PeRsOnaliSed care Planning for oldER people with frailty (PROSPER): protocol for a randomised controlled trial.

BACKGROUND: Frailty is common in older age and is characterised by loss of biological reserves across multiple organ systems. These changes associated with frailty mean older people can be vulnerable to sudden, dramatic changes in health because of relatively small problems. Older people with frailty are at increased risk of adverse outcomes including disability, hospitalisation, and care home admission, with associated reduction in quality of life and increased NHS and social care costs. Personalised Care Planning offers an anticipatory, preventative approach to supporting older adults to live independently for longer, but it has not been robustly evaluated in a population of older adults with frailty. METHODS: Following an initial feasibility study, this multi-centre, individually randomised controlled trial aims to establish whether personalised care planning for older people improves health-related quality of life. It will recruit 1337 participants from general practices across Yorkshire and Humber and Mid-Mersey in the North of England. Eligible patients will be aged 65 and over with an electronic frailty index score of 0.21 or above, living in their own homes, without severe cognitive impairment and not in receipt of end-of-life care. Following confirmation of eligibility, informed consent and baseline data collection, participants will be individually randomised to the PeRsOnaliSed care Planning for oldER people with frailty (PROSPER) intervention or usual care in a 2.6:1 allocation ratio. Participants will not be blinded to allocation, but data collection and analysis will be blinded. The intervention will be delivered over 12 weeks by a Personal Independence Co-ordinator worker based within a voluntary sector organisation, Age UK. The primary outcomes are health-related quality of life, measured using both the physical and mental components of the Short-Form 12 Item Health Questionnaire at 12 months after randomisation. Secondary outcomes comprise activities of daily living, self-management capabilities and loneliness, admission to care homes, hospitalisations, and health and social care resource use at 12 months post randomisation. Parallel cost-effectiveness and process evaluations will be conducted alongside the trial. DISCUSSION: The PROSPER study will evaluate the effectiveness and cost-effectiveness of a personalised care planning approach for older people with frailty and inform the process of its implementation. TRIAL REGISTRATION: ISRCTN16123291 .  Registered on  28 August 2020.

New Horizons in artificial intelligence in the healthcare of older people.

Artificial intelligence (AI) in healthcare describes algorithm-based computational techniques which manage and analyse large datasets to make inferences and predictions. There are many potential applications of AI in the care of older people, from clinical decision support systems that can support identification of delirium from clinical records to wearable devices that can predict the risk of a fall. We held four meetings of older people, clinicians and AI researchers. Three priority areas were identified for AI application in the care of older people. These included: monitoring and early diagnosis of disease, stratified care and care coordination between healthcare providers. However, the meetings also highlighted concerns that AI may exacerbate health inequity for older people through bias within AI models, lack of external validation amongst older people, infringements on privacy and autonomy, insufficient transparency of AI models and lack of safeguarding for errors. Creating effective interventions for older people requires a person-centred approach to account for the needs of older people, as well as sufficient clinical and technological governance to meet standards of generalisability, transparency and effectiveness. Education of clinicians and patients is also needed to ensure appropriate use of AI technologies, with investment in technological infrastructure required to ensure equity of access.

Eligibility screening older research participants using remote cognitive assessment-experiences and reflections from a primary care randomised controlled trial.

BACKGROUND: The COVID-19 pandemic forced many research teams to adjust the way they conduct studies, including moving to remote delivery of some or all of their recruitment and data collection processes. The Montreal Cognitive Assessment (MoCA) is widely used in research and is available in multiple formats for different groups and assessment settings. Here, we reflect on our experiences of administering the MoCA Blind/Telephone as part of the initial telephone eligibility check for participation in a randomised controlled trial with community-dwelling older people with frailty. MAIN BODY: In response to COVID-19, a number of changes were made to the trial's screening and recruitment procedures, to minimise the amount of time the researchers would spend in the participants' homes when recruitment began in May 2021. One of the changes was for the researchers to conduct a cognitive assessment for eligibility during an initial telephone call, rather than during the subsequent home visit for consent and baseline data collection. We found that in comparison with conducting the assessment in-person, telephone administration caused uncertainty for the researchers about whether participants were struggling to answer questions due to cognition or hearing impairment. Some participants experienced practical difficulties when combining holding a telephone and completing one of the assessment items. It was hard for the researchers to judge the emotional impact that undertaking the assessment was having on the older people on the telephone, without visual warning signs of fatigue or mood. We discuss the potential impact of these issues on trial recruitment and participant engagement, and the feasibility of videoconferencing as an alternative method of conducting the MoCA. CONCLUSION: The MoCA is a useful tool when cognitive impairment is part of screening and data collection and it is helpful to have the option to use the test remotely. However, as we have found, telephone testing is not always straightforward. Researchers should weigh up the pros and cons for each individual study, especially those involving older adults. If choosing remote methods, consider the practicality of using videoconferencing and think about the possible impact of telephone assessment on the relationship with the (potential) research participants. TRIAL REGISTRATION: Personalised care planning for older people with frailty ISRCTN16123291 28/08/2020.

Implementing personalised care planning for older people with frailty: a process evaluation of the PROSPER feasibility trial.

BACKGROUND: Personalised Care Planning (PCP) is a collaborative approach used in the management of chronic conditions. Core components of PCP are shared decision making to achieve joint goal setting and action planning by the clinician and patient. We undertook a process evaluation within the PROSPER feasibility trial to understand how best to implement PCP for older people with frailty in the community. METHODS: The trial was set in two localities in England. We observed training sessions and intervention delivery at three time points during the 12-week intervention period. We interviewed delivery teams before, during and after the intervention period, as well as primary care staff. We interviewed older people who had received, declined or withdrawn from PCP. We explored training of staff delivering PCP, structures, mechanisms and resources needed for delivery, and influences on uptake. We undertook a framework approach to data analysis. FINDINGS: We observed thirteen training sessions and interviewed seven delivery staff, five primary care staff, and twenty older people, including seven who had declined or withdrawn from the intervention. Delivery teams successfully acquired skills and knowledge, but felt underprepared for working with people with lower levels of frailty. Timing of training was critical and 'top-ups' were needed. Engagement with primary care staff was tenuous. Older people with lower frailty were unclear of the intervention purpose and benefits, goal setting and action planning. CONCLUSIONS: PCP has the potential to address the individualised needs of older people with frailty. However, training requires careful tailoring and is ideally on-going. Considerable efforts are required to integrate statutory and voluntary stakeholders, understanding the expectations and contributions of each agency from the outset. In addition, older people with frailty need time and support to adjust to new ways of thinking about their own health now and in the future so they can participate in shared decision making. These key factors will be essential when developing models of care for delivering PCP to support older people with frailty to sustain their independence and quality of life. TRIAL REGISTRATION: ISRCTN 12,363,970 - 08/11/2018.

Social care costs for community-dwelling older people living with frailty.

International evidence indicates that older people with frailty are more likely to access social care services, compared to nonfrail older people. There is, however, no robust evidence on costs of social care provided for community-dwelling older people living with frailty in their own homes. The main objective of this study was to examine the relationship between community-dwelling older people living with frailty, defined using the cumulative deficit model, and annual formal social care costs for the 2012-2018 period. A secondary objective was to estimate formal social care spending for every 1% reduction in the number of older people who develop frailty over 1 year. Secondary analysis of prospective cohort data from two large nationally representative community-based cohort studies in England was performed. Respondents aged ≥75 were used in the main analysis and respondents aged 65-74 in sensitivity testing. We used regression tree modelling for formal social care cost analysis including frailty, age, gender, age at completing education and living with partner as key covariates. We employed a minimum node size stopping criteria to limit tree complexity and overfitting and applied 'bootstrap aggregating' to improve robustness. We assessed the impact of an intervention for every 1% decrease in the number of individuals who become frail over 1 year in England. Results show that frailty is the strongest predictor of formal social care costs. Mean social care costs for people who are not frail are £321, compared with £2,895 for individuals with frailty. For every 1% of nonfrail people not transitioning to frailty savings of £4.4 million in annual expenditures on formal social care in England are expected, not including expenditure on care homes. Given considerably higher costs for individuals classed as frail compared to nonfrail, a successful intervention avoiding or postponing the onset of frailty has the potential to considerably reduce social care costs.

Community Ageing Research 75+ (CARE75+) REMOTE study: a remote model of recruitment and assessment of the health, well-being and social circumstances of older people.

INTRODUCTION: The Community Ageing Research 75+ (CARE75+) study is a longitudinal cohort study collecting extensive health and social data, with a focus on frailty, independence and quality of life in older age. CARE75+ was the first international experimental frailty research cohort designed using trial within cohorts (TwiCs) methodology, aligning epidemiological research with clinical trial evaluation of interventions to improve the health and well-being of older people. CARE75+ REMOTE is an extension of CARE75+ using a remote model that does not require face-to-face interactions for data collection in the current circumstances of a global pandemic and will provide an efficient, sustainable data collection model. METHODS AND ANALYSIS: Prospective cohort study using TwiCs. One thousand community-dwelling older people (≥75 years) will be recruited from UK general practices by telephone. Exclusions include: nursing home/care home residents; those with an estimated life expectancy of 3 months or less; and people receiving palliative care. DATA COLLECTION: Assessments will be conducted by telephone, web-submission or postal questionnaire: baseline, 6 months, 12 months, 18 months, 24 months, 30 months and 36 months. Measures include activities of daily living, mood, health-related quality of life, comorbidities, medications, frailty, informal care, healthcare and social care service use. Consent will be sought for data linkage and invitations to additional studies (sub-studies). ETHICS AND DISSEMINATION: CARE75+ was approved by the National Research Ethics Service (NRES) Committee Yorkshire and the Humber-Bradford Leeds 10 October 2014 (14/YH/1120). CARE75+ REMOTE (amendment 13) was approved on the 18th November 2020. Consent is sought if an individual is willing to participate and has capacity to provide informed consent. Consultee assent is sought if an individual lacks capacity. Results will be disseminated in peer-reviewed scientific journals and conferences. Results will be summarised and disseminated to study participants via newsletters, local engagement events and on a bespoke website. TRIAL REGISTRATION NUMBER: ISRCTN16588124.

The cost of community research-recruiting community-dwelling participants to a feasibility primary care cluster randomised controlled trial.

BACKGROUND: To support a robust evidence base for the organisation and provision of community-delivered health services for older people, clinical trials need to be designed to account for community-based participant recruitment. There is currently little reported information available on the time and cost of recruiting community-dwelling older people, which makes the completion of cost attribution documentation problematic when applying for research funding. MAIN BODY: We aimed to establish the amount of researcher time it takes to recruit community-dwelling older people to a feasibility primary care cluster randomised controlled trial, including collecting baseline data. The trial was part of a programme of work investigating an intervention to improve the quality of life for older people with frailty. Two researchers conducting home visits to recruit and collect baseline data from participants recorded the time spent on travelling to and from the visit, at the visit itself and any associated administration. The median total researcher activity time per visit was 148 min. We discuss the various elements of recruitment and data collection activity and the factors that impacted the length of time taken, including location, individuals' capacity and cognition, hearing and visual impairment and the desire for social contact. CONCLUSION: Studies cannot reach their recruitment targets if they are unrealistically planned and resourced. We recommend that trials recruiting older people in the community allocate two and a half hours of researcher time per person, on average, for consent, baseline data collection, travel and administration. We acknowledge that a variety of different factors will mean that researcher activity will vary between different community-based trials. Our findings give a good starting point for timing calculations, and evidence on which to base the justification of research activity costings. TRIAL REGISTRATION: Personalised care planning for older people with frailty ISRCTN12363970 . 08/11/2018.

Behaviour change techniques in personalised care planning for older people: a systematic review.

BACKGROUND: Personalised care planning (PCP) interventions have the potential to provide better outcomes for older people and are a key focus in primary care practice. Behaviour change techniques (BCTs) can maximise effectiveness of such interventions, but it is uncertain which BCTs are most appropriate in PCP for older adults. AIM: To identify BCTs used in successful PCP interventions for older people aged ≥65 years. DESIGN AND SETTING: Systematic review. METHOD: The authors searched 12 databases from date of inception to 30 September 2017. They identified randomised controlled trials (RCTs) of interventions involving participants aged ≥65 years, and contextually related to PCP. Five areas of risk of bias were assessed. The Michie et al, BCT taxonomy was used for coding. RESULTS: Twenty-three RCTs involving 6489 participants (average age 74 years) described PCP interventions targeting the general older adult population and older people with specific long-term conditions (for example, heart disease, diabetes, stroke). Just over half of the studies were deemed to be at a low risk of bias. Eleven 'promising' BCTs were identified in five trials reporting significant improvements in quality of life (QoL). Six BCTs were reported in all five of these trials: 'goal setting', 'action planning', 'problem solving', 'social support', 'instructions on how to perform a behaviour', and 'information on health consequences'. Modes of delivery varied. CONCLUSION: Future PCP interventions to improve QoL for people aged ≥65 years may benefit from focusing on six specific BCTs. Better reporting of BCTs would enhance future design and implementation of such interventions.

Normative Estimates and Agreement Between 2 Measures of Health-Related Quality of Life in Older People With Frailty: Findings From the Community Ageing Research 75+ Cohort.

BACKGROUND: Previous studies have summarized evidence on health-related quality of life for older people, identifying a range of measures that have been validated, but have not sought to present results by degree of frailty. Furthermore, previous studies did not typically use quality-of-life measures that generate an overall health utility score. Health utility scores are a necessary component of quality-adjusted life-year calculations used to estimate the cost-effectiveness of interventions. METHODS: We calculated normative estimates in mean and standard deviation for EQ-5D-5L, short-form 36-item health questionnaire in frailty (SF-36), and short-form 6-dimension (SF-6D) for a range of established frailty models. We compared response distributions across dimensions of the measures and investigated agreement using Bland-Altman and interclass correlation techniques. RESULTS: The EQ-5D-5L, SF-36, and SF-6D scores decrease and their variability increases with advancing frailty. There is strong agreement between the EQ-5D-5L and SF-6D across the spectrum of frailty. Agreement is lower for people who are most frail, indicating that different components of the 2 instruments may have greater relevance for people with advancing frailty in later life. There is a greater risk of ceiling effects using the EQ-5D-5L rather than the SF-6D. CONCLUSIONS: We recommend the SF-36/SF-6D as an appropriate measure of health-related quality of life for clinical trials if fit older people are the planned target. In trials of interventions involving older people with increasing frailty, we recommend that both the EQ-5D-5L and SF36/SF6D are included, and are used in sensitivity analyses as part of cost-effectiveness evaluation.

Study protocol for a cluster randomised controlled feasibility trial evaluating personalised care planning for older people with frailty: PROSPER V2 27/11/18.

BACKGROUND: Frailty is characterised by increased vulnerability to falls, disability, hospitalisation and care home admission. However, it is relatively reversible in the early stages. Older people living with frailty often have multiple health and social issues which are difficult to address but could benefit from proactive, person-centred care. Personalised care planning aims to improve outcomes through better self-management, care coordination and access to community resources. METHODS: This feasibility cluster randomised controlled trial aims to recruit 400 participants from 11 general practice clusters across Bradford and Leeds in the north of England. Eligible patients will be aged over 65 with an electronic frailty index score of 0.21 (identified via their electronic health record), living in their own homes, without severe cognitive impairment and not in receipt of end of life care. After screening for eligible patients, a restricted 1:1 cluster-level randomisation will be used to allocate practices to the PROSPER intervention, which will be delivered over 12 weeks by a personal independence co-ordinator worker, or usual care. Following initial consent, participants will complete a baseline questionnaire in their own home including measures of health-related quality of life, activities of daily living, depression and health and social care resource use. Follow-up will be at six and 12 months. Feasibility outcomes relate to progression criteria based around recruitment, intervention delivery, retention and follow-up. An embedded process evaluation will contribute to iterative intervention optimisation and logic model development by examining staff training, intervention implementation and contextual factors influencing delivery and uptake of the intervention. DISCUSSION: Whilst personalised care planning can improve outcomes in long-term conditions, implementation in routine settings is poor. We will evaluate the feasibility of conducting a cluster randomised controlled trial of personalised care planning in a community population based on frailty status. Key objectives will be to test fidelity of trial design, gather data to refine sample size calculation for the planned definitive trial, optimise data collection processes and optimise the intervention including training and delivery. TRIAL REGISTRATION: ISRCTN12363970 - 08/11/18.

Recruiting older people from the Pakistani community in Community Ageing Research 75.

Older people from a South Asian background, particularly Pakistanis, are under-represented in health research, possibly because their recruitment to studies is hampered by language barriers and cultural differences. This article describes the observations of two bi-lingual researchers (FM and IJ) who successfully recruited older people (≥75 years) from Bradford's South Asian population to the Community Ageing Research 75+ Study (CARE 75+), a longitudinal cohort study collecting an extensive range of health, social and economic outcome data. The researchers recruited non-English-speaking Pakistani participants, ensuring they were flexible with appointments to accommodate the wishes of family members, who were often present during consent and assessment visits. Using community language was an important facilitator, and questions (and constructs) were translated to the community dialect (Potwari). To date, 233 South Asian people have been invited to participate in CARE75+, and 78 have been recruited (recruitment rate=33%), of which 62 are of Pakistani origin. The observed recruitment rate for South Asian participants is comparable to that of the whole study population (36%). Language barriers should not be used as a basis for excluding participants from research studies. Appropriate facilitation, through skilled researchers who have knowledge of, and are attuned to, the cultural sensitivities of the community, can allow recruitment of BME participants to research studies.

Community ageing research 75+ study (CARE75+): an experimental ageing and frailty research cohort.

INTRODUCTION: The Community Ageing Research 75+ Study (CARE75+) is a longitudinal cohort study collecting an extensive range of health, social and economic data, with a focus on frailty, independence and quality of life in older age. CARE75+ is the first international experimental frailty research cohort designed using Trial within Cohorts (TwiCs) methodology, to align applied epidemiological research with clinical trial evaluation of interventions to improve the health and well-being of older people living with frailty. METHODS AND ANALYSIS: Prospective cohort study using a TwiCs design. One thousand community-dwelling older people (≥75 years) will be recruited from UK general practices. Nursing home residents, those with an estimated life expectancy of 3 months or less and people receiving palliative care will be excluded. Data collection assessments will be face to face in the person's home at baseline, 6 months, 12 months, 24 months and 48 months, including assessments of frailty, cognition, mood, health-related quality of life, comorbidity, medications, resilience, loneliness, pain and self-efficacy. A modified protocol for follow-up by telephone or web based will be offered at 6 months. Consent will be sought for data linkage and invitations to additional studies, including intervention studies using the TwiCs design. A blood sample biobank will be established for future basic science studies. ETHICS AND DISSEMINATION: CARE75+ was approved by the NRES Committee Yorkshire and the Humber-Bradford Leeds 10 October 2014 (14/YH/1120). Formal written consent is sought if an individual is willing to participate and has capacity to provide informed consent. Consultee assent is sought if an individual lacks capacity.Study results will be disseminated in peer-reviewed scientific journals and scientific conferences. Key study results will be summarised and disseminated to all study participants via newsletters, local older people's publications and local engagement events. Results will be reported on a bespoke CARE75+ website. TRIAL REGISTRATION NUMBER: ISRCTN16588124;Results stage.

Convergent validity of the electronic frailty index.

Background: the electronic frailty index (eFI) has been developed and validated using routine primary care electronic health record data. The focus of the original big data study was on predictive validity as a form of criterion validation. Convergent validity is a subtype of construct validity and considered a core component of the validity of a test. Objective: to investigate convergent validity between the eFI and research standard frailty measures. Design: cross-sectional validation study using data from the Community Ageing Research 75+ (CARE 75+) cohort. Setting: multi-site UK community-based cohort study. Subjects: three hundred fifty-three community-dwelling older people (median age 80 years, IQR 77-84), excluding care home residents and people in the terminal stage of life. Median eFI score of participants was 0.22 (IQR 0.14-0.31). Methods: convergent validities between the eFI and: a research standard frailty index (FI); the phenotype model of frailty; Clinical Frailty Scale (CFS) and Edmonton Frail Scale were assessed using scatter plots and Spearman's rank tests to estimate correlation coefficients (Spearman's rho, ρ) and 95% confidence intervals. Results: results indicate strong correlation between the eFI and both the research standard FI (ρ = 0.68, 95% CI 0.62-0.74) and Edmonton Frail Scale (ρ = 0.63, 95% CI 0.57-0.69). There was evidence for moderate correlation between the eFI and both the CFS (ρ = 0.59, 95% CI 0.49-0.65) and phenotype model (ρ = 0.51, 95% CI 0.42-0.59). Conclusions: This study provides evidence for convergent validity of the eFI, a core component of test validity.

The PiTSTOP study: a feasibility cluster randomized trial of delirium prevention in care homes for older people.

BACKGROUND AND OBJECTIVES: delirium is a distressing but potentially preventable condition common in older people in long-term care. It is associated with increased morbidity, mortality, functional decline, hospitalization and significant healthcare costs. Multicomponent interventions, addressing delirium risk factors, have been shown to reduce delirium by one-third in hospitals. It is not known whether this approach is also effective in long-term care. In previous work, we designed a bespoke delirium prevention intervention, called 'Stop Delirium!' In preparation for a definitive trial of Stop Delirium, we sought to address key aspects of trial design for the particular circumstances of care homes. DESIGN: a cluster randomized feasibility study with an embedded process evaluation. SETTING AND PARTICIPANTS: residents of 14 care homes for older people in one metropolitan district in the UK. INTERVENTION: Stop Delirium!: a 16-month-enhanced educational package to support care home staff to address key delirium risk factors. Control homes received usual care. MEASUREMENTS: we collected data to determine the following: recruitment and attrition; delirium rates and variability between homes; feasibility of measuring delirium, resource use, quality of life, hospital admissions and falls; and intervention implementation and adherence. RESULTS: two-thirds (215) of eligible care home residents were recruited. One-month delirium prevalence was 4.0% in intervention and 7.1% in control homes. Proposed outcome measurements were feasible, although our approach appeared to underestimate delirium. Health economic evaluation was feasible using routinely collected data. CONCLUSION: a definitive trial of delirium prevention in long-term care is needed but will require some further design modifications and pilot work.

Keeping it credible in cohort multiple Randomised Controlled Trials: the Community Ageing Research 75+ (CARE 75+) study model of patient and public involvement and engagement.

PLAIN ENGLISH SUMMARY: There are well documented benefits to involving patients and the public in research. However, there is little research published about their involvement in large complex studies such as cohort multiple Randomised Controlled Trials (cmRCTs). The cmRCT method establishes a group of participants, with a common characteristic (e.g. older people) who will be followed over a number of years. Other (sub) studies can also recruit from this pool of people. This method offers researchers many advantages, including being able to recruit from more hard to reach groups. However, cmRCTs also have features which can make it more complicated to involve patients and the public. For example more than one study may take place at the same time; studies may be spread out over a large geographical area and they may include a wide range of topics. In spite of these difficulties we have developed a way of working with patients, the public and researchers that provides stability over time but allows flexibility along the way. Our model of working has saved us time and money; helped us to recruit more widely, and enabled us to focus our research in areas that are important to older people with frailty. ABSTRACT: Background There is increasing guidance on how to make the most of the rich seam of data provided by large cohort studies, and growing recognition of the benefits of cohort multiple Randomised Controlled Trials (cmRCT) in health research. In contrast, there is a lack of discussion about patient and public involvement and engagement (PPIE) in these large and complex research infrastructures. Our aim was to create a structure to enable meaningful, sustainable public involvement within the cmRCT framework. We have established a core reference group of four key individuals with extensive links to other relevant local community structures and individuals. Results Using the CARE 75+ model we have engaged with a wide variety of patients and the public in a relatively short space of time. Activities have included scrutiny of protocols and assessment tools, and process evaluations; resulting in system efficiencies, increased recruitment and a more focused research agenda. Conclusions There is a need for strong public oversight and flexible models of PPIE in cmRCTs. The model of PPIE developed in the Community Ageing Research 75+ study presents one potential way to foster expertise and enable diversity.

Pilot trial of Stop Delirium! (PiTStop)--a complex intervention to prevent delirium in care homes for older people: study protocol for a cluster randomised controlled trial.

BACKGROUND: Delirium (or acute confusion) is a serious illness common in older people, in which a person's thinking and perceptions may be affected. Reducing delirium is important because of the considerable distress it causes, and the poor outcomes associated with it, such as increased admissions to hospital, falls, mortality and costs to the National Health Service (NHS). Preventing delirium is possible using multicomponent interventions; successful interventions in hospitals have reduced it by one-third. However, there is little research to guide practice in care homes, where it is common because of the clustering of known risk factors (older age, frailty, and dementia). In previous work we developed a multicomponent intervention to prevent delirium in care homes, called Stop Delirium! The intervention was based upon evidence from the research literature relating to the prevention of delirium and on strategies to change professional practice. Before starting a large costly trial of Stop Delirium!, this pilot study will test and help improve the design and feasibility of the trial protocol. METHODS/DESIGN: We plan to conduct a cluster randomised pilot trial in 14 care homes (independent residential and nursing). Following recruitment of residents (over 60 years, consenting or with consultee agreement, able to communicate in English, and not in palliative care) participating homes will be randomised, stratified by size of home and proportion of residents with dementia. Stop Delirium! will be delivered to intervention homes over 16 months, with controls receiving usual care. The primary outcome measure will be the presence of delirium on any day during a one-month post-intervention period.We will collect data to determine 1) recruitment and attrition rates, 2) feasibility of various outcomes measurements, and 3) feasibility of capturing health resource use (resident diaries and by examining health records). We will estimate the between-cluster variation for the primary outcome, delirium occurrence. DISCUSSION: This pilot study will refine methods for the definitive trial. The lessons learnt will also contribute to implementing National Institute for Health and Clinical Excellence (NICE) delirium guidelines, which recommend multicomponent interventions for delirium prevention. TRIAL REGISTRATION: ISRCTN27972532.

Interventions for preventing delirium in older people in institutional long-term care.

BACKGROUND: Delirium is a common and distressing complication of a range of stressor events including infection, new medications and environment change that is often experienced by older people with frailty and dementia. Older people living in institutional long-term care (LTC)are at high risk of delirium, which increases the risk of admission to hospital, development of or worsening of dementia, and mortality.Delirium is also associated with substantial healthcare costs. Although it is possible to prevent delirium in the hospital setting by providing multicomponent delirium prevention interventions it is currently unclear whether interventions to prevent delirium in LTCare effective. OBJECTIVES: To assess the effectiveness of interventions for preventing delirium in older people in long term care. SEARCH METHODS: We searched ALOIS (www.medicine.ox.ac.uk/alois) - the Cochrane Dementia and Cognitive Improvement Group's Specialised Register- on 23 April 2013. The search was as sensitive as possible to identify all studies on ALOIS relating to delirium. We ran additional separate searches in major healthcare databases, trial registers, the Cochrane Central Register of Controlled Trials (CENTRAL) and grey literature sources, to ensure that the search was as comprehensive as possible. SELECTION CRITERIA: We included randomised controlled trials (RCTs) and cluster-randomised controlled trials (cluster-RCTs) of single- and multi componentn on-pharmacological and pharmacological interventions for preventing delirium in older people (aged 65 years and over) in permanent LTC residence. DATA COLLECTION AND ANALYSIS: Two independent review authors examined the titles and abstracts of citations identified by the search for eligibility and extracted data, with any disagreements settled by consensus. Primary outcomes were prevalence, incidence and severity of delirium. Secondary outcomes included new diagnosis of dementia, activities of daily living, quality of life and adverse outcomes. We used risk ratios (RRs)as measures of treatment effect for dichotomous outcomes and hazard ratios (HR) for time to event data.Main results We included two trials that recruited 3636 participants.Both were complex single-component non-pharmacological delirium prevention interventions. Risk of bias for many items was unclear due to inadequate reporting. Notably, there was no evidence of blinding of trial participants or assessors in either trial. One small cluster-RCT (n = 98) of a hydration-based intervention reported no reduction in delirium incidence in the intervention group compared to control (RR 0.85, 95% confidence interval (CI) 0.18 to 4.00, analysis not adjusted for clustering, very low quality evidence). Results were imprecise and there were serious limitations evident in trial design.One large cluster-RCT (n = 3538) of a computerised system to identify medications that may contribute to delirium risk and trigger a pharmacist-led medication review reported a large reduction in delirium incidence (12-month HR 0.42, CI 0.34 to 0.51, moderat equality evidence) but no clear evidence of reduction in hospital admissions (HR 0.89, CI 0.72 to 1.10, moderate quality evidence), in mortality (HR 0.88, CI 0.66 to 1.17, moderate quality evidence) or in falls risk (HR 1.03, CI 0.92 to 1.15, moderate quality evidence).Authors' conclusions Our review identified very limited evidence on interventions for preventing deliriumin older people in LTC. Introduction of a software based intervention to identify medications that could contribute to delirium risk so that a pharmacist-led medication review and monitoring plan can be initiated may reduce incidence of delirium for older people in institutional LTC. This is based on one large RCT in the United States and may not be practical in other countries which do not have comparable information technology services available in care homes. Our review identified only one ongoing pilot trial of a multicomponent delirium prevention intervention and no trials of pharmacological agents. Future trials of computerised medication management systems and multicomponent non-pharmacological and pharmacological delirium prevention interventions for older people in LTC are needed to help inform the provision of evidence based care for this vulnerable group.