Title: A multi-centre cluster randomised controlled trial to evaluate the Guide to Action Care Home fall prevention programme in care homes for older people.(FinCH)
Funder: Department of Health and Social Care

Abstract: Design: Multicentre cluster randomised controlled trial Setting: UK care homes Target population 1. Residents of old age care homes who are not terminally ill or receiving short term respite care. 2. Care homes with robust falls recording, willing to implement the GtACH process and who are not already using a structured falls risk assessment and risk reduction programme. Health technology The intervention is the Guide to Action Care Home (GtACH) systematic process delivered to care home residents by care home staff who have been trained i and are supported. GtACH is a systematic falls risk assessment and action process, co designed by care home and NHS staff, based on NICE clinical guidelines. The assessment takes 15 minutes and actions take up to two hours per resident. The control conditions reflect usual practice. Usual practice requires care home staff to be trained sufficiently to meet legal requirements and to write care plans for each resident but this does not include systematic routine training in fall prevention or the routine use of a systematic falls assessment tool or a falls prevention decision support tool. Residents in both groups will be eligible for usual medical and community services. Measurement of costs and outcome Data will be collected from care home records as this was found reliable in a feasibility study, NHS data, residents and care home staff acting as proxy. Researchers collecting and analysing data will be blinded to treatment allocation. Times are from randomisation. Primary • Rate of falls between three and six months Secondary • Rate of falls at 9 and 12 months At 6 and 12 month - • Fall injuries • Days in hospital • Death • Health and Social service use • Physical activity (PAM-RC) • Functional ability (Barthel Index) • Quality of life (DEMQOL-U-5D, DEMQOL-P-4D), • Health (EQ-5D-5L and EQ-5D-5L proxy) • Medication use Economic study: Within trial cost-effectiveness and utility analyses from NHS and personal social service perspective. The choice to use several health measures reflects the fact that the utility value sets, DEMQOL-U and DEMQOL-P-U, have not been widely used or validated but EQ-5D-5L has successfully been used in care homes. Concurrent process evaluation: To explore implementation of the GtACH process 12 staff focus groups and 30 stakeholder interviews, observations and documentary analysis will be completed. Thematic analysis approaches, constant comparison, progressive focusing of field observations, and memo-writing will be used to construct categories and sub-categories. Sample size: 1308 residents from 66 CHs are required to detect a 33% falls rate reduction in the intervention group. This assumes a falls rate of 2.5 falls per year per resident in the control group, 1:1 allocation, 80% power, a two-sided significance level of 5%, an average cluster size of 20 residents, an intra-cluster coefficient of 0.1 and 16% attrition. 6 sites will each recruit 11 CHs. Randomisation: Variable block randomisation at care home level by Norwich Clinical Trials Unit using a web-based randomisation service. Timetable: 3 years: 6 months set-up; 12 months recruitment; 12 months follow up; 6 months analysis, write-up and dissemination. Team expertise: Falls prevention, care home research and management, multicentre clinical trials, health economics, medical statistics, implementation science, concurrent process analysis

Lay abstract: Care Home residents fall five times more often than elderly frail people living in their own homes. Of those residents who fall nearly 1 in 10 suffer a broken bone, 1 in 5 is admitted to hospital and 1 in 5 will die within the year as a result of this injury. These people suffer pain, immobility and fear of further falls with high personal and financial costs. Currently hip fractures cost £1.4 billion per annum and the number of fractures is set to double by 2050. It is imperative that there is a reduction in the high level of falls in care homes. However, the physical environment and the decline in the resident’s memory have prevented this from being achieved through the traditioonal falls prevention programmes. The Guide to Action Care Home (GtACH) falls prevention is a unique process which involves falls prevention experts, usually employed by the NHS, training care home staff in small groups to systematically assess residents fall risk and then provide actions to reduce falls risks. The GtACH process was developed by a team comprising residents, clinicians, care home staff, carers and researchers. It has been published and won a prize for innovation. Previous studies have demonstrated that care homes are keen to take part in GtACH research, staff will attend GtACH training, GtACH processes can be implemented with residents and falls can be reliably ascertained from care home records. However we still do not know if the GtACH process can reduce falls rates in care home residents and the costs to the NHS. The proposed trial called FinCH (Falls in Care Homes) will compare falls rates in homes where staff are trained to use the GtACH process with homes that are providing usual care. Sixty six care homes and 1308 residents will be recruited in sites across the UK (Nottingham City, Nottinghamshire County, Sheffield, Leicester, Derby and Norwich). In each care home we will ensure both managers and residents or their named person give consent and provide information. Then the participating care homes will be randomly allocated to either the GtACH process or usual care. If allocated to the GtACH process, care home staff will attend the training and all residents will be offered the assessment and actions. At 3, 6, 9 and 12 months after randomisation data will be collected from each consenting resident on falls and fractures, changes in medication and equipment use, quality of life, activity and if a person has died. This information will be taken from care home records, residents, families, care home staff and NHS records. We will interview care home staff about the training and the GtACH process and will observe how it is used in care homes. We will use the data to compare the GtACH process homes with usual care homes. Our hypothesis is that residents in GtACH homes will experience a lower rate of falls compared to residents in usual care homes. Alongside this we will use the data to explore the economic consequences of providing the GtACH process and the success of embedding the GtACH process into care homes. The results will be disseminated to care home practices, residents, their families and carers as well as at professional conferences and in journal articles.

Research activity codes: 7.1 INDIVIDUAL CARE NEEDS
Health categories: INJURIES AND ACCIDENTS