General practitioner workforce sustainability to maximise effective and equitable patient care: a realist review protocol.

INTRODUCTION: There are not enough general practitioners (GPs) in the UK National Health Service. This problem is worse in areas of the country where poverty and underinvestment in health and social care mean patients experience poorer health compared with wealthier regions. Encouraging more doctors to choose and continue in a GP career is a government priority. This review will examine which aspects of the healthcare system affect GP workforce sustainability, how, why and for whom. METHODS AND ANALYSIS: A realist review is a theory-driven interpretive approach to evidence synthesis, that brings together qualitative, quantitative, mixed-methods research and grey literature. We will use a realist approach to synthesise data from the available published literature to refine an evidence-based programme theory that will identify the important contextual factors and underlying mechanisms that underpin observed outcomes relating to GP workforce sustainability. Our review will follow Pawson's five iterative stages: (1) finding existing theories, (2) searching for evidence, (3) article selection, (4) data extraction and (5) synthesising evidence and drawing conclusions. We will work closely with key stakeholders and embed patient and public involvement throughout the review process to refine the focus of the review and enhance the impact and relevance of our research. ETHICS AND DISSEMINATION: This review does not require formal ethical approval as it draws on secondary data from published articles and grey literature. Findings will be disseminated through multiple channels, including publication in peer-reviewed journals, at national and international conferences, and other digital scholarly communication tools such as video summaries, X and blog posts. PROSPERO REGISTRATION NUMBER: CRD42023395583.

Exploratory factor analysis and Rasch analysis to assess the structural validity of the Adult Social Care Outcomes Toolkit Proxy version (ASCOT-Proxy) completed by care home staff.

PURPOSE: Rasch analysis and exploratory factor analysis (EFA) were used to evaluate the structural validity of the ASCOT-Proxy measures completed by staff on behalf of older adults resident in care homes, by comparison to the ASCOT-SCT4, the measure of social care-related quality of life (SCRQoL) from which the ASCOT-Proxy was developed. METHODS: EFA was conducted on the ASCOT-SCT4 and the two ASCOT-Proxy measures (Proxy-Proxy, Proxy-Resident), to determine if they retained the single factor of the original ASCOT-SCT4 measure found in samples of older community-dwelling adults. Rasch analysis was also applied to measures with a single factor structure in the EFA. RESULTS: ASCOT-Proxy-Resident had a single factor structure, as did the original ASCOT-SCT4 (also, found in this analysis when completed by care home staff). The ASCOT-Proxy-Proxy had a two factor structure. Rasch analysis of ASCOT-Proxy-Resident and ASCOT-SCT4 had an acceptable model fit, internal consistency and met the assumptions of unidimensionality and local independence. There was evidence of less than optimal distinguishability at some thresholds between responses, and low frequency of rating of the 'high level needs'. CONCLUSION: The ASCOT-Proxy-Resident is a valid instrument of SCRQoL for older adults resident in care homes, completed by staff proxies. Due to the two-factor structure, which differs from the original ASCOT-SCT4, we do not recommend the use of the ASCOT-Proxy-Proxy measure, although collecting data as part of the ASCOT-Proxy questionnaire may support its feasibility and acceptability. Further qualitative study of how care home staff complete and perceive the ASCOT-Proxy is encouraged for future studies.

Physical Activity Inclusion in Dementia-Friendly Communities: A Mixed Methods Study.

Dementia-friendly communities (DFCs) are a policy-endorsed approach to community engagement in England that promotes social inclusion to enable people affected by dementia to live well. Research suggests that physical activity is beneficial in encouraging social connection and improving health. A mixed method sequential study design in England involving a national survey (n = 31) and semistructured interviews (n = 65) in three DFCs was carried out. The aim was to understand how DFCs enable people affected by dementia to participate in physical activities. An evaluation framework for DFCs was used to organize and interpret the data, and analysis was informed by the inclusive (social) citizen lens. Findings showed that DFCs offered a range of adapted dementia-inclusive and dementia-specific activities; however, people were not routinely offered information at time of diagnosis. Local authorities (councils) were key to enable access to information and infrastructure change to support sustainable inclusion within their local community.

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.

Enabling health and maintaining independence for older people at home (HomeHealth trial): a multicentre randomised controlled trial.

BACKGROUND: NHS frailty services commonly target more severely frail older people, despite evidence suggesting frailty can be prevented or reversed when addressed at an earlier stage. HomeHealth is a new home-based, manualised voluntary sector service supporting older people with mild frailty to maintain their independence through behaviour change. Over six appointments, a trained HomeHealth worker discusses what matters to the older person and supports them to set and achieve goals around mobility, nutrition, socialising and/or psychological wellbeing. The service showed promising effects in a feasibility trial. We aimed to test the clinical and cost-effectiveness of HomeHealth for maintaining independence in older people with mild frailty compared with treatment as usual. METHODS: In this single-blind multicentre randomised controlled trial, we recruited community-dwelling older people aged 65 years or older with mild frailty from 27 general practices, community groups and sheltered housing in London, Yorkshire, and Hertfordshire. Participants were randomly assigned (1:1) to receive either HomeHealth monthly for 6 months or treatment as usual (usual GP and outpatient care, no specific frailty services). Our primary outcome was independence in activities of daily living, measured by blinded outcome assessors using the modified Barthel Index, and analysed using linear mixed models, including 6-month and 12-month data and controlling for baseline Barthel score and site. The study was approved by the Social Care Research Ethics Committee, and all participants provided written or orally recorded informed consent. This study is registered with the ISRCTN registry, ISRCTN54268283. FINDINGS: This trial took place between Jan 18, 2021, and July 4, 2023. We recruited 388 participants (mean age 81·4 years; 64% female [n=250], 94% White British/European [n=364], 2·5% Asian [n=10], 1·5% Black [n=6], 2·0% other [n=8]). We achieved high retention for 6-month follow-up (89%, 345/388), 12-month follow-up (86%, 334/388), and medical notes data (89%, 347/388). 182 (93%) of 195 participants in the intervention group completed the intervention, attending a mean of 5·6 appointments. HomeHealth had no effect on Barthel Index scores at 12 months (mean difference 0·250, 95% CI -0·932 to 1·432). At 6 months, there was a small reduction in psychological distress (-1·237, -2·127 to -0·348) and frailty (-0·124, -0·232 to -0·017), and at 12 months, we found small positive effects on wellbeing (1·449, 0·124 to 2·775) in those receiving HomeHealth. Other outcomes in analysis to date showed no significant difference. Health economic outcomes (including quality of life, capability, health services use and care needs or burden) are pending. INTERPRETATION: This high-quality trial showed that HomeHealth did not maintain independence in older people with mild frailty, and had limited effects upon secondary outcomes. Future studies need to explore different ways to promote health in this population. FUNDING: National Institute for Health and Care Research Health Technology Assessment (NIHR HTA).

Funded hospital discharges to care homes: a cohort study.

BACKGROUND: Optimising timely discharge from hospitals is an international priority. In 2020, the Coronavirus disease 2019 (COVID-19) pandemic resulted in the United Kingdom Government implementing the Discharge to Assess (D2A) model across England. This funded temporary care home placement to allow further recovery and assessment of care needs outside of the hospital. OBJECTIVES: Determine if older adults discharged from hospital to care homes after implementation of D2A differ in their characteristics or outcomes. DESIGN AND METHODS: Two cohorts of older adults discharged from hospital to care homes pre- and post-implementation of the D2A model (n = 244), with 6 months of follow-up. Data were extracted from routinely collected healthcare records. RESULTS: The mean duration of the hospital admission was reduced (29 vs. 23 days (P = 0.02)) but discharges to care homes did not increase with implementation of D2A (n = 161 in both cohorts prior to exclusions). In July-December 2020 (post-implementation), 28% of people were living in a private residence 6 months post-discharge, compared with 18% in the same period in 2019 (P = 0.09). When those who died were excluded, this changed to 40 vs. 28% (P = 0.19). There was no change in 6-month mortality (26 vs. 35% (P = 0.17)), and no increase in readmission rate (0.48 vs. 0.63 (P = 0.21) readmissions-per-patient over 6 months). No differences in key characteristics were found. However, patients were placed in care homes further from admission addresses (17.3 vs. 9.8 km (P = 0.00001)). CONCLUSIONS: Implementation of D2A did not result in poorer outcomes but was associated with a reduced length of hospital stay.

The use of constant observation with people with dementia in hospitals: a mixed-methods systematic review.

OBJECTIVES: Constant observation is used in hospitals with people with dementia to manage their safety. However, opportunities for proactive care are not consistently recognised or utilised. A systematic review of constant observation was conducted to understand measures of effectiveness and facilitators for person-centred approaches. METHOD: Electronic databases were searched between 2010 and 2022. Four reviewers completed screening, quality assessments and data extraction with 20% checked for consistency. Findings were presented through narrative synthesis (PROSPERO registration CRD42020221078). FINDINGS: Twenty-four studies were included. Non-registered staff without specific training were the main providers of constant observation. Assessments and processes clarifying the level of observation encouraged reviews that linked initiation and discontinuation to a patient's changing needs. Examples of person-centred care, derived from studies of volunteers or staff employed to provide activities, demonstrated meaningful engagement could reassure a person and improve their mood. Proactive approaches that anticipated distress were thought to reduce behaviours that carried a risk of harm but supporting evidence was lacking. CONCLUSION: Non-registered staff are limited by organisational efforts to reduce risk, leading to a focus on containment. Trained staff who are supported during constant observation can connect with patients, provide comfort and potentially reduce behaviours that carry a risk of harm.

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.

Provision of palliative and end-of-life care in UK care homes during the COVID-19 pandemic: A mixed methods observational study with implications for policy.

Introduction: Little consideration has been given to how the provision of palliative and end-of-life care in care homes was affected by COVID-19. The aims of this study were to: (i) investigate the response of UK care homes in meeting the rapidly increasing need for palliative and end-of-life care during the COVID-19 pandemic and (ii) propose policy recommendations for strengthening the provision of palliative and end-of-life care within care homes. Materials and methods: A mixed methods observational study was conducted, which incorporated (i) an online cross-sectional survey of UK care homes and (ii) qualitative interviews with care home practitioners. Participants for the survey were recruited between April and September 2021. Survey participants indicating availability to participate in an interview were recruited using a purposive sampling approach between June and October 2021. Data were integrated through analytic triangulation in which we sought areas of convergence, divergence, and complementarity. Results: There were 107 responses to the survey and 27 interviews. We found that (i) relationship-centered care is crucial to high-quality palliative and end-of-life care within care homes, but this was disrupted during the pandemic. (ii) Care homes' ability to maintain high-quality relationship-centered care required key "pillars" being in place: integration with external healthcare systems, digital inclusion, and a supported workforce. Inequities within the care home sector meant that in some services these pillars were compromised, and relationship-centered care suffered. (iii) The provision of relationship-centered care was undermined by care home staff feeling that their efforts and expertise in delivering palliative and end-of-life care often went unrecognized/undervalued. Conclusion: Relationship-centered care is a key component of high-quality palliative and end-of-life care in care homes, but this was disrupted during the COVID-19 pandemic. We identify key policy priorities to equip care homes with the resources, capacity, and expertise needed to deliver palliative and end-of-life care: (i) integration within health and social care systems, (ii) digital inclusivity, (iii) workforce development, (iv) support for care home managers, and (v) addressing (dis)parities of esteem. These policy recommendations inform, extend, and align with policies and initiatives within the UK and internationally.

Assessing cognitive decline in Vietnamese older adults using the Montreal Cognitive Assessment-Basic (MoCA-B) and Informant Questionnaire on Cognitive Decline in the Elderly (IQCODE) during the COVID-19 pandemic: A feasibility study.

Objectives: The lack of cognitive assessment tools suitable for people with minimal formal education is a barrier to identify cognitive impairment in Vietnam. Our aims were to (i) evaluate the feasibility of conducting the Montreal Cognitive Assessment-Basic (MoCA-B) and Informant Questionnaire On Cognitive Decline in the Elderly (IQCODE) remotely on the Vietnamese older adults, (ii) examine the association between the two tests, (iii) identify demographic factors correlated with these tools. Methods: The MoCA-B was adapted from the original English version, and a remote testing procedure was conducted. One hundred seventy-three participants aged 60 and above living in the Vietnamese southern provinces were recruited via an online platform during the COVID-19 pandemic. Results: IQCODE results showed that the proportions of rural participants classified as having mild cognitive impairment and dementia were substantially higher than those in urban areas. Levels of education and living areas were associated with IQCODE scores. Education attainment was also the main predictor of MoCA-B scores (30% of variance explained), with an average of 10.5 points difference between those with no formal education and those who attended university. Conclusions: It is feasible to administer the IQCODE and MoCA-B remotely in the Vietnamese older population. Education attainment played a stronger role in predicting MoCA-B scores than IQCODE, suggesting the influence of this factor on MoCA-B scores. Further study is needed to develop socio-culturally appropriate cognitive screening tests for the Vietnamese population.

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.

General practitioners' role in improving health care in care homes: a realist review.

BACKGROUND: Despite recent focus on improving health care in care homes, it is unclear what role general practitioners (GPs) should play. To provide evidence for future practice we set out to explore how GPs have been involved in such improvements. METHODS: Realist review incorporated theory-driven literature searches and stakeholder interviews, supplemented by focussed searches on GP-led medication reviews and end-of-life care. Medline, Embase, CINAHL, PsycInfo, Web of Science, and the Cochrane library were searched. Grey literature was identified through internet searches and professional networks. Studies were included based upon relevance. Data were coded to develop and test contexts, mechanisms, and outcomes for improvements involving GPs. RESULTS: Evidence was synthesized from 30 articles. Programme theories described: (i) "negotiated working with GPs," where other professionals led improvement and GPs provided expertise; and (ii) "GP involvement in national/regional improvement programmes." The expertise of GPs was vital to many improvement programmes, with their medical expertise or role as coordinators of primary care proving pivotal. GPs had limited training in quality improvement (QI) and care home improvement work had to be negotiated in the context of wider primary care commitments. CONCLUSIONS: GPs are central to QI in health care in care homes. Their contributions relate to their specialist expertise and recognition as leaders of primary care but are challenged by available time and resources to develop this role.

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.

Models of Care and Relationships with Care Homes: Cross-Sectional Survey of English General Practices.

The Enhanced Health in Care Homes framework for England sets out standards for how primary care should work with care homes. How care home staff and General Practitioners work together and the quality of their working relationships are core to resident healthcare. This study explored the current models of care and relationships between General Practitioners' practices and care homes. Sixty-seven respondents from 35 practices were recruited in the East of England and completed a semi-structured online survey. Responses were analysed using descriptive statistics. Free text responses were interpreted thematically. The number of care homes that practices supported ranged from 0-15. Most reported having designated General Practitioners working with care homes and a good working relationship. Despite the national rollout of the Enhanced Health in Care Homes framework, two-thirds reported no recent changes in how they worked with care homes. There is a shift towards practices working with fewer care homes and fewer accounts of fractured working relationships, suggesting that residents' access to primary care is improving. The continuing variability suggests further work is needed to ensure it is driven by context, not inequitable provision. Future work needs to address how policy changes are changing work practices and residents' health outcomes.

A suite of evaluation resources for Dementia Friendly Communities: Development and guidance for use.

OBJECTIVES: In the context of a growing number of dementia friendly communities (DFCs) globally, a need remains for robust evaluation, and for tools to capture relevant evidence. This paper reports the development of a suite of evaluation resources for DFCs through a national study in England. METHODS: Fieldwork took place in six diverse case study sites across England. A mixed methods design was adopted that entailed documentary analysis, focus groups, interviews, observations, and a survey. Participants were people affected by dementia and practice-based stakeholders. A national stakeholder workshop was held to obtain input beyond the research sites. A workshop at the end of the study served to check the resonance of the findings and emerging outputs with stakeholders from the case study DFCs. RESULTS: The study had three key outputs for the evaluation of DFCs: First, an evaluation framework that highlights thematic areas to be considered in evaluating DFCs. Second, a Theory of Change that presents inputs into a DFC and short, medium and longer term outcomes. Third, a matrix for assessing a DFC's degree of maturity, which enables a sense of the kinds of outcomes a DFC might realistically aspire to. These three outputs form a suite of interlinking and complementary evaluation resources for DFCs. CONCLUSIONS: The study has contributed evidence-based resources for monitoring and evaluation that complement existing frameworks. They can be applied to arrive at a detailed assessment of how well a DFC works for people affected by dementia, and at insights into the underlying factors that can guide future policy and practice.

Development of a core outcome set for the evaluation of interventions to prevent COVID-19 in care homes (COS-COVID-PCARE Study).

BACKGROUND: People living in care homes have experienced devastating impact from COVID-19. As interventions to prevent the transmission of COVID-19 are developed and evaluated, there is an urgent need for researchers to agree on the outcomes used when evaluating their effectiveness. Having an agreed set of outcomes that are used in all relevant trials can ensure that study results can be compared. OBJECTIVE: The aim of the study was to develop a core outcome set (COS) for trials assessing the effectiveness of pharmacological and non-pharmacological interventions for preventing COVID-19 infection and transmission in care homes. METHODS: The study used established COS methodology. A list of candidate outcomes was identified by reviewing registered trials to evaluate interventions to prevent COVID-19 in care homes. Seventy key stakeholders participated in a Delphi survey, rating the candidate outcomes on a nine-point scale over two rounds, with the opportunity to propose additional outcomes. Stakeholders included care home representatives (n = 19), healthcare professionals (n = 20), people with personal experience of care homes (n = 7), researchers (n = 15) and others (n = 9). Outcomes were eligible for inclusion if they met an a priori threshold. A consensus meeting with stakeholders resulted in agreement of the final outcome set. RESULTS: Following the Delphi and consensus meeting, twenty-four outcomes were recommended for inclusion. These are grouped across four domains of infection, severity of illness, mortality, and 'other' (intervention specific or life impact). Due to the considerable heterogeneity between care homes, residents, and interventions, the relevance and importance of outcomes may differ between trial contexts. Intervention-specific outcomes would be included only where relevant to a given trial, thus reducing the measurement burden. CONCLUSION: Using a rapid response approach, a COS for COVID-19 prevention interventions in care homes has been developed. Future work should focus on identifying instruments for measuring these outcomes, and the interpretation and application of the COS across different trial contexts. Beyond COVID-19, the outcomes identified in this COS may have relevance to other infectious diseases in care homes, and the rapid response approach may be useful as preparation for future pandemics.

From Warkworth House to the 21st century care homes: progress marked by persistent challenges.

Long-term care homes play an essential role within health and social care. Successful measures to support older people at home for longer have led to increased prevalence of disability, frailty and cognitive impairment in those who live in care homes over the last two decades. The need for care home places is projected to increase for the next two decades. Modern care homes provide care for people who are predominantly over 80, have multiple long-term conditions, take multiple medicines, are physically dependent and live with cognitive impairment. Residents do better when services recognise the contributions of staff and care home providers rather than treating residents as individual patients living in a communal setting. There is a strong case given residents' frailty, multimorbidity and disability, that care should be structured around Comprehensive Geriatric Assessment (CGA). Care should be designed to allow opportunities for multiprofessional teams to come together for CGA, particularly if healthcare professionals are based outside care homes. Good data about care homes and residents are central to efforts to deliver high quality care-in some countries, these data are collected but not collated. Collating such data is a priority. Care home staff are under-recognised and underpaid-parity of pay and opportunity with NHS staff is the bare minimum to ensure that the best are recruited and retained in the sector. During the COVID-19 pandemic, residents and relatives have frequently been left out of decisions about policies that affect them, and better consultation is needed to deliver high quality care.

Clinical and cost-effectiveness of a personalised health promotion intervention enabling independence in older people with mild frailty ('HomeHealth') compared to treatment as usual: study protocol for a randomised controlled trial.

BACKGROUND: Frailty is clinically associated with multiple adverse outcomes, including reduced quality of life and functioning, falls, hospitalisations, moves to long-term care and mortality. Health services commonly focus on the frailest, with highest levels of need. However, evidence suggests that frailty is likely to be more reversible in people who are less frail. Evidence is emerging on what interventions may help prevent or reduce frailty, such as resistance exercises and multi-component interventions, but few interventions are based on behaviour change theory. There is little evidence of cost-effectiveness. Previously, we co-designed a new behaviour change health promotion intervention ("HomeHealth") to support people with mild frailty. HomeHealth is delivered by trained voluntary sector support workers over six months who support older people to work on self-identified goals to maintain their independence, such as strength and balance exercises, nutrition, mood and enhancing social engagement. The service was well received in our feasibility randomised controlled trial and showed promising effects upon outcomes. AIM: To test the clinical and cost-effectiveness of the HomeHealth intervention on maintaining independence in older people with mild frailty in comparison to treatment as usual (TAU). METHODS: Single-blind individually randomised controlled trial comparing the HomeHealth intervention to TAU. We will recruit 386 participants from general practices and the community across three English regions. Participants are included if they are community-dwelling, aged 65 + , with mild frailty according to the Clinical Frailty Scale. Participants will be randomised 1:1 to receive HomeHealth or TAU for 6 months. The primary outcome is independence in activities of daily living (modified Barthel Index) at 12 months. Secondary outcomes include instrumental activities of daily living, quality of life, frailty, wellbeing, psychological distress, loneliness, cognition, capability, falls, carer burden, service use, costs and mortality. Outcomes will be analysed using linear mixed models, controlling for baseline Barthel score and site. A health economic analysis and embedded mixed-methods process evaluation will be conducted. DISCUSSION: This trial will provide definitive evidence on the effectiveness and cost-effectiveness of a home-based, individualised intervention to maintain independence in older people with mild frailty in comparison to TAU, that could be implemented at scale if effective. TRIAL REGISTRATION: ISRCTN, ISRCTN54268283 . Registered 06/04/2020.

End of life care in UK care homes - controlled drugs: systematic review and narrative synthesis.

BACKGROUND: Controlled drugs (CDs) such as opioids and midazolam are commonly used in end-of-life care symptom management for care home residents. AIM: To review the published evidence concerning the prescribing, storage, use and disposal of CDs for end-of-life care for care home residents in the UK. DESIGN: Systematic review and narrative synthesis. METHODS: Seven databases (Medline, CINAHL, Embase, PsycINFO, Web of Science, Cochrane Library, and Social Care Online) were searched from January 2000 to January 2021, alongside reference, citation and journal hand searches. Gough's 'Weight of Evidence' framework was used to appraise the relevance of studies to the review questions. RESULTS: The search yielded 1279 titles, from which 125 abstracts and then 42 full-text papers were screened. 14 papers were included in the synthesis. Prescribing is primarily by general practitioners, with administration by nurses. Nurses frequently report feeling inadequately trained in the use of CDs. The storage, monitoring and disposal of end-of-life care CDs in UK care homes has not been researched to date. The attitudes and experiences of residents and family members regarding these medications also remain unknown. CONCLUSION: The current widespread use of CDs for end-of-life care in care homes has a limited evidence base. The lack of research concerning the storing, monitoring and disposing of CDs, alongside the limited evidence concerning resident and family members' perspectives, is a significant knowledge deficit that requires urgent attention. PROSPERO REGISTRATION NUMBER: CRD42020173014.

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.