Background: As people age and accumulate long-term conditions, their physical activity and physical function declines, resulting in disability and loss of independence. Primary care is well placed to empower individuals and communities to reduce this decline; however, the best approach is uncertain. Objectives: To develop a programme theory to explain the mechanisms through which interventions improve physical activity and physical function in people with long-term conditions in different primary care contexts, and to co-design a prototype intervention. Data sources: Systematic literature searches of relevant databases with forwards and backwards citation tracking, grey literature searches and further purposive searches were conducted. Qualitative data were collected through workshops and interviews. Design: Realist evidence synthesis and co-design for primary care service innovation. Setting: Primary care in Wales and England. Participants: Stakeholders included people with long-term conditions, primary care professionals, people working in relevant community roles and researchers. Methods: The realist evidence synthesis combined evidence from varied sources of literature with the views, experiences and ideas of stakeholders. The resulting context, mechanism and outcome statements informed three co-design workshops and a knowledge mobilisation workshop for primary care service innovation. Results: Five context, mechanism and outcome statements were developed. (1) Improving physical activity and function is not prioritised in primary care (context). If the practice team culture is aligned to the elements of physical literacy (mechanism), then physical activity promotion will become routine and embedded in usual care (outcome). (2) Physical activity promotion is inconsistent and unco-ordinated (context). If specific resources are allocated to physical activity promotion (in combination with a supportive practice culture) (mechanism), then this will improve opportunities to change behaviour (outcome). (3) People with long-term conditions have varying levels of physical function and physical activity, varying attitudes to physical activity and differing access to local resources that enable physical activity (context). If physical activity promotion is adapted to individual needs, preferences and local resources (mechanism), then this will facilitate a sustained improvement in physical activity (outcome). (4) Many primary care practice staff lack the knowledge and confidence to promote physical activity (context). If staff develop an improved sense of capability through education and training (mechanism), then they will increase their engagement with physical activity promotion (outcome). (5) If a programme is credible with patients and professionals (context), then trust and confidence in the programme will develop (mechanism) and more patients and professionals will engage with the programme (outcome). A prototype multicomponent intervention was developed. This consisted of resources to nurture a culture of physical literacy, materials to develop the role of a credible professional who can promote physical activity using a directory of local opportunities and resources to assist with individual behaviour change. Limitations: Realist synthesis and co-design is about what works in which contexts, so these resources and practice implications will need to be modified for different primary care contexts. Conclusions: We developed a programme theory to explain how physical activity could be promoted in primary care in people with long-term conditions, which informed a prototype intervention. Future work: A future research programme could further develop the prototype multicomponent intervention and assess its acceptability in practice alongside existing schemes before it is tested in a feasibility study to inform a future randomised controlled trial. Study registration: This study is registered as PROSPERO CRD42018103027. Funding: This project was funded by the National Institute for Health Research (NIHR) Health Services and Delivery Research programme and will be published in full in Health Services and Delivery Research; Vol. 9, No. 16. See the NIHR Journals Library website for further project information.
Background Organising health-care services for residents living in care homes is an important area of development in the UK and elsewhere. Medical care is provided by general practitioners in the UK, and the unique arrangement of the NHS means that general practitioners are also gatekeepers to other health services. Despite recent focus on improving health care for residents, there is a lack of knowledge about the role of general practitioners. Objectives First, to review reports of research and quality improvement (or similar change management) in care homes to explore how general practitioners have been involved. Second, to develop programme theories explaining the role of general practitioners in improvement initiatives and outcomes. Design A realist review was selected to address the complexity of integration of general practice and care homes. Setting Care homes for older people in the UK, including residential and nursing homes. Participants The focus of the literature review was the general practitioner, along with care home staff and other members of multidisciplinary teams. Alongside the literature, we interviewed general practitioners and held consultations with a Context Expert Group, including a care home representative. Interventions The primary search did not specify interventions, but captured the range of interventions reported. Secondary searches focused on medication review and end-of-life care because these interventions have described general practitioner involvement. Outcomes We sought to capture processes or indicators of good-quality care. Data sources Sources were academic databases [including MEDLINE, EMBASE™ (Elsevier, Amsterdam, the Netherlands), Cumulative Index to Nursing and Allied Health Literature, PsycInfo® (American Psychological Association, Washington, DC, USA), Web of Science™ (Clarivate Analytics, Philadelphia, PA, USA) and Cochrane Collaboration] and grey literature using Google Scholar (Google Inc., Mountain View, CA, USA). Methods Realist And Meta-narrative Evidence Syntheses: Evolving Standards (RAMESES) guidelines were followed, comprising literature scoping, interviews with general practitioners, iterative searches of academic databases and grey literature, and synthesis and development of overarching programme theories. Results Scoping indicated the distinctiveness of the health and care system in UK and, because quality improvement is context dependent, we decided to focus on UK studies because of potential problems in synthesising across diverse systems. Searches identified 73 articles, of which 43 were excluded. To summarise analysis, programme theory 1 was ‘negotiated working with general practitioners’ where other members of the multidisciplinary team led initiatives and general practitioners provided support with the parts of improvement where their skills as primary care doctors were specifically required. Negotiation enabled matching of the diverse ways of working of general practitioners with diverse care home organisations. We found evidence that this could result in improvements in prescribing and end-of-life care for residents. Programme theory 2 included national or regional programmes that included clearly specified roles for general practitioners. This provided clarity of expectation, but the role that general practitioners actually played in delivery was not clear. Limitations One reviewer screened all search results, but two reviewers conducted selection and data extraction steps. Conclusions If local quality improvement initiatives were flexible, then they could be used to negotiate to build a trusting relationship with general practitioners, with evidence from specific examples, and this could improve prescribing and end-of-life care for residents. Larger improvement programmes aimed to define working patterns and build suitable capacity in care homes, but there was little evidence about the extent of local general practitioner involvement. Future work Future work should describe the specific role, capacity and expertise of general practitioners, as well as the diversity of relationships between general practitioners and care homes. Study registration This study is registered as PROSPERO CRD42019137090. Funding This project was funded by the National Institute for Health Research (NIHR) Health Services and Delivery Research programme and will be published in full in Health Services and Delivery Research; Vol. 9, No. 20. See the NIHR Journals Library website for further project information.
Background Stroke Early Supported Discharge (ESD) is a service innovation that facilitates discharge from hospital and delivery of specialist rehabilitation in patients’ homes. There is currently widespread implementation of ESD services in many countries, driven by robust clinical trial evidence. In England, the type of ESD service patients receive on the ground is variable, and in some regions, ESD is still not offered at all. This protocol presents a study designed to investigate the mechanisms and outcomes of implementing ESD at scale in real-world conditions. This will help to establish which models of ESD are most effective and in what context. Methods A realist evaluation approach composed of two interlinking work packages will be adopted to investigate how and why ESD works, for whom and in what circumstances. Work package 1 (WP1) will begin with a rapid evidence synthesis to formulate preliminary realist hypotheses. Quantitative analyses of historical prospective Sentinel Stroke National Audit Programme (SSNAP) data will be performed to evaluate service outcomes based on the degree to which evidence-based ESD has been implemented. Work package 2 (WP2) will involve the qualitative investigation of purposively selected case study sites featuring in WP1 and covering different regions in England. The perspectives of clinicians, managers, commissioners, and service users will be explored qualitatively. Cost implications of ESD models will be examined using a cost-consequence analysis. Cross-case comparisons and triangulation of the data sources from both work packages will be performed to test, revise, and refine initial programme theories and address research aims. Discussion This study will investigate whether and how current large-scale implementation of ESD is achieving the outcomes suggested by the evidence base. The theory-driven evaluation approach will highlight key mechanisms and contextual conditions necessary to optimise outcomes and allow us to draw transferable lessons to inform the effective implementation and sustainability of ESD in clinical practice. In addition, the methodological framework will progress the theoretical understanding of implementation and evaluation of complex rehabilitation interventions in stroke care. Trial registration ISRCTN: 15568163, registration date: 26 October 2018.
Background: For people in mental health crisis, acute day units provide daily structured sessions and peer support in non-residential settings as an alternative to crisis resolution teams. Objectives: To investigate the provision, effectiveness, intervention acceptability and re-admission rates of acute day units. Design: Work package 1 – mapping and national questionnaire survey of acute day units. Work package 2.1 – cohort study comparing outcomes during a 6-month period between acute day unit and crisis resolution team participants. Work package 2.2 – qualitative interviews with staff and service users of acute day units. Work package 3 – a cohort study within the Mental Health Minimum Data Set exploring re-admissions to acute care over 6 months. A patient and public involvement group supported the study throughout. Setting and participants: Work package 1 – all non-residential acute day units (NHS and voluntary sector) in England. Work packages 2.1 and 2.2 – four NHS trusts with staff, service users and carers in acute day units and crisis resolution teams. Work package 3 – all individuals using mental health NHS trusts in England. Results: Work package 1 – we identified 27 acute day units in 17 out of 58 trusts. Acute day units are typically available on weekdays from 10 a.m. to 4 p.m., providing a wide range of interventions and a multidisciplinary team, including clinicians, and having an average attendance of 5 weeks. Work package 2.1 – we recruited 744 participants (acute day units, n = 431; crisis resolution teams, n = 312). In the primary analysis, 21% of acute day unit participants (vs. 23% of crisis resolution team participants) were re-admitted to acute mental health services over 6 months. There was no statistically significant difference in the fully adjusted model (acute day unit hazard ratio 0.78, 95% confidence interval 0.54 to 1.14; p = 0.20), with highly heterogeneous results between trusts. Acute day unit participants had higher satisfaction and well-being scores and lower depression scores than crisis resolution team participants. The health economics analysis found no difference in resource use or cost between the acute day unit and crisis resolution team groups in the fully adjusted analysis. Work package 2.2 – 36 people were interviewed (acute day unit staff, n = 12; service users, n = 21; carers, n = 3). There was an overwhelming consensus that acute day units are highly valued. Service users found the high amount of contact time and staff continuity, peer support and structure provided by acute day units particularly beneficial. Staff also valued providing continuity, building strong therapeutic relationships and providing a variety of flexible, personalised support. Work package 3 – of 231,998 individuals discharged from acute care (crisis resolution team, acute day unit or inpatient ward), 21.4% were re-admitted for acute treatment within 6 months, with women, single people, people of mixed or black ethnicity, those living in more deprived areas and those in the severe psychosis care cluster being more likely to be re-admitted. Little variation in re-admissions was explained at the trust level, or between trusts with and trusts without acute day units (adjusted odds ratio 0.96, 95% confidence interval 0.80 to 1.15). Limitations: In work package 1, some of the information is likely to be incomplete as a result of trusts’ self-reporting. There may have been recruitment bias in work packages 2.1 and 2.2. Part of the health economics analysis relied on clinical Health of the Nations Outcome Scale ratings. The Mental Health Minimum Data Set did not contain a variable identifying acute day units, and some covariates had a considerable number of missing data. Conclusions: Acute day units are not provided routinely in the NHS but are highly valued by staff and service users, giving better outcomes in terms of satisfaction, well-being and depression than, and no significant differences in risk of re-admission or increased costs from, crisis resolution teams. Future work should investigate wider health and care system structures and the place of acute day units within them; the development of a model of best practice for acute day units; and staff turnover and well-being (including the impacts of these on care). Funding: This project was funded by the National Institute for Health Research (NIHR) Health Services and Delivery Research programme and will be published in full in Health Services and Delivery Research; Vol. 9, No. 18. See the NIHR Journals Library website for further project information.
Background: The increasing number of older, complex patients who require emergency admission to hospital has prompted calls for better models of medical generalist care, especially for smaller hospitals, whose size constrains resources and staffing. Objective: To investigate the strengths and weaknesses of the current models of medical generalism used in smaller hospitals from patient, professional and service perspectives. Methods: The design was a mixed-methods study. Phase 1 was a scoping and mapping exercise to create a typology of models of care, which was then explored further through 11 case studies. Phase 2 created a classification using the Hospital Episode Statistics of acute medical ‘generalist’ and ‘specialist’ work and described differences in workload and explored the links between case mix, typology and length of stay and between case mix and skill mix. Phase 3 analysed the relationships between models of care and patient-level costs. Phase 4 examined the strengths and weaknesses of the models of care through focus groups, a discrete choice experiment and an exploration of the impact of typology on other outcomes. Results: In total, 50 models of care were explored through 48 interviews. A typology was constructed around generalist versus specialist patterns of consultant working. Twenty-five models were deployed by 48 hospitals, and no more than four hospitals used any one model of care. From the patient perspective, analysis of Hospital Episode Statistics data of 1.9 million care episodes found that the differences in case mix between hospitals were relatively small, with 65–70% of episodes accounted for by 20 case types. The skill mix of hospital staff varied widely; there were no relationships with case mix. Patients exhibited a preference for specialist care in the discrete choice experiment but indicated in focus groups that overall hospital quality was more important. From a service perspective, qualitative work found that models of care were contingent on complex constellations of factors, including staffing, the local hospital environment and policy imperatives. Neither the model of care nor the case mix accounted for variability in the length of stay (no associations were significant at p < 0.05). No significant differences were found in the costs of the models. Professionally, the preferences of doctors for specialist versus generalist work depended on their experiences of providing care and were associated with a healthy organisational culture and a co-operative approach to managing emergency work. Concepts of medical generalism were found to be complex and difficult to define, with theoretical models differing markedly from models in action. Limitations: Smaller hospitals in multisite trusts were excluded, potentially leading to sample bias. The rapidly changing nature of the models limited the analysis of typology against outcomes. Conclusions: The case mix of smaller hospitals was dominated by patients with presentations amenable to generalist approaches to care; however, there was no evidence to support any particular pattern of consultant working. Matching hospital staff to better meet local need and the creation of more collaborative working environments appear more likely to improve care in smaller hospitals than changing models. Future work: The exploration of the relationships between workforce, measures of hospital culture, models of care, costs and outcomes in both smaller and larger hospitals is urgently required to underpin service reforms. Study registration: This study is registered as Integrated Research Application System project ID 191393. Funding: This project was funded by the National Institute for Health Research (NIHR) Health Services and Delivery Research programme and will be published in full in Health Services and Delivery Research; Vol. 9, No. 4. See the NIHR Journals Library website for further project information.
Background: Many global health challenges may be targeted by changing people’s behaviour. Behaviours including cigarette smoking, physical inactivity and alcohol misuse, as well as certain dietary behaviours, contribute to deaths and disability by increasing the risk of cancers, cardiovascular diseases and diabetes. Interventions have been designed to change these health behaviours with a view to reducing these health risks. However, the effectiveness of these interventions has been quite variable and further information is needed to enhance their success. More information is needed about the specific processes that underlie the effectiveness of intervention strategies. Aim: Researchers have developed a taxonomy of 93 behaviour change techniques (i.e. the active components of an intervention that bring about behavioural change), but little is known regarding their potential mechanisms of action (i.e. the processes through which a behaviour change technique affects behaviour). We therefore aimed to examine links between behaviour change techniques and mechanisms of action. Method: First, we conducted a literature synthesis study of 277 behaviour change intervention studies, from which we extracted information on links, described by authors, between behaviour change techniques and mechanisms of action, and identified an average of 10 links per intervention report. Second, behaviour change experts (n = 105) were engaged in a three-round consensus study in which they discussed and rated their confidence in the presence/absence of ‘links’ and ‘non-links’ between commonly used behaviour change techniques (n = 61) and a set of mechanisms of action (n = 26). Ninety links and 460 ‘non-links’ reached the pre-set threshold of 80% agreement. To enhance the validity of these results, a third study was conducted that triangulated the findings of the first two studies. Discrepancies and uncertainties between the studies were included in a reconciliation consensus study with a new group of experts (n = 25). The final results identified 92 definite behaviour change technique–mechanism of action links and 465 definite non-links. In a fourth study, we examined whether or not groups of behaviour change techniques used together frequently across interventions revealed shared theoretical underpinnings. We found that experts agreed on the underlying theory for three groups of behaviour change techniques. Results: Our results are potentially useful to policy-makers and practitioners in selecting behaviour change techniques to include in behaviour change interventions. However, our data do not demonstrate that the behaviour change techniques are effective in targeting the mechanism of action; rather, the links identified may be the ‘best bets’ for interventions that are effective in changing mechanisms of action, and the non-links are unlikely to be effective. Researchers examining effectiveness of interventions in either primary studies or evidence syntheses may consider these links for further investigation. Conclusion: To make our results usable by researchers, practitioners and policy-makers, they are available in an online interactive tool, which enables discussion and collaboration (https://theoryandtechniquetool.humanbehaviourchange.org/); accessed 1 March 2020. This work, building on previous work to develop the behaviour change technique taxonomy, is part of an ongoing programme of work: the Human Behaviour Change Project (www.humanbehaviourchange.org/; accessed 1 March 2020). Funding: This project was funded by the Medical Research Council via its Methodology Panel: ‘Developing methodology for designing and evaluating theory-based complex interventions: an ontology for linking behaviour change techniques to theory’ (reference MR/L011115/1).
Background: Care home staff have a critical bearing on quality. The staff employed, the training they receive and how well they identify and manage residents’ needs are likely to influence outcomes. The Care Act 2014 (Great Britain. The Care Act 2014. London: The Stationery Office; 2014) requires services to improve ‘well-being’, but many residents cannot self-report and are at risk of exclusion from giving their views. The Adult Social Care Outcomes Toolkit enables social care-related quality of life to be measured using a mixed-methods approach. There is currently no equivalent way of measuring aspects of residents’ health-related quality of life. We developed new tools for measuring pain, anxiety and depression using a mixed-methods approach. We also explored the relationship between care home quality, residents’ outcomes, and the skill mix and employment conditions of the workforce who support them. Objectives: The objectives were to develop and test measures of pain, anxiety and depression for residents unable to self-report; to assess the extent to which regulator quality ratings reflect residents’ care-related quality of life; and to assess the relationship between aspects of the staffing of care homes and the quality of care homes. Design: This was a mixed-methods study. Setting: The setting was care homes for older adults in England. Participants: Care home residents participated. Results: Three measures of pain, anxiety and low mood were developed and tested, using a mixed-methods approach, with 182 care home residents in 20 care homes (nursing and residential). Psychometric testing found that the measures had good construct validity. The mixed-methods approach was both feasible and necessary with this population, as the majority of residents could not self-report. Using a combined data set (n = 475 residents in 54 homes) from this study and the Measuring Outcomes in Care Homes study (Towers AM, Palmer S, Smith N, Collins G, Allan S. A cross-sectional study exploring the relationship between regulator quality ratings and care home residents’ quality of life in England. Health Qual Life Outcomes 2019;17:22) we found a significant positive association between residents’ social care-related quality of life and regulator (i.e. Care Quality Commission) quality ratings. Multivariate regression revealed that homes rated ‘good/outstanding’ are associated with a 12% improvement in mean current social care-related quality of life among residents who have higher levels of dependency. Secondary data analysis of a large, national sample of care homes over time assessed the impact of staffing and employment conditions on Care Quality Commission quality ratings. Higher wages and a higher prevalence of training in both dementia and dignity-/person-centred care were positively associated with care quality, whereas high staff turnover and job vacancy rates had a significant negative association. A 10% increase in the average care worker wage increased the likelihood of a ‘good/outstanding’ rating by 7%. Limitations: No care homes rated as inadequate were recruited to the study. Conclusions: The most dependent residents gain the most from homes rated ‘good/outstanding’. However, measuring the needs and outcomes of these residents is challenging, as many cannot self-report. A mixed-methods approach can reduce methodological exclusion and an over-reliance on proxies. Improving working conditions and reducing staff turnover may be associated with better outcomes for residents. Future work: Further work is required to explore the relationship between pain, anxiety and low mood and other indicators of care homes quality and to examine the relationship between wages, training and social care outcomes. Funding: This project was funded by the National Institute for Health Research (NIHR) Health Services and Delivery Research programme and will be published in full in Health Services and Delivery Research; Vol. 9, No. 19. See the NIHR Journals Library website for further project information.
Background: The NHS emergency and urgent care system is under pressure as demand for services increases each year. NHS 111 is a telephone triage service designed to provide advice and signposting to appropriate services for people with urgent health-care problems. A new service, NHS 111 Online, has been introduced across England as a digital alternative that can be accessed using a website or a smartphone application. The effects and usefulness of this service are unknown. Objectives: To explore the impact of NHS 111 Online on the related telephone service and urgent care system activity and the experiences of people who use those services. Design and methods: A mixed-methods design of five related work packages comprising an evidence review; a quantitative before-and-after time series analysis of changes in call activity (18/38 sites); a descriptive comparison of telephone and online services with qualitative survey (telephone, n = 795; online, n = 3728) and interview (32 participants) studies of service users; a qualitative interview study (16 participants) of staff; and a cost–consequences analysis. Results: The online service had little impact on the number of triaged calls to the NHS 111 telephone service. For every 1000 online contacts, triaged telephone calls increased by 1.3% (1.013, 95% confidence interval 0.996 to 1.029; p = 0.127). Recommendations to attend emergency and urgent care services increased between 6.7% and 4.2%. NHS 111 Online users were less satisfied than users of the telephone service (50% vs. 71%; p < 0.001), and less likely to recommend to others (57% vs. 69%; p < 0.001) and to report full compliance with the advice given (67.5% vs. 88%; p < 0.001). Online users were less likely to report contacting emergency services and more likely to report not making any contact with a health service (31% vs. 16%; p < 0.001) within 7 days of contact. Thirty-five per cent of online users reported that they did not want to use the telephone service, whereas others preferred its convenience and speed. NHS 111 telephone staff reported no discernible increase or decrease in their workload during the first year of operation of NHS 111 Online. If online and telephone services operate in parallel, then the annual costs will be higher unless ≥ 38% of telephone contacts move to online contacts. Conclusions: There is some evidence that the new service has the potential to create new demand. The service has expanded significantly, so it is important to find ways of promoting the right balance in numbers of people who use the online service instead of the telephone service if it is to be effective. There is a clear need and preference by some people for an online service. Better information about when to use this service and improvements to questioning may encourage more uptake. Limitations: The lack of control arm means that impact could have been an effect of other factors. This work took place during the early implementation phase, so findings may change as the service expands. Future work: Further development of the online triage process to make it more ‘user friendly’ and to enable users to trust the advice given online could improve use and increase satisfaction. Better understanding of the characteristics of the telephone and online populations could help identify who is most likely to benefit and could improve information about when to use the service. Trial registration: Current Controlled Trials ISRCTN51801112. Funding: This project was funded by the National Institute for Health Research (NIHR) Health Services and Delivery Research programme and will be published in full in Health Services and Delivery Research; Vol. 9, No. 21. See the NIHR Journals Library website for further project information.
Background: NHS England’s 7-day services policy comprised 10 standards to improve access to quality health care across all days of the week. Six standards targeted hospital specialists on the assumption that their absence caused the higher mortality associated with weekend hospital admission: the ‘weekend effect’. The High-intensity Specialist-Led Acute Care (HiSLAC) collaboration investigated this using the implementation of 7-day services as a ‘natural experiment’. Objectives: The objectives were to determine whether or not increasing specialist intensity at weekends improves outcomes for patients undergoing emergency hospital admission, and to explore mechanisms and cost-effectiveness. Design: This was a two-phase mixed-methods observational study. Year 1 focused on developing the methodology. Years 2–5 included longitudinal research using quantitative and qualitative methods, and health economics. Methods: A Bayesian systematic literature review from 2000 to 2017 quantified the weekend effect. Specialist intensity measured over 5 years used self-reported annual point prevalence surveys of all specialists in English acute hospital trusts, expressed as the weekend-to-weekday ratio of specialist hours per 10 emergency admissions. Hospital Episode Statistics from 2007 to 2018 provided trends in weekend-to-weekday mortality ratios. Mechanisms for the weekend effect were explored qualitatively through focus groups and on-site observations by qualitative researchers, and a two-epoch case record review across 20 trusts. Case-mix differences were examined in a single trust. Health economics modelling estimated costs and outcomes associated with increased specialist provision. Results: Of 141 acute trusts, 115 submitted data to the survey, and 20 contributed 4000 case records for review and participated in qualitative research (involving interviews, and observations using elements of an ethnographic approach). Emergency department attendances and admissions have increased every year, outstripping the increase in specialist numbers; numbers of beds and lengths of stay have decreased. The reduction in mortality has plateaued; the proportion of patients dying after discharge from hospital has increased. Specialist hours increased between 2012/13 and 2017/18. Weekend specialist intensity is half that of weekdays, but there is no relationship with admission mortality. Patients admitted on weekends are sicker (they have more comorbid disease and more of them require palliative care); adjustment for severity of acute illness annuls the weekend effect. In-hospital care processes are slightly more efficient at weekends; care quality (errors, adverse events, global quality) is as good at weekends as on weekdays and has improved with time. Qualitative researcher assessments of hospital weekend quality concurred with case record reviewers at trust level. General practitioner referrals at weekends are one-third of those during weekdays and have declined further with time. Limitations: Observational research, variable survey response rates and subjective assessments of care quality were compensated for by using a difference-in-difference analysis over time. Conclusions: Hospital care is improving. The weekend effect is associated with factors in the community that precede hospital admission. Post-discharge mortality is increasing. Policy-makers should focus their efforts on improving acute and emergency care on a ‘whole-system’ 7-day approach that integrates social, community and secondary health care. Future work: Future work should evaluate the role of doctors in hospital and community emergency care and investigate pathways to emergency admission and quality of care following hospital discharge. Funding: This project was funded by the National Institute for Health Research (NIHR) Health Services and Delivery Research programme and will be published in full in Health Services and Delivery Research; Vol. 9, No. 13. See the NIHR Journals Library website for further project information.
Background: In 2013, 70% of people who were homeless on admission to hospital were discharged back to the street without having their care and support needs addressed. In response, the UK government provided funding for 52 new specialist homeless hospital discharge schemes. This study employed RAMESES II (Realist And Meta-narrative Evidence Syntheses: Evolving Standards) guidelines between September 2015 and 2019 to undertake a realist evaluation to establish what worked, for whom, under what circumstances and why. It was hypothesised that delivering outcomes linked to consistently safe, timely care transfers for homeless patients would depend on hospital discharge schemes implementing a series of high-impact changes (resource mechanisms). These changes encompassed multidisciplinary discharge co-ordination (delivered through clinically led homeless teams) and ‘step-down’ intermediate care. These facilitated time-limited care and support and alternative pathways out of hospital for people who could not go straight home. Methods: The realist hypothesis was tested empirically and refined through three work packages. Work package 1 generated seven qualitative case studies, comparing sites with different types of specialist homeless hospital discharge schemes (n = 5) and those with no specialist discharge scheme (standard care) (n = 2). Methods of data collection included interviews with 77 practitioners and stakeholders and 70 people who were homeless on admission to hospital. A ‘data linkage’ process (work package 2) and an economic evaluation (work package 3) were also undertaken. The data linkage process resulted in data being collected on > 3882 patients from 17 discharge schemes across England. The study involved people with lived experience of homelessness in all stages. Results: There was strong evidence to support our realist hypothesis. Specialist homeless hospital discharge schemes employing multidisciplinary discharge co-ordination and ‘step-down’ intermediate care were more effective and cost-effective than standard care. Specialist care was shown to reduce delayed transfers of care. Accident and emergency visits were also 18% lower among homeless patients discharged at a site with a step-down service than at those without. However, there was an impact on the effectiveness of the schemes when they were underfunded or when there was a shortage of permanent supportive housing and longer-term care and support. In these contexts, it remained (tacitly) accepted practice (across both standard and specialist care sites) to discharge homeless patients to the streets, rather than delay their transfer. We found little evidence that discharge schemes fired a change in reasoning with regard to the cultural distance that positions ‘homeless patients’ as somehow less vulnerable than other groups of patients. We refined our hypothesis to reflect that high-impact changes need to be underpinned by robust adult safeguarding. Strengths and limitations: To our knowledge, this is the largest study of the outcomes of homeless patients discharged from hospital in the UK. Owing to issues with the comparator group, the effectiveness analysis undertaken for the data linkage was limited to comparisons of different types of specialist discharge scheme (rather than specialist vs. standard care). Future work: There is a need to consider approaches that align with those for value or alliance-based commissioning where the evaluative gaze is shifted from discrete interventions to understanding how the system is working as a whole to deliver outcomes for a defined patient population. Funding: This project was funded by the National Institute for Health Research (NIHR) Health Services and Delivery Research programme and will be published in full in Health Services and Delivery Research; Vol. 9, No. 17. See the NIHR Journals Library website for further project information.
BackgroundDrug-related problems and potentially inappropriate prescribing impose a huge burden on patients and the health-care system. The most widely used tools for appropriate prescription in older adults in England and in other European countries are the Screening Tool of Older People’s Prescriptions (STOPP)/Screening Tool to Alert to the Right Treatment (START) tools. STOPP/START tools support medicines optimisation for older adults.ObjectivesTo identify, test and refine the programme theories underlying how interventions based on the STOPP/START tools are intended to work, for whom, in what circumstances and why, as well as the resource use and cost requirements or impacts.DesignA realist synthesis.SettingPrimary care, hospital care and nursing homes.PatientsPatients aged ≥ 65 years.InterventionsAny intervention based on the use of the STOPP/START tools.Review methodsDatabase and web-searching was carried out to retrieve relevant evidence to identify and test programme theories about how interventions based on the use of the STOPP/START tools work. A project reference group made up of health-care professionals, NHS decision-makers, older people, carers and members of the public was set up. In phase 1 we identified programme theories about STOPP/START interventions on how, for whom, in what contexts and why they are intended to work. We searched the peer-reviewed and grey literature to identify documents relevant to the research questions. We interviewed experts in the field in our reference group to gain input on our list of candidate context–mechanism–outcome configurations, to identify additional context–mechanism–outcome configurations and to identify additional literature and/or relevant concepts. In phase 2 we reviewed and synthesised relevant published and unpublished empirical evidence and tested the programme theories using evidence from a larger set of empirical studies.ResultsWe developed a single logic model structured around three key mechanisms: (1) personalisation, (2) systematisation and (3) evidence implementation. Personalisation: STOPP/START-based interventions are based on shared decision-making, taking into account patient preferences, experiences and expectations (mechanisms), leading to increased patient awareness, adherence, satisfaction, empowerment and quality of life (outcomes). Systematisation: STOPP/START tools provide a standardised/systematic approach for medication reviews (mechanisms), leading to changes in professional and organisational culture and burden/costs (outcomes). Evidence implementation: delivery of STOPP/START-based interventions is based on the implementation of best evidence (mechanisms), reducing adverse outcomes through appropriate prescribing/deprescribing (outcomes). For theory testing, we identified 40 studies of the impact of STOPP/START-based interventions in hospital settings, nursing homes, primary care and community pharmacies. Most of the interventions used multiple mechanisms. We found support for the impact of the personalisation and evidence implementation mechanisms on selected outcome variables, but similar impact was achieved by interventions not relying on these mechanisms. We also observed that the impact of interventions was linked to the proximity of the selected outcomes to the intervention in the logic model, resulting in a clearer benefit for appropriateness of prescribing, adverse drug events and prescription costs.LimitationsNone of the available studies had been explicitly designed for evaluating underlying causal mechanisms, and qualitative information was sparse.ConclusionsNo particular configuration of the interventions is associated with a greater likelihood of improved outcomes in given settings.Study registrationThis study is registered as PROSPERO CRD42018110795.FundingThis project was funded by the National Institute for Health Research (NIHR) Health Services and Delivery Research programme and will be published in full inHealth Services and Delivery Research; Vol. 9, No. 23. See the NIHR Journals Library website for further project information.
Background: 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. Objectives: 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. Design: 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. Setting: Hospice at home services across England. Participants: 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. Main outcome measures: 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. Results: 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. Limitations: 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. Conclusions: 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: Future research should explore the use of volunteers in the hospice at home setting and evaluate approaches to bereavement support. 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. 24. See the NIHR Journals Library website for further project information.
Background More effective ways of managing symptoms of chronic and terminal illness enable patients to be cared for, and to die, at home. This requires patients and family caregivers to manage complex medicines regimens, including powerful painkillers that can have serious side effects. Little is known about how patients and family caregivers manage the physical and emotional work of managing medicines in the home or the support that they receive from health-care professionals and services. Objective To investigate how patients with serious and terminal illness, their family caregivers and the health-care professionals manage complex medication regimens and routines of care in the domestic setting. Design A qualitative study involving (1) semistructured interviews and group discussions with 40 health-care professionals and 21 bereaved family caregivers, (2) 20 patient case studies with up to 4 months’ follow-up and (3) two end-of-project stakeholder workshops. Setting This took place in Nottinghamshire and Leicestershire, UK. Results As patients’ health deteriorated, family caregivers assumed the role of a care co-ordinator, undertaking the everyday work of organising and collecting prescriptions and storing and administering medicines around other care tasks and daily routines. Participants described the difficulties of navigating a complex and fragmented system and the need to remain vigilant about medicines prescribed, especially when changes were made by different professionals. Access to support, resilience and coping capacity are mediated through the resources available to patients, through the relationships that they have with people in their personal and professional networks, and, beyond that, through the wider connections – or disconnections – that these links have with others. Health-care professionals often lacked understanding of the practical and emotional challenges involved. All participants experienced difficulties in communication and organisation within a health-care system that they felt was complicated and poorly co-ordinated. Having a key health professional to support and guide patients and family caregivers through the system was important to a good experience of care. Limitations The study achieved diversity in the recruitment of patients, with different characteristics relating to the type of illness and socioeconomic circumstances. However, recruitment of participants from ethnically diverse and disadvantaged or hard-to-reach populations was particularly challenging, and we were unable to include as many participants from these groups as had been originally planned. Conclusions The study identified two key and inter-related areas in which patient and family caregiver experience of managing medicines at home in end-of-life care could be improved: (1) reducing work and responsibility for medicines management and (2) improving co-ordination and communication in health care. It is important to be mindful of the need for transparency and open discussion about the extent to which patients and family caregivers can and should be co-opted as proto-professionals in the technically and emotionally demanding tasks of managing medicines at the end of life. Future work Priorities for future research include investigating how allocated key professionals could integrate and co-ordinate care and optimise medicines management; the role of domiciliary home care workers in supporting medicines management in end-of-life care; patient and family perspectives and understanding of anticipatory prescribing and their preferences for involvement in decision-making; the experience of medicines management in terminal illness among minority, disadvantaged and hard-to-reach patient groups; and barriers to and facilitators of increased involvement of community pharmacists in palliative and end-of-life care. Funding This project was funded by the National Institute for Health Research (NIHR) Health Services and Delivery Research programme and will be published in full in Health Services and Delivery Research; Vol. 9, No. 14. See the NIHR Journals Library website for further project information.
Background: For systematic reviews to be rigorous, deliverable and useful, they need a well-defined review question. Scoping for a review also requires the specification of clear inclusion criteria and planned synthesis methods. Guidance is lacking on how to develop these, especially in the context of undertaking rapid and responsive systematic reviews to inform health services and health policy. Objective: This report describes and discusses the experiences of review scoping of three commissioned research centres that conducted evidence syntheses to inform health and social care organisation, delivery and policy in the UK, between 2017 and 2020. Data sources: Sources included researcher recollection, project meeting minutes, e-mail correspondence with stakeholders and scoping searches, from allocation of a review topic through to review protocol agreement. Methods: We produced eight descriptive case studies of selected reviews from the three teams. From case studies, we identified key issues that shape the processes of scoping and question formulation for evidence synthesis. The issues were then discussed and lessons drawn. Findings: Across the eight diverse case studies, we identified 14 recurrent issues that were important in shaping the scoping processes and formulating a review’s questions. There were ‘consultative issues’ that related to securing input from review commissioners, policy customers, experts, patients and other stakeholders. These included managing and deciding priorities, reconciling different priorities/perspectives, achieving buy-in and engagement, educating the end-user about synthesis processes and products, and managing stakeholder expectations. There were ‘interface issues’ that related to the interaction between the review team and potential review users. These included identifying the niche/gap and optimising value, assuring and balancing rigour/reliability/relevance, and assuring the transferability/applicability of study evidence to specific policy/service user contexts. There were also ‘technical issues’ that were associated with the methods and conduct of the review. These were choosing the method(s) of synthesis, balancing fixed and fluid review questions/components/definitions, taking stock of what research already exists, mapping versus scoping versus reviewing, scoping/relevance as a continuous process and not just an initial stage, and calibrating general compared with specific and broad compared with deep coverage of topics. Limitations: As a retrospective joint reflection by review teams on their experiences of scoping processes, this report is not based on prospectively collected research data. In addition, our evaluations were not externally validated by, for example, policy and service evidence users or patients and the public. Conclusions: We have summarised our reflections on scoping from this programme of reviews as 14 common issues and 28 practical ‘lessons learned’. Effective scoping of rapid, responsive reviews extends beyond information exchange and technical procedures for specifying a ‘gap’ in the evidence. These considerations work alongside social processes, in particular the building of relationships and shared understanding between reviewers, research commissioners and potential review users that may be reflective of consultancy, negotiation and co-production models of research and information use. Funding: This report has been based on work commissioned by the National Institute for Health Research (NIHR) Health Services and Delivery Research (HSDR) programme as three university-based evidence synthesis centres to inform the organisation, delivery and commissioning of health and social care; at the University of Exeter (NIHR 16/47/22), the University of Sheffield (NIHR 16/47/17) and the University of York (NIHR 16/47/11). This report was commissioned by the NIHR HSDR programme as a review project (NIHR132708) within the NIHR HSDR programme. This project was funded by the NIHR HSDR programme and will be published in full in Health Services and Delivery Research; Vol. 9, No. 15. See the NIHR Journals Library website for further project information.
Background: Cognitive impairment is common in older people admitted to hospital, but previous research has focused on single conditions. Objective: This project sits in phase 0/1 of the Medical Research Council Framework for the Development and Evaluation of Complex Interventions. It aims to develop an understanding of current health-care outcomes. This will be used in the future development of a multidomain intervention for people with confusion (dementia and cognitive impairment) in general hospitals. The research was conducted from January 2015 to June 2018 and used data from people admitted between 2012 and 2013. Design: For the review of outcomes, the systematic review identified peer-reviewed quantitative epidemiology measuring prevalence and associations with outcomes. Screening for duplication and relevance was followed by full-text review, quality assessment and a narrative review (141 papers). A survey sought opinion on the key outcomes for people with dementia and/or confusion and their carers in the acute hospital (n = 78). For the analysis of outcomes including cost, the prospective cohort study was in a medical admissions unit in an acute hospital in one Scottish health board covering 10% of the Scottish population. The participants (n = 6724) were older people (aged ≥ 65 years) with or without a cognitive spectrum disorder who were admitted as medical emergencies between January 2012 and December 2013 and who underwent a structured nurse assessment. ‘Cognitive spectrum disorder’ was defined as any combination of delirium, known dementia or an Abbreviated Mental Test score of < 8 out of 10 points. The main outcome measures were living at home 30 days after discharge, mortality within 2 years of admission, length of stay, re-admission within 2 years of admission and cost. Data sources: Scottish Morbidity Records 01 was linked to the Older Persons Routine Acute Assessment data set. Results: In the systematic review, methodological heterogeneity, especially concerning diagnostic criteria, means that there is significant overlap in conditions of patients presenting to general hospitals with confusion. Patients and their families expect that patients are discharged in the same or a better condition than they were in on admission or, failing that, that they have a satisfactory experience of their admission. Cognitive spectrum disorders were present in more than one-third of patients aged ≥ 65 years, and in over half of those aged ≥ 85 years. Outcomes were worse in those patients with cognitive spectrum disorders than in those without: length of stay 25.0 vs. 11.8 days, 30-day mortality 13.6% vs. 9.0%, 1-year mortality 40.0% vs. 26.0%, 1-year mortality or re-admission 62.4% vs. 51.5%, respectively (all p < 0.01). There was relatively little difference by cognitive spectrum disorder type; for example, the presence of any cognitive spectrum disorder was associated with an increased mortality over the entire period of follow-up, but with different temporal patterns depending on the type of cognitive spectrum disorder. The cost of admission was higher for those with cognitive spectrum disorders, but the average daily cost was lower. Limitations: A lack of diagnosis and/or standardisation of diagnosis for dementia and/or delirium was a limitation for the systematic review, the quantitative study and the economic study. The economic study was limited to in-hospital costs as data for social or informal care costs were unavailable. The survey was conducted online, limiting its reach to older carers and those people with cognitive spectrum disorders. Conclusions: Cognitive spectrum disorders are common in older inpatients and are associated with considerably worse health-care outcomes, with significant overlap between individual cognitive spectrum disorders. This suggests the need for health-care systems to systematically identify and develop care pathways for older people with cognitive spectrum disorders, and avoid focusing on only condition-specific pathways. Future work: Development and evaluation of a multidomain intervention for the management of patients with cognitive spectrum disorders in hospital. Study registration: This study is registered as PROSPERO CRD42015024492. Funding: This project was funded by the National Institute for Health Research (NIHR) Health Services and Delivery Research programme and will be published in full in Health Services and Delivery Research; Vol. 9, No. 8. See the NIHR Journals Library website for further project information.
Background: Most deaths still take place in hospital; cost-effective commissioning of end-of-life resources is a priority. This review provides clarity on the effectiveness of hospital-based specialist palliative care. Objectives: The objectives were to assess the effectiveness and cost-effectiveness of hospital-based specialist palliative care. Population: Adult patients with advanced illnesses and their unpaid caregivers. Intervention: Hospital-based specialist palliative care. Comparators: Inpatient or outpatient hospital care without specialist palliative care input at the point of entry to the study, or community care or hospice care provided outside the hospital setting (usual care). Primary outcomes: Patient health-related quality of life and symptom burden. Data sources: Six databases (The Cochrane Library, MEDLINE, EMBASE, Cumulative Index to Nursing and Allied Health Literature, PsycINFO and CareSearch), clinical trial registers, reference lists and systematic reviews were searched to August 2019. Review methods: Two independent reviewers screened, data extracted and assessed methodological quality. Meta-analysis was carried out using RevMan (The Cochrane Collaboration, The Nordic Cochrane Centre, Copenhagen, Denmark), with separate synthesis of qualitative data. Results: Forty-two randomised controlled trials involving 7779 participants (6678 patients and 1101 unpaid caregivers) were included. Diagnoses of participants were as follows: cancer, 21 studies; non-cancer, 14 studies; and mixed cancer and non-cancer, seven studies. Hospital-based specialist palliative care was offered in the following models: ward based (one study), inpatient consult (10 studies), outpatient (six studies), hospital at home or hospital outreach (five studies) and multiple settings that included hospital (20 studies). Meta-analyses demonstrated significant improvement favouring hospital-based specialist palliative care over usual care in patient health-related quality of life (10 studies, standardised mean difference 0.26, 95% confidence interval 0.15 to 0.37; I2 = 3%) and patient satisfaction with care (two studies, standardised mean difference 0.36, 95% confidence interval 0.14 to 0.57; I2 = 0%), a significant reduction in patient symptom burden (six studies, standardised mean difference –0.26, 95% confidence interval –0.41 to –0.12; I2 = 0%) and patient depression (eight studies, standardised mean difference –0.22, 95% confidence interval –0.34 to –0.10; I2 = 0%), and a significant increase in the chances of patients dying in their preferred place (measured by number of patients with home death) (seven studies, odds ratio 1.63, 95% confidence interval 1.23 to 2.16; I2 = 0%). There were non-significant improvements in pain (four studies, standardised mean difference –0.16, 95% confidence interval –0.33 to 0.01; I2 = 0%) and patient anxiety (five studies, mean difference –0.63, 95% confidence interval –2.22 to 0.96; I2 = 76%). Hospital-based specialist palliative care showed no evidence of causing serious harm. The evidence on mortality/survival and cost-effectiveness was inconclusive. Qualitative studies (10 studies, 322 participants) suggested that hospital-based specialist palliative care was beneficial as it ensured personalised and holistic care for patients and their families, while also fostering open communication, shared decision-making and respectful and compassionate care. Limitation: In almost half of the included randomised controlled trials, there was palliative care involvement in the control group. Conclusions: Hospital-based specialist palliative care may offer benefits for person-centred outcomes including health-related quality of life, symptom burden, patient depression and satisfaction with care, while also increasing the chances of patients dying in their preferred place (measured by home death) with little evidence of harm. Future work: More studies are needed of populations with non-malignant diseases, different models of hospital-based specialist palliative care, and cost-effectiveness. Study registration: This study is registered as PROSPERO CRD42017083205. Funding: This project was funded by the National Institute for Health Research (NIHR) Health Services and Delivery Research programme and will be published in full in Health Services and Delivery Research; Vol. 9, No. 12. See the NIHR Journals Library website for further project information.
IntroductionPeople with long-term conditions typically have reduced physical functioning, are less physically active and therefore become less able to live independently and do the things they enjoy. However, assessment and promotion of physical function and physical activity is not part of routine management in primary care. This project aims to develop evidence-based recommendations about how primary care can best help people to become more physically active in order to maintain and improve their physical function, thus promoting independence.Methods and analysisThis study takes a realist synthesis approach, following RAMESES guidance, with embedded co-production and co-design. Stage 1 will develop initial programme theories about physical activity and physical function for people with long-term conditions, based on a review of the scientific and grey literature, and two multisector stakeholder workshops using LEGO® SERIOUS PLAY®. Stage 2 will involve focused literature searching, data extraction and synthesis to provide evidence to support or refute the initial programme theories. Searches for evidence will focus on physical activity interventions involving the assessment of physical function which are relevant to primary care. We will describe ‘what works’, ‘for whom’ and ‘in what circumstances’ and develop conjectured programme theories using context, mechanism and outcome configurations. Stage 3 will test and refine these theories through individual stakeholder interviews. The resulting theory-driven recommendations will feed into Stage 4 which will involve three sequential co-design stakeholder workshops in which practical ideas for service innovation in primary care will be developed.Ethics and disseminationHealthcare and Medical Sciences Academic Ethics Committee (Reference 2018-16308) and NHS Wales Research Ethics Committee 5 approval (References 256 729 and 262726) have been obtained. A knowledge mobilisation event will address issues relevant to wider implementation of the intervention and study findings. Findings will be disseminated through peer-reviewed journal publications, conference presentations and formal and informal reports.PROSPERO registration numberCRD42018103027.
Background: People with severe mental illness experience poorer health outcomes than the general population. Diabetes contributes significantly to this health gap. Objectives: The objectives were to identify the determinants of diabetes and to explore variation in diabetes outcomes for people with severe mental illness. Design: Under a social inequalities framework, a concurrent mixed-methods design combined analysis of linked primary care records with qualitative interviews. Setting: The quantitative study was carried out in general practices in England (2000–16). The qualitative study was a community study (undertaken in the North West and in Yorkshire and the Humber). Participants: The quantitative study used the longitudinal health records of 32,781 people with severe mental illness (a subset of 3448 people had diabetes) and 9551 ‘controls’ (with diabetes but no severe mental illness), matched on age, sex and practice, from the Clinical Practice Research Datalink (GOLD version). The qualitative study participants comprised 39 adults with diabetes and severe mental illness, nine family members and 30 health-care staff. Data sources: The Clinical Practice Research Datalink (GOLD) individual patient data were linked to Hospital Episode Statistics, Office for National Statistics mortality data and the Index of Multiple Deprivation. Results: People with severe mental illness were more likely to have diabetes if they were taking atypical antipsychotics, were living in areas of social deprivation, or were of Asian or black ethnicity. A substantial minority developed diabetes prior to severe mental illness. Compared with people with diabetes alone, people with both severe mental illness and diabetes received more frequent physical checks, maintained tighter glycaemic and blood pressure control, and had fewer recorded physical comorbidities and elective admissions, on average. However, they had more emergency admissions (incidence rate ratio 1.14, 95% confidence interval 0.96 to 1.36) and a significantly higher risk of all-cause mortality than people with diabetes but no severe mental illness (hazard ratio 1.89, 95% confidence interval 1.59 to 2.26). These paradoxical results may be explained by other findings. For example, people with severe mental illness and diabetes were more likely to live in socially deprived areas, which is associated with reduced frequency of health checks, poorer health outcomes and higher mortality risk. In interviews, participants frequently described prioritising their mental illness over their diabetes (e.g. tolerating antipsychotic side effects, despite awareness of harmful impacts on diabetes control) and feeling overwhelmed by competing treatment demands from multiple morbidities. Both service users and practitioners acknowledged misattributing physical symptoms to poor mental health (‘diagnostic overshadowing’). Limitations: Data may not be nationally representative for all relevant covariates, and the completeness of recording varied across practices. Conclusions: People with severe mental illness and diabetes experience poorer health outcomes than, and deficiencies in some aspects of health care compared with, people with diabetes alone. Future work: These findings can inform the development of targeted interventions aimed at addressing inequalities in this population. Study registration: National Institute for Health Research (NIHR) Central Portfolio Management System (37024); and ClinicalTrials.gov NCT03534921. Funding: This project was funded by the NIHR Health Services and Delivery Research programme and will be published in full in Health Services and Delivery Research; Vol. 9, No. 10. See the NIHR Journals Library website for further project information.
Background: An underperforming doctor puts patient safety at risk. Remediation is an intervention intended to address underperformance and return a doctor to safe practice. Used in health-care systems all over the world, it has clear implications for both patient safety and doctor retention in the workforce. However, there is limited evidence underpinning remediation programmes, particularly a lack of knowledge as to why and how a remedial intervention may work to change a doctor’s practice. Objectives: To (1) conduct a realist review of the literature to ascertain why, how, in what contexts, for whom and to what extent remediation programmes for practising doctors work to restore patient safety; and (2) provide recommendations on tailoring, implementation and design strategies to improve remediation interventions for doctors. Design: A realist review of the literature underpinned by the Realist And MEta-narrative Evidence Syntheses: Evolving Standards quality and reporting standards. Data sources: Searches of bibliographic databases were conducted in June 2018 using the following databases: EMBASE, MEDLINE, Cumulative Index to Nursing and Allied Health Literature, PsycINFO, Education Resources Information Center, Database of Abstracts of Reviews of Effects, Applied Social Sciences Index and Abstracts, and Health Management Information Consortium. Grey literature searches were conducted in June 2019 using the following: Google Scholar (Google Inc., Mountain View, CA, USA), OpenGrey, NHS England, North Grey Literature Collection, National Institute for Health and Care Excellence Evidence, Electronic Theses Online Service, Health Systems Evidence and Turning Research into Practice. Further relevant studies were identified via backward citation searching, searching the libraries of the core research team and through a stakeholder group. Review methods: Realist review is a theory-orientated and explanatory approach to the synthesis of evidence that seeks to develop programme theories about how an intervention produces its effects. We developed a programme theory of remediation by convening a stakeholder group and undertaking a systematic search of the literature. We included all studies in the English language on the remediation of practising doctors, all study designs, all health-care settings and all outcome measures. We extracted relevant sections of text relating to the programme theory. Extracted data were then synthesised using a realist logic of analysis to identify context–mechanism–outcome configurations. Results: A total of 141 records were included. Of the 141 studies included in the review, 64% related to North America and 14% were from the UK. The majority of studies (72%) were published between 2008 and 2018. A total of 33% of articles were commentaries, 30% were research papers, 25% were case studies and 12% were other types of articles. Among the research papers, 64% were quantitative, 19% were literature reviews, 14% were qualitative and 3% were mixed methods. A total of 40% of the articles were about junior doctors/residents, 31% were about practicing physicians, 17% were about a mixture of both (with some including medical students) and 12% were not applicable. A total of 40% of studies focused on remediating all areas of clinical practice, including medical knowledge, clinical skills and professionalism. A total of 27% of studies focused on professionalism only, 19% focused on knowledge and/or clinical skills and 14% did not specify. A total of 32% of studies described a remediation intervention, 16% outlined strategies for designing remediation programmes, 11% outlined remediation models and 41% were not applicable. Twenty-nine context–mechanism–outcome configurations were identified. Remediation programmes work when they develop doctors’ insight and motivation, and reinforce behaviour change. Strategies such as providing safe spaces, using advocacy to develop trust in the remediation process and carefully framing feedback create contexts in which psychological safety and professional dissonance lead to the development of insight. Involving the remediating doctor in remediation planning can provide a perceived sense of control in the process and this, alongside correcting causal attribution, goal-setting, destigmatising remediation and clarity of consequences, helps motivate doctors to change. Sustained change may be facilitated by practising new behaviours and skills and through guided reflection. Limitations: Limitations were the low quality of included literature and limited number of UK-based studies. Future work: Future work should use the recommendations to optimise the delivery of existing remediation programmes for doctors in the NHS. Study registration: This study is registered as PROSPERO CRD42018088779. Funding: This project was funded by the National Institute for Health Research (NIHR) Health Services and Delivery Research programme and will be published in full in Health Services and Delivery Research; Vol. 9, No. 11. See the NIHR Journals Library website for further project information.
