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AbstractObjectivesTo determine the clinical and cost effectiveness of a multifactorial fall prevention programme compared with usual care in long term care homes.DesignMulticentre, parallel, cluster randomised controlled trial.SettingLong term care homes in the UK, registered to care for older people or those with dementia.Participants1657 consenting residents and 84 care homes. 39 were randomised to the intervention group and 45 were randomised to usual care.InterventionsGuide to Action for Care Homes (GtACH): a multifactorial fall prevention programme or usual care.Main outcome measuresPrimary 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.ResultsMean 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.ConclusionsThe GtACH programme was associated with a reduction in fall rate and cost effectiveness, without a decrease in activity or increase in dependency.Trial registrationISRCTN34353836.

Background Dementia often eventually leads to dependency on others and finally to residential care. However, in Norway about half of the dementia population lives at home, due to individual and political wishes. There is scarce and inconclusive knowledge of how living in a nursing home differs from living at home for persons with dementia (PWDs) with regard to their quality of life (QoL). The first aim of the study was therefore to compare QoL, cognitive and physical functions, social contacts, sleep patterns, physical activity levels, exposure to light, and medication of PWDs in nursing homes and home-dwelling PWDs, and whether living in nursing homes was associated with a lower QoL than living at home for PWDs. A second aim was to examine if possible differences between residencies in QoL were consistent over time. Methods The cross-sectional study was based on baseline data from two RCT studies of PWDs. A total of 15 nursing homes with adapted units for PWDs and 23 adapted day care centres for home-dwelling PWDs recruited 78 and 115 participants respectively. Trained nurses scored sociodemographic data, level of dementia (on the Clinical Dementia Rating scale), amount of medication, and QoL (QUALID). Sleep patterns, physical activity levels, and light exposure were measured by actigraphy. A multiple regression analysis was used to test the association between residency and QoL. The association between residency and change in QoL over time was investigated by linear regression analysis of a subsample with follow-up data. Results Home-dwelling PWDs showed significantly higher QoL than PWDs in nursing homes. This difference was maintained even after stratifying on the severity of dementia. Home-dwelling PWDs with moderate dementia showed significantly less use of walking aids, more social contact, higher levels of activity and exposure to daylight, and less use of psychotropic medications. The regression model explained 28 % of the variance in QoL in persons with moderate dementia. However, only residency contributed significantly in the model. Residency also significantly predicted negative change over time in QoL. Conclusion The study indicated that living at home as long as possible is not only desirable for economic or health political reasons but also is associated with higher QoL for persons with moderate dementia. More studies are needed to investigate how QoL could be increased for PWDs in nursing homes.

Background Trials are at risk of contamination bias which can occur when participants in the control group are inadvertently exposed to the intervention. This is a particular risk in rehabilitation studies where it is easy for trial interventions to be either intentionally or inadvertently adopted in control settings. The Falls in Care Homes (FinCH) trial is used in this paper as an example of a large randomised controlled trial of a complex intervention to explore the potential risks of contamination bias. We outline the FinCH trial design, present the potential risks from contamination bias, and the strategies used in the design of the trial to minimise or mitigate against this. The FinCH trial was a multi-centre randomised controlled trial, with embedded process evaluation, which evaluated whether systematic training in the use of the Guide to Action Tool for Care Homes reduced falls in care home residents. Data were collected from a number of sources to explore contamination in the FinCH trial. Where specific procedures were adopted to reduce risk of, or mitigate against, contamination, this was recorded. Data were collected from study e-mails, meetings with clinicians, research assistant and clinician network communications, and an embedded process evaluation in six intervention care homes. During the FinCH trial, there were six new falls prevention initiatives implemented outside the study which could have contaminated our intervention and findings. Methods used to minimise contamination were: cluster randomisation at the level of care home; engagement with the clinical community to highlight the risks of early adoption; establishing local collaborators in each site familiar with the local context; signing agreements with NHS falls specialists that they would maintain confidentiality regarding details of the intervention; opening additional research sites; and by raising awareness about the importance of contamination in research among participants. Conclusion Complex rehabilitation trials are at risk of contamination bias. The potential for contamination bias in studies can be minimized by strengthening collaboration and dialogue with the clinical community. Researchers should recognise that clinicians may contaminate a study through lack of research expertise.

Objective To determine whether vaccination of care home staff against influenza indirectly protects residents. Design Pair matched cluster randomised controlled trial. Setting Large private chain of UK care homes during the winters of 2003-4 and 2004-5. Participants Nursing home staff (n=1703) and residents (n=2604) in 44 care homes (22 intervention homes and 22 matched control homes). Interventions Vaccination offered to staff in intervention homes but not in control homes. Main outcome measures The primary outcome was all cause mortality of residents. Secondary outcomes were influenza-like illness and health service use in residents. Results In 2003-4 vaccine coverage in full time staff was 48.2% (407/884) in intervention homes and 5.9% (51/859) in control homes. In 2004-5 uptake rates were 43.2% (365/844) and 3.5% (28/800). National influenza rates were substantially below average in 2004-5. In the 2003-4 period of influenza activity significant decreases were found in mortality of residents in intervention homes compared with control homes (rate difference −5.0 per 100 residents, 95% confidence interval −7.0 to −2.0) and in influenza-like illness (P=0.004), consultations with general practitioners for influenza-like illness (P=0.008), and admissions to hospital with influenza-like illness (P=0.009). No significant differences were found in 2004-5 or during periods of no influenza activity in 2003-4. Conclusions Vaccinating care home staff against influenza can prevent deaths, health service use, and influenza-like illness in residents during periods of moderate influenza activity. Trial registration National Research Register N0530147256.

Background The COME-ON study was a cluster-controlled trial of a complex intervention that consisted of a blended training program, local interdisciplinary meetings, and interdisciplinary case conferences in Belgian nursing homes. The intervention was associated with significant improvements in the appropriateness of prescribing. The aims of this study were to describe the implementation of the intervention and to explore the experiences of participants, for the purpose of identifying factors associated with implementation and perceived impact and to draw lessons for future implementation. Methods We performed a mixed-method process evaluation. Questionnaires and reports were used to collect quantitative data on implementation and experiences from the 24 NHs and participating healthcare professionals (coordinating physicians, general practitioners, pharmacists, and nurses) in the intervention group. Multidisciplinary focus groups focusing on factors associated with implementation and perceived impact were conducted in 11 NHs. Results Overall, the rate of implementation and the satisfaction of participants were good, despite some variability between NHs and HCPs. Although perceived impact on nursing home residents varied, most participants perceived a positive impact for themselves. Factors associated with implementation and perceived impact were identified at different levels: intervention, healthcare professionals, organization, and external context. The interdisciplinary and face-to-face approaches were recognized as key elements for the success of the intervention, despite organizational constraints. The attitude of general practitioners was identified both as a barrier to and a facilitator for implementation and its success. The professional role and competency of the pharmacist influenced perceived impact. The pre-existing relationships between HCPs and the presence of a leader facilitated implementation and perceived impact. Remuneration was deemed necessary for the study and for future implementation. Conclusions Overall, the intervention, and more specifically its interdisciplinary aspect, was well implemented and appreciated by HCPs. This probably contributed to the positive effect on the appropriateness of prescribing. Future implementation must take into account the various factors found to affect implementation and perceived impact, in order to maximize effect and sustainability. Trial registration Current Controlled Trials ISRCTN66138978; registered 18 November 2015, retrospectively registered, https://www.isrctn.com/ISRCTN66138978

Abstract Objective To assess the effect of family style mealtimes on quality of life, physical performance, and body weight of nursing home residents without dementia. Design Cluster randomised trial. Setting Five Dutch nursing homes. Participants 178 residents (mean age 77 years). Two wards in each home were randomised to intervention (95 participants) or control groups (83). Intervention During six months the intervention group took their meals family style and the control group received the usual individual pre-plated service. Main outcome measures Quality of life (perceived safety; autonomy; and sensory, physical, and psychosocial functioning), gross and fine motor function, and body weight. Results The difference in change between the groups was significant for overall quality of life (6.1 units, 95% confidence interval 2.1 to 10.3), fine motor function (1.8 units, 0.6 to 3.0), and body weight (1.5 kg, 0.6 to 2.4). Conclusion Family style mealtimes maintain quality of life, physical performance, and body weight of nursing home residents without dementia. Trial registration Clinical trials NCT00114582

Abstract Objective To assess whether a multifaceted intervention can reduce the number of prescriptions for antimicrobials for suspected urinary tract infections in residents of nursing homes. Design Cluster randomised controlled trial. Setting 24 nursing homes in Ontario, Canada, and Idaho, United States. Participants 12 nursing homes allocated to a multifaceted intervention and 12 allocated to usual care. Outcomes were measured in 4217 residents. Interventions Diagnostic and treatment algorithm for urinary tract infections implemented at the nursing home level using a multifaceted approach—small group interactive sessions for nurses, videotapes, written material, outreach visits, and one on one interviews with physicians. Main outcome measures Number of antimicrobials prescribed for suspected urinary tract infections, total use of antimicrobials, admissions to hospital, and deaths. Results Fewer courses of antimicrobials for suspected urinary tract infections per 1000 resident days were prescribed in the intervention nursing homes than in the usual care homes (1.17 v 1.59 courses; weighted mean difference −0.49, 95% confidence intervals −0.93 to −0.06). Antimicrobials for suspected urinary tract infection represented 28.4% of all courses of drugs prescribed in the intervention nursing homes compared with 38.6% prescribed in the usual care homes (weighted mean difference −9.6%, −16.9% to −2.4%). The difference in total antimicrobial use per 1000 resident days between intervention and usual care groups was not significantly different (3.52 v 3.93; weighted mean difference −0.37, −1.17 to 0.44). No significant difference was found in admissions to hospital or mortality between the study arms. Conclusion A multifaceted intervention using algorithms can reduce the number of antimicrobial prescriptions for suspected urinary tract infections in residents of nursing homes.

Key Points Highlights poor oral health of care home residents in Wales and compares their oral health status to similar age older people living in the community. Highlights need for better oral care and prevention and monitoring mechanism. Background UK adult dental health surveys (ADHS) exclude care home residents from sampling. Aim To understand oral health status of care home residents in Wales using ADHS criteria. Method Cross sectional survey of care home residents in Wales using a questionnaire and oral examination contemporaneous with, and paralleling, the ADHS 2009. 708 randomly selected participants from 213 randomly selected care homes participated including individuals with and without capacity. Results 72.8% of residents had tooth decay. Compared to older adults examined in the ADHS, residents are less likely to brush teeth/dentures twice a day (37% vs 63%), more likely to only attend a dentist when they have a problem (63% vs 26%), have more teeth with active decay (3.1 vs 0.9), more have current dental pain (13% vs 5%) and other morbidity (open pulp, ulceration, fistulae, abscess 27% vs 10%). High decay is present in both recently admitted and longer term residents. There was some regional variation in levels of oral hygiene. Conclusion Oral health status of older people resident in care homes in Wales is poor. Findings suggest more could be done to improve preventive care both before and after admission to the care home.

The aim of this study was to evaluate the effectiveness of carers' education on improvements in oral health and denture hygiene of care-dependent and cognitively impaired older people in nursing homes compared to those without intervention. A total of 219 seniors living in 14 nursing homes in southwest Germany (intervention: n=144; control: n=75) were enrolled in this study. For each participant, Plaque Control Record (PCR), Gingival Bleeding Index (GBI), Denture Hygiene Index (DHI) and Community Periodontal Index of Treatment Needs (CPITN) were assessed at baseline and six months following the interventions. In addition, demographic parameters such as age, sex, chronic diseases, permanent medications, level of dependency and cognitive state were recorded. In the intervention homes, education for caregivers was provided and ultrasound baths for denture cleaning were implemented. Changes in the dental target variables PCR, GBI, CPITN and DHI during the six-month study period were compared between subjects in the intervention and the control groups as well as between subjects with and without dementia. Additionally, multivariate models were compiled for each dental index to evaluate possible confounders. In the intervention group, PCR and DHI significantly improved during the study period ( <0.001). Oral health and denture hygiene improved likewise in subjects with and without dementia. In the control group, no significant improvements were observed ( >0.05). Carers' education improves oral health of people in nursing homes over a clinically relevant period of time. Implementation of ultrasound baths is a simple and effective measure to improve denture hygiene of both institutionalized elderly people and seniors with dementia and in severe need of care. From a clinical standpoint, it is noteworthy that the respective interventions can be easily implemented in everyday care routine.

IntroductionMany people living with advanced dementia live and die in nursing care homes. The quality of life, care and dying experienced by these people is variable. Namaste Care is a multisensory programme of care developed for people with advanced dementia. While there is emerging evidence that Namaste Care may be beneficial for people with dementia, there is a need to conduct a feasibility study to establish the optimum way of delivering this complex intervention and whether benefits can be demonstrated in end-of-life care, for individuals and service delivery. The aim of the study is to ascertain the feasibility of conducting a full trial of the Namaste Care intervention.Methods and analysisA feasibility study, comprising a parallel, two-arm, multicentre cluster controlled randomised trial with embedded process and economic evaluation. Nursing care homes (total of eight) who deliver care to those with advanced dementia will be randomly allocated to intervention (delivered at nursing care home level) or control. Three participant groups will be recruited: residents with advanced dementia, informal carers of a participating resident and nursing care home staff. Data will be collected for 6 months. Feasibility objectives concern the recruitment and sampling of nursing homes, residents, informal carers and staff; the selection and timing of primary (quality of dying and quality of life) and secondary clinical outcome measures (person centredness, symptom presence, agitation, quality of life, resource use and costs and residents’ activity monitored using actigraphy). Acceptability, fidelity and sustainability of the intervention will be assessed using semistructured interviews with staff and informal carers.Ethics and disseminationThis protocol has been approved by NHS Wales Research Ethics Committee 5 (ref: 17/WA0378). Dissemination plans include working with a public involvement panel, through a website (http://www.namastetrial.org.uk), social media, academic and practice conferences and via peer reviewed publications.Trial registration number ISRCTN14948133; Pre-results.