Outcome measures from international older adult care home intervention research: a scoping review.

BACKGROUND: Care homes are increasingly important settings for intervention research to enhance evidence-informed care. For such research to demonstrate effectiveness, it is essential that measures are appropriate for the population, setting and practice contexts. OBJECTIVE: To identify care home intervention studies and describe the resident outcome measures used. DESIGN: Scoping review. METHODS: We reviewed international care home research published from 2015 to August 2022. We searched MEDLINE, EMBASE, CINAHL and ASSIA. We included any intervention study conducted in a care home, reporting resident outcomes. We extracted resident outcome measures, organised these using the domains of an adapted framework and described their use. RESULTS: From 7,330 records screened, we included 396 datasets reported in 436 publications. These included 12,167 care homes and 836,842 residents, with an average of 80 residents per study. The studies evaluated 859 unique resident outcomes 2,030 times using 732 outcome measures. Outcomes were evaluated between 1 and 112 times, with 75.1% of outcomes evaluated only once. Outcome measures were used 1-120 times, with 68.4% of measures used only once. Only 14 measures were used ≥20 times. Functional status, mood & behaviour and medications were the commonest outcome domains assessed. More than half of outcomes were assessed using scales, with a fifth using existing records or administrative data. CONCLUSIONS: There is significant heterogeneity in the choice and assessment of outcomes for intervention research in care homes. There is an urgent need to develop a consensus on useful and sensitive tools for care homes, working with residents, families and friends and staff.

Contextual factors influencing complex intervention research processes in care homes: a systematic review and framework synthesis.

BACKGROUND: Care homes are complex settings to undertake intervention research. Barriers to research implementation processes can threaten studies' validity, reducing the value to residents, staff, researchers and funders. We aimed to (i) identify and categorise contextual factors that may mediate outcomes of complex intervention studies in care homes and (ii) provide recommendations to minimise the risk of expensive research implementation failures. METHODS: We conducted a systematic review using a framework synthesis approach viewed through a complex adaptive systems lens. We searched: MEDLINE, Embase, CINAHL, ASSIA databases and grey literature. We sought process evaluations of care home complex interventions published in English. Narrative data were indexed under 28 context domains. We performed an inductive thematic analysis across the context domains. RESULTS: We included 33 process evaluations conducted in high-income countries, published between 2005 and 2019. Framework synthesis identified barriers to implementation that were more common at the task and organisational level. Inductive thematic analysis identified (i) avoiding procedural drift and (ii) participatory action and learning as key priorities for research teams. Research team recommendations include advice for protocol design and care home engagement. Care home team recommendations focus on internal resources and team dynamics. Collaborative recommendations apply to care homes' individual context and the importance of maintaining positive working relationships. DISCUSSION: Researchers planning and undertaking research with care homes need a sensitive appreciation of the complex care home context. Study implementation is most effective where an intervention is co-produced, with agreed purpose and adequate resources to incorporate within existing routines and care practices.

The uptake and use of a minimum data set (MDS) for older people living and dying in care homes: a realist review.

BACKGROUND: Care homes provide long term care for older people. Countries with standardised approaches to residents' assessment, care planning and review (known as minimum data sets (MDS)) use the aggregate data to guide resource allocation, monitor quality, and for research. Less is known about how an MDS affects how staff assess, provide and review residents' everyday care. The review aimed to develop a theory-driven understanding of how care home staff can effectively implement and use MDS to plan and deliver care for residents. METHODS: The realist review was organised according to RAMESES (Realist And Meta-narrative Evidence Synthesis: and Evolving Standards) guidelines. There were three overlapping stages: 1) defining the scope of the review and theory development on the use of minimum data set 2) testing and refining candidate programme theories through iterative literature searches and stakeholders' consultations as well as discussion among the research team; and 3) data synthesis from stages 1 and 2. The following databases were used MEDLINE via OVID, Embase, CINAHL (Cumulative Index to Nursing and Allied Health Literature), ASSIA [Applied Social Sciences Citation Index and Abstracts]) and sources of grey literature. RESULTS: Fifty-one papers informed the development of three key interlinked theoretical propositions: motivation (mandates and incentives for Minimum Data Set completion); frontline staff monitoring (when Minimum Data Set completion is built into the working practices of the care home); and embedded recording systems (Minimum Data Set recording system is integral to collecting residents' data). By valuing the contributions of staff and building on existing ways of working, the uptake and use of an MDS could enable all staff to learn with and from each other about what is important for residents' care CONCLUSIONS: Minimum Data Sets provides commissioners service providers and researchers with standardised information useful for commissioning planning and analysis. For it to be equally useful for care home staff it requires key activities that address the staff experiences of care, their work with others and the use of digital technology. REGISTRATION: PROSPERO registration number CRD42020171323.

Effects of the Norfolk diabetes prevention lifestyle intervention (NDPS) on glycaemic control in screen-detected type 2 diabetes: a randomised controlled trial.

BACKGROUND: The purpose of this trial was to test if the Norfolk Diabetes Prevention Study (NDPS) lifestyle intervention, recently shown to reduce the incidence of type 2 diabetes in high-risk groups, also improved glycaemic control in people with newly diagnosed screen-detected type 2 diabetes. METHODS: We screened 12,778 participants at high risk of type 2 diabetes using a fasting plasma glucose and glycosylated haemoglobin (HbA1c). People with screen-detected type 2 diabetes were randomised in a parallel, three-arm, controlled trial with up to 46 months of follow-up, with a control arm (CON), a group-based lifestyle intervention of 6 core and up to 15 maintenance sessions (INT), or the same intervention with additional support from volunteers with type 2 diabetes trained to co-deliver the lifestyle intervention (INT-DPM). The pre-specified primary end point was mean HbA1c compared between groups at 12 months. RESULTS: We randomised 432 participants (CON 149; INT 142; INT-DPM 141) with a mean (SD) age of 63.5 (10.0) years, body mass index (BMI) of 32.4 (6.4) kg/m2, and HbA1c of 52.5 (10.2) mmol/mol. The primary outcome of mean HbA1c at 12 months (CON 48.5 (9.1) mmol/mol, INT 46.5 (8.1) mmol/mol, and INT-DPM 45.6 (6.0) mmol/mol) was significantly lower in the INT-DPM arm compared to CON (adjusted difference -2.57 mmol/mol; 95% CI -4.5, -0.6; p = 0.007) but not significantly different between the INT-DPM and INT arms (-0.55 mmol/mol; 95% CI -2.46, 1.35; p = 0.57), or INT vs CON arms (-2.14 mmol/mol; 95% CI -4.33, 0.05; p = 0.07). Subgroup analyses showed the intervention had greater effect in participants < 65 years old (difference in mean HbA1c compared to CON -4.76 mmol/mol; 95% CI -7.75, -1.78 mmol/mol) than in older participants (-0.46 mmol/mol; 95% CI -2.67, 1.75; interaction p = 0.02). This effect was most significant in the INT-DPM arm (-6.01 mmol/mol; 95% CI -9.56, -2.46 age < 65 years old and -0.22 mmol/mol; 95% CI -2.7, 2.25; aged > 65 years old; p = 0.007). The use of oral hypoglycaemic medication was associated with a significantly lower mean HbA1c but only within the INT-DPM arm compared to CON (-7.0 mmol/mol; 95% CI -11.5, -2.5; p = 0.003). CONCLUSION: The NDPS lifestyle intervention significantly improved glycaemic control after 12 months in people with screen-detected type 2 diabetes when supported by trained peer mentors with type 2 diabetes, particularly those receiving oral hypoglycaemics and those under 65 years old. The effect size was modest, however, and not sustained at 24 months. TRIAL REGISTRATION: ISRCTN34805606 . Retrospectively registered 14.4.16.

An International Comparison of EQ-5D-5L and EQ-5D-3L for Use in Cost-Effectiveness Analysis.

OBJECTIVES: To estimate the impact of using EQ5D-5L (5L) compared with EQ5D-3L (3L) in cost-effectiveness analyses in 6 countries with 3L and 5L values: Germany, Japan, Korea, The Netherlands, China, and Spain. METHODS: Eight cost-effectiveness analyses based on clinical studies with 3L provided 11 pairwise comparisons. We estimated cost-effectiveness by applying the appropriate country values for 3L to observed responses. We re-estimated cost-effectiveness for each country by predicting the 5L tariff score for each respondent, for each country, using a previously published mapping method. We compared results in terms of impact on estimated incremental quality-adjusted life-year (QALY) gain and cost-effectiveness ratios. RESULTS: For most countries the impact of moving from 3L to 5L is to lower the incremental QALY gain in the majority of comparisons. The only exception to this was Japan, where 4 out of 11 cases (37%) saw lower QALYs gained when using 5L. The mean and median reductions in health gain, in those case studies where 5L does lead to lower health gain, are largest in The Netherlands (84% mean reduction, 41% median reduction), Germany (68% and 27%), and Spain (30% and 31%). For most countries, those studies where 5L leads to lower health gain see larger reductions than the gains in studies showing the opposite tendency. CONCLUSIONS: Overall, 3L and 5L are not interchangeable in these countries. Differences between results are large, but the direction of change can be unpredictable. These findings should prompt further investigation into the reasons for differences.

Extended and standard duration weight-loss programme referrals for adults in primary care (WRAP): a randomised controlled trial.

BACKGROUND: Evidence exist that primary care referral to an open-group behavioural programme is an effective strategy for management of obesity, but little evidence on optimal intervention duration is available. We aimed to establish whether 52-week referral to an open-group weight-management programme would achieve greater weight loss and improvements in a range of health outcomes and be more cost-effective than the current practice of 12-week referrals. METHODS: In this non-blinded, parallel-group, randomised controlled trial, we recruited participants who were aged 18 years or older and had body-mass index (BMI) of 28 kg/m2 or higher from 23 primary care practices in England. Participants were randomly assigned (2:5:5) to brief advice and self-help materials, a weight-management programme (Weight Watchers) for 12 weeks, or the same weight-management programme for 52 weeks. We followed-up participants over 2 years. The primary outcome was weight at 1 year of follow-up, analysed with mixed-effects models according to intention-to-treat principles and adjusted for centre and baseline weight. In a hierarchical closed-testing procedure, we compared combined behavioural programme arms with brief intervention, then compared the 12-week programme and 52-week programme. We did a within-trial cost-effectiveness analysis using person-level data and modelled outcomes over a 25-year time horizon using microsimulation. This study is registered with Current Controlled Trials, number ISRCTN82857232. FINDINGS: Between Oct 18, 2012, and Feb 10, 2014, we enrolled 1269 participants. 1267 eligible participants were randomly assigned to the brief intervention (n=211), the 12-week programme (n=528), and the 52-week programme (n=528). Two participants in the 12-week programme had been found to be ineligible shortly after randomisation and were excluded from the analysis. 823 (65%) of 1267 participants completed an assessment at 1 year and 856 (68%) participants at 2 years. All eligible participants were included in the analyses. At 1 year, mean weight changes in the groups were -3·26 kg (brief intervention), -4·75 kg (12-week programme), and -6·76 kg (52-week programme). Participants in the behavioural programme lost more weight than those in the brief intervention (adjusted difference -2·71 kg, 95% CI -3·86 to -1·55; p<0·0001). The 52-week programme was more effective than the 12-week programme (-2·14 kg, -3·05 to -1·22; p<0·0001). Differences between groups were still significant at 2 years. No adverse events related to the intervention were reported. Over 2 years, the incremental cost-effectiveness ratio (ICER; compared with brief intervention) was £159 per kg lost for the 52-week programme and £91 per kg for the 12-week programme. Modelled over 25 years after baseline, the ICER for the 12-week programme was dominant compared with the brief intervention. The ICER for the 52-week programme was cost-effective compared with the brief intervention (£2394 per quality-adjusted life-year [QALY]) and the 12-week programme (£3804 per QALY). INTERPRETATION: For adults with overweight or obesity, referral to this open-group behavioural weight-loss programme for at least 12 weeks is more effective than brief advice and self-help materials. A 52-week programme produces greater weight loss and other clinical benefits than a 12-week programme and, although it costs more, modelling suggests that the 52-week programme is cost-effective in the longer term. FUNDING: National Prevention Research Initiative, Weight Watchers International (as part of an UK Medical Research Council Industrial Collaboration Award).

EQ-5D-5L versus EQ-5D-3L: The Impact on Cost Effectiveness in the United Kingdom.

OBJECTIVES: To model the relationship between the three-level (3L) and the five-level (5L) EuroQol five-dimensional questionnaire and examine how differences have an impact on cost effectiveness in case studies. METHODS: We used two data sets that included the 3L and 5L versions from the same respondents. The EuroQol Group data set (n = 3551) included patients with different diseases and a healthy cohort. The National Data Bank data set included patients with rheumatoid disease (n = 5205). We estimated a system of ordinal regressions in each data set using copula models to link responses of the 3L instrument to those of the 5L instrument and its UK tariff, and vice versa. Results were applied to nine cost-effectiveness studies. RESULTS: Best-fitting models differed between the EuroQol Group and the National Data Bank data sets in terms of the explanatory variables, copulas, and coefficients. In both cases, the coefficients of the covariates and latent factors between the 3L and the 5L instruments were significantly different, indicating that moving between instruments is not simply a uniform re-alignment of the response levels for most dimensions. In the case studies, moving from the 3L to the 5L caused a decrease of up to 87% in incremental quality-adjusted life-years gained from effective technologies in almost all cases. Incremental cost-effectiveness ratios increased, often substantially. Conversely, one technology with a significant mortality gain saw increased incremental quality-adjusted life-years. CONCLUSIONS: The 5L shifts mean utility scores up the utility scale toward full health and compresses them into a smaller range, compared with the 3L. Improvements in quality of life are valued less using the 5L than using the 3L. The 3L and the 5L can produce substantially different estimates of cost effectiveness. There is no simple proportional adjustment that can be made to reconcile these differences.

Economic Evaluation of Complete Revascularization for Patients with Multivessel Disease Undergoing Primary Percutaneous Coronary Intervention.

OBJECTIVES: To determine the cost-effectiveness of complete revascularization at index admission compared with infarct-related artery (IRA) treatment only, in patients with multivessel disease undergoing primary percutaneous coronary intervention (P-PCI) for ST-segment elevation myocardial infarction. METHODS: An economic evaluation of a multicenter randomized trial was conducted, comparing complete revascularization at index admission to IRA-only P-PCI in patients with multivessel disease (12-month follow-up). Overall hospital costs (costs for P-PCI procedure(s), hospital length of stay, and any subsequent re-admissions) were estimated. Outcomes were major adverse cardiac events (MACEs, a composite of all-cause death, recurrent myocardial infarction, heart failure, and ischemia-driven revascularization) and quality-adjusted life-years (QALYs) derived from the three-level EuroQol five-dimensional questionnaire. Multiple imputation was undertaken. The mean incremental cost and effect, with associated 95% confidence intervals, the incremental cost-effectiveness ratio, and the cost-effectiveness acceptability curve were estimated. RESULTS: On the basis of 296 patients, the mean incremental overall hospital cost for complete revascularization was estimated to be -£215.96 (-£1390.20 to £958.29), compared with IRA-only, with a per-patient mean reduction in MACEs of 0.170 (0.044 to 0.296) and a QALY gain of 0.011 (-0.019 to 0.041). According to the cost-effectiveness acceptability curve, the probability of complete revascularization being cost-effective was estimated to be 72.0% at a willingness-to-pay threshold value of £20,000 per QALY. CONCLUSIONS: Complete revascularization at index admission was estimated to be more effective (in terms of MACEs and QALYs) and cost-effective (overall costs were estimated to be lower and complete revascularization thereby dominated IRA-only). There was, however, some uncertainty associated with this decision.

Activity provider-facilitated patient and public involvement with care home residents.

BACKGROUND: In care home research, residents are rarely included in patient and public involvement and engagement (PPIE) despite their lived experiences of day-to-day care. This paper reports on a novel approach to PPIE, developed in response to Covid-19, and utilised in a large UK-based study focused on care homes. PPIE sessions were facilitated on behalf of the research team by Activity Providers (APs) already working within the care homes. This paper provides an account of how PPIE with care home residents can be achieved. METHODS: An exploratory design was used to see if it was possible to support "in-house" PPIE, with researchers working at a distance in partnership with care home staff. The National Activity Providers Association recruited five APs working in care homes. A series of optional discussion or activity sessions were developed by the research team in partnership with APs, tailored to reflect the research topics of interest and to make sessions accessible to residents with differing needs. RESULTS: APs facilitated four rounds of PPIE with up to 56 residents per topic, including individuals living with cognitive and communication impairments. Topics discussed included residents' views on data use, measuring quality of life and the prioritisation of care-related data for study collection. Feedback from the residents was observed to have unexpected and positive changes to participating care homes' practice. APs valued participation and working with researchers. They identified acquisition of new skills and insights into residents' thoughts and preferences as direct benefits. Challenges included time pressures on APs and managing emotive feedback. APs were able to approach residents at times convenient to them and in ways that best suited their individual needs. PPIE with residents provided different perspectives, particularly with respect to the importance of different types of data, and constructive challenge about some of the research team's assumptions. CONCLUSIONS: PPIE with APs as research partners is a promising approach to working in an inclusive and participatory way with care home residents. The voices of older care home residents, including those living with cognitive or communicative impairments, are important for the successful and meaningful completion of research.

In recent years there has been increasing interest in research relating to care homes. It is relatively rare that care home residents are given the chance to influence this research; often, family members or care home staff are asked to speak on their behalf. Research can influence residents' future care, and it is important to find ways of involving residents in research that are meaningful and enjoyable. This research paper discusses a new approach to involving care home residents in research. It begins by recounting how the approach came about, then covers how well it has worked so far, finally reflecting on the benefits and challenges of working in a new way. The researchers originally planned to go into care homes themselves to speak to residents, but with the onset of the Covid-19 pandemic this was no longer possible. Instead, Activity Providers already working in care homes were recruited via the National Activity Providers Association (NAPA) to help. They used activities and discussion prompts developed with the research team to speak to residents about the study. The research team hoped to make getting involved in research meaningful and interesting for residents. The team also wanted to make sure that as many people as possible living with conditions like dementia could get involved too. Comments and suggestions from residents were fed back to the research team to help them make decisions about how the research should be done.

Data resource profile: the virtual international care homes trials archive (VICHTA).

Introduction: Randomised controlled trials (RCTs) conducted in care home settings address a range of health conditions impacting older people, but often include a common core of data about residents and the care home environment. These data can be used to inform service provision, but accessing these data can be challenging. Methods: The Virtual International Care Home Trials Archive (VICHTA) collates care home RCTs conducted since 2010, with >100 participants, across multiple conditions, with documented eligibility criteria, initially identified from a scoping review. A Steering Committee comprising contributing trialists oversees proposed uses of fully anonymised data. We characterised available demography and outcomes to inform potential analyses. Data are accessible via application to the Virtual Trials Archives, through a secure online analysis platform. Trial recruitment is ongoing and future expansion will include international studies. Results: The first phase of VICHTA includes data from six UK RCTs, with individual participant data (IPD) on 5,674 residents across 308 care homes. IPD include age, sex, dementia status, length of stay, quality of life, clinical outcome measures, medications, resource use, and care home characteristics, such as funding, case mix, and occupancy. Follow-up ranges between four and sixteen months. Conclusions: VICHTA collates and makes accessible data on a complex and under-represented research population for novel analyses, and to inform design of future studies. Planned expansion to international care home RCTs will facilitate a wider range of research questions. Interested collaborators can submit trial data or request data at http://www.virtualtrialsarchives.org.

Piloting of a minimum data set for older people living in care homes in England: protocol for a longitudinal, mixed-methods study.

INTRODUCTION: Health and care data are routinely collected about care home residents in England, yet there is no way to collate these data to inform benchmarking and improvement. The Developing research resources And minimum data set for Care Homes' Adoption and use study has developed a prototype minimum data set (MDS) for piloting. METHODS AND ANALYSIS: A mixed-methods longitudinal pilot study will be conducted in 60 care homes (approximately 960 residents) in 3 regions of England, using resident data from cloud-based digital care home records at two-time points. These will be linked to resident and care home level data held within routine National Health Service and social care data sets. Two rounds of focus groups with care home staff (n=8-10 per region) and additional interviews with external stakeholders (n=3 per region) will explore implementation and the perceived utility of the MDS. Data will be assessed for completeness and timeliness of completion. Descriptive statistics, including percentage floor and ceiling effects, will establish data quality. For validated scales, construct validity will be assessed by hypothesis testing and exploratory factor analysis will establish structural validity. Internal consistency will be established using Cronbach's alpha. Longitudinal analysis of the pilot data will demonstrate the value of the MDS to each region. Qualitative data will be analysed inductively using thematic analysis to understand the complexities of implementing an MDS in care homes for older people. ETHICS AND DISSEMINATION: The study has received ethical approval from the London Queen's Square Research Ethics Committee (22/LO/0250). Informed consent is required for participation. Findings will be disseminated to: academics working on data use and integration in social care, care sector organisations, policy makers and commissioners. Findings will be published in peer-reviewed journals. Partner NIHR Applied Research Collaborations, the National Care Forum and the British Geriatrics Society will disseminate policy briefs.

Developing a minimum data set for older adult care homes in the UK: exploring the concept and defining early core principles.

Reforms to social care in response to the COVID-19 pandemic, in the UK and internationally, place data at the heart of proposed innovations and solutions. The principles are not well established of what constitutes core, or minimum, data to support care home residents. Often, what is included privileges data on resident health over day-to-day care priorities and quality of life. This Personal View argues for evidence-based principles on which to base the development of a UK minimum data set (MDS) for care homes. Co-produced work involving care home staff and older people working with stakeholders is required to define and agree the format, content, structure, and operationalisation of the MDS. Implementation decisions will determine the success of the MDS, affecting aspects including data quality, completeness, and usability. Care home staff who collect the data need to benefit from the MDS and see value in their contribution, and residents must derive benefit from data collection and synthesis.

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.

Cost-effectiveness of a lifestyle intervention in preventing Type 2 diabetes.

OBJECTIVES: Previous research has suggested people with impaired fasting glucose (IFG) are less likely to develop Type 2 diabetes (T2DM) if they receive prolonged structured diet and exercise advice. This study examined the within-trial cost-effectiveness of such lifestyle interventions. METHODS: Screen-detected participants with either newly diagnosed T2DM or IFG were randomized 2:1 to intervention versus control (usual care) between February and December 2009, in Norfolk (UK). The intervention consisted of group based education, physiotherapy and peer support sessions, plus telephone contacts from T2DM volunteers. We monitored healthcare resource use, intervention costs, and quality of life (EQ-5D). The incremental cost per quality-adjusted life-year (QALY) gain (incremental cost effectiveness ratio [ICER]), and cost effectiveness acceptability curves (CEAC) were estimated. RESULTS: In total, 177 participants were recruited (118 intervention, 59 controls), with a mean follow-up of 7 months. Excluding screening and recruitment costs, the mean cost was estimated to be £551 per participant in the intervention arm, compared with £325 in the control arm. The QALY gains were -0.001 and -0.004, respectively. The intervention was estimated to have an ICER of £67,184 per QALY (16 percent probability of being cost-effective at the £20,000/QALY threshold). Cost-effectiveness estimates were more favorable for IFG participants and those with longer follow-up (≥ 4 months) (ICERs of £20,620 and £17,075 per QALY, respectively). CONCLUSIONS: Group sessions to prevent T2DM were not estimated to be within current limits of cost-effectiveness. However, there was a large degree of uncertainty surrounding these estimates, suggesting the need for further research.

Protocol for the development of a repository of individual participant data from randomised controlled trials conducted in adult care homes (the Virtual International Care Homes Trials Archive (VICHTA)).

BACKGROUND: Approximately 418,000 people live in care homes in the UK, yet accessible, robust data on care home populations and organisation are lacking. This hampers our ability to plan, allocate resources or prevent risk. Large randomised controlled trials (RCTs) conducted in care homes offer a potential solution. The value of detailed data on residents' demographics, outcomes and contextual information captured in RCTs has yet to be fully realised. Irrespective of the intervention tested, much of the trial data collected overlaps in terms of structured assessments and descriptive information. Given the time and costs required to prospectively collect data in these populations, pooling anonymised RCT data into a structured repository offers benefit; secondary analyses of pooled RCT data can improve understanding of this under-researched population and enhance the future trial design. This protocol describes the creation of a project-specific repository of individual participant data (IPD) from trials conducted in care homes and subsequent expansion into a legacy dataset for wider use, to address the need for accurate, high-quality IPD on this vulnerable population. METHODS: Informed by scoping of relevant literature, the principal investigators of RCTs conducted in adult care homes in the UK since 2010 will be invited to contribute trial IPD. Contributing trialists will form a Steering Committee who will oversee data sharing and remain gatekeepers of their own trial's data. IPD will be cleaned and standardised in consultation with the Steering Committee for accuracy. Planned analyses include a comparison of pooled IPD with point estimates from administrative sources, to assess generalisability of RCT data to the wider care home population. We will also identify key resident characteristics and outcomes from within the trial repository, which will inform the development of a national minimum dataset for care homes. Following project completion, management will migrate to the Virtual Trials Archives, forming a legacy dataset which will be expanded to include international RCTs, and will be accessible to the wider research community for analyses. DISCUSSION: Analysis of pooled IPD has the potential to inform and direct future practice, research and policy at low cost, enhancing the value of existing data and reducing research waste. We aim to create a permanent archive for care home trial data and welcome the contribution of emerging trial datasets.

Lifestyle Intervention With or Without Lay Volunteers to Prevent Type 2 Diabetes in People With Impaired Fasting Glucose and/or Nondiabetic Hyperglycemia: A Randomized Clinical Trial.

Importance: Nearly half of the older adult population has diabetes or a high-risk intermediate glycemic category, but we still lack trial evidence for effective type 2 diabetes prevention interventions in most of the current high-risk glycemic categories. Objective: To determine whether a group-based lifestyle intervention (with or without trained volunteers with type 2 diabetes) reduced the risk of progression to type 2 diabetes in populations with a high-risk glycemic category. Design, Setting, and Participants: The Norfolk Diabetes Prevention Study was a parallel, 3-arm, group-based, randomized clinical trial conducted with up to 46 months of follow-up from August 2011 to January 2019 at 135 primary care practices and 8 intervention sites in the East of England. We identified 141 973 people at increased risk of type 2 diabetes, screened 12 778 (9.0%), and randomized those with a high-risk glycemic category, which was either an elevated fasting plasma glucose level alone (≥110 and <126 mg/dL [to convert to millimoles per liter, multiply by 0.0555]) or an elevated glycated hemoglobin level (≥6.0% to <6.5%; nondiabetic hyperglycemia) with an elevated fasting plasma glucose level (≥100 to <110 mg/dL). Interventions: A control arm receiving usual care (CON), a theory-based lifestyle intervention arm of 6 core and up to 15 maintenance sessions (INT), or the same intervention with support from diabetes prevention mentors, trained volunteers with type 2 diabetes (INT-DPM). Main Outcomes and Measures: Type 2 diabetes incidence between arms. Results: In this study, 1028 participants were randomized (INT, 424 [41.2%] [166 women (39.2%)]; INT-DPM, 426 [41.4%] [147 women (34.5%)]; CON, 178 [17.3%] [70 women (%39.3)]) between January 1, 2011, and February 24, 2017. The mean (SD) age was 65.3 (10.0) years, mean (SD) body mass index 31.2 (5) (calculated as weight in kilograms divided by height in meters squared), and mean (SD) follow-up 24.7 (13.4) months. A total of 156 participants progressed to type 2 diabetes, which comprised 39 of 171 receiving CON (22.8%), 55 of 403 receiving INT (13.7%), and 62 of 414 receiving INT-DPM (15.0%). There was no significant difference between the intervention arms in the primary outcome (odds ratio [OR], 1.14; 95% CI, 0.77-1.7; P = .51), but each intervention arm had significantly lower odds of type 2 diabetes (INT: OR, 0.54; 95% CI, 0.34-0.85; P = .01; INT-DPM: OR, 0.61; 95% CI, 0.39-0.96; P = .033; combined: OR, 0.57; 95% CI, 0.38-0.87; P = .01). The effect size was similar in all glycemic, age, and social deprivation groups, and intervention costs per participant were low at $153 (£122). Conclusions and Relevance: The Norfolk Diabetes Prevention lifestyle intervention reduced the risk of type 2 diabetes in current high-risk glycemic categories. Enhancing the intervention with DPM did not further reduce diabetes risk. These translatable results are relevant for current diabetes prevention efforts. Trial Registration: ISRCTN Registry Identifier: ISRCTN34805606.

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.

Cost-effectiveness of a day hospital falls prevention programme for screened community-dwelling older people at high risk of falls.

BACKGROUND: multifactorial falls prevention programmes for older people have been proved to reduce falls. However, evidence of their cost-effectiveness is mixed. DESIGN: economic evaluation alongside pragmatic randomised controlled trial. INTERVENTION: randomised trial of 364 people aged ≥70, living in the community, recruited via GP and identified as high risk of falling. Both arms received a falls prevention information leaflet. The intervention arm were also offered a (day hospital) multidisciplinary falls prevention programme, including physiotherapy, occupational therapy, nurse, medical review and referral to other specialists. MEASUREMENTS: self-reported falls, as collected in 12 monthly diaries. Levels of health resource use associated with the falls prevention programme, screening (both attributed to intervention arm only) and other health-care contacts were monitored. Mean NHS costs and falls per person per year were estimated for both arms, along with the incremental cost-effectiveness ratio (ICER) and cost effectiveness acceptability curve. RESULTS: in the base-case analysis, the mean falls programme cost was £349 per person. This, coupled with higher screening and other health-care costs, resulted in a mean incremental cost of £578 for the intervention arm. The mean falls rate was lower in the intervention arm (2.07 per person/year), compared with the control arm (2.24). The estimated ICER was £3,320 per fall averted. CONCLUSIONS: the estimated ICER was £3,320 per fall averted. Future research should focus on adherence to the intervention and an assessment of impact on quality of life.

Uptake and use of a minimum data set (MDS) for older people living and dying in care homes in England: a realist review protocol.

INTRODUCTION: Care homes provide nursing and social care for older people who can no longer live independently at home. In the UK, there is no consistent approach to how information about residents' medical history, care needs and preferences are collected and shared. This limits opportunities to understand the care home population, have a systematic approach to assessment and documentation of care, identifiy care home residents at risk of deterioration and review care. Countries with standardised approaches to residents' assessment, care planning and review (eg, minimum data sets (MDS)) use the data to understand the care home population, guide resource allocation, monitor services delivery and for research. The aim of this realist review is to develop a theory-driven understanding of how care home staff implement and use MDS to plan and deliver care of individual residents. METHODS AND ANALYSIS: A realist review will be conducted in three research stages.Stage 1 will scope the literature and develop candidate programme theories of what ensures effective uptake and sustained implementation of an MDS.Stage2 will test and refine these theories through further iterative searches of the evidence from the literature to establish how effective uptake of an MDS can be achieved.Stage 3 will consult with relevant stakeholders to test or refine the programme theory (theories) of how an MDS works at the resident level of care for different stakeholders and in what circumstances. Data synthesis will use realist logic to align data from each eligible article with possible context-mechanism-outcome configurations or specific elements that answer the research questions. ETHICS AND DISSEMINATION: The University of Hertfordshire Ethics Committee has approved this study (HSK/SF/UH/04169). Findings will be disseminated through briefings with stakeholders, conference presentations, a national consultation on the use of an MDS in UK long-term care settings, publications in peer-reviewed journals and in print and social media publications accessible to residents, relatives and care home staff. PROSPERO REGISTRATION NUMBER: CRD42020171323; this review protocol is registered on the International Prospective Register of Systematic Reviews.