The Patient Safety Collaborative Evaluation Study (The PiSCES Study)
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Background Having investigated avoidable deaths and other occurrences of harm to patients at Mid-Staffordshire Hospital, the Francis Inquiry made 290 recommendations for actions to reduce the likelihood of such events recurring. A prominent part of the government’s response was to ask Don Berwick to chair a National Patient Safety Advisory Group to advise the government on a ‘whole-system’ Patient Safety Improvement Programme. The Group proposed establishing Patient Safety Collaboratives (PSC), drawing upon the experience of Quality Improvement Collaboratives, particularly the Institute of Healthcare Improvement (IHI) 'Breakthrough Series' From 2014, Collaboratives in the NHS were implemented through the regional Academic Health Science Networks (AHSN). Most research about the effects of Collaboratives has been uncontrolled and fragmented across a range of activities and target outcomes, often self-reported. Few studies report clearly how Collaboratives carried their work out, making it hard to identify what the ‘active ingredient’ is. Few contained evidence about the determinants of ‘success’ (as opposed to abundant hypotheses and conjectures). Neither is it known what kinds of clinical work (e.g. for which care groups) may be more amenable than others to improvement by PSC methods, although Collaboratives based hospitals have been most widely reported. We evaluated how this action taken in response to the Francis Inquiry was implemented and some of the consequences, and used our findings as the evidence base to present some some policy implications and further research proposals. Research Questions (RQ) This study addressed six research questions: RQ1: How has PSC implementation varied across the 15 Academic Health Science Network (AHSN) regions? RQ2: What organisational changes have providers made? How have they done this and what have they learned from the PSCs? RQ3: How were resources used for PSCs’ implementation activities? What are the costs of participation and implementation? RQ4: Have the PSCs made a detectable difference on rates of harm and adverse events involving patients as measured using routine data? RQ5: Has change in practice taken place on the front-line of services? RQ6: What generalisable knowledge can be shared about this? Methods We made a mixed methods observational comparison of PSC mechanisms, contexts and outcomes. We combined three methods each of which broadly corresponded to one stage of PSC implementation: 1. An Implementation study of how PSCs were set up, of AHSN roles in establishing and maintaining regional networks, and of how provider-level NHS managers and clinicians used PSC-initiated ideas and resources to influence clinical practice, monitor and improve clinical quality and safety. Our study looked at all 15 PSCs, studied three of them in greater detail, and within them selected different types of provider for in-depth study. 2. Patient safety culture surveys. The Francis and Berwick reports emphasised strengthening safety culture as a method for making clinical practice safer. Using the Safety, Communication, Operational Reliability and Engagement (SCORE) survey, we measured changes in patient safety ‘culture’ in six clinical teams undertaking PSC-initiated activities. We also analysed NHS Staff Survey data. 3. Analysis of routine administrative data. To assess how much patient safety and outcomes had changed we quantitatively analysed routinely collected administrative data relevant to PSCs’ intended outcomes. Our data sources were 61 semi structured in-depth interviews of key informants: SCORE survey data from 72 sites (first round) and from the six of these sites which had also made a second-round (repeat) survey during the study period: and England-wide data on in-patient satisfaction, quality improvement, managerial support for staff, fairness and effectiveness of procedures for reporting errors, recommendation of one’s own work-place, incident reporting and hospital mortality. Findings How PSC implementation varied across the 15 AHSNs (RQ1) Each AHSN applied elements of three strategies for improving patient quality and safety at provider level: • A facilitative strategy, which built where possible on existing QI and safety work in healthcare providers, but was constrained by the local history and resources – or lack of them – in these areas of work. A facilitative strategy made it harder to attribute any changes in working practices and outcomes unequivocally to PSC activities. • An educative strategy of educating, training and developing individual ‘change agents’ to implement changed working practices to improve patient safety at clinic level. • A national priority focussed strategy of adopting ‘work-streams’ from among the current national priorities, resulting in several PSCs developing similar work-streams (e.g. sepsis prevention). There were tensions between the facilitative approach and the national priority focus, which some informants thought was closer to a performance management approach. In general, PSCs and NHS staff favoured shifting from a ‘blame’ culture to learning culture focused on service development as more conducive to activities to improve patient safety. Where SCORE surveys were used (which was increasingly, but from a small base), they were implemented the same way everywhere. PSCs differed in terms of which elements and mechanisms of collaboratives they emphasised. Partly because the Francis report was a response to problems in hospital services, and because Collaboratives originated in (US) hospitals, participation was proportionately greater among acute hospitals than elsewhere, which partly reflected the technical challenges of making the Collaborative model relevant to non-hospital services. General practices apart, the only non-NHS providers participating were some care homes and pharmacies. Organisational changes that providers made and what they have learned from the PSCs (RQ2) Not all provider organisations participated in the PSCs. The willingness of NHS senior managers to engage with PSCs varied across setting. When they were willing, organisational upheaval including leadership changes made trusts’ engagement harder to sustain. In providers that did participate, the main organisational factors reported to aid PSC implementation were: • Initial expenditure for start-up training and preparing management information systems to serve (also) as a measurement system for clinical teams’ QI work • Recruiting trained QI and safety experts or ‘champions’ at all organisational levels, most critically at Board and clinical team levels; this was often done with PSC support and encouragement. • Ensuring that these champions had the leadership skills to motivate and empower clinical teams and to create safe spaces for staff to speak up or suggest changes. • Building structures and processes, at both whole-organisation and at clinical team levels, to sustain the changed working practices. • Allocating staff time not only to engage in QI and learning events, but so that they can subsequently utilise their learning at work. • 'Bottom-up' approaches to safety improvement promoted provider-level engagement and motivation by adapting the activities that PSCs were promoting to local needs. • Measurement support for front-line staff At the time of this study, the development and use of formal measurement systems to support QI activities had not yet materialised. The other change we had expected but did not observe was in safety climate, particularly at clinical team level. Although PSC activity, including the SCORE surveys, had impacts upon clinical teams’ working practices in the sites we studied (see below) these changes occurred without measurable changes in workplace safety climate. In summary, we found: 1. Some qualitative evidence of safety climate change in the intended direction, including increased staff engagement and shifts away from a blame culture towards a more ‘open lea
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