Title: Mixed methods analysis of the London Hyperacute Stroke System: identifying lessons on 24/7 working (METRO-24/7)
Funder: Department of Health and Social Care

Abstract: It has been repeatedly demonstrated across a range of acute settings that outcomes are poorer in secondary healthcare systems in the developed world outside the conventional five day working week (Bell and Redelmeier, 2001, Freemantle et al., 2012). At the same time some studies report equivalent or better outcomes for some patients treated outside the working week (Aylin et al., 2013, Luyt et al., 2007, Concha et al., 2013). While contested, such studies indicate that high quality out of hours care is possible and that changes in organisation of services might address the current performance gap. Several possible causes for an ‘out of hours effect’ are proposed but there are likely to be many relevant factors associated with out of hours working, including reduced staffing levels (Needleman et al., 2011, Freemantle et al., 2012) and reduced access to supporting investigations (Freemantle et al., 2012). Stroke is a leading cause of mortality and the most common cause of disability in the developed world (MacDonald et al., 2000, Geddes et al., 1996). Stroke is defined by the World Health Organisation as an event associated with “rapidly developing clinical signs of focal or global disturbance of cerebral function, lasting more than 24 hours or until death, with no apparent non-vascular cause” (WHO MONICA Project Investigators, 1988). Stroke shares similar pathways with other medical conditions and most specifically with acute cardiac disease (which is itself a leading cause of mortality and functional disability). International research indicates that weekend stroke admissions are associated with higher levels of mortality (Saposnik et al., 2007, Janszky et al., 2007), and lower likelihood of being discharged to same place of residence (Janszky et al., 2007). However, the picture for stroke is complicated by research covering specialist stroke units, which provide round the clock access to thrombolysis for hyperacute stroke. Research from the US, Australia and Israel suggest that such units reduce the disparity between in hours and out of hours care for stroke patients, with studies showing no significant ‘weekend effect’ in stroke patients in terms of such outcomes as length of stay, mortality, and functional outcome (both in hospital and at 90 days) (Albright et al., 2012, Streifler et al., 2012), and another suggesting the only significant ‘out of hours’ effect was on ‘door to needle’ time, but not patient outcomes (Fang et al., 2013). In the United Kingdom in Greater London a complete service change resulted in July 2010 in the opening of eight Hyperacute Stroke Units (HASUs) that were designated to provide comprehensive stroke care for up to the first 72 hours of care for patients presenting with recent stroke. All eight HASUs were set up according to the same designation criteria and provide round the clock access to thrombolysis and stroke nursing care (Fulop et al., 2013a). Since 2010 the majority of these HASUs have been placed in the top quartile and usually at or near the very top of the table for performance according to quality criteria specified in the national audit of stroke care (the Royal College of Physicians-supported Stroke Improvement National Audit Programme (SINAP)). However, HASUs do not provide the same level of access to therapists, consultant opinion or diagnostic investigations out of working hours as they do within hours. The HASU consultants have no contractual obligation to be on site during the evenings and there are no minimum staffing levels for therapists or doctors at weekends. Basic head imaging is expected to be performed for all patients within one hour of admission but there are otherwise no obligations for these services to provide more detailed imaging out of hours. Finally the HASUs work very closely with the Acute Stroke Units (ASUs) and with Community Rehabilitation Services. In general neither the ASUs nor the community teams are contracted to provide a normal service at weekends causing the discharges from the HASU to be funnelled into a weekday discharge pathway. By drawing together a range of qualitative and quantitative data, this research will provide an opportunity to identify lessons about the development, provision, effects and cost of 24/7 stroke care in the London HASU system. Finally, this study will complement an ongoing NIHR-funded evaluation of the reconfiguration of stroke services in London, Greater Manchester and the Midlands and East of England, led by co-investigator Fulop: this research combines quantitative and qualitative methods to analyse the processes by which the reconfigured London model was developed and implemented, the factors influencing these processes, and the impact the reconfiguration has had on service provision, costs and quality of care (Fulop et al., 2013a, Fulop et al., 2013b). The objectives are: 1.To investigate the extent to which evidence based care received by stroke patients differs between IH and OH services in London HASUs. 2.To investigate the extent to which clinical outcomes differ between IH and OH services in the London HASUs. 3.To investigate how IH and OH services are organised and provided in London HASUs. 4.To investigate how these services are perceived by stakeholders (including stroke clinicians, patients and carers). 5.To investigate the costs of acute stroke care in London HASUs on different days and at different times of admission. METHOD This is a mixed methods study, drawing together quantitative and qualitative approaches. The quantitative analysis will examine whether performance on selected clinical process and outcome measures is influenced by day or time of admission, staffing levels and other inputs (objectives 1 and 2); and an economic analysis (objective 5) will examine current service costs during and outside conventional working hours and how much it would cost to extend work shifts to provide more uniform care 24/7. The qualitative analysis (objectives 3 and 4) will use a comparative case study approach to draw together documentary, interview and observation data on how London’s HASUs organise and deliver 24/7 stroke care in practice, how these service patterns have been influenced by workforce and organisational factors, and how stakeholders including staff, patients and carers experience these services. The case study approach allows examination of how efforts to bring about change interact with the context in which they take place (Baker, 2011, Yin, 2009). This study will collect qualitative and quantitative data from all eight London HASUs. The quantitative and economic analyses draw on a range of data sources covering London’s HASUs. Data sources include data submitted to the Sentinel Stroke National Audit Programme (SSNAP), local staffing levels and staffing structures and training programmes covering the period 1/1/2014 – 31/12/2014. We will regress our primary and secondary outcomes against different combinations of series of covariates of interest. Our primary outcomes are in-hospital mortality, mortality at three months post admission and dependency at 6 months. In the economic analysis we will calculate the mean costs per patient receiving IH and OH care from an NHS and personal social services perspective. The time frame will be from admission to the HASU until three months after stroke. The cost components will include length of stay, interventions, therapy and stroke specific treatment. The qualitative analysis will combine deductive elements with generation and testing of theories from the raw data as it emerges. By focusing interviews and observations on measures analysed quantitatively (for example workforce factors, provision of evidence based care, and clinical outcomes in IH and OH periods), it will be possible to examine factors influencing the current provision of services and their effectiveness both in hours and out of hours. In this way, qualitative data will support identification of factors that may explain the results of the quantitative analyses. We will thus provide lessons on how 24/7 care is currently provided in London HASUs and factors influencing this. The focus on contextual issues may permit identification of lessons that may be generalised to 24/7 working beyond the London and stroke care settings. This process will also involve using analytic conferences where the research team will discuss the analysis and interpretation of the findings. This will provide opportunities to clarify conflicting understandings and to facilitate reflexivity (Barry et al., 1999). References ALBRIGHT, K. C. et al. (2012) Cerebrovascular Diseases, 34, 424-429. AYLIN, P. et al. (2013) BMJ, 346 10.1136/bmj.f2424. BAKER, G. R. (2011) BMJ Qual Saf, 20, i30-i35 10.1136/bmjqs.2010.046490. BARRY, C. A Qualitative health research 9, 26-44. BELL, C. M. & REDELMEIER, D. A. (2001) New England Journal of Medicine, 345, 663-668. CONCHA, O. P. et al. (2013) BMJ Quality & Safety, 10.1136/bmjqs-2013-002218. FANG, K. et al. (2013) Journal of Stroke and Cerebrovascular Diseases. FREEMANTLE, N. et al. (2012) JRSM, 105, 74-84. FULOP, N. et al. (2013a) Implement Sci, 8 doi:10.1186/1748-5908-8-5. FULOP, N. et al. (2013b) Retrieved from http://www.netscc.ac.uk/hsdr/projdetails.php?ref=10-1009-09 GEDDES, J. et al. (1996) Journal of epidemiology and community health, 50, 140-143. JANSZKY, I. et al. (2007) Stroke, 38, e94-e94. LUYT, C.-E. et al. (2007) Critical care medicine, 35, 3-11. MACDONALD, B. et al. (2000) Brain, 123, 665-676. NEEDLEMAN, J. et al. (2011) New England Journal of Medicine, 364, 1037-1045. SAPOSNIK, G. et al. (2007) Stroke, 38, 1211-1215. STREIFLER, J. et al. (2012) European Journal of Neurology, 19, 643-647. WHO MONICA PROJECT INVESTIGATORS (1988). J Clin Epidemiol, 41, 105-14. YIN, R. K. (2009) Case study research: design and methods, London, Sage Publications.

Lay abstract: Research conducted in the United Kingdom and internationally suggests that patients receive poorer care if admitted or treated outside conventional working hours. This difference in performance has been reported for many different conditions and has become known as the ‘weekend effect’. The reasons for this effect remain the subject of ongoing speculation, but identification of dominant causal factors is complicated by a small number of studies that report equivalent or better outcomes for some patients treated outside the working week. Although contested, such studies indicate that high quality out of hours care may be possible and that changes in organisation of services might address the current performance gap. In order to minimise unacceptable variation in care quality it has been argued that the National Health Service in England and Wales needs to change from the standard model of five day working to a fully operational twenty-four hours a day, seven days per week (hereafter referred to as 24/7) service that is both safe for patients and financially sustainable. However, there is limited evidence on how 24/7 services should be organised and the processes by which services might be developed. Recent work by the Academy of Medical Royal Colleges proposes three patient-centred standards that if provided would deliver consistent inpatient care irrespective of the day of the week. These standards are daily consultant review; daily access to pivotal diagnostic tests requested by the consultant; and daily access to inpatient and community therapy services. To develop understanding of effective 24/7 services, this study uses quantitative and qualitative methods to analyse organisation and provision of 24/7 care for a common disorder (acute stroke) in a large population (stroke admissions in London), focusing on services provided in all eight Hyperacute Stroke Units (HASUs), which were implemented across London in 2010. In this research we will investigate for differences in received care for patients admitted within working hours and those admitted outside working hours and evaluate whether this leads to different outcomes. We will seek to understand how the different HASUs are organised and how these services are perceived by staff and patients and their carers. Finally we will determine the costs of acute stroke care in the London HASUs on different days and at different times of admission. In addition to traditional dissemination methods, such as presentations to conferences and publications in academic and professional journals (relating to stroke and to health service management more widely), study findings will be shared in a number of ways. We will disseminate progress and findings to a wide range of local stakeholders, including London stroke clinicians, commissioners, and patients and carers. We will distribute accessible summaries of our work, for example through online bulletins and regular updates on the project website. We will also give presentations to relevant groups, such as service user groups and meetings of London stroke clinicians, as well as presenting findings to the participating HASUs. We anticipate that lessons drawn from this research will be of use to a wide range of stakeholders (e.g. patients, clinical professionals and commissioners) in London and elsewhere in the United Kingdom who are interested in provision of 24/7 services in stroke and other acute healthcare settings.

Research activity codes: 7.1 INDIVIDUAL CARE NEEDS;8.1 ORGANISATION AND DELIVERY OF SERVICES
Health categories: STROKE