Title: Prevention of Falls Injury Trial
Funder: Department of Health and Social Care

Abstract: Context: Common falls prevention strategies used in primary care settings include advice and information, structured exercise, and multi-factorial risk-reduction programmes. Little is known about the comparative effectiveness and cost-effectiveness of these strategies. Objective: To estimate the comparative effectiveness and cost-effectiveness of advice, structured exercise and a multi-factorial fall prevention programme, for the prevention of fall injuries among older people living in the community. Design: A 3-arm, cluster-randomised controlled trial with economic evaluation. The unit of randomisation will be the General Practice, and minimisation will be used to ensure balance in the allocation of practices by list size and area socio-economic status. Population: 9,000 people (60 practices) aged over 70 years living in the community, including people in sheltered accommodation, but excluding people living in nursing or residential care homes. Interventions: Practices will be randomly allocated to one of the trial interventions, which they will adopt as usual care practice for the duration of the trial. The three trial arms interventions are: Advice: We will utilise evidence that, for older people, advice about the positive aspects of treatment (e.g. regaining or improving balance/mobility) as opposed to negative (e.g. falls) is a more acceptable presentation and likely to result in greater uptake. Exercise: We will use the Otago Exercise Program, delivered either on a group basis or at home. The program has a good evidence base in relation to falls, but has not been tested formally in the UK setting. MFFP. We will base MFFP on an existing programme (Tinetti et al., 1994) that is safe and feasible in the community setting. We will undertake an update and consensus building exercise (with members of the British Geriatrics Society) to ensure that the intervention is fully informed. Outcomes: The trial is powered (80%) to detect (p<0.05) a moderate difference in fracture rate, from 6% to 4% (RR 0.67). Peripheral fracture data, aggregated at the practice level, will be sourced from primary care, HES and self-report. Falls and HRQoL (secondary outcomes) will be assessed in random sub-samples of the trial population by postal questionnaire at 4 month intervals.

Lay abstract: Falls and fractures are common and serious health problems for older people. The UK government recognised this problem and in 2004, in view of the importance of the problem, elected to develop a guideline through the National Institute of Clinical Excellence (NICE the body that decides which treatments the NHS should be funded to provide). The guideline was based on the available evidence at that time (up to 2003), which included a high quality review of all of the evidence conducted by the Cochrane Collaboration. Although the amount of evidence available was limited, the Cochrane Review concluded that multi-factorial fall prevention services were likely to be the most effective. NICE took this recommendation forward, and undertook some preliminary economic evaulation. Professor McCabe led the evaluation for NICE, and concluded that there was insufficient data available to determine cost-effectiveness of different options to treatment, including MFFPs. NICE decided to leave it for a few years to let more research come into the public domain. They then commissioned Profs Lamb and McCabe to update the evidence and determine whether or not it would now be possible to generate economic models. We undertook a very rigorous review of the evidence, which has just been published in the British Medical Journal. The results of this were suprising,with the accumulation of evidence, it looks like MFFPs are considerably less effective than originally anticipated, and there is no evidence that we can prevent fractures with these treatments. At the same time colleagues in New Zealand have published a review which suggests exercise maybe just as effective as MFFP, but would be quite a bit cheaper. This has brought to the surface a lot of uncertainty, and the need to conduct a large trial which will answer several questions which are important considerations when trying to plan and implement services. This includes which types of treatments are most effective (advice, exercise or MFFP); whether they reduce fractures as well as falls; whether the treatments have effects on the onset or progression of other problems that occur alongside or are linked to falls; whether the treatments work best in people who are fitter and well (and hence able to respond better) or those who are frail (who are at much greater chance of falling, but may not find the treatments so easy to stick with). Owing to falls being a very common problem, an important component of any evaluation is how acceptable the treatments are, and if people will naturally be more attracted to some types of treatments as opposed to others. We have to be able to maximise the number of people who will engage in fallers services. We have designed a trial that is able to answer these very complicated questions, and assembled a team of people who are expert in various areas. We will need to develop a good way of engaging with users as we develop the trial interventions, looking at barriers against uptake, and also of ensuring the trial is informed by patients of the NHS. The treatments being tested in this trial are low risk treatments. We have set this up as a cluster randomised trial. The practices will be trained in an intervention strategy, and then they will adopt that strategy as their routine practice for the duration of the trial. We do not perceive this to be a problem, the treatments are low risk and are recommended by clinical guidelines for the management of people who have fallen. Consent for the treatments will be usual clinical consent just like any other treatments delivered by doctors or other healthcare practitioners. We will ask people to consent to us accessing their medical records during follow up, and to provide us with some information by questionnaire. We will access anonymised and aggregated information directly from practices about fractures, but will not ask individual people to provide consent for this information. The team is well placed to carry out this research. We have a wide range of expertise including clinical experience of falls prevention, exercise interventions, self-assessment and screening for fall risk, user involvement, as well as methodological skills in statistics and economics. People in the team are recognised as international experts in their respective fields, and we feel we are a strong team equipped to deal with the complexities that will be presented in designing and running the trial, as well as in ensuring that we deliver interventions that are top quality and affordable to the NHS. The costs of this research are high. However, it is important to remember that we are planning to recruit a large number of patients, and we need to improve systems for data capture and monitoring. We know that there are certain elements of our project which are critical to whether or not we can deliver value for money. We will use a method called futility analysis to incorporate the concerns that exist in this respect and will terminate the trial early (and hence minimise the cost) if appropriate. We have calculated the cost carefully. The NHS spends over £34 million each year on fall prevention services, and working out which is the best way to do this will be cost-effective. We will also learn how to get health systems to implement new strategies for falls prevention, and contribute to the translation of research findings into practice.

Research activity codes: 3.1 PRIMARY PREVENTION INTERVENTIONS TO MODIFY BEHAVIOURS OR PROMOTE WELL-BEING
Health categories: DISPUTED AETIOLOGY AND OTHER