial for up to 5 years will be undertaken making assumptions of persistence of the intervention effects and translation of falls reduction into a fracture reduction. Sample size: We will recruit and randomise 1299 participants and randomise in a 2:1 ratio to reduce costs (i.e., 866 to usual care and 433 to intervention). This allows for 10% attrition and gives us 90% power (2p = 0.05) to show a difference of fallers of 60% in the control group and 50% in the intervention group or from 50% in the control group to 40% in the intervention. The study would also have 90% power (2p = 0.05) to show a reduction of 8% (i.e., 30% to 22%) in the proportion of participants who have at least one injurious fall assuming that 60% of falls result in an injury, as is the case in the REFORM cohort. Qualitative implementation evaluation: We will undertake a series of interviews with key stakeholders to understand the barriers and facilitators to the implementation of the intervention, were it shown to be effective. Project timetable including recruitment rate: Trial duration would be 31 months. Start date would be 01/06/2016; recruitment, randomisation and treatment would start 01/10/2016 and last until 31/06/2017 (9 months). Recruitment would be 33 participants a week with 11 being allocated to treatment. Follow-up would be for 12 months until 28/02/2018. Data cleaning analysis and report writing would be completed by 31/01/2019. The team:includes academic and NHS OTs; statisticians; health economists; qualitative researchers; trial managers; PPI; and trial methodologists.

Lay abstract: Falls are a major source of morbidity and cost to society. Most falls occur at home and previous research has indicated that environmental hazards around the home are an important cause of falls. The latest Cochrane systematic review in this area suggests that occupational therapist visits to peoples' homes to assess and recommend corrections to potential falls hazards in the home can lead to a significant reduction in falls. Previously some of the applicants undertook a pilot trial of home visits by occupational therapists and found that the incidence of falling was reduced from 69% to 57%, which was statistically significant. In the present application we want see if these preliminary findings hold up in a larger study and undertake a cost effectiveness analysis. We will recruit and randomise 1299 participants (433 to be visited by an occupational therapist and 866 to usual care). This will enable us to have sufficient statistical power to show a 10% (i.e, 60% to 50%) reduction in the incidence of falls over 12 months. The participants will be recruited from 3 existing cohorts of people who have either taken part in recent NIHR studies (eg, REFORM trial of a podiatry intervention for falls prevention) or are part of the Yorkshire health study cohort or from general practices. All of the participants will have an elevated risk of falling in that they will have either fallen in the last 12 months before randomisation or they have an increased fear of falling. Both of these factors leads to a substantial increased risk of falling in the following 12 months. Because members of these cohorts have consented to be approached to take part in further research and for two of the cohorts we have detailed knowledge of their falls' history it is anticipated that recruitment to the trial should be relatively straightforward. Once recruited and randomised all participants will be asked to complete a monthly falls calendar for 12 months. Additionally we will follow them up, by postal questionnaire, for information on costs and quality of life. Those participants allocated to the intervention group will receive at least one home visit by a qualified occupational therapist to assess the home for hazards and make recommendations for changes. Four weeks later the therapist will ring the participant to assess whether the recommendations have been implemented. The main outcome of the study is the proportion of participants who have had one or more falls in the 12 months following randomisation. Secondary outcomes include time to first fall, rate of falling, quality of life and cost effectiveness. As part of the evaluation we will also include a qualitative component to examine implementation approaches should the intervention be effective. Furthermore, we have set up a patient reference group who will advise and support the research team throughout the study duration.

Research activity codes: 3.2 INTERVENTIONS TO ALTER PHYSICAL AND BIOLOGICAL ENVIRONMENTAL RISKS;6.7 PHYSICAL
Health categories: INJURIES AND ACCIDENTS