Showing papers in "Health and social care delivery research in 2022"

Early evaluation of the Children and Young People's Mental Health Trailblazer programme: a rapid mixed-methods study.

Abstract: Background The Children and Young People's Mental Health Trailblazer programme is funding the creation of new mental health support teams to work in schools and further education colleges. Mental health support teams directly support children and young people with 'mild to moderate' mental health problems and work with school and college staff to promote well-being for all. A new workforce of education mental health practitioners is being trained for the teams. Objective(s) The National Institute for Health and Care Research Birmingham, RAND and Cambridge Evaluation Rapid Evaluation Centre and Policy Innovation and Evaluation Research Unit undertook an early evaluation of the Trailblazer programme to examine the development, implementation and early progress of mental health support teams in the programme's first 25 'Trailblazer' sites. Design A mixed-methods evaluation, comprising three work packages: 1. Establishing the baseline and understanding the development and early impacts of the Trailblazer sites, including two rounds of surveys with key informants and participating education settings in all 25 sites. 2. More detailed research in five purposively selected Trailblazer sites, including interviews with a range of stakeholders and focus groups with children and young people. 3. Scoping and developing options for a longer-term assessment of the programme's outcomes and impacts. Fieldwork was undertaken between November 2020 and February 2022. The University of Birmingham Institute for Mental Health Youth Advisory Group was involved throughout the study, including co-producing the focus groups with children and young people. Results Substantial progress had been made implementing the programme, in challenging circumstances, and there was optimism about what it had the potential to achieve. The education mental health practitioner role had proven popular, but sites reported challenges in retaining education mental health practitioners, and turnover left mental health support teams short-staffed and needing to re-recruit. Education settings welcomed additional mental health support and reported positive early outcomes, including staff feeling more confident and having faster access to advice about mental health issues. At the same time, there were concerns about children who had mental health problems that were more serious than 'mild to moderate' but not serious enough to be accepted for specialist help, and that the interventions offered were not working well for some young people. Mental health support teams were generally spending more time supporting children with mental health problems than working with education settings to develop 'whole school' approaches to mental health and well-being, and service models in some sites appeared to be more clinically oriented, with a strong focus on mental health support teams' therapeutic functions. Limitations Despite efforts to maximise participation, survey response rates were relatively low and some groups were less well represented than others. We were not able to gather sufficiently detailed data to develop a typology of Trailblazer sites, as was planned. Conclusions Key lessons for future programme implementation include: - Whether mental health support teams should expand support to children and young people with more complex and serious mental health problems. - How to keep the twin aims of prevention and early intervention in balance. - How to retain education mental health practitioners once trained. Future work The findings have important implications for the design of a longer-term impact evaluation of the programme, which is due to commence in summer 2023. Study registration Ethical approval from the University of Birmingham (ERN_19-1400 - RG_19-190) and London School of Hygiene and Tropical Medicine (Ref: 18040) and Health Research Authority approval (IRAS 270760). Funding The Birmingham, RAND and Cambridge Evaluation Rapid Evaluation Centre is funded by the National Institute for Health and Care Research Health Services and Delivery Research programme (HSDR 16/138/31). The Policy Innovation and Evaluation Research Unit is funded by the NIHR Policy Research Programme (PR-PRU-1217-20602).

General practitioners working in or alongside the emergency department: the GPED mixed-methods study

Abstract: Emergency care is facing a steadily rising demand. In response, hospitals have implemented new models of care that locate general practitioners in or alongside the emergency department. We aimed to explore the effects of general practitioners working in or alongside the emergency department on patient care, the primary care and acute hospital team, and the wider system, as well as to determine the differential effects of different service models. This was a mixed-methods study in three work packages. Work package A classified current models of general practitioners working in or alongside the emergency department in England. We interviewed national and local leaders, staff and patients to identify the hypotheses underpinning these services. Work package B used a retrospective analysis of routinely available data. Outcome measures included waiting times, admission rates, reattendances, mortality and the number of patient attendances. We explored potential cost savings. Work package C was a detailed mixed-methods case study in 10 sites. We collected and synthesised qualitative and quantitative data from non-participant observations, interviews and a workforce survey. Patients and the public were involved throughout the development, delivery and dissemination of the study. High-level goals were shared between national policy-makers and local leads; however, there was disagreement about the anticipated effects. We identified eight domains of influence: performance against the 4-hour target, use of investigations, hospital admissions, patient outcome and experience, service access, workforce recruitment and retention, workforce behaviour and experience, and resource use. General practitioners working in or alongside the emergency department were associated with a very slight reduction in the rate of reattendance within 7 days; however, the clinical significance of this was judged to be negligible. For all other indicators, there was no effect on performance or outcomes. However, there was a substantial degree of heterogeneity in these findings. This is explained by the considerable variation observed in our case study sites, and the sensitivity of service implementation to local factors. The effects on the workforce were complex; they were often positive for emergency department doctors and general practitioners, but less so for nursing staff. The patient-streaming process generated stress and conflict for emergency department nurses and general practitioners. Patients and carers were understanding of general practitioners working in or alongside the emergency department. We found no evidence that staff concerns regarding the potential to create additional demand were justified. Any possible cost savings associated with reduced reattendances were heavily outweighed by the cost of the service. The reliability of our data sources varied and we were unable to complete our quantitative analysis entirely as planned. Participation in interviews and at case study sites was voluntary. Service implementation was highly subject to local context and micro-level influences. Key success factors were interprofessional working, staffing and training, streaming, and infrastructure and support. Further research should study the longer-term effects of these services, clinician attitudes to risk and the implementation of streaming. Additional work should also examine the system effects of national policy initiatives, develop methodologies to support rapid service evaluation and study the relationship between primary and secondary care. This trial is registered as ISRCTN51780222. This project was funded by the National Institute for Health and Care Research (NIHR) Health and Social Care Delivery Research programme and will be published in full in Health and Social Care Delivery Research; Vol. 10, No. 30. See the NIHR Journals Library website for further project information.

Prehospital video triage of potential stroke patients in North Central London and East Kent: rapid mixed-methods service evaluation

Abstract: In response to COVID-19, alongside other service changes, North Central London and East Kent implemented prehospital video triage: this involved stroke and ambulance clinicians communicating over FaceTime (Apple Inc., Cupertino, CA, USA) to assess suspected stroke patients while still on scene. To evaluate the implementation, experience and impact of prehospital video triage in North Central London and East Kent. A rapid mixed-methods service evaluation (July 2020 to September 2021) using the following methods. (1) Evidence reviews: scoping review (15 reviews included) and rapid systematic review (47 papers included) on prehospital video triage for stroke, covering usability (audio-visual and signal quality); acceptability (whether or not clinicians want to use it); impact (on outcomes, safety, experience and cost-effectiveness); and factors influencing implementation. (2) Clinician views of prehospital video triage in North Central London and East Kent, covering usability, acceptability, patient safety and implementation: qualitative analysis of interviews with ambulance and stroke clinicians (n = 27), observations (n = 12) and documents (n = 23); a survey of ambulance clinicians (n = 233). (3) Impact on safety and quality: analysis of local ambulance conveyance times (n = 1400; April to September 2020). Analysis of national stroke audit data on ambulance conveyance and stroke unit delivery of clinical interventions in North Central London, East Kent and the rest of England (n = 137,650; July 2018 to December 2020). (1) Evidence: limited but growing, and sparse in UK settings. Prehospital video triage can be usable and acceptable, requiring clear network connection and audio-visual signal, clinician training and communication. Key knowledge gaps included impact on patient conveyance, patient outcomes and cost-effectiveness. (2) Clinician views. Usability – relied on stable Wi-Fi and audio-visual signals, and back-up processes for when signals failed. Clinicians described training as important for confidence in using prehospital video triage services, noting potential for ‘refresher’ courses and joint training events. Ambulance clinicians preferred more active training, as used in North Central London. Acceptability – most clinicians felt that prehospital video triage improved on previous processes and wanted it to continue or expand. Ambulance clinicians reported increased confidence in decisions. Stroke clinicians found doing assessments alongside their standard duties a source of pressure. Safety – clinical leaders monitored and managed potential patient safety issues; clinicians felt strongly that services were safe. Implementation – several factors enabled prehospital video triage at a system level (e.g. COVID-19) and more locally (e.g. facilitative governance, receptive clinicians). Clinical leaders reached across and beyond their organisations to engage clinicians, senior managers and the wider system. (3) Impact on safety and quality: we found no evidence of increased times from symptom onset to arrival at services or of stroke clinical interventions reducing in studied areas. We found several significant improvements relative to the rest of England (possibly resulting from other service changes). We could not interview patients and carers. Ambulance data had no historic or regional comparators. Stroke audit data were not at patient level. Several safety issues were not collected routinely. Our survey used a convenience sample. Prehospital video triage was perceived as usable, acceptable and safe in both areas. Qualitative research with patients, carers and other stakeholders and quantitative analysis of patient-level data on care delivery, outcomes and cost-effectiveness, using national controls. Focus on sustainability and roll-out of services. This study is registered as PROSPERO CRD42021254209. This project was funded by the National Institute for Health and Care Research (NIHR) Health and Social Care Delivery Research programme and will be published in full in Health and Social Care Delivery Research; Vol. 10, No. 26. See the NIHR Journals Library website for further project information.

Understanding approaches to continence care for people living with dementia in acute hospital settings: an ethnographic study

Abstract: The acute hospital setting has become a key site of care for people living with dementia. People living with dementia are one of the largest populations in our hospitals, with the Department of Health and Social Care recognising that 25–50% of all acute hospital admissions are people who are also living with dementia. However, people living with dementia are a highly vulnerable group in the hospital setting and, following an acute admission, their functional abilities can deteriorate quickly and significantly. Detailed research is required to explore what constitutes ‘good care’. This study’s focus was a common, but poorly understood, aspect of everyday care for people living with dementia during an acute admission, that is continence care. We asked the following questions: what caring practices are observable when interacting with this patient group? How do ward teams respond to and manage continence needs? What informs these approaches? What are staff doing and why? This ethnography was informed by the symbolic interactionist research tradition, focusing on understanding how action and meaning are constructed within a setting. In-depth evidence-based analysis of everyday care enabled us to examine how ward staff responded to the continence care needs of people living with dementia and to follow the consequences of their actions. We carried out a mixed-methods systematic narrative review to refine our approach to fieldwork and analysis. This ethnography was carried out for 180 days, across 12 months, in six wards in three hospitals across England and Wales that were purposefully selected to represent a range of hospital types, geographies and socioeconomic catchments. In addition to general observations, 108 individuals participated directly in this study, contributing to 562 ethnographic interviews. Ten detailed case studies were also undertaken with people living with dementia. This study identified ‘pad cultures’ as an embedded practice on these acute wards. The routine use of continence pads among people living with dementia (regardless of continence and independence) was widespread. The use of continence pads was viewed as a precautionary strategy, the rationale being to provide safeguards, ensure containment and prevent ‘accidents’ or incontinence episodes, with an expectation that patients living with dementia not only will wear pads, but will use them. These ‘pad cultures’ enabled the number of unscheduled interruptions to the institutionally mandated timetabled work of these wards to be reduced, but had significant impacts on people living with dementia and, in turn, wider consequences for these individuals and their identities. Ward staff described feeling abandoned with the responsibility of caring for large numbers of people living with dementia, believing that it was impossible to work in other ways to support their patient’s continence. The limitations identified included the potential for the Hawthorne effect to influence data collection. In collaboration with a specialist dementia care and continence teams, the findings are informing the development of education and training at the interactional and organisational level. This study is registered as PROSPERO CRD42018119495. This project was funded by the National Institute for Health and Care Research (NIHR) Health and Social Care Delivery Research programme and will be published in full in Health and Social Care Delivery Research; Vol. 10, No. 14. See the NIHR Journals Library website for further project information.

Design and evaluation of an interactive quality dashboard for national clinical audit data: a realist evaluation

Abstract: National audits aim to reduce variations in quality by stimulating quality improvement. However, varying provider engagement with audit data means that this is not being realised. The aim of the study was to develop and evaluate a quality dashboard (i.e. QualDash) to support clinical teams’ and managers’ use of national audit data. The study was a realist evaluation and biography of artefacts study. The study involved five NHS acute trusts. In phase 1, we developed a theory of national audits through interviews. Data use was supported by data access, audit staff skilled to produce data visualisations, data timeliness and quality, and the importance of perceived metrics. Data were mainly used by clinical teams. Organisational-level staff questioned the legitimacy of national audits. In phase 2, QualDash was co-designed and the QualDash theory was developed. QualDash provides interactive customisable visualisations to enable the exploration of relationships between variables. Locating QualDash on site servers gave users control of data upload frequency. In phase 3, we developed an adoption strategy through focus groups. ‘Champions’, awareness-raising through e-bulletins and demonstrations, and quick reference tools were agreed. In phase 4, we tested the QualDash theory using a mixed-methods evaluation. Constraints on use were metric configurations that did not match users’ expectations, affecting champions’ willingness to promote QualDash, and limited computing resources. Easy customisability supported use. The greatest use was where data use was previously constrained. In these contexts, report preparation time was reduced and efforts to improve data quality were supported, although the interrupted time series analysis did not show improved data quality. Twenty-three questionnaires were returned, revealing positive perceptions of ease of use and usefulness. In phase 5, the feasibility of conducting a cluster randomised controlled trial of QualDash was assessed. Interviews were undertaken to understand how QualDash could be revised to support a region-wide Gold Command. Requirements included multiple real-time data sources and functionality to help to identify priorities. Audits seeking to widen engagement may find the following strategies beneficial: involving a range of professional groups in choosing metrics; real-time reporting; presenting ‘headline’ metrics important to organisational-level staff; using routinely collected clinical data to populate data fields; and dashboards that help staff to explore and report audit data. Those designing dashboards may find it beneficial to include the following: ‘at a glance’ visualisation of key metrics; visualisations configured in line with existing visualisations that teams use, with clear labelling; functionality that supports the creation of reports and presentations; the ability to explore relationships between variables and drill down to look at subgroups; and low requirements for computing resources. Organisations introducing a dashboard may find the following strategies beneficial: clinical champion to promote use; testing with real data by audit staff; establishing routines for integrating use into work practices; involving audit staff in adoption activities; and allowing customisation. The COVID-19 pandemic stopped phase 4 data collection, limiting our ability to further test and refine the QualDash theory. Questionnaire results should be treated with caution because of the small, possibly biased, sample. Control sites for the interrupted time series analysis were not possible because of research and development delays. One intervention site did not submit data. Limited uptake meant that assessing the impact on more measures was not appropriate. The extent to which national audit dashboards are used and the strategies national audits use to encourage uptake, a realist review of the impact of dashboards, and rigorous evaluations of the impact of dashboards and the effectiveness of adoption strategies should be explored. This study is registered as ISRCTN18289782. This project was funded by the National Institute for Health and Care Research (NIHR) Health and Social Care Delivery Research programme and will be published in full in Health and Social Care Delivery Research; Vol. 10, No. 12. See the NIHR Journals Library website for further project information.

Optimum models of hospice at home services for end-of-life care in England: a realist-informed mixed-methods evaluation

Abstract: Many people prefer to die at home when the time comes. Hospice at home services aim to support patients to achieve this. A range of hospice at home services exist; some services have been evaluated, but there has been limited evidence synthesis. The main objective was to find out what models of hospice at home services work best, for whom and in what circumstances. Other objectives supported this aim, including an analysis of the health economic costs of hospice at home models. The study was an overarching, non-interventional, realist evaluation comprising three phases. Phase 1 was a survey of hospice at home services. Phase 2 involved 12 case studies, grouped into four models on the basis of size and 24 hours per day, 7 days per week (24/7), operations, from which quantitative and health economics data were gathered. Qualitative interview data from bereaved carers, commissioners and providers were analysed to generate context–mechanism–outcome configurations. Phase 3 comprised stakeholder consensus meetings. Hospice at home services across England. A total of 70 hospice at home managers responded to the survey. A total of 339 patient and family/informal carer dyads were recruited; 85 hospice at home providers and commissioners were interviewed. A total of 88 stakeholders participated in consensus meetings. The quality of dying and death of patients was assessed by bereaved carers (using the Quality of Dying and Death questionnaire). A patient’s use of services was collected using the Ambulatory and Home Care Record. Hospice at home services varied; two-thirds were mainly charitably funded, and not all operated 24/7. Most patients (77%) had cancer. Hospice at home services overall provided care that was likely to deliver ‘a good death’, and 73% of patients died in their preferred place. Six context–mechanism–outcome configurations captured factors relevant to providing optimum hospice at home services: (1) sustainability (of the hospice at home service); (2) volunteers (use of, in the hospice at home service); (3) integration and co-ordination (with the wider health and social care system); (4) marketing and referral (of the hospice at home service); (5) knowledge, skills and ethos (of hospice at home staff); and (6) support directed at the carer at home. Key markers of a good service included staff who had time to care, providing hands-on care; staff whose knowledge and behaviour promoted supportive relationships and confidence through the process of dying; and services attending to the needs of the informal carer. Areas of potential improvement for most hospice at home services were the use of volunteers in hospice at home, and bereavement care. The study had the following limitations – heterogeneity of hospice at home services, variations in numbers and patient clinical statuses at recruitment, a low Quality of Dying and Death questionnaire response rate, and missing data. Only patients with an informal carer involved on a daily basis were eligible for the study. Hospice at home services delivered high-quality care and a ‘good death’, with the majority of patients dying in their stated preferred place. Hospice at home providers can improve their impact by focusing on the features identified that deliver the best patient outcomes. Commissioners can facilitate patient preference and reduce the number of hospital deaths by working with hospice at home services to secure their financial sustainability and increase the numbers and range of patients admitted to hospice at home services. Future research should explore the use of volunteers in the hospice at home setting and evaluate approaches to bereavement support. This project was funded by the National Institute for Health and Care Research (NIHR) Health and Social Care Delivery Research programme and will be published in full in Health and Social Care Delivery Research; Vol. 10, No. 24. See the NIHR Journals Library website for further project information.

Experiences of children and young people from ethnic minorities in accessing mental health care and support: rapid scoping review

Abstract: Mental health problems are common among children and young people in the UK. Some young people from ethnic minority backgrounds experience mental health problems in different ways from those from non-ethnic minority backgrounds. Furthermore, those from ethnic minority backgrounds often experience greater difficulties in accessing mental health support and variable levels of engagement with services, and may prefer different support to their white British peers. To describe the nature and scope of qualitative research about the experiences of children and young people from ethnic minority backgrounds in seeking or obtaining care or support for mental health problems. We searched seven bibliographic databases (Applied Social Sciences Index and Abstracts, Cumulative Index to Nursing and Allied Health Literature, MEDLINE, PsycInfo®, Health Management Information Consortium, Social Policy and Practice, and Web of Science) using relevant terms on 23 June 2021. The scoping review included qualitative research about young people’s experiences of seeking or engaging with services or support for mental health problems. Included studies were published from 2012 onwards, were from the UK, were about those aged 10–24 years and were focused on those from ethnic minority backgrounds (i.e. not white British). Study selection, data extraction and quality assessment (with ‘Wallace’ criteria) were conducted by two reviewers. We provide a descriptive summary of the aims, scope, sample, methods and quality of the included studies, and a selected presentation of authors’ findings (i.e. no formal synthesis). From 5335 unique search records, we included 26 papers or reports describing 22 diverse qualitative studies. Most of the studies were well conducted and clearly described. There were studies of refugees/asylum seekers (n = 5), university students (n = 4) and studies among young people experiencing particular mental health problems (n = 14) (some studies appear in multiple categories): schizophrenia or psychosis (n = 3), eating disorders (n = 3), post-traumatic stress disorder (n = 3, in asylum seekers), substance misuse (n = 2), self-harm (n = 2) and obsessive–compulsive disorder (n = 1). There were also three studies of ethnic minority young people who were receiving particular treatments (cognitive–behavioural therapy, multisystemic therapy for families and a culturally adapted family-based talking therapy). Most studies had been conducted with young people or their parents from a range of different ethnic backgrounds. However, nine studies were conducted with particular ethnic groups: asylum seekers from Afghanistan (n = 2), and black and South Asian (n = 2), black African and black Caribbean (n = 2), South Asian (n = 1), Pakistani or Bangladeshi (n = 1) and Orthodox Jewish (n = 1) people. The studies suggested a range of factors that influence care-seeking and access to mental health care, in terms of the beliefs and knowledge of young people and their parents, the design and promotion of services, and the characteristics of care professionals. Poor access was attributed to a lack of understanding of mental health problems, lack of information about services, lack of trust in care professionals, social stigma and cultural expectations about mental resilience. As this was a rapid scoping review, there was only a basic synthesis of the research findings. Future research about young people from ethnic minorities could cover a wider range of ethnic minorities, sample and analyse experiences from particular ethnic minorities separately, cover those accessing different services for different needs, and adopt multiple perspectives (e.g. service user, carer, clinician, service management). This study is registered as https://osf.io/wa7bf/. This project was funded by the National Institute for Health and Care Research (NIHR) Health and Social Care Delivery programme and will be published in full in Health and Social Care Delivery; Vol. 10, No. 22. See the NIHR Journals Library website for further project information.

Hospital at Home admission avoidance with comprehensive geriatric assessment to maintain living at home for people aged 65 years and over: a RCT

Abstract: Evidence is required to guide the redesign of health care for older people who require hospital admission. We assessed the clinical effectiveness and cost-effectiveness of geriatrician-led admission avoidance hospital at home with comprehensive geriatric assessment, the experiences of older people and their caregivers, and how the services differed. A multisite, randomised, open trial of comprehensive geriatric assessment hospital at home, compared with admission to hospital, using a 2 : 1 (hospital at home to hospital) ratio, and a parallel economic and process evaluation. Participants were randomised using a secure online system. Participants were recruited from primary care or acute hospital assessment units from nine sites across the UK. Older people who required hospital admission because of an acute change in health. Geriatrician-led admission avoidance hospital at home with comprehensive geriatric assessment. The main outcome, ‘living at home’ (the inverse of death or living in a residential care setting), was measured at 6-month follow-up. Secondary outcomes at 6 months were the incidence of delirium, mortality, new long-term residential care, cognitive impairment, ability to perform activities of daily living, quality-adjusted survival, length of stay and transfer to hospital. Secondary outcomes at 12 months were living at home, new long-term residential care and mortality. Participants were allocated to hospital at home (n = 700) or to hospital (n = 355). All reported relative risks (RRs) were adjusted and are reported for hospital at home compared with hospital. There were no significant differences between the groups in the proportions of patients ‘living at home’ at 6 months [528/672 (78.6%) vs. 247/328 (75.3%), RR 1.05, 95% confidence interval (CI) 0.95 to 1.15; p = 0.36] or at 12 months [443/670 (66.1%) vs. 219/325 (67.4%), RR 0.99, 95% CI 0.89 to 1.10; p = 0.80]; mortality at 6 months [114/673 (16.9%) vs. 58/328 (17.7%), RR 0.98, 95% CI 0.65 to 1.47; p = 0.92] or at 12 months [188/670 (28.1%) vs. 82/325 (25.2%), RR 1.14, 95% CI 0.80 to 1.62]; the proportion of patients with cognitive impairment [273/407 (67.1%) vs. 115/183 (62.8%), RR 1.06, 95% CI 0.93 to 1.21; p = 0.36]; or in ability to perform the activities of daily living as measured by the Barthel Index (mean difference 0.24, 95% CI –0.33 to 0.80; p = 0.411; hospital at home, n = 521 patients contributed data; hospital, n = 256 patients contributed data) or Comorbidity Index (adjusted mean difference 0.0002, 95% CI –0.15 to 0.15; p = 0.10; hospital at home, n = 474 patients contributed data; hospital, n = 227 patients contributed data) at 6 months. The varying denominator reflects the number of participants who contributed data to the different outcomes. There was a significant reduction in the RR of living in residential care at 6 months [37/646 (5.7%) vs. 27/311 (8.7%), RR 0.58, 95% CI 0.45 to 0.76; p < 0.001] and 12 months [39/646 (6.0%) vs. 27/311 (8.7%), RR 0.61, 95% CI 0.46 to 0.82; p < 0.001], a significant reduction in risk of delirium at 1 month [10/602 (1.7%) vs. 13/295 (4.4%), RR 0.38, 95% CI 0.19 to 0.76; p = 0.006] and an increased risk of transfer to hospital at 1 month [173/672 (25.7%) vs. 64/330 (19.4%), RR 1.32, 95% CI 1.06 to 1.64; p = 0.012], but not at 6 months [343/631 (54.40%) vs. 171/302 (56.6%), RR 0.95, 95% CI 0.86 to 1.06; p = 0.40]. Patient satisfaction was in favour of hospital at home. An unexpected adverse event that might have been related to the research was reported to the Research Ethics Committee. At 6 months, there was a mean difference in NHS, personal social care and informal care costs (mean difference –£3017, 95% CI –£5765 to –£269), and no difference in quality-adjusted survival. Older people and caregivers played a crucial role in supporting the delivery of health care. In hospital at home this included monitoring a patient’s health and managing transitional care arrangements. The findings are most applicable to patients referred from an acute hospital assessment unit. Comprehensive geriatric assessment hospital at home can provide a cost-effective alternative to hospitalisation for selected older people. Further research that includes a stronger element of carer support might generate evidence to improve health outcomes. This trial is registered as ISRCTN60477865. This project was funded by the National Institute for Health Research (NIHR) Health and Social Care Delivery Research programme and will be published in full in Health and Social Care Delivery Research; Vol. 10, No. 2. See the NIHR Journals Library website for further project information.

Using simulation and machine learning to maximise the benefit of intravenous thrombolysis in acute stroke in England and Wales: the SAMueL modelling and qualitative study

Abstract: Stroke is a common cause of adult disability. Expert opinion is that about 20% of patients should receive thrombolysis to break up a clot causing the stroke. Currently, 11–12% of patients in England and Wales receive this treatment, ranging between 2% and 24% between hospitals. We sought to enhance the national stroke audit by providing further analysis of the key sources of inter-hospital variation to determine how a target of 20% of stroke patients receiving thrombolysis may be reached. We modelled three aspects of the thrombolysis pathway, using machine learning and clinical pathway simulation. In addition, the project had a qualitative research arm, with the objective of understanding clinicians’ attitudes to use of modelling and machine learning applied to the national stroke audit. Anonymised data were collected for 246,676 emergency stroke admissions to acute stroke teams in England and Wales between 2016 and 2018, obtained from the Sentinel Stroke National Audit Programme. Use of thrombolysis could be predicted with 85% accuracy for those patients with a chance of receiving thrombolysis (i.e. those arriving within 4 hours of stroke onset). Machine learning models allowed prediction of likely treatment choice for each patient at all hospitals. A clinical pathway simulation predicted hospital thrombolysis use with an average absolute error of 0.5 percentage points. We found that about half of the inter-hospital variation in thrombolysis use came from differences in local patient populations, and half from in-hospital processes and decision-making. Three changes were applied to all hospitals in the model: (1) arrival to treatment in 30 minutes, (2) proportion of patients with determined stroke onset times set to at least the national upper quartile and (3) thrombolysis decisions made based on majority vote of a benchmark set of 30 hospitals. Any single change alone was predicted to increase national thrombolysis use from 11.6% to between 12.3% and 14.5% (with clinical decision-making having the most effect). Combined, these changes would be expected to increase thrombolysis to 18.3% (and to double the clinical benefit of thrombolysis, as speed increases also improve clinical benefit independently of the proportion of patients receiving thrombolysis); however, there would still be significant variation between hospitals depending on local patient population. For each hospital, the effect of each change could be predicted alone or in combination. Qualitative research with 19 clinicians showed that engagement with, and trust in, the model was greatest in physicians from units with higher thrombolysis rates. Physicians also wanted to see a machine learning model predicting outcome with probability of adverse effect of thrombolysis to counter a fear that driving thrombolysis use up may cause more harm than good. Models may be built using data available in the Sentinel Stroke National Audit Programme only. Not all factors affecting use of thrombolysis are contained in Sentinel Stroke National Audit Programme data and the model, therefore, provides information on patterns of thrombolysis use in hospitals, but is not suitable for, or intended as, a decision aid to thrombolysis. Machine learning and clinical pathway simulation may be applied at scale to national audit data, allowing extended use and analysis of audit data. Stroke thrombolysis rates of at least 18% look achievable in England and Wales, but each hospital should have its own target. Future studies should extend machine learning modelling to predict the patient-level outcome and probability of adverse effects of thrombolysis, and apply co-production techniques, with clinicians and other stakeholders, to communicate model outputs. This project was funded by the National Institute for Health and Care Research (NIHR) Health and Social Care Delivery Research programme and will be published in full in Health and Social Care Delivery Research; Vol. 10, No. 31. See the NIHR Journals Library website for further project information.

Safety of disinvestment in mid- to late-term follow-up post primary hip and knee replacement: the UK SAFE evidence synthesis and recommendations

Abstract: Joint replacement surgery has revolutionised the management of degenerative joint disease. Increasing demand for surgery and post-surgical reviews has overwhelmed orthopaedic services and, consequently, many centres have reduced or stopped follow-up. Such disinvestment is without an evidence base and raises questions regarding the consequences to patients. To produce evidence- and consensus-based recommendations as to how, when and on whom follow-up should be conducted. Our research question was ‘Is it safe to disinvest in mid- to late-term follow-up of hip and knee replacement?’. The study comprised three complementary evidence synthesis work packages to inform a final consensus process. Work package 1 was a systematic review of the clinical effectiveness and cost-effectiveness literature. Work package 2 used routine national data sets (i.e. the Clinical Practice Research Datalink–Hospital Episode Statistics, Hospital Episode Statistics–National Joint Registry–patient-reported outcome measures) to identify pre, peri and postoperative predictors of mid- to late-term revision, and prospective data from 560 patients to understand how patients present for revision surgery. Work package 3 used a Markov model to simulate the survival, health-related quality of life and NHS costs of patients following hip or knee replacement surgery. Finally, evidence from work packages 1–3 informed a face-to-face consensus panel, which involved 32 stakeholders. Our overarching statements are as follows: (1) these recommendations apply to post primary hip and knee replacement follow-up; (2) the 10-year time point in these recommendations is based on a lack of robust evidence beyond 10 years; and (3) in these recommendations, the term ‘complex cases’ refers to individual patient and surgical factors that may increase the risk of replacement failure. Our recommendations are as follows: for Orthopaedic Data Evaluation Panel 10A* (ODEP-10A*) minimum implants, it is safe to disinvest in routine follow-up from 1 to 10 years post non-complex hip and knee replacement provided that there is rapid access to orthopaedic review; (2) for ODEP-10A* minimum implants in complex cases or non-ODEP-10A* minimum implants, periodic follow-up post hip and knee replacement may be required from 1 to 10 years; (3) at 10 years post hip and knee replacement, clinical and radiographic evaluation is recommended; and (4) after 10 years post hip and knee replacement, frequency of further follow-up should be based on the 10-year assessment (note that ongoing rapid access to orthopaedic review is still required) [Stone M, Smith L, Kingsbury S, Czoski-Murray C, Judge A, Pinedo-Villanueva R, et al. Evidence-based follow-up recommendations following primary hip and knee arthroplasty (UK SAFE). Orthop Proc 2020;102–B:13. https://doi.org/10.1302/1358-992X.2020.5.013]. The current absence of data beyond 10 years restricted the evidence base. For ODEP-10A* prostheses, the UK SAFE programme demonstrated that it is safe to disinvest in routine follow-up in the 1- to 10-year period after non-complex hip and knee replacement. At 10 years, clinical and radiographic review is recommended. Complex cases, implants not meeting the 10A* criteria and follow-up after revision surgery are not covered by this recommendation. The evidence base for follow-up after 10 years requires further evaluation. Further work should establish the most clinically effective and cost-effective model of delivering a rapid access service and evaluate alternative models for follow-up services, such as virtual clinics. Finally, the needs and outcomes of patients who are symptomatic but do not have appropriate follow-up should be investigated. This study is registered as PROSPERO CRD42017053017. This project was funded by the National Institute for Health and Care Research (NIHR) Health and Social Care Delivery Research programme and will be published in full in Health and Social Care Delivery Research; Vol. 10, No. 16. See the NIHR Journals Library website for further project information.

Implementation of ‘Freedom to Speak Up Guardians’ in NHS acute and mental health trusts in England: the FTSUG mixed-methods study

Abstract: The introduction of ‘Freedom to Speak Up Guardians’ into every NHS trust in England was intended to support workers and trusts to better raise, respond to and learn from speaking-up concerns. However, only broad guidance was provided on how to implement the role. As a result, there is the potential for important local differences to emerge as the role is implemented across England. The overall aim of this study was to better understand the implementation of Guardians in acute trusts and mental health trusts. The Freedom to Speak Up Guardian role was conceptualised as a complex intervention consisting of several interacting and interlocking components spanning the macro level (national organisations), the meso level (individual trusts) and the micro level (employees, teams and wards/units). A mixed-methods study was designed, which consisted of three work packages: (1) a systematic narrative review of the international literature regarding interventions promoting ‘speaking up’ by health-care employees; (2) semistructured telephone interviews with Guardians working in acute hospital trusts and mental health trusts; and (3) qualitative case studies of Freedom to Speak Up Guardian implementation, consisting of observations and interviews undertaken in four acute trusts and two mental health trusts. Interviews were also undertaken with national stakeholders. Acute trusts and mental health NHS trusts in England. Work package 2: Freedom to Speak Up Guardians (n = 87) were interviewed. Work package 3: 116 interviews with key stakeholders involved in pre-implementation and early implementation decision-making, workers who had spoken up to the Guardian, and national stakeholders. Wide variability was identified in how the Guardian role had been implemented, resourced and deployed by NHS trusts. ‘Freedom to Speak Up Guardian’ is best considered an umbrella term, and multiple versions of the role exist simultaneously across England. Any comparisons of Guardians’ effectiveness are likely to be possible or meaningful only when this variability is properly accounted for. Many Freedom to Speak Up Guardians identified how a lack of available resources, especially time scarcity, negatively and significantly affected their ability to effectively respond to concerns; their opportunities to collect, analyse and learn from speaking-up data; and, more generally, the extent to which they developed their role and speak-up culture. It is possible that those whom we interviewed were more receptive of Freedom to Speak Up Guardians or may have been biased by ‘socially desirability’, and their answers may not always have represented respondents’ true perceptions. Optimal implementation of the Guardian role has five components: (1) establishing an early, collaborative and coherent strategy congruent with the values of Freedom to Speak Up fosters the implementation of (2) policies and robust, yet supportive, practices (3) informed by frequent and reflexive monitoring of Freedom to Speak Up implementation that is (4) underpinned by sufficient time and resource allocation that leads to (5) a positive implementation climate that is congruent with Freedom to Speak Up values and is well placed to engender positive and sustainable Freedom to Speak Up culture and the well-being of a Guardian. The following recommendations for future research are considered to be of equal priority. Studies of the speaking-up experiences of minority communities and ‘seldom-heard’ workforce groups are a priority requirement. There is also value in undertaking a similar study in non-hospital settings and where peripatetic working is commonplace, such as in ambulance services and in primary care settings. The role of human resources and ‘middle managers’ in the management of concerns is an area requiring further research, especially regarding concerns relating to unprofessional and transgressive behaviours. Devolved administrations in Scotland and Wales have adopted different approaches to speaking up; research undertaken in these contexts would offer valuable comparative insights. Researching the Guardian role ≥ 5 years post implementation is recommended to understand the medium-term impact and the longer-term sustainability of the role and well-being of Guardians. This study is registered as ISRCTN38163690 and has the study registration CRD42018106311. This project was funded by the National Institute for Health and Care Research (NIHR) Health and Social Care Delivery Research programme and will be published in full in Health and Social Care Delivery Research; Vol. 10, No. 23. See the NIHR Journals Library website for further project information.

Intensive support teams for adults with intellectual disabilities displaying challenging behaviour: the IST-ID mixed-methods study

Abstract: National policy recommends intensive support teams for all areas of England for adults with intellectual disabilities who display challenging behaviour. However, to the best of our knowledge, there has not been a systematic evaluation of intensive support teams to date. Our objectives were to identify and describe the geographical distribution and characteristics of intensive support teams in England; to create a typology of intensive support teams; to investigate clinical and cost outcomes of intensive support team models and factors associated with those outcomes; and to explore professionals’, service users’ and carers’ experiences and describe the wider system context in which they operate. This was a two-phase mixed-methods study. In phase 1, a national survey examined the intensive support team models in operation in England. In phase 2, an observational study of adults with intellectual disabilities investigated the clinical effectiveness and cost-effectiveness of the two intensive support team models. Semistructured interviews with intensive support team managers and professionals, carers, and adults with intellectual disabilities explored their experiences of intensive support team care. In parallel, we examined service-level outcomes related to the function of intensive support teams. Phase 1 included 80 intensive support teams serving 242 community intellectual disability services in England. Phase 2 included 21 intensive support teams, half of which were in the enhanced intensive support teams model and half of which were in the independent model. In phase 1, a total of 73 intensive support team managers provided data. In phase 2, a total of 226 participants with intellectual disabilities from 21 intensive support teams (enhanced: teams, n = 11; participants, n = 115; independent: teams, n = 10; participants, n = 111) were enrolled in the study. A total of 42 stakeholders were interviewed. The main outcome measure was the Aberrant Behaviour Checklist-Community, version 2, total score. Additional data sources were the carer and self-reported questionnaires, qualitative interviews and focus groups. Two intensive support team models were identified in England – enhanced and independent. Challenging behaviour at 9 months was reduced in both intensive support team models (β 3.08, 95% confidence interval –7.32 to 13.48; p = 0.561), but the observed Aberrant Behaviour Checklist-Community, version 2, score reduction appeared larger in the independent model than in the enhanced model (21% vs. 13%, respectively). No statistically significant differences were found in the secondary outcomes [Psychiatric Assessment Schedule for Adults with Developmental Disabilities Clinical Interview organic condition (odds ratio 1.09, 95% confidence interval 0.39 to 3.02), affective or neurotic disorder (odds ratio 0.91, 95% confidence interval 0.32 to 2.59), or psychotic disorder score (odds ratio 1.08, 95% confidence interval 0.21 to 5.50); risk score (β 1.12, 95% confidence interval –0.44 to 2.68); or quality of life questionnaire score (β –2.63, 95% confidence interval –5.65 to 0.40)]. Similarly, no differences were observed between models in relation to cost-effectiveness (health and social care costs mean difference £3409.95, 95% confidence interval –£9957.92 to £4039.89; societal costs mean difference –£4712.30, 95% confidence interval –£11,124.85 to £2106.36). The experiences of stakeholders did not differ between the intensive support team models, with carers and adults with intellectual disabilities valuing service accessibility, person-centred care and engagement. All stakeholders reported a range of barriers to intensive support team care. Service-level data and the operational policies from intensive support teams showed variation in organisational function and the roles of intensive support teams. The most commonly delivered intervention was positive behaviour support. The study describes the operation of intensive support teams in England and identified two distinct models. We did not find advantages or disadvantages associated with clinical outcomes between models, nor did we find cost differences. On this basis, we recommend that local services decide which model best suits their circumstances. This was not a randomised controlled trial. It is possible that confounding factors have not been controlled for as there was no matching between intensive support teams. Last, there was no comparison with usual care. There is need to develop model fidelity and investigate clinical effectiveness and cost-effectiveness in a randomised controlled evaluation of intensive support teams against treatment as usual. This study is registered as ClinicalTrials.gov NCT03586375, Integrated Research Application System (IRAS) 239820 and National Institute for Health and Care Research (NIHR) Central Portfolio Management System (CPMS) 38554. This project was funded by the National Institute for Health and Care Research (NIHR) Health and Social Care Delivery Research programme and will be published in full in Health and Social Care Delivery Research; Vol. 10, No. 33. See the NIHR Journals Library website for further project information.

Scale, scope and impact of skill mix change in primary care in England: a mixed-methods study

Abstract: General practices have had difficulty recruiting and retaining enough general practitioners to keep up with increasing demand for primary health care in recent years. Proposals to increase workforce capacity include a policy-driven strategy to employ additional numbers and a wider range of health professionals. Our objective was to conduct a comprehensive study of the scale, scope and impact of changing patterns of practitioner employment in general practice in England. This included an analysis of employment trends, motivations behind employment decisions, staff and patient experiences, and how skill mix changes are associated with outcome measures and costs. NHS Digital workforce data (2015–19) were used to analyse employment changes and to look at their association with outcomes data, such as the General Practitioner Patient Survey, General Practitioner Worklife Survey, prescribing data, Hospital Episode Statistics, Quality and Outcomes Framework and NHS payments to practices. A practice manager survey (August–December 2019) explored factors motivating general practices’ employment decisions. An in-depth case study of five general practices in England (August–December 2019) examined how a broader range of practitioners is experienced by practice staff and patients. We found a 2.84% increase in reported full-time equivalent per 1000 patients across all practitioners during the study period. The full-time equivalent of general practitioner partners decreased, while the full-time equivalent of salaried general practitioners, advanced nurse practitioners, clinical pharmacists, physiotherapists, physician associates and paramedics increased. General practitioners and practice managers reported different motivating factors regarding skill mix employment. General practitioners saw skill mix employment as a strategy to cope with a general practitioner shortage, whereas managers prioritised potential cost-efficiencies. Case studies demonstrated the importance of matching patients’ problems with practitioners’ competencies and ensuring flexibility for practitioners to obtain advice when perfect matching was not achieved. Senior clinicians provided additional support and had supervisory and other responsibilities, and analysis of the General Practitioner Worklife Survey data suggested that general practitioners’ job satisfaction may not increase with skill mix changes. Patients lacked information about newer practitioners, but felt reassured by the accessibility of expert advice. However, General Practitioner Patient Survey data indicated that higher patient satisfaction was associated with a higher general practitioner full-time equivalent. Quality and Outcomes Framework achievement was higher when more practitioners were employed (i.e. full-time equivalent per 1000 patients). Higher clinical pharmacist full-time equivalents per 1000 patients were associated with higher quality and lower cost prescribing. Associations between skill mix and hospital activity were mixed. Our analysis of payments to practices and prescribing costs suggested that NHS expenditure may not decrease with increasing skill mix employment. These findings may reflect turbulence during a period of rapid skill mix change in general practice. The current policy of employing staff through primary care networks is likely to accelerate workforce change and generate additional challenges. Skill mix implementation is challenging because of the inherent complexity of general practice caseloads; it is associated with a mix of positive and negative outcome measures. Findings from this study will inform future funding applications for projects that seek to examine the nature and impact of evolving multiprofessional teams in primary care. This project was funded by the National Institute for Health and Care Research (NIHR) Health and Social Care Delivery Research programme and will be published in full in Health and Social Care Delivery Research; Vol. 10, No. 9. See the NIHR Journals Library website for further project information.

Optimising the impact of health services research on the organisation and delivery of health services: a mixed-methods study

Abstract: The limitations of ‘knowledge transfer’ are increasingly recognised, with growing interest in ‘knowledge co-production in context’. One way of achieving the latter is by ‘embedding’ researchers in health service settings, yet how to deliver such schemes successfully is poorly understood. The objectives were to examine the nature of ‘embedded knowledge co-production’ and explore how embedded research initiatives can be designed more effectively. The study used four linked workstreams. Workstream 1 involved two parallel literature reviews to examine how ‘knowledge co-production’ and ‘embedded research’ are conceptualised, operationalised and discussed. In workstream 2, a scoping review of exisiting or recent ‘embedded researcher’ schemes in UK health settings was carried out. Workstream 3 involved developing four in-depth case studies on such schemes to understand their mechanisms, effectiveness and challenges. In workstream 4, insights from the other workstreams were used to provide recommendations, guidance and templates for the different ways embedded co-production may be framed and specified. The overall goal was to help those interested in developing and using such approaches to understand and address the design choices they face. Embedded research initiatives in UK health settings. Data were sourced from the following: analysis of the published and grey literature (87 source articles on knowledge co-production, and 47 published reports on extant embedded research initiatives), documentation and interviews with key actors across 45 established embedded research initiatives, in-depth interviews and site observations with 31 participants over 12 months in four intensive case studies, and informal and creative engagement in workshops (n = 2) and with participants in embedded research initiatives who joined various managed discussion forums. The participants were stakeholders and participants in embedded research initiatives. The literature reviews from workstream 1 produced practical frameworks for understanding knowledge co-production and embedded research initiatives, which, with the scoping review (workstream 2), informed the identification and articulation of 10 design concerns under three overarching categories: intent (covering outcomes and power dynamics), structures (scale, involvement, proximity and belonging) and processes (the functional activities, skills and expertise required, nature of the relational roles, and the learning mechanisms employed). Current instances of embedded research were diverse across many of these domains. The four case studies (workstream 3) added insights into scheme dynamics and life cycles, deepening understanding of the overarching categories and showing the contingencies experienced in co-producing knowledge. A key finding is that there was often a greater emphasis on embeddedness per se than on co-production, which can be hard to discern. Finally, the engaging and influencing activities running throughout (workstream 4) allowed these research-rooted insights to be translated into practical tools and resources, evidenced by peer-reviewed publications, for those interested in exploring and developing the approach. Embedded research has a strong underpinning rationale, and more is becoming known about its design and management challenges. The tools and resources developed in this project provide a coherent evidence-informed framework for designing, operationalising and managing such schemes. It cannot yet be said with clarity that the potential benefits of embedded research are always deliverable, nor what the cost would be. With the means to describe and categorise different types of embedded research initiatives, more evaluative work is now needed to examine the relative merits and costs of different designs. This project was funded by the National Institute for Health Research (NIHR) Health and Social Care Delivery Research programme and will be published in full in Health and Social Care Delivery Research; Vol. 10, No. 3. See the NIHR Journals Library website for further project information.

Evidence and methods required to evaluate the impact for patients who use social prescribing: a rapid systematic review and qualitative interviews

Abstract: Social prescribing encourages health-care and other professionals to refer patients to a link worker, who will develop a personalised plan to improve the patient’s health and well-being. We explore the feasibility of evaluating the service. The objective was to answer the following research questions. (1) What are the most important evaluation questions that an impact study could investigate? (2) What data are already available at a local or national level and what else would be needed? (3) Are there sites delivering at a large enough scale and in a position to take part in an impact study? (4) How could the known challenges to evaluation (e.g. information governance and identifying a control group) be addressed? Data sources included MEDLINE ALL (via Ovid), searched from inception to 14 February 2019, and the first 100 hits of a Google (Google Inc., Mountain View, CA, USA) search. Rapid systematic review – electronic searches up to February 2019. Studies included any study design or outcomes. Screening was conducted by one reviewer; eligibility assessment and data extraction were undertaken by two reviewers. Data were synthesised narratively. Qualitative interviews – data from 25 participants in different regions of England were analysed using a pragmatic framework approach across 12 areas including prior data collection, delivery sites, scale and processes of current service delivery, and known challenges to evaluation. Views of key stakeholders (i.e. patients and academics) were captured. Rapid systematic review – 27 out of 124 studies were included. We identified outcomes and highlighted research challenges. Important evaluation questions included identification of the most appropriate (1) outcomes and (2) methods for dealing with heterogeneity. Qualitative interviews – social prescribing programmes are holistic in nature, covering domains such as social isolation and finance. Service provision is heterogeneous. The follow-on services that patients access are often underfunded or short term. Available data – there was significant heterogeneity in data availability, format and follow-up. Data were collected using a range of tools in ad hoc databases across sites. Non-attendance data were frequently not captured. Service users are more deprived and vulnerable than the overall practice population. Feasibility and potential limitations of an evaluation – current data collection is limited in determining the effectiveness of the link worker social prescribing model; therefore, uniform data collection across sites is needed. Standardised outcomes and process measures are required. Cost–utility analysis could provide comparative values for assessment alongside other NHS interventions. This was a rapid systematic review that did not include a systematic quality assessment of studies. COVID-19 had an impact on the shape of the service. We were not able to examine the potential causal mechanisms in any detail. We describe possible future research approaches to determine effectiveness and cost-effectiveness evaluations; all are limited in their application. (1) Evaluation using currently available, routinely collected health-care, costing and outcomes data. (2) Evaluative mixed-methods research to capture the complexity of social prescribing through understanding heterogeneous service delivery across comparative settings. Cost-effectiveness evaluation using routinely available costing and outcomes data to supplement qualitative data. (3) Interventional evaluative research, such as a cluster randomised controlled trial focused on the link worker model. Cost-effectiveness data collected as part of the trial. Mature data are currently not available. There needs to be an agreement across schemes on the key outcomes that need to be measured, harmonisation of data collection, and follow-up referrals (how and when). This project was funded by the National Institute for Health and Care Research (NIHR) Health and Social Care Delivery Research programme and will be published in full in Health and Social Care Delivery Research; Vol. 10, No. 29. See the NIHR Journals Library website for further project information.

Interventions to optimise the outputs of national clinical audits to improve the quality of health care: a multi-method study including RCT

Abstract: National clinical audit programmes aim to improve patient care by reviewing performance against explicit standards and directing action towards areas not meeting those standards. Their impact can be improved by (1) optimising feedback content and format, (2) strengthening audit cycles and (3) embedding randomised trials evaluating different ways of delivering feedback. The objectives were to (1) develop and evaluate the effects of modifications to feedback on recipient responses, (2) identify ways of strengthening feedback cycles for two national audits and (3) explore opportunities, costs and benefits of national audit participation in a programme of trials. An online fractional factorial screening experiment (objective 1) and qualitative interviews (objectives 2 and 3). Participants were clinicians and managers involved in five national clinical audits – the National Comparative Audit of Blood Transfusions, the Paediatric Intensive Care Audit Network, the Myocardial Ischaemia National Audit Project, the Trauma Audit & Research Network and the National Diabetes Audit – (objective 1); and clinicians, members of the public and researchers (objectives 2 and 3). We selected and developed six online feedback modifications through three rounds of user testing. We randomised participants to one of 32 combinations of the following recommended specific actions: comparators reinforcing desired behaviour change; multimodal feedback; minimised extraneous cognitive load for feedback recipients; short, actionable messages followed by optional detail; and incorporating ‘the patient voice’ (objective 1). The outcomes were intended actions, including enactment of audit standards (primary outcome), comprehension, user experience and engagement (objective 1). For objective 1, the primary analysis included 638 randomised participants, of whom 566 completed the outcome questionnaire. No modification independently increased intended enactment of audit standards. Minimised cognitive load improved comprehension (+0.1; p = 0.014) and plans to bring audit findings to colleagues’ attention (+0.13, on a –3 to +3 scale; p = 0.016). We observed important cumulative synergistic and antagonistic interactions between modifications, participant role and national audit. The analysis in objective 2 included 19 interviews assessing the Trauma Audit Research Network and the National Diabetes Audit. The identified ways of strengthening audit cycles included making performance data easier to understand and guiding action planning. The analysis in objective 3 identified four conditions for effective collaboration from 31 interviews: compromise – recognising capacity and constraints; logistics – enabling data sharing, audit quality and funding; leadership – engaging local stakeholders; and relationships – agreeing shared priorities and needs. The perceived benefits of collaboration outweighed the risks. The online experiment assessed intended enactment as a predictor of actual clinical behaviour. Interviews and surveys were subject to social desirability bias. National audit impacts may be enhanced by strengthening all aspects of feedback cycles, particularly effective feedback, and considering how different ways of reinforcing feedback act together. Embedded randomised trials evaluating different ways of delivering feedback within national clinical audits are acceptable and may offer efficient, evidence-based and cumulative improvements in outcomes. This trial is registered as ISRCTN41584028. This project was funded by the National Institute for Health and Care Research (NIHR) Health and Social Care Delivery Research programme and will be published in full in Health and Social Care Delivery Research; Vol. 10, No. 15. See the NIHR Journals Library website for further project information.

End-of-life care for people with severe mental illness: the MENLOC evidence synthesis

Abstract: People with severe mental illness have significant comorbidities and a reduced life expectancy. This project answered the following question: what evidence is there relating to the organisation, provision and receipt of care for people with severe mental illness who have an additional diagnosis of advanced incurable cancer and/or end-stage lung, heart, renal or liver failure and who are likely to die within the next 12 months? The objectives were to locate, appraise and synthesise relevant research; to locate and synthesise policy, guidance, case reports and other grey and non-research literature; to produce outputs with clear implications for service commissioning, organisation and provision; and to make recommendations for future research. This systematic review and narrative synthesis followed international standards and was informed by an advisory group that included people with experience of mental health and end-of-life services. Database searches were supplemented with searches for grey and non-research literature. Relevance and quality were assessed, and data were extracted prior to narrative synthesis. Confidence in synthesised research findings was assessed using the Grading of Recommendations, Assessment, Development and Evaluation and the Confidence in the Evidence from Reviews of Qualitative Research approaches. One hundred and four publications were included in two syntheses: 34 research publications, 42 case studies and 28 non-research items. No research was excluded because of poor quality. Research, policy and guidance were synthesised using four themes: structure of the system, professional issues, contexts of care and living with severe mental illness. Case studies were synthesised using five themes: diagnostic delay and overshadowing, decisional capacity and dilemmas, medical futility, individuals and their networks, and care provision. A high degree of confidence applied to 10 of the 52 Grading of Recommendations, Assessment, Development and Evaluation and Confidence in the Evidence from Reviews of Qualitative Research summary statements. Drawing on these statements, policy, services and practice implications are as follows: formal and informal partnership opportunities should be taken across the whole system, and ways need to be found to support people to die where they choose; staff caring for people with severe mental illness at the end of life need education, support and supervision; services for people with severe mental illness at the end of life necessitate a team approach, including advocacy; and the timely provision of palliative care requires proactive physical health care for people with severe mental illness. Research recommendations are as follows: patient- and family-facing studies are needed to establish the factors helping and hindering care in the UK context; and studies are needed that co-produce and evaluate new ways of providing and organising end-of-life care for people with severe mental illness, including people who are structurally disadvantaged. Only English-language items were included, and a meta-analysis could not be performed. Future research co-producing and evaluating care in this area is planned. This study is registered as PROSPERO CRD42018108988. This project was funded by the National Institute for Health Research (NIHR) Health and Social Care Delivery Research programme and will be published in full in Health and Social Care Delivery Research; Vol. 10, No. 4. See the NIHR Journals Library website for further project information.

Equal access to hospital care for children with learning disabilities and their families: a mixed-methods study

Abstract: To our knowledge, there has yet to be a comprehensive review of how well hospital services are meeting the needs of children and young people (hereafter referred to as children) with learning disability and their families. The extent to which their experiences differ from those of parents of children without learning disability is not known. The views and experiences of children with learning disability are almost non-existent in the literature. To identify the cross-organisational, organisational and individual factors in NHS hospitals that facilitate and prevent children with learning disability and their families receiving equal access to high-quality care and services, and to develop guidance for NHS trusts. A four-phase transformative, mixed-methods case study design comparing the experiences of children with and children without learning disability, their parents and health-care staff. Phase 1 comprised interviews with senior managers (n = 65), content analysis of hospital documents and a staff survey (n = 2261) across 24 hospitals in England, including all specialist children’s hospitals. Phases 2–4 involved seven of these hospitals. Phase 2 involved (a) interviews and photography with children and their parents (n = 63), alongside a parent hospital diary and record of safety concerns; (c) hospital staff interviews (n = 98) and community staff survey (n = 429); and (d) retrospective mapping of hospital activity. During phase 3, children (n = 803) and parents (n = 812) completed satisfaction surveys. Phase 4 involved seeking consultation on the findings. A model for mixed-methods data analysis and synthesis was used. Qualitative data were managed and analysed thematically, supported with NVivo (QSR International, Warrington, UK). Quantitative data were analysed using parametric and non-parametric descriptive statistics. Nationally, there is considerable uncertainty within hospitals and variation between hospitals in terms of the policies, systems and practices in place specifically for children with learning disability. Staff are struggling to individualise care and are being let down by an inadequate system. Attitudes and assumptions can have a lasting impact on parents and children. The findings serve as a useful guide to trusts about how best to meet the Learning Disability Improvement standards that have been set. Safety issues and quality of care affect all children in acute hospitals and their parents, but the impact on children with learning disability and their parents is much greater. Individualising care is key. Our findings suggest that staff may need to undertake training and gain experience to build their skills and knowledge about children with learning disability generally, as well as generate knowledge about the individual child through proactively working in partnership with parents before their child’s admission. The findings also suggest that we may need to address the impact of children’s hospitalisation on parents’ health and well-being. The greatest need is for the development and validation of an instrument for the assessment and management of risk in children with learning disability in hospital. We cannot say with certainty that the sites selected are representative of all services caring for children with learning disability. The study has been registered on the National Institute for Health and Care Research (NIHR) Clinical Research Network portfolio as 20461 (phase 1) and 31336 (phases 2–4). This project was funded by the NIHR Health and Social Care Delivery Research programme and will be published in full in Health and Social Care Delivery Research; Vol. 10, No. 13. See the NIHR Journals Library website for further project information.

Shared decision-making during childbirth in maternity units: the VIP mixed-methods study

Abstract: NHS policy emphasises shared decision-making during labour and birth. There is, however, limited evidence concerning how decision-making happens in real time. Our objectives were as follows – create a data set of video- and audio-recordings of labour and birth in midwife-led units; use conversation analysis to explore how talk is used in shared decision-making; assess whether or not women’s antenatal expectations are reflected in experiences and whether or not the interactional strategies used (particularly the extent to which decisions are shared) are associated with women’s postnatal satisfaction; and disseminate findings to health-care practitioners and service users to inform policy on communication in clinical practice. This was a mixed-methods study. The principal method was conversation analysis to explore the fine detail of interaction during decision-making. Derived from the conversation analysis, a coding frame was developed to quantify interactions, which were explored alongside questionnaire data concerning women’s antenatal expectations and preferences, and women’s experiences of, and postnatal satisfaction with, decision-making. Semistructured interviews with health-care practitioners explored factors shaping decision-making. The study took place in midwife-led units at two English NHS trusts. A total of 154 women (aged ≥ 16 years with low-risk pregnancies), 158 birth partners and 121 health-care practitioners consented to be recorded. Of these participants, 37 women, 43 birth partners and 74 health-care practitioners were recorded. Midwives initiate the majority of decisions in formats that do not invite women’s participation (i.e. beyond consenting). The extent of optionality that midwives provide varies with the decision. Women have most involvement in decisions pertaining to pain relief and the third stage of labour. High levels of satisfaction are reported. There is no statistically significant relationship between midwives’ use of different formats of decision-making and any measures of satisfaction. However, women’s initiation of decisions, particularly relating to pain relief (e.g. making lots of requests), is associated with lower satisfaction. Our data set is explored with a focus on decision initiation and responses, leaving other important aspects of care (e.g. midwives’ and birth partners’ interactional techniques to facilitate working with pain) underexplored, which might be implicated in decision-making. Despite efforts to recruit a diverse sample, ethnic minority women are under-represented. Policy initiatives emphasising patient involvement in decision-making are challenging to enact in practice. Our findings illustrate that women are afforded limited optionality in decision-making, and that midwives orient to guidelines/standard clinical practice in pursuing particular decisional outcomes. Nonetheless, the majority of women were satisfied with their experiences. However, when women needed to pursue decisions, particularly concerning pain relief, satisfaction is lower. Conversation analysis demonstrates that such ‘women-initiated’ decision-making occurs in the context of midwives’ avoiding pharmacological methods of pain relief at particular stages of labour. We suggest that future research address the following – the barriers to inclusion of ethnic minority research participants, decision-making in obstetric units, systematic understanding of how pain relief decisions are pursued/resolved, conversation analysis of interactional elements beyond the specific decision-making context, interactional ‘markers’ of the emotional labour and inclusion of antenatal encounters. This trial is registered as ISRCTN16227678 and National Institute for Health and Care Research (NIHR) CRN Portfolio (CMPS):32505 and IRAS:211358. This project was funded by the National Institute for Health and Care Research (NIHR) Health and Social Care Delivery Research programme and will be published in full in Health and Social Care Delivery Research; Vol. 10, No. 36. See the NIHR Journals Library website for further project information.

Patient and carer access to medicines at end of life: the ActMed mixed-methods study

Abstract: Patient access to medicines at home during the last 12 months of life is critical for effective symptom control, prevention of distress and unplanned admission to hospital. The limited evidence suggested problems with different components of service delivery and, to the best of our knowledge, the impact of innovations in end-of-life service delivery has remained unevaluated. To provide an evaluation of patient and carer access to medicines at end of life within the context of models of service delivery. The study used a multiphase mixed-methods design, comprising (1) a systematic literature review; (2) an online questionnaire survey of health-care professionals delivering end-of-life care; (3) evaluative mixed-method case studies of service delivery models, including cost and cost-effectiveness analysis; (4) interviews with community pharmacists and pharmaceutical wholesalers and distributors; and (5) an expert consensus-building workshop. Community and primary care end-of-life services in England. Health-care professionals delivering end-of-life care and patients living at home in the last 12 months of life and their carers. A systematic review identified a lack of evidence on service delivery models and patient experiences of accessing medicines at end of life. A total of 1327 health-care professionals completed an online survey. The findings showed that general practitioners remain a predominant route for patients to access prescriptions, but nurses and primary care-based pharmacists are also actively contributing. However, only 42% of clinical nurse specialists and 27% of community nurses were trained as prescribers. The majority (58%) of prescribing nurses and pharmacists did not have access to an electronic prescribing system. Health-care professionals’ satisfaction with access to shared patient records to facilitate medicines access was low, with 39% of health-care professionals either not at all or only slightly satisfied. Respondents perceived that there would be a significant improvement in pain control if access to medicines was greater. Case studies (n = 4) highlighted differences in speed and ease of access to medicines between service delivery models. Health-care professionals’ co-ordination facilitated the access process. The work of co-ordination was frequently burdensome, for example because general practitioner services were hard to access or because the stock of community pharmacy medicines was unreliable. Prescription cost differentials between services were substantial when accounting for the eligible population over the medium term. The supply chain generally ensured stocks of palliative medicines, but this was underpinned by onerous work by community pharmacists navigating multiple complex systems and wholesaler interfaces. Patient records lacked sufficient detail for timelines to be constructed. Commissioners of community pharmacy services and wholesalers and distributors were difficult to recruit. Accessing medicines required considerable co-ordination work. Delays in access were linked to service delivery models that were over-reliant on general practitioners prescribing, unreliable stocks of community pharmacy medicines and clinical nurse specialists’ lack of access to electronic prescribing. Key issues were relationships and team integration, diversifying the prescriber workforce, access to shared records and improved community pharmacy stock. Further research should consider policy and practice action for nursing and pharmacy services to fulfil their potential to help patients access medicines, together with attention to improving co-ordination and shared electronic records across professional service interfaces. This study is registered as CRD42017083563 and the trial is registered as ISRCTN12762104. This project was funded by the National Institute for Health and Care Research (NIHR) Health and Social Care Delivery Research programme and will be published in full in Health and Social Care Delivery Research; Vol. 10, No. 20. See the NIHR Journals Library website for further project information.

Assessment and management pathways of older adults with mild cognitive impairment: descriptive review and critical interpretive synthesis

Abstract: Background Mild cognitive impairment in older adults is a risk factor for dementia. Mild cognitive impairment is a result of a diverse range of underlying causes and may progress to dementia, remain stable or improve over time. Objectives We aimed to assess the evidence base around the assessment and management pathway of older adults with mild cognitive impairment in community/primary care, hospital and residential settings. Data sources In January 2021, we searched MEDLINE, EMBASE, PsycInfo ® , Scopus, Cumulative Index to Nursing and Allied Health Literature, The Cochrane Library (i.e. Cochrane Database of Systematic Reviews and Cochrane Central Register of Controlled Trials), Science Citation Index and Social Science Citation Index. The search was limited to studies published in English between 2010 and 2020. Grey literature and citation searches were also performed. Methods We performed two separate evidence reviews: (1) a descriptive review with narrative synthesis focusing on diagnosis, service provision and patient experience; and (2) a critical interpretive synthesis of evidence on the advantages and disadvantages of ‘mild cognitive impairment’ as a diagnostic label. Results A total of 122 studies were included in the descriptive review, of which 29 were also included in the critical interpretive synthesis. Study participants were most commonly recruited from populations of community-living older adults or those who had sought medical help from their general practitioner for memory problems. Follow-up searching identified a further 11 studies for the critical interpretive synthesis. The descriptive review identified multiple barriers to efficient diagnosis, starting with patient reluctance to seek help. General practitioners have a variety of cognitive tests available, but substantial numbers of patients meeting criteria for dementia do not have a diagnosis recorded. Patients may be referred to a memory clinic, but these clinics are mainly intended to identify and support people with dementia, and people with mild cognitive impairment may be discharged back to their general practitioner until symptoms worsen. Availability of scanning and biomarker tests is patchy. Qualitative studies show that patients with mild cognitive impairment and their carers find the process of investigation and diagnosis difficult and frustrating to negotiate. The key finding from the critical interpretive synthesis was that the need for a ‘timely’ diagnosis outweighs the ongoing debate about the value, or otherwise, of early investigation and labelling of memory problems. Determining what is a timely diagnosis involves balancing the perspectives of the patient, the health system and the clinician. Conclusions The two reviews reported here have applied different ‘lenses’ to the same body of evidence. Taken together, the reviews highlight the importance of a timely diagnosis for memory problems and identify barriers to obtaining such a diagnosis, from reluctance to seek help through to patchy availability of advanced diagnostic tests. Limitations The review was primarily descriptive, reflecting the prespecified review questions. Study selection was complicated by lack of a consistent definition of mild cognitive impairment and its overlap with other memory disorders. It was not possible to employ double study selection, data extraction or quality assessment, although processes of checking and verification were used throughout the review. Future work Priorities include evaluating remote methods of memory assessment and preparing for the likely future availability of disease-modifying treatments for early dementia. Research is needed on the investigation of memory problems in hospital and social care settings. Study registration This study is registered as PROSPERO CRD42021232535. Funding This project was funded by the National Institute for Health and Care Research (NIHR) Health and Social Care Delivery Research programme and will be published in full in Health and Social Care Delivery Research ; Vol. 10, No. 10. See the NIHR Journals Library website for further project information.

Impact of telephone triage on access to primary care for people living with multiple long-term health conditions: rapid evaluation

Abstract: Telephone triage is a service innovation in which every patient asking to see a general practitioner or other primary care professional calls the general practice and usually speaks to a receptionist first, who records a few details. The patient is then telephoned back by the general practitioner/primary care professional. At the end of this return telephone call with the general practitioner/primary care professional, either the issue is resolved or a face-to-face appointment is arranged. Before the COVID-19 pandemic, telephone triage was designed and used in the UK as a tool for managing demand and to help general practitioners organise their workload. During the first quarter of 2020, much of general practice moved to a remote (largely telephone) triage approach to reduce practice footfall and minimise the risk of COVID-19 contact for patients and staff. Ensuring equitable care for people living with multiple long-term health conditions (‘multimorbidity’) is a health policy priority. We aimed to evaluate whether or not the increased use of telephone triage would affect access to primary care differently for people living with multimorbidity than for other patients. We used data from the English GP Patient Survey to explore the inequalities impact of introducing telephone triage in 154 general practices in England between 2011 and 2017. We looked particularly at the time taken to see or speak to a general practitioner for people with multiple long-term health conditions compared with other patients before the COVID-19 pandemic. We also used data from Understanding Society, a nationally representative survey of households from the UK, to explore inequalities in access to primary care during the COVID-19 pandemic (between April and November 2020). Using data from before the COVID-19 pandemic, we found no evidence (p = 0.26) that the impact of a general practice moving to a telephone triage approach on the time taken to see or speak to a general practitioner was different for people with multimorbidity and for people without. During the COVID-19 pandemic, we found that people with multimorbidity were more likely than people with no long-term health conditions to have a problem for which they needed access to primary care. Among people who had a problem for which they would normally try to contact their general practitioner, there was no evidence of variation based on the number of conditions as to whether or not someone did try to contact their general practitioner; whether or not they were able to make an appointment; or whether they were offered a face-to-face, an online or an in-person appointment. Survey non-response, limitations of the specific survey measures of primary care access that were used, and being unable to fully explore the quality of the telephone triage and consultations were all limitations. These results highlight that, although people with multimorbidity have a greater need for primary care than people without multimorbidity, the overall impact for patients of changing to a telephone triage approach is larger than the inequalities in primary care access that exist between groups of patients. Future evaluations of service innovations and the ongoing changes in primary care access should consider the inequalities impact of their introduction, including for people with multimorbidity. This project was funded by the National Institute for Health and Care Research (NIHR) Health and Social Care Delivery Research programme and will be published in full in Health and Social Care Delivery Research; Vol. 10, No. 18. See the NIHR Journals Library website for further project information.

Developing programme theories of leadership for integrated health and social care teams and systems: a realist synthesis

Abstract: As the organisation of health and social care in England moves rapidly towards greater integration, the resulting systems and teams will require distinctive leadership. However, little is known about how the effective leadership of these teams and systems can be supported and improved. In particular, there is relatively little understanding of how effective leadership across integrated care teams and systems may be enacted, the contexts in which this might take place and the subsequent implications this has on integrated care. This realist review developed and refined programme theories of leadership of integrated health and social care teams and systems, exploring what works, for whom and in what circumstances. The review utilised a realist synthesis approach, informed by the Realist And Meta-narrative Evidence Syntheses: Evolving Standards (RAMESES) publication standards, to explore existing literature on the leadership of integrated care teams and systems, complemented by ongoing stakeholder consultation. Empirical evidence specifically addressing leadership of integrated teams or services was limited, with only 36 papers included in the review. The evidence collected from these 36 papers was synthesised to identify and build a comprehensive description of the mechanisms of leadership of integrated teams and systems and their associated contexts and outcomes. Consultation with key stakeholders with a range of expertise throughout the process ensured that the review remained grounded in the reality of health and social care delivery and addressed practice and policy challenges. Evidence was identified for seven potentially important components of leadership in integrated care teams and systems. These were ‘inspiring intent to work together’, ‘creating the conditions to work together’, ‘balancing multiple perspectives’, ‘working with power’, ‘taking a wider view’, ‘a commitment to learning and development’ and ‘clarifying complexity’. No empirical evidence was found for an eighth mechanism, ‘fostering resilience’, although stakeholders felt that this was potentially an important, long-term component of leadership. A key message of the review was that empirical research often focused on the importance of who the leader of an integrated team or service was (i.e. their personality traits and characteristics) rather than what they did (i.e. the specific role that they played in integrated working), although stakeholders considered that a focus on leader personality was not sufficient. Other key messages highlighted the way in which power and influence are used by integrated service leaders and identified the hierarchies between health and social care which complicate the leading of integrated teams and systems. Evidence specifically addressing leadership of integrated care teams and systems was limited and lacking in detail, which restricted the degree to which definitive conclusions could be drawn around what works, for whom and in what circumstances. Research into the leadership of integrated care teams and systems is limited and underdeveloped, with ideas often reverting to existing framings of leadership in which teams and organisations are less complex. In making explicit some of the assumptions about how leaders lead integrated care teams and systems this review has contributed significant new perspectives, offering fresh theoretical grounding that can be built on, developed and tested further. By making explicit some of the assumptions underlying the leadership of integrated care teams and systems, this review has generated new perspectives that can be built on, developed and tested further. This study is registered as PROSPERO CRD42018119291. This project was funded by the National Institute for Health Research (NIHR) Health and Social Care Delivery Research programme and will be published in full in Health and Social Care Delivery Research; Vol. 10, No. 7. See the NIHR Journals Library website for further project information.

Perioperative exercise programmes to promote physical activity in the medium to long term: systematic review and qualitative research

Abstract: In England, more than 4 million hospital admissions lead to surgery each year. The perioperative encounter (from initial presentation in primary care to postoperative return to function) offers potential for substantial health gains in the wider sense and over the longer term. The aim was to identify, examine and set in context a range of interventions applied perioperatively to facilitate physical activity in the medium to long term. The following databases were searched – Cochrane Central Register of Controlled Trials, MEDLINE, the Cumulative Index to Nursing and Allied Health Literature, EMBASE, PsycINFO and SPORTDiscus in October 2020. Clinical trials databases were also searched, and backward and forward citation searches were conducted. We undertook a systematic review; ran database searches in October 2020; extracted data; conducted risk-of-bias assessments of studies; and used Grading of Recommendations Assessment, Development and Evaluation assessments. We conducted focus groups and interviews with people running services designed to promote physical activity, to understand the practical and contextual factors that make such interventions ‘work’. Although the two streams of work were conducted independently, we considered overlapping themes from their findings. In the review, we found 51 randomised controlled trials and two quasi-randomised trials; nine non-randomised studies formed a supplementary data set. Studies included 8604 adults who had undergone (or were undergoing) surgery, and compared 67 interventions facilitating physical activity. Most interventions were started postoperatively and included multiple components, grouped as follows: education and advice, behavioural mechanisms and physical activity instruction. Outcomes were often measured using different tools; pooling of data was not always feasible. Compared with usual care, interventions may have slightly increased the amount of physical activity, engagement in physical activity and health-related quality of life at the study’s end (moderate-certainty evidence). We found low-certainty evidence of an increase in physical fitness and a reduction in pain, although effects generally favoured interventions. Few studies reported adherence and adverse events; certainty of these findings was very low. Although infrequently reported, participants generally provided positive feedback. For the case studies, we conducted two online focus groups and two individual interviews between November 2020 and January 2021, with nine participants from eight services of physical activity programmes. Conceptual and practical aspects included how the promotion of physical activity can be framed around the individual to recruit and retain patients; how services benefit from committed and compassionate staff; how enthusiasts, data collection and evidence play key roles; and how digital delivery could work as part of a blended approach, but inequalities in access must be considered. Outcome measures in the review varied and, despite a large data set, not all studies could be pooled. This also limited the exploration of differences between interventions; components of interventions often overlapped between studies, and we could not always determine what ‘usual care’ involved. The case study exploration was limited by COVID-19 restrictions; we were unable to visit sites and observe practice, and the range of services in the focus groups was also limited. Evidence from the review indicates that interventions delivered in the perioperative setting, aimed at enhancing physical activity in the longer term, may have overall benefit. The qualitative analysis complemented these findings and indicated that interventions should be focused around the individual, delivered locally and compassionately, and promoted by a patient’s full clinical team. There is a need to develop a core outcome set for similar studies to allow quantitative synthesis. Future work should also investigate the experiences of patients in different contexts, such as different communities, and with different surgical indications. This study is registered as PROSPERO CRD42019139008. This project was funded by the National Institute for Health and Care Research (NIHR) Health and Social Care Delivery Research programme and will be published in full in Health and Social Care Delivery Research; Vol. 10, No. 21. See the NIHR Journals Library website for further project information.

Using pulse oximeters in care homes for residents with COVID-19 and other conditions: a rapid mixed-methods evaluation

Abstract: There are over 15,000 care homes in England, with a total of approximately 450,000 beds. Most residents are older adults, some with dementia, and other residents are people of any age with physical or learning disabilities. Using pulse oximetry in care homes can help the monitoring and care of residents with COVID-19 and other conditions. To explore the views of care home staff, and the NHS staff they interact with, with regard to using pulse oximetry with residents, as well as the NHS support provided for using pulse oximetry. We carried out a rapid mixed-methods evaluation of care homes in England, comprising (1) scoping interviews with NHS leaders, care association directors and care home managers, engaging with relevant literature and co-designing the evaluation with a User Involvement Group; (2) an online survey of care homes; (3) interviews with care home managers and staff, and with NHS staff who support care homes, at six purposively selected sites; and (4) synthesis, reporting and dissemination. The study team undertook online meetings and a workshop to thematically synthesise findings, guided by a theoretical framework. We obtained 232 survey responses from 15,362 care homes. Although this was a low (1.5%) response rate, it was expected given exceptional pressures on care home managers and staff at the time of the survey. We conducted 31 interviews at six case study sites. Pulse oximeters were used in many responding care homes before the pandemic and use of pulse oximeters widened during the pandemic. Pulse oximeters are reported by care home managers and staff to provide reassurance to residents and their families, as well as to staff. Using pulse oximeters was usually not challenging for staff and did not add to staff workload or stress levels. Additional support provided through the NHS COVID Oximetry @home programme was welcomed at the care homes receiving it; however, over half of survey respondents were unaware of the programme. In some cases, support from the NHS, including training, was sought but was not always available. The survey response rate was low (1.5%) and so findings must be treated with caution. Fewer than the intended number of interviews were completed because of participant unavailability. Throughout the COVID-19 pandemic, care homes may have been asked to complete numerous other surveys etc., which may have contributed to these limitations. Owing to anonymity, the research team was unable to determine the range of survey respondents across location, financial budget or quality of care. Using pulse oximeters in care homes is considered by managers and staff to have been beneficial to care home residents. Ongoing training opportunities for care home staff in use of pulse oximeters would be beneficial. Escalation processes to and responses from NHS services could be more consistent, alongside promoting the NHS COVID Oximetry @home programme to care homes. Further research should include the experiences of care home residents and their families, as well as finding out more from an NHS perspective about interactions with care home staff. Research to investigate the cost-effectiveness of pulse oximetry in care homes, and of the NHS COVID Oximetry @home programme of support, would be desirable. This project was funded by the National Institute for Health and Care Research (NIHR) Health and Social Care Delivery Research programme and will be published in full in Health and Social Care Delivery Research; Vol. 10, No. 35. See the NIHR Journals Library website for further project information.

Group clinics for young adults living with diabetes in an ethnically diverse, socioeconomically deprived population: mixed-methods evaluation

Abstract: Our research was based on the expressed need to evaluate the potential for group clinics to enhance care within the NHS for people with long-term conditions. We aimed to explore the scope, feasibility, impact and potential scalability of group clinics for young adults with diabetes who have poor experiences of care and clinical outcomes. We applied a participatory approach to the entire research process, where appropriate. Four NHS trusts delivering diabetes care to young adults in ethnically diverse and socioeconomically deprived communities. We involved 135 young adults as participants in our research (73 at two intervention sites and 62 at two control sites). A realist review synthesised existing evidence for group clinics to understand ‘what works, for whom, under what circumstances’. Using the realist review findings and a scoping exercise, we used co-design to develop a model of group clinic-based care, which we then implemented and evaluated using primarily qualitative methods, with quantitative and costs analyses to inform future evaluations. Young adults reported positive experiences from the group clinics. However, across the group clinics delivered, only one-third (on average) of those invited to specific clinics attended, despite substantial efforts to encourage attendance, and only 37 out of 73 (51%) participants attended any group clinics. Social learning helped the acquisition of new knowledge and normalisation of experiences. Group clinics met previously unreached emotional needs, and the relationships that formed between young adults, and between them and the staff facilitating the clinics, were key. Clinical staff delivered the clinics using a facilitatory approach, and a youth worker helped to ensure that the care model was developmentally appropriate. Existing organisational structures presented substantial challenges to the delivery of group clinics, and there was considerable hidden work required by the staff delivering them. Group clinics may augment one-to-one care but do not necessarily replace it. The average cost of each group clinic, per participant, was £127–58. Engagement in co-design and the research process and participation in the group clinics was challenging, and limited our quantitative data analysis. These limitations had implications for the fidelity of the intervention and generalisability of our findings. During the research, we established that group clinics would not replace existing care, and that further work is required to understand the theoretical base of ‘blended’ models of care, and the potential of digital offers, before a definitive evaluation (a cluster-randomised trial) can be designed. Our findings show that young adults with diabetes, including those in deprived and ethnically diverse settings, have positive experiences of group-based care, and it may augment existing one-to-one care. However, engagement with group-based care is challenging despite the participatory design. Future research is needed to develop the group clinic model prior to definitive evaluation. This study is registered as CRD42017058726 and ISRCTN83599025. This project was funded by the National Institute for Health and Care Research (NIHR) Health and Social Care Delivery Research programme and will be published in full in Health and Social Care Delivery Research; Vol. 10, No. 25. See the NIHR Journals Library website for further project information.

Co-ordinated care for people affected by rare diseases: the CONCORD mixed-methods study

Abstract: A condition is defined as rare if it affects fewer than 1 in 2000 people in the general population. Limited evidence suggests that care is poorly co-ordinated for people affected by rare conditions. To investigate if and how care of people with rare conditions is co-ordinated in the UK, and how people affected by rare conditions would like care to be co-ordinated. A mixed-methods study comprising (1) a scoping review to develop a definition of co-ordinated care and identify components of co-ordinated care (n = 154 studies); (2) an exploratory qualitative interview study to understand the impact of a lack of co-ordinated care (n = 15 participants); (3) a national survey among people affected by rare conditions of experiences of care co-ordination (n = 1457 participants); (4) a discrete choice experiment of preferences for co-ordination (n = 996 participants); (5) the development of a taxonomy of co-ordinated care for rare conditions (n = 79 participants); and (6) a review of costs of providing co-ordinated care. Health services for people affected by rare conditions, including gatekeeping to social care provision and third-sector care. Adult patients with rare conditions, parents/carers of children or adults with rare conditions and health-care professionals (e.g. doctors, nurses and allied health professionals) involved in the care of people with rare conditions. No limits were set on the rare conditions included or where people live in the UK. Participants were sampled from patient and provider networks and organisations. A definition of co-ordinated care for rare conditions was developed. Care for people affected by rare diseases was found to be not well co-ordinated. For example, only 12% of 760 adult patients affected by a rare disease reported that they had a formal care co-ordinator, 32% reported that they attended a specialist centre and 10% reported that they had a care plan. Patients, parents/carers and health-care professionals all would like care to be better co-ordinated, with some differences in preferences reported by patients and parents/carers and those reported by health-care professionals. Our taxonomy of care co-ordination for rare conditions outlined six domains: (1) ways of organising care, (2) ways of organising teams, (3) responsibilities, (4) how often care appointments and co-ordination take place, (5) access to records and (6) mode of communication. It was not possible to capture the experiences of people affected by every rare condition. Our sampling strategy in the study may have been biased if study participants were systematically different from the population affected by rare conditions. The cost analysis was limited. There is evidence of a lack of co-ordinated care for people affected by rare diseases. This can have a negative impact on the physical and mental health of patients and families, and their financial well-being. Further research would be beneficial to develop feasible, clinically effective and cost-effective models of care co-ordination, using the taxonomy developed in this study. This study is registered as NIHR Clinical Research Network Portfolio reference number 41132, Research Registry reference number research registry6351 and Integrated Research Application System reference number 254400. This project was funded by the National Institute for Health Research (NIHR) Health and Social Care Delivery Research programme and will be published in full in Health and Social Care Delivery Research; Vol. 10, No. 5. See the NIHR Journals Library website for further project information.

Vertical integration of GP practices with acute hospitals in England and Wales: rapid evaluation

Abstract: Background Vertical integration refers to merging organisations that operate at different stages along the patient pathway. An organisation running an acute hospital and also operating primary care medical practices (i.e. general medical practitioner practices, also known as ‘general practices’) is an example of vertical integration. Evidence is limited concerning the advantages and disadvantages of different arrangements for implementing vertical integration, their rationale and their impact. Objectives Our aim was to (1) understand the rationale for, and early impact of, vertical integration in the NHS in England and Wales and (2) develop a theory of change for vertical integration. Design We carried out a rapid qualitative cross-comparative case study evaluation at three sites in England ( n = 2) and Wales ( n = 1), which comprised three work packages: (1) a rapid review of literature, telephone scoping interviews and a stakeholder workshop; (2) interviews with stakeholders across case study sites, alongside observations of strategic meetings and analysis of key documents from the sites; and (3) development of a theory of change for each site and for vertical integration overall. Results We interviewed 52 stakeholders across the three case study sites; however, gaining access to and arranging and completing non-participant observations proved difficult. The single most important driver of vertical integration proved to be the maintenance of primary care local to where patients live. Vertical integration of general practices with organisations running acute hospitals has been adopted in some locations in England and Wales to address the staffing, workload and financial difficulties faced by some general practices. The opportunities created by vertical integration’s successful continuation of primary care, namely to develop patient services in primary care settings and better integrate them with secondary care, were exploited to differing degrees across the three sites. There were notable differences between the sites in organisational and clinical integration. Closer organisational integration was attributed to previous good relationships between primary and secondary care locally, and to historical planning and preparation towards integrated working across the local health economy. The net impact of vertical integration on health system costs is argued by local stakeholders to be beneficial. Limitations Across all three case study sites, the study team was unable to complete the desired number of non-participant observations. The pace of data collection during early interviews and documentary analysis varied. Owing to the circumstances of the COVID-19 pandemic during project write-up, the team was unable to undertake site-specific workshops during data analysis and an overall workshop with policy experts. Conclusions The main impact of vertical integration was to sustain primary medical care delivery to local populations in the face of difficulties with recruiting and retaining staff, and in the context of rising demand for care. This was reported to enable continued patient access to local primary care and associated improvements in the management of patient demand. Future work The patient experience of vertical integration, effectiveness of vertical integration in terms of impact on secondary care service utilisation (e.g. accident and emergency attendances, emergency admissions and length of stay) and patient access (e.g. general practitioner and practice nurse appointments) to primary care requires further evaluation. Funding This project was funded by the National Institute for Health and Care Research (NIHR) Health and Social Care Delivery Research programme and will be published in full in Health and Social Care Delivery Research ; Vol. 10, No. 17. See the NIHR Journals Library website for further project information.

Brief education supported psychological treatment for adolescent borderline personality disorder: the BEST feasibility RCT

Abstract: Borderline personality disorder is a severe mental health condition characterised by a pattern of emotional instability, interpersonal dysfunction, disturbed self-image and impulsive behaviour, including self-harm. Symptoms of borderline personality disorder typically emerge during adolescence. Although there is compelling evidence in support of early intervention for borderline personality disorder, current evidence-based interventions are resource intensive, with the result that few young people access timely treatment. Therefore, there is an urgent need for accessible interventions to facilitate early intervention for adolescents with borderline personality disorder symptoms. The first objective was to adapt a brief psychological treatment for adolescent borderline personality disorder that had previously been delivered within secondary mental health services for co-delivery within schools and colleges. The second objective was to assess the feasibility of evaluating the clinical effectiveness and cost-effectiveness of this intervention in a future randomised controlled trial. We first conducted a rapid evidence synthesis of barriers to and facilitators of the implementation of indicated mental health interventions for adolescents within educational settings and piloted the prototype intervention with three schools/colleges. Based on the findings of the evidence synthesis and pilot, we refined the intervention and study procedures in preparation for a feasibility randomised controlled trial. The feasibility randomised controlled trial involved 12 schools and colleges, whose pastoral staff members received training to deliver the intervention alongside a mental health practitioner. Participants were randomised in a 1 : 1 ratio to receive either the BEST (Brief Education Supported Treatment) intervention plus treatment as usual or treatment as usual alone. Participants were assessed pre randomisation (baseline) and at 12 and 24 weeks post randomisation. Mixed-methods process data were collected to understand how the intervention was implemented, to assess acceptability and to monitor contamination of the control arm. Young people eligible to participate were aged 13–18 years, reported symptoms of borderline personality disorder above an established threshold and had a history of repeated self-harm. The intervention was refined based on findings of the rapid evidence synthesis, which included 50 studies, feedback from staff participants in the pilot and analysis of session recordings. In the feasibility randomised controlled trial, we randomised 32 participants prior to the premature closure of recruitment. The rate of recruitment was slower than anticipated but would probably have narrowly surpassed our progression criterion over the full recruitment window. Participant retention was high (89.5% at 12 weeks and 73.7% at 24 weeks) and the performance of the proposed outcome measures was satisfactory. We did not find any evidence that participants allocated to the treatment-as-usual arm received the BEST intervention or its components. Fidelity of intervention delivery was high (93.5% of recordings rated as adherent) and the intervention was viewed as offering benefits for individual participants, practitioners involved in co-delivery and the wider school/college. The feasibility randomised controlled trial was disrupted by the closure of schools and colleges in response to the COVID-19 pandemic. This reduced the window for participant recruitment and limited the data that could be collected. The refined BEST intervention was able to be delivered successfully within schools and colleges and was found to be acceptable to staff and young people. The findings provide support for continuing this programme of research and would inform the design of a future trial. This trial is registered as ISRCTN16862589. This project was funded by the National Institute for Health and Care Research (NIHR) Health and Social Care Delivery Research programme and will be published in full in Health and Social Care Delivery Research; Vol. 10, No. 37. See the NIHR Journals Library website for further project information.

Healthcare Leadership with Political Astuteness and its role in the implementation of major system change: the HeLPA qualitative study

Abstract: The implementation of change in health and care services is often complicated by the ‘micropolitics’ of the care system. There is growing recognition that health and care leaders need to develop and use types of ‘political skill’ or ‘political astuteness’ to understand and manage the micropolitics of change. The aim of this study was to produce a new empirical and theoretical understanding of the acquisition, use and contribution of leadership with ‘political astuteness’, especially in the implementation of major system change, from which to inform the co-design of training, development and recruitment resources. The qualitative study comprised four work packages. Work package 1 involved two systematic literature reviews: one ‘review of reviews’ on the concept of political astuteness and another applying the learning from this to the health services research literature. Work package 2 involved biographical narrative interviews with 66 health and care leaders to investigate their experiences of acquiring and using political skills in the implementation of change. Work package 3 involved in-depth qualitative case study research with nine project teams drawn from three regional Sustainability and Transformation Partnerships operating in different English regions. Work package 4 involved a series of co-design workshops to develop learning materials and resources to support service leaders’ acquisition and use of political skills and astuteness. The concepts of political skills and astuteness have had growing influence on health services research, yet these have tended to emphasise a relatively individualised and behavioural view of change leadership. The interview study suggests that, although leaders certainly use individual skills and behaviours when implementing change, change processes are contingent on local contextual factors and the patterns of collective action in the forms of interlocking constellations of political interactions. The in-depth case study research further shows these interactive, contingent and collective processes in the implementation of major system change. The study finds that major system change occurs over several linked stages, each involving particular controversies for which skills, strategies and actions are needed. Informed by these findings, and through a series of co-design workshops, the study has produced a set of resources and materials and a workbook to support individuals and project teams to acquire and develop political skill. The study was complicated by the COVID-19 pandemic and there were difficulties in recruiting in-depth cases for observational research, and also recruiting patient and community groups. Health and care leaders can develop and use a range of skills, strategies and actions to understand and navigate the diverse interests that complicate change. Building on the literature, the study presents a novel empirical framework of these skills, strategies and behaviours, and shows how they are used in the implementation of major system change. This study concludes with a set of co-designed learning resources and materials to support future leaders to develop similar skills and strategies. Further evidence is needed on the contribution of the learning resources on leadership activities and to understand the contribution of political skills to other areas of service governance. This study is registered as researchregistery4020. This project was funded by the National Institute for Health and Care Research (NIHR) Health and Social Care Delivery Research programme and will be published in full in Health and Social Care Delivery Research; Vol. 10, No. 11. See the NIHR Journals Library website for further project information.