A realist evaluation of a multifactorial falls prevention programme in care homes.

BACKGROUND: falls in care homes are common, costly and hard to prevent.Multifactorial falls programmes demonstrate clinical and cost-effectiveness, but the heterogeneity of the care home sector is a barrier to their implementation. A fuller appreciation of the relationship between care home context and falls programme delivery will guide development and support implementation. METHODS: this is a multi-method process evaluation informed by a realist approach.Data include fidelity observations, stakeholder interviews, focus groups, documentary review and falls-rate data. Thematic analysis of qualitative data and descriptive statistics are synthesised to generate care home case studies. RESULTS: data were collected in six care homes where a falls programme was trialled. Forty-four interviews and 11 focus groups complemented observations and document review.The impact of the programme varied. Five factors were identified: (i) prior practice and (ii) training may inhibit new ways of working; (iii) some staff may be reluctant to take responsibility for falls; (iv) some may feel that residents living with dementia cannot be prevented from falling; and, (v) changes to management may disturb local innovation.In some care homes, training and improved awareness generated a reduction in falls without formal assessments being carried out. CONCLUSIONS: different aspects of the falls programme sparked different mechanisms in different settings, with differing impact upon falls.The evaluation has shown that elements of a multifactorial falls programme can work independently of each other and that it is the local context (and local challenges faced), which should shape how a falls programme is implemented.

A multidomain decision support tool to prevent falls in older people: the FinCH cluster RCT.

BACKGROUND: Falls in care home residents are common, unpleasant, costly and difficult to prevent. OBJECTIVES: The objectives were to evaluate the clinical effectiveness and cost-effectiveness of the Guide to Action for falls prevention in Care Homes (GtACH) programme. DESIGN: A multicentre, cluster, parallel, 1 : 1 randomised controlled trial with embedded process evaluation and economic evaluation. Care homes were randomised on a 1 : 1 basis to the GtACH programme or usual care using a secure web-based randomisation service. Research assistants, participating residents and staff informants were blind to allocation at recruitment; research assistants were blind to allocation at follow-up. NHS Digital data were extracted blindly. SETTING: Older people's care homes from 10 UK sites. PARTICIPANTS: Older care home residents. INTERVENTION: The GtACH programme, which includes care home staff training, systematic use of a multidomain decision support tool and implementation of falls prevention actions, compared to usual falls prevention care. OUTCOMES: The primary trial outcome was the rate of falls per participating resident occurring during the 90-day period between 91 and 180 days post randomisation. The primary outcome for the cost-effectiveness analysis was the cost per fall averted, and the primary outcome for the cost-utility analysis was the incremental cost per quality adjusted life-year. Secondary outcomes included the rate of falls over days 0-90 and 181-360 post randomisation, activity levels, dependency and fractures. The number of falls per resident was compared between arms using a negative binomial regression model (generalised estimating equation). RESULTS: A total of 84 care homes were randomised: 39 to the GtACH arm and 45 to the control arm. A total of 1657 residents consented and provided baseline measures (mean age 85 years, 32% men). GtACH programme training was delivered to 1051 staff (71% of eligible staff) over 146 group sessions. Primary outcome data were available for 630 GtACH participants and 712 control participants. The primary outcome result showed an unadjusted incidence rate ratio of 0.57 (95% CI 0.45 to 0.71; p < 0.01) in favour of the GtACH programme. Falls rates were lower in the GtACH arm in the period 0-90 days. There were no other differences between arms in the secondary outcomes. Care home staff valued the training, systematic strategies and specialist peer support, but the incorporation of the GtACH programme documentation into routine care home practice was limited. No adverse events were recorded. The incremental cost was £20,889.42 per Dementia Specific Quality of Life-based quality-adjusted life-year and £4543.69 per quality-adjusted life-year based on the EuroQol-5 dimensions, five-level version. The mean number of falls was 1.889 (standard deviation 3.662) in the GtACH arm and 2.747 (standard deviation 7.414) in the control arm. Therefore, 0.858 falls were averted. The base-case incremental cost per fall averted was £190.62. CONCLUSION: The GtACH programme significantly reduced the falls rate in the study care homes without restricting residents' activity levels or increasing their dependency, and was cost-effective at current thresholds in the NHS. FUTURE WORK: Future work should include a broad implementation programme, focusing on scale and sustainability of the GtACH programme. LIMITATIONS: A key limitation was the fact that care home staff were not blinded, although risk was small because of the UK statutory requirement to record falls in care homes. TRIAL REGISTRATION: This trial is registered as ISRCTN34353836. FUNDING: This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 26, No. 9. See the NIHR Journals Library website for further project information.

Falls in care home residents are common, unpleasant, costly and hard to prevent. We tested whether or not the Guide to Action for falls prevention in Care Homes (GtACH) programme was effective in preventing falls. In this programme, care home staff were systematically trained and supported in the assessment of residents' risk of falling and the generation of a falls reduction care plan. We undertook a randomised controlled trial comparing the GtACH programme with usual care, which does not involve this systematic attention to falls prevention. We also undertook a process evaluation, observing organisational and care processes, and an economic study to evaluate value for money. A total of 39 care homes were randomly allocated to the GtACH programme and 45 care homes were randomly allocated to usual care, involving a total of 1657 residents. The main comparison between the two arms was the rate of falls during months 4­6 after randomisation, when we expected any effect to be at its peak. We also assessed the falls rates before and 6 months after this period. We measured activity and dependency levels, as it was important to be sure that any reduction in the rate of falls was not achieved through restrictive care practices. We saw a 43% reduction in the falls rates of the GtACH programme participants during months 4­6, without observing any reduction in residents' activity or dependency. Care home staff and relatives were positive about the GtACH programme. The GtACH programme was good value for money, as it was likely to be cost-effective. The effect of the programme waned over months 6­12, which may be because some staff did not embed the GtACH programme in their usual practice routines, and awareness levels may have dropped.

Multifactorial falls prevention programme compared with usual care in UK care homes for older people: multicentre cluster randomised controlled trial with economic evaluation.

OBJECTIVES: To determine the clinical and cost effectiveness of a multifactorial fall prevention programme compared with usual care in long term care homes. DESIGN: Multicentre, parallel, cluster randomised controlled trial. SETTING: Long term care homes in the UK, registered to care for older people or those with dementia. PARTICIPANTS: 1657 consenting residents and 84 care homes. 39 were randomised to the intervention group and 45 were randomised to usual care. INTERVENTIONS: Guide to Action for Care Homes (GtACH): a multifactorial fall prevention programme or usual care. MAIN OUTCOME MEASURES: Primary outcome measure was fall rate at 91-180 days after randomisation. The economic evaluation measured health related quality of life using quality adjusted life years (QALYs) derived from the five domain five level version of the EuroQoL index (EQ-5D-5L) or proxy version (EQ-5D-5L-P) and the Dementia Quality of Life utility measure (DEMQOL-U), which were self-completed by competent residents and by a care home staff member proxy (DEMQOL-P-U) for all residents (in case the ability to complete changed during the study) until 12 months after randomisation. Secondary outcome measures were falls at 1-90, 181-270, and 271-360 days after randomisation, Barthel index score, and the Physical Activity Measure-Residential Care Homes (PAM-RC) score at 91, 180, 270, and 360 days after randomisation. RESULTS: Mean age of residents was 85 years. 32% were men. GtACH training was delivered to 1051/1480 staff (71%). Primary outcome data were available for 630 participants in the GtACH group and 712 in the usual care group. The unadjusted incidence rate ratio for falls between 91 and 180 days was 0.57 (95% confidence interval 0.45 to 0.71, P<0.001) in favour of the GtACH programme (GtACH: six falls/1000 residents v usual care: 10 falls/1000). Barthel activities of daily living indices and PAM-RC scores were similar between groups at all time points. The incremental cost was £108 (95% confidence interval -£271.06 to 487.58), incremental QALYs gained for EQ-5D-5L-P was 0.024 (95% confidence interval 0.004 to 0.044) and for DEMQOL-P-U was 0.005 (-0.019 to 0.03). The incremental costs per EQ-5D-5L-P and DEMQOL-P-U based QALY were £4544 and £20 889, respectively. CONCLUSIONS: The GtACH programme was associated with a reduction in fall rate and cost effectiveness, without a decrease in activity or increase in dependency. TRIAL REGISTRATION: ISRCTN34353836.

Learning from a successful process evaluation in care homes.

INTRODUCTION: process evaluations (PE) are increasingly used in parallel with randomised controlled trials (RCT) to inform the implementation of complex health interventions. This paper explores the learning accrued from conducting a PE within the Falls in Care Homes Study (FinCH), a large UK RCT. METHODS: in the FinCH study, six purposively sampled care homes provided data for the PE, which followed a realist approach. In this study researchers kept written diaries of their experiences in completing the interviews, focus groups and observations. We have reflected on these and present the main themes for discussion. FINDINGS: care home staff were enthusiastic to participate in the PE but researchers found it difficult to collect data due to staff not having time to take part, environmental factors such as no space for focus groups and low levels of research understanding. Researchers found that the expectations of the PE protocol were often unrealistic due to these limitations. Flexible and pragmatic approaches such as interviews in place of focus groups enabled data collection but required a reduced sample size and length of data collection to be accepted by researchers. CONCLUSION: to enable care home staff to participate in successful PEs, researchers should build flexibility into research schedules, spend time building trust, collaborate with all levels of care home staff prior to data collection, increase research capacity in care home staff and co-design research projects.

Reflections on qualitative data analysis training for PPI partners and its implementation into practice.

PLAIN ENGLISH SUMMARY: Service users should be involved in every part of the research process, including analysis of qualitative research data such as interviews and focus groups. To enhance their participation, confidence and contributions, training and support for both the 'professional' researcher and lay member of public is essential. Historically this has taken a number of forms from short 1 day training sessions through to training spread out over several months. There currently is limited guidance on the quantity and content of such training sessions for Patient and Public Involvement (PPI) Partners. This paper discusses and explores the content and delivery of qualitative analysis training held over two sessions of 3 h duration to members of a University PPI group. The training was designed by experienced qualitative researchers and PPI partners based on available literature and research expertise. Training included the theory of qualitative research methods, and practical qualitative analysis coding skills. These skills were developed through the use of 'mock' interviews which participants practiced coding in supportive group sessions. Their feedback on the training is provided. One of the PPI partners subsequently went onto code data with a researcher working on a funded research study, and has reflected on both the training sessions and the subsequent analysis of the data. These reflections have been supplemented by reflections of the researcher who worked alongside the PPI partner, revealing that the process challenged perspectives and helped them view data through a service users eyes. A positive working relationship was central to this. BACKGROUND: Service users should be involved in every part of the research process to ensure that interventions are fit for those whom they are intended to help. Involving service users in analysing qualitative data such as focus groups and interviews has been recognised as particularly valuable. Older people have frequently been less involved in these initiatives. A wide range of training programmes have been proposed but there is currently limited guidance on the quantity and content of training sessions to support training Patient and Public Involvement (PPI) Partners. This paper discuses and explores the content and delivery of qualitative data analysis training to members of a University PPI Group. BODY: Existing literature on PPI in qualitative data analysis was reviewed by the research team and an outline programme was designed. This comprised of two three hour sessions held at an easily accessible venue familiar to members of the PPI group. The course included theories behind qualitative research methodology and methods, what is coding and how to code independently and as part of a research team using Thematic Analysis. A mock research question was generated and two mock interviews were completed, audio recorded and transcribed verbatim. This provided participants with real life experience of coding data. The session was positively reviewed and said to be interesting, enjoyable and provided a good overview of qualitative analysis. One of the PPI partners subsequently went onto code data with a researcher working on a funded research study, and has reflected on both the training sessions and the subsequent analysis of the data. These reflections have been supplemented by reflections of the researcher who worked alongside the PPI, revealing that the process challenged perspectives and helped them view data through a service users eyes. A positive working relationship was central to this. CONCLUSIONS: Feedback suggests that the training enabled PPI partners to become active members of the research team in qualitative data analysis. There is a need for further research into the optimal amount of training needed by PPI's to participate as partners in qualitative analysis.

Perspectives of healthcare professionals in England on falls interventions for people with dementia: a qualitative interview study.

OBJECTIVE: To explore the experiences of healthcare professionals working in falls prevention and memory assessment services in providing assessments and interventions for falls risk reduction in people with dementia. DESIGN: This is a qualitative study using 19 semistructured interviews. Interviews were analysed through thematic analysis. SETTING: Community-based falls and memory assessment services in the East Midlands, UK. PARTICIPANTS: Nurses (n=10), physiotherapists (n=5), occupational therapists (n=3) and a psychiatrist (n=1). RESULTS: Three substantive themes were identified: challenges posed by dementia, adaptations to make falls prevention appropriate for people with dementia and organisational barriers. Patients' poor recall, planning and increased behavioural risk associated with dementia were key problems. Healthcare professionals provided many suggestions on how to overcome these challenges, such as adapting exercise interventions by using more visual aids. Problems associated with cognitive impairment created a need for additional support, for instance longer interventions, and supervision by support workers, to enable effective intervention, yet limited resources meant this was not always achievable. Communication between mental and physical health teams could be ineffective, as services were organised as separate entities, creating a reliance on third parties to be intermediaries. Structural and organisational factors made it difficult to deliver optimal falls prevention for people living with dementia. CONCLUSIONS: Healthcare professionals experience challenges in providing falls prevention to people with dementia at the individual and organisational levels. Interventions can be adapted for people with dementia, but this requires additional resources and improved integration of services. Future research is needed to develop and test the effectiveness and cost-effectiveness of such services.

Comprehensive geriatric assessment on an acute medical unit: a qualitative study of older people's and informal carer's perspectives of the care and treatment received.

OBJECTIVE: This qualitative study was imbedded in a randomized controlled trial evaluating the addition of geriatricians to usual care to enable the comprehensive geriatric assessment process with older patients on acute medical units. The qualitative study explored the perspectives of intervention participants on their care and treatment. DESIGN: A constructivist study incorporating semi-structured interviews that were conducted in patients' homes within six weeks of discharge from the acute medical unit. These interviews were recorded, transcribed, and analysed using thematic analysis. SETTING: An acute medical unit in the United Kingdom. PARTICIPANTS: Older patients ( n = 18) and their informal carers ( n = 6) discharged directly home from an acute medical unit, who had been in the intervention group of the randomized controlled trial. RESULTS: Three core themes were constructed: (1) perceived lack of treatment on the acute medical unit; (2) nebulous grasp of the role of the geriatrician; and (3) on-going health and activities of daily living needs postdischarge. These needs impacted upon the informal carers, who either took over, or helped the patients to complete their activities of daily living. Despite the help received with activities of daily living, a lot of the patients voiced a desire to complete these activities themselves. CONCLUSIONS: The participants perceived they were just monitored and observed on the acute medical unit, rather than receiving active treatment, and spoke of on-going unresolved health and activity of daily living needs following discharge, despite receiving the additional intervention of a geriatrician.

The Falls In Care Home study: a feasibility randomized controlled trial of the use of a risk assessment and decision support tool to prevent falls in care homes.

OBJECTIVE: To explore the feasibility of implementing and evaluating the Guide to Action Care Home fall prevention intervention. DESIGN: Two-centre, cluster feasibility randomized controlled trial and process evaluation. SETTING: Purposive sample of six diverse old age/learning disability, long stay care homes in Nottinghamshire, UK. SUBJECTS: Residents aged over 50 years, who had fallen at least once in the past year, not bed-bound, hoist-dependent or terminally ill. INTERVENTIONS: Intervention homes (n = 3) received Guide to Action Care Home fall prevention intervention training and support. Control homes (n = 3) received usual care. OUTCOMES: Recruitment, attrition, baseline and six-month outcome completion, contamination and intervention fidelity, compliance, tolerability, acceptance and impact. RESULTS: A total of 81 of 145 (56%) care homes expressed participatory interest. Six of 22 letter respondent homes (27%) participated. The expected resident recruitment target was achieved by 76% (52/68). Ten (19%) residents did not complete follow-up (seven died, three moved). In intervention homes 36/114 (32%) staff attended training. Two of three (75%) care homes received protocol compliant training. Staff valued the training, but advised greater management involvement to improve intervention implementation. Fall risks were assessed, actioned and recorded in care records. Of 115 recorded falls, 533/570 (93%) of details were complete. Six-month resident fall rates were 1.9 and 4.0 per year for intervention and control homes, respectively. CONCLUSIONS: The Guide to Action Care Home is implementable under trial conditions. Recruitment and follow-up rates indicate that a definitive trial can be completed. Falls (primary outcome) can be ascertained reliably from care records.

Rehabilitation aimed at improving outdoor mobility for people after stroke: a multicentre randomised controlled study (the Getting out of the House Study).

BACKGROUND: One-third of stroke patients are dependent on others to get outside their homes. This can cause people to become housebound, leading to increased immobility, poor health, isolation and misery. There is some evidence that outdoor mobility rehabilitation can reduce these limitations. OBJECTIVE: To test the clinical effectiveness and cost-effectiveness of an outdoor mobility rehabilitation intervention for stroke patients. DESIGN: Multicentre, parallel-group randomised controlled trial, with two groups allocated at a 1 : 1 ratio plus qualitative participant interviews. SETTING: Fifteen UK NHS stroke services throughout England, Scotland and Wales. PARTICIPANTS: A total of 568 stroke patients who wished to get out of the house more often, mean age of 71 years: 508 reached the 6-month follow-up and 10 were interviewed. INTERVENTION: Control was delivered prior to randomisation to all participants, and consisted of verbal advice and transport and outdoor mobility leaflets. Intervention was a targeted outdoor mobility rehabilitation programme delivered by 29 NHS therapists to 287 randomly chosen participants for up to 12 sessions over 4 months. MAIN OUTCOME MEASURES: Primary outcome was participant health-related quality of life, measured by the Short Form questionnaire-36 items, version 2 (Social Function domain), 6 months after baseline. Secondary outcomes were functional ability, mobility, number of journeys (from monthly travel diaries), satisfaction with outdoor mobility (SWOM), psychological well-being and resource use [health care and Personal Social Services (PSS)] 6 months after baseline. Carer well-being was recorded. All outcome measures were collected by post and repeated 12 months after baseline. Outcomes for the groups were compared using statistical significance testing and adjusted for multiple membership to account for the effect of multiple therapists at different sites. Interviews were analysed using interpretive phenomenology to explore confidence. RESULTS: A median of seven intervention sessions [interquartile range (IQR) 3-7 sessions], median duration of 369 minutes (IQR 170-691.5 minutes) per participant was delivered. There was no significant difference between the groups on health-related quality of life (social function). There were no significant differences between groups in functional ability, psychological well-being or SWOM at 6- or 12-month follow-ups. There was a significant difference observed for travel journeys with the intervention group being 42% more likely to make a journey compared with the control group [rate ratio 1.42, 95% confidence interval (95% CI) 1.14 to 1.67] at 6 months and 76% more likely (rate ratio 1.76, 95% CI 1.36 to 1.95) at 12 months. The number of journeys was affected by the therapist effect. The mean incremental cost (total NHS and PSS cost) of the intervention was £3413.75 (95% CI -£448.43 to £7121.00), with an incremental quality-adjusted life-year gain of -0.027 (95% CI -0.060 to 0.007) according to the European Quality of Life-5 Dimensions and -0.003 (95% CI -0.016 to 0.006) according to the Short Form questionnaire-6 Dimensions. At baseline, 259 out of 281 (92.2%) participants in the control group were dissatisfied with outdoor mobility but at the 6-month assessment this had reduced to 77.7% (181/233), a 15% reduction. The corresponding reduction in the intervention group was slightly greater (21%) than 268 out of 287 (93.4%) participants dissatisfied with outdoor mobility at baseline to 189 out of 261 (72.4%) at 6 months. Participants described losing confidence after stroke as being detrimental to outdoor mobility. Recruitment and retention rates were high. The intervention was deliverable by the NHS but had a neutral effect in all areas apart from potentially increasing the number of journeys. This was dependent on the therapist effect, meaning that some therapists were more successful than others. The control appeared to affect change. CONCLUSIONS: The outdoor mobility intervention provided in this study to these stroke patients was not clinically effective or cost-effective. However, the provision of personalised information and monthly diaries should be considered for all people who wish to get out more. TRIAL REGISTRATION: Current Controlled Trials ISRCTN58683841. FUNDING: This project was funded by the NIHR Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 18, No. 29. See the NIHR Journals Library website for further project information.