HEALTH SERVICES AND DELIVERY RESEARCH

Transcription

1 HEALTH SERVICES AND DELIVERY RESEARCH VOLUME 3 ISSUE 40 SEPTEMBER 2015 ISSN A reaist anaysis of hospita patient safety in Waes: appied earning for aternative contexts from a mutisite case study Andrea Herepath, Martin Kitchener and Justin Waring DOI /hsdr03400

2

3 A reaist anaysis of hospita patient safety in Waes: appied earning for aternative contexts from a mutisite case study Andrea Herepath, 1,2 Martin Kitchener 2 * and Justin Waring 3 1 Sir Roand Smith Centre for Strategic Management, Department of Entrepreneurship, Strategy and Innovation, Lancaster University Management Schoo, Lancaster University, Lancaster, UK 2 Cardiff Business Schoo, Cardiff University, Cardiff, UK 3 Nottingham University Business Schoo, University of Nottingham, Nottingham, UK *Corresponding author Decared competing interests of authors: none Discaimer: This report contains transcripts of interviews conducted in the course of the research, or simiar, and contains anguage that may offend some readers. Pubished September 2015 DOI: /hsdr03400 This report shoud be referenced as foows: Herepath A, Kitchener M, Waring J. A reaist anaysis of hospita patient safety in Waes: appied earning for aternative contexts from a mutisite case study. Heath Serv Deiv Res 2015;3(40).

4

5 Heath Services and Deivery Research ISSN (Print) ISSN (Onine) This journa is a member of and subscribes to the principes of the Committee on Pubication Ethics (COPE) ( Editoria contact: nihredit@southampton.ac.uk The fu HS&DR archive is freey avaiabe to view onine at Print-on-demand copies can be purchased from the report pages of the NIHR Journas Library website: Criteria for incusion in the Heath Services and Deivery Research journa Reports are pubished in Heath Services and Deivery Research (HS&DR) if (1) they have resuted from work for the HS&DR programme or programmes which preceded the HS&DR programme, and (2) they are of a sufficienty high scientific quaity as assessed by the reviewers and editors. HS&DR programme The Heath Services and Deivery Research (HS&DR) programme, part of the Nationa Institute for Heath Research (NIHR), was estabished to fund a broad range of research. It combines the strengths and contributions of two previous NIHR research programmes: the Heath Services Research (HSR) programme and the Service Deivery and Organisation (SDO) programme, which were merged in January The HS&DR programme aims to produce rigorous and reevant evidence on the quaity, access and organisation of heath services incuding costs and outcomes, as we as research on impementation. The programme wi enhance the strategic focus on research that matters to the NHS and is keen to support ambitious evauative research to improve heath services. For more information about the HS&DR programme pease visit the website: This report The research reported in this issue of the journa was funded by the HS&DR programme or one of its preceding programmes as project number 10/1007/06. The contractua start date was in October The fina report began editoria review in Apri 2014 and was accepted for pubication in January The authors have been whoy responsibe for a data coection, anaysis and interpretation, and for writing up their work. The HS&DR editors and production house have tried to ensure the accuracy of the authors report and woud ike to thank the reviewers for their constructive comments on the fina report document. However, they do not accept iabiity for damages or osses arising from materia pubished in this report. This report presents independent research funded by the Nationa Institute for Heath Research (NIHR). The views and opinions expressed by authors in this pubication are those of the authors and do not necessariy refect those of the NHS, the NIHR, NETSCC, the HS&DR programme or the Department of Heath. If there are verbatim quotations incuded in this pubication the views and opinions expressed by the interviewees are those of the interviewees and do not necessariy refect those of the authors, those of the NHS, the NIHR, NETSCC, the HS&DR programme or the Department of Heath. Queen s Printer and Controer of HMSO This work was produced by Herepath et a. under the terms of a commissioning contract issued by the Secretary of State for Heath. This issue may be freey reproduced for the purposes of private research and study and extracts (or indeed, the fu report) may be incuded in professiona journas provided that suitabe acknowedgement is made and the reproduction is not associated with any form of advertising. Appications for commercia reproduction shoud be addressed to: NIHR Journas Library, Nationa Institute for Heath Research, Evauation, Trias and Studies Coordinating Centre, Apha House, University of Southampton Science Park, Southampton SO16 7NS, UK. Pubished by the NIHR Journas Library ( produced by Prepress Projects Ltd, Perth, Scotand (

6 Heath Services and Deivery Research Editor-in-Chief Professor Ray Fitzpatrick Professor of Pubic Heath and Primary Care, University of Oxford, UK NIHR Journas Library Editor-in-Chief Professor Tom Waey Director, NIHR Evauation, Trias and Studies and Director of the HTA Programme, UK NIHR Journas Library Editors Professor Ken Stein Chair of HTA Editoria Board and Professor of Pubic Heath, University of Exeter Medica Schoo, UK Professor Andree Le May Chair of NIHR Journas Library Editoria Group (EME, HS&DR, PGfAR, PHR journas) Dr Martin Ashton-Key Consutant in Pubic Heath Medicine/Consutant Advisor, NETSCC, UK Professor Matthias Beck Chair in Pubic Sector Management and Subject Leader (Management Group), Queen s University Management Schoo, Queen s University Befast, UK Professor Aieen Carke Professor of Pubic Heath and Heath Services Research, Warwick Medica Schoo, University of Warwick, UK Dr Tessa Criy Director, Crysta Bue Consuting Ltd, UK Dr Peter Davidson Director of NETSCC, HTA, UK Ms Tara Lamont Scientific Advisor, NETSCC, UK Professor Eaine McCo Director, Newcaste Cinica Trias Unit, Institute of Heath and Society, Newcaste University, UK Professor Wiiam McGuire Professor of Chid Heath, Hu York Medica Schoo, University of York, UK Professor Geoffrey Meads Professor of Heath Sciences Research, Facuty of Education, University of Winchester, UK Professor John Norrie Heath Services Research Unit, University of Aberdeen, UK Professor John Powe Consutant Cinica Adviser, Nationa Institute for Heath and Care Exceence (NICE), UK Professor James Raftery Professor of Heath Technoogy Assessment, Wessex Institute, Facuty of Medicine, University of Southampton, UK Dr Rob Riemsma Reviews Manager, Keijnen Systematic Reviews Ltd, UK Professor Heen Roberts Professor of Chid Heath Research, UCL Institute of Chid Heath, UK Professor Heen Snooks Professor of Heath Services Research, Institute of Life Science, Coege of Medicine, Swansea University, UK Professor Jim Thornton Professor of Obstetrics and Gynaecoogy, Facuty of Medicine and Heath Sciences, University of Nottingham, UK Pease visit the website for a ist of members of the NIHR Journas Library Board: Editoria contact: nihredit@southampton.ac.uk NIHR Journas Library

7 DOI: /hsdr03400 HEALTH SERVICES AND DELIVERY RESEARCH 2015 VOL. 3 NO. 40 Abstract A reaist anaysis of hospita patient safety in Waes: appied earning for aternative contexts from a mutisite case study Andrea Herepath, 1,2 Martin Kitchener 2* and Justin Waring 3 1 Sir Roand Smith Centre for Strategic Management, Department of Entrepreneurship, Strategy and Innovation, Lancaster University Management Schoo, Lancaster University, Lancaster, UK 2 Cardiff Business Schoo, Cardiff University, Cardiff, UK 3 Nottingham University Business Schoo, University of Nottingham, Nottingham, UK *Corresponding author Kitchenermj@cardiff.ac.uk Background: Hospita patient safety is a major socia probem. In the UK, poicy responses focus on the introduction of improvement programmes that seek to impement evidence-based cinica practices using the Mode for Improvement, Pan-Do-Study-Act cyce. Empirica evidence that the outcomes of such programmes vary across hospitas demonstrates that the context of their impementation matters. However, the reationships between features of context and the impementation of safety programmes are both undertheorised and poory understood in empirica terms. Objectives: This study is designed to address gaps in conceptua, methodoogica and empirica knowedge about the infuence of context on the oca impementation of patient safety programmes. Design: We used concepts from critica reaism and institutiona anaysis to conduct a quaitative comparative-intensive case study invoving 21 hospitas across a seven Wesh heath boards. We focused on the oca impementation of three foca interventions from the 1000 Lives + patient safety programme: Improving Leadership for Quaity Improvement, Reducing Surgica Compications and Reducing Heath-care Associated Infection. Our main sources of data were 160 semistructured interviews, observation and 1700 heath poicy and organisationa documents. These data were anaysed using the reaist approaches of abstraction, abduction and retroduction. Setting: Wesh Government and NHS Waes. Participants: Interviews were conducted with 160 participants incuding government poicy eads, heath managers and professionas, partner agencies with strategic oversight of patient safety, advocacy groups and academics with expertise in patient safety. Main outcome measures: Identification of the contextua factors pertinent to the oca impementation of the 1000 Lives + patient safety programme in Wesh NHS hospitas. Resuts: An innovative conceptua framework harnessing reaist socia theory and institutiona theory was produced to address chaenges identified within previous appications of reaist inquiry in patient safety research. This invoved the deveopment and use of an expanatory intervention context mechanism agency outcome (I-CMAO) configuration to iustrate the processes behind impementation of a change programme. Our findings, iustrated by mutipe nested I-CMAO configurations, show how oca impementation of patient safety interventions are impacted and modified by particuar aspects of context: specificay, isomorphism, by which an intervention becomes adapted to the environment in which it is impemented; institutiona ogics, the beiefs and vaues underpinning the intervention and its source, and their perceived egitimacy among different groups of heath-care professionas; and the reationa structure and power dynamics of the Queen s Printer and Controer of HMSO This work was produced by Herepath et a. under the terms of a commissioning contract issued by the Secretary of State for Heath. This issue may be freey reproduced for the purposes of private research and study and extracts (or indeed, the fu report) may be incuded in professiona journas provided that suitabe acknowedgement is made and the reproduction is not associated with any form of advertising. Appications for commercia reproduction shoud be addressed to: NIHR Journas Library, Nationa Institute for Heath Research, Evauation, Trias and Studies Coordinating Centre, Apha House, University of Southampton Science Park, Southampton SO16 7NS, UK. v

8 ABSTRACT functiona group, that is, those tasked with impementing the initiative. This dynamic interpay shapes and guides actions eading to the normaisation or the rejection of the patient safety programme. Concusions: Heightened awareness of the infuence of context on the oca impementation of patient safety programmes is required to inform the design of such interventions and to ensure their effective impementation and operationaisation in the day-to-day practice of heath-care teams. Future work is required to eaborate our conceptua mode and findings in simiar settings where different interventions are introduced, and in different settings where simiar innovations are impemented. Funding: The Nationa Institute for Heath Research Heath Services and Deivery Research programme. vi NIHR Journas Library

9 DOI: /hsdr03400 HEALTH SERVICES AND DELIVERY RESEARCH 2015 VOL. 3 NO. 40 Contents List of tabes List of figures Gossary List of abbreviations Pain Engish summary Scientific summary xi xiii xv xxi xxiii xxv Chapter 1 Introduction 1 Overview 1 Patient safety: a major socia probem of our time 1 The extent and burden of the probem 1 Foundations of the probem 2 The patient safety agenda 4 Patient safety improvement programmes Lives + nationa programme in NHS Waes 5 Design, impementation and evauation 7 Hospita patient safety: a reaist anaysis 7 Context matters 7 Aim and objectives 8 Report structure 8 Intended audience 9 Chapter 2 Conceptua framework 11 Overview 11 Foundations of reaist inquiry 11 Reaist inquiry 12 Addressing the chaenges of reaist inquiry 14 Socioogica institutionaism 15 Reaist socia theory 16 Reaist anaysis: an eaborated intervention context mechanism agency outcome mode 16 Intervention: a distinct anaytica category 16 Context: structura conditioning 18 Mechanism: sociocutura interaction 21 Agency and ensuing outcomes: structura and cutura eaboration or reproduction 23 Summary 24 Queen s Printer and Controer of HMSO This work was produced by Herepath et a. under the terms of a commissioning contract issued by the Secretary of State for Heath. This issue may be freey reproduced for the purposes of private research and study and extracts (or indeed, the fu report) may be incuded in professiona journas provided that suitabe acknowedgement is made and the reproduction is not associated with any form of advertising. Appications for commercia reproduction shoud be addressed to: NIHR Journas Library, Nationa Institute for Heath Research, Evauation, Trias and Studies Coordinating Centre, Apha House, University of Southampton Science Park, Southampton SO16 7NS, UK. vii

10 CONTENTS Chapter 3 Research design 25 Overview 25 Research ethics and access permissions in NHS Waes 25 Anonymisation 25 Comparative case study approach 25 Ontoogica and epistemoogica aignment to reaist anaysis 26 Case site seection and samping strategy 26 Data coection, coding and anaysis 27 Patient and pubic invovement 34 Chaenges encountered in the operationaisation of the study 34 Access to patient stories and organisationa cuture survey data 34 Suppementary quantitative data quaity 35 Chapter 4 Institutionaisation of the 1000 Lives + nationa programme in NHS Waes: bureaucratisation, heath-care poicy and patient safety 37 Overview 37 Institutiona ogics framing the bureaucratisation of 1000 Lives + 37 Bureaucratic state ogic 38 Capitaist market ogic repaced by coaboration 42 Professiona ogic 43 Democratic ogic Lives +, heath poicy and patient safety 43 Patient safety governance processes in NHS Waes 46 Externa oversight of heath-care quaity and patient safety 48 Patient safety and competing contextua chaenges Lives + institutionaisation: preiminary understanding of oca impementation 49 Disconfirmation 50 Deinstitutionaisation 50 Preinstitutionaisation 58 Theorisation 58 Diffusion 58 Reinstitutionaisation 58 Summary 59 Chapter 5 Institutionaisation of the 1000 Lives + programme in NHS Waes: normaisation, heath-care practices and patient safety 61 Overview 61 Possibe mechanisms fostering the normaisation of 1000 Lives + 61 Coherence 61 Cognitive participation 61 Coective action 62 Refexive monitoring Lives +, heath-care practice and patient safety 63 Mode for Improvement, Pan-Do-Study-Act approach 65 Board eadership, foowership and change 67 Teamwork, coaboration and emancipation 68 Buiding the ethos of patient safety: pride and shame in heath-care practice Lives + institutionaisation: eaborated understanding of oca impementation 70 Summary 81 viii NIHR Journas Library

11 DOI: /hsdr03400 HEALTH SERVICES AND DELIVERY RESEARCH 2015 VOL. 3 NO. 40 Chapter 6 Improving eadership for quaity improvement 83 Overview 83 Foca intervention, aim and drivers 83 Mortaity reviews, WakRounds and patient stories 85 Reaist anaysis and comparative case study 86 Structura conditioning: structura and cutura emergent properties in the Wesh heath-care fied 87 First-order emergents for board-eve actors centra to the institutionaisation of ILQI 89 Second-order emergents and situationa ogic 92 Sociocutura interaction: agency and strategic negotiation 92 Structura eaboration or reproduction in the Wesh heath-care fied Lives + institutionaisation: ILQI oca impementation of the foca intervention and contribution to the I-CMAO configuration spanning the Wesh heath-care fied 96 Summary 107 Chapter 7 Reducing Surgica Compications 109 Overview 109 Foca intervention, aim and drivers 109 Word Heath Organization Surgica Safety Checkist 109 Reaist anaysis and comparative case study 111 Structura conditioning: structura and cutura emergent properties in the Wesh heath-care fied 112 First-order emergents for key actors centra to the institutionaisation of the Word Heath Organization Surgica Safety Checkist 114 Second-order emergents and situationa ogic 117 Sociocutura interaction: agency and strategic negotiation 117 Structura eaboration or reproduction in the Wesh heath-care fied Lives + institutionaisation: RSC oca impementation of the foca intervention and contribution to the I-CMAO configuration spanning the Wesh heath-care fied 122 Summary 131 Chapter 8 Reducing Heath-care-Associated Infection 133 Overview 133 Foca intervention, aim and drivers 133 Heath-care-associated infection, prevention and contro 133 Reaist anaysis and comparative case study 135 Structura conditioning: structura and cutura emergent properties in the Wesh heath-care fied 136 First-order emergents for key actors centra to the institutionaisation of Reducing Heath-care Associated Infection 139 Second-order emergents and situationa ogic 142 Sociocutura interaction: agency and strategic negotiation 142 Structura eaboration or reproduction in the Wesh heath-care fied Lives + institutionaisation: RHAI oca impementation of the foca intervention and contribution to the I-CMAO configuration spanning the Wesh heath-care fied 146 Summary 155 Queen s Printer and Controer of HMSO This work was produced by Herepath et a. under the terms of a commissioning contract issued by the Secretary of State for Heath. This issue may be freey reproduced for the purposes of private research and study and extracts (or indeed, the fu report) may be incuded in professiona journas provided that suitabe acknowedgement is made and the reproduction is not associated with any form of advertising. Appications for commercia reproduction shoud be addressed to: NIHR Journas Library, Nationa Institute for Heath Research, Evauation, Trias and Studies Coordinating Centre, Apha House, University of Southampton Science Park, Southampton SO16 7NS, UK. ix

12 CONTENTS Chapter 9 Discussion and concusion 157 Overview 157 Which contextua factors matter: how, why and for whom? 157 Contextua organisationa factors pertinent to the heath outcomes of hospita patient safety interventions 158 Mechanisms that interact with contextua organisationa factors to generate the heath outcomes of hospita patient safety interventions 160 Mediation and refexive theorisation 164 Deveopment and hypothesis testing of reationships between contextua organisationa factors, mechanisms and the heath outcomes of hospita patient safety interventions 164 Limitations of the study 165 Possibe appications 166 Contribution of the study to patient safety research 167 Future project outputs 168 Future research 168 Priorities for practice 169 Reaist anaysis 169 Reaist anaysis: refinement of the concepts of context and mechanism 169 Reaist anaysis: refinement of agency and outcome 170 Design of patient safety improvement programmes 170 Oversight of the impementation and operationaisation of patient safety improvement programmes 170 Acknowedgements 171 References 173 Appendix 1 Summary of case study organisations 217 Appendix 2 Semistructured interview questionnaire 219 Appendix 3 Data search strategy 223 Appendix 4 Study invitation etter, information sheet and consent to be interviewed form 227 x NIHR Journas Library

13 DOI: /hsdr03400 HEALTH SERVICES AND DELIVERY RESEARCH 2015 VOL. 3 NO. 40 List of tabes TABLE 1 Patient safety: the foundations of the probem 2 TABLE 2 Poicy anaysis: data sources 28 TABLE 3 Research participants 29 TABLE 4 Data coding: preiminary and suppementary frameworks 30 TABLE 5 Pubic inquiries into patient safety faiures: data sources 34 TABLE 6 Intervention context mechanism agency outcome configuration: infrastructura system Wesh Government 55 TABLE 7 Intervention context mechanism agency outcome configuration: infrastructura system pubic sector partner agencies 56 TABLE 8 Intervention context mechanism agency outcome configuration: institutiona setting NHS Waes and constituent heath boards 56 TABLE 9 Intervention context mechanism agency outcome configuration: interpersona reations hospita mutisite department/hospita site-based ward (functiona team) 57 TABLE 10 Intervention context mechanism agency outcome configuration: interpersona reations 73 TABLE 11 Improving Leadership for Quaity Improvement I-CMAO configuration: infrastructura system Wesh Government 98 TABLE 12 Improving Leadership for Quaity Improvement I-CMAO configuration: institutiona setting NHS Waes and constituent heath boards 99 TABLE 13 Improving Leadership for Quaity Improvement I-CMAO configuration: institutiona setting interpersona reations 100 TABLE 14 Loca impementation of ILQI: Abertawe Bro Morgannwg University Heath Board RAMI 102 TABLE 15 Loca impementation of ILQI: Aneurin Bevan University Heath Board RAMI 103 TABLE 16 Loca impementation of ILQI: Betsi Cadwaadr University Heath Board RAMI 103 TABLE 17 Loca impementation of ILQI: Cardiff and Vae University Heath Board RAMI 104 TABLE 18 Loca impementation of ILQI: Cwm Taf University Heath Board RAMI 104 Queen s Printer and Controer of HMSO This work was produced by Herepath et a. under the terms of a commissioning contract issued by the Secretary of State for Heath. This issue may be freey reproduced for the purposes of private research and study and extracts (or indeed, the fu report) may be incuded in professiona journas provided that suitabe acknowedgement is made and the reproduction is not associated with any form of advertising. Appications for commercia reproduction shoud be addressed to: NIHR Journas Library, Nationa Institute for Heath Research, Evauation, Trias and Studies Coordinating Centre, Apha House, University of Southampton Science Park, Southampton SO16 7NS, UK. xi

14 LIST OF TABLES TABLE 19 Loca impementation of ILQI: Hywe Dda University Heath Board RAMI 105 TABLE 20 Loca impementation of ILQI: Powys (Teaching) Heath Board RAMI 105 TABLE 21 Improving Leadership for Quaity Improvement: reaist anaysis signposting how the empirica data connect to I-CMAO 106 TABLE 22 Reducing Surgica Compications I-CMAO configuration: infrastructura system Wesh Government 124 TABLE 23 Reducing Surgica Compications I-CMAO configuration: institutiona setting NHS Waes and constituent heath boards 125 TABLE 24 Reducing Surgica Compications I-CMAO configuration: institutiona setting interpersona reations 126 TABLE 25 Reducing Surgica Compications: oca impementation never events across NHS Waes heath boards: 1 Apri 2012 to 31 March TABLE 26 Reducing Surgica Compications: oca impementation never events across NHS Waes heath boards, 1 Apri 2013 to 31 March TABLE 27 Reducing Surgica Compications: reaist anaysis signposting how the empirica data connect to I-CMAO 129 TABLE 28 Reducing heath-care-associated infection I-CMAO configuration: infrastructura system Wesh Government 148 TABLE 29 Reducing heath-care-associated infection I-CMAO configuration: institutiona setting NHS Waes and constituent heath boards 149 TABLE 30 Reducing heath-care-associated infection I-CMAO configuration: institutiona setting interpersona reations 150 TABLE 31 Reducing heath-care-associated infection: oca impementation WHAIP. Data are rates of MRSA boodstream infections per 100,000 bed-days 153 TABLE 32 Reducing heath-care-associated infection: oca impementation WHAIP. Data are rates of S. aureus boodstream infections per 100,000 bed-days 153 TABLE 33 Reducing heath-care-associated infection: reaist anaysis signposting how the empirica data connect to I-CMAO 154 xii NIHR Journas Library

15 DOI: /hsdr03400 HEALTH SERVICES AND DELIVERY RESEARCH 2015 VOL. 3 NO. 40 List of figures FIGURE Lives + nationa patient safety programme areas 6 FIGURE 2 Mode for improvement 7 FIGURE 3 Basic I-CMAO schematic 17 FIGURE 4 Transation from a CMO configuration to an I-CMAO configuration 17 FIGURE 5 Contextua strata: structura conditioning, hierarchica and heterarchica metamechanisms 20 FIGURE 6 Mechanism: mediation via refexive theorisation vs. habituation 22 FIGURE 7 Schedue of data methods and sources 27 FIGURE 8 Institutiona ogics in the Wesh heath-care institutiona fied 39 FIGURE 9 Institutiona ogics in the Wesh heath-care institutiona fied: dominant and subordinate ogics in a compementary, co-existent or countervaiing aignment 41 FIGURE 10 Bureaucratisation of 1000 Lives + : hierarchica metamechanism operating across the contextua strata of the infrastructura system and institutiona setting 51 FIGURE 11 Bureaucratisation of 1000 Lives + : hierarchica metamechanism operating across the contextua strata of the interpersona system within NHS Waes heath boards 53 FIGURE 12 Normaisation of 1000 Lives + : heterarchica meta-mechanism operating across contextua strata 71 FIGURE 13 Normaisation of the 1000 Lives + heterarchica metamechanism operating across contextua strata: egitimisation 76 FIGURE 14 Normaisation of the 1000 Lives + heterarchica metamechanism operating across contextua strata: formaisation 78 FIGURE 15 Normaisation of the 1000 Lives + heterarchica metamechanism operating across contextua strata: innovation 80 FIGURE 16 Driver diagram: ILQI 84 FIGURE 17 Improving Leadership for Quaity Improvement: heterarchica metamechanism operating across contextua strata 97 FIGURE 18 Driver diagram: RSC 110 FIGURE 19 The WHOSSC 111 Queen s Printer and Controer of HMSO This work was produced by Herepath et a. under the terms of a commissioning contract issued by the Secretary of State for Heath. This issue may be freey reproduced for the purposes of private research and study and extracts (or indeed, the fu report) may be incuded in professiona journas provided that suitabe acknowedgement is made and the reproduction is not associated with any form of advertising. Appications for commercia reproduction shoud be addressed to: NIHR Journas Library, Nationa Institute for Heath Research, Evauation, Trias and Studies Coordinating Centre, Apha House, University of Southampton Science Park, Southampton SO16 7NS, UK. xiii

16 LIST OF FIGURES FIGURE 20 Reducing Surgica Compications: heterarchica metamechanism operating across contextua strata 123 FIGURE 21 Driver diagram: RHAI 134 FIGURE 22 Reducing heath-care-associated infection: heterarchica metamechanism operating across contextua strata management of antibiotic drugs 147 xiv NIHR Journas Library

17 DOI: /hsdr03400 HEALTH SERVICES AND DELIVERY RESEARCH 2015 VOL. 3 NO. 40 Gossary Abduction Abduction is a hypothesis or inference that expains an observation. It differs from deduction or induction because it infers a prior condition that gives rise to what is observed, rather than making assumptions about what wi be true as a consequence of the observation. Abduction is a ogic of discovery used in reaist research to set out an expanatory account of a mechanism acting in a given context. Abstraction In reaist research, abstraction is a step in the anaytica process that is used to identify and isoate in thought discrete aspects of an object. The point of abstraction is, therefore, to seect one or more aspects, components or attributes and their reationships in order to understand how they impact socia reaity. Actor An individua who performs specific acts (see Agent). Agency The purposive action of individuas (and organisations) that is the foundation of changing practice. Agent; agentic An agent is simiar to an actor, but is one who acts within a socia structure, athough there is debate about the degree to which the structure may or may not affect the action. In agentic transactions, peope are seen as producers as we as products of socia systems. Agentic emergent properties See Emergent properties. The Campbe Coaboration The Campbe Coaboration is an internationa research network that produces systematic reviews of the effects of socia interventions (see Systematic review). Causaity; causa configuration See Mechanism. Cochrane Cochrane is an internationa research network that produces systematic reviews of the effects of heath-care interventions (mainy randomised controed trias) to assist the decision-making of poicy-makers, heath-care professionas and others (see Systematic review). Coercive force In terms of organisationa change, a coercive force is one that imposes a change (e.g. by reguation). Cognitive Cognitive processes are the menta processes of perception, memory, judgement and reasoning. They may be used consciousy or happen unconsciousy. Cognitive processes use existing knowedge and generate new knowedge. Comparative case study A research design that faciitates the ongitudina intensive anaysis and comparison of different cases, typicay an organisation or a discrete function within an organisation. Constraints In Archerian critica reaism, constraints are causa powers that are interna to structura and cutura emergent properties. For anything to exert the power of a constraint it has to obstruct the achievement of a specific enterprise. Context mechanism outcome configuration A configuration, used in reaist inquiry, to expain what aspects of an intervention work, for whom, why and in what circumstances. Queen s Printer and Controer of HMSO This work was produced by Herepath et a. under the terms of a commissioning contract issued by the Secretary of State for Heath. This issue may be freey reproduced for the purposes of private research and study and extracts (or indeed, the fu report) may be incuded in professiona journas provided that suitabe acknowedgement is made and the reproduction is not associated with any form of advertising. Appications for commercia reproduction shoud be addressed to: NIHR Journas Library, Nationa Institute for Heath Research, Evauation, Trias and Studies Coordinating Centre, Apha House, University of Southampton Science Park, Southampton SO16 7NS, UK. xv

18 GLOSSARY Couping decouping With regard to patient safety interventions, couping refers to the deiberate connection to and decouping to the deiberate disconnection from organisationa structures and associated practices that enhance the egitimacy and effectiveness of such interventions. Critica reaism Critica reaism is a compex body of ideas: a movement in phiosophy, the human sciences and simiar practices that describes an interface between the natura and socia word. It is most cosey associated with the work of Roy Bhaskar, Margaret Archer and Andrew Sayer, among others. Cutura emergent properties See Emergent properties. Distributed eadership Distributed eadership is eadership which, rather than being performed soey by one person, is shared between severa peope. It refers to purposive, concertive action, rather than aggregated, individua acts. Important forms of concertive action are coaboration, intuitive understandings that emerge from cose working reationships and a variety of structura reations and institutionaised arrangements. Under distributed eadership some functions may be shared by severa members of a group, some may be aocated to individua members and a particuar function may be performed by different peope at different times. Ear, nose and throat surgery Otoaryngoogists (or otorhinoaryngoogists) are commony referred to as ENT (ear, nose and throat) surgeons and dea with the diagnosis, evauation and management of diseases of the head and neck and, principay, the ears, nose and throat. Emergents; emergent properties Emergents or emergent properties are new features or transformations that differ quaitativey from the eements from which they came and, therefore, cannot be returned to their previous forms (e.g. the NHS, once formed, coud not be returned to the private institutions which predated it). Agentia emergent properties are transformations that come about as a resut of deiberate action at the eve of the individua, group or organisation (e.g. the NHS was created by Aneurin Bevan and the Labour government of the day). Cutura emergent properties are transformations that are infuenced by the cutura situation (the prevaiing cimate shaped by peope s coective beiefs, vaues or ideoogies) in which they occur (e.g. the NHS was infuenced by both egaitarian principes and a beief that free heath care woud profit the nation by improving the heath of the workforce). Structura emergent properties are transformations that are infuenced by the circumstances in which they occur, be they physica or socia (e.g. the structure of the NHS was infuenced by existing heath-care structures and the perceived needs of the post-war popuation). Enabements In Archerian critica reaism enabements are causa powers that are interna to structura and cutura emergent properties. For anything to exert the power of an enabement it has to aid the achievement of a specific enterprise. Epistemoogy The nature and scope of knowedge what we think can be known about the word. Additionay, the study of knowedge, and justified beief, centred on the creation and dissemination of knowedge in particuar areas of inquiry. Escherichia coi Escherichia coi are a group of bacteria that are an important part of the norma intestina fora of humans. Most strains of E. coi are harmess. However, some strains of E. coi can cause iness, typicay diarrhoea or urinary tract, respiratory or bood infections. Extended-spectrum beta-actamase Some strains of E. coi and Kebsiea pneumonia produce an enzyme caed extended-spectrum beta-actamase. This enzyme can break down antibiotics and make them ineffective. Infections caused by extended-spectrum beta-actamase-producing strains of these bacteria are, therefore, difficut to treat. xvi NIHR Journas Library

19 DOI: /hsdr03400 HEALTH SERVICES AND DELIVERY RESEARCH 2015 VOL. 3 NO. 40 First-order emergents (see Emergents) First-order emergents are the resuts of socia interaction. In Archerian critica reaism, first-order emergents manifest as the agent s invountaristic pacement within the broader socia context and roe array; their vested interests; the opportunity costs associated with different courses of action; and their perceived interpretive freedom and scope for strategic directiona guidance. Functiona team The group of peope who carry out the tasks invoved in running a ward or department. Generative mechanism See Mechanism. Heath-care-associated infection Heath-care-associated infection refers to infections that occur as a resut of contact with the heath-care system. Heterarchy A non-hierarchica system of organisation characterised by horizonta positioning of power and authority, with individuas sharing the same status. Hierarchy A system of organisation characterised by vertica ranking reative to status or authority. Higher-order societa ogics See Institutions and Institutiona ogics. Hospita-acquired infection Hospita-acquired infection aso known as nosocomia infection refers to an infection that deveops in a patient 48 hours after admission to a hospita. Infections that occur within the first 48 hours are referred to as community-acquired. Hospita standardised mortaity ratio Hospita standardised mortaity ratio is the ratio of the actua number of acute in-hospita deaths to the expected number of in-hospita deaths. Institutiona ogics Institutiona ogics focus on how broader beief systems shape organisationa interests and individua preferences, define actors expectations about each other s behaviour and organise their enduring reations with each other. In institutiona theory, higher-order societa ogics refer to the centra institutions of contemporary societies for exampe the famiy, the capitaist market, organised reigion, the state and democracy which inform the core organising principes of these different sectors of society. Institutiona ogics aso operate at the eve of professions. Institutiona piars: reguative, normative and cutura-cognitive Institutions are conceptuaised as composed of three piars: the reguative piar, which stresses rue setting, monitoring and sanctioning activities, both forma and informa; the normative piar, which sets out what is considered to be appropriate behaviour given the demands of the situated context; and the cutura-cognitive piar, which emphasises the centraity of common schemas that guide behaviour. Institutiona theory Institutiona theory is one of the dominant perspectives within organisation and management theory. Institutiona work The purposive action of individuas and organisations aimed at creating, maintaining, enhancing and disrupting institutions. Institutions Institutions are the taken-for-granted socia prescriptions that guide the behaviour of actors in different societa, organisationa and professiona contexts. Intervention context mechanism agency outcome configuration A configuration used in reaist anaysis to expain what aspects of an intervention work, for whom, why and in what circumstances. Intransitive dimension (see Ontoogy) The intransitive dimension is synonymous with ontoogy and refers to the objects in the domain of the rea of any human inquiry, theoretica or practica. Queen s Printer and Controer of HMSO This work was produced by Herepath et a. under the terms of a commissioning contract issued by the Secretary of State for Heath. This issue may be freey reproduced for the purposes of private research and study and extracts (or indeed, the fu report) may be incuded in professiona journas provided that suitabe acknowedgement is made and the reproduction is not associated with any form of advertising. Appications for commercia reproduction shoud be addressed to: NIHR Journas Library, Nationa Institute for Heath Research, Evauation, Trias and Studies Coordinating Centre, Apha House, University of Southampton Science Park, Southampton SO16 7NS, UK. xvii

20 GLOSSARY Isomorphic institutionaism Increased simiarity between institutions over time. Kebsiea species Kebsiea species are a group of bacteria that are an important part of the norma intestina fora of man. Usuay, heathy peope do not get Kebsiea infections. However, in heath-care settings, patients who are receiving ong courses of certain antibiotics and those whose care requires invasive medica devices such as ventiators (breathing machines) or intravenous (vein) catheters are at risk of Kebsiea infections. Legitimacy façade In respect to patient safety interventions, a egitimacy façade is the outward appearance of adhering to guideines whie, in reaity, deviation from such guideines is seen in day-to-day practice. Mechanism The power to bring about change: the characteristic way(s) of acting possessed by things by virtue of their intrinsic structures. In reaist enquiry, mechanisms refer to the engines of expanation embodied in an agent s reasoning and their seective attention to the disparate resources offered through a socia programme. Mechanisms are aso part of a causa configuration emergent from a custer of contextua factors and organisationa components. Mediation of structure by agency In Archerian critica reaism, the mediation of structure by agency refers to the conditioning infuence of context on the actions of individuas. Metamechanism A metamechanism is a compex bunde of mechanisms. Metaphysics The branch of phiosophy that deas with the first principes of things, incuding abstract concepts such as being, knowing, identity, time and space. Methodoogy Methodoogy is the systematic, theoretica anaysis of the methods used in research. Meticiin-resistant Staphyococcus aureus Staphyococcus aureus is a type of bacteria commony found on human skin. Most of the time, S. aureus does not cause any harm. Meticiin-resistant S. aureus is a bacterium that is resistant to many antibiotics. In the community most meticiin-resistant S. aureus infections are skin infections. However, in heath-care settings, such as hospitas and nursing homes, meticiin-resistant S. aureus may cause ife-threatening boodstream infections, pneumonia, endocarditis (infection of the heart vaves), osteomyeitis (bone infection) and surgica site infections. Mimetic force In terms of organisationa change, a mimetic force is one which copies a change perceived to be successfu esewhere. Morphogenesis The process of socia transformation. Morphogenetic-morphostatic cyce The morphogenetic-morphostatic cyce is a method of anaysing the compex interpay of structure, cuture and agency across three tempora phases: structura conditioning, sociocutura interaction and structura reproduction or eaboration. Morphostasis The process of socia reproduction. Never events Serious, argey preventabe patient safety incidents that shoud not occur if the avaiabe preventative measures have been impemented. They incude incidents such as wrong site surgery and a retained instrument after operation. Normative force In terms of organisationa change, a normative force is one in which change is aigned with what is perceived to be an existing norm, or standard. xviii NIHR Journas Library

21 DOI: /hsdr03400 HEALTH SERVICES AND DELIVERY RESEARCH 2015 VOL. 3 NO. 40 Nosocomia infection See Hospita-acquired infection. Ontoogy The branch of metaphysics that deas with the nature of being or the way we think the word is. Periphera venous cannua A periphera venous cannua is a very thin tube inserted into a sma periphera vein for therapeutic purposes such as the administration of medications, fuids or bood products. Point prevaence survey A point prevaence survey is a count of the number of patients with a particuar condition or treatment (in this report either a heath-care-associated infection or an antimicrobia agent) at a particuar time (a specified day), as a proportion of the tota number of patients who are hospitaised at that particuar time. A point prevaence survey counts the condition or treatment ony if it is present on the specified day of the survey, and does not count it if it is present at other times during the patient stay in the hospita. Refexive agency In Archerian critica reaism, refexive agency originates within the interna conversation of the individua s domain of menta privacy. Refexive theorisation Refexive theorisation, the fina stage of the mediation of structure by agency, occurs through three stages: discernment, the preiminary review stage of an issue of concern, where refective retrospective and prospective thought informs practica action; deiberation, invoving the ranking of such concerns against others; and dedication, entaiing their prioritisation and aignment to foster a faibe yet corrigibe commitment to a chosen path. Reationa structure Reationa structure refers to socia reations, or the ties that bind socia actors, specificay the pattern of causa interconnections and interdependencies among agents occupying defined roes, and their subsequent actions. Reationa structure is, therefore, the nexus of connections among actors causay affecting their actions and, in turn, causay affected by them. Reproduction In reaist research, reproduction refers to a ack of change, persistence of the status quo ante. Retroduction In reaist research, retroduction is a step in the anaytica process that is used to refine understanding of a distinctive process or mechanism when the basic conditions for its existence have been eaborated. Risk-adjusted mortaity index Risk-adjusted mortaity index is a statistica too by which an estimate is made of probabiity of death for a admitted patients. Taking into account factors such as age, sex, diagnoses, procedure, cinica grouping and admission type, it aows a cacuation of risk of death. From this prediction it cacuates the number in a popuation expected to die. In pubishing such data, comparisons are made between the numbers of patients who actuay die and those predicted. Where the numbers are the same, the risk-adjusted mortaity index wi be reported as 100. Second-order emergents Second-order emergents are the resuts of necessary and interna reations among first-order emergents. In Archerian critica reaism, the second stage of the mediation of structure to agency addresses how an individua or group, confronted by contextua conditioning, exercise their subjective and refexive menta powers to formuate their strategic goas, individuay or coectivey. This array of infuences gives rise to four potentia second-order emergents necessary compementarities, necessary incompatibiities, contingent compementarities and contingent incompatibiities which foster the accompanying situationa ogics of protection, correction/compromise, opportunism and eimination. The situationa ogic utimatey brought to pass through strategic negotiation be that via power-induced compiance, reciproca exchange or the harmonisation of desires represents the mechanism of morphogenesis or morphostasis. Queen s Printer and Controer of HMSO This work was produced by Herepath et a. under the terms of a commissioning contract issued by the Secretary of State for Heath. This issue may be freey reproduced for the purposes of private research and study and extracts (or indeed, the fu report) may be incuded in professiona journas provided that suitabe acknowedgement is made and the reproduction is not associated with any form of advertising. Appications for commercia reproduction shoud be addressed to: NIHR Journas Library, Nationa Institute for Heath Research, Evauation, Trias and Studies Coordinating Centre, Apha House, University of Southampton Science Park, Southampton SO16 7NS, UK. xix

22 GLOSSARY Situated context Situated context refers to one of the many contexts in which groups and individuas ive and work, and which infuence their actions in a particuar environment. Situationa ogic: contingent compementarities A prevaiing situationa ogic of contingent compatibiities entais a situationa ogic of pure opportunism that generates fundamenta change. Situationa ogic: contingent incompatibiities A prevaiing situationa ogic of contingent incompatibiities gives rise to the tensions in the strategic arena and fosters morphogenesis. Here, opposing factions become party to the situationa ogic of eimination, where the greatest gain coincides with inficting maximum injuries on the other side. Situationa ogic: necessary compementarities A prevaiing situationa ogic of necessary compementarities depicts a strategic arena in which transformation threatens the oss of vested interest a round. Necessary compementarities, therefore, generate a situationa ogic of protection that is conducive to morphostasis. Situationa ogic: necessary incompatibiities A prevaiing situationa ogic of necessary incompatibiities depicts a strategic arena that is marked by incompatibiities between institutions, which are nonetheess internay and necessariy reated. Accordingy, a situationa ogic of compromise arises because necessary incompatibiities means that the promotion of vested interests has to be a cautious baancing act a weighing of gains against osses where to accrue bonuses is aso to invite or incur penaties. The fragiity of this structura conditioning, therefore, offers a subte potentia for change. Situationa ogic of protection See Situationa ogic: necessary compementarities. Structura emergent properties See Emergent properties. Systematic review A systematic review is a iterature review that aims to identify, criticay appraise, seect and synthesise pubished research studies that address a particuar research issue. A systematic review typicay incudes a description of the findings of the coection of research studies. The systematic review may aso incude a quantitative pooing of data caed a meta-anaysis. Third-order emergents In Archerian critica reaism, third-order emergents arise from the effects of first- and second-order infuences on the outcomes of the intervention. This concept, therefore, captures structura and ideationa differentiation, together with the regrouping inherent to the power pay of a diverse array of agents. Transitive dimension The transitive dimension is synonymous with epistemoogy and refers to human understanding of the objects in the domain of the rea. Venous thromboemboism Venous thromboemboism is a condition that incudes both deep-vein thrombosis and pumonary emboism. Deep-vein thrombosis is the formation of a bood cot in a deep vein, usuay in the eg or pevic veins. Pumonary emboism is a sudden bockage in a ung artery, usuay caused by a bood cot that traves to the ung from a vein in the eg. xx NIHR Journas Library

23 DOI: /hsdr03400 HEALTH SERVICES AND DELIVERY RESEARCH 2015 VOL. 3 NO. 40 List of abbreviations CAUTI catheter-associated urinary tract infection MRSA meticiin-resistant Staphyococcus aureus CHC CMO HIW HOWIS HSMR I-CMAO Community Heath Counci context mechanism outcome Heathcare Inspectorate Waes Heath of Waes Information Service Hospita Standardised Mortaity Ratio intervention context mechanism agency outcome NISCHR PSOW PVC RAMI RHAI RSC Nationa Institute for Socia Care and Heath Research Pubic Services Ombudsman for Waes periphera venous cannua risk-adjusted mortaity index Reducing Heath-care-Associated Infection Reducing Surgica Compications IHI ILQI Institute for Heathcare Improvement Improving Leadership for Quaity Improvement WHAIP WHO Wesh Heathcare Associated Infection Programme Word Heath Organization IPAC MI-PDSA infection prevention and contro Mode for Improvement, Pan-Do-Study-Act WHOSSC Word Heath Organization Surgica Safety Checkist Queen s Printer and Controer of HMSO This work was produced by Herepath et a. under the terms of a commissioning contract issued by the Secretary of State for Heath. This issue may be freey reproduced for the purposes of private research and study and extracts (or indeed, the fu report) may be incuded in professiona journas provided that suitabe acknowedgement is made and the reproduction is not associated with any form of advertising. Appications for commercia reproduction shoud be addressed to: NIHR Journas Library, Nationa Institute for Heath Research, Evauation, Trias and Studies Coordinating Centre, Apha House, University of Southampton Science Park, Southampton SO16 7NS, UK. xxi

24

25 DOI: /hsdr03400 HEALTH SERVICES AND DELIVERY RESEARCH 2015 VOL. 3 NO. 40 Pain Engish summary The safety of patients in British hospitas is a major socia probem because 1 in 10 is harmed during his or her care. UK poicy responses focus on new improvement programmes to impement mutipe evidence-based interventions, such as checkists of what shoud be done during surgery. Such interventions are tested on a sma scae (e.g. in one operating theatre) before being roed out more widey. Athough it is known that the success of the programmes varies among hospitas, it is not known why. This is the first study to examine how the contextua features of a hospita (e.g. its size) and its environment (e.g. poitica vaues) combine to infuence patient safety programmes. Our study had two main parts. First, we deveoped a new mode for anaysing the impementation of improvement programmes that directs attention to mutipe ayers of context. Second, we used our mode to conduct seven in-depth case studies of the 1000 Lives + patient safety programme across Waes. The main source of our information was 160 interviews, suppemented by our archive of neary 2000 documents, and the observation of practice. Our findings show how, for specified programme interventions (e.g. surgica checkists), hospita and environmenta features combine to derive varied outcomes seen as either more or ess successfu by stakehoders such as pubic, professionas, researchers and poicy-makers. Our mode and findings provide a vauabe basis from which stakehoders can (a) better understand existing improvement programmes and (b) design more effective ones in the future. Queen s Printer and Controer of HMSO This work was produced by Herepath et a. under the terms of a commissioning contract issued by the Secretary of State for Heath. This issue may be freey reproduced for the purposes of private research and study and extracts (or indeed, the fu report) may be incuded in professiona journas provided that suitabe acknowedgement is made and the reproduction is not associated with any form of advertising. Appications for commercia reproduction shoud be addressed to: NIHR Journas Library, Nationa Institute for Heath Research, Evauation, Trias and Studies Coordinating Centre, Apha House, University of Southampton Science Park, Southampton SO16 7NS, UK. xxiii

26

27 DOI: /hsdr03400 HEALTH SERVICES AND DELIVERY RESEARCH 2015 VOL. 3 NO. 40 Scientific summary Background Hospita patient safety is a major socia probem that is centra to goba debates about the quaity, affordabiity and sustainabiity of heath care. It is widey appreciated that patient safety is shaped by government poicy and demands a nuanced baance of heath-care system design and resources to create high-reiabiity organisations. Yet other factors intervene. Organisationa performance management processes and governance systems, together with the beiefs and vaues of heath-care professionas, moud the oca cutures of care. Patient safety, therefore, demands eadership at a eves in the NHS. However, heath-care professiona eadership especiay medica remains paramount, and may function as catayst for, or barrier to, patient safety improvement. In the UK, it is estimated that 1 in 10 hospita patients is harmed during his or her care, and 1 in 300 dies as a resut of adverse events such as hospita-acquired infection. Aong with these human costs, safety incidents are a drain on NHS resources, costing an estimated 3.5B a year in additiona bed-days and negigence caims. This to of avoidabe harm manifests in various forms. Untoward errors, which occur during drug prescribing, suppy and administration, represent a significant and persistent burden. So, too, do those that arise as a consequence of surgery. A more veied cause is incorrect diagnosis, compounded by variation in the deivery of evidence-based medica care. In the UK, poicy responses focus on the introduction of patient safety programmes that seek improvements in service reiabiity through the impementation of evidence-based cinica practices using the Mode for Improvement, Pan-Do-Study-Act cyce. Empirica evidence that the outcomes of such programmes vary across hospitas demonstrates that the context of their impementation matters. However, the reationships between features of context and the outcomes of safety programmes are both undertheorised and poory understood in empirica terms. Objectives This study is the first to empoy insights from institutiona theory within a reaist anaysis framework to study the impementation of patient safety programmes. It is designed to address gaps in methodoogica, conceptua and empirica knowedge about the infuence of context on the oca impementation of patient safety programmes. Our aim is to ascertain which contextua factors matter how, why and for whom in order that processes and outcomes of future patient safety improvement may be improved. The study has five main objectives: 1. to identify and anayse the organisationa factors (e.g. structure, cuture and manageria priorities) pertinent to the heath outcomes of hospita patient safety interventions 2. to identify and anayse the contextua mechanisms, centred on heath-care professionas beief systems, which interact with organisationa factors to generate the heath outcomes of hospita patient safety interventions 3. to deveop and test hypotheses concerning reationships between organisationa factors, mechanisms and the heath outcomes of hospita patient safety interventions 4. to produce a theoreticay grounded and evidence-based mode of which organisationa factors matter, how they matter and why they matter 5. to estabish and disseminate essons for a broad range of stakehoders concerned with patient safety poicy and management. Queen s Printer and Controer of HMSO This work was produced by Herepath et a. under the terms of a commissioning contract issued by the Secretary of State for Heath. This issue may be freey reproduced for the purposes of private research and study and extracts (or indeed, the fu report) may be incuded in professiona journas provided that suitabe acknowedgement is made and the reproduction is not associated with any form of advertising. Appications for commercia reproduction shoud be addressed to: NIHR Journas Library, Nationa Institute for Heath Research, Evauation, Trias and Studies Coordinating Centre, Apha House, University of Southampton Science Park, Southampton SO16 7NS, UK. xxv

28 SCIENTIFIC SUMMARY Methods The research design comprised a critica reaist and institutiona anaysis of a quaitative comparativeintensive case study ocated within the Wesh Government and NHS Waes. Encompassing seven heath boards and 21 hospitas, the study focused on the oca impementation of three foca interventions seected from the 1000 Lives + nationa patient safety programme: (i) Improving Leadership for Quaity Improvement; (ii) Reducing Surgica Compications; and (iii) Reducing Heath-care-Associated Infection. Case site seection criteria centred on a two-stage samping strategy. In phase 1, four cear and readiy operabe criteria corporate parent, compexity, function and geographica coverage were empoyed to define the purposive sampe of case site hospitas within each heath board (see Appendix 1 in main report). Through this approach, three within-case comparators were seected from each heath board: (1) a major hospita, (2) a district genera hospita and (3) a sma community hospita. Primary data coection incuded 160 semistructured interviews, undertaken with Wesh Government poicy eads; executive directors, senior managers and professionas in NHS Waes heath boards; pubic sector partner agencies with strategic oversight of patient safety; advocacy groups; and academics with expertise in patient safety. These data were compemented by overt observation of practice and the coection of reevant organisationa documents and outcome data (e.g. risk-adjusted mortaity index; never events ) within each heath board. Secondary data coection focused on an anaysis of UK and devoved Wesh heath-care poicy spanning the period from 1997 to The UK coaition government s White and Green Papers, together with other key egisative proposas, were accessed from the Department of Heath s website, whie those of the former UK New Labour government were sourced via the Nationa Archives. Reevant Wesh Government documents, together with those from the Nationa Assemby for Waes, were accessed from site-specific poicy archives. In addition, Wesh heath circuars and Ministeria etters spanning the period were accessed via the Heath of Waes Information Service intranet. A repository in excess of 1700 documents was, therefore, estabished and archived in an eectronic database to faciitate the exporation of the context and structura conditioning of the foca Wesh heath-care system. These data were compemented by an anaysis of pubic inquiries into recent faiings in heath-care provision, together with a comprehensive anaysis of patient safety research. Data anaysis centred on interviewees perceptions of their working environments, the power pay inherent to the strategic negotiation of change during the oca impementation of each foca intervention and their experience of the ensuing outcomes. Outcome data were substantiated by reevant organisationa documents within each heath board. The atter stages of anaysis invoved abstraction and retroduction, processes which identify and examine various components of the foca intervention to aid understanding of the ways in which they combined and interacted in each particuar situation. In this way, the mechanisms operating within the various environments were identified through a combination of theory and experimenta observation. Resuts Methodoogica deveopment of reaist anaysis in patient safety As one of the first studies of patient safety to appy reaist phiosophy of socia science across inception, design, fiedwork, anaysis and writing, this study has generated a number of features that may inform the fied of patient safety research. Unike the majority of heath services research studies, this study has taken seriousy, and expicated, reaist ontoogy (theories of being) and epistemoogy (theories of knowedge). These foundations of our research conditioned its design, conduct and reporting. Moreover, our consideration of ontoogica depth heped to shape our conceptuaisation of contextua strata and the identification and expanation of the underying mechanisms that shape structure, agency, socia reations and ensuing practices. xxvi NIHR Journas Library

29 DOI: /hsdr03400 HEALTH SERVICES AND DELIVERY RESEARCH 2015 VOL. 3 NO. 40 In terms of anaysis, this one of the first studies of heath services research to use the reaist methods of abstraction, abduction and retroduction to devise an expanatory structure through a combination of theory and experimenta observation. Whie acknowedging the many chaenges posed by the critica reaist approach, and that the concusions of our anaysis are both provisiona and faibe, this study demonstrates its vaue in heping to reconstruct the basic conditions, structures and mechanisms reating to the foca objects of our research. Conceptua deveopment of intervention context mechanism agency outcome configurations in the reaist anaysis of patient safety interventions We have deveoped an innovative framework that harnesses reaist socia theory and institutiona theory to address chaenges we identify within existing appications of reaist inquiry in patient safety research. Four refinements are advanced to hep expain which contextua factors matter, how they matter and why they matter. First, so that we may understand precisey what is working, for whom, how and in what circumstances, we incude intervention as a separate anaytica category in our reaist anaysis. Second, we forward a view of situated context as stratified, conditioned, reationa and temporay dynamic. This invoves identifying the dominant structura and cutura emergent properties in pay, and separating context from its mediation. Third, we ink both mediation and refexive theorisation to mechanism, thus distinguishing the conceptua eements of mechanism from its ensuing outcomes. Within outcomes we incude the agentia emergent properties, expressed through the unfoding strategic negotiation of change and the mode of institutiona work enacted, which deiver sustainabe outcomes, be they eaborative or reproductive. Finay, in our reaist framework, outcome is not perceived as a simpe, singe aspect of change, such as a defined heath outcome. Rather, we concentrate on structura and ideationa differentiation, reproduction and change. This fine-grained reaist anaysis, therefore, iuminates the fundamenta effects of beiefs and vaues institutiona ogics on the propensity to act, reveaing the contested nature of institutiona change, heath-care practice evoution, and, thus, socia eaboration. The products of our framework are demonstrated through the deveopment of expanatory intervention context mechanism agency outcome (I-CMAO) configurations, where I is a specified component of a patient safety intervention; C is the situated context; M is the mechanism of expanation expressed in peopes refexive theorisation and reasoning; A is agency, the ensuing actions undertaken to broker change; and O is outcome, cassed in this study as a structura and cutura eaboration or reproduction that manifests over time. The foca patient safety interventions examined in this study were framed in reation to bureaucratisation and normaisation, thereby generating mutipe nested I-CMAO configurations. These iustrate that oca impementation is moduated by context, specificay isomorphism, by which an intervention becomes adapted to the environment in which it is impemented; the manifestation of compementary, co-existent or countervaiing institutiona ogics, and their perceived egitimacy among different groups of heath-care professionas; and the reationa structure and power dynamics of the functiona group, that is those tasked with impementing the initiative. This dynamic interpay shapes and guides actions eading to the normaisation or the rejection of the patient safety programme. Empirica contribution of reaist anaysis to patient safety research For each of the three foca interventions of 1000 Lives + programme anaysed, this study offers a nuanced expanation of how oca conditions differentiay combine with mechanisms to derive various quaitativey different outcomes. Refecting socia reaity, these causa configurations are compex and nested. Accordingy, we augment our textua description with an innovative series of expanatory graphics. Queen s Printer and Controer of HMSO This work was produced by Herepath et a. under the terms of a commissioning contract issued by the Secretary of State for Heath. This issue may be freey reproduced for the purposes of private research and study and extracts (or indeed, the fu report) may be incuded in professiona journas provided that suitabe acknowedgement is made and the reproduction is not associated with any form of advertising. Appications for commercia reproduction shoud be addressed to: NIHR Journas Library, Nationa Institute for Heath Research, Evauation, Trias and Studies Coordinating Centre, Apha House, University of Southampton Science Park, Southampton SO16 7NS, UK. xxvii

30 SCIENTIFIC SUMMARY This approach to the presentation of our findings aows us to ceary specify how particuar configurations of factors, across mutipe ayers of context, generate the outcomes of patient safety interventions, as outined beow. At the eve of the ward or department and those that work in it (the functiona team), context is perceived to be distinctivey different from that of the wider organisation. Indeed, it resonates with that of a bounded heath-care manageria or cinica micro-work system. We argue that this finding chaenges the use of the heath-care organisation as a unit of anaysis for patient safety programmes. Across the stratified contextua strata of the Wesh heath-care institutiona fied, each individua whatever their position or professiona status has to negotiate, both personay and as part of a functiona team the infuences of the institutiona ogics evident in their environments. Furthermore, our findings indicate that the precise baance of such ogics impacts patient safety. The paradigmatic ogic of bureaucratic command and contro, which fosters mandated engagement with 1000 Lives + via coercive institutiona isomorphism is dominant at the eve of the infrastructura system. However, professiona ogic is ascendant at sub-board organisationa eves across each heath board. This gives rise to confict between ogics that chaenges the mora and pragmatic egitimacy of the 1000 Lives + programme. Importanty, it is not the centra issue of patient care that promotes such contestation, but the means through which it is imposed. Mandated engagement is perceived in a pejorative ight as a means of management contro that erodes professiona autonomy, a core component of professiona ogic. The oca impementation of the 1000 Lives + programme is widey couped to desired programme goas. However, when key actors institutiona ogics are in opposition, the operationaisation of 1000 Lives + is distorted and disruptive behaviours that hinder the remouding of underying beief systems, thereby diminishing the egitimacy and mora foundation of the 1000 Lives + programme. High-status professiona individuas, typicay board-eve managers and consutant medica or surgica heath-care practitioners, pay a pivota roe in reconfiguring other actors beief systems to support the oca impementation of 1000 Lives +. Our findings, therefore, echo those that recognise the roe of manageria, medica and nurse eadership in patient safety, especiay in faciitating change across different staff teams. However, there was a need to empower and emancipate a wider array of heath-care staff to ead patient safety. These findings provide a vauabe resource for poicy-makers, managers and practitioners, ocay, nationay and internationay. They can aid stakehoders to deveop improvement interventions that are more ikey to work for specified stakehoders in their oca contingent circumstances, thereby eading to the design of more differentiated and context-sensitive patient safety interventions. Concusions Heightened awareness of the infuence of situated context on the oca impementation of patient safety programmes is required to inform the design of such interventions, and to ensure their effective impementation and operationaisation in the day-to-day practice of heath-care teams. Funding Funding for this study was provided by the Heath Services and Deivery Research programme of the Nationa Institute for Heath Research. xxviii NIHR Journas Library

31 DOI: /hsdr03400 HEALTH SERVICES AND DELIVERY RESEARCH 2015 VOL. 3 NO. 40 Chapter 1 Introduction Overview This chapter introduces our study and is presented in three main parts. We begin by discussing the deveopment of patient safety as the fied of research that is concerned with one of the most significant socia probems of our time: avoidabe harm, waste and variation in heath-care. Using the avaiabe iterature, we outine the nature of this probem and present five factors which are thought to represent its foundations: (1) deficits in cutures of care, (2) eadership inadequacies, (3) ineffective team working, (4) probematic governance systems and (5) imited patient and pubic engagement. We then introduce the current agenda for patient safety improvement across the devoved NHS in the UK. Second, we discuss the roe of patient safety improvement programmes. We consider the design, impementation and evauation of these compex socia interventions and highight the current ack of systematic anaysis of reations between contextua (organisationa and environmenta) factors and the outcomes of patient safety interventions. We then introduce the foca case of our study, the 1000 Lives + nationa patient safety programme in Waes, and the three interventions seected for our detaied anaysis: Improving Leadership for Quaity Improvement (ILQI), Reducing Surgica Compications (RSC) and Reducing Heath-care-Associated Infection (RHAI). We concude this chapter by outining the aim and objectives of our study, the structure of this report and the report s intended audience. Patient safety: a major socia probem of our time Since the pubication in 2000 of To Err is Human: Buiding a Safer Heath System, 1 patient safety has become recognised as a major socia probem of our time. It now sits at the centre of goba debates about the quaity, affordabiity and sustainabiity of heath care. 2 6 Since 2000, understandings of the prevention, detection and mitigation of harm have improved. 4,7 13 Cruciay, from an earier concentration on individua factors, it is now recognised that the consistent deivery of high-quaity, safe and effective heath care is compex and mutidimensiona. Considered at higher system eves of anaysis, it has been shown that patient safety is shaped by government poicy and demands a nuanced baance of heath-care system design 22,23 and resources to create high-reiabiity organisations. 24,25 At the organisationa eve of anaysis, it has been demonstrated that patient safety is mouded by cuture, capacity, processes and governance systems, and that each is enhanced by distributed (shared, see Gossary) eadership At the eve of heath-care practice, it is known that patient safety is informed by the beiefs and vaues of heath-care professionas, and is utimatey underpinned by their persona commitment to care. 42,43 The extent and burden of the probem Despite growing awareness of the chaenges posed by patient safety, and concerted improvements efforts within some heath-care systems, 47,48 considerabe hospita patient safety probems persist. Goba estimates of the burden of harm vary. However, they are normay reported to be around 10% of a inpatient admissions with a range of %, 49 though such resuts are infuenced by the means of measurement empoyed In the UK, it is estimated that 1 in 10 NHS hospita patients is harmed during his or her care, and 1 in 300 dies as a resut of adverse events such as acquired infection. 54,55 Aong with these human costs, safety incidents are a drain on NHS resources, costing an estimated 3.5B per year in additiona bed-days and negigence caims. 56 Queen s Printer and Controer of HMSO This work was produced by Herepath et a. under the terms of a commissioning contract issued by the Secretary of State for Heath. This issue may be freey reproduced for the purposes of private research and study and extracts (or indeed, the fu report) may be incuded in professiona journas provided that suitabe acknowedgement is made and the reproduction is not associated with any form of advertising. Appications for commercia reproduction shoud be addressed to: NIHR Journas Library, Nationa Institute for Heath Research, Evauation, Trias and Studies Coordinating Centre, Apha House, University of Southampton Science Park, Southampton SO16 7NS, UK. 1

32 INTRODUCTION Avoidabe harm takes various forms. Errors occurring during drug prescribing, suppy and administration represent a significant and persistent burden So, too, do those that arise as a consequence of surgery. 63,64 A more hidden cause is, quite simpy, incorrect diagnosis In addition, there is variation in the deivery of medica and nursing care. 70,71 Faiure in the safety of care is a particuar issue for high-risk patient groups, 72,73 but a patients may be at risk of harm, for instance, from communication deficits at handover; from ow staffing, 78 especiay at weekends; or because the deivery of care coincides with the infux of a new cohort of junior doctors in training. 79,80 Foundations of the probem Rising concerns about patient safety have ed, in recent years, to a number of pubic enquiries into highy pubicised faiures of the heath-care system, such as patient safety faiings at the Mid Staffordshire NHS Foundation Trust, 81 events at the Bristo Roya Infirmary 82 and the Roya Liverpoo Chidren s Hospita, 83 and the actions of Dr Harod Shipman. 84 The major reports pubished foowing these enquiries have heped to identify reasons for the faiures 85 and have sought ways of improving the safety of patients. 86 Taken as a whoe, the findings of successive UK inquiries have emphasised five issues that can be seen as foundations of the probem of patient safety: (1) deficits in cutures of care, (2) eadership inadequacies, (3) ineffective team working, (4) probematic reguatory oversight and governance systems and (5) imited patient and pubic engagement. We summarise these issues, and the recommendations made to address and eiminate them, in Tabe 1, as a way of introducing what was known (by us), prior to our study, about the context of patient safety. TABLE 1 Patient safety: the foundations of the probem Deficits in cuture(s) of care Recommended improvements We wi make demonstrabe progress towards reducing avoidabe deaths in our hospitas, rather than debating what mortaity statistics can and cannot te us about the quaity of care hospitas are providing No hospita, however big, sma or remote, wi be an isand unto itsef. Professiona, academic and manageria isoation wi be a thing of the past The NHS shoud continuay and forever reduce patient harm by embracing whoeheartedy an ethic of earning. Mastery of quaity and patient safety sciences and practices shoud be part of initia preparation and ifeong education of a heath-care professionas, incuding managers and executives The NHS shoud become a earning organisation. Its eaders shoud create and support the capabiity for earning, and therefore change, at scae, within the NHS. It shoud be committed to: pacing the quaity of patient care, especiay patient safety, above a other aims engaging, empowering, and hearing patients and carers throughout the entire system and at a times fostering whoe-heartedy the growth and deveopment of a staff, incuding their abiity and support to improve the processes in which they work embracing transparency unequivocay and everywhere, in the service of accountabiity, trust and the growth of knowedge Leadership inadequacies Recommended improvements The boards and eadership of provider and commissioning organisations wi be confidenty and competenty using data and other inteigence for the forensic pursuit of quaity improvement. They, aong with patients and the pubic, wi have rapid access to accurate, insightfu and easy-to-use data about quaity at service-ine eve Junior doctors in speciaist training wi not be seen just as the cinica eaders of tomorrow, but as the cinica eaders of today. The NHS wi join the best organisations in the word by harnessing the energy and creativity of its 50,000 young doctors A eaders concerned with NHS heath care poitica, reguatory, governance, executive, cinica and advocacy shoud pace quaity of care in genera, and patient safety in particuar, at the top of their priorities for investment, inquiry, improvement, reguar reporting, encouragement and support 2 NIHR Journas Library

33 DOI: /hsdr03400 HEALTH SERVICES AND DELIVERY RESEARCH 2015 VOL. 3 NO. 40 TABLE 1 Patient safety: the foundations of the probem (continued) Ineffective team working Recommended improvements Nurse staffing eves and ski mix wi appropriatey refect the caseoad and the severity of iness of the patients they are caring for and be transparenty reported by trust boards A NHS organisations wi understand the positive impact that happy and engaged staff have on patient outcomes, incuding mortaity rates, and wi be making this a key part of their quaity improvement strategy Government, Heath Education Engand and NHS Engand shoud assure that sufficient staff are avaiabe to meet the NHS s needs now and in the future. Heath-care organisations shoud ensure that staff are present in appropriate numbers to provide safe care at a times and that they are we supported Probematic reguatory oversight and governance systems Recommended improvements Patients and cinicians wi have confidence in the quaity assessments made by the Care Quaity Commission, not east because they wi have been active participants in inspections Transparency shoud be compete, timey and unequivoca. A non-persona data on quaity and safety, whether assembed by government, organisations or professiona societies, shoud be shared in a timey fashion with a parties who want it, incuding, in accessibe form, with the pubic Supervisory and reguatory systems shoud be simpe and cear. They shoud avoid diffusion of responsibiity. They shoud be respectfu of the goodwi and sound intention of the vast majority of staff. A incentives shoud point in the same direction We support responsive reguation of organisations, with a hierarchy of responses. Recourse to crimina sanctions shoud be extremey rare, and shoud function primariy as a deterrent to wifu or reckess negect or mistreatment Limited patient and pubic engagement Recommended improvements Patients, carers and members of the pubic wi increasingy fee ike they are being treated as vita and equa partners in the design and assessment of their oca NHS. They shoud aso be confident that their feedback is being istened to and see how this is impacting on their own care and the care of others Patients and their carers shoud be present, powerfu and invoved at a eves of heath-care organisations from wards to the boards of trusts A organisations shoud seek out the patient and carer voice as an essentia asset in monitoring the safety and quaity of care Cuture(s) of care Inquiries into the events at the Mid Staffordshire NHS Foundation Trust draw attention to the cuture of care in the NHS. 5,87 89 Unfortunatey, as noted by Professor Jon Gasby, 81 The troube with cuture is everyone bames it when things go wrong but no-one reay knows what it is or how to change it. Thisissueiscompounded when viewing (as we do) heath-care organisations as comprising mutipe cutures/cutura frames, rather than as a singe cuture of care. These points notwithstanding, research indicates that five aspects of cuture are of particuar saience to patient safety: (1) the need for a cuture of compassion in care; 81 (2) the probematic intra- and interprofessiona hierarchies, which priviege a perceived eite at the expense of the broader heath-care team; 41,90 92 (3) the cuture of bame that retards the promotion of adverse incident reporting and discosure of harm to patients; 42,93 95 (4) the cuture of buying that, regrettaby, appears to be widespread across the NHS; and (5) the cuture of unreenting pressure to attain government targets, which creates arangeofunintendedanddysfunctionaconsequences Leadership It is we recognised that patient safety improvement requires sustained investment in deveoping eadership skis at a eves in the NHS and its aigned reguatory organisations. 82 Faiures in strategic eadership may arise across the pubic sector, 112 with such faiures attributed to, for instance, the detrimenta impact of externa pressures, structura change 16 and the chaenges posed by the goba financia downturn. 116 Queen s Printer and Controer of HMSO This work was produced by Herepath et a. under the terms of a commissioning contract issued by the Secretary of State for Heath. This issue may be freey reproduced for the purposes of private research and study and extracts (or indeed, the fu report) may be incuded in professiona journas provided that suitabe acknowedgement is made and the reproduction is not associated with any form of advertising. Appications for commercia reproduction shoud be addressed to: NIHR Journas Library, Nationa Institute for Heath Research, Evauation, Trias and Studies Coordinating Centre, Apha House, University of Southampton Science Park, Southampton SO16 7NS, UK. 3

34 INTRODUCTION Nevertheess, such contextua constraints do not obviate the need for distributed eadership in heath care from board to ward. 30,36,117 The detrimenta impact on patient safety of a weak board and senior management team, marred by professiona disengagement, poor governance and a ack of focus on the standards of care, has been iustrated in the Francis Inquiry. 81 However, at the point of care, professiona eadership, especiay medica, remains paramount and may function as catayst for, or barrier to, patient safety improvement. 28,90, Team work Research shows that, given the compexity and mutidiscipinary nature of modern heath care, effective team working is an important eement in patient safety, 33,126,127 necessitating good communication and co-ordination, 119,128 particuary in high-pressure environments such as the operating theatre. 74,75, It aso requires a degree of consistency in the meanings, beiefs and vaues that frame different heath-care professionas commitment to care. 39 Yet effective team working remains vunerabe to the adverse effects of hierarchy, 134 poor staffing, 81 enmity and confict 30 and the human factors that give rise to team fragiity. 135 Greater understanding of such human factors, specificay with regard to (i) human error, (ii) the roe of heath-care worker performance and (iii) the design of heath-care technoogy, is increasingy recognised as core to patient safety But to be successfu, this, too, necessitates carefu consideration of the oca context and the informa cuture of cinica practice. 139 Reguatory oversight and governance systems Pubic inquiries into faiures in patient safety have consistenty sought to enhance reguatory oversight 81,82 and heighten both professiona and organisationa systems of governance. 83,84,140 It has been argued that these pressures have eroded professiona sef-reguation, 141 repacing this traditiona mode of contro with an increasingy egaised reguatory system. 142 As a consequence, organisationa, professiona and work group boundaries have shifted. 143 This has the potentia to foster defensive activity, 144 which, as evidenced in the Francis Inquiry, 81 may prove detrimenta to the safe provision of heath care. Patient and pubic engagement A fina foundation of the probem of patient safety that emerges from recent inquiries is the weak representation of patients, their famiies and carers at a eves of the heath-care system. Lauded as a more bottom-up approach to service panning and provision, 145 a robust patient-centred focus is increasingy considered a core dimension of heath-care quaity. 146 This invoves providing opportunity for patient, and broader ay, invovement in professiona oversight bodies 84 and heath-care organisations forma governance structures, as we as active patient engagement in decisions about their care and the ensuing evauation of their experience The patient safety agenda In 2013, the Francis Inquiry 81 was accompanied by two major reports into hospita patient safety. The first was a review into the quaity of care and treatment provided by 14 hospita trusts in Engand, ed by Sir Bruce Keogh, Nationa Medica Director for the NHS in Engand. 157 Whie this review acknowedged (as other commentators did ) the difficuties in adopting mortaity measures as an indicator of hospita performance, it aso set out core features of high-quaity care for patients. The second, a report by the Nationa Advisory Group on the Safety of Patients in Engand, ed by Don Berwick, President Emeritus of the Institute for Heathcare Improvement (IHI), 161 aso endorsed these goas. Each addresses the foundations of the socia probem of patient safety that are outined in Tabe 1. The improvement agenda proposed by these two recent reports is exacting. It demands changes in poicies, the education of heath-care professionas and wider NHS workforce and further research into the quaity and safety of heath care. 5 4 NIHR Journas Library

35 DOI: /hsdr03400 HEALTH SERVICES AND DELIVERY RESEARCH 2015 VOL. 3 NO. 40 Patient safety improvement programmes Recent reports and inquiries indicate that the goba debate has progressed from the recognition and acknowedgement of the foundations of the probem of patient safety to the quest for systemic soutions to the chaenges it poses. 88, In Engand, a specia heath authority of the NHS, the Nationa Patient Safety Agency, was estabished in 2001 with the remit of monitoring patient safety. It identified the need to introduce patient safety improvement programmes to hep foster oca capacity and progress from a bame cuture to one that was perceived to be just and capabe of faciitating the open reporting of errors and near-misses. 168 Informed by the work of the US-based IHI, 162 and advances in safety within other industries, 22,169,170 NHS hospita patient safety programmes have typicay sought to achieve improvements by impementing evidence-based cinica practices and enhancing performance monitoring systems Athough the Nationa Patient Safety Agency was dissoved in 2012, these poicy goas continue to be pursued, in Engand, through the NHS Commissioning Board and the Safer Patients initiative sponsored by the Heath Foundation, a charitabe trust, and in Waes through the 1000 Lives campaign and its successor, the 1000 Lives + nationa programme, the focus of this study Lives + nationa programme in NHS Waes Patient safety interventions range from isoated interventions within a discrete heath-care setting, such as the estimation of intraoperative bood oss 174 or the vaidation of specific measures of harm, 175 through to nationa programmes of the type we are investigating in this study. 176 In Apri 2008, the Wesh 1000 Lives + campaign was aunched by a coaborative invoving the Wesh Assemby Government s Cinica Governance Support and Deveopment Unit, the Waes Centre for Heath, the Nationa Leadership and Innovation Agency for Heathcare, the Nationa Pubic Heath Service and the Nationa Patient Safety Agency. It had two distinct goas: (1) to reduce by 1000 the number of deaths caused by suboptima care and (2) to reduce by 50,000 the number of adverse incidents. A heath-care organisations in NHS Waes vounteered to participate in the programme. In 2010, the campaign was superseded by the 1000 Lives + nationa programme. This continued the ethos of high-quaity person-centred care and offered a broader range of patient safety interventions, and aigned resources, for NHS Waes heath boards to impement. This ambitious and compex intervention buit on the momentum of its predecessor and now forms a core component of the Wesh Government s deivery framework for the NHS in Waes. As iustrated in Figure 1, 1000 Lives + comprises a compex array of 11 core programme improvement areas. In this study, our attention is concentrated on three foca interventions: (1) ILQI, (2) RSC and (3) RHAI. The 1000 Lives + programme and its predecessor are adaptations of the IHI s100,000livescampaign. 162,177 Both are informed by the Mode for Improvement (MI), deveoped by Langey et a., 178 depicted in Figure 2.This mode 179,180 first directs attention to three questions: what are we trying to accompish?; how wi we know that a change is an improvement?; and what changes can we make that wi resut in improvement? It then prescribes the impementation of soutions through a Mode for Improvement, Pan-Do-Study-Act (MI-PDSA) cyce. Centred on Deming s systemofprofoundknowedge, 178 the MI-PDSA approach is an acknowedged cornerstone of the science of improvement, 44,181 and is informed by a diverse array of theoretica perspectives. The MI-PDSA cyce has been promoted by the IHI as the means to foster the transformation of patient safety. 172 The strength and success of this promotion is refected in the way that the MI-PDSA approach has been appied across a range of contexts, and to a variety of issues. Many of these themes are of direct reevance to this study, incuding (i) the roe of oca champions in eading change; (ii) the education of heath-care professionas in evidence-based practice change; (iii) the impementation of the Word Heath Organization Surgica Safety Checkist (WHOSSC); 169, (iv) the deveopment and impementation of anti-infective prescribing poicies, incuding those for correct hand hygiene; 195 and (v) the arge-scae transformation of heath-care services through a heightened emphasis on patient safety. 5,196 Queen s Printer and Controer of HMSO This work was produced by Herepath et a. under the terms of a commissioning contract issued by the Secretary of State for Heath. This issue may be freey reproduced for the purposes of private research and study and extracts (or indeed, the fu report) may be incuded in professiona journas provided that suitabe acknowedgement is made and the reproduction is not associated with any form of advertising. Appications for commercia reproduction shoud be addressed to: NIHR Journas Library, Nationa Institute for Heath Research, Evauation, Trias and Studies Coordinating Centre, Apha House, University of Southampton Science Park, Southampton SO16 7NS, UK. 5

36 INTRODUCTION Improving Leadership for Quaity Improvement Reducing mortaity and harm WakRounds Reducing Heath-care-Associated Infections Reducing catheter-associated urinary tract infections Reducing harm from periphera venous cannuae Hand hygiene compiance Compiance with oca antimicrobia use poicy Improving Medicines Management Reduction in INR > 5 and INR > 8 in hospita and community settings Improving Acute Care Reducing harm from acute coronary syndromes Rapid repose to acute iness earning sets (RRAILS) Improving critica care centra ine and ventiator bundes Improving mouth care for adut patients in hospita Improving Surgica Care Enhances recovery after surgery Eective coorecta surgery Eective hip and knee arthropasty Transforming theatres Reducing surgica compications Normothermia Appropriate pre-operative hair remova WHO surgica safety checkist Transforming Care Community setting Acute setting Reducing hospita-acquired pressure ucers (SKIN Bunde) Transforming Maternity Services Reducing mortaity and harm by improving the recognition and response to the acutey deteriorating woman Reducing mortaity and harm from venous thromboemboism in pregnancy and the postnata period Reducing preventabe sti birth in Waes Improving Primary and Community Care Reducing chronic heart faiure Improving care for patients with atria fibriation The primary care trigger too Improving medicines management Improving care for patients with earning disabiities (Learning disabiities annua heath check) Reducing harm in denta care Reducing harm from fas in the community Menta Heath Identifying depression in hospita settings Improving dementia care Prescribing of psychotropics Eating disorder First episode psychosis Improving Stroke Care Life after stroke Improving the reiabiity of acute stroke care Improving eary rehabiitation foowing stroke Improving the reiabiity of transient ischaemic attack services Preventing Hospita-Acquired Thrombosis FIGURE Lives + nationa patient safety programme areas. 6 NIHR Journas Library

37 DOI: /hsdr03400 HEALTH SERVICES AND DELIVERY RESEARCH 2015 VOL. 3 NO. 40 What are we trying to accompish? How wi we know that change is an improvement? What change can we make that wi resut in improvement? Act Study Pan Do FIGURE 2 Mode for improvement. Design, impementation and evauation The 1000 Lives + nationa programme incorporated a range of IHI-inspired patient safety interventions that have been utiised wordwide. 5 These incude (i) the use of checkists; (ii) care bundes (checkists and associated directive guideines) for high-risk drugs 197 and invasive practices; 192,198,199 (iii) muticomponent interventions, such as those advocated for the prevention and management of pressure ucers, fas and hospita-acquired infections; and (iv) various other forms of intervention, incuding staff training, 118, adverse event simuation, 207,208 computer-assisted care management, 62,209 nationa and/or oca aert systems and trigger toos. 28,53,210,211 Hospita patient safety: a reaist anaysis Context matters Despite having a basic improvement approach in common, the differences in scae and scope of the patient safety programmes impact on both the compexity of their impementation and the evauation of their outcomes 5,168, and the reported outcomes of these interventions are marked by considerabe variation. However, athough pubic inquiries and research evidence now concur that patient safety is, in part, a matter of context, 168 there has been very imited systematic and independent anaysis of the reationship between organisationa factors which shape the oca context of heath care and the outcomes of patient safety interventions. 124, Prior to this study, reationships between the recenty advocated four high-priority features of organisationa context: 5,223 (1) externa factors such as reguatory requirements; (2) organisationa structura characteristics; (3) eadership, team work and patient safety cuture; and (4) management priorities and the outcomes of safety programmes were both undertheorised and poory understood in empirica terms. 224 As a resut, the context of patient safety remained amorphous 225 and i defined. 226 In contrast, this study is designed to address the conceptua and empirica knowedge gaps invoving the context of patient safety. Queen s Printer and Controer of HMSO This work was produced by Herepath et a. under the terms of a commissioning contract issued by the Secretary of State for Heath. This issue may be freey reproduced for the purposes of private research and study and extracts (or indeed, the fu report) may be incuded in professiona journas provided that suitabe acknowedgement is made and the reproduction is not associated with any form of advertising. Appications for commercia reproduction shoud be addressed to: NIHR Journas Library, Nationa Institute for Heath Research, Evauation, Trias and Studies Coordinating Centre, Apha House, University of Southampton Science Park, Southampton SO16 7NS, UK. 7

38 INTRODUCTION Aim and objectives This study empoys insights from institutiona theory 227 within a reaist anaysis framework to examine the impact of context on the impementation of the 1000 Lives + nationa programme across the Wesh NHS. We present and expain our conceptua framework in Chapter 2. Our approach arises from an appreciation that the infuence of organisationa features on hospita patient safety programmes cannot be readiy understood from traditiona evauation methods. 236,274 Buiding on findings from previous studies of the design 237 impementation, 21,220,238,239 and outcomes 146,240 of patient safety improvement programmes, we examine the impementation of three foca interventions in a mutisite comparative-intensive case study of hospitas in NHS Waes. We seek to revea the compex interpay of context and concerns, 234,235 captured through the organisationa factors and competing institutiona ogics beief systems which guide acceptance of, or resistance to, the oca adoption and adaptation of patient safety programmes. 3,240 This reaist anaysis of patient safety aims to ascertain which contextua factors matter, and how, why and for whom they matter, in the hope that processes and outcomes of future improvement programmes may be improved. Hence the unit of anaysis in this study is the process of oca impementation of the 1000 Lives + programme, centred on the three foca interventions (rather than an evauation of the 1000 Lives + programme per se). The study has five main objectives: 1. to identify and anayse the organisationa factors (e.g. structure, cuture and manageria priorities) pertinent to the heath outcomes of hospita patient safety interventions 2. to identify and anayse the contextua mechanisms (ogics or beief systems) that interact with organisationa factors to generate the heath outcomes of hospita patient safety interventions 3. to deveop and test hypotheses concerning reationships between organisationa factors, mechanisms and the heath outcomes of hospita patient safety interventions 4. to produce a theoreticay grounded and evidence-based mode of which organisationa factors matter, how they matter and why they matter 5. to estabish and disseminate essons for a broad range of stakehoders concerned with patient safety poicy and management. The achievement of these objectives shoud aow us to suggest how a particuar configuration of organisationa factors may infuence the mechanisms that ead to more or ess successfu heath outcomes of the three foca safety interventions considered. It is hoped that these findings wi inform poicy-makers, managers and practitioners, ocay, nationay and internationay; wi empower stakehoders to deveop improvement interventions that are more ikey to work in their oca contingent circumstances; and may serve as a diagnostic too to be used as a precursor to the design of more differentiated and context-sensitive interventions in future. Report structure The remainder of this report is presented in eight further chapters. Recognising the compexity of the subject matter and the novety of our conceptua framework, we have produced an innovative set of expanatory schematics to accompany each chapter, in addition to our use of standard data tabes and figures. Beow, we outine the structure of this report and the way in which we combine text, expanatory schematics and other forms of data presentation to ensure the carity of our reporting. Chapter 2 presents the conceptua framework deveoped in this study reaist anaysis and defines our eaboration of estabished approaches to reaist inquiry, centred on Archerian critica reaism and augmented by socioogica institutionaism and neo-institutiona theory (see Figures 3 6). Chapter 3 presents the research design comparative case study and mutimethod approach to data coection and anaysis (incuding our aignment to reaist anaysis) (see Figure 7 and Tabes 2 5). 8 NIHR Journas Library

39 DOI: /hsdr03400 HEALTH SERVICES AND DELIVERY RESEARCH 2015 VOL. 3 NO. 40 Chapters 4 and 5 present our anaysis of the impementation and institutionaisation of the 1000 Lives + programme in NHS Waes. Together, they form the foundation for our reaist anaysis of the three foca interventions seected from the programme. Chapter 4 presents our anaysis of the bureaucratisation of 1000 Lives + programme across NHS Waes, defining our preiminary understanding of the oca impementation of the 1000 Lives + programme (see Figures 8 11 and Tabes 6 9). Chapter 5 expores interpersona and individua engagement with 1000 Lives + to offer an account of the normaisation of the programme at the eve of the functiona team within each heath board (see Figures and Tabe 10). Chapters 6 8 present our reaist anaysis of the three foca interventions ILQI, RSC and RHAI and our understanding of the compex and dynamic reationships between organisationa factors, generative mechanisms and the outcomes of hospita patient safety interventions: Chapter 6, Improving Leadership for Quaity Improvement (see Figures 16 and 17, and Tabes 11 21); Chapter 7, Reducing Surgica Compications (see Figures and Tabes 22 27); and Chapter 8, Reducing Heath-care Associated Infection (see Figures 21 and 22, and Tabes 28 33). Chapter 9 presents the discussion and concusion of our study, wherein we debate which contextua factors appear to impact on the impementation of patient safety improvement programmes, promoting or retarding their oca success. In addition, we discuss the generaisabiity of our findings, the imitations of our study and potentia for future work in this important area. Intended audience Throughout this report we have been concerned to ensure that our findings are accessibe to the pubic, professionas, researchers and poicy-makers wishing to (a) better understand existing improvement programmes and (b) design more effective ones in the future. We hope that our innovative use of neat description and summary graphics wi assist in this objective, and the summaries presented in Chapters 1 and 9 are written for this extended audience in particuar. In addition, we hope that much of the detaied narrative in the report wi be of reevance to socia scientists and others with an academic interest in the reaist anaysis of compex organisationa phenomena. Queen s Printer and Controer of HMSO This work was produced by Herepath et a. under the terms of a commissioning contract issued by the Secretary of State for Heath. This issue may be freey reproduced for the purposes of private research and study and extracts (or indeed, the fu report) may be incuded in professiona journas provided that suitabe acknowedgement is made and the reproduction is not associated with any form of advertising. Appications for commercia reproduction shoud be addressed to: NIHR Journas Library, Nationa Institute for Heath Research, Evauation, Trias and Studies Coordinating Centre, Apha House, University of Southampton Science Park, Southampton SO16 7NS, UK. 9

40

41 DOI: /hsdr03400 HEALTH SERVICES AND DELIVERY RESEARCH 2015 VOL. 3 NO. 40 Chapter 2 Conceptua framework Overview This chapter presents the reaist anaysis framework that was deveoped and then used in this study. It is presented in three main parts. We begin by introducing the foundationa reaist phiosophy of socia science together with the approach to reaist inquiry that underpins our framework. We then define the manner through which intervention, context, mechanism and outcome have traditionay been conceptuaised and identify four chaenges that have emerged. The second section of this chapter, guided by Pawson s 241 beief that methods gain their spurs by thoughtfu adaptation rather than mindess repication, introduces the conceptua resources from socioogica institutionaism and Archerian critica reaism that we have empoyed to address the chaenges of appying reaist inquiry. In the fina section, we draw from those resources and set out our innovative approach to the interpay of intervention, context and mechanisms in reaist anaysis. Briefy, our eaborations to reaist inquiry are as foows. First, we incude intervention as a separate anaytica category in our reaist anaysis so that we may understand precisey what is working, for whom, how and in what circumstances. Second, we forward a view of situated context as being stratified, conditioned, reationa and temporay dynamic. Next, we distinguish the conceptua eements of mechanism from its ensuing outcomes and demonstrate the fundamenta roe of beiefs and vaues, institutiona ogics, on the propensity to act. Finay, in our reaist anaysis framework, outcome is not perceived as a simpe, singe aspect of change, such as a defined heath outcome. Rather, we consider patterns of structura, poitica and ideationa eaboration and maintenance. Foundations of reaist inquiry Reaist inquiry has emerged at the forefront of theory-informed poicy evauation methodoogy in heath services and in other areas of socia scientific enquiry. 228, Orthodox strategies for marshaing evidence in heath-care research, epitomised by the Campbe and Cochrane Coaborations systematic reviews, seek to produce answers to the question what works?. In contrast, reaist inquiry seeks to better bridge the gap between research, poicy and practice by addressing the question what works for whom, why and in what circumstances?. 242,247 Within reaist schoarship, two main approaches have gained prominence. Reaist evauation is the mode of inquiry for primary research, in which new data are coected from origina sources. Its companion, reaist review or synthesis, is the secondary research equivaent and invoves anaysis and interpretation of existing data. Both reaist modes pace emphasis on expanation of the interpay of contextua circumstances and mechanisms that foster the success or faiure of an intervention. The principa aim is to refine understanding of how and why the intervention operates through the deveopment of a more nuanced expication of what is termed programme theory, that is, the impicit or expicit hypotheses about anticipated outcomes on which a series of interventions (such as 1000 Lives + ) are based. 247 Reaist inquiry is rooted in the reaist tradition in the phiosophy of science. At base, reaism steers a path between empiricist/positivist and constructivist accounts of scientific expanation 243 and is regarded as the principa post-positivistic perspective. 242 Queen s Printer and Controer of HMSO This work was produced by Herepath et a. under the terms of a commissioning contract issued by the Secretary of State for Heath. This issue may be freey reproduced for the purposes of private research and study and extracts (or indeed, the fu report) may be incuded in professiona journas provided that suitabe acknowedgement is made and the reproduction is not associated with any form of advertising. Appications for commercia reproduction shoud be addressed to: NIHR Journas Library, Nationa Institute for Heath Research, Evauation, Trias and Studies Coordinating Centre, Apha House, University of Southampton Science Park, Southampton SO16 7NS, UK. 11

42 CONCEPTUAL FRAMEWORK The schoarship of Pawson and other reaists is underpinned by a generative theory of causation. Hence the aim of reaist research, such as ours, is not to identify variabes that associate with one another as advocated by positivism. Instead, the research goa is to surface and expain how the association itsef came about. 248 In this mode of inquiry, anaysis is directed towards the identification and expanation of the underying generative mechanisms which shape structure, agency, socia reations and ensuing practices that are reproduced and/or transformed. 249,250 The reaist approach to reviewing the evidence from compex interventions such as patient safety improvement programmes, therefore, assumes that deterministic theories cannot aways expain or predict outcomes in every context. 251 The aim of reaist inquiry is to further inform our understanding of the nuanced interpay between context, mechanism and outcome for particuar interventions Its hamark is, therefore, a quest to progress from a presumptive definition through to an evidence-informed refinement of a causa expanation. 247,255,256 Cruciay, the concusions of reaist studies are recognised to be both provisiona and faibe. 257 Reaist inquiry In reaist inquiry, testabe propositions of how an intervention is perceived to work are depicted through context mechanism outcome configurations (hereafter, CMO configurations). 228 In essence, a CMO configuration is a hypothesis that the programme outcome (O) emerges because of the action of some underying mechanisms (M), which come into operation ony in particuar contexts (C). 256 Each CMO configuration, therefore, expicates and progressivey refines the scope of the origina programme theory In this manner, a virtuous circe is competed, fostering deeper understanding of the opportunities and chaenges presented by an intervention, to inform future poicy and practice. Reaist inquiry has gained increasing acceptance in heath-care research, in part owing to its suitabiity for examining the impementation of compex interventions in heterogeneous, mutiprofessiona socia systems However, a number of chaenges have emerged concerning the operationaisation of each component of the CMO configuration. These chaenges are discussed in the foowing four sections. Intervention Foowing Pawson, we recognise that whie interventions designed to foster individua, organisationa or system change (e.g. patient safety improvement programmes) are compex and diverse, 260,267,268 they often depict consistent features. However, each intervention is dependent on coaborative human agency (motivated action) to achieve their effects. Consequenty, the impementation chain of an intervention wi be shaped by inconsistencies, as individuas and coectives, each differenty enabed or constrained by the socia system, engage with, adopt and adapt or utimatey reject the resources and reasoning provided by the programme. 251 The operationaisation of an intervention is, therefore, contextuay dependent, infuenced by the socia system into which it is introduced and apt to mutate in situ. 251,269 There have been a number of reaist approaches to anaysing interventions in heath-care organisations. For instance, an eary appication of reaist inquiry into intervention in heath care was research undertaken by Greenhagh et a. into a major reorganisation of four inner-london heath-care organisations 176,261,270 They present an incusive anaysis of the interwoven components of an intervention, together with a postuated theory for each facet. 176,261,270,271 Simiary hoistic approaches are iustrated in Byng et a. s evauation of a compex heath services intervention targeted towards peope with ong-term menta iness, 264,272 Manzano-Santaea s reaist evauation of financia incentives in Engish hospita discharge poicy, 273 and other causa expanations of interventions targeted at various stakehoder groups, incuding (i) patients; (ii) specific groups of heath-care and aigned workers, and (iii) the standardisation of evidence-based practice through protoco-based care Aongside reaist approaches that have been appied to consider whoe interventions, more seective anayses of the discrete components of an intervention are depicted in studies such as Leone s evauation of an iicit drug deterrence programme. 288 This sanctions-based intervention is considered ony with regard to the effects of its mandatory interview component. Simiar approaches are demonstrated in other reaist 12 NIHR Journas Library

43 DOI: /hsdr03400 HEALTH SERVICES AND DELIVERY RESEARCH 2015 VOL. 3 NO. 40 studies of heath-care settings, such as (i) Baise and Keges evauation of the deveopment of the quaity management movement in heath-care systems in Europe and Africa; 263 (ii) Ogrinc and Bataden s evauation of teaching about improvement of care in a cinica setting; 289 and (iii) Pittam et a. s evauation of empoyment advice provided to hep peope with menta heath probems gain work. 290 Thus, it may be argued that previous appications of reaist inquiry in heath care have appied the concept of intervention inconsistenty. Moreover, in our view, intervention is reguary underspecified and is too often confated with context. As wi be described ater (see Intervention: a distinct anaytica category), in this study we have tried to address these probems by treating intervention as a separate anaytica category. Context In reaist inquiry, four concentric ayers of context are typicay defined: (1) the broader infrastructura system, the outermost ayer; (2) the institutiona setting, encompassing the cutura aspects of a given contextua domain; (3) the interpersona reationships which constitute the reationa structure within which actors are embedded; and (4) the individua capacities of the key actors. 242 However, with rare exceptions (e.g. the work of Greenhagh et a. 270 and of Byng et a. 264 ), reaist studies in heath care have, typicay, been imited to a domain-specific notion of context. For exampe, focus may be directed towards the broader infrastructura system and associated aspects of the institutiona setting as iustrated in Evans and Kioran s reaist evauation of tacking heath inequaities through partnership working 291 or Pommier et a. s anaysis of heath promotion activities within the French education system. 292 Aternativey, reaist inquiries have focused on discrete organisationa sites 293 as in Oroviogoicoechea et a. s evauation of the impact of a computerised hospita information system on nurses cinica practice, 294,295 Pittam et a. s evauation of empoyment advice for those with menta heath issues, 290,296 and Toson et a. s study of managed cinica networks in the care of individuas with cancer-reated pain. 297 More recenty, other aspects of context have been considered within reaist studies in heath care. These typicay encompass the notion of organisationa cuture and infuences emerging from wider interorganisationa aignment. 3, Key contextua features incude eadership,bothbycorporatemanagementandbycinica heath-care professionas, 81,181,301 and governance systems, incuding performance monitoring, evauation and feedback, which is increasingy patient informed. 28,146,302 Overa, as noted by Shekee et a, 223 many previous appications of reaist inquiry have faied to agree on what eements of context are most infuentia and how context shoud be conceptuaised. 27,303,304 We have tried to avoid this probem by using a mutieve approach to this issue (see Context: structura conditioning). Mechanism As originay described by Pawson, the mechanisms of a programme describe what it is about programmes and interventions that bring about any effects and are the processes by which subjects interpret and act on the intervention stratagem. 228,241,242 Thus, it is not programmes that work per se. Rather, it is the underying reasons or resources that they offer subjects that generate change. 305 In this view, mechanisms expain causa reations by describing the powers, propensity or particuar ways of acting inherent to a system and are inked to, but not synonymous with, the underying programme theory. 306,307 Further insight into the nature of mechanisms is contributed by the work of Hedström and Yikoski, 308 who contend that a mechanism is a causa process that produces an effect or phenomenon. In addition, they posit that a mechanism has structure and operates in hierarchica sequence. This conceptuaisation paraes that of Feetwood, 306 who sees mechanisms as consisting of a custer of causa factors or components comprising socia structures, practices, reations, rues and resources, with each custer possessing the powers, capacities and potentias to do certain things. It is aso important to appreciate that mechanisms produce contextuay moduated effects according to their spatiotempora reations with other objects, and have their own causa powers and iabiities, which may trigger, bock or modify their action. 309,310 Queen s Printer and Controer of HMSO This work was produced by Herepath et a. under the terms of a commissioning contract issued by the Secretary of State for Heath. This issue may be freey reproduced for the purposes of private research and study and extracts (or indeed, the fu report) may be incuded in professiona journas provided that suitabe acknowedgement is made and the reproduction is not associated with any form of advertising. Appications for commercia reproduction shoud be addressed to: NIHR Journas Library, Nationa Institute for Heath Research, Evauation, Trias and Studies Coordinating Centre, Apha House, University of Southampton Science Park, Southampton SO16 7NS, UK. 13

44 CONCEPTUAL FRAMEWORK In reaist inquiries, mechanisms are typicay presented as part of a CMO configuration. 311,312 Indeed, some studies extend this expanatory anaysis to expose the specific roes of different components of the intervention. This is exempified in Mazzocato et a. s study, 313 where candidate mechanisms, attributed to the operationaisation of service improvement methods, are used to define mutipe CMO configurations. However, in studies where CMO configurations are not deveoped, merey disconnected mechanisms or outcomes, as opposed to a causa expanation, may be reported, as in Harris et a. s 314 reaist review of journa cubs and Gunawardena s 315 review of the effectiveness of geriatric day hospitas. It is acknowedged in reaist inquiry that one CMO configuration may be embedded in another or configured in a series (in which the outcome of one CMO becomes the context for the next in the chain of impementation steps). 307 This aspect of reaist inquiry remains underdeveoped, as it demands a highy compex formuation of CMO configurations In addition, athough it is acknowedged that mechanisms encompass the reasoning of its participants, this aspect of reaist inquiry is aso itte expored, 256 with few studies reporting participants thoughts about why they chose to change, or indeed adhere to, their estabished practice (for two exceptions, see Dieeman et a. 319 and Jackson et a. 320 ). The reative negect of this aspect of mechanism may not be surprising as, as noted in Vassiev et a. s reaist review of the roe of socia networks in the management of chronic iness, 321 unpacking and conceptuaising reasoning is fraught with difficuty as justifications for choices can operate within different, and often contradictory, stances. Outcome In reaist inquiry, an outcome cannot be perceived as a simpe, singe aspect of change. The mutifaceted nature of an intervention, particuary when impemented within different organisations, each shaped by their own contextua constraints and enabements, eads to different patterns of socia transformation. 243,269 Many appications of reaist inquiry in heath care attempt to present the heath outcomes of interventions. However, as noted by Foyd et a., 322 the specification and measurement of outcomes poses chaenges. For exampe, heath outcomes may be obscured, merged with context and mechanism and depicted as factors, 323 or simpy framed in terms of the intervention s effectiveness. 324 Outcomes supported by CMO configurations, and thus setting out a cear expanatory argument, such as Tiey s 325 reaist evauation of a British crime reduction programme, do something to tacke this probem. However, few studies expicity address more subte and aigned outcomes arising from the intervention. To summarise, the above section has suggested that, despite the contributions made by reaist inquiries in heath care, four issues have consistenty chaenged researchers who have sought to appy existing modes: (1) the tendency to confate intervention with context; (2) the imited conceptuaisation of context and mechanism, thereby inhibiting rigorous anaysis of their boundaries; (3) the preoccupation with heath outcomes, as opposed to wider organisationa and systemic gains or osses; and (4) the imited capacity to frame the dynamic, tempora, interpay of intervention, context, mechanisms and outcomes. We now move on to expain how we sought to address these issues through an eaborated mode of reaist anaysis. Addressing the chaenges of reaist inquiry In our reaist anaysis framework, we empoy resources from socioogica institutionaism and Archerian critica reaism to hep better specify context and mechanism and hence to address the chaenges outined above. In the next two sections we introduce the key concepts that inform the revised CMO mode we present in Reaist anaysis: an eaborated intervention context mechanism agency outcome mode. 14 NIHR Journas Library

45 DOI: /hsdr03400 HEALTH SERVICES AND DELIVERY RESEARCH 2015 VOL. 3 NO. 40 Socioogica institutionaism Within organisation studies, there has been a growing disenchantment with anaytica perspectives that emphasise the infuence of manageria rationaity within organisationa ife. 326 Rejecting the tenets of strategic management and cassica economic theory, socioogica institutionaists examine the significance of institutions, the reguative, normative and cognitive [see Gossary] structures that provide stabiity and meaning to socia behaviour. 327 Some of the main contributions to understanding institutiona change and inertia in heath care have emerged from anayses conducted at the eve of organisationa fieds, defined as communities of organisations that partake of a common meaning system and whose participants interact more frequenty and fatefuy with one another than with actors outside of the fied. 328 In a semina exampe, DiMaggio and Powe 329 suggest that within organisationa fieds, three forces mimetic (copying those perceived to be successfu), coercive (e.g. reguation) and normative (e.g. stemming from professiona norms) combine to produce powerfu tempates of what constitutes egitimate organisationa structure and action, and we use these terms in our anayses of the data from our study. In common with critica reaism, socioogica institutionaism depicts a word of virtua depth, 330 stratified and organised through different eves of institutiona structures, aong with their ogics, or commony hed sets of beiefs and vaues. There are higher, or macro-eve, structures; these incude societa systems such as the bureaucratic state, capitaist markets, democracy and reigion. Then come meso-eve structures characterised as organisation sectors or fieds; these are composed of those organisations that are invoved in a particuar issue or poicy community. The concept incorporates fied-eve structures, participating organisations and the peope working within and between these organisations. For instance, the fied of heath-care organisations comprises distinctive actors, diverse institutiona ogics and distinct governance structures. Finay, there is the micro-eve of the individua organisation, together with further intraorganisationa eves or groups. Typicay, the mutipicity of ogics in a given domain is represented as some combinations of (i) higherorder societa ogics, 331 (ii) fied-eve ogics 332 and (iii) institutiona or cutura ogics. 333 At the societa eve, heterogeneous higher-order ogics scupt the socia word, conveying the core organising principes of different sectors. 331 Institutiona ogics orchestrate ower-eve institutiona strata and ensuing practices. They shape organisationa interests, individua preferences, define actors expectations about each other s behaviour and organise their enduring reations with each other. 330,334 Previous studies of UK heath-care fieds have concentrated on the roe of, and dynamics among, three ogics: professionaism, bureaucracy and market. Professiona ogic was dominant for much of the twentieth century and gave workers with speciaised knowedge (e.g. doctors) cutura and materia privieges, incuding the power to organise and contro their own work and that of others. 335,336 The primary justification for these arrangements was that service deivery is optimised when it is under the contro of experts acting with the atruism they are assumed to deveop during proonged training and sociaisation. During the atter part of the twentieth century, successive governments promoted combinations of two aternative ogics in heath care: (1) bureaucratic ogic, which hods that service deivery is improved under the administrative contro of work using techniques of performance management, and (2) market ogic, which hods that improved service deivery arises from conditions of competition among providers and choice among cients. In our framework, mutipe ayers of ogics constitute and provide the inherent structure to context. However, organisationa actors (or agents) may go aong with or activey resist these socia prescriptions, 337 thus inhibiting or supporting change. The process of institutiona change is, therefore, both enabed and constrained by (i) the array of institutions, which compose and condition the substructure of the heath-care fied, and (ii) agentia theorisation, refexivity and ensuing modes of institutiona work Accordingy, even though institutions provide meaning to socia ife, such conditioning is non-deterministic. 229,341 Queen s Printer and Controer of HMSO This work was produced by Herepath et a. under the terms of a commissioning contract issued by the Secretary of State for Heath. This issue may be freey reproduced for the purposes of private research and study and extracts (or indeed, the fu report) may be incuded in professiona journas provided that suitabe acknowedgement is made and the reproduction is not associated with any form of advertising. Appications for commercia reproduction shoud be addressed to: NIHR Journas Library, Nationa Institute for Heath Research, Evauation, Trias and Studies Coordinating Centre, Apha House, University of Southampton Science Park, Southampton SO16 7NS, UK. 15

46 CONCEPTUAL FRAMEWORK Reaist socia theory To further eaborate reaist inquiry, we turn to Margaret Archer s semina work on critica reaism As in Herepath s study, 342 our approach empoys Archer s conceptua approach to structure, 229 cuture 230 and agency, 231 together with her ater work on refexivity Our reasons for incorporating Archer s reaist socia theory are threefod. First, Archer s ontoogica stance hods structure (context) and agency (mechanism) as separate entities. Consequenty, Archer offers hep to researchers who strugge over this distinction when anaysing the compex interpay of context and mechanism during the deveopment of CMO configurations. Second, an Archerian approach resonates with socioogica institutionaism. 343,344 Hence by harnessing institutiona theory within an Archerian approach, institutions are given their due recognition and tempora roe as both symboic constructions and a set of materia practices which guide actors behaviours. 345 This heps to revea the mutipe ogics which shape adherence to, or disregard for, the components of an improvement programme and its underying ethos. Third, an Archerian approach offers a robust methodoogica framework composed of three phases, 229 which parae the context, mechanism and outcome components of a CMO configuration. Therefore, methodoogicay, the researcher is guided by an aigned approach that heps to distinguish the boundaries between context and mechanism and to revea possibe causa inks between them. Reaist anaysis: an eaborated intervention context mechanism agency outcome mode This section expains how our mode of reaist anaysis draws from the resources outined above to address the chaenges of reaist inquiry. Intervention: a distinct anaytica category Our first eaboration to reaist inquiry is to incude intervention as a separate anaytica category in our reaist anaysis mode. This stems from our recognition that athough reaist studies have adopted simiar Pawsonian conceptions of intervention, the absence of intervention as an anaytica component has encouraged its underspecification and confation within context. 286 We therefore consider that there is an imperative within reaist inquiry to (i) expicity define the intervention I and (ii) add this to Pawson s origina CMO formua to produce intervention context mechanism agency outcome (I-CMAO) configurations. This aows us to understand precisey what is working in a situated context, for whom, how and in what broader circumstances. This refinement is depicted in Figures 3 and 4, and this method of representation forms the basis of a the transationa schematics for the reaist anaysis presented in Chapters NIHR Journas Library

47 DOI: /hsdr03400 HEALTH SERVICES AND DELIVERY RESEARCH 2015 VOL. 3 NO. 40 Context Outcome n 1 Outcome n 2 Intervention Mechanism Agency Outcome n 3 Outcome n Outcome n 5 FIGURE 3 Basic I-CMAO schematic. Figure 3: key point summary In Figure 3 we depict a schematic representation of an I-CMAO configuration. Point 1 highights the introduction of an intervention into a given context. Point 2 highights the activation of a mechanism. Point 3 highights the ensuing agency that gives rise to outcomes. Reaist inquiry (CMO) Time Context Mechanism Outcome Reaist anaysis (I-CMAO) Time Intervention Foca intervention expicit components and associated resources offered by 1000 Lives + Context Contextua structura conditioning (see Figure 5) Mechanism: mediation via refexive theorisation First- and second-order emergents, situationa ogic (see Figure 6) Agency and institutiona work Emergents actions Outcome: socia eaboration/ reproduction Ensuing change or resistance to change which manifests over time FIGURE 4 Transation from a CMO configuration to an I-CMAO configuration. Queen s Printer and Controer of HMSO This work was produced by Herepath et a. under the terms of a commissioning contract issued by the Secretary of State for Heath. This issue may be freey reproduced for the purposes of private research and study and extracts (or indeed, the fu report) may be incuded in professiona journas provided that suitabe acknowedgement is made and the reproduction is not associated with any form of advertising. Appications for commercia reproduction shoud be addressed to: NIHR Journas Library, Nationa Institute for Heath Research, Evauation, Trias and Studies Coordinating Centre, Apha House, University of Southampton Science Park, Southampton SO16 7NS, UK. 17

48 CONCEPTUAL FRAMEWORK Figure 4: key point summary In the upper graphic of Figure 4 we depict a schematic representation of a CMO configuration. As asserted in Reaist inquiry, a CMO configuration is a hypothesis that the programme outcome (O) emerges because of the action of some underying mechanisms (M), which ony come into operation in particuar contexts (C). Point 1 highights the absence of intervention as a separate aspect of the anaysis. Point 2 highights the difficuty that may arise in distinguishing context from mechanism in reaist inquiry due, in part, to the ack of carity and consistency with which context is conceptuaised and operated. Point 3 draws attention to outcome in reaist inquiry. An outcome cannot be perceived as a simpe, singe aspect of change; however, few studies expicity address more subte and aigned outcomes, which arise consequentia to the intervention, impacting socia eaboration or reproduction. To address these issues, in the ower graphic of Figure 4, we depict a schematic representation of our I-CMAO configuration and set out our four eaborations. First, as indicated by point 4, we incude intervention as a separate anaytica category embedded with the context under consideration. Second, at point 5 we forward a view of context as stratified, conditioned, reationa and temporay dynamic, as expanded in Figure 5. In doing so, we seek to define the situated context, through the dominant structura and cutura emergent properties in pay, their attendant mechanisms and, thus, the impact on ower contextua strata. Third, at point 6 we apportion mediation and refexive theorisation to mechanism. In this manner, we distinguish the conceptua eements of mechanism from its ensuing outcome (this is expanded in Figure 6). Point 7 highights our goa of examining the ensuing process of institutiona change, as opposed to that which utimatey manifests as an outcome, thereby recognising that such change unfods through time, may be contested and may be at different stages of maturation in different situationa contexts. Finay, as depicted in point 8, outcome is not perceived as a simpe, singe aspect of change. Rather, we seek to revea structura and ideationa differentiation. Context: structura conditioning As noted earier, both reaist inquiry and socioogica institutionaism not ony stress the importance of context 228 but aso warn that to enabe meaningfu expanatory anaysis, context cannot be reduced to the spatia, geographica or institutiona ocation into which a socia programme is introduced and that a more nuanced understanding of the mutipe ayers that compose a given context must be estabished. 236,244,257 Guided by the approach to reaist inquiry adopted by Pawson, 228 we address the need to deveop a more subte anaysis of context by specifying four main eves of contextua hierarchy (infrastructura system, institutiona setting, interpersona reations and individua) with a but the individua eve divided into substrata (see Figure 5). 18 NIHR Journas Library

49 DOI: /hsdr03400 HEALTH SERVICES AND DELIVERY RESEARCH 2015 VOL. 3 NO. 40 At the highest hierarchica eve, we see the infrastructura system of the Wesh heath-care state as comprising three strata: (1) the higher-order societa ogics which moud this contextua arena; (2) the Wesh Government, as a devoved substate nation, and (3) the pubic sector partner agencies with reguatory oversight of heath-care quaity and patient safety, which operate in cose iaison with, but distinct from, the Wesh Government and NHS Waes. The second highest hierarchica eve of context, the institutiona setting, is conceptuaised through two strata: (4) NHS Waes, as a corporate whoe, and (5) its seven constituent heath boards as distinct mutisite organisations. The third eve, interpersona reationships, which constitute the reationa structure within which actors are embedded, is captured across two further strata: (6) a hospita site-based ward or mutisite department and (7) the functiona team (the group of peope who carry out the tasks invoved in running a ward or department). Our fina stratum (8) describes the capacities of the individua actors. However, a stratified mode of context provides ony the basic architecture of our argument, as it acks the means to consider context as situated, meaning dynamic, conditioned, reationa and temporay fuid. In essence, we see the dynamism of context as contoured by emergent structura, cutura and agentia powers across time. Our recourse to Archerian critica reaism, together with the work of Herepath, 342 therefore offers a more compex yet nuanced means to deveop I-CMAO configurations. An underying premise of reaist theory and research is that context affects or mediates ensuing agentia actions 346 and hence the structura constraints and enabements of context are mediated to the agent as first-order emergents. First-order emergents encompass agents pacement within their broader socia context and roes, their vested interests, the opportunity costs associated with different courses of action and, thus, their perceived interpretive freedom. Such first-order emergents impact differenty on each agent, enabing or frustrating the attainment of their desired goas depending on their socia bargaining power, both as individuas and as members of groups. Consequenty, our anaysis of how context impinges on agents is stratified across three eves: socia position, how their roes reate to others and the cutura ogics of the institutiona domain within which they are situated. In this way we expose the contextua constraints and enabements imposed on the agent. The second stage by which the constraints and enabements of context are mediated addresses how agents, conditioned by their contexts, think about and infuence the formuation of their desired projects, both individuay and coectivey. 232 These infuences give rise to potentia second-order emergents (i.e the resuts of the resuts of the first-order emergent properties 346 ), which in their turn affect the ways in which an intervention is impemented. Accordingy, in our reaist anaysis, we separate context from its mediation (or the effects of the context on the intervention). As depicted in Figure 5, we first specify the expicit stratum concerned, so that hierarchica and heterarchica infuences may be more readiy appreciated within a situated context. Second, we identify dominant structura and cutura emergent properties within that context to define the structura conditioning in pay. Third, we apportion its mediation to mechanism, as expanded in Mechanism: sociocutura interaction. Queen s Printer and Controer of HMSO This work was produced by Herepath et a. under the terms of a commissioning contract issued by the Secretary of State for Heath. This issue may be freey reproduced for the purposes of private research and study and extracts (or indeed, the fu report) may be incuded in professiona journas provided that suitabe acknowedgement is made and the reproduction is not associated with any form of advertising. Appications for commercia reproduction shoud be addressed to: NIHR Journas Library, Nationa Institute for Heath Research, Evauation, Trias and Studies Coordinating Centre, Apha House, University of Southampton Science Park, Southampton SO16 7NS, UK. 19

50 CONCEPTUAL FRAMEWORK Heterarchica metamechanism 3 2 Higher-order societa ogics mouding the contextua arena Infrastructura system Wesh Government Institutiona setting Interpersona reations (reationa structure) Structura conditioning Pubic sector partner agencies (e.g. Community Heath Councis) NHS Waes as a corporate whoe NHS Waes seven heath boards Hospita mutisite department Hospita site-based ward (functiona team) Hierarchica metamechanism Individua 1 Individua FIGURE 5 Contextua strata: structura conditioning, hierarchica and heterarchica metamechanisms. Figure 5: key point summary In Figure 5, we iustrate our view of context as stratified, conditioned, reationa and temporay dynamic through the steps of the contextua strata. This shows how the outcome of one I-CMAO becomes the context for the next in the chain of impementation steps. In point 1, we depict the coective weight of structura conditioning impacting across contextua strata. This notion, as expanded in Context: structura conditioning, is an underying premise of reaist inquiry and Archerian reaist socia theory. In addition, we highight the notion of a meta mechanism that functions as a carrier for the 1000 Lives + nationa programme across NHS Waes. Point 2, therefore, depicts a hierarchica meta mechanism emergent from the bureaucratisation of the programme across the poicy/practice gap in NHS Waes. Furthermore, point 3 depicts a heterarchica metamechanism inherent to normaisation of the programme at the eve of the functiona team across inked strata. 20 NIHR Journas Library

51 DOI: /hsdr03400 HEALTH SERVICES AND DELIVERY RESEARCH 2015 VOL. 3 NO. 40 Mechanism: sociocutura interaction In her ater work, Archer has refined her conceptuaisation of the mediation of contextua infuences, which, she contends, is undertaken via two mechanisms: habituation, guiding routine action, and refexivity, guiding those actions which demand a more creative response. 338 Criticay, Archer asserts that such refexive theorisation occurs through three stages: (1) discernment, the preiminary review stage of an issue of concern, where refective retrospective and prospective thought informs practica action; (2) deiberation, invoving the ranking of such concerns against others; and (3) dedication, entaiing their prioritisation and aignment to foster a faibe yet correctabe commitment to a chosen path. Refexive theorisation thus represents the expicit interpay of socia context and persona concerns that ies at the heart of Pawson s notion of mechanism. Foowing this approach, in our reaist anaysis we aocate contextua mediation to mechanism, and to this we add refexive theorisation. Furthermore, as depicted in Figure 6, we distinguish the conceptua eements of mechanism from its ensuing outcome, iuminating the fundamenta roe of beiefs and vaues institutiona ogics on the propensity to act, and reveaing the contested nature of institutiona change and practice evoution. In this study of the 1000 Lives + programme, we examine the demarcation between context and mechanism, focusing on mediation, refexive theorisation, ensuing agency via negotiation and the mode of institutiona work enacted during two fundamenta institutiona processes: bureaucratisation and normaisation. These, we contend, operate as sociocutura and organisationa meta mechanisms, the underpinning carriers 347 of the processes of heath-care change desired by 1000 Lives +. In essence, it is through successfu embedding within these fundamenta meta-mechanisms that the patient safety programme becomes institutionaised. Bureaucratisation Given that the ogic of the bureaucratic state is predominanty that of command and contro, we envisaged bureaucratisation as a vertica, top-down meta mechanism. In this manner, the Wesh Government has enacted state-centric contro over NHS Waes. This is exempified by the gradua bureaucratisation of the 1000 Lives + nationa patient safety programme; specificay, the shift from optiona engagement to mandatory engagement as defined in the Wesh Government s tier 1 performance targets for NHS Waes. Such bureaucratisation now composes and conditions the substructure of the heath-care fied, creating a context of poiticised force majeure. We therefore examine the consequences of adherence to the 1000 Lives + programme and describe the mechanisms which foster institutiona couping to, and decouping from, patient safety governance processes. 85,348,349 Drawing on the work of Greenwood et a., 227 as we as terminoogy used by Lewin and Schein, 350,351 we frame such institutiona change through six stages disconfirmation, deinstitutionaisation, preinstitutionaisation, theorisation, diffusion and reinstitutionaisation and use these to deveop our understanding of the oca impementation of the 1000 Lives + programme, as set out in Chapter 4. Normaisation We envisaged normaisation as a heterarchica metamechanism operating (i) horizontay across discrete functiona teams, such as poicy, heath-care management or heath-care cinica professionas; and (ii) hierarchicay, bottom-up and top-down, across conceptua strata. Hence, to provide deeper insight into the impementation of the 1000 Lives + programme, we use normaisation process theory, as deveoped by May et a., to refine our understanding of how agency embedded this patient safety improvement programme in a oca context. The concept of normaisation acknowedges that those invoved in the process of institutiona change have to undertake institutiona work and thus theorise in a refexive manner 338,356 to reconfigure ensuing practices to meet oca conditions. 357 Queen s Printer and Controer of HMSO This work was produced by Herepath et a. under the terms of a commissioning contract issued by the Secretary of State for Heath. This issue may be freey reproduced for the purposes of private research and study and extracts (or indeed, the fu report) may be incuded in professiona journas provided that suitabe acknowedgement is made and the reproduction is not associated with any form of advertising. Appications for commercia reproduction shoud be addressed to: NIHR Journas Library, Nationa Institute for Heath Research, Evauation, Trias and Studies Coordinating Centre, Apha House, University of Southampton Science Park, Southampton SO16 7NS, UK. 21

52 Intervention Foca intervention, expicit components and associated resources offered by 1000 Lives + Context Refexivity: attention to contexts and concerns Agency Contextua structura conditioning Refexive action and commitment to a chosen path 2 1 CONCEPTUAL FRAMEWORK Discernment Aignment of institutiona ogics Deiberation Dedication First-order emergents: Invountaristic pacement Vested interests Opportunity costs Perceived interpretive freedom Strategic directiona guidance Second-order emergents and situationa ogic in pay: Necessary compementarities (protection) Necessary incompatibiities (correction/compromise) 1 Contingent compementarities (opportunism) Contingent incompatibiities (eimination) Intervention: aignment to dominant ogic orchestrating impementation Compementary Co-existent Countervaiing Inattention to contexts and concerns Habitation: Institutiona maintenance Practice maintenance Socia reproduction of the status quo ante FIGURE 6 Mechanism: mediation via refexive theorisation vs. habituation. 22 NIHR Journas Library

53 DOI: /hsdr03400 HEALTH SERVICES AND DELIVERY RESEARCH 2015 VOL. 3 NO. 40 Figure 6: key point summary Figure 6 shows a preiminary outine of the key components of a mechanism. As noted in Figure 3, we apportion mediation and refexive theorisation to mechanism. We thus distinguish the conceptua eements of mechanism from its ensuing outcome: the agentia emergent properties, expressed through the unfoding strategic negotiation of change, and the mode of institutiona work enacted, to deiver sustainabe outcomes, be they eaborative or reproductive. In point 1, we depict Archer s refinement of her notion of contextua conditioning via the mediation of structure by agency. This, Archer contends, is undertaken via two mechanisms: habituation, guiding routine action, and refexivity, guiding those actions that demand a more creative response. This manifests through three stages: discernment, the preiminary review stage of an issue of concern, where refective retrospective and prospective thought informs practica action; deiberation, the ranking of such concerns against others; and dedication, their prioritisation and aignment to foster a faibe yet corrigibe commitment to a chosen path. Such refexive agency thus represents the expicit interpay of socia context and persona concerns. In point 2 we assert that this three-stage process is moduated by the aignment of institutiona ogics. Compementarity, co-existence or contradistinction via a countervaiing stance thus impact first- and second-order emergents to shape the individua s situation ogic and the ensuing stance that emerges from their deiberation and dedication to a chosen path. This mid-range theory presented four possibe generative mechanisms coherence, cognitive participation, coective action and refexive monitoring which are viewed to be centra to the embedding and integration of institutionay refined practices. As May and Finch 353 point out, such mechanisms are subject to the power pay of socia actors. Therefore, by focusing on normaisation, our examination of the impementation of the 1000 Lives + nationa programme was sensitised to the dynamic interpay of mutipe ogics. Agency and ensuing outcomes: structura and cutura eaboration or reproduction In our reaist anaysis framework, outcome is not perceived as a simpe, singe aspect of change such as a defined heath outcome. Instead, it is recognised that the mutifaceted nature of an intervention, particuary when impemented within different organisations, each shaped by their own contextua constraints and enabements, gives rise to discordant mechanisms which trigger different patterns of socia transformation. 243,269 Moreover, such outcome patterns are contingent on a the tiny process and positioning issues that occur on the way to the goa. 244 Our framework is, therefore, concerned with the expication of these unfoding actions over time. Specificay, we seek to examine the means through which the heath-care practice change advocated by the 1000 Lives + programme, and the three foca interventions we consider in depth, are negotiated by the functiona teams positioned within the contextua strata depicted in Figure 5. We thus seek to iuminate how heath-care practice evoves (or not) over time, by considering the third-order emergents impacting within the contextua arena. Third-order emergents arise from the effects of first- and second-order infuences on the outcomes of the intervention. 229 This concept, therefore, captures structura and ideationa differentiation, together with the regrouping inherent to the power pay of a diverse array of agents. Queen s Printer and Controer of HMSO This work was produced by Herepath et a. under the terms of a commissioning contract issued by the Secretary of State for Heath. This issue may be freey reproduced for the purposes of private research and study and extracts (or indeed, the fu report) may be incuded in professiona journas provided that suitabe acknowedgement is made and the reproduction is not associated with any form of advertising. Appications for commercia reproduction shoud be addressed to: NIHR Journas Library, Nationa Institute for Heath Research, Evauation, Trias and Studies Coordinating Centre, Apha House, University of Southampton Science Park, Southampton SO16 7NS, UK. 23

54 CONCEPTUAL FRAMEWORK Summary We argue in this chapter that, as an estabished methodoogica compement to the critica reaism of which Pawson is a key advocate, and as an innovative ens for reaist inquiry, an Archerian approach provides both an expanatory framework for examining the interpay between structure (context) and agency (mechanism) and a viabe means for deveoping and refining emergent I-CMAO configurations. In seeking to demarcate context from mechanism and intervention, our stratified mode of context depicts strata as hierarchica and interconnected. This purposey deviates from the notion of context bifurcated into externa and interna domains, 216,358 and echoes the broader reaist iterature in terms of a socioogy divided into eves. 359,360 Moreover, by reveaing the mechanisms that operate within and between these conceptua strata, as each action-eve or arena is, simutaneousy, a framework for action and a product of action, 330 we carry forward these generative threads into our reaist anaysis to define the web of mechanisms operating within the foca context. 24 NIHR Journas Library

55 DOI: /hsdr03400 HEALTH SERVICES AND DELIVERY RESEARCH 2015 VOL. 3 NO. 40 Chapter 3 Research design Overview This chapter sets out our research design and approach to data coection and anaysis. First, acknowedging recent changes to research ethics and access permissions in NHS Waes, we provide a step-by-step account of our actions in the start-up stage to the study. Second, our comparative case study research design is presented, expaining our approach to reaist anaysis, case site seection and samping strategy, and to data coection, coding and anaysis. Finay, we refect on the chaenges encountered during our research across NHS Waes and discuss their impact on our reaist anaysis of hospita patient safety. Research ethics and access permissions in NHS Waes In February 2011, foowing notification of the award from the Nationa Institute for Heath Research Heath Services and Deivery Research programme, an Integrated Research Appication System project data set was deveoped prior to the forma start of the study in October Over the next 4 months, working in coaboration with the Nationa Institute for Socia Care and Heath Research (NISCHR) Patient Safety and Heathcare Quaity Registered Research Group, hosted by the Schoo of Medicine, Cardiff University, and in cose iaison with the Director Genera, Heath and Socia Services and NHS Waes Chief Executive, the in principe engagement of a NHS Waes seven oca heath boards [Abertawe Bro Morgannwg University Heath Board; Aneurin Bevan University Heath Board; Betsi Cadwaadr University Heath Board; Cardiff and Vae University Heath Board; Cwm Taf University Heath Board; Hywe Dda University Heath Board; and Powys (Teaching) Heath Board] was secured. In each heath board, study contacts with deegated strategic oversight for patient safety were recruited at medica director or associate medica director eve. Having gained NHS Waes in principe engagement, sponsorship of the study was secured from Cardiff University and the required documents were submitted to the Main Research Ethics Committee (MREC) for Waes. MREC approva was granted in August 2011 and site-specific NHS research and deveopment forms were submitted to the newy estabished NISCHR Permissions Co-ordinating Unit. Foowing this, fu ethica and research governance permissions were obtained from Cardiff Business Schoo, Cardiff University, and research passports were obtained for Herepath and Kitchener. Research vaidation and goba governance approva was obtained in September The research and deveopment committees of the seven heath boards granted site-specific research permission and researcher access by December 2011, and Herepath and Kitchener received either honorary research contracts or etters of access. Anonymisation A seven heath boards in NHS Waes participated in the study. Summary data describing each organisation are presented in Appendix 1. To ensure anonymity from this stage of the report onwards, participant heath boards are identified via a randomy assigned code etter from A to G. Numeric subscripts are then used to identify a constituent major hospita (X 1 ), a constituent district genera hospita (X 2 ) or a constituent sma oca community hospita (X 3 ). Comparative case study approach The study set out to examine which contextua factors matter and how they matter, and to expain why they matter in the hope that this may ead to improvement in the design, processes and outcomes of patient safety programmes. A comparative case study research design is appropriate for research of this nature 361 and was therefore adopted and aigned to reaist anaysis as discussed beow. Queen s Printer and Controer of HMSO This work was produced by Herepath et a. under the terms of a commissioning contract issued by the Secretary of State for Heath. This issue may be freey reproduced for the purposes of private research and study and extracts (or indeed, the fu report) may be incuded in professiona journas provided that suitabe acknowedgement is made and the reproduction is not associated with any form of advertising. Appications for commercia reproduction shoud be addressed to: NIHR Journas Library, Nationa Institute for Heath Research, Evauation, Trias and Studies Coordinating Centre, Apha House, University of Southampton Science Park, Southampton SO16 7NS, UK. 25

56 RESEARCH DESIGN Comparative case studies in reaist informed research are shaped by five methodoogica principes: (1) expication of structure and context; (2) expication of events; (3) abduction and retroduction (see Ontoogica andepistemoogica aignment to reaist anaysis, beow); (4) empirica corroboration (ensuring that proposed mechanisms have causa power and better expanatory power than aternatives 365 ); and (5) trianguation and mutimethods (using mutipe approaches to support causa anaysis based on a variety of data types and sources, anaytica methods, investigators and theories 365 ). Each of these features are empoyed throughout Chapters 4 8. Ontoogica and epistemoogica aignment to reaist anaysis The basic premise, or ontoogy, of critica reaist informed research is that the word may be viewed as stratified into three domains in which are apparent structures, mechanisms, powers and reations; events and actions; and experiences and perceptions. 362,363 Research in this tradition focuses on the identification and expanation of the underying generative mechanisms that shape structure, agency and the socia reations that are reproduced and/or transformed. 252 The nature of the approach taken by reaist research does impose imitations on what may be reveaed through a comparative case study research design. However, it is a viabe means for discerning structures and mechanisms, conveyed through our understanding of the socia word and, thus, subject to revision as our coective knowedge is refined. 363,365 Nevertheess, one cannot connect powers or causa mechanisms to events and perceptions easiy or securey by simpe inspection. 366 This is because, once set in motion, they continue to have an infuence even if other countervaiing powers and mechanisms prevent this infuence manifesting itsef. The act of drawing concusions from a comparative case study is, therefore, a compex matter. It is informed by epistemoogy (what we think is known), the nature of the comparisons made between cases and the mode of inference empoyed. Comparative case study research designs using a critica reaist approach must, therefore, seek to define constraining and enabing socia structures, encompassing organisations, groups and individuas, together with the rues, practices, technoogica artefacts, discourse and cuture which they manifest. 365 In addition, socia actors interpretations of such structures, and their beiefs, vaues and theories, require detaied consideration. The comparisons made between cases draw on abductive and retroductive modes of inference as opposed to inductive and deductive. 363,364 Abduction invoves the production of an eementary account of a basic process or mechanism. 363 Retroduction buids on this anaytica stage to reconstruct the basic conditions for such phenomena to be what they are, so fostering knowedge of the conditions, structures and mechanisms in pay. 362,363 Abstraction forms the basis of both abduction and retroduction. As empiricay demonstrated by Herepath, 342 abstraction draws out the various components within the situated context so that the researcher may gain new insight into the way they combine and interact. Case site seection and samping strategy Case site seection was based on a two-stage samping strategy. In phase 1, four cear and readiy operabe criteria corporate parent, compexity, function and geographica coverage were empoyed to define the purposive sampe of case-site hospitas within each heath board (see Appendix 1), and three within-case comparators were seected from each heath board: (1) a major hospita, (2) a district genera hospita and (3) a sma community hospita. This approach ensured theoretica variation in I-CMAO configurations by optimising the scope for description, interpretation and expanatory anaysis, whie reducing chance associations In contrast, in phase 2, the focus of the study was narrowed to four oca heath boards, and centred on deeper examination of the most promising I-CMAO configurations for the three foca interventions examined from the 1000 Lives + programme. 26 NIHR Journas Library

57 DOI: /hsdr03400 HEALTH SERVICES AND DELIVERY RESEARCH 2015 VOL. 3 NO. 40 Data coection, coding and anaysis In adopting an overarching approach that combined reaist inquiry with regard to the expication of I-CMAO configurations, this study sought to examine the contextua conditioning which predated the aunch of the 1000 Lives + programme, together with the mechanisms which emerged from the socia interaction of different groups of heath-care workers engaged in its impementation, and the subsequent outcome on the embedded practices of day-to-day heath-care practice. As iustrated by the schedue of data methods and sources iustrated in Figure 7, and expanded in the foowing four sections, a wide range of data coection methods were used. 256 Literature review Preiminary anaysis of the institutiona fied 1 Pubic inquiry anaysis Poicy anaysis Document anaysis: NHS Waes 2 1 Case study: phase I Identification of candidate I-CMAO configurations for further anaysis in phase 2 Interviews Observation of practice Reaist anaysis 2 Interviews Case study: phase 2 Observation of practice Reaist anaysis Refinement of I-CMAO configurations 3 FIGURE 7 Schedue of data methods and sources. Figure 7: key point summary In Figure 7 we set out a schematic of data methods and sources, expanded beow. As set out in point 1, a series of data searches were undertaken. These incuded one that centred on pubic inquiries (see Tabe 5) as a means of gaining rapid awareness of significant systemic heath-care deivery and patient safety faiures. The iterature review, poicy and document anaysis was maintained throughout the duration of the study. Points 2 and 3 depict the preiminary identification of candidate I-CMAO configurations and their progressive refinement throughout the study. Queen s Printer and Controer of HMSO This work was produced by Herepath et a. under the terms of a commissioning contract issued by the Secretary of State for Heath. This issue may be freey reproduced for the purposes of private research and study and extracts (or indeed, the fu report) may be incuded in professiona journas provided that suitabe acknowedgement is made and the reproduction is not associated with any form of advertising. Appications for commercia reproduction shoud be addressed to: NIHR Journas Library, Nationa Institute for Heath Research, Evauation, Trias and Studies Coordinating Centre, Apha House, University of Southampton Science Park, Southampton SO16 7NS, UK. 27

58 RESEARCH DESIGN Wesh heath-care poicy context data To buid a coherent expanatory anaysis of the context and events that ed to the deveopment and impementation of the 1000 Lives + programme, our research commenced with an anaysis of UK and devoved Wesh heath-care poicy spanning the period from 1997 to As indicated in Tabe 2, the UK coaition government s White and Green Papers, together with other key egisative proposas, were accessed and downoaded from the Department of Heath s website. Those of the former UK New Labour government were sourced via the Nationa Archives. Reevant Wesh Government documents, together with those from the Nationa Assemby for Waes, were accessed from site-specific poicy archives. In addition, Wesh heath circuars and ministeria etters spanning the period were accessed via the Heath of Waes Information Service (HOWIS) intranet. A repository in excess of 1700 documents was estabished and archived in an eectronic database to faciitate the exporation of the structura conditioning of the Wesh heath-care system. Three anaytica frameworks informed the coding of these data: (1) Friedand and Aford s depiction of higher-order societa ogics; 331 (2) Barber s three paradigms of pubic sector reform; 370 and (3) Hood s doctrina components of new pubic management. 371,372 Coectivey, these focused our approach to contextua conditioning and set out the requisite vocabuary 373 through which the infrastructura system specificay, the organisationa and professiona governance processes structuring heath-care quaity and patient safety coud be abstracted from the poicy archive. As iustrated in Chapter 4, this centred on the interpay of the higher-order societa ogic of the bureaucratic state with the fied-eve ogics of the market, professionaism and democracy in heath poicy. Anaysis of these data reveaed the systemic, paradigmatic, dominant and subordinate institutiona ogics, which condition NHS Waes structuray and cuturay, and impact on infrastructura systems underpinning hospita patient safety. In addition, our consideration of bureaucratisation and normaisation sensitised us to the generative mechanisms which foster institutiona couping to and decouping from patient safety governance processes, as we as the compex web of constraints and enabements which impact on differenty positioned socia actors and condition their response to the deveopment and impementation of the 1000 Lives + programme. TABLE 2 Poicy anaysis: data sources UK government poicy Current White and Green Papers (UK coaition government from 2010) were accessed via the Department of Heath ( White and Green Papers (UK New Labour government from 1997 to 2010) were accessed via the Nationa Archives ( Pubications/DH_ ) Wesh Government poicy Wesh Government ( = en) Nationa Assemby for Waes (egisation) ( HOWIS intranet site ( Access to this third site was granted to the authors through the receipt of honorary research contracts or etters of access from NHS Waes constituent heath boards 28 NIHR Journas Library

59 DOI: /hsdr03400 HEALTH SERVICES AND DELIVERY RESEARCH 2015 VOL. 3 NO. 40 Semistructured reaist interviews To refine our expanatory anaysis of the context and events that ed to the deveopment and impementation of the 1000 Lives + programme, we sought empirica corroboration from participants in the seven Wesh heath boards. In each heath board, an initia section of potentia research participants was identified in cose iaison with the study s oca contact. As summarised in Tabe 3, individuas were purposivey drawn from a wide range of organisationa roes. These encompassed the corporate management structure, cinica professionas and those occupying hybrid positions such as heath-care cinica professionas in manageria roes. Foowing confirmation of individuas consent to participate in the study, reaist interviews were undertaken, 228 guided by the questionnaire defined in Appendix 2. In addition, during each interview, respondents were asked to suggest further potentia research participants. This snowba approach heped to secure access to staff across NHS Waes with reevant knowedge and expertise in the three foca patient safety interventions examined. It aso provided the opportunity to gain permission to observe meetings and the estabished practices of heath-care deivery. Additiona research participants for the study were drawn from the research team s extensive network of contacts across the Wesh pubic service, comprising (i) the Wesh Government s Department of Heath and Socia Services; (ii) externa organisations tasked with the strategic oversight of patient safety in NHS Waes; and (iii) heath-care professiona bodies. Finay, to hep refine the study s emergent findings, word-eading academics with research interests in heath-care quaity and patient safety were aso interviewed. Therefore, as summarised in Tabe 3, a tota of 160 interviews, face to face or by teephone, digitay recorded and professionay transcribed, were undertaken across phases 1 and 2 of the study. Interviews ranged in duration from 30 minutes to 90 minutes, with a mean time of 40 minutes. TABLE 3 Research participants Examper roes Number Wech Government 10 Poicy eads NHS Waes, board-eve executive directors 20 Chair, Chief Executive, Director of Medicine, Director of Nursing, Director of Therapies and Heath Science, Director of Workforce and Organisationa Deveopment Non-executive directors, heath board stakehoder representatives NHS Waes, sub-board-eve associate directors 20 Associate Director of Medicine, Associate Director of Nursing, Associate Director of Therapies and Heath Science, Associate Director of Workforce and Organisationa Deveopment, Associate Director Corporate Performance NHS Waes, medica and surgica staff 20 Consutant-grade staff, 1000 Lives + oca eads, junior doctors in training NHS Waes, nursing staff 40 Ward managers, ward sisters, band 6 through to band 2 NHS Waes, pharmacy staff 20 Departmenta managers, cinica pharmacists antibiotic medicines management, cinica pharmacists surgica/theatre department management, 1000 Lives + eads 1000 Lives + nationa programme 10 Team members Externa stakehoders 20 Pubic sector partner agencies with externa oversight of patient safety Advocacy groups Academics with expertise in patient safety Tota 160 Queen s Printer and Controer of HMSO This work was produced by Herepath et a. under the terms of a commissioning contract issued by the Secretary of State for Heath. This issue may be freey reproduced for the purposes of private research and study and extracts (or indeed, the fu report) may be incuded in professiona journas provided that suitabe acknowedgement is made and the reproduction is not associated with any form of advertising. Appications for commercia reproduction shoud be addressed to: NIHR Journas Library, Nationa Institute for Heath Research, Evauation, Trias and Studies Coordinating Centre, Apha House, University of Southampton Science Park, Southampton SO16 7NS, UK. 29

60 RESEARCH DESIGN The transcript of each interview was vaidated by (i) correcting errors, predominanty typographica, that arose most typicay from the use of compex medica terminoogy; and (ii) correcting queries, annotated and time-marked by the transcriber, that arose from the use of medica and heath poicy acronyms (e.g. VTE meaning venous thromboemboism; AQF meaning annua quaity framework ). These data were then coded in a two-stage process. First, a centra registry data fie was created on an externa hard drive, incuding (i) the interviewee s assigned anonymisation code; (ii) their name; (iii) their gender; (iv) their profession; (v) their roe; (vi) their hybrid status; (vii) the anonymisation codes for their empoying heath board (or other organisation) and, if reevant, (viii) the anonymisation codes for their base site hospita. Access to this data fie was password protected and restricted to Herepath and Kitchener. Second, transcripts were coded in accordance with the framework defined in Tabe 4, and records inked to the centra registry data fie. TABLE 4 Data coding: preiminary and suppementary frameworks Theme Subtheme Preiminary coding framework: NHS inquiries recommendations impacting heath-care quaity Reguation Acts of Pariament Heath-care quaity standards Higher education Reguatory oversight via externa pubic sector agency Reguatory oversight via NHS organisation Reguatory oversight via professiona body Corporate governance Financia management Human resource management Performance management: interagency coaboration reconfiguration Cinica governance Cinica audit Continuous professiona deveopment Professiona standards management: revaidation reicensure Patient engagement Consumer Citizen Patient Suppementary coding framework: infrastructura system Wesh Government Heath-care poicy and patient safety Poitica advocacy for heath-care quaity and patient safety Poicy commitment to 1000 Lives + nationa programme Institutionaisation bureaucratisation/normaisation: co-optation formaisation egitimisation negotiation transmission Poicy commitment to patient safety 30 NIHR Journas Library

61 DOI: /hsdr03400 HEALTH SERVICES AND DELIVERY RESEARCH 2015 VOL. 3 NO. 40 TABLE 4 Data coding: preiminary and suppementary frameworks (continued) Theme Subtheme Deveoping an ethos of patient safety Leadership of patient safety Poitica advocacy for heath-care quaity and patient safety Poicy commitment to 1000 Lives + nationa programme Poicy commitment to patient safety Interna oversight of patient safety Heath-care quaity standards Performance management frameworks: constraints and enabements Externa oversight of patient safety Patient compaints procedures Reationship with externa bodies tasked with externa oversight of patient safety Institutionaisation bureaucratisation/normaisation: formaisation democratisation verification Reationship with professiona bodies via poicy eads Suppementary coding framework: institutiona setting NHS Waes as a corporate whoe/nhs Waes heath boards 1000 Lives + nationa programme Emergence and institutionaisation in NHS Waes programme eadership and foowership: board-eve eadership cinica eadership team work and distributed eadership roe of oca champions for 1000 Lives + foca interventions Institutionaisation bureaucratisation/normaisation: co-optation formaisation egitimisation Deveoping an ethos of patient safety Education and patient safety Leadership of patient safety Poitica advocacy for heath-care quaity and patient safety Organisationa commitment to 1000 Lives + nationa programme Organisationa commitment to patient safety Organisationa earning and patient safety Externa oversight of patient safety Patient compaints procedures Reationship with externa bodies tasked with externa oversight of patient safety Reationship with professiona bodies Reationship with Wesh Government, Department of Heath and Socia Care Interna oversight of patient safety Governance structures Measuring and monitoring patient safety Patient compaints procedures (Putting Things Right) Risk assessment (Wesh Risk Poo) Impact of reconfiguration of patient safety Organisationa reconfiguration Cinica services reconfiguration System and process reaignment across heath board continued Queen s Printer and Controer of HMSO This work was produced by Herepath et a. under the terms of a commissioning contract issued by the Secretary of State for Heath. This issue may be freey reproduced for the purposes of private research and study and extracts (or indeed, the fu report) may be incuded in professiona journas provided that suitabe acknowedgement is made and the reproduction is not associated with any form of advertising. Appications for commercia reproduction shoud be addressed to: NIHR Journas Library, Nationa Institute for Heath Research, Evauation, Trias and Studies Coordinating Centre, Apha House, University of Southampton Science Park, Southampton SO16 7NS, UK. 31

62 RESEARCH DESIGN TABLE 4 Data coding: preiminary and suppementary frameworks (continued) Theme Subtheme Suppementary coding framework: institutiona setting and interpersona reations hospita mutisite department/hospita site-based ward (functiona team) 1000 Lives + nationa programme Engagement with 1000 Lives + nationa programme: oca eadership and foowership roe of champions constraints and enabements Engagement with 1000 Lives + nationa programme team and associated resources: resources empoyed within foca intervention networking events site-specific engagement Adoption of MI-PDSA approach: constraints and enabements Context of heath-care deivery Perception of context: perception of strata sense of enabements and constraints from above and beow perception of inks and permeabiity Team work: distributed eadership heterarchica/hierarchica authority reationa structure Institutionaisation bureaucratisation/normaisation: emancipation identification innovation knowedge mobiisation egitimisation vaidation Suppementary coding framework: mechanism Institutionaisation Coercive institutiona isomorphism Mimetic institutiona isomorphism Normative institutiona isomorphism Normaisation Coherence Cognitive participation Refexive monitoring Refexive theorisation Discernment Deiberation Dedication Reason Suppementary coding framework: agency Institutiona work mode and disposition to act Creative Disruptive Maintenance Mutimoda Suppementary coding framework: outcome Beiefs and vaues Knowedge, practica skis Micro-competence deveopment Perception of outcome Structura eaboration, reproduction or foca invariance Cutura eaboration, reproduction or foca invariance Agentia eaboration, reproduction or foca invariance 32 NIHR Journas Library

63 DOI: /hsdr03400 HEALTH SERVICES AND DELIVERY RESEARCH 2015 VOL. 3 NO. 40 Initiay, as described in Chapter 2, our data were anaysed to examine the bureaucratisation of 1000 Lives + programme (see Chapter 4), and its ensuing normaisation at the eve of the functiona team within each heath board (see Chapter 5). This stage of our anaysis drew on two institutiona theories. First, as noted in Chapter 2, we utiised the work of Greenwood et a. 227 and their six inked institutiona mechanisms: disconfirmation, deinstitutionaisation, preinstitutionaisation, theorisation, diffusion and reinstitutionaisation. Second, guided by the work of May et a., 352,353 the process of oca impementation was framed through the mechanisms that foster the normaisation of compex interventions in daiy heath-care practice. These stages shaped our deiberation and expication of the 1000 Lives + programme s I-CMAO configuration spanning the Wesh heath-care institutiona fied. These data were further interrogated through our innovative approach to reaist anaysis, as iustrated in Chapters 6 8. Drawing on the work of Herepath, 342 interview transcripts were anaysed to identify first-, second- and third-order emergents. In this manner, interviewees perceptions of their situated context were ascertained, together with the power pay inherent to strategic negotiation of change, and ensuing outcome. These atter stages invoved abstraction to draw out various components of the foca intervention and so faciitate the conceptuaisation of their interpay, through combination and interaction, in the situated context. This was then suppemented by retroduction. Therefore, the generative mechanisms that operated through an emergent causa configuration were surfaced through a combination of theory and experimenta observation. 228 Given the number of interview data coected, the seection of excerpts for incusion in the report had to be constrained. To respond to this requirement we adopted the foowing format for references to transcription data in Chapters 4 8. First, succinct statements, which captured interviewees perceptions of context and their beiefs, vaues and refections and, thus, the refexive theorisation inherent to mechanisms together with ensuing actions, and outcomes, were prioritised. Throughout Chapters 4 8, such data excerpts are identified by a chapter code and number. For exampe, transcription 4:01, beow, indicates the first transcription excerpt incuded in Chapter 4. Where data from interviews are used to make a point but excerpts are not incuded in the text, this is indicated in a simiar way, but without beow. Fu transcripts of a interview data, incuding those discussed but not iustrated in the report owing to editoria word constraints, are archived in a suppementary data fie. These may be obtained for persona research use ony from the corresponding author of this report. In contrast to the weath of interview data incuded, imited observationa data are auded to in this report. This deiberate restriction is a resut of the marked disparity between overt observation of practice undertaken during the study and inherenty opportunistic covert observation of practice that arose across mutipe case sites. Suppementary organisationa data Six suppementary forms of case site-specific data were aso coected. These encompassed (i) Executive Board papers; (ii) heath board mortaity data; (iii) Wesh heath-care-associated infection programme data; (iv) externa inspection reports from Heathcare Inspectorate Waes (HIW), Community Heath Councis (CHCs) across Waes, the Waes Audit Office and the Pubic Services Ombudsman for Waes (PSOW); (v) 50 hours observation of estabished day-to-day heath-care practice undertaken to discern embedded eadership, theatre and infection prevention and contro (IPAC) practices; and (vi) feedback sessions to NHS Waes and the 1000 Lives + team, during which our posited I-CMAO configurations were tested and refined. Suppementary secondary data To gain an in-depth appreciation of the contextua issues impacting on hospita patient safety, and sensitise our subsequent anaysis, the reports generated by six pubic inquiries into safety faiures in the NHS, isted in Tabe 5, were coected. Queen s Printer and Controer of HMSO This work was produced by Herepath et a. under the terms of a commissioning contract issued by the Secretary of State for Heath. This issue may be freey reproduced for the purposes of private research and study and extracts (or indeed, the fu report) may be incuded in professiona journas provided that suitabe acknowedgement is made and the reproduction is not associated with any form of advertising. Appications for commercia reproduction shoud be addressed to: NIHR Journas Library, Nationa Institute for Heath Research, Evauation, Trias and Studies Coordinating Centre, Apha House, University of Southampton Science Park, Southampton SO16 7NS, UK. 33

64 RESEARCH DESIGN TABLE 5 Pubic inquiries into patient safety faiures: data sources 1. Inquiry into quaity and practice within the Nationa Heath Service arising from the actions of Rodney Ledward (pubished June 2000) The Kerr/Hasam Inquiry (pubished Juy 2005) The Shipman Inquiry (pubished January 2002 to January 2005): 84 i. Third Report: Death Certification and the Investigation of Deaths by Coroners (pubished Juy 2003) ii. Fourth Report: The Reguation of Controed Drugs in the Community (pubished Juy 2004) iii. Fifth Report: Safeguarding Patients: Lessons from the Past Proposas for the Future (pubished December 2004) 4. Roya Liverpoo Chidren s Hospita Inquiry (Ader Hey) (pubished January 2001) Bristo Roya Infirmary Inquiry (pubished Juy 2001) Mid Staffordshire NHS Foundation Trust Inquiry (pubished February 2010) Mid Staffordshire NHS Foundation Trust Pubic Inquiry (pubished February 2013) 81 For the purposes of this study, data in the form of 954 reported recommendations the espoused essons to be earned for the future to improve the design, deivery and sustainabiity of safe heath-care services were coected and archived in an eectronic database. This provided further rich insight into the infrastructura system underpinning hospita patient safety, its compex nature and embedded institutions. Acknowedging that the notion of comparing the reports and recommendations from different pubic inquiries is somewhat contestabe, 378 we therefore coded the abstracted recommendations descriptivey, across (i) reguatory oversight, (ii) corporate governance, (iii) cinica governance and (iv) patient engagement. These data were then coded once more in accordance with the nature of the probems/ issues identified, as depicted in Tabe 4. The anaysis of these data with respect to extant NHS governance processes heped to identify institutiona decouping the creation and maintenance of gaps between symboicay adopted forma poicies and actua organisationa practices 379 which foster institutionaisation of aberrant practice. 346 In this manner, we identified the common vunerabiities which impact adversey on patient safety, and their advocated remedies. This anaysis informed both the deveopment of our interview too and the seection of our preiminary I-CMAO configurations. Patient and pubic invovement Current hospita patients were not invoved in the design, deveopment or operationaisation of this study. However, a broader ay (and patient) perspective was activey sought. Working in cose iaison with the NISCHR Cinica Research Centre s Invoving Peope Programme, two ay representatives were appointed to the study s advisory board. Each provided insight into the patient experience of heath care. Moreover, this was augmented by their coective insight into (i) patient advocacy, (ii) participation in heath-board-eve stakehoder reference groups and (iii) prior experience of advisory board roes in other heath-care studies impemented in NHS Waes. Chaenges encountered in the operationaisation of the study Two issues arose during the operation of our study that required deviation from the origina research protoco. Access to patient stories and organisationa cuture survey data During the design and deveopment of the grant appication for this study, the research team was assured of access to an archive of patient stories and organisationa cuture survey data hed by the 1000 Lives + programme team. Foowing the commencement of the study, working in cose iaison with the 34 NIHR Journas Library

65 DOI: /hsdr03400 HEALTH SERVICES AND DELIVERY RESEARCH 2015 VOL. 3 NO Lives + programme team, three critica issues emerged on review of these data. First, and most importanty, these data acked ethica approva and informed patient consent for use for research purposes. Second, the patient stories data had been coected via inconsistent means and acked the requisite information to verify or contact data sources. Given such issues, these data were, therefore, used in a restricted manner to inform the phase 1 interview guide. Third, with respect to the organisationa cuture survey data, that archive refected the organisationa boundaries prior to the reconfiguration of NHS Waes. The research teams therefore considered that such historica data provide imited insight into NHS Waes evoving cutura composition post reconfiguration. These data were, therefore, used ony to inform the research team s understanding of organisationa context, and the organisationa egacy effect that it imparts, within each reconfigured heath board. Suppementary quantitative data quaity During phases 1 and 2 of the study, data from interviews and documentary anaysis indicated that, with respect to the foca interventions ILQI and RSC, the desired suppementary quantitative data were of inconsistent quaity. This issue did not impact RHAI because mandatory surveiance data were avaiabe via the Wesh Heathcare Associated Infection Programme (WHAIP) ed by Pubic Heath Waes. The research team discussed this issue at ength with the study s advisory board and commissioners, who advocated the continued investigation of the three foca interventions adjusted to refect the broader organisationa outcomes of the 1000 Lives + programme and foca interventions. Queen s Printer and Controer of HMSO This work was produced by Herepath et a. under the terms of a commissioning contract issued by the Secretary of State for Heath. This issue may be freey reproduced for the purposes of private research and study and extracts (or indeed, the fu report) may be incuded in professiona journas provided that suitabe acknowedgement is made and the reproduction is not associated with any form of advertising. Appications for commercia reproduction shoud be addressed to: NIHR Journas Library, Nationa Institute for Heath Research, Evauation, Trias and Studies Coordinating Centre, Apha House, University of Southampton Science Park, Southampton SO16 7NS, UK. 35

66

67 DOI: /hsdr03400 HEALTH SERVICES AND DELIVERY RESEARCH 2015 VOL. 3 NO. 40 Chapter 4 Institutionaisation of the 1000 Lives + nationa programme in NHS Waes: bureaucratisation, heath-care poicy and patient safety Overview Chapters 4 and 5 present our anaysis of the impementation and institutionaisation of the 1000 Lives + programme in NHS Waes. Together, they form the foundation for our anayses of the three foca interventions ILQI, RSC and RHAI that are presented in Chapters 6, 7 and 8, respectivey. This chapter presents our anaysis of the bureaucratisation of the 1000 Lives + programme at the higher, infrastructura system eve of the Wesh heath-care fied. In contrast, Chapter 5 is focused at ower contextua eves and expores interpersona and individua engagement with 1000 Lives + to offer an account of the normaisation of the programme at the eve of the functiona team. In this chapter, we first expore the institutiona ogics mouding the Wesh heath-care fied and expain how these conditioning infuences have framed the impementation and ensuing bureaucratisation of the 1000 Lives + programme. Second, to penetrate beyond the rhetoric of poicy and espoused best practice, we examine actors perceptions of the manner in which the 1000 Lives + programme has become an integra part of Wesh heath-care poicy. Specificay, we consider its integration with organisationa and professiona patient safety governance processes operating across the Wesh heath-care fied. In doing so, we gain further insight into the bureaucratisation of 1000 Lives + and set out our understanding of the pragmatic issues which foster institutiona couping to, or decouping from, these governance processes. This chapter, therefore, serves to sensitise our subsequent anayses to the deveopment of patient safety practices in NHS Waes. Finay, we set out our understanding of the oca impementation of the 1000 Lives + programme, anchored to the underpinning MI-PDSA approach. Institutiona ogics framing the bureaucratisation of 1000 Lives + At a systemic eve, the post-devoution Wesh heath-care fied paraes that of the UK Engish NHS and is characterised by the centra roe of government in overseeing the coective production, provision and consumption of heath care. 380 The underying principes and vaues underpinning the NHS in Waes remain grounded in the traditiona socia democratic communitarian ethos apparent at the inception of the NHS in the 1940s 381 and access to its operationa service infrastructure remains based on the principe of citizenship. 382 When considering the provision of pubic services at the infrastructura eve, Barber 370 suggests three paradigms bureaucratic command and contro, quasi-markets, and devoution and transparency 370,383 which may be depoyed within a government system if it is to baance equity and diversity with support for high quaity. Queen s Printer and Controer of HMSO This work was produced by Herepath et a. under the terms of a commissioning contract issued by the Secretary of State for Heath. This issue may be freey reproduced for the purposes of private research and study and extracts (or indeed, the fu report) may be incuded in professiona journas provided that suitabe acknowedgement is made and the reproduction is not associated with any form of advertising. Appications for commercia reproduction shoud be addressed to: NIHR Journas Library, Nationa Institute for Heath Research, Evauation, Trias and Studies Coordinating Centre, Apha House, University of Southampton Science Park, Southampton SO16 7NS, UK. 37

68 BUREAUCRATISATION, HEALTH-CARE POLICY AND PATIENT SAFETY The cassica notion of bureaucratic command and contro is forwarded as the means of pursuing change to address pubic service faiure, poicy or program priorities, and to demonstrate this response to a wider pubic and poitica audience. The aternative formation of a quasi-market ogic is supported by governments that wish to introduce market forces within a pubic service system to provide the individua with choice across a range of providers to improve performance. Finay, the devoution of responsibiity to frontine units, augmented by the overt communication of performance measures to patients and staff to enabe informed comparisons to be made (transparency), stems from a ogic of choice. This is deemed necessary to reform a service where the conditions for the success of quasi-markets are not present. In practice, according to Barber, 370 a of these paradigms are ikey to co-exist within arge-scae systems, such as heath care, athough the precise baance of paradigmatic institutiona ogics within a given heath-care fied positions one into dominance whie the remainder function in a subordinate capacity. Hence we woud argue that, whie the UK remains embematic of new pubic management, 384 our data suggest that NHS Waes is far more representative of a new pubic service ogic with the paradigmatic ogic of bureaucratic command and contro occupying a dominant position, tempering the ogics of the market, professionaism and democracy in heath poicy. Patient safety and associated governance processes appear, therefore, to be primariy structured and directed by the reguatory agency of the Wesh Government. Bureaucratic state ogic As iustrated in Figure 8, the ogic of the bureaucratic state is expressed through an array of structura features that incucate a pervasive performance measurement and management ethos across the Wesh heath-care fied. 385,386 Much of this was introduced under the UK New Labour government, such as new systems for cinica governance, a statutory duty of quaity and evidence-based nationa service frameworks. That government aso aid the foundations for an array of arm s-ength bodies that retain the scope for direct intervention in the NHS in Engand and Waes. 387 Some have even seen this as a precursor to the egitimisation of the roe of the state as the guarantor of socia provision, rather than as the soe provider, 388 a stance which resonated with the poicy approach of the 2010 UK Conservative Libera Democrat coaition government. However, whie the ogic of the bureaucratic state imposes a sense of contro, the efficient use of resources resides argey within the contro of discrete professionas. 389 This ogic is, therefore, tempered by the wieding of professiona power at the individua and group eve, 390 as iustrated in Figures 8 and 9. In Waes, the bureaucratic state ogic of the Wesh Government orchestrates the top-down performance measurement and management of the 1000 Lives campaign and the successor 1000 Lives + programme. For exampe, under the mante of 1000 Lives +, NHS Waes constituent organisations are tasked to (i) set appropriate oca targets for the reduction of harm and hospita mortaity, initiay by empoying the Trigger Too for hospitas; (ii) demonstrate participation in 1000 Lives + through the appointment of executive eads; and (iii) coect robust data so that oca variation in service provision may be identified, anaysed and understood, resuting in the deveopment of inteigent targets for service improvement and patient safety. 391 Strategic oversight of such actions rests with the Nationa Quaity and Safety Forum instituted in NIHR Journas Library

69 DOI: /hsdr03400 HEALTH SERVICES AND DELIVERY RESEARCH 2015 VOL. 3 NO. 40 Reigion Capitaist market Democracy Famiy 1 Bureaucratic state 2 Paradigmatic ogic: command and contro Dominant ogic: top-down performance management Nationa Service Frameworks Annua Quaity Framework Performance assessment and inspection by externa bodies Direct intervention 3 4 Subordinate ogic: Coaboration Heath board integration of primary, secondary and tertiary heath care Partnership frameworks Mutiagency deveopment of patient care pathways 1000 Lives + mini-coaboratives Subordinate ogic: Professionaism Leadership and aigned professiona deveopment frameworks Agenda for change workforce deveopment, roe redesign Organisationa deveopment Service improvement (e.g Lives + Mode for Improvement) Subordinate ogic: Democracy Citizen-centred services patient- and famiy-centred heath care Users shaping services from beow Voice and coproduction Broader stakehoder engagement (e.g. Putting Things Right) FIGURE 8 Institutiona ogics in the Wesh heath-care institutiona fied. Queen s Printer and Controer of HMSO This work was produced by Herepath et a. under the terms of a commissioning contract issued by the Secretary of State for Heath. This issue may be freey reproduced for the purposes of private research and study and extracts (or indeed, the fu report) may be incuded in professiona journas provided that suitabe acknowedgement is made and the reproduction is not associated with any form of advertising. Appications for commercia reproduction shoud be addressed to: NIHR Journas Library, Nationa Institute for Heath Research, Evauation, Trias and Studies Coordinating Centre, Apha House, University of Southampton Science Park, Southampton SO16 7NS, UK. 39

70 BUREAUCRATISATION, HEALTH-CARE POLICY AND PATIENT SAFETY Figure 8: key point summary In Figure 8 we depict a schematic representation of the Wesh heath-care institutiona fied. As indicated in Chapter 2 (see Socioogica institutionaism), the mutipicity of ogics in this domain are represented as some combinations of (i) higher-order societa ogics; (ii) fied-eve ogics; and (iii) institutions or cutura ogics, each composed of reguative, normative and cutura-cognitive piars. Point 1 iustrates the heterogeneous higher-order ogics (the bureaucratic state, capitaist market, democracy, nucear famiy and reigion) that scupt the socia word, conveying the core organising principes of these different sectors. In both connection and contention with each other, they are hed in dynamic tension due to their inherent compementarities and contradictions. Such institutiona ogics, therefore, orchestrate ower-eve institutiona strata and ensuing practices: shaping organisationa interests; individua preferences; and the ensuing repertoire of anticipated behaviours which define actors expectations about each other s behaviour and organise their enduring reations with each other. Point 2 depicts the expression of this interpay at the eve of the Wesh heath-care fied. Here, the higher-order societa ogic of the bureaucratic state is dominant. Accordingy, the paradigmatic ogic of bureaucratic command and contro predominates. Point 3 of our expanatory schematic iustrates the fied-eve expression of the dominant ogic of the bureaucratic state, expressed through an array of structura features that incucate a pervasive performance measurement and management ethos across the Wesh heath-care fied. Point 4 depicts the fied-eve expression of the subordinate ogics of coaboration, professionaism and democracy. 40 NIHR Journas Library

71 DOI: /hsdr03400 HEALTH SERVICES AND DELIVERY RESEARCH 2015 VOL. 3 NO Dominant ogic Bureaucratic state Higher-order societa ogics Wesh Government NHS Waes Coaboration Professionaism Democracy NHS Waes heath boards 2 Dominant ogic Democracy Coaboration Professionaism Bureaucratic state Pubic sector partner agencies Dominant ogic Bureaucratic state 4 Confict between dominant ogics Dominant ogic Professionaism 3 Dominant ogic Professionaism Hospita mutisite department Hospita site-based ward (functiona team) Heath-care professionas: Poicy eads Corporate management Medicine Nursing Other heath care 1000 Lives + nationa programme team Coaboration Bureaucratic state Democracy FIGURE 9 Institutiona ogics in the Wesh heath-care institutiona fied: dominant and subordinate ogics in a compementary, co-existent or countervaiing aignment. Queen s Printer and Controer of HMSO This work was produced by Herepath et a. under the terms of a commissioning contract issued by the Secretary of State for Heath. This issue may be freey reproduced for the purposes of private research and study and extracts (or indeed, the fu report) may be incuded in professiona journas provided that suitabe acknowedgement is made and the reproduction is not associated with any form of advertising. Appications for commercia reproduction shoud be addressed to: NIHR Journas Library, Nationa Institute for Heath Research, Evauation, Trias and Studies Coordinating Centre, Apha House, University of Southampton Science Park, Southampton SO16 7NS, UK. 41

72 BUREAUCRATISATION, HEALTH-CARE POLICY AND PATIENT SAFETY Figure 9: key point summary In Figure 9, informed by the findings of our reaist anaysis in Overview, we iustrate how the dominance of one ogic vs. another is infuenced by contextua strata. Point 1 depicts the ogic of the bureaucratic state as dominant across the infrastructura and institutiona setting of our study. However, as indicated at point 2, the ogic of democracy is dominant for pubic sector partner agencies with strategic oversight of patient safety. In addition, as indicated at point 3, at ower contextua strata specificay, a hospita mutisite department or site-based ward the functiona team is orchestrated by a dominant professiona ogic. As indicated in point 4, this therefore draws different professiona ogics into contention and potentia confict with that of the bureaucratic state. Capitaist market ogic repaced by coaboration The UK New Labour government foowed the Conservative adherence to new pubic management, aiming to increase the efficiency and quaity of service provision through the ogic of the capitaist market. For the UK heath-care fied this approach coud be seen in the encouragement of aspects of competition, contestabiity and practice-based commissioning, and the same stance ingered on in the 2010 UK Conservative Libera Democrat coaition government s heath-care poicy. However, in the post-devoution Wesh heath-care fied, this ogic has been opposed and repaced by coaboration. 392 Importanty, the Government of Waes Act (2006) requires the Wesh Government to work in forma partnership with the vountary sector, oca government and businesses. This constitutes a set of operationa requirements not paraeed esewhere in the UK. 393 The NHS reforms in Waes have, therefore, sought to incucate a new set of behaviours repacing competition with coaboration, joint working and whoe-systems thinking to foster a greater emphasis on quaity and patient safety outcomes. This coaborative ogic is interwoven throughout the 1000 Lives + programme, as evidenced by its integra mini-coaboratives, and nationa earning and networking events, which foster co-operation, knowedge sharing and peer chaenge. Furthermore, strategic oversight of heath-care standards and patient safety performance in Waes requires coaboration across the Nationa Quaity and Safety Forum, Wesh Government, HIW, PSOW, CHCs and heath-care providers, incuding those in the independent sector. 42 NIHR Journas Library

73 DOI: /hsdr03400 HEALTH SERVICES AND DELIVERY RESEARCH 2015 VOL. 3 NO. 40 Professiona ogic Despite Waes adoption of a coaborative approach, the ideoogica approach to pubic management reform adopted by the UK government sti impacts on Waes through its reserved powers. Thus, at the fied eve, professiona ogic be that corporate management or the array of hierarchicay positioned heath-care professionas 394 remains constrained. Indeed, what can be seen is an expicit focus on workforce deveopment (and, thus, organisationa deveopment) through a manageriaist variant of transformationa eadership, 395 roe redesign and adherence to prescriptive standards that seek to buid staff capacity and capabiity whie reducing service variation. 396 This ogic is inescapaby interwoven with performance management. As asserted in the current quaity deivery pan for NHS Waes, 391 the operationaisation of the 1000 Lives + programme is centra to the buiding of staff capacity and capabiity across NHS Waes: 1000 Lives + wi continue to be the core NHS improvement programme, ensuring a common and consistent anguage and approach to improvement. Heath Boards and Trusts wi agree a pan to train 25 per cent of their directy empoyed and contractor workforce in quaity improvement methodoogy (at basic, expert or eadership eve) by the end of March 2014, supported by 1000 Lives +. Achieving Exceence: The Quaity Deivery Pan for the NHS in Waes (2012) 391 Democratic ogic Athough the ogic of democracy, expressed in poicy through the desire for heightened user participation, engagement and contro over pubic services, appeared in the Conservative Party s genera eection manifesto of 1979, it reached new heights during the first term of the New Labour government. Beginning with the promotion of openness and pubic invovement in the NHS, 397 it progressed to the heightened egitimacy and authority of ay voices 398 and the ater adoption of a Scandinavian mode of expicit patient choice which evoved into individuaisation and coproduction. However, it is uncertain if this approach can or wi be fuy reaised, as its impementation is dependent on many factors, not east that appropriate program design is essentia if engagement with the citizen-consumer is to be effective. 399,400 In the Wesh heath-care fied, given the overt rejection of market ogic, the poicy evers for provider puraism and ensuing choice were not avaiabe. Waes has, therefore, embraced a citizen-centred mode, 392 adhering to notions of coectivism and standardisation as in the traditiona sociaist vaues of equaity, socia justice and socia incusion in poicy. 401 The 1000 Lives + programme expicity seeks to activey engage patients in the coproduction of their heath care. Indeed, as expanded in Chapter 6, patient stories represent an important means of gaining feedback. In addition, an aigned programme, Putting Things Right, aunched in Apri 2011 ( faciitates the communication of what are coectivey termed concerns (compaints, caims and incidents reports) into the standards of heath-care deivery and patient safety in NHS Waes. This operates in parae with NHS Waes governance framework Lives +, heath poicy and patient safety The 1000 Lives + programme is a compex, muticomponent patient safety intervention and is an integra part of the Wesh Government s poicy framework for NHS Waes. 391,402 A heath boards and trusts are invoved in its operation. The Wesh Government and Pubic Heath Waes host its codirectors and core team of improvement faciitators. Strategic oversight is provided by a dedicated programme board Lives + is supported by a facuty comprising a sma group of senior cinica and manageria eaders who are tasked to ensure the rigour and cinica credibiity of the evidence-based interventions promoted. In addition, the facuty buids capacity and capabiity at oca and nationa eves by providing mentorship within cinica arenas, and through its contribution to the design and deivery of resources and training Queen s Printer and Controer of HMSO This work was produced by Herepath et a. under the terms of a commissioning contract issued by the Secretary of State for Heath. This issue may be freey reproduced for the purposes of private research and study and extracts (or indeed, the fu report) may be incuded in professiona journas provided that suitabe acknowedgement is made and the reproduction is not associated with any form of advertising. Appications for commercia reproduction shoud be addressed to: NIHR Journas Library, Nationa Institute for Heath Research, Evauation, Trias and Studies Coordinating Centre, Apha House, University of Southampton Science Park, Southampton SO16 7NS, UK. 43

74 BUREAUCRATISATION, HEALTH-CARE POLICY AND PATIENT SAFETY materias. The 1000 Lives + core team and facuty are augmented by an active network of students and academics committed to quaity improvement and patient safety in NHS Waes. As outined in Chapter 1, the 1000 Lives + programme seeks to support organisations and individuas to deiver heath care of the highest quaity for the peope of Waes. Composed of an array of aigned improvement programmes, summarised in Figure 1, it adheres to an internationay recognised MI-PDSA 178 approach. This supports the use of sma tests of change to estabish new ways of working that can be repicated and adapted across NHS Waes. The broader infrastructure of 1000 Lives + incudes a website ( waes.nhs.uk) that enabes access to pubications and resources. These provide taiored support for each improvement area, together with notification of nationa events, opportunities for networking, knowedge mobiisation and coective earning. These resources are aigned to a web-based nationa earning programme for a NHS Waes staff and contractors (Improving Quaity Together: home) together with the resources offered by Patient Safety Waes ( Our discussions with poicy eads, drawn from the upper echeons of the Wesh Government, highighted the manner in which the 1000 Lives + programme has become estabished in the Wesh heath-care fied and a core poicy ever for heath-care transformation in NHS Waes, as expressed in the excerpt from transcription 4:01, beow (N.B. the fu text of a transcriptions can be found in a suppementary data fie; see Chapter 3, Data coection, coding and anaysis, Semistructured reaist interviews) Lives + has become institutionaised it s become part of the fabric it s part of the way in which poicy is being deivered and therefore a of the mechanisms that report progress on poicy are by proxy reporting 1000 Lives + progress; abeit I don t think it s quite that expicit. But I think the bureaucracy that sits behind the poitics of poicy have become enmeshed with 1000 Lives +. Poicy ead, Wesh Government (146); transcription 4:01 The 1000 Lives + programme was widey viewed to have been buit around the Wesh Government s tier 1 performance targets for NHS Waes (transcriptions 4:02 and 4:03). Indeed, the reative success of 1000 Lives + had enabed other poicy programmes to be associated with and inked to this compex intervention (transcription 4:04, beow) Lives + is something that peope are using in order to be abe to engage NHS staff in improvement work it s a badge, a brand and, what has happened here is that things have ended up being tagged onto 1000 Lives +. Through its own reative success 1000 Lives + has become a magnet for ots of other things that peope want to get in on the back of; it s amost become a Trojan horse way of getting something in the poicy system! But it s mandated now, it s how we do change. Poicy ead, Wesh Government (150); transcription 4:04 Respondents aso saw ministeria advocacy as important to the institutionaisation of the 1000 Lives + programme (transcription 4:05, beow). [T]hey stuck their head out, we above the poitica parapet by coming out and pubicay endorsing, or at east acknowedging that, in heath care, things can go wrong we can cause harm, be it through variation, misjudgement, error or mapractice: we damage patients. Poicy ead, Wesh Government (081); transcription 4:05 44 NIHR Journas Library

75 DOI: /hsdr03400 HEALTH SERVICES AND DELIVERY RESEARCH 2015 VOL. 3 NO. 40 Such advocacy was augmented by eite engagement across NHS Waes (transcription 4:06). Isomorphic institutionaism (increased simiarity over time), vectored through the work of the IHI, was aso perceived to have payed a centra roe in brokering ministeria and wider eite engagement (transcriptions 4:07 and 4:08, beow). There was an awareness, back in 2006 and 2007, that we shoud be doing better in terms of patient safety. I think that awareness was raised by the work of the Institute for Heathcare Improvement to some extent some of the key protagonists in the origina campaign were cosey invoved with the IHI but it was a bod commitment by the minister, the decision to actuay aunch the 1000 Lives Campaign. The abe 1000 Lives that abe, it impied that there were 1000 avoidabe deaths, which is quite a brave thing to say. I m not sure that we re sti that brave. Poicy ead, Wesh Government (145); transcription 4:08 However, such eite engagement had aso given rise to a context marred by coercive isomorphism 329 (enforced simiarity), one in which it was difficut to criticise the 1000 Lives + nationa programme for fear of jeopardising reationships with future eaders of the Wesh NHS (transcription 4:09, beow). Wearing my naive yet poitica hat, the one thing you do not do is te 1000 Lives + it s faiing that is ike insuting their firstborn and saying it s ugy too many peope high up the food chain poiticians, chief executive, medica directors have signed up to this, and to pubicy say it s not working is dangerous, not just for getting the process done but dangerous for individuas. So you need to be a bit more savvy about that! Waes is a very sma community everyone knows everyone so I am very mindfu that if I pissed off someone here: you piss off today s medica director, you are enemies with tomorrow s chief exec of NHS Waes! Poicy ead, Wesh Government (144); transcription 4:09 Indeed, the human factors inherent to poicy deveopment the barriers created through persona enmity and petty jeaousies compounded this note of discord (transcription 4:10, beow). The 1000 Lives + nationa programme is a source of hostiity. [Why do you think it is a source of hostiity?] There re a number of eements in pay but, to be frank, it comes down to personaities and persona jeaousies. It s about how, and with whom, it a started. In the beginning, we had [Name 1] and [Name 2] both strong, charismatic personaity types, who have their advocates and detractors, and who were, especiay [Name 1], cosey tied to the minister [Minister for Heath and Socia Services]. Now, these were the key figures, and some peope across the service are advocates of them not the 1000 Lives + nationa programme whist others are not: but that s just the way it is, in a waks of ife, some peope reject what you re saying, not because they ve thought about it, or hod a contrary view but just because you re saying it: so it s persona enmity. There re a number of ****ed-up reationships out there! God, you know how boody parochia it can be. So, these persona tensions and jeaousies because that s what they are, jeaousies about who s standing in the ministeria imeight; who is favour of the month these cause significant barriers to programme uptake, buy-in, and impementation. Poicy ead, Wesh Government (081); transcription 4:10 Queen s Printer and Controer of HMSO This work was produced by Herepath et a. under the terms of a commissioning contract issued by the Secretary of State for Heath. This issue may be freey reproduced for the purposes of private research and study and extracts (or indeed, the fu report) may be incuded in professiona journas provided that suitabe acknowedgement is made and the reproduction is not associated with any form of advertising. Appications for commercia reproduction shoud be addressed to: NIHR Journas Library, Nationa Institute for Heath Research, Evauation, Trias and Studies Coordinating Centre, Apha House, University of Southampton Science Park, Southampton SO16 7NS, UK. 45

76 BUREAUCRATISATION, HEALTH-CARE POLICY AND PATIENT SAFETY Patient safety governance processes in NHS Waes The 1000 Lives + programme has now become integrated within organisationa and professiona patient safety governance processes operating across the Wesh heath-care fied and this compex patient safety intervention was perceived to symboise and be part of the anguage of working together (transcription 4:11, beow). I think 1000 Lives +, certainy, because by its very nature it s a coaborative approach, it gives you a way of getting peope in a room. Aso, because it s badged 1000 Lives + it probaby doesn t fee as threatening to some board-eve stakehoders it s a convenient badge that s become a metaphor for working together the terminoogy, it s become part of the patient safety anguage of NHS Waes. Poicy ead, Wesh Government (146); transcription 4:11 Strategic oversight of patient safety The 1000 Lives + programme functions under the auspices of the statutory Quaity and Safety Committee in each heath board. The programme was typicay supported by a oca steering group at hospita eve (transcription 4:12, beow, and transcriptions 4:13 and 4:14). We have a structure that, I think, is pretty much standard for heath boards in Waes. Our main committee is the Quaity and Safety Committee every organisation has statutory duty to have a Quaity and Safety Committee or something termed aong those ines but we aso have a subgroup of the Quaity and Safety Committee caed the Cinica Effectiveness Committee, which is a group ed by the Medica Director, and, as the name impies, that receives the reports of the 1000 Lives + work as we as interna, externa audits, research and deveopment, and stuff ike that. Associate Director, case site G 1 (011); transcription 4:12 Within this organisationa structure, deegated strategic oversight routiney rested with three core board-eve roes (transcription 4:15, beow). We have a 1000 Lives + impementation group that s chaired by the medica director, the director of nursing and the director of therapies and heath sciences the three with the cinica portfoio but it s aso supported and attended by the director of pubic heath. Associate Director, case site D 1 (049); transcription 4:15 The strategic oversight of patient safety was supported by other board-eve and non-executive positions, and this had impacted the cuture of the organisations (transcription 4:16, beow, and transcription 4:17). My view is that everything that s in the portfoio of the Workforce and Organisation Deveopment Director is about safety. It s about quaity and safety because that is the utimate aim. The quaity and the safety of the services provided are as high as they can be achieved within the resources avaiabe. So, that s at the heart of everything that s in the portfoio from recruitment, job design, right away through to performance management and ongoing deveopment, CPD [continuous professiona deveopment] and eadership deveopment I think that a of those eements, which are centra to human resource management, are around systems and processes that buid or undermine the cuture of patient safety. They are a core panks of my roe, I think, and the roe of my team. Executive Director, Workforce and Organisation Deveopment, case site G 1 (012); transcription 4:16 Sub-board-eve managers aso payed a roe in supporting the operation of 1000 Lives +. This was typicay centred on data coation and reporting to the Quaity and Safety Committee (transcriptions 4:18 and 4:19). 46 NIHR Journas Library

77 DOI: /hsdr03400 HEALTH SERVICES AND DELIVERY RESEARCH 2015 VOL. 3 NO. 40 Patient safety practices and the burden of proof The 1000 Lives + programme was perceived to have improved front-ine practitioners awareness of the safety of their patients. However, this was dependent on the successfu embedding of the underpinning MI-PDSA methodoogy 178 (transcriptions 4:20 and 4:21). The programme was aso associated with increased paperwork and audit processes (transcriptions 4:22 and 4:26, beow) Lives + generates a ot of paperwork but it s not just 1000 Lives + that generates paperwork. I think, with nursing, it s just that, you know, we have to keep records it s proof, proof, proof a the time; prove that you ve done it, prove that you ve done it and now there is just so much documentation just to admit a patient takes an awfuy ong time. But the government want proof, they want us to know that yes we ve got 1000 Lives + in pace. But there s so much paperwork and some of it doesn t aways foow the patient because we share notes now, sometimes, and that amost muddies the water in some respect. It s a huge amount on notes and things! Pus there s the amount of audits we do we get audited to death [What do you get audited on?] We get audited on use of sharps bins; we get audited on the environment and whether we re using the correct bins; we get audited on infection contro; documentation audits, you know, it just seems that there s so much auditing. Mattresses get audited: there s just heaps of audits that go on. Ward manager, case site G 3 (086); transcription 4:24 There s an awfu ot of paperwork invoved in patient care today. With 1000 Lives + for every bunde that is deveoped you think: oh boy, here we go! The deivery of care has got to be the paramount importance to us, it s no good thinking: yes, I can tick a the boxes but not actuay doing the care. So, you give the care, and then you have to find the time to do the assessments, the evauations, and tick the boxes and everything. Aso, you have to have the care pans that go with the bunde or care pathway, and they have to be inked and cross-referenced. Those have to be updated every week, sometimes more than that, depending on the stabiity of the patient because obviousy that can vary. It woud be nice if the documentation coud be streamined in such a way that, instead of having so many new documents, perhaps we coud have one document that encompasses many things. Ward manager, case site B 2 (056); transcription 4:26 The burden of data coection in order to document adherence to prescribed care practices, together with the growth of nursing metrics (transcription 4:27, beow), may pose a fundamenta risk to 1000 Lives +, as it may foster disengagement from the purpose of the programme and threaten reducing adherence to a tick-box exercise. One respondent commented that it coud become simpy a massive bureaucracy to feed the minister (transcription 4:28). [What performance indicators and nursing metrics are coected at ward eve to monitor patient safety?] Boody he, what are the performance indicators? Everything! There s a whoe set they go through to the Wesh Government there s a whoe section on patient safety, infection contro, workoad, sickness absence, 1000 Lives +! It s just measures: it s a way of auditing us at a ward eve. It s spit into different sections but the one section you d be interested in with 1000 Lives + is the one with patient safety. [What issues do they monitor?] They ook at things ike, we there s quite a few parts which woud reate to it, ike you audit how many patients have had their armbands on. So you say, choose 12 patients, go round the 12, how many of the 12 have got armbands on, and it gives you a percentage figure. Once you ve cicked that button and it s gone in, you can t change anything. So it does hep, at the ward eve, it gives me an indication, it gives me an indication if things are acking. Ward manager, case site B 1 (060); transcription 4:27 In addition, decouping of practice from the intent of poicy was fostered through the faiure to vaidate data and to enforce adherence to guideines (transcriptions 4:29 and 4:30). Queen s Printer and Controer of HMSO This work was produced by Herepath et a. under the terms of a commissioning contract issued by the Secretary of State for Heath. This issue may be freey reproduced for the purposes of private research and study and extracts (or indeed, the fu report) may be incuded in professiona journas provided that suitabe acknowedgement is made and the reproduction is not associated with any form of advertising. Appications for commercia reproduction shoud be addressed to: NIHR Journas Library, Nationa Institute for Heath Research, Evauation, Trias and Studies Coordinating Centre, Apha House, University of Southampton Science Park, Southampton SO16 7NS, UK. 47

78 BUREAUCRATISATION, HEALTH-CARE POLICY AND PATIENT SAFETY Externa oversight of heath-care quaity and patient safety In Waes, HIW, CHCs and the PSOW provide externa oversight of heath-care quaity and patient safety. Such audit processes were seen as heping to vaidate the deivery of appropriate heath-care standards, promoting change through identifying service faiings (transcription 4:31, beow). Heathcare Inspectorate Waes did a spot audit here, ast October I think it was, and on the particuar morning they came in I wasn t here, I wasn t on duty, and the sister wasn t here and there were a coupe of staff off it was absoutey bedam! There were two patients dying, so two ots of famiy in and there were doctors everywhere, because it was after 9 o cock and a oad of medica students came to the ward. The inen troey with the fresh inen for the day had been thrown in. Peope were doing breakfast; they were sti doing breakfast! It ooked ike an absoute bombsite apparenty. And in the audit they competey foored us... but, since then, I think it did us a favour because there were some things that we d been fighting to get done because, as you know, this is an od ward. So there are things that we ve managed to get changed on the back of this audit. So it s done us itte favours. Ward manager, case site B 1 (060); transcription 4:31 Furthermore, audits provided an important externa source of data, countering parochiaism and strengthening democratic chaenge across NHS Waes (transcription 4:32, beow). [Do you report back to the Wesh Government?] For Wesh Government we, there s a firewa between them and us [a CHC in Waes] but we are an agent of government. However, having said that, we are a pain in their side we say things they don t want to hear the poitica view is obviousy very different. But it s my duty to te the truth to government, to te them: actuay you re not providing sufficient care, or your heath boards with sufficient money to provide that care, and patients are strugging. Utimatey, you re to bame guys don t bame the heath boards you re to bame. Basicay, we re seeing the NHS being removed by steath. The government are going to be very cross with me, but I have a duty to speak on behaf of patients, so there you go! [Does the poiticisation of heath care make it difficut for you to expose probems?] Yes, if it ands in the minister s ap and the minister doesn t ike it! There be a eve of ba bouncing between government civi servants and the CHCs simpy because they don t want that to and on the Minister s desk. I can t say I bame them. But it is my job to speak honesty on behaf of patients. Patients are David to the NHS Goiath and how on earth can they possiby fight that giant? Chief Executive, CHC in Waes (073); transcription 4:32 The roe of critica friend, working in creative tension with a partner heath board, is centra to the scrutiny of oca heath services and advocacy support to compainants (transcription 4:33). However, for some heath boards, these vita reationships may be fraught (transcription 4:34). Moreover, in discussions with such externa organisations, though awareness of the 1000 Lives + programme was evident, monitoring of adherence to its practices was overshadowed by the use of competing performance measures. Heath boards were aso concerned with this issue (transcription 4:35, beow). The Heathcare Standard we ve just got used to, we, for me, it s now much more of a narrative you te your story it s ike we ve gone from a series of MOTs and driving tests and garage inspections to a sticker on the back of the car saying: How s my driving?. It s a bit ike: here s the standards for heath care, how do you think you are doing?. Not one of them is a genuine standard, which reay confuses staff; they re basicay a ist of aspirationa statements and we re eft essentiay to our own devices about how we decide whether we meet them or not. My joke was that they coud have saved a ot of time and money by just printing a ot of mouse-mats with the standards on because it s an aide memoire it s basicay a wish ist. So that s a different approach to quaity improvement. We re now encouraged to be more sef-refective and sef-reiant but it is difficut because peope aways get things wrong and screw up and how do you egisate for that? Executive Director, case site G 1 (011); transcription 4:35 48 NIHR Journas Library

79 DOI: /hsdr03400 HEALTH SERVICES AND DELIVERY RESEARCH 2015 VOL. 3 NO. 40 Patient safety and competing contextua chaenges The 1000 Lives + programme, and the predecessor 1000 Lives campaign, have been impemented during a major structura reconfiguration of NHS Waes. This has created a contextua chaenge, specificay for the eadership and communication of the patient safety agenda (transcription 4:36, beow) adding to the potentia for distraction (transcriptions 4:37 and 4:38). Post reconfiguration, I suppose, the size of the organisation brings its own chaenges it s a huge chaenge how do you communicate things effectivey when you re that big? For 1000 Lives + and other heath board strategies, my biggest chaenge is keeping in touch with what the organisation s priorities are what is [name] chief priority as chief executive, how is he driving that forward if we re going to make things change in ine with his strategy, you ve got to know what it is. If you don t know what it is, how on earth are we going to do that? There re so many tiers to go through now. I don t want to harp back a the time but it s a vaid comparison because before I coud tak directy to the chief executive because I d see him in the corridor, and the medica director; those reationships were direct then, weren t they? Before you had the key peope in your organisation that physica proximity, amost a direct route on a forma and informa basis you woud be kept up to speed when things were going on. But now, it s ost. Associate Director, case site B 2 (009); transcription 4:36 However, the greatest chaenge arises, unsurprisingy, from unstinting financia pressures. A areas of NHS Waes are expected to do more with ess and this confronts the 1000 Lives + programme with a stark chaenge (transcriptions 4:39 and 4:40, beow). If we are to keep up the momentum on 1000 Lives + the area that we need to keep pushing is the business case for quaity to have the evidence from a of the 1000 Lives + improvement programmes to show where the cost savings are to buid that bank of evidence for cost savings through quaity improvement; that s where we need to get to. Poicy ead, Wesh Government (065); transcription 4: Lives + institutionaisation: preiminary understanding of oca impementation Our study focused on the compex interpay of the 1000 Lives + nationa programme in the context of the Wesh heath-care institutiona fied. The unit of anaysis in this study was the process of oca impementation of 1000 Lives + and the three foca interventions seected for detaied consideration: ILQI, RSC and RHAI. The first stage of our anaysis sought to examine the process of institutiona change as it emerged during the progressive bureaucratisation of 1000 Lives + programme, in order to understand the manner in which the programme has become part of the context of the Wesh heath-care institutiona fied. Drawing on the work of Greenwood et a., 227 as we as terminoogy used by Lewin 350 and Schein, 351 we framed such institutiona change through six inked stages: disconfirmation (Greenwood et a. 227 see this stage as triggered by precipitating jots, in this instance recognition that patient safety is a continuing probem), deinstitutionaisation, preinstitutionaisation, theorisation, diffusion and reinstitutionaisation. We aso refect on the impact and interpay of institutiona ogics in the Wesh heath-care fied and, as iustrated in Figures 8 and 9, consider the reationships between dominant and subordinate ogics, be they compementary, co-existent or countervaiing. Queen s Printer and Controer of HMSO This work was produced by Herepath et a. under the terms of a commissioning contract issued by the Secretary of State for Heath. This issue may be freey reproduced for the purposes of private research and study and extracts (or indeed, the fu report) may be incuded in professiona journas provided that suitabe acknowedgement is made and the reproduction is not associated with any form of advertising. Appications for commercia reproduction shoud be addressed to: NIHR Journas Library, Nationa Institute for Heath Research, Evauation, Trias and Studies Coordinating Centre, Apha House, University of Southampton Science Park, Southampton SO16 7NS, UK. 49

80 BUREAUCRATISATION, HEALTH-CARE POLICY AND PATIENT SAFETY Disconfirmation The overarching goas of 1000 Lives + signa the need for institutiona change through an admission that patients are not being cared for as we as they shoud be: what Schein, buiding on Lewin s theories of panned change, cas an act of disconfirmation 350,351 (Figures 10 and 11 and Tabes 6 9). Thus, the process of institutiona change in the Wesh heath-care fied begins with the transmission of the IHI s infuentia MI-PDSA approach via eite institutiona carriers, 403,404 such as ministers and government officias, who, by conveying their poitica advocacy for such change sticking their heads above the poitica parapet, as one respondent put it promote the concept, encouraging others to introduce its ethos and practices by processes of imitation (mimetic institutiona isomorphism 329 ) and/or officia directive (coercive institutiona isomorphism 329 ). In this context, the ogic of the bureaucratic state is dominant, rendering the ogics of coaboration, profession and democracy into a compementary stance under the infuence of ministeria authorisation. However, it shoud be noted that impementation may be undermined when actors find it difficut to meet the organisationa goas by using the expicit poicies and procedures, and proceed to modify them, a process known as gaming 405 (see Figure 11, point 2, and Chapter 7, Reaist anaysis and comparative case study, Sociocutura interaction: agency and strategic negotiation). At the eve of the infrastructura system (see Tabe 6), the systemic egitimisation of the IHI s MI-PDSA approach is signaed by the aigned names: 1000 Lives campaign and 1000 Lives + nationa programme. Meanwhie, its formaisation is marked through the embedding of these patient safety interventions in Wesh heath-care poicy and governance systems. As expanded in Tabe 7, both added democracy and authentication come from pubic sector partner agencies tasked with the externa oversight of heath-care quaity and patient safety, with their inspection regimens encouraging adherence to 1000 Lives + standards, beiefs and norms. Indeed, during the transition from the campaign to the nationa programme, the use of the 1000 Lives + and associated MI-PDSA approach became embedded in the Wesh Government s heath-care poicy, notaby in its tier 1 targets and aigned performance metrics. Deinstitutionaisation At the eve of NHS Waes and its constituent heath boards, deinstitutionaisation, the second facet of the 1000 Lives + oca impementation, can be seen as the 1000 Lives + programme s mandate is egitimised via the Wesh Government s Department of Heath and Socia Care (see Tabe 8). Formaisation then ensues as the programme is paced under the statutory oversight of oca Quaity and Safety Committees (see Figure 11). Through oca acts of co-optation in each heath board, eaders are assigned to each foca intervention. They are tasked to identify potentia systemic faiures, anticipate adverse events and reframe such issues as a socia probem to be addressed through coaboration with heath-care professionas across NHS Waes constituent heath boards. A wider range of heath-care actors are graduay co-opted into 1000 Lives + contributing to the mutiprofessiona and mutisite co-ordination of patient safety. This generates interna chaenge through which previousy accepted standards of quaity and safety for exampe, the nature and frequency of adverse outcomes in theatre 169,191,406 or for centra venous catheter-reated boodstream infections 407 are viewed in a pejorative ight. Practitioners, acting as institutiona entrepreneurs, 41 now coectivey adopt a new normative standard eading to practice-based change 181 and the rejection of od habits. This eads to institutiona change and strengthens the coective wi to create an organisationa cuture attuned to quaity improvement NIHR Journas Library

81 FIGURE 10 Bureaucratisation of 1000 Lives + : hierarchica metamechanism operating across the contextua strata of the infrastructura system and institutiona setting. Continued: Figure 11 NHS Waes as a corporate whoe Tabe 8: I-CMAO configuration Co-optation Formaisation Legitimisation Structura conditioning Subordinate ogics Performance management Coaboration Professionaism Democracy Verification Democratisation 1 Pubic sector partner agencies Tabe 7: I-CMAO configuration Legitimisation Formaisation Dominant ogic Bureaucratic state Wesh Government Tabe 6: I-CMAO configuration Negotiation Transmission Co-optation Hierarchica metamechanism Mimetic isomorphism Coercive isomorphism Normative isomorphism Higher-order societa ogics mouding the contextua arena Institutiona setting NHS Waes as a corporate whoe NHS Waes seven heath boards Infrastructura system Higher-order societa ogics mouding the contextua arena Wesh Government Pubic sector partner agencies (e.g. community heath councis) DOI: /hsdr03400 HEALTH SERVICES AND DELIVERY RESEARCH 2015 VOL. 3 NO. 40 Queen s Printer and Controer of HMSO This work was produced by Herepath et a. under the terms of a commissioning contract issued by the Secretary of State for Heath. This issue may be freey reproduced for the purposes of private research and study and extracts (or indeed, the fu report) may be incuded in professiona journas provided that suitabe acknowedgement is made and the reproduction is not associated with any form of advertising. Appications for commercia reproduction shoud be addressed to: NIHR Journas Library, Nationa Institute for Heath Research, Evauation, Trias and Studies Coordinating Centre, Apha House, University of Southampton Science Park, Southampton SO16 7NS, UK. 51

82 BUREAUCRATISATION, HEALTH-CARE POLICY AND PATIENT SAFETY Figure 10: key point summary In Figure 10 we depict the bureaucratisation of the 1000 Lives + nationa programme across the infrastructura system and institutiona setting of the Wesh heath-care fied. In point 1 the process of institutiona change begins with the transmission of the IHI s hegemonic MI-PDSA approach via eite institutiona carriers, who enact mimetic institutiona isomorphism to introduce its practices within the Wesh heath-care fied. In point 2 eite institutiona agents, through acts of co-optation and negotiation, spread and egitimise the MI-PDSA approach, graduay co-opt others through mimetic and coercive institutiona isomorphism. The egitimisation of the IHI s MI-PDSA approach is signaed by the aigned names 1000 Lives + campaign and 1000 Lives + nationa programme. In point 3 the formaisation of the 1000 Lives + nationa programme is marked by the embedding of its patient safety interventions in Wesh heath-care poicy notaby tier 1 performance targets and associated interna and externa governance systems. In this manner, the context is conditioned for NHS Waes, its constituent heath boards and their empoyees at the departmenta eve or that of the ward-based functiona team. In point 4 foowing the egitimisation of the 1000 Lives + programme s mandate, adverse events are reframed as a socia probem to be addressed through the coaborative engagement and the ensuing agency of heath-care professionas in NHS Waes constituent heath boards. Locaised formaisation is seen, cataysing mutiprofessiona and mutisite co-ordination of patient safety via the statutory Quaity and Safety Committee and aigned governance structures, augmented by distributed eadership of the patient safety agenda across the manageria strata. 52 NIHR Journas Library

83 DOI: /hsdr03400 HEALTH SERVICES AND DELIVERY RESEARCH 2015 VOL. 3 NO. 40 Interpersona reations Hospita mutisite department Hospita site-based ward (functiona team) Individua Individua Dominant ogic Bureaucratic state Subordinate ogics Performance management Coaboration Professionaism Democracy NHS Waes heath boards Tabe 8: I-CMAO configuration Legitimisation Formaisation Co-optation 1 2 Mimetic isomorphism Coercive isomorphism Normative isomorphism Structura conditioning Hierarchica metamechanism Structura change Board-eve eadership Quaity and Safety Committee Hospita mutisite department Tabe 9: I-CMAO configuration Structura change Audit 1000 Lives + nationa programme paperwork Innovation Hospita site-based ward (functiona team) Tabe 9: I-CMAO configuration Identification Knowedge mobiisation Vaidation Legitimisation Mora/ pragmatic Individua Emancipation FIGURE 11 Bureaucratisation of 1000 Lives + : hierarchica metamechanism operating across the contextua strata of the interpersona system within NHS Waes heath boards. Queen s Printer and Controer of HMSO This work was produced by Herepath et a. under the terms of a commissioning contract issued by the Secretary of State for Heath. This issue may be freey reproduced for the purposes of private research and study and extracts (or indeed, the fu report) may be incuded in professiona journas provided that suitabe acknowedgement is made and the reproduction is not associated with any form of advertising. Appications for commercia reproduction shoud be addressed to: NIHR Journas Library, Nationa Institute for Heath Research, Evauation, Trias and Studies Coordinating Centre, Apha House, University of Southampton Science Park, Southampton SO16 7NS, UK. 53

84 BUREAUCRATISATION, HEALTH-CARE POLICY AND PATIENT SAFETY Figure 11: key point summary In Figure 11 we extend our depiction of the bureaucratisation of the 1000 Lives + nationa programme to consider the interpersona eve. In point 1 innovation is seen to be brokered through the pragmatic evidence-based earning of the 1000 Lives + embedded MI-PDSA approach. This is driven by coercive, mimetic and normative institutiona isomorphism. Importanty, at this juncture, as iustrated in Figure 9, professiona ogic asserts dominance, thereby generating the potentia for discord. In point 2 identification and awareness of systemic patient safety faiings, fostered through the testing of a rapid cyce of change with the MI-PDSA approach, heightens coaboration and communication across the mutidiscipinary team, giving rise to knowedge mobiisation and greater understanding of variation in heath-care service deivery. Yet the burden of data coection and demands of vaidation may retard meaningfu engagement and give rise to the situated practice of gaming. This increased knowedge and understanding of the unfoding change reveas common areas of faiing systemic and human so that the conceptuaisation of the desired institutiona change is further refined. In this manner, the mora and pragmatic egitimisation of 1000 Lives + arises, heping to overcome reuctance and resistance to engage and its institutionaisation across NHS Waes. 54 NIHR Journas Library

85 DOI: /hsdr03400 HEALTH SERVICES AND DELIVERY RESEARCH 2015 VOL. 3 NO. 40 TABLE 6 Intervention context mechanism agency outcome configuration: infrastructura system Wesh Government Intervention Context Mechanism 1000 Lives + nationa programme Wesh Government Institutiona isomorphism: mimetic, coercive and normative Agency and institutiona work Agency transmission eite institutiona carriers enact mimetic institutiona isomorphism, adopting the IHI s hegemonic MI-PDSA approach to patient safety Institutiona work creation eite institutiona actors reconfigure key actors beief systems Exempar transcriptions: 4:05 (T145) couping 4:07 (T081) couping Agency co-optation eite institutiona actors empoy their poitica advocacy and socia position to foster the co-optation of others across their manageria and professiona networks Institutiona work creation eite institutiona actors reconfigure key actors beief systems Exempar transcriptions: 4:06 (T054) couping 4:09 (T054) decouping 4:10 (T081) couping Agency negotiation eite institutiona actors and co-opted others set the strategic direction Institutiona work creation eite institutiona actors enact poitica work to reconstruct rues, rights and access to resources, thereby inking 1000 Lives + nationa programme to tier 1 performance targets Exempar transcriptions: 4:02 (T145) couping 4:07 (T081) couping Agency egitimisation eite institutiona actors and co-opted others embrace 1000 Lives + and MI-PDSA approach and embed in heath-care poicy and performance frameworks Institutiona work creation eite institutiona actors enact poitica work to reconstruct rues, rights and access to resources, thereby inking 1000 Lives + nationa programme to tier 1 performance targets Institutiona work disruption eite institutiona actors dissociate from 1000 Lives +, fostering decouping Exempar transcriptions: 4:01 (T146) couping 4:02 (T145) couping Agency formaisation mandated engagement with 1000 Lives + and the MI-PDSA approach to address NHS Waes organisationa faiings and attain nationa heath-care standards Institutiona work creation eite institutiona carriers enact poitica work to reconstruct rues, rights and access to resources, thereby inking 1000 Lives + nationa programme to tier 1 performance targets Exempar transcriptions: 4:03 (T124) couping 4:04 (T150) couping 4:08 (T143) couping Outcome 1000 Lives + nationa programme institutionaised into poicy processes Queen s Printer and Controer of HMSO This work was produced by Herepath et a. under the terms of a commissioning contract issued by the Secretary of State for Heath. This issue may be freey reproduced for the purposes of private research and study and extracts (or indeed, the fu report) may be incuded in professiona journas provided that suitabe acknowedgement is made and the reproduction is not associated with any form of advertising. Appications for commercia reproduction shoud be addressed to: NIHR Journas Library, Nationa Institute for Heath Research, Evauation, Trias and Studies Coordinating Centre, Apha House, University of Southampton Science Park, Southampton SO16 7NS, UK. 55

86 BUREAUCRATISATION, HEALTH-CARE POLICY AND PATIENT SAFETY TABLE 7 Intervention context mechanism agency outcome configuration: infrastructura system pubic sector partner agencies Intervention Context Mechanism 1000 Lives + nationa programme Pubic sector partner agencies Institutiona isomorphism: predominanty normative Agency and institutiona work Agency formaisation mandated engagement with 1000 Lives + and the MI-PDSA informs the inspection regimens adopted by pubic sector partner agencies Institutiona work maintenance pubic sector partner agencies inspection regimens foster adherence to 1000 Lives + standards, espoused beiefs and norms Agency democratisation patient and pubic voice harnessed providing democratic chaenge to improve patient safety Institutiona work maintenance pubic sector partner agencies inspection regimens foster adherence to 1000 Lives + standards, espoused beiefs and norms Exempar transcriptions: 4:32 (T073) couping 4:33 (T087) couping Agency verification eve of attainment of 1000 Lives + standards informs the externa oversight of patient safety and further informs interna NHS and Wesh Government monitoring of heath-care standards Institutiona work maintenance pubic sector partner agencies inspection regimens foster adherence to 1000 Lives + standards, espoused beiefs and norms Exempar transcriptions: 4:31 (T060) couping 4:34 (T075) couping 4:35 (T011) decouping Outcome 1000 Lives + nationa programme institutionaised within existing processes supporting the externa oversight of patient safety TABLE 8 Intervention context mechanism agency outcome configuration: institutiona setting NHS Waes and constituent heath boards Intervention Context Mechanism 1000 Lives + nationa programme NHS Waes as a corporate whoe/nhs Waes heath boards Institutiona isomorphism: coercive Agency and institutiona work Agency egitimisation 1000 Lives + becomes part of the anguage and practice of patient safety in NHS Waes. Institutiona entrepreneurs reassert a normative standard to hasten practice-based change Institutiona work creation eite board-eve institutiona actors undertake poitica work to reconstruct rues, rights and access to resources, thereby inking 1000 Lives + nationa programme to the attainment of the Wesh Government s tier 1 performance targets Exempar transcriptions: 4:11 (T146) couping Agency formaisation mutiprofessiona and mutisite co-ordination of patient safety via the statutory Quaity and Safety Committee and aigned governance structures Institutiona work creation eite board-eve institutiona actors undertake poitica work to reconstruct rues, rights and access to resources, thereby inking 1000 Lives + nationa programme to the attainment of the Wesh Government s tier1performance targets Exempar transcriptions: 4:12 (T011) couping 4:13 (T074) couping 4:14 (T026) couping 4:15 (T049) couping Agency co-optation distributed eadership of the patient safety agenda across the manageria strata Institutiona work creation eite board-eve institutiona actors undertake poitica work to reconstruct rues, rights and access to resources, thereby inking 1000 Lives + nationa programme to the attainment of the Wesh Government stier1performancetargets Exempar transcriptions: 4:16 (T012) couping 4:17 (T043) couping 4:18 (T022 couping 4:19 (T025) couping Outcome 1000 Lives + nationa programme institutionaised within existing processes supporting the interna oversight of patient safety 56 NIHR Journas Library

87 DOI: /hsdr03400 HEALTH SERVICES AND DELIVERY RESEARCH 2015 VOL. 3 NO. 40 TABLE 9 Intervention context mechanism agency outcome configuration: interpersona reations hospita mutisite department/hospita site-based ward (functiona team) Intervention Context Mechanism 1000 Lives + nationa programme Hospita mutisite department/hospita site-based ward (functiona team) Institutiona isomorphism: coercive, mimetic, progressing to normative Agency and institutiona work Agency innovation individua and organisationa pragmatic evidence-based earning is demonstrated through adherence to the MI-PDSA approach Institutiona work creation functiona team s beief and meaning systems reconfigured Exempar transcriptions: 4:20 (T070) couping Agency identification performance measurement and monitoring of patient safety heighten awareness of faiings Institutiona work creation functiona team s beief and meaning systems reconfigured Exempar transcriptions: 4:18 (T022) couping Agency knowedge mobiisation coaboration and heightened communication across the mutidiscipinary team promotes individua, team and organisationa earning Institutiona work creation functiona team s beief and meaning systems reconfigured Exempar transcriptions: 4:21 (T052) couping Agency vaidation data coection for formaised patient safety governance monitoring demonstrates attainment of tier 1 targets Institutiona work maintenance functiona team s performance supports adherence to existing interna and externa governance systems Exempar transcriptions: 4:22 (T060) couping 4:26 (T056) couping 4:29 (T060) couping Agency egitimisation (mora/pragmatic) 1000 Lives + mora and pragmatic egitimacy fosters mainstreaming of the intervention across NHS Waes Institutiona work creation functiona team s beief and meaning systems reconfigured Exempar transcriptions: 4:40 (T065) couping Agency emancipation 1000 Lives + and the MI-PDSA approach faciitate informed chaenge and change of the status quo Institutiona work disruptive functiona team s underpinning core assumptions and beiefs adapted to new heath-care roe-position practices Exempar transcriptions: 4:20 (T070) couping Outcome 1000 Lives + nationa programme institutionaised in daiy heath-care practice Queen s Printer and Controer of HMSO This work was produced by Herepath et a. under the terms of a commissioning contract issued by the Secretary of State for Heath. This issue may be freey reproduced for the purposes of private research and study and extracts (or indeed, the fu report) may be incuded in professiona journas provided that suitabe acknowedgement is made and the reproduction is not associated with any form of advertising. Appications for commercia reproduction shoud be addressed to: NIHR Journas Library, Nationa Institute for Heath Research, Evauation, Trias and Studies Coordinating Centre, Apha House, University of Southampton Science Park, Southampton SO16 7NS, UK. 57

88 BUREAUCRATISATION, HEALTH-CARE POLICY AND PATIENT SAFETY Preinstitutionaisation This constitutes the third facet of the oca impementation of the 1000 Lives + programme and is demonstrated at the interpersona eve, impacting functiona teams, be they the executive board or ward-based cinicians. Importanty, as iustrated in Figure 9, in the context of the hospita department or ward-based functiona team, professiona ogic (re)gains dominance. This creates the potentia for discord between the different professiona ogics of heath-care management, medicine, nursing and other aied professiona groups, athough Tabe 9 depicts this in a benign manner. As iustrated in Figure 11, innovation can emerge from the evidence-based earning of the MI-PDSA approach. 172,409,410 The use of data to inform practice heightens the identification and awareness of systemic patient safety faiings. 24,181,411 Furthermore, coaboration and communication across the mutidiscipinary team is increased through testing of a rapid cyce of change. 172,180,187,412 This gives rise to knowedge mobiisation and greater understanding of variation in heath-care service deivery. 187 However, the burden of data coection and demands of vaidation may retard meaningfu engagement and give rise to the practice of gaming. 405 In addition, because performance measurement and monitoring systems are mandatory, the ogic of the bureaucratic state again asserts dominance. This again creates the potentia for discord among ogics as iustrated by the decouping expressed in the exempar transcriptions. Theorisation This is centra to the conceptua framework empoyed in our study. Greenwood et a. 227 contend that this manifests through the (i) specification of genera organisationa faiings; (ii) justification of abstract possibe soutions; and (iii) assertions of mora and pragmatic egitimacy. Hence, in refining perceptions of cause and effect, refexive theorisation represents a key stage in individua and coective socia actors adaptive response to institutiona change. 413 It underpins the notion of mechanism, set out in Chapter 2, as the embodiment of an agent s reasoning and their seective attention to the disparate resources offered through the 1000 Lives + nationa programme. As depicted in Figure 11, the impementation and bureaucratisation of 1000 Lives + increases knowedge and understanding of the unfoding change, reveaing common areas of faiing and enabing refinements to be made. Such egitimisation heps to overcome reuctance and resistance to engage, 127,414,415 and so aids its institutionaisation across NHS Waes. This end may be achieved through mutidiscipinary team-based discussion, 169,189,219 incuding focus groups with patients 151,416 and heath-care professionas, 417 together with dedicated support for interorganisationa earning. 261,418 Such processes aid emancipation of staff, giving them the authority, whatever their rank, to insist on correct safety procedures being foowed. However, shoud this theorisation stage fai to change peope s vaues and attitudes appropriatey, this may precipitate institutiona decouping, 348,349 giving rise to the emergence of a egitimacy façade 85 and the faiure of the intervention. Diffusion Diffusion through wider adoption constitutes the fifth facet of the oca impementation of the 1000 Lives + programme. However, as noted by Berwick, 419 continuous effort is required to maintain and spread the gain associated with such practice change. As iustrated in Tabe 7, at this interface the ogic of democracy assumes dominance, fostering the externa oversight of patient safety via pubic sector partner agencies inspection regimens to support this goa. Reinstitutionaisation This is the fina facet of the 1000 Lives + oca impementation, refecting widespread organisationa acceptance of and adherence to the new programme. However, this, too, in acknowedging an ongoing commitment to the embedded MI-PDSA approach, must evove with the shifting dynamic of the evidence-base 3 5 and progressive rehabituaisation NIHR Journas Library

89 DOI: /hsdr03400 HEALTH SERVICES AND DELIVERY RESEARCH 2015 VOL. 3 NO. 40 Summary In Chapter 4, we anayse the structura change inherent to bureaucratisation of the 1000 Lives + programme at the higher, infrastructura system eve of the Wesh heath-care fied. This anaysis defines our preiminary understanding of the programme s oca impementation and how the 1000 Lives + programme becomes part of the context of the Wesh heath-care institutiona fied. Queen s Printer and Controer of HMSO This work was produced by Herepath et a. under the terms of a commissioning contract issued by the Secretary of State for Heath. This issue may be freey reproduced for the purposes of private research and study and extracts (or indeed, the fu report) may be incuded in professiona journas provided that suitabe acknowedgement is made and the reproduction is not associated with any form of advertising. Appications for commercia reproduction shoud be addressed to: NIHR Journas Library, Nationa Institute for Heath Research, Evauation, Trias and Studies Coordinating Centre, Apha House, University of Southampton Science Park, Southampton SO16 7NS, UK. 59

90

91 DOI: /hsdr03400 HEALTH SERVICES AND DELIVERY RESEARCH 2015 VOL. 3 NO. 40 Chapter 5 Institutionaisation of the 1000 Lives + programme in NHS Waes: normaisation, heath-care practices and patient safety Overview This chapter continues our examination of the institutionaisation of the 1000 Lives + patient safety programme in NHS Waes. Presented in three main parts, it is focused at contextua eves beow the fied eve and expores interpersona and individua engagement with 1000 Lives + to gain a deeper understanding of its progressive normaisation across NHS Waes. First, guided by the mode proposed by May et a., 352,353 we anayse the patient safety iterature to consider mechanisms that may foster the normaisation of compex interventions in daiy heath-care practice. Second, we enrich this expanatory anaysis through consideration of in-depth discussions hed with a wide range of heath-care practitioners concerning their perceptions of the normaisation of 1000 Lives + and the deveopment of patient safety practices in NHS Waes. Specificay, we examine the 1000 Lives + MI-PDSA approach, the distributed eadership and the teamwork inherent to its operationaisation. We then iustrate the nuanced impact of pride and shame in buiding the ethos of patient safety and examine the pragmatic issues that foster institutiona couping to, or decouping from, such activities. Finay, we eaborate our understanding of the oca impementation of the 1000 Lives + programme. This forms the foundation for our anayses of the three foca interventions presented in Chapters 6 8. Possibe mechanisms fostering the normaisation of 1000 Lives + As discussed in Chapter 2, we draw on institutiona theory to inform our understanding of the generative mechanisms, specificay the roes of contextua constraints and enabements, and ensuing refexive theorisation; and May s 352,353 moduating roes of coherence, cognitive participation, coective action and refexive monitoring, thought to foster the normaisation of 1000 Lives + in NHS Waes. Coherence As expressed in May s normaisation process theory, 352,353 coherence means that a practice an ensembe of beiefs, behaviours and acts that manipuate or organise objects and others is made possibe by a set of ideas about its meaning, uses and utiity and by sociay defined and organised competencies. 353 In this regard, the 1000 Lives + programme may be seen as a materia object which faciitates the improvement of the patient safety in NHS Waes through the way in which the heath-care team, both individuay and coectivey, think about and understand its meaning and carry out the practices invoved. As evident from patient safety studies undertaken in NHS Waes, 210 the coherence and foundationa competence of the 1000 Lives + programme is ceary inked to the underpinning MI-PDSA approach. 178,219 This method of service improvement has been advocated in heath care for many years and its widespread adoption in deveoped heath-care systems promotes heath-care actors awareness of the MI-PDSA approach as accepted practice, 353 so aiding its embedding into day-to-day working. 186 Cognitive participation The 1000 Lives + programme is normaised through ongoing cognitive participation, defined by May and Finch 353 as the symboic and rea enroments and engagements of human actors that position them for the interactiona and materia work of coective action. Queen s Printer and Controer of HMSO This work was produced by Herepath et a. under the terms of a commissioning contract issued by the Secretary of State for Heath. This issue may be freey reproduced for the purposes of private research and study and extracts (or indeed, the fu report) may be incuded in professiona journas provided that suitabe acknowedgement is made and the reproduction is not associated with any form of advertising. Appications for commercia reproduction shoud be addressed to: NIHR Journas Library, Nationa Institute for Heath Research, Evauation, Trias and Studies Coordinating Centre, Apha House, University of Southampton Science Park, Southampton SO16 7NS, UK. 61

92 NORMALISATION, HEALTH-CARE PRACTICES AND PATIENT SAFETY Athough cognitive participation in the 1000 Lives + programme is underpinned by the MI-PDSA approach, specificay with regard to the promotion of a consistent approach across its muticomponent improvement programmes, 424 other resources make vauabe contributions. For exampe, the 1000 Lives + programme team, improvement guides and oca and nationa earning events each faciitate cognitive participation through education and practice-based ski deveopment. Such earning, whether at an individua, 187,421, an organisationa 12,411 or a system-wide eve, 24,428 is fundamenta to heath-care practice change, as is the need for senior organisationa eaders to deveop a comparabe eve of awareness of 1000 Lives +, the MI-PDSA approach and associated drivers. 429 Cognitive participation thus heps to ensure that systemic and organisationa factors giving rise to patient negect are addressed, 430 whie knowedge sharing and trust are enhanced. 431 Coective action The cognitive participation of socia actors gives rise to coective purposive action aimed at some goa. However, with respect to the 1000 Lives + programme, such goa-orientation may incude resistance, subversion or reinvention, as we as affirmation and compiance with the core features of this patient safety programme. The normaisation of 1000 Lives + is, therefore, dependent on institutiona and professiona work that defines and operationaises the desired features of 1000 Lives +, aigned factors which promote or inhibit socia actors enacting of 1000 Lives + and socia actors coective investment of effort in such practices. 353 For the 1000 Lives + programme, two processes which faciitate coective action are interactiona workabiity and reationa integration. 352 These invove cross-team co-operation, 432 notaby via enhanced communication; 433,434 the deveopment of shared goas, meanings and expectations; 435 and accountabiity and confidence in the interna and externa credibiity fostered by mandated oca and nationa monitoring of 1000 Lives +. Furthermore, given the expicit steps defined in each discrete patient safety intervention, 1000 Lives + represents a vaid and recognised practica aide memoire. In this way, the programme heps to increase awareness of patient-reated issues, procedures and anticipated risks across functiona heath-care teams, 436 incuding both pubic and popuation heath care. 437 Other processes which faciitate coective action are ski-set workabiity and contextua integration. 352 Ski-set workabiity describes how work is divided up among practitioners with different but compementary skis. 353 For exampe, empirica investigation of the WHOSSC, the foca intervention discussed in Chapter 7, supports the view that defined aocation of work, where the assessment of intraoperative bood oss is apportioned to surgeons, patient-specific airways management to the anaesthesia team and steriity and equipment issues to nurses, 438 enhances the performance of the operating theatre team. However, such task definition does remain susceptibe to entrenched roe boundaries and perceived surgica autonomy, which may impact adversey on safety cuture. 439 Contextua integration, as the term suggests, refers to the integration of 1000 Lives + within a socia context and its interpay with extant structures and organisationa procedures. As May and Finch 353 point out, integration may not be easy to achieve in some contexts and wi require coective effort from those invoved. Refexive monitoring Practices, even when estabished, demand refexive monitoring to ensure appropriate performance. 338,353,440 Patterns of coective action, and their outcomes, are therefore continuousy evauated by participants in impementation processes, both formay and informay, and with a greater or esser degree of intensity depending on their interest and invovement. 353 The normaisation of the 1000 Lives + programme in day-to-day practice is, therefore, dependent on institutiona and professiona work that defines and organises the everyday understanding of 1000 Lives +, aigned factors which promote or inhibit socia actors appraisa of 1000 Lives + and socia actors coective investment in its ongoing theorisation and refined understanding NIHR Journas Library

93 DOI: /hsdr03400 HEALTH SERVICES AND DELIVERY RESEARCH 2015 VOL. 3 NO. 40 Individua and coective refection of actua practice against expicit and more tacit norms, whie centra to the embedding of a practice, 356, may differ markedy from forma governance procedures and standards, in some cases giving rise to a façade of egitimacy. 85 Empirica studies of patient safety have aso highighted the human barriers to incident reporting, despite its centra roe in organisationa earning and the estabishment of a stronger safety cuture. 412 In the foowing section, we seek to examine the views and experiences of individuas and groups during the institutionaisation of the 1000 Lives + programme, and so to understand the processes invoved in the operationaisation, subversion or reconstruction of its associated practices Lives +, heath-care practice and patient safety During in-depth discussions with a wide range of heath-care practitioners across NHS Waes, we asked each participant to refect on the notion of context. As set out beow, transcription 5:01 succincty expresses the sense of context as situated, demarcated by reationa ties and distinct from that of the wider organisation. I think what is key, when you consider the way in which 1000 Lives + is impemented, is consideration of context. [What do mean by context?] The immediate area of its impementation and the peope invoved. Look, you can work with one ward to impement it. They do it there, and you can then spread it; but when you do spread it you have to customise it to make it work for the peope who are there in that new context. You can t just pick up something deveoped in one area of your organisation and assume it wi fit into another without you, at east, considering where they re coming from! So, you can t reay define organisationa context to impement, context has to be kept reay sma you work within that area, have a testing period, and then spread and renew. That s how it s done. I think that is key to a ot of what we can manage. Associate Director, case site C 2 (014); transcription 5:01 This perception is repicated throughout our discussions and subsequent anaysis of the impementation and operationaisation of 1000 Lives +. As one respondent described, 1000 Lives + has normaised in discrete pockets. This has created disparity between adjacent wards within a given hospita case site (transcription 5:02, beow). What I see is pockets of interests in 1000 Lives +.It s ed by individuas who have cutivated a team around them and given them work to do, so it s being ed by peope who are enthusiastic or buy into certain areas where their interests ie. But it s not systemic: there are good pockets in the organisation and areas that aren t reached you can have wards on opposite sides of a corridor where one s engaged and the other isn t. As a consequence, it s reying on enthusiasm rather than a systematic approach. Sustainabiity at an organisationa, corporate eve is needed, so that everything is aigned toward patient safety. Executive Director, Workforce and Organisation Deveopment, case site G 1 (012); transcription 5:02 Normaisation is, thus, restricted to those who perceive meaning in 1000 Lives + owing to aignment with their beiefs, and whose cognitive participation and commitment buids and co-ordinates the engagement of others. This finding offers expanatory insight into the perceived faiure of such compex patient safety interventions 168 and underscores Pawson s iron aw of evauation: the expected vaue of any net impact assessment of any arge scae socia program is zero. 241 Queen s Printer and Controer of HMSO This work was produced by Herepath et a. under the terms of a commissioning contract issued by the Secretary of State for Heath. This issue may be freey reproduced for the purposes of private research and study and extracts (or indeed, the fu report) may be incuded in professiona journas provided that suitabe acknowedgement is made and the reproduction is not associated with any form of advertising. Appications for commercia reproduction shoud be addressed to: NIHR Journas Library, Nationa Institute for Heath Research, Evauation, Trias and Studies Coordinating Centre, Apha House, University of Southampton Science Park, Southampton SO16 7NS, UK. 63

94 NORMALISATION, HEALTH-CARE PRACTICES AND PATIENT SAFETY Acknowedgement of the fragmented nature of its normaisation does not, however, detract from the undeniabe focus that 1000 Lives + offers heath-care practitioners in NHS Waes. Those who vaue the initiative consider it as something rea and visibe that they can use to hep them to forward the cause of patient safety (transcription 5.03, beow). Before 1000 Lives and 1000 Lives + before SPI [Safer Patients Initiative] peope were saying: we want to keep patients safe, we don t want to do them harm. We, of course, that s what we want to do, I mean, that s a given. But with patient safety now, we have the 1000 Lives + ogo, we have information at the front of the hospita; there s something you can hang your hat on! It has rea organisation! It s not just some nebuous patient safety concept. There s somebody eading it, there were newsetters, there are graphs so that you can see, you can see the improvements that have been made Lives + is making it rea, I woud say not that it wasn t rea before but, you know, now it has something; it s tangibe, it s a coordinated, it s centraised. So, say if somebody had a good idea for improving patient safety, rather than saying: sha I go to my ine manager? We, they re never any good, they nod but they won t do anything, who ese can I go to?. They ve got someone you can go to! You ve got the 1000 Lives + patient safety group, and you just go on the intranet and find out the reevant person, and you know they wi take it seriousy. They may or may not be managing it but you know they wi take it seriousy because that s what they do that s the hat that they wear so they re not trying to jugge between cinica effectiveness, patient safety, and saving money. Patient safety isn t just something competing for their time, their skis and resources. That is what 1000 Lives + is: it starts and finishes with patient safety. Pharmacist, Antibiotics Medicines Management, case site D 2 (020); transcription 5:03 Such coherence appears to resonate equay with patients and with the pubic (transcription 5:04). On the other hand, there is a sense that bureaucratic impatience may be hampering the successfu impementation of 1000 Lives + across NHS Waes, eaving some staff in its wake (transcription 5:05, beow). I think with 1000 Lives + we have been pushed on to get on to the next ones [improvement programmes] before it s sort of embedded. For exampe, the NEWS Score [Nationa Eary Warning Score] is not embedded, it s embedding. Ward manager, case site C 3 (T080); transcription 5:05 For instance, athough aware of the 1000 Lives + programme, some key medica staff remain disengaged (transcriptions 5:06 and 5:07, beow). I ve had doctors teing me that it s, you know, not nonsense but it s one of those fads. So they ve obviousy made up their mind they re not going to pay any attention to 1000 Lives + and it s ofno reevance to them. I think, as with anything, you have peope just being boody minded for whatever reason! Associate Director, case site F 1 (026); transcription 5:06 I think some consutants aren t aware of 1000 Lives +. They have it in their periphera fied. They are aware that it exists but it doesn t impact on their ives, and some think it s probaby a good thing but it sti doesn t impact on their ives. Consutant gastroenteroogist, case site F 1 (027); transcription 5:07 64 NIHR Journas Library

95 DOI: /hsdr03400 HEALTH SERVICES AND DELIVERY RESEARCH 2015 VOL. 3 NO. 40 The poicy pacing and positioning of the 1000 Lives + programme across NHS Waes is, therefore, contributing to the fragmentation of its normaisation. Unequa engagement with the resources offered by this patient safety intervention further stymies progress, as its main adherents are those who are invoved in, and aready agree with, the aspirations of the programme (transcription 5:09, beow). Ithinkwith1000Lives + they re seing it to those who ve bought in you know, the peope who are designing the programmes and deivering them Ithinkit s importanttothem.butwhetherstaffinthe NHS are reay engaged, I don t know.imean,here,andthisisasmahospita,wedon t getadoctors foowing the sticker initiative [antibiotic prescribing guideines]. Some do, some don t: there s awaysan excuse not to do it, whether it s toomuchwork,tootime-consuming,whatever,theyawayshaveexcuses. Another aspect to this, though, is the rate of turnover. FP1 2s [junior doctors undertaking foundation training] rotate so quicky, and they may not be within the same heath board, et aone hospita, so there s itte time for them to earn the system before they re off again. On the whoe, it s thestaffthatdon t rotate that maintain the system against, or despite, those who are just passing through. Pharmacist, Antibiotics Medicines Management, case site B 2 (001); transcription 5:09 The meaningfu engagement of wider NHS staff is undeniaby key to the normaisation and sustainabiity 1000 Lives +. Specificay, non-rotating staff are centra, as they provide the contextua and reationa continuity necessary for coherence. This is the foundation the programme must return to, and reinforce, to prevent the dissipation of its goas (transcription 5:10). Mode for Improvement, Pan-Do-Study-Act approach The centra roe of the MI-PDSA approach, asserted in Putative mechanisms fostering the normaisation of 1000 Lives +, is ceary evident in the study s participant heath boards. This approach provides a recognised framework for heath-care practice change and feedback that, through the Improving Quaity Together website, benefits from institutiona work via the ongoing support of the 1000 Lives + nationa programme (transcription 5:11, beow, and transcription 5:12). The PDSA approach provides a framework for improvement but you sti need eadership, you need ideas and execution, so you ve sti got to generate the wi in the peope that you re working with first. Then you ve got to have change ideas that are based on evidence and not just pucked out of the air you actuay have things that have to be tested and then you test them; you don t just assume they work in practice. But the approach gives peope the freedom to test them, measure and earn from the process. So, I think, if I was to say anything, it s a framework, and its heped teams to focus on a name, on a measure, that wi te them whether or not they re getting towards their aim, and on a change that wi hopefuy hep them to achieve that aim. Wesh Government, poicy ead (033); transcription 5:11 Transcription 5:13, beow, describes the roe of PDSA in buiding coherence, cognitive participation and coective action to enabe heath-care staff to design and deiver practice change. The mode for improvement [MI-PDSA], we it s, it s a tried and tested approach, part of improvement science. Look, traditionay we ve gone: here s a probem; here s the soution, and we ve tried to fit the probem to the soution even if it invoves putting a square peg in a round hoe just get on and do it! And, for a sorts of reasons, peope don t just get on and do it because, because things aren t fit for purpose. So the issue of using the mode for improvement is you enabe peope. You start from the very beginning, you know you expose the need you propery measure and identify the probem and enabe peope to understand that the probem ies with them and that they can do something about it, which is quite empowering. And then, obviousy, you guide a soution, and some of those soutions are their own, though most of the time we take an evidence-based practice approach. We introduce them to the evidence-based practice and the methodoogy the improvement methodoogy so that they can go out and they can get started straight away by having an idea, testing it on one patient one time, one nurse, one doctor! It s quick and easy, it doesn t require whoe Queen s Printer and Controer of HMSO This work was produced by Herepath et a. under the terms of a commissioning contract issued by the Secretary of State for Heath. This issue may be freey reproduced for the purposes of private research and study and extracts (or indeed, the fu report) may be incuded in professiona journas provided that suitabe acknowedgement is made and the reproduction is not associated with any form of advertising. Appications for commercia reproduction shoud be addressed to: NIHR Journas Library, Nationa Institute for Heath Research, Evauation, Trias and Studies Coordinating Centre, Apha House, University of Southampton Science Park, Southampton SO16 7NS, UK. 65

96 NORMALISATION, HEALTH-CARE PRACTICES AND PATIENT SAFETY engagement of masses of staff, they can just go out and graduay, graduay buid and earn from those very sma tests of change and they can adapt existing materia to make it fit for purpose. We ve got the methodoogy it s simpe, it s safe it requires itte or no investment at the beginning in terms of staff resource. There is strong eadership over supporting a of these programmes, so that there is an accountabiity route, so you can t just go away and do nothing, there are ines of accountabiity through oca working, through direct and divisiona quaity and safety meetings, and then through to the steering the 1000 Lives + steering group and the quaity and safety committee. But it s simpe, the methodoogy is simpe, it s intuitive, ogica, and it s reay enabing peope to deveop and make the system do what is right to do, easy to do. Associate Director, case site D 1 (049); transcription 5:13 The inherent simpicity of the approach is viewed to aid its adoption and the sense of oca ownership and engagement that underpin its normaisation across NHS Waes (transcriptions 5:14, 5:15 and 5:16). Moreover, as iustrated in transcription 5:17, beow, the MI-PDSA approach heps in surfacing the need for improvement, and confidence in the efficacy of its structured processes gives a sense of security that faciitates positive sma steps towards change. We, I think, fundamentay, it provides us with a foca point to get around the tabe to actuay acknowedge there s a probem in the first pace and that we ve got a structure to foow that s going to take us in the direction towards soving it. That we might not necessariy sove it in the first pace it might take a coupe of times of going through the process to resove it but it gives us that format to be abe to: it s a buiding bock to start to ook at what the probem is, within a structured way. And I think it s something, it s amost ike a baby s dummy, I think it s something that we just, it s amost a comfort banket for us. Ward manager, case site G 3 (084); transcription 5:17 This markedy positive stance paces emphasis on the MI-PDSA s incrementa approach to service deveopment and the empowerment of staff (transcription 5:18). However, two issues countervai: the potentia for misuse as an instrument of contro (transcription 5:19), and disagreement over the vaidity of the evidence base for the efficacy of the 1000 Lives + programme (transcription 5:20, beow) Lives + programme team are, in the main, focused on achieving practica, pragmatic activities across NHS Waes which seek to generate service improvements and change. But in NHS Waes, on the other side, you ve got medica and other professionas and academics who work to a competey different standard of evidence in terms of rigorous knowedge-based scientific work: you know how expicit medica or epidemioogica statistica modeing is! So, for them, the introduction of 1000 Lives + is, we, it s competey counter-cutura. The reports that the 1000 Lives programme team were stating were the outcomes of the initia programme, in terms of mortaity statistics, we some view it a as some poitica conspiracy that s being sod to the NHS, and the pubic it s spin, fuff, crap it s not vaid data, it s not coected in a robust manner, it s fawed. Oh God: pease save me from the tyranny of evidence! [What do you mean by the tyranny of evidence?] It s a kier phrase, isn t it, in fact it s the kier phrase. [What do you mean?] It s used by professionas in heath care to stop action, to destroy the potentia for change: Oh, we can t do that, the evidence-base is too weak; their argument is fawed, the data s mismanaged. [Anything to maintain the status quo?] Status quo ante! The evidence-based for the 1000 Lives + nationa programme has been systematicay attacked by the other factions for one side, it s evidence and truth; for the other, it s spin and fuff and reaity is caught in the midde. Poicy ead, Wesh Government (081); transcription 5:20 66 NIHR Journas Library

97 DOI: /hsdr03400 HEALTH SERVICES AND DELIVERY RESEARCH 2015 VOL. 3 NO. 40 Board eadership, foowership and change Executive-eve eadership of patient safety augments the normaisation of the 1000 Lives + programme in NHS Waes (transcription 5:21, beow). If the job of the Executive Team is not about patient safety organisationa fitness, systems, processes, governance structures then I don t understand the job! Executive Director, Workforce and Organisation Deveopment, case site G 1 (012); transcription 5:21 Beyond the board, there is acknowedgement of the need for eaders with expertise in quaity improvement methodoogy to support staff and maintain their commitment to patient safety (transcription 5:22, beow). Such roes are, therefore, pivota for the successfu transition of the ownership of the patient safety agenda from the 1000 Lives + programme team to the heath board. My refection on the PDSA process and instruction is, as a methodoogy, it s a very good one. The probem with regards to its appication is that you need somebody who is a PDSA expert within the organisation a eader and change management mentor who can support the various mini-coaboratives with quaity improvement methodoogy to harness what peope are doing. Associate Director, case site F 1 (026); transcription 5:22 However, some respondents indicated a degree of resentment about the obigatory nature of the 1000 Lives + programme and suggested that such commands to engage may be eft unheeded (transcriptions 5:23, and 5:24 beow). The 1000 Lives + nationa programme and the campaign it s command and contro rather than a grass-roots cuture change it hasn t been created by the peope. It s not of the peope. It s an imposition. It s contro. It s from Cardiff. It s very much a Cardiff thing that is being pushed to everyone ese because: we know better. Outside Cardiff, it fees remote and distant and not part of us, it s something that we a recognise as important, ceary, but we don t necessariy own it. Consutant gastroenteroogist, case site F 1 (T027); transcription 5:24 There was a widespread beief that effective board eadership of patient safety is paramount (transcriptions 5:25 and 5:26) but the importance of cinica eadership of patient safety throughout the organisation, so directing teamwork, communication and coaboration to deiver the desired practice change, was aso emphasised (transcription 5:27, beow). Cinica eadership is key credibe cinica eadership and that s a about empowerment of band 7 nurses. When we re in escaation, when beds are crazy, that s when it s hard. It s then you need your band 7 nurses to turn around and te you what isn t safe. That s something we re working reay hard at but that s a whoe cuture change. But the 1000 Lives + PDSA cyces did give them a feeing of empowerment that they coud make and own changes, they coud take chances in the way that suited their ward or theatre or wherever they were doing it: it wasn t that we were teing them how to do it, it was about them trying it and seeing how it worked, and changing it unti it did work in their area. So, I think that they, the areas that did fee empowered through 1000 Lives +, combined with the data that they were coecting, we they knew whether they were doing something good or not, and those two things woud motivate change. Associate Director, case site A 2 (T069); transcription 5:27 Queen s Printer and Controer of HMSO This work was produced by Herepath et a. under the terms of a commissioning contract issued by the Secretary of State for Heath. This issue may be freey reproduced for the purposes of private research and study and extracts (or indeed, the fu report) may be incuded in professiona journas provided that suitabe acknowedgement is made and the reproduction is not associated with any form of advertising. Appications for commercia reproduction shoud be addressed to: NIHR Journas Library, Nationa Institute for Heath Research, Evauation, Trias and Studies Coordinating Centre, Apha House, University of Southampton Science Park, Southampton SO16 7NS, UK. 67

98 NORMALISATION, HEALTH-CARE PRACTICES AND PATIENT SAFETY Teamwork, coaboration and emancipation For heath-care practitioners who have invested meaning in the 1000 Lives + programme, and who adhere to its practices, the programme functions as a raying point, buiding coective action and ensuing teamwork. This aids coaboration and communication across different areas of the empoying heath board and represents an important aspect of the institutiona maintenance work that heps to reproduce the norms and beiefs inherent to 1000 Lives + (transcription 5:28, beow, and transcription 5:29). There are other nurse managers and practice deveopment nurses within the organisation that I tend to work with quite cosey. For exampe, with my coeague in surgery, we deivery simiar sort of teaching about 1000 Lives +, so we ink up and deiver sessions together. That way we coud pu staff from both of our Directorates, increase numbers, and it s easier when you ve got someone ese there. We aso meet as a group four times a year, so any deveopment and training needs, and that kind of thing, can be discussed and we can agree how things may be taken forward. I know certain of my coeagues were very heaviy invoved with the SPI [Safer Patients Initiative] work and the first phase of 1000 Lives they deivered a the corporate training around the PDSA methodoogy and that type of thing. They re good contacts to have! Ward manager, case site D 1 (T010); transcription 5:28 In teamwork situations, the 1000 Lives + programme is perceived to empower heath-care staff in roes traditionay subordinate to the profession of medicine. The emancipation of these staff heps to break down the entrenched barriers that prohibit chaenge and scope for change (transcription 5:30, beow) Lives + gives them [nursing staff] the freedom to question, which they might not previousy have had the confidence to do, as it gives them a format to do it and it s standardised. Aso, you get ess chaenge back when you are questioning something because everybody here s been exposed to 1000 Lives +. Theatre manager, case site A 1 (T008); transcription 5:30 Empowerment and engagement with others simiary motivated by 1000 Lives + is seen to have ed to patient safety improvements (transcription 5:31). However, there is a view that the atent potentia of staff is yet to be reaised in NHS Waes (transcription 5:32, beow). I think the key to the next step is, if you ike, taking the stabiisers off the bike Lives + has supported staff to do specific projects and that has enabed them to have the confidence to say: this is why, and this is how we re going to do it. The next step is: this is my idea, and this is what I want to do. But how is that picked up and supported by the organisation when it s not an externa prompt is the question. I think the NHS is quite bad at thinking about change normay because we re reeing from it being imposed. Associate Director, case site G 1 (T011); transcription 5:32 Buiding the ethos of patient safety: pride and shame in heath-care practice During discussions with the wide range of heath-care practitioners interviewed across NHS Waes, the 1000 Lives + programme appeared to be aigned with feeings of both pride and shame in heath-care practice. On the one hand, a strong sense of achievement is depicted in transcriptions 5:33 and 5:34 (beow) and highights the reinforcing roe of individua refexive monitoring and objective success in fostering meaningfu engagement. Our ast pressure ucer was approximatey we ve had two in the ast three and a haf years we ve got a very good record. I m so proud of our record on pressure ucer prevention. We have nurses, now, who ve never seen pressure ucers. I m reay proud of it. I have this massive thing about pressure ucers; I have a zero toerance of them! Nurse manager, case site A 2 (T058); transcription 5:33 68 NIHR Journas Library

99 DOI: /hsdr03400 HEALTH SERVICES AND DELIVERY RESEARCH 2015 VOL. 3 NO. 40 If you ve had 300 days free of MRSA [meticiin-resistant Staphyococcus aureus], C. diff. [Costridium difficie] or pressure ucers in this organisation, it is ceebrated with cake! I think, maybe a few years ago, I might have been: that s a bit gimmicky but, actuay, the feedback from staff and patients is reay positive, and we make sure that patients are invoved in that ceebration. So, we do media, some pubicity around it as we, there s aways features in our oca press about a team, ward or department that s working particuary we. I think that s positive for our organisation but actuay it s positive from a pubic perspective because it gives some confidence in the service. Too often bad news is good news, isn t it? Associate Director, case site A 1 (T025); transcription 5:34 Indeed, receiving praise for their efforts is seen as centra to staff s continued motivation and commitment to 1000 Lives + (transcription 5:35). This positive stance is, however, baanced by the use of bame and shame, prompted via the reporting mechanisms inherent to its governance structures across NHS Waes (transcription 5:36). Another respondent spoke of the desensitising effect of being perceived to fai, suggesting that this ed to an exaggerated determination not to go beyond the strict parameters of their current task (transcription 5:37, beow). Rather than bad practice being done, there are ess opportunities for good practice. Peope are becoming desensitised by pubic perceptions of faiure. It is norma, now, to sit next to a phone and not answer it because it isn t going to be for you, and you re going to be interrupted from your job. The nurse is in a tabard saying do not disturb me on my drug round; that s wonderfu, but you ve got three consutants doing their ward round too! In the good od days, a sister or staff nurse woud come round with me. Now, I ve got to try and find a nurse and a you get is: it s not my bay, I m sorry, I m on Bay B, so they don t know the patient how many nurses does it take to change a ight bub? Oh sorry, that ight bub isn t in my bay it s that compartmentaised. The sisters have got an awfu time; they ve got, they re getting kind of beaten at a ends. The number of staff you have on the wards the ratio of nurses to patients has gone down apparenty, there s some paper which says that s safe but then there s a the other things as we. I think that s, you know, that s the concern. Consutant, paiative medicine, case site A 1 (T052); transcription 5:37 In addition, for those who wecome the new emphasis on patient safety and take a pride in adhering to the precepts of 1000 Lives +, there may be a deep sense of shame when faiures in patient safety do occur (transcription 5:38, beow). So, with 1000 Lives + we thought we ve cracked it, it s done! But I was waking out of the ward one evening at about 9 o cock at night, and we have, aways on our ward, we have a poicy of putting our safety crosses in the pubic area. So, I was waking out of the ward and I saw this red square on the pressure ucer monitoring, and I said to mysef: some idiot s made a mistake on the safety cross. I went back into the ward and they said: no, actuay, we ve had a pressure ucer, and we a wanted to cut our wrists, reay, it was a very depressing moment. Consutant surgeon, case site B 1 (T062); transcription 5:38 Queen s Printer and Controer of HMSO This work was produced by Herepath et a. under the terms of a commissioning contract issued by the Secretary of State for Heath. This issue may be freey reproduced for the purposes of private research and study and extracts (or indeed, the fu report) may be incuded in professiona journas provided that suitabe acknowedgement is made and the reproduction is not associated with any form of advertising. Appications for commercia reproduction shoud be addressed to: NIHR Journas Library, Nationa Institute for Heath Research, Evauation, Trias and Studies Coordinating Centre, Apha House, University of Southampton Science Park, Southampton SO16 7NS, UK. 69

100 NORMALISATION, HEALTH-CARE PRACTICES AND PATIENT SAFETY The ethos of care stimuated by the 1000 Lives + programme is, therefore, constrained by the fragmented nature of its normaisation. As expressed in transcription 5:39, and more so in transcription 5:40 beow, there is a profound disjuncture. For some, 1000 Lives + and its associated MI-PDSA approach have been activey embraced, resuting in its progressive normaisation: 1000 Lives + is, therefore, absorbed into daiy practice. Yet for others, athough its mandated nature enforces engagement, this has been resisted: 1000 Lives + is, therefore, ony adsorbed onto (i.e. there is token commitment ony and it is not propery integrated) daiy practice and, in this transitiona state, it may fai to institutionaise across NHS Waes. Sometimes it can fee we re doing 1000 Lives + for the sake of 1000 Lives +! We because, you know, peope don t necessariy see their mini-coaborative within the context of the overa quaity improvement, patient safety improvement reducing waste, variation, and harm from the poicy perspective and I don t think as an organisation we ve been very good at pacing those mini-coaboratives within the context of the overa quaity improvement and patient safety improvement agenda. I think that s why it just sometimes fees ike one of those stand aone things that peope do and, I think, we ve ost a trick. Associate Director, case site F 1 (T026); transcription 5: Lives + institutionaisation: eaborated understanding of oca impementation Previousy, in Chapter 4, we set out our anaysis of the bureaucratisation of 1000 Lives + programme across the higher eves of context, thereby defining our preiminary understanding of the oca impementation of 1000 Lives +. Buiding on the findings presented in this chapter, we now seek to integrate the roe of the mechanisms that appear to be invoved in the normaisation of the 1000 Lives + programme at ower eves of context. Figure 12 demonstrates three ways in which existing institutiona ogics, or the coective beiefs and vaue systems of those invoved, may affect the outcomes of an intervention. First, where ogics are not aigned, the intervention may be opposed, with peope deiberatey seeking to maintain existing and habitua practices, and activey chaenging attempts to impose new ways of working. Second, where institutiona ogics co-exist, whie they may not activey reject, peope may nonetheess ignore or give itte thought or attention to the imposed changes. Whie this may ead to apparent revision of practice, because peope s vaues and beief systems have not been changed it is ikey that if the coercive eement is removed practice wi revert to the status quo ante. Hence impementation of an intervention can be effective ony when beiefs and vaue systems are aigned within a particuar context, as shown in the third eement of Figure 12. In these circumstances, coherence, cognitive participation and refexive monitoring of the desired institutiona change are fostered and new procedures are absorbed into daiy practice and become routinised over time. It is from such environments, which function as foci for change, that areas initiay ess receptive to the proposed changes may be graduay recruited through processes of imitation and normaisation. Tabe 10 sets out aigned transcription dyads showing divergent stances to normaisation. These revea the impact of coherence, cognitive participation, coective action and refexive monitoring in a situated heath-care context. 70 NIHR Journas Library

101 Coherence fais to manifest Cognitive participation stance opposed Refexive monitoring stance opposed Countervaiing 5 Co-existent Inattention to coherence Cognitive participation is not fostered Refexive monitoring is not fostered 3 4 Normative and mimetic Compimentary institutiona isomorphism Habituation Institutiona change opposed and habituated practice maintained Coercive institutiona isomorphism contested Fragie normaisation Institutiona change absorbed into daiy practice by coercive institutiona isomorphism Normaisation Institutiona change absorbed into daiy heath-care practice by normative institutiona isomorphism Manifests at the eve of the cinica microwork system 1 DOI: /hsdr03400 HEALTH SERVICES AND DELIVERY RESEARCH 2015 VOL. 3 NO Aignment of ogics Coherence manifests Cognitive participation is fostered Refexive monitoring of change FIGURE 12 Normaisation of 1000 Lives + : heterarchica meta-mechanism operating across contextua strata. Queen s Printer and Controer of HMSO This work was produced by Herepath et a. under the terms of a commissioning contract issued by the Secretary of State for Heath. This issue may be freey reproduced for the purposes of private research and study and extracts (or indeed, the fu report) may be incuded in professiona journas provided that suitabe acknowedgement is made and the reproduction is not associated with any form of advertising. Appications for commercia reproduction shoud be addressed to: NIHR Journas Library, Nationa Institute for Heath Research, Evauation, Trias and Studies Coordinating Centre, Apha House, University of Southampton Science Park, Southampton SO16 7NS, UK. 71

102 NORMALISATION, HEALTH-CARE PRACTICES AND PATIENT SAFETY Figure 12: key point summary In Figure 12 we depict the mechanisms that foster normaisation coherence, cognitive participation and refexive monitoring and set out the impact on the aignment of institutiona ogics, as expanded beow. In point 1, institutiona ogics are not aigned, imiting the potentia for coherence. In such a scenario the desired institutiona change is resisted, habituated practices continue and attempts to impose change are chaenged. Under these situated contextua conditions, mechanisms to generate change, athough operationa, are ineffectua. In point 2, institutiona ogics co-exist without fostering contradistinction and confict. However, in this scenario, the potentia for coherence to manifest is imited owing to inattention. Accordingy, cognitive participation and refexive monitoring do not occur and peope s beiefs and vaues are not revised. A fragie normaisation occurs, through which the mandated institutiona change is compusoriy imposed onto, but not into, daiy practice. However, if such forces are removed, the desired institutiona change may revert to the status quo ante. Under these situated contextua conditions, such generative mechanisms, though operationa, are imited. In contrast, in point 3, the aignment of institutiona ogics is compementary. This, we assert, fosters coherence, cognitive participation and refexive monitoring of the desired institutiona change, and new practices are absorbed into daiy practice. Under these situated contextua conditions such generative mechanisms catayse the desired institutiona change and faciitate the evoution of heath-care practice. Furthermore, such sites act as foci for change through normative and mimetic isomorphic institutionaism (processes of imitation and normaisation) and wi graduay infuence change in initiay ess receptive areas (see points 4 and 5). Importanty, as expored in ater figures, such generative mechanisms are moduated by the reationa structures within the situated context, specificay by the interpay of oca eadership, team working and encutured vaues. 72 NIHR Journas Library

103 DOI: /hsdr03400 HEALTH SERVICES AND DELIVERY RESEARCH 2015 VOL. 3 NO. 40 TABLE 10 Intervention context mechanism agency outcome configuration: interpersona reations Intervention Component Context 1000 Lives + nationa programme MI-PDSA Hospita mutisite department/hospita site-based ward (functiona team) Mechanisms Institutiona isomorphism: coercive, mimetic and normative Coherence, cognitive participation, refexive monitoring Agency and institutiona work Normaisation: couping to 1000 Lives + and MI-PDSA approach Habituation: decouping from 1000 Lives + and MI-PDSA approach Agency innovation Institutiona work creation Leadership: distributed eadership of evidence guided, practice-based change promoted Team work: centred on practice-based earning to deveop micro-competences across the cinica micro work system Encutured vaues: creativity and accountabiity of evidence guided, practice-based change Agency innovation Institutiona work maintenance Leadership: disparaging notions of the quaity and rigor of practice-based evidence hinders innovation potentia Team work: the rejection of practice-based evidence impairs team working and innovation across the cinica micro work system Encutured vaues: potentia of change stymied by contested notion of evidence Agency identification Institutiona work creation Leadership: distributed eadership of evidence guided, practice-based change supports identification of patient safety faiings Team work: action oriented to address identified faiings Encutured vaues: 1000 Lives + and confidence in the MI-PDSA approach gives a sense of security, faciitating chaenge to suboptima practices Agency identification Institutiona work maintenance Leadership: imited eadership of evidence guided, practice-based change Team work: isoated, inward focused, with faiure to connect to heath-board-wide change agenda Encutured vaues: 1000 Lives + and MI-PDSA function as standaone things that peope do, imiting organisationa earning from the identification of suboptima practices Agency knowedge mobiisation Institutiona work creation Leadership: continuous chaenge to earn from poor practice that resuts in untoward patient harm Team work: cohesive with a high vaue paced on earning and feedback to promote patient safety Encutured vaues: refexive, open, ow-bame approach, responsive and receptive to earning opportunities Agency knowedge mobiisation Institutiona work maintenance Leadership: imited chaenge to earn from poor practice that resuts in untoward patient harm Team work: ow vaue paced on earning and feedback to promote patient safety Encutured vaues: faiure in patient safety is par for the course, to be expected, and matters ony if peope actuay make a big dea about it Agency vaidation Institutiona work maintenance Leadership: distributed eadership of evidence guided, practice-based change promoted Team work: heightened focus on measurement and management of practice-based change Encutured vaues: ownership of change agenda within situated context, augmented by sense of doing something good Agency vaidation Institutiona work maintenance Leadership: faiure to adequatey manage cinica team s perceptions of impact of 1000 Lives + Team work: demotivated by faiure to engender positive change Encutured vaues: faiure to ensure feedback to staff that the practice-based change has resuted in the attainment of patient benefit erodes 1000 Lives + vaue continued Queen s Printer and Controer of HMSO This work was produced by Herepath et a. under the terms of a commissioning contract issued by the Secretary of State for Heath. This issue may be freey reproduced for the purposes of private research and study and extracts (or indeed, the fu report) may be incuded in professiona journas provided that suitabe acknowedgement is made and the reproduction is not associated with any form of advertising. Appications for commercia reproduction shoud be addressed to: NIHR Journas Library, Nationa Institute for Heath Research, Evauation, Trias and Studies Coordinating Centre, Apha House, University of Southampton Science Park, Southampton SO16 7NS, UK. 73

104 NORMALISATION, HEALTH-CARE PRACTICES AND PATIENT SAFETY TABLE 10 Intervention context mechanism agency outcome configuration: interpersona reations (continued) Agency and institutiona work Agency egitimisation (mora/pragmatic) Institutiona work creation Leadership: heightened awareness of patient safety Team work: 1000 Lives + resonates with staff and functions as a foca point for patient safety Encutured vaues: saving ives through high-quaity, safe and effective heath care Agency egitimisation (mora/pragmatic) Institutiona work maintenance Leadership: dismissive cinica eadership Team work: stymied by fragmented egitimacy Encutured vaues: 1000 Lives + is a management fad not owned by cinica team Institutiona work disruptive Leadership: deveopment of eadership roes in roes traditionay subordinate to medicine Team work: heightened distributed eadership across heath-care team, specificay band 7 nurses Encutured vaues: nurse-ed, evidence guided, practice-based change Agency emancipation Institutiona work maintenance Leadership: traditiona eadership roe position-practices unchaenged and opposed to 1000 Lives + Team work: distributed eadership across heath-care team unchanged Encutured vaues: 1000 Lives + is a management fad not owned by cinica team Outcome Couping 1000 Lives + nationa programme and MI-PDSA approach embraced and absorbed into daiy practice Exempar transcriptions Decouping 1000 Lives + nationa programme and MI-PDSA approach resisted and adsorbed into daiy practice Agency innovation Institutiona work creation 5:13 (T049) Couping 5:20 (T081) Decouping Agency identification Institutiona work creation 5:17 (T084) Couping 5:40 (T026) Decouping Agency knowedge mobiisation Institutiona work creation 5:38 (T062) Couping 5:39 (T062) Decouping Agency vaidation Institutiona work maintenance 5:18 (T069) Couping 5:12 (T046) Decouping Agency egitimisation (mora/pragmatic) Institutiona work creation 5:04 (T025) Couping 5:06 (T026) Decouping Agency emancipation Institutiona work disruptive 5:27 (T069) Couping 5:24 (T027) Decouping 74 NIHR Journas Library

105 DOI: /hsdr03400 HEALTH SERVICES AND DELIVERY RESEARCH 2015 VOL. 3 NO. 40 Figures portray the institutiona change driven by the bureaucratisation of 1000 Lives +. Our discussion considers three exampes of processes invoved in the normaisation of the 1000 Lives + programme: (1) egitimisation, (2) formaisation and (3) innovation. 1. Legitimisation: Tabe 10, transcriptions 5:02 and 5:24 and Figure 13 show how egitimisation is moduated. In transcription 5:02 (see 1000 Lives +, heath-care practice and patient safety), compementarity between bureaucratic state, professiona and coaborative ogics resuts in perceptions of coherence with 1000 Lives +. However, the ensuing cognitive participation of those who buy into certain areas where their interests ie promotes contained coective action, directed to deiver the aigned vested interests of those who occupy the orchestrating eadership position in this situated context. In contrast, transcription 5:24 (see Buiding the ethos of patient safety: pride and shame in heath-care practice) depicts the overt rejection of the dominant ogic of the bureaucratic state. Professiona ogic is, therefore, shifted from its subordinate roe into an ascendant position. Given the contradiction between these co-existent ogics, theorisation prevents coherence from deveoping. This inhibits cognitive participation and coective action. As a resut, 1000 Lives + is viewed as not part of us. In this context, decouping from the nationa programme arises. 2. Formaisation: Tabe 10, Figure 14 and transcription 5:29 (see reference in Teamwork, coaboration and emancipation) suggest that formaisation is moduated by compementarity between bureaucratic state, professiona and coaborative ogics. This promotes adherence to the governance structures which support the 1000 Lives + nationa programme. However, the subteties of individuas reasoning and use of the resources provided by 1000 Lives + are exposed in transcription 5:36 (see reference in Buiding the ethos of patient safety: pride and shame in heath-care practice). Athough no overt rejection of the dominant ogic of the bureaucratic state is expressed, professiona ogic and coaborative ogic are not hed in a compementary stance. Instead, they occupy a co-existent stance that fosters professiona protection and a ack of coaboration. In this context, couping to the governance structures that support 1000 Lives + is fragie. 3. Innovation: Tabe 10, Figure 15 and transcriptions 5:13 and 5:20 demonstrate how innovation is moduated, whie transcription 5:13 (see Mode for improvement and PDSA approach) iustrates the nuances of normaisation. Once again, the ogic of the bureaucratic state is embraced and hed in cose aignment with professiona and coaborative ogics. This promotes strong coherence with the 1000 Lives + nationa programme The mode for improvement [MI-PDSA], we it s, it s a tried and tested approach, part of improvement science resuting in the cognitive participation, coective action and refexive monitoring of heath-care staff who can go out and they can get started straight away by having an idea, testing it on one patient one time, one nurse, one doctor!. In contrast, transcription 5:20 (see Mode for improvement and PDSA approach) highights a profound disjuncture between the ogic of the bureaucratic state and one facet of medica professiona ogic the contestation between care and science 373 that stymies engagement with 1000 Lives + owing to disagreement over the vaidity of the evidence base: what the respondent in this transcription cas the tyranny of evidence. This fundamenta discord impacts on theorisation. It imits coherence and erodes the means for meaningfu engagement with 1000 Lives +.Asa resut, normaisation and, thus, institutionaisation are hampered. We suggest that the mechanisms that appear to foster normaisation moduate the processes of bureaucratisation through ampification of the compementarity or contradiction between ogics in the institutiona fied. However, of those considered coherence, cognitive participation, coective action and refexive monitoring ony three are seen as generative mechanisms (coherence, cognitive participation and refexive monitoring), whie coective action is simpy an outcome of such refexive theorisation and, thus, an expression of agency. In the next chapter we examine and deveop I-CMAO configurations for three foca interventions from the 1000 Lives + programme using theories of structure, agency and socia change. Queen s Printer and Controer of HMSO This work was produced by Herepath et a. under the terms of a commissioning contract issued by the Secretary of State for Heath. This issue may be freey reproduced for the purposes of private research and study and extracts (or indeed, the fu report) may be incuded in professiona journas provided that suitabe acknowedgement is made and the reproduction is not associated with any form of advertising. Appications for commercia reproduction shoud be addressed to: NIHR Journas Library, Nationa Institute for Heath Research, Evauation, Trias and Studies Coordinating Centre, Apha House, University of Southampton Science Park, Southampton SO16 7NS, UK. 75

106 NORMALISATION, HEALTH-CARE PRACTICES AND PATIENT SAFETY Heterarchica metamechanism Higher-order societa ogics 1 Infrastructura system Wesh Government Legitimisation Pubic sector partner agencies 4 2 NHS Waes as a corporate whoe NHS Waes heath boards Hospita mutisite department Structura conditioning Institutiona setting Interpersona reations (reationa structure) Legitimisation Legitimisation Hospita site-based ward (functiona team) 3 Legitimisation Mora/pragmatic Individua Individua Co-existent/ countervaiing ogics 4 FIGURE 13 Normaisation of the 1000 Lives + heterarchica metamechanism operating across contextua strata: egitimisation. Mimetic isomorphism Coercive isomorphism Normative isomorphism 76 NIHR Journas Library

107 DOI: /hsdr03400 HEALTH SERVICES AND DELIVERY RESEARCH 2015 VOL. 3 NO. 40 Figure 13: key point summary In Figure 13 we depict the egitimisation of the 1000 Lives + nationa programme across the Wesh heath-care institutiona fied, centred on ower contextua strata at heath board, hospita mutisite department, hospita site-based ward and individua eves. In point 1, in situated contexts where ogics are in aignment: Agency egitimisation eite institutiona actors and co-opted others embrace 1000 Lives + and MI-PDSA approach and embed in heath-care poicy and performance frameworks. Institutiona work creation eite institutiona actors enact poitica work to reconstruct rues, rights and access to resources, thereby inking 1000 Lives + nationa programme to tier 1 performance targets. In point 2, in situated contexts where ogics are in aignment: Agency egitimisation 1000 Lives + becomes part of the anguage and positioned-practices of patient safety in NHS Waes, fostering coaboration and systemic chaenge among institutiona entrepreneurs who reassert a new normative standard to precipitate practice-based change. Institutiona work creation eite board-eve institutiona actors enact poitica work to reconstruct rues, rights and access to resources, thereby inking 1000 Lives + nationa programme to the attainment of the Wesh Government s tier 1 performance targets. In point 3, in situated contexts where ogics are in aignment: Agency egitimisation (mora/pragmatic) 1000 Lives + mora and pragmatic egitimacy fosters mainstreaming of the intervention across NHS Waes. Institutiona work creation functiona team s beief and meaning systems reconfigured. In point 4, the impact of co-existent or countervaiing institutiona ogics is depicted as corrosive feedback that chaenges egitimisation and, therefore, normaisation. Queen s Printer and Controer of HMSO This work was produced by Herepath et a. under the terms of a commissioning contract issued by the Secretary of State for Heath. This issue may be freey reproduced for the purposes of private research and study and extracts (or indeed, the fu report) may be incuded in professiona journas provided that suitabe acknowedgement is made and the reproduction is not associated with any form of advertising. Appications for commercia reproduction shoud be addressed to: NIHR Journas Library, Nationa Institute for Heath Research, Evauation, Trias and Studies Coordinating Centre, Apha House, University of Southampton Science Park, Southampton SO16 7NS, UK. 77

108 NORMALISATION, HEALTH-CARE PRACTICES AND PATIENT SAFETY Heterarchica metamechanism Higher-order societa ogics 1 Infrastructura system Wesh Government Legitimisation Pubic sector partner agencies 2 NHS Waes as a corporate whoe NHS Waes heath boards Hospita mutisite department Structura conditioning Institutiona setting Interpersona reations (reationa structure) Individua Legitimisation Legitimisation Hospita site-based ward (functiona team) Individua Co-existent/ countervaiing ogics 3 FIGURE 14 Normaisation of the 1000 Lives + heterarchica metamechanism operating across contextua strata: formaisation. Coercive isomorphism Normative isomorphism 78 NIHR Journas Library

109 DOI: /hsdr03400 HEALTH SERVICES AND DELIVERY RESEARCH 2015 VOL. 3 NO. 40 Figure 14: key point summary In Figure 14 we depict the formaisation of the 1000 Lives + nationa programme across the Wesh heath-care institutiona fied, centred on ower contextua strata at heath board, hospita mutisite department, hospita site-based ward and individua eves. In point 1, in situated contexts where ogics are in aignment: Agency formaisation mandated engagement with 1000 Lives + and the MI-PDSA approach to address NHS Waes organisationa faiings and attain nationa heath-care standards. Institutiona work creation eite institutiona carriers enact poitica work to reconstruct rues, rights and access to resources, thereby inking 1000 Lives + nationa programme to tier 1 performance targets. In point 2, in situated contexts where ogics are in aignment: Agency formaisation mutiprofessiona and mutisite co-ordination of patient safety via the statutory Quaity and Safety Committee and aigned governance structures. Institutiona work creation eite board-eve institutiona actors enact poitica work to reconstruct rues, rights and access to resources, thereby inking 1000 Lives + nationa programme to the attainment of the Wesh Government s tier 1 performance targets. In point 3, the impact of co-existent or countervaiing institutiona ogics is depicted as corrosive feedback. However, this is insufficient to over-ride mandated performance management and governance processes. Queen s Printer and Controer of HMSO This work was produced by Herepath et a. under the terms of a commissioning contract issued by the Secretary of State for Heath. This issue may be freey reproduced for the purposes of private research and study and extracts (or indeed, the fu report) may be incuded in professiona journas provided that suitabe acknowedgement is made and the reproduction is not associated with any form of advertising. Appications for commercia reproduction shoud be addressed to: NIHR Journas Library, Nationa Institute for Heath Research, Evauation, Trias and Studies Coordinating Centre, Apha House, University of Southampton Science Park, Southampton SO16 7NS, UK. 79

110 NORMALISATION, HEALTH-CARE PRACTICES AND PATIENT SAFETY Heterarchica metamechanism Higher-order societa ogics Infrastructura system Wesh Government Formaisation Pubic sector partner agencies 3 2 NHS Waes as a corporate whoe NHS Waes heath boards Hospita mutisite department Innovation Structura conditioning Institutiona setting Interpersona reations (reationa structure) Individua 1 Hospita site-based ward (functiona team) Individua Co-existent/ countervaiing ogics Identification Knowedge mobiisation Vaidation Legitimisation Mora/ pragmatic Emancipation FIGURE 15 Normaisation of the 1000 Lives + heterarchica metamechanism operating across contextua strata: innovation. Coercive isomorphism Normative isomorphism 80 NIHR Journas Library

111 DOI: /hsdr03400 HEALTH SERVICES AND DELIVERY RESEARCH 2015 VOL. 3 NO. 40 Figure 15: key point summary In Figure 15 we depict innovation cataysed by the 1000 Lives + nationa programme across the Wesh heath-care institutiona fied, centred on ower contextua strata at heath board, hospita mutisite department, hospita site-based ward and individua eves. In point 1, in situated contexts where ogics are in aignment: Agency innovation individua and organisationa pragmatic evidence-based earning manifests through adherence to the MI-PDSA approach. Institutiona work creation functiona team s beief and meaning systems reconfigured. In point 2, the impact of compementary institutiona ogics is depicted as positive feedback that supports the formaisation of evidence-based innovation across NHS Waes. In point 3, the impact of co-existent or countervaiing institutiona ogics is depicted as corrosive feedback. Summary In Chapter 5, we anaysed the cutura change inherent to normaisation of the 1000 Lives + programme at the eve of the functiona team. We expored the roe of contextua constraints and enabements, and ensuing refexive theorisation, across the dynamic interpay of mutipe ogics, and considered the moduating roes of coherence, cognitive participation and refexive monitoring. Queen s Printer and Controer of HMSO This work was produced by Herepath et a. under the terms of a commissioning contract issued by the Secretary of State for Heath. This issue may be freey reproduced for the purposes of private research and study and extracts (or indeed, the fu report) may be incuded in professiona journas provided that suitabe acknowedgement is made and the reproduction is not associated with any form of advertising. Appications for commercia reproduction shoud be addressed to: NIHR Journas Library, Nationa Institute for Heath Research, Evauation, Trias and Studies Coordinating Centre, Apha House, University of Southampton Science Park, Southampton SO16 7NS, UK. 81

112

113 DOI: /hsdr03400 HEALTH SERVICES AND DELIVERY RESEARCH 2015 VOL. 3 NO. 40 Chapter 6 Improving eadership for quaity improvement Overview Chapters 6 8 set out our reaist anayses of the three foca interventions seected from the 1000 Lives + programme in NHS Waes: ILQI, RSC and RHAI. To aid the expanation of our argument, each is structured in the same manner, as set out beow. In this chapter we examine ILQI, a programme aimed at heping organisationa eaders to take a systematic approach to the impementation of practica interventions. We first consider three eadership activities designed to buid the wi to make measurabe systemic improvement, specificay (i) setting aims and monitoring progress through oca mortaity reviews; (ii) demonstrating visibe eadership via WakRounds ; and (iii) the use of patient stories at board eve. We review such practices to highight their acknowedged benefits and the barriers that impede their normaisation into daiy practice. Second, we undertake a reaist anaysis of the progressive institutionaisation of ILQI, thereby setting out our comparative case study of sites A, B, C and D. In doing so, we expain the structura conditioning, sociocutura interaction and structura eaboration or reproduction fostered through the actions of three groups of key actors directors of medicine, nursing, and therapies and heath science together with their coeagues in respective associate roes. We concentrate on these actors because they are formay tasked with the impementation of the ILQI under the 1000 Lives + programme. In addition, to aid our understanding of context and mechanism, we examine the perspectives of poicy eads, heath board chairs, chief executive officers and other manageria staff aigned to these professiona groups. Finay, informed by the findings of our reaist anaysis, we set out our understanding of the ILQI I-CMAO configuration. Foca intervention, aim and drivers Improving Leadership for Quaity Improvement is the first of the three foca interventions considered in this study. This improvement programme aims to support board members and other organisationa eaders to take a systematic approach to the impementation of practica eadership interventions to promote transformationa quaity improvement. ILQI has graduay become embedded in NHS Waes annua operating frameworks, 445 quaity frameworks 446 and associated deivery pans. 391,402 Furthermore, ILQI is supported by an aigned organisationa and workforce deveopment strategy, 447 a web-based nationa earning programme for a NHS Waes staff and contractors Improving Quaity Together ( and associated onine resources offered by Patient Safety Waes ( Improving Leadership for Quaity Improvement is centred on the appointment of executive eve eads for the different interventions within the 1000 Lives + programme. It cas for the appication of the underpinning MI-PDSA approach to inform the deveopment of inteigent targets for priority cinica services. As iustrated in Figure 16, ILQI advocates three drivers for change. The first aims to buid the wi to make measurabe improvement as quicky as possibe. This directs senior eaders to cutivate staff engagement, enthusiasm and commitment at a eves of the organisation. The second aims to encourage and spread ideas about aternatives to the status quo, which are robust enough to form the basis of new working systems. This chaenges senior eaders to support staff to impement such change. The third aims to oversee the impementation of a range of improvement initiatives within the organisation. This tasks senior eaders to deveop a cuture of heath-care quaity and patient safety. ILQI, as a core part of a Wesh heath-service-wide governance agenda, therefore assists heath boards to set oca targets to reduce harm and mortaity. Queen s Printer and Controer of HMSO This work was produced by Herepath et a. under the terms of a commissioning contract issued by the Secretary of State for Heath. This issue may be freey reproduced for the purposes of private research and study and extracts (or indeed, the fu report) may be incuded in professiona journas provided that suitabe acknowedgement is made and the reproduction is not associated with any form of advertising. Appications for commercia reproduction shoud be addressed to: NIHR Journas Library, Nationa Institute for Heath Research, Evauation, Trias and Studies Coordinating Centre, Apha House, University of Southampton Science Park, Southampton SO16 7NS, UK. 83

114 IMPROVING LEADERSHIP FOR QUALITY IMPROVEMENT Aim Drivers Leadership interventions Set aims and monitor progress 1 Wi Demostrate visibe eadership 2 Hear stories 3 Change the cuture Lead sustainabe quaity improvement by reducing harm, waste and variation Ideas Seek and share new evidence of best practice. Use the reevant cinica content area guide Estabish executive and organisationa accountabiity Execution Use the mode for improvement Focus on earning and deveopment FIGURE 16 Driver diagram: ILQI. Figure 16: key point summary Figure 16 depicts the driver diagram for the foca intervention, ILQI. Attention is directed to three eadership activities designed to buid the wi to make measurabe systemic improvement, as defined beow: point 1, setting aims and monitoring progress through oca mortaity reviews point 2, demonstrating visibe eadership via WakRounds and point 3, the use of patient stories at board eve. To aid our understanding of the interpay of context and mechanism in the operationaisation of this foca intervention, the perspectives of poicy eads, heath board chairpersons, chief executive officers and other manageria staff aigned to these professiona groups enrich our anaysis. 84 NIHR Journas Library

115 DOI: /hsdr03400 HEALTH SERVICES AND DELIVERY RESEARCH 2015 VOL. 3 NO. 40 Acknowedging the interconnected features of this intervention, our attention focused on three eadership activities designed to buid the wi to make measurabe systemic improvement to patient safety, specificay (i) setting aims and monitoring progress through oca mortaity reviews; (ii) demonstrating visibe eadership via WakRounds; and (iii) the use of patient stories at board eve. Mortaity reviews, WakRounds and patient stories As outined in Chapter 1, heath-care quaity and patient safety demand effective and co-ordinated eadership from poiticians, 448,449 executive-eve managers 81,450 and their subordinate staff whether corporate or cinica professionas 451 who interact with patients, directy or indirecty, 4,88,204,452,453 in the coproduction of their care. 146,155,454 Heath-care eadership is, therefore, inherenty distributed 30,36,455,456 and compex, 457 and necessitates active foowership. 458 Furthermore, it is moduated by a range of other factors which impact patient safety and the cuture of care, most notaby (i) organisationa governance processes, audit and monitoring systems; (ii) management processes and their reception by staff; 29, (iii) team-centred earning and oca commitment to education; 11,207, (iv) an individua and coective focus on practice innovation; 43,475 and (v) the deveopment of an organisationa cuture of care, wherein transparency, communication and mutua respect are vaued. 22, Mortaity reviews In the aftermath of the pubic inquiry into faiings at the Mid Staffordshire NHS Foundation Trust, 81 excess mortaity has been openy debated as a means to fag concerns with hospita patient care Beyond the NHS, this approach has been used in other deveoped heath-care systems to monitor organisationa performance and to compare such performance between hospitas. 483,484 However, the vaidity and reiabiity of the Hospita Standardised Mortaity Ratio (HSMR) and other means of measurement, such as the risk-adjusted mortaity index (RAMI), is dependent on comprehensive, accurate and consistenty appied cinica coding. Consequenty, the use of such measures as HSMR as a screening too for distinguishing ow-quaity hospitas from high-quaity hospitas remains in doubt ,485 because the ink between HSMR and organisationa factors is ambiguous. 160 In addition, it has not yet been proved that HSMR reporting necessariy eads to worthwhie improvement in quaity of care and patient outcomes. 483 Given this unresoved debate, and wide variation in hospita mortaity, the impact of eadership on mortaity, whether or not adjusted for case-based severity and cross-inked with resource measures, 486,487 appears somewhat uncear. However, hospita-based monitoring of a-cause mortaity through review meetings constitutes an important board-eve and medica governance resource and may provide deeper insight into emergent patterns, thereby heping to identify trends to guide oca improvement efforts 488 and to revea their impact on the provision of care over time. 489,490 In addition, they may provide assurance that patients are not dying as a consequence of unsafe cinica practices. 491 Other markers or proxy measures of eadership are associated with mortaity. For exampe, a significant and positive association has been found between a higher percentage of cinicians on boards, the quaity ratings of service providers and ower morbidity rates; 32 Mortaity rates have aso been inked to greater use of high-performance human resource practices; 492 nursing staffing ratios and ski mix 78,493 and hospita pay for performance. 494 Wright et a. 495 aso found that good eadership, organisationa management practices and information systems, supported by a quaity improvement strategy based on robust oca evidence, training and a community-wide approach, may be effective in reducing hospita mortaity. The evidence suggests, therefore, that mortaity measurement may assist boards in thinking strategicay about what it takes, from a systems perspective, to achieve patient safety. 496 WakRounds Board engagement in the patient safety agenda can aso be increased by enhancing their coective iteracy in heath-care quaity, governance processes and aigned service improvement methods. 497 One means to achieve this is WakRounds Perceived as a key eadership practice in heath care, WakRounds foster situationa awareness and hep management to periodicay assess new or unresoved vunerabiities that may affect safety and care quaity. WakRounds, therefore, potentiay provide (i) a forum for front-ine Queen s Printer and Controer of HMSO This work was produced by Herepath et a. under the terms of a commissioning contract issued by the Secretary of State for Heath. This issue may be freey reproduced for the purposes of private research and study and extracts (or indeed, the fu report) may be incuded in professiona journas provided that suitabe acknowedgement is made and the reproduction is not associated with any form of advertising. Appications for commercia reproduction shoud be addressed to: NIHR Journas Library, Nationa Institute for Heath Research, Evauation, Trias and Studies Coordinating Centre, Apha House, University of Southampton Science Park, Southampton SO16 7NS, UK. 85

116 IMPROVING LEADERSHIP FOR QUALITY IMPROVEMENT staff to report and discuss patient safety probems with oca eaders, so that the voice of the caregiver infuences the ongoing board-eve debate; 501 (ii) an opportunity to improve teamwork and communication within and across units; and (iii) a supportive environment in which staff and eaders hep to deveop potentia soutions for patient safety and service deivery issues a refined through the underpinning MI-PDSA approach. 506 Improvements in patient safety have been inked to the frequency of exposure to WakRounds 507 but their sustained operation demands significant organisationa wi, project management and commitment from board-eve eaders. 499 Research is now beginning to penetrate the compex socia processes that underpin WakRounds so that their potentia to foster executive-eve earning is enhanced. 508,509 However, the deveopment and maintenance of appropriate organisationa feedback mechanisms is known to be a significant chaenge. 510,511 Patient stories These are a means for the patient and their famiy, advocate or carer to forward their persona narrative of harm in order to activey contribute to the coproduction of safe care. 512,513 Considering the notion of harm from the perspective of the patient offers insight into aternative heath-care priorities, 514 incuding (i) the psychoogica and emotiona aspects of harm 515 and (ii) the harm and distrust caused by deays in communicating patient safety incidents to patients, 516 compounded by (iii) that which arises owing to their excusion from the critica conversations which shape the provision of their individua care. 132,153 By providing rich insight into the reaity of heath-care provision through description and diaogue, patient stories can inform organisationa governance processes and service redeveopment through experience-based design. 520 However, athough patient stories may inform, equip and chaenge organisationa eaders to improve the deivery of heath care, they aso expose them to the fear of reputationa and financia risk generated by the broader dissemination of harrowing narratives of harm. 521 This presents a barrier to the deveopment of a safety cuture. Tasking board-eve eaders to hear patient stories as the first agenda item at every board meeting may revea the human face of harm. 522 However, if rendered down to just another performance measure, amid an array of others, such narratives wi do itte to foster appropriate remedia action. 105 Indeed, dysfunctiona consequences may arise owing to entrenched historica and cutura precedents, specificay beiefs anchored to heath-care performance and autonomy Cognitive psychoogica expanations of the way such individuas process patient feedback of this type, together with the corresponding socia rues which frame their ensuing action or inaction, 303, therefore constitute an important arena of patient safety research for socia scientists. 530 Reaist anaysis and comparative case study To examine the dynamic interaction of the foca intervention and context, ascertaining emergent mechanisms and ensuing outcomes, we now undertake a critica reaist anaysis of the progressive institutionaisation of the 1000 Lives + programme s ILQI. Our case study considers sites A, B, C and D, which, owing to high eves of access and wide-ranging staff engagement, offered rich insights into the unfoding impementation of the ILQI. Our anaysis focuses primariy on three groups of key actors directors of medicine, nursing, and therapies and heath science, together with their coeagues in respective associate roes tasked with the impementation of the ILQI under the auspices of the 1000 Lives + programme. However, we aso use data from poicy eads, heath board chairpersons, chief executive officers and other manageria staff aigned to these professiona groups. First, we consider the foca intervention in context and expore the dominant structura and cutura emergent properties impacting board-eve actors. Next, to revea the generative mechanisms in pay, we examine mediation via first- and second-order emergents and the resutant situationa ogic. Then, to examine the initiation of change, we expore the unfoding strategic negotiation of change and the mode of institutiona work enacted. Finay, we refect on the nature of any sustained outcome, be that eaborative or reproductive. 86 NIHR Journas Library

117 DOI: /hsdr03400 HEALTH SERVICES AND DELIVERY RESEARCH 2015 VOL. 3 NO. 40 This anaysis forms the foundation of our refinement of the I-CMAO configuration spanning the Wesh heath-care fied in 1000 Lives + institutionaisation: ILQI oca impementation of the foca intervention and contribution to the I-CMAD configuration spanning the Wesh heath-care fied. Structura conditioning: structura and cutura emergent properties in the Wesh heath-care fied Initiay, we discussed the dominant structura and cutura infuences impacting heath board-eve actors during the institutionaisation of the 1000 Lives + programme and ILQI with poicy eads in the Wesh Government. As commented in transcriptions 6:01 and 6:02 (beow) and as previousy refected in transcription 4:01 the 1000 Lives + programme was deepy integrated with heath-care poicy deveopment in Waes. The 1000 Lives + nationa programme has been a vehice to do ots and ots of things; it s been very usefu. Now, for pretty much a projects when we get to the stage where there s some poicy that we need to do in Wesh Government and, I think, even more so foowing Francis the impementation is designed with the methodoogy that sits behind 1000 Lives + in mind because it s there, and peope can understand it, and so they can use it in order to be abe to move stuff forward. Poicy ead, Wesh Government (145); transcription 6:01 What we ve started to introduce this year this new financia year just started is we ve tweaked the tier 1 targets and we ve created basicay five domains of quaity. So we ve tried to refect much more broady what boards are doing. We ve pioted aongside it the principe of what I woud ca a bit of improvement methodoogy. We ve sort of aid out a series of matrixes or grids of competencies that we expect boards to be abe to dispay on a scae of 1 to 5 a scae of maturity so what we re trying to do is to move it away, a bit, from just target driven to being more about deveopment. As I m trying to make it more deveopmenta, it is starting to get coser to the 1000 Lives + type approach. Poicy ead, Wesh Government (146); transcription 6:02 Such poicy actors hed robust views on the dominant structura emergent properties impacting heath boards: it s finance, reconfiguration, staffing, and heath-care quaity performance (transcription 6:03, beow). What are the structura constraints on the 1000 Lives + nationa programme? That s an interesting question, we coud probaby spend the next hour just discussing that; but I do my best to be succinct. The first structura constraint is, obviousy, the financia difficuties that a pubic services now face in ight of the goba economic downturn. Second, for NHS Waes, it s the major reconfiguration, and that s sti ongoing, as we have to address the configuration of services and their provision across Waes, so there s a rippe effect across a heath boards as they reconfigure. A that wi create heated poitica and pubic debate because, in Waes, as esewhere, peope are fiercey protective of their heath-care services they sti criticise them but they don t want services shifted to other sites away from their ocaity. That creates staffing constraints for a heath boards, especiay those further off the M4 corridor. As I m sure you are aware, there are major difficuties in some areas of Waes, in terms of the recruitment and retention of genera practitioners, some acute speciaisms, accident and emergency, and others. And then, of course, we have the Francis Report, which, I beieve, wi heighten governance and performance management systems, as we saw after the Kennedy Report into Bristo Roya Infirmary. So, it s finance, reconfiguration, staffing, and heath-care quaity performance, they re the main ones, at east! Poicy ead, Wesh Government (143); transcription 6:03 Financia constraints were aso seen to have a specific adverse effect on patient safety (transcription 6:04). Queen s Printer and Controer of HMSO This work was produced by Herepath et a. under the terms of a commissioning contract issued by the Secretary of State for Heath. This issue may be freey reproduced for the purposes of private research and study and extracts (or indeed, the fu report) may be incuded in professiona journas provided that suitabe acknowedgement is made and the reproduction is not associated with any form of advertising. Appications for commercia reproduction shoud be addressed to: NIHR Journas Library, Nationa Institute for Heath Research, Evauation, Trias and Studies Coordinating Centre, Apha House, University of Southampton Science Park, Southampton SO16 7NS, UK. 87

118 IMPROVING LEADERSHIP FOR QUALITY IMPROVEMENT Beyond the goas of 1000 Lives + and ILQI, these acknowedged structura constraints shaped the strategic context to the deivery of the Wesh Governments tier 1 targets, and their active management and mitigation was centra to the bureaucratic contro exerted over each heath board (transcription 6:05, beow). [How do you hod NHS Waes heath boards to account for their performance?] We have an escaation framework basicay four eves of escaation, five if you incude zero we monitor heath boards, as they have to perform against the targets that they re supposed to achieve, and if they re performing against a of the standards then they woudn t be escaated. Basicay, they re aowed to get on with it and, to a degree, we actuay pu away from the eve of assurance that we seek. So we coud get to the stage where you might ony, you know, touch them quartery or haf-yeary. But we re not at that point with anybody at the moment. Once things start to go wrong somebody s missing their targets we then escaate to eve 1, 2, 3 and up to 4. At each of those eves there s a sighty higher eve of intervention. Each of these woud be just a bit more forcefu: you need to have got to a recovery pan by this ; we need you to be showing you re doing a recovery pan, if they don t do that they go up another eve and that carries on and the frequency increases. Basicay, by the time we ve got to eve 4, the chair wi probaby be having conversations with the minister, and the chief executive wi be probaby having conversations with the chief executive of NHS Waes. Throughout this process what we re ooking at is, essentiay, what have we got to do with this board; is there something that s needed in way of turning around behaviour, turning around attitude, turning around performance? Does that mean we have to bring something or someone in? We can bring to bear quite a ot of sanctions, in terms of aterations to their aocation of money. Now, we don t normay get to that stage but we re very cose with a few boards at the minute we do have to recognise, as is happening in NHS Engand, that performance is very difficut in the current financia environment so the whoe system is just basicay not quite as sick as it woud have been even a year ago. Poicy ead, Wesh Government (146); transcription 6:05 Another respondent viewed the Francis Report to have been the main cutura impact on heath boards during the institutionaisation of the 1000 Lives + programme and ILQI (transcription 6:06). Other structura and cutura constraints arose from the institutionaised deegation of strategic oversight of patient safety and, thus, 1000 Lives + and ILQI to the eadership of directors and associate directors of medicine, nursing, and therapies and heath science (transcriptions 6:07 and 6:08, beow, and transcription 6:09). Post Francis, I think that the cutura constraints which wi impact on NHS Waes heath boards and 1000 Lives + nationa programme stem from driving forward a transparent cuture of compassionate care we ve set out our views on that so, that is a about the professions, their traditiona practices, turfs and turf wars, recognising that errors do happen, and that we can make change to mitigate some of them, though it wi take rea eadership and time to change the cuture. Poicy ead, Wesh Government (145); transcription 6:07 The quaity of our services and patient safety issues, though they fa within my remit as accountabe officer, are deegated to other board members. You find this across NHS Waes. Certainy, for 1000 Lives + it be the medica director, nursing director, and the one for therapies and heath sciences or whatever tite is appied for this type of board-eve roe that hod the strategic focus for the patient safety agenda. Typicay, it be their associate directors who wi be more invoved, operationay, in the ro-out of 1000 Lives +. This isn t an abdication or abrogation of responsibiity, it s deegation through to the cinica professionas who utimatey deiver care to patients and whose practices 1000 Lives + is attempting to transform. [What about your engagement in mortaity measurement, WakRounds, and use of patient stories at board eve?] Yes, we do those. But that is ony part of what we do, there s more to managing this heath board than addressing 1000 Lives +. Chief Executive, case site A 1 (078); transcription 6:08 88 NIHR Journas Library

119 DOI: /hsdr03400 HEALTH SERVICES AND DELIVERY RESEARCH 2015 VOL. 3 NO. 40 First-order emergents for board-eve actors centra to the institutionaisation of ILQI The dominant structure and cuture described in the previous section shaped the context and conditioned the actions of the board-eve directors and associate directors centra to the institutionaisation of the ILQI. Beow, we set out how actors in such professiona roe-positions refected on first-order emergents such as their deegated eadership of the ILQI, their vested interests and perceived opportunity costs associated with various courses of action, and seek to discern how this shaped their interpretive freedom and scope for purposive action to support patient safety. Director of medicine and associates The vested interests of directors of medicine and their associates, tasked with the strategic oversight of the 1000 Lives + programme and ILQI, ay primariy in the successfu deveopment of a systematic ocay agreed approach to undertaking the mortaity review in the aftermath of the structura reconfiguration of NHS Waes (transcriptions 6:10 and 6:11, beow, and transcriptions 6:12 and 6:13). In terms of 1000 Lives +, my main focus is the mortaity reviews, and reporting through the system that has been estabished with the Wesh Government. We ve done a board paper, two board papers in a row, which address how do we measure harm, how do we measure our morbidity, our mortaity. So it s a key roe. With 1000 Lives +, the mortaity reviews have been around a programme of work ooking at how we, how do we actuay understand where the harm is occurring. It s a systematic process one of the main things that [name, NHS Waes Chief Executive and Director Genera, Wesh Government] asked the medica directors to do, probaby in 2010, was to do systematic case notes reviews so we have a system whereby I was probaby ooking at 25% of the deaths, not a the deaths, because we have 50 deaths a week! So we embarked upon earning through reviewing about 15 sets of notes a week with the senior governance adviser and with aso one of the associate directors of medicine. We tried various different ways, in terms of pro formas, and we did a the PDSA-type work but in the end we ve setted on a detaied notes review using the goba trigger too. I have to say that we continued that right up unti January when there was the debate about pubishing RAMI. Athough we didn t fee that we earnt in excess, we did earn above and beyond what we knew about the organisation through that process. Medica Director, case site D 1 (117); transcription 6:10 [Prior to 1000 Lives + was there any systematic process for reviewing mortaity across the heath board s hospita sites?] We the kick-off, actuay, was, you know, when this organisation came into being; there had been chaos! There was the organisation, and predecessor organisation or organisations as you know, we ve had to endure a ot of change we had the interim trust with a competey different executive team, and a competey different interim medica eadership and management structure, that was just basicay trying to keep the thing ticking over reay. Then we were presented as a new edition, [heath board name], and more systematic scrutiny of our statistics started, and one them was that our RAMI which was worrying. So, that was the situation when the heath board came into being and, obviousy, as medica director, I was tasked to do something about it. Certain parts of the organisation may we have been ooking at quaity initiatives before that but reay I think getting a grip on the mortaity review and embracing 1000 Lives +, which we did as organisation at that point, added coherence to the whoe thing. So, when you asked me specificay what had been done before, I woud say that it was very hit and miss. Now, with 1000 Lives +, I have a cear focus on mortaity. I don t want to harp on about it, but you re asking about eadership and what we do as an organisation, I think that s a very good exampe how it s been successfu. I mean, at the moment we re into year 3, something ike week 12 or 13, where every singe week, every singe death in the organisation is ooked at by a senior medica a senior doctor every singe one, and a report Queen s Printer and Controer of HMSO This work was produced by Herepath et a. under the terms of a commissioning contract issued by the Secretary of State for Heath. This issue may be freey reproduced for the purposes of private research and study and extracts (or indeed, the fu report) may be incuded in professiona journas provided that suitabe acknowedgement is made and the reproduction is not associated with any form of advertising. Appications for commercia reproduction shoud be addressed to: NIHR Journas Library, Nationa Institute for Heath Research, Evauation, Trias and Studies Coordinating Centre, Apha House, University of Southampton Science Park, Southampton SO16 7NS, UK. 89

120 IMPROVING LEADERSHIP FOR QUALITY IMPROVEMENT goes to the chief executive. The information from that review which, of course, when we get concerns highighted, concerns are investigated more deepy and reported back, hopefuy through auspices of medica director the essons earned, the themes, and so forth are communicated back, right the way across the whoe of the organisation, primary care and everything. Medica Director, case site F 1 (042); transcription 6:11 Moreover, such vested interests were cosey aigned to those of poicy eads with the Wesh Government. Therefore, through the 1000 Lives + programme and ILQI, the systematisation of mortaity reviews brought bureaucratic state ogic, professiona (medica) ogic and a coaborative ogic into a compementary stance (transcription 6:14, beow). I think, in Waes, because we had a we-deveoped sort of coaborative approach, we were abe to engage cinicians in the audit of their oca mortaity eves, and what was going on. But we re using the nationa indicator in a very, very simpistic way, which I think is good, to just say: hey ook, this wi te us if there is a probem. But we then go into that audit work that rea work on the ground, to say we actuay, are they doing a the things they shoud be doing to reay understand and make sure that this is right. [Long pause] In a way, what we ve avoided, so far, is getting dragged into this idea that s going on in Engand where you keep hauing out the top five and sort of having a pubic process about their mortaity eves. What we ve tended to go for is: we et s get them working on it. Now having done that, and it being, at east so far, quite a successfu approach, we re now ooking at how that set of principes coud be carried into other areas. So when we start ooking at deveoping unschedued care markers, or panned care, or whatever it might be, we re ooking at whether we coud underpin it with an audit type approach, which says: these are a the good things you shoud be doing, how are you doing against a of these; if you re doing a these things, how are you monitoring your outcomes. Actuay, some of these higher-eve measures are underpinned now with something that s a bit more substantia than just making sure you re getting everybody through. So we re trying to adopt amost a two-tier approach a set of nationa standard type measures which we try and keep as simpe as we can, but underpin it with a different approach around a more detaied understanding and audit. Poicy ead, Wesh Government (146); transcription 6:14 Director of nursing and associates In contrast to the directors of medicine, the vested interests of directors of nursing and their associates were aigned with the successfu oca co-ordination of the various patient safety interventions emergent from 1000 Lives and 1000 Lives +. Though the forma remit of their roes was to be professionay accountabe for nursing practice, such roes typicay absorbed a wide range of other stuff (transcription 6:15, beow). As Director of Nursing, I m professionay accountabe for nurses and midwives across the heath board about 5500 registrants and 3000 heath-care support workers so I advise the board on the professiona agenda. I ve aso hod joint executive responsibiity with the medica director and director of therapies and heath scientist for cinica governance. In respect of 1000 Lives + I ve got some key executive ead roes, for exampe infection prevent and contro; but I aso have executive ead roes for the Transforming Care programme. Directors of nursing often abe ourseves directors of nursing and stuff because we tend to pick up a ot! Director of Nursing, case site B 1 (030); transcription 6:15 90 NIHR Journas Library

121 DOI: /hsdr03400 HEALTH SERVICES AND DELIVERY RESEARCH 2015 VOL. 3 NO. 40 Work associated with the 1000 Lives + programme and ILQI was frequenty co-ordinated with medica eads, highighting the compementary aignment of professiona (nursing) and professiona (medica) ogics (transcription 6:16, beow). I am one of the assistant directors of nursing we re each site based in a district genera hospita and I work very cosey with the site-based assistant medica director. We work together to ensure that we undertake safety WakRounds, and other features of the 1000 Lives + nationa programme to buid eadership capacity, and to ensure that we provide that support and visibiity for front-ine staff. So it s very important that, between ourseves, that we undertake them jointy, preferaby. Assistant Director of nursing, case site C 1 (093); transcription 6:16 Executive nurse eadership was viewed as pivota for the successfu institutionaisation of the 1000 Lives + intervention bundes apportioned to nursing for their impementation (transcription 6:17, beow). The 1000 Lives + skin bunde has got an executive ead our assistant director of nursing who s very active. They have study days are coordinated by her secretary, and they have three sessions that they run for each area. In contrast, my experience with the catheter bunde has been difficut. I coudn t faciitate that for my area because I haven t had an active executive ead. But the skin bunde, certainy with their executive ead, has worked reay we, and spread to areas from across the heath board, incuding private nursing homes and things! We d ove to do that with the catheters, but we just haven t been abe to break down the barriers to get across and to access peope who can make those inks for us. Senior nurse, IPAC, case site D 1 (034); transcription 6:17 Director of therapies and heath science and associates Directors of therapies and heath science were newy estabished board-eve roes (transcription 6:18). Consequenty, their vested interests centred on coming up to speed with the demands of the roe as we as their executive eadership of 1000 Lives + interventions associated with ILQI. In this regard, the professiona ogic enacted was firmy aigned to professiona (medica), professiona (nursing) and professiona (management) ogics in a compementary stance (transcription 6:18, beow, and transcription 6:19). My earning curve with the origina 1000 Lives campaign and now the 1000 Lives + nationa programme, you know, it s been particuary steep over the ast 3 or 4 years! Just coming into the director roe for therapies and heath sciences we didn t have these director roes previousy, so we re a new to boards in the first pace and so the medica and nursing directors portfoios have shifted around. But this definitey fet ike quite a daunting prospect, I fet it needed a eve of expertise; I d need to have an enormous amount of expertise. I have obviousy been earning and asking questions, just the same with any board roe, we a need to have teams, support around us, peope who can give you expert advice. So I ve had to ask questions and get into some of the detai, just to get my head around it, and I ve come back out again. Do you see what I mean? With the 1000 Lives + nationa programme, I think, possiby, it s been even more chaenging for my nurse director coeague. From an organisationa perspective across Waes, 1000 Lives +, a great dea does come down to the director of nursing. It is very much a nursing domain. Director of Therapies, case site C 1 (118); transcription 6:18 Queen s Printer and Controer of HMSO This work was produced by Herepath et a. under the terms of a commissioning contract issued by the Secretary of State for Heath. This issue may be freey reproduced for the purposes of private research and study and extracts (or indeed, the fu report) may be incuded in professiona journas provided that suitabe acknowedgement is made and the reproduction is not associated with any form of advertising. Appications for commercia reproduction shoud be addressed to: NIHR Journas Library, Nationa Institute for Heath Research, Evauation, Trias and Studies Coordinating Centre, Apha House, University of Southampton Science Park, Southampton SO16 7NS, UK. 91

122 IMPROVING LEADERSHIP FOR QUALITY IMPROVEMENT Second-order emergents and situationa ogic In case sites A to D, the interpay of structura, cutura and agentia emergent properties impacted on the three groups of actors centra to the institutionaisation of the 1000 Lives + programme and ILQI. Structuray, the presence of necessary and interna inkages of a compementary nature between structures such as the mandated bureaucratic performance management systems and associated 1000 Lives + and ILQI goas, notaby the RAMI, which was integrated into oca mortaity measurement practices, rendered these performance management and governance institutions mutuay reinforcing. Simiary, structura resiience emerged from the co-ordinated action of directors of medicine, nursing, and therapies and heath sciences, as coective champions of 1000 Lives + and the broader patient safety agenda. Second, at board eve, the institutionaisation of 1000 Lives + and ILQI draws professiona ogic into aignment with that of the bureaucratic state. Moreover, there is coaescence and cohesion across medica, nursing, aied professiona and heath-care management ogics. This paces each into a compementary stance, fosters the cross-cutura systematisation of facets of 1000 Lives + and ILQI across NHS Waes and promotes the reproduction of such practices across each heath board. Consequenty, at board eve, the ILQI operated under a situationa ogic of protection that mouded sociocutura interaction, agency, strategic negotiation and the ensuing mode of institutiona work. Sociocutura interaction: agency and strategic negotiation A situationa ogic of protection emerged from a context of necessary and interna inkages of a compementary nature between systemic structures and harmonising ogics. However, given the status of the peope invoved, the inherent change agenda overarching the 1000 Lives + programme and, thus, the ILQI were executed from a position of high negotiating strength. Beow, we highight this compex interpay in both a discrete case site and across mutipe case sites, drawing out different degrees of bureaucratisation and normaisation to hep understand the interpay of the foca intervention, context and mechanism. Power-induced compiance and poitica sanction To examine the adoption of power-induced compiance under a board-eve situationa ogic of protection and to trace its impact across management tiers, we refect on some of our discussions with respondents in case site B. At this site the chief executive had visiby responded to the bureaucratic demand for engagement with 1000 Lives + and ILQI, and WakRounds had aso become successfuy integrated and thus normaised as an expected professiona roe-position practice (transcription 6:20, beow). Our approach to 1000 Lives + is refected by the eadership of the heath board. WakRounds are a centra aspect of 1000 Lives + but [name, chief executive officer] is out and about to each of the main hospita sites to deiver our monthy team brief, and that team brief is expected to be cascaded out to other managers then they speak to their eads, their teams, on a one to one, that s the expectation so that eadership and visibiity is there in addition to the WakRounds. That s about four a month, or eight a month with the team briefings and the open forums, on top of which the director of nursing aso does theirs about four a year and goes out and about and meet the nurses and midwives across the organisation. So they try their best to communicate and be visibe, but they can t be as visibe as they used to be because of the size of the organisation. Associate Director, case site B 2 (009); transcription 6:20 Thus, under a situationa ogic of protection, the chief executive enacted the practices mandated for his roe, buiding them into an ambassadoria dispay that promoted simiar enactment by other board-eve and sub-board manageria actors. Furthermore, such activity was appreciated for its very hands-on and approachabe manner (transcription 6:21). 92 NIHR Journas Library

123 DOI: /hsdr03400 HEALTH SERVICES AND DELIVERY RESEARCH 2015 VOL. 3 NO. 40 Transcription 6:22 (beow) reveas the impact of the Francis Report 81 as a parae driver for change across NHS Waes, one that was used in an overt act of professiona roe-positiona power to deiver higher standards of care. One of the things that I did, to address patient safety, was to remove a ward sister from the ward and we changed the team because there was a deep-rooted cuture in that ward, that went back years and years and years. So I removed the ward sister and put two registered nurses through a discipinary. It was ike a vocano going up. Idon twanttoturnthisintoabamecuturebutwheretherearefaiingsandpoorstandardsofpracticeor poor eadership they either want to be a ward sisterandathatentaisortheydon t so we re making some quite hard moves at the moment and I think that, given Francis, I think it stherighttimetodothatnow. Director of Nursing, case site B 1 (030); transcription 6:22 Such power was aso used to enabe those invoved to drive forward their evoving patient safety agenda by the dispay of visibe eadership ( wak the wards ); the engagement and co-option of medica staff to act as cinica champions for 1000 Lives + ( we must have the medica champions out there ); and buiding the wi for change across the functiona heath-care team ( strong cinica eadership to give teams the confidence to chaenge ) (transcriptions 6:23 to 6:25). Reciproca exchange and the harmonisation of desires A more subte depoyment of power arose through reciproca exchange and the harmonisation of desires with other key professiona actors. At case site A, board-eve actors exerted their manageria contro and co-opted their associates who demonstrated interest and reevant cinica expertise to ead the impementation. Thus, the impementation of 1000 Lives + gained further visibe professiona eadership coser to the point of care (transcription 6:26, beow). Given my professiona background, and experience of service deivery, I ve aways been reay interested in quaity and safety, so as associate director, I was tasked with patient safety and patient experience. I m responsibe for sorting out the patient experience agenda working out how we can capture the patient experience and making sure that we cose the oop. So if we discover something about patient experience through patient satisfaction, patient stories, compaints or anything ike that, I aim to ensure that we cose the oop in terms of the organisationa earning. And for good practice as we because, obviousy, as part of that feedback, I get to find out what s reay good about our service. It s not aways about what s reay bad about our services...! I aso work with cinicians and managers to put in any action pans, in terms of any work, if things aren t up to standard, or if there s some deveopmenta work that needs to be put in pace. So, if my eary warning system is teing me that I ve got signs of a probem in an area then, obviousy, I work with the area and the managers to see what needs to be done to improve quaity and service. And I work with cinicians to make sure our poicies and procedures are up to date and fit for purpose. Associate Director, case site A 1 (048); transcription 6:26 Such eadership, in itsef, fostered the engagement of consutant medica staff with aigned cinica interests. This promoted further medica engagement with 1000 Lives +,[... if you ve got somebody at that eve that drives it, it s so much easier. Medica eadership makes it work a ot quicker than management (transcription 6:28)] and, utimatey, the oca eadership of discrete interventions [ it s oca eadership because they understand the pressure within the organisation, and what makes a difference Queen s Printer and Controer of HMSO This work was produced by Herepath et a. under the terms of a commissioning contract issued by the Secretary of State for Heath. This issue may be freey reproduced for the purposes of private research and study and extracts (or indeed, the fu report) may be incuded in professiona journas provided that suitabe acknowedgement is made and the reproduction is not associated with any form of advertising. Appications for commercia reproduction shoud be addressed to: NIHR Journas Library, Nationa Institute for Heath Research, Evauation, Trias and Studies Coordinating Centre, Apha House, University of Southampton Science Park, Southampton SO16 7NS, UK. 93

124 IMPROVING LEADERSHIP FOR QUALITY IMPROVEMENT within that particuar area (transcription 6:29)]. Creative institutiona work, targeted at those who were beievers in the aims of 1000 Lives + programme and, therefore, motivated to engage by a strong sense of coherence, aided its normaisation in practice (transcription 6:27, beow). The thing that enabed it to happen [1000 Lives + nationa programme], the paces where it happened, it was due to the individuas who were committed to it. [Was that imited to consutant-eve cinica eadership or were others invoved?] Both. In our heath board, here, there s mysef and there s a consutant, and we re both who committed to it. You need righty or wrongy peope isten to consutants, peope isten to doctors you can have the best nurse in the word, who s an expert in something, but they re sti a nurse. It s a hierarchica cuture in the NHS. Doctors don t earn doctors are not prepared to earn from nurses they earn from doctors: it s competey wrong. Some of the universities are now doing a ot more mutiprofessiona earning, the Peninsuar Medica Schoo, you know, they re fantastic at this sort of stuff. So, because there s this hierarchica thing, you do need consutant eadership but that can t work on its own. [You need nurse eadership and broader foowership to embedded 1000 Lives + into practice?] Yes. Consutant, paiative medicine, case site A 1 (052); transcription 6:27 In case sites B, C and D, the depoyment of power through reciproca exchange and the harmonisation of desires ed to simiar patterns of expert co-optation to promote resource contro of the 1000 Lives + programme at the point of care. However, discussions at each case site exposed different features. For exampe, in case site B, reciproca exchange, manifested through knowedge, fows from board to ward and to the 1000 Lives + programme team (transcriptions 6:30 to 6:33). At case site C, reciproca exchange was depoyed to buid intraprofessiona coherence and commitment to 1000 Lives + for medica and nursing professionas (transcriptions 6:34 and 6:35). Finay, at case site D, reciproca exchange manifested, once again, through knowedge fows from board to ward (transcriptions 6:36 and 6:37). This was aso marked by a subte shift in expertise to ower management tiers, iustrating the normaisation of 1000 Lives +, and, thus, the inherent successfu impementation of ILQI. Structura eaboration or reproduction in the Wesh heath-care fied We aso sought to gauge key actors perceptions of the structura eaboration or reproduction that had emerged under a situationa ogic of protection. A nationa programme team member described how, through the formaisation of ILQI, a network of patient safety eaders, heath-care professionas from manageria, medica, nursing and other aied groups, had evoved (transcription 6:38, beow). We, throughout the 1000 Lives campaign and 1000 Lives +, there were some specific interventions that were focused on board-eve eaders. But we quicky recognised that, actuay, the peope that we needed to get at were often senior eaders who didn t have a forma board-eve roe. Another thing was that, because of the eve of disruption with the NHS in Waes due to the reconfiguration there weren t peope in a the formay appointed board roes, so you had a much more, a ooser coaition of senior eaders that we needed to engage with. But one of the things that we have recognised, increasingy, is that to achieve a connection between the cinica teams working on programmes and an organisation eve focus invoves much more than board-eve eaders and front ine eaders. It invoves a network of peope throughout the organisation Lives + nationa programme team member (089); transcription 6:38 This notabe structura change, in indoctrinating others, promoted the distributed eadership of patient safety and the oca integration of the 1000 Lives + programme at each case site. Furthermore, the structura change associated with the integration of mortaity reviews into the Wesh Government s performance management framework was viewed to have added an important critica ens through which to view patient safety, providing a vaued means of organisationa earning (transcriptions 6:39 to 6:41). 94 NIHR Journas Library

125 DOI: /hsdr03400 HEALTH SERVICES AND DELIVERY RESEARCH 2015 VOL. 3 NO. 40 In contrast, cutura change was viewed as far more fragmented. This was viewed as owing party to the pejorative perception of 1000 Lives + as a nurse-dominated agenda and party to the time demanded for such cutura evoution, if not revoution (transcriptions 6:42 to 6:44, beow). One success is that it s certainy been embraced by the nursing profession but I d ike to see it embraced by the mutidiscipinary teams in a broader context. Some of the other professions are quite dismissive: it s a nursey-nursey thing. Poicy ead, Wesh Government (140); transcription 6:42 I do think we have driven structura change through 1000 Lives + but, I think, cutura change is sower. It s happening, no doubt, and the new website wi, I hope, hep NHS Waes to buid a workforce that has a detaied understanding of service improvement the skis and knowedge, the capabiities to sustain patient safety and the sense of empowerment to act. Poicy ead, Wesh Government (145); transcription 6:43 That notion, that simpe acknowedgement that, in the Wesh NHS, we do harm. It s poiticay difficut to stand-up and say that but I beieve it s the start of rea cuture change: a revoution in care. Poicy ead, Wesh Government (081); transcription 6:44 Importanty, the cutura change that was in pay incuded some notes of discord. For instance, the means of guiding care coud become an end in itsef, much to the detriment of the patient (transcription 6:45, beow). The nurses have become conditioned, in some respects to, if they re having a probem with a patient, they reach for a piece of paper to document behaviours. So I give you an exampe of one of the recent wards that I ve been working on it s a very, very busy trauma ward and we have a big probem with oder peope becoming deayed transfers of care because it s difficut for us to discharge oder peope, with high intensity needs, out into a more appropriate setting once their orthopaedic and the trauma care is finished. One of our patients on this particuar ward has, is competey dependent, unabe to verbaise her needs or her wants, bed bound, reiant on us for everything, from feeding, to turning, to toieting, to trying to interpret communication. And in that, ceary, she becomes very frustrated. So she s taken to grabbing out or grabbing nurses as they re turning her. Instead of the nurses stopping and thinking how can we better interact with her, and how can we reassure her more, they ve reached for a behaviour chart. So now her behaviours are being documented instead of actuay stopping and thinking about what can we do differenty et s document the bad behaviour is their response. I think, as a nurse eader, that s what we re conditioning our nurses to do. Associate Director, case site C 1 (119); transcription 6:45 In addition, some aspects of WakRounds and the use of patient stories were found wanting. For some respondents, WakRounds were centred on good news stories that acked feedback and action at ward eve rather than providing a means for transparent and open discussions (transcriptions 6:46 to 6:49), and ownership of the voice behind the patient story was a source of concern for others. However, overa the 1000 Lives + programme s ILQI was considered to be a catayst for change (transcription 6:50). In Waes, the NHS is characterised by a management stye which is probaby best described as pace setting, so it tends to have a pace setting management stye. And 1000 Lives + and coaborative working and engagement with the pubic and a of those sorts of things, is more about a coaching stye. So for me, it s getting that right baance between targets setting a pace and underpinning it with something, which then coaches peope at the best way of how they can do those maturey, so it s how we go about bringing that together, which for me is the absoute chaenge that we ve got. And it seems very easy to say that but when you think of the characteristics that you re changing to do that, it s immense. Poicy ead, Wesh Government (146); transcription 6:50 Queen s Printer and Controer of HMSO This work was produced by Herepath et a. under the terms of a commissioning contract issued by the Secretary of State for Heath. This issue may be freey reproduced for the purposes of private research and study and extracts (or indeed, the fu report) may be incuded in professiona journas provided that suitabe acknowedgement is made and the reproduction is not associated with any form of advertising. Appications for commercia reproduction shoud be addressed to: NIHR Journas Library, Nationa Institute for Heath Research, Evauation, Trias and Studies Coordinating Centre, Apha House, University of Southampton Science Park, Southampton SO16 7NS, UK. 95

126 IMPROVING LEADERSHIP FOR QUALITY IMPROVEMENT 1000 Lives + institutionaisation: ILQI oca impementation of the foca intervention and contribution to the I-CMAO configuration spanning the Wesh heath-care fied In this section, we seek to further our understanding of the oca impementation of ILQI and define its contribution to the 1000 Lives + programmes I-CMAO configuration spanning the Wesh heath-care fied. In case sites A D, ILQI was targeted primariy at executive board-eve actors. Hence this foca intervention connected the infrastructura system of the Wesh Government and the Department of Heath and Socia Care to NHS Waes heath boards. Viewed at a high eve of abstraction, as iustrated in Figure 17, the institutiona change inherent to formaisation, therefore, shaped the context of action for such actors. The 1000 Lives + and the MI-PDSA approach were embedded in Wesh Government tier 1 targets and associated escaation framework. The ILQI, therefore, served to define expected performance across the Wesh heath-care fied. Such bureaucratisation, through command and contro of board-eve actors, signaed the egitimisation of the ILQI s mandate. Board-eve negotiation, formaisation and co-optation of others promoted the deinstitutionaisation of redundant board practices and fostered the preinstitutionaisation of mortaity reviews, associated RAMI (see Tabes 17 23), WakRounds and the use of patient stories at board eve. Hence across each case site, with respect to the 1000 Lives + programme and ILQI, the mandated context for a was comparabe and overty coercive. In each heath board, innovation emerged from the evidence-based earning arising from the MI-PDSA approach. As ceary iustrated with respect to mortaity reviews in transcriptions 6:10 and 6:11 (see Director of medicine and associates), identification of probems and systematic faiings, cataysed knowedge mobiisation and the vaidation of extant cinica coding practices, thus promoting the broader mora and pragmatic egitimisation of the newy normaised practice. In this manner, the actors invoved drew on the resources of the 1000 Lives + programme, notaby RAMI monitoring guideines. Tabes show, respectivey, I-CMAO configurations iustrating the infrastructura system of the Wesh Government, the institutiona setting of NHS Waes and its constituent heath boards and interpersona reationships within the institutiona settings. 96 NIHR Journas Library

127 DOI: /hsdr03400 HEALTH SERVICES AND DELIVERY RESEARCH 2015 VOL. 3 NO. 40 Heterarchica metamechanism Infrastructura system Higher-order societa ogics Wesh Government Pubic sector partner agencies NHS Waes as a corporate whoe NHS Waes heath boards Hospita mutisite Innovation department Hospita site-based ward Structura conditioning Institutiona setting Interpersona reations (reationa structure) Individua Co-optation 5 Negotiation 2 4 Legitimisation Formaisation Legitimisation Formaisation Co-optation (functiona team) Individua Co-existent/ countervaiing ogics 1 3 Identification Knowedge mobiisation Vaidation Legitimisation Mora/ pragmatic Emancipation FIGURE 17 Improving Leadership for Quaity Improvement: heterarchica metamechanism operating across contextua strata. Mimetic isomorphism Coercive isomorphism Normative isomorphism Queen s Printer and Controer of HMSO This work was produced by Herepath et a. under the terms of a commissioning contract issued by the Secretary of State for Heath. This issue may be freey reproduced for the purposes of private research and study and extracts (or indeed, the fu report) may be incuded in professiona journas provided that suitabe acknowedgement is made and the reproduction is not associated with any form of advertising. Appications for commercia reproduction shoud be addressed to: NIHR Journas Library, Nationa Institute for Heath Research, Evauation, Trias and Studies Coordinating Centre, Apha House, University of Southampton Science Park, Southampton SO16 7NS, UK. 97

128 IMPROVING LEADERSHIP FOR QUALITY IMPROVEMENT Figure 17: key point summary In Figure 17 we depict the impementation of the mortaity review component of the ILQI foca intervention. At point 1 we draw attention to the formaisation of this process in Wesh Government poicy, thereby mandating engagement by a heath boards, typicay under the strategic oversight of the medica director. In point 2 structura constraint impacts at the eve of the executive team, fostering the co-optation of other medica eads and cinica coding staff, who are to operationaise the mortaity review across the heath board together with its associated audit practices. In point 3 mandated engagement drives the innovation cyce in the situated context, so that new practices for measuring harm, morbidity and mortaity emerge. This, therefore, functions as a fundamenta stage in organisationa earning with respect to heath-care quaity and patient safety. In point 4 we depict feedback to Wesh Government and pubic sector partner agencies as the impementation and operationaisation of the mortaity review component of the ILQI foca intervention graduay systematises across NHS Waes. In point 5 co-existent and countervaiing ogics are muted by structura constraint. TABLE 11 Improving Leadership for Quaity Improvement I-CMAO configuration: infrastructura system Wesh Government Intervention Component Context 1000 Lives + nationa programme ILQI (centred on mortaity review as an exempar) Wesh Government Mechanisms Institutiona isomorphism coercive, mimetic and normative Coherence, cognitive participation and refexive monitoring Agency and institutiona work Normaisation: couping to 1000 Lives +, ILQI and mortaity review Habituation: decouping to 1000 Lives +, ILQI and mortaity review Agency formaisation Institutiona work creation Leadership: distributed across poicy and professiona domains Team work: poicy eads and professiona engagement across aigned organisations Encutured vaues: centred on defining ILQI and mortaity review as mandated evidencebased practices Decouping imited by structura and cutura constraints within infrastructura system Outcome 1000 Lives + nationa programme, ILQI and mortaity review institutionaised into poicy processes Exempar transcriptions Agency formaisation Institutiona work creation 6:01 (T145) Couping 6:02 (T146) Couping 6:03 (T143) Couping 6:05 (T146) Couping 98 NIHR Journas Library

129 DOI: /hsdr03400 HEALTH SERVICES AND DELIVERY RESEARCH 2015 VOL. 3 NO. 40 TABLE 12 Improving Leadership for Quaity Improvement I-CMAO configuration: institutiona setting NHS Waes and constituent heath boards Intervention Component Context 1000 Lives + nationa programme ILQI (centred on mortaity review as an exempar) NHS Waes/NHS Waes heath boards Mechanisms Institutiona isomorphism coercive, mimetic and normative Coherence, cognitive participation and refexive monitoring Agency and institutiona work Normaisation: couping to 1000 Lives +, ILQI and mortaity review Habituation: decouping to 1000 Lives +, ILQI and mortaity review Agency negotiation under a situationa ogic of protection Institutiona work creation/maintenance Leadership: board-eve Team work: harnesses mutiprofessiona eadership at board eve to foster adoption of ILQI and mortaity review, in cose iaison with and via co-optation of sub-board eadership Encutured vaues: mandated adherence to ILQI and mortaity review Decouping imited by structura and cutura constraints within infrastructura system Agency egitimisation Institutiona work creation Leadership: board eve Team work: dependent on reationa structure of three core board-eve roes with oversight of patient safety: directors of medicine, nursing, therapies and heath science Encutured vaues: mandated adherence to ILQI and mortaity review Decouping imited by structura and cutura constraints within infrastructura system Agency formaisation Institutiona work creation Leadership: board eve Team work: centred on reationa structure across director of medicine and associate roes Encutured vaues: mandated adherence to LWSQI and mortaity review Decouping imited by structura and cutura constraints within infrastructura system Agency co-optation Institutiona work creation Leadership: board eve Team work: centred on reationa structure across director of medicine and associate roes Encutured vaues: mandated adherence to ILQI and mortaity review Decouping imited by structura and cutura constraints within infrastructura system Outcome Couping 1000 Lives + nationa programme, ILQI and mortaity review approach embraced and absorbed into extant management, interna governance and audit processes Decouping imited by structura and cutura constraints within infrastructura system continued Queen s Printer and Controer of HMSO This work was produced by Herepath et a. under the terms of a commissioning contract issued by the Secretary of State for Heath. This issue may be freey reproduced for the purposes of private research and study and extracts (or indeed, the fu report) may be incuded in professiona journas provided that suitabe acknowedgement is made and the reproduction is not associated with any form of advertising. Appications for commercia reproduction shoud be addressed to: NIHR Journas Library, Nationa Institute for Heath Research, Evauation, Trias and Studies Coordinating Centre, Apha House, University of Southampton Science Park, Southampton SO16 7NS, UK. 99

130 IMPROVING LEADERSHIP FOR QUALITY IMPROVEMENT TABLE 12 Improving Leadership for Quaity Improvement I-CMAO configuration: institutiona setting NHS Waes and constituent heath boards (continued) Exempar transcriptions Agency negotiation under a situationa ogic of protection Institutiona work creation 6:08 (T076) Couping 6:10 (T117) Couping 6:26 (T048) Couping 6:31 (T016) Decouping 6:34 (T116) Couping Agency egitimisation Institutiona work creation 6:04 (T051) Couping 6:07 (T078) Couping Agency formaisation Institutiona work creation 6:08 (T076) Couping 6:16 (T093) Couping 6:22 (T030) Couping Agency co-optation Institutiona work creation LWSQI, Leading the Ways to Safety and Quaity Improvement. 6:07 (T078) Couping 6:09 (T117) Couping 6:11 (T042) Couping 6:13 (T116) Couping 6:17 (T034) Decouping TABLE 13 Improving Leadership for Quaity Improvement I-CMAO configuration: institutiona setting interpersona reations Intervention Component Context 1000 Lives + nationa programme ILQI (centred on mortaity review as an exempar) Hospita mutisite department/hospita site-based ward (functiona team) Mechanisms Institutiona isomorphism Coercive, mimetic and normative Coherence, cognitive participation and refexive monitoring Agency and institutiona work Normaisation: couping to 1000 Lives +, ILQI and mortaity review Habituation: decouping to 1000 Lives +, ILQI and mortaity review Agency innovation Institutiona work creation Leadership: board eve with mortaity review primariy distributed across medica profession Team work: centred on reationa structure across director of medicine and associate roes, with input from cinica coding Encutured vaues: mandated adherence to ILQI and mortaity review Decouping imited by structura and cutura constraints within infrastructura system Agency identification Institutiona work creation Leadership: board eve with mortaity review primariy distributed across medica profession Team work: centred on reationa structure across director of medicine and associate roes Encutured vaues: mandated adherence to ILQI and mortaity review Decouping imited by structura and cutura constraints within infrastructura system Agency knowedge mobiisation Institutiona work creation Leadership: board eve with mortaity review primariy distributed across medica profession Team work: centred on reationa structure across director of medicine and associate roes and wider board-eve input Encutured vaues: mandated adherence to ILQI and mortaity review Decouping imited by structura and cutura constraints within infrastructura system 100 NIHR Journas Library

131 DOI: /hsdr03400 HEALTH SERVICES AND DELIVERY RESEARCH 2015 VOL. 3 NO. 40 TABLE 13 Improving Leadership for Quaity Improvement I-CMAO configuration: institutiona setting interpersona reations (continued) Agency and institutiona work Agency vaidation Institutiona work creation Leadership: board eve with mortaity review primariy distributed across medica profession Team work: centred on reationa structure across director of medicine and associate roes and wider board-eve input Encutured vaues: mandated adherence to ILQI and mortaity review Decouping imited by structura and cutura constraints within infrastructura system Agency egitimisation (mora/pragmatic) Institutiona work creation Leadership: board eve with mortaity review primariy distributed across medica profession Team work: centred on reationa structure bridging infrastructura system and director of medicine roes Encutured vaues: mandated adherence to ILQI and mortaity review Decouping imited by structura and cutura constraints within infrastructura system Agency emancipation Institutiona work disruptive Top-down mandated task centred on eite boardeve roes with imited scope of emancipation of ower-eve roes in management hierarchy Decouping imited by structura and cutura constraints within infrastructura system Outcome Couping 1000 Lives + nationa programme, ILQI and mortaity review approach embraced and absorbed into daiy practice Exempar transcriptions Decouping imited by structura and cutura constraints within infrastructura system Agency innovation Institutiona work creation 6:26 (T048) Couping 6:30 (T079) Couping 6:32 (T056) Couping 6:46 (T052) Decouping Agency identification Institutiona work creation 6:14 (T146) Couping 6:36 (T050) Couping 6:37 (T046) Couping 6:39 (T022) Couping Agency knowedge mobiisation Institutiona work creation 6:18 (T118) Couping 6:20 (T009) Couping 6:24 (T044) Decouping 6:27 (T052) Decouping 6:33 (T039) Decouping 6:41 (T117) Couping Agency vaidation Institutiona work maintenance 6:45 (T119) Couping 6:48 (T069) Couping Agency egitimisation (mora/pragmatic) Institutiona work creation 6:28 (T079) Decouping 6:29 (T025) Couping 6:43 (T145) Decouping 6:47 (T010) Decouping Agency emancipation Institutiona work disruptive 6:25 (T030) Couping 6:35 (T080) Couping 6:40 (T049s) Couping Queen s Printer and Controer of HMSO This work was produced by Herepath et a. under the terms of a commissioning contract issued by the Secretary of State for Heath. This issue may be freey reproduced for the purposes of private research and study and extracts (or indeed, the fu report) may be incuded in professiona journas provided that suitabe acknowedgement is made and the reproduction is not associated with any form of advertising. Appications for commercia reproduction shoud be addressed to: NIHR Journas Library, Nationa Institute for Heath Research, Evauation, Trias and Studies Coordinating Centre, Apha House, University of Southampton Science Park, Southampton SO16 7NS, UK. 101

132 IMPROVING LEADERSHIP FOR QUALITY IMPROVEMENT Tabes iustrate the type of information about mortaity rates in hospitas made pubicy avaiabe as part of the new emphasis on transparency in reation to patient safety. We now turn to the findings of our reaist anaysis. For iustration, we focus ony on the mortaity review component of the ILQI, and thus primariy on the generative mechanisms and ensuing agency attributed to directors of medicine. Figure 17 and Tabe 21 support our discussion. As signposted in Tabe 21, the bureaucratic sense of force majeure that drove engagement with ILQI gave rise to aigned first-order emergents in board-eve actors. This incuded compiance with task aocation and appropriate action to ensure deivery in accordance with the dominant ogic of the bureaucratic state. Given the compementary inkages between systemic structura and cutura ogics, this fostered a situationa ogic of protection. 229 In part, this was sef-referentia: board-eve actors had to engage, visiby, in the eadership of patient safety, so aiding the normaisation of such practices within the board. The sociocutura interaction encouraged by board-eve activity centred on strategic negotiation across management tiers and professiona networks. Driven by the board and honed through the 1000 Lives + MI-PDSA approach, egitimisation, formaisation and co-optation ensued. This drove the innovation cyce, as iustrated in Figure 17. An objective outcome of ILQI was the normaisation of the three practices mortaity reviews, WakRounds and patient stories examined in this chapter. The reationa structure at each site had aso evoved, encouraging the diffusion of the ILQI, and thus the 1000 Lives + programme, and promoting a cuture of organisationa earning. However, cutura change was restricted by medica disengagement, notaby via chaenge to the mora and pragmatic egitimacy of some components of the 1000 Lives + programme, the burden of documentation and weak feedback from boards to wards. We return to these issues in Chapter 7, where we examine the impementation of our second foca intervention under far more chaenging constraints. TABLE 14 Loca impementation of ILQI: Abertawe Bro Morgannwg University Heath Board RAMI Reporting period Heath board Morriston Singeton Neath Port Tabot Princess of Waes January 2011 to December February 2011 to January March 2011 to February Apri 2011 to March May 2011 to Apri June 2011 to May Juy 2011 to June August 2011 to Juy September 2011 to August October 2011 to September November 2011 to October December 2011 to November January 2012 to December RAMI data accessed via NIHR Journas Library

133 DOI: /hsdr03400 HEALTH SERVICES AND DELIVERY RESEARCH 2015 VOL. 3 NO. 40 TABLE 15 Loca impementation of ILQI: Aneurin Bevan University Heath Board RAMI Reporting period Heath board Roya Gwent Nevie Ha Ystrad Fawr January 2011 to December February 2011 to January March 2011 to February Apri 2011 to March May 2011 to Apri June 2011 to May Juy 2011 to June August 2011 to Juy September 2011 to August October 2011 to September November 2011 to October December 2011 to November January 2012 to December RAMI data accessed via TABLE 16 Loca impementation of ILQI: Betsi Cadwaadr University Heath Board RAMI Reporting period Heath board Gwynedd Gan Gwyd Wrexham January 2011 to December February 2011 to January March 2011 to February Apri 2011 to March May 2011 to Apri June 2011 to May Juy 2011 to June August 2011 to Juy September 2011 to August October 2011 to September November 2011 to October December 2011 to November January 2012 to December RAMI data accessed via Queen s Printer and Controer of HMSO This work was produced by Herepath et a. under the terms of a commissioning contract issued by the Secretary of State for Heath. This issue may be freey reproduced for the purposes of private research and study and extracts (or indeed, the fu report) may be incuded in professiona journas provided that suitabe acknowedgement is made and the reproduction is not associated with any form of advertising. Appications for commercia reproduction shoud be addressed to: NIHR Journas Library, Nationa Institute for Heath Research, Evauation, Trias and Studies Coordinating Centre, Apha House, University of Southampton Science Park, Southampton SO16 7NS, UK. 103

134 IMPROVING LEADERSHIP FOR QUALITY IMPROVEMENT TABLE 17 Loca impementation of ILQI: Cardiff and Vae University Heath Board RAMI Reporting period Heath board Waes LLandough January 2011 to December February 2011 to January March 2011 to February Apri 2011 to March May 2011 to Apri June 2011 to May Juy 2011 to June August 2011 to Juy September 2011 to August October 2011 to September November 2011 to October December 2011 to November January 2012 to December RAMI data accessed via TABLE 18 Loca impementation of ILQI: Cwm Taf University Heath Board RAMI Reporting period Heath board Roya Gamorgan Prince Chares January 2011 to December February 2011 to January March 2011 to February Apri 2011 to March May 2011 to Apri June 2011 to May Juy 2011 to June August 2011 to Juy September 2011 to August October 2011 to September November 2011 to October December 2011 to November January 2012 to December RAMI data accessed via NIHR Journas Library

135 DOI: /hsdr03400 HEALTH SERVICES AND DELIVERY RESEARCH 2015 VOL. 3 NO. 40 TABLE 19 Loca impementation of ILQI: Hywe Dda University Heath Board RAMI Reporting period Heath board Brongais Gangwii Prince Phiip Withybush January 2011 to December February 2011 to January March 2011 to February Apri 2011 to March May 2011 to Apri June 2011 to May Juy 2011 to June August 2011 to Juy September 2011 to August October 2011 to September November 2011 to October December 2011 to November January 2012 to December RAMI data accessed via TABLE 20 Loca impementation of ILQI: Powys (Teaching) Heath Board RAMI Hospita site Discharges, n Deaths, n Mortaity, % Brecon Bronys Ystradgynais Knighton Landrindod Wes Machyneth Lanidoes Newtown Weshpoo Powys (Teaching) Heath Board offers a speciaist but more restricted range of services and therefore does not participate in the RAMI scheme owing to the tendency to produce inaccurate RAMI scores. RAMI data accessed via Queen s Printer and Controer of HMSO This work was produced by Herepath et a. under the terms of a commissioning contract issued by the Secretary of State for Heath. This issue may be freey reproduced for the purposes of private research and study and extracts (or indeed, the fu report) may be incuded in professiona journas provided that suitabe acknowedgement is made and the reproduction is not associated with any form of advertising. Appications for commercia reproduction shoud be addressed to: NIHR Journas Library, Nationa Institute for Heath Research, Evauation, Trias and Studies Coordinating Centre, Apha House, University of Southampton Science Park, Southampton SO16 7NS, UK. 105

136 IMPROVING LEADERSHIP FOR QUALITY IMPROVEMENT TABLE 21 Improving Leadership for Quaity Improvement: reaist anaysis signposting how the empirica data connect to I-CMAO Intervention Component Context Leading the Ways to Safety and Quaity Improvement (ILQI) Mortaity review Structura conditioning of the institutiona setting: NHS Waes heath boards executive-eve impementation of 1000 Lives + nationa programme Structura emergent properties Structura constraints and enabements shaped by the bureaucratic processes of formaisation emergent from the infrastructura system of the Department of Heath and Socia Care impact 1000 Lives + and ILQI Structura resiience was derived from the mutuay reinforcing presence of necessary, interna and compementary inkages between systemic structures, e.g. the mandated bureaucratic performance management systems and associated 1000 Lives + and ILQI goas, notaby mortaity measurement Structura resiience aso emerged from the tripartite interock and soidarity between directors of medicine, nursing, and therapies and heath sciences, as coective champions of, and advocates for, 1000 Lives + and the broader patient safety agenda Cutura emergent properties Cutura constraints, attributed to the Francis Report, impact on the directors of medicine, nursing, therapies and heath science who have deegated strategic oversight of patient safety, and thus 1000 Lives + and ILQI Socia actors Directors of medicine: the foca intervention, ILQI-mortaity review is targeted to board-eve actors but is primariy addressed by directors of medicine Socia position Eite power roe with high socia position, professiona standing and widespread networks Roe-position practices Professiona roe-position practices encompass organisation wide management and, specificay, professiona eadership of medica staff. They therefore permeate across the heath boards hospita site-based wards or mutisite departments, through to the eve of the functiona team and individua doctor Mechanism Institutiona ogics and nature of aignment between core actors First-order emergents Second-order emergents Situationa ogic Refexive theorisation Mediation of structura conditioning to core actors and their refexive theorisation The institutionaisation of 1000 Lives + and ILQI draws professiona ogic into aignment with that of the bureaucratic state. Moreover, there is coaescence and cohesion across medica, nursing, aied professiona and heath-care management ogics, thereby pacing each into a compementary stance. This fosters the systematisation of 1000 Lives + and ILQI across the cutura system eve of NHS Waes, and promotes the reproduction of such practices across each heath board The vested interests of directors of medicine and their associates, tasked with the strategic oversight of the 1000 Lives + programme and ILQI, ay primariy in the successfu deveopment of a systematic ocay agreed approach to undertaking the mortaity review in the aftermath of the structura reconfiguration of NHS Waes Necessary compementarities Protection Compementarity between the dominant ogic of the bureaucratic state, professiona (medica) ogic and coaborative ogic fosters coherence, cognitive participation and refexive monitoring. This resuts in the discernment of issues, deiberation of their importance and dedication of ensuing agency in aignment to the goas of the ILQI 106 NIHR Journas Library

137 DOI: /hsdr03400 HEALTH SERVICES AND DELIVERY RESEARCH 2015 VOL. 3 NO. 40 TABLE 21 Improving Leadership for Quaity Improvement: reaist anaysis signposting how the empirica data connect to I-CMAO (continued) Agency and institutiona work Agentia emergent properties Agency, the unfoding strategic negotiation of change, and the mode of institutiona work enacted Given the high status of such actors, the inherent change agenda overarching the 1000 Lives + programme, and thus the ILQI, was executed from a position of considerabe negotiating strength Strategic negotiation Power-induced compiance and poitica sanction Exempar transcriptions: 6:10, 6:11, 6:14, 6:41 Reciproca exchange and harmonisation of desires Exempar transcriptions: 6:07, 6:09, 6:12, 6:39 Institutiona work Outcome Structura Cutura Agentia Primariy creative and augmented by actions which maintain reevant associated practices Socia eaboration, reproduction or invariance Integration of mortaity reviews into the Wesh Government s performance management framework was viewed to have added an important critica ens through which to view patient safety and the maturation of the heath-care quaity agenda in NHS waes amid organisationa reconfiguration Cutura change was viewed to be far more fragmented A network of patient safety eaders, heath-care professionas from manageria, medica, nursing and other aied groups, evoved Summary In Chapter 6, we examined the oca impementation of the foca intervention ILQI and discussed its contribution to the 1000 Lives + programmes I-CMAO configuration across the Wesh heath-care fied. Queen s Printer and Controer of HMSO This work was produced by Herepath et a. under the terms of a commissioning contract issued by the Secretary of State for Heath. This issue may be freey reproduced for the purposes of private research and study and extracts (or indeed, the fu report) may be incuded in professiona journas provided that suitabe acknowedgement is made and the reproduction is not associated with any form of advertising. Appications for commercia reproduction shoud be addressed to: NIHR Journas Library, Nationa Institute for Heath Research, Evauation, Trias and Studies Coordinating Centre, Apha House, University of Southampton Science Park, Southampton SO16 7NS, UK. 107

138

139 DOI: /hsdr03400 HEALTH SERVICES AND DELIVERY RESEARCH 2015 VOL. 3 NO. 40 Chapter 7 Reducing Surgica Compications Overview In this chapter we examine RSC, the second foca intervention drawn from the 1000 Lives + nationa programme. Our focus is expicity directed to one strand of this compex intervention: the WHOSSC. To begin, we set out a brief overview of RSC, defining its muticomponent structure, aim and drivers. This we augment with a review of the WHOSSC, highighting its emergence, acknowedged benefits and the perceived barriers that impede its normaisation into daiy practice. Second, we undertake a reaist anaysis of the institutionaisation of RSC and the WHOSSC, through a comparative case study of sites A, B, C and D. In doing so, we expain the structura conditioning, sociocutura interaction and structura eaboration or reproduction fostered through the actions of three groups of key actors: theatre managers, consutant surgeonsandanaesthetists,andtheatrenurses.weconcentrateonthese groups as they were formay tasked with the impementation of the RSC within the 1000 Lives + programme. Again, to aid our understanding of context and mechanism, we aso consider the perspectives of poicy eads and other senior heath-care management staff. Finay, informed by the findings of our reaist anaysis we set out our understanding of the RSC-WHOSSC I-CMAO configuration. Foca intervention, aim and drivers Reducing Surgica Compications aims to support theatre department staff to deiver high-quaity, safe and effective care for adut patients undergoing surgica procedures in a hospita setting. As iustrated in Figure 18, RSC is composed of four interventions to reduce the number of infections after surgery, two interventions to improve teamwork and three to faciitate patient invovement in their care. In this study, attention focused on the WHOSSC, 531 a too for cinica teams to improve the safety of surgery by reducing deaths and compications. Word Heath Organization Surgica Safety Checkist The WHOSSC evoved from the Safe Surgery Saves Lives initiative, estabished by the Word Aiance for Patient Safety as part of the Word Heath Organization s (WHO) efforts to reduce the number of surgica deaths across the word. This initiative sought to harness poitica commitment and cinica wi to address important safety issues. The principa concerns were poor communication among team members; inadequate surgica and anaesthetic safety practices; and avoidabe surgica infection. 531 As iustrated in Figure 19, the WHOSSC is characterised by simpicity and brevity, and is composed of a series of questions to guide the co-ordinated actions of the theatre team. Notaby, many of the individua steps advocated are accepted as routine practice. But, as expanded beow, such acceptance does not reduce the barriers to its coective adoption. 531 It is, therefore, acknowedged that to foster engagement and enhance compiance, 532 each theatre team must adapt the WHOSSC to their needs and routine operative workfow and to address many different types of surgery With increasing acceptance of the WHOSSC, 546 aigned approaches have been adapted to address broader surgica issues and hazards There have aso been more subte changes such as the adjustment of the timing of questions ikey to cause anxiety to patients. 173 Queen s Printer and Controer of HMSO This work was produced by Herepath et a. under the terms of a commissioning contract issued by the Secretary of State for Heath. This issue may be freey reproduced for the purposes of private research and study and extracts (or indeed, the fu report) may be incuded in professiona journas provided that suitabe acknowedgement is made and the reproduction is not associated with any form of advertising. Appications for commercia reproduction shoud be addressed to: NIHR Journas Library, Nationa Institute for Heath Research, Evauation, Trias and Studies Coordinating Centre, Apha House, University of Southampton Science Park, Southampton SO16 7NS, UK. 109

140 REDUCING SURGICAL COMPLICATIONS Content area Drivers Interventions Administer prophyactic antimicrobias appropriatey Preventing surgica-site infections Use recommended hair remova methods Maintain gycaemic contro for known diabetics RSCs Creating a team cuture attuned to detecting and rectifying intraoperative errors Maintain perioperative normothermia Use team briefings at the beginning of the ist Use WHOSSC for each patient 1 Patient invovement Patient education Patient awareness of risks Patient invovement in care FIGURE 18 Driver diagram: RSC. Figure 18: key point summary Figure 18 depicts the driver diagram for the foca intervention, RSC, focusing specificay on one strand of this muticomponent intervention, the WHOSSC. To aid our understanding of the interpay of context and mechanism in the operationaisation of this intervention, we sought the perspectives of theatre managers, consutant surgeons and anaesthetists, and theatre nurses, each tasked with the impementation of the RSC and WHOSSC under the auspices of the 1000 Lives + nationa programme. 110 NIHR Journas Library

141 DOI: /hsdr03400 HEALTH SERVICES AND DELIVERY RESEARCH 2015 VOL. 3 NO. 40 FIGURE 19 The WHOSSC. Source: Reproduced with permission. Since its inception, the WHOSSC has proved to be a robust means of reducing perioperative compications. 70,406,551,552 Empirica research supports assertions that the WHOSSC (i) saves ives; (ii) improves communication across the surgica team; 558 (iii) reduces the occurrence of wrong-site surgery; 63 (iv) promotes adherence to defined antibiotic protocos, thereby reducing the incidence of surgica-site infection; and (v) fosters more efficient use of theatre time and resources, 556 whie supporting appropriate staffing eves. 439 Despite such obvious benefits, operationaisation of the WHOSSC may be poor. 70,190, Faiures to foow the checkist incude not identifying the patient; undertaking a wrong-site surgery or procedure; 565 and faiing to identify staff members. 123,566 In addition, pressure of time may ead to surgica procedures being started before the checkist is competed Faiure to compete sign out is another common deviation. 122 Poor engagement by anaesthetists, 71 surgeons 570 and nursing staff due to resistance and gaps in knowedge has aso been reported. 435,543,571 Reaist anaysis and comparative case study We now undertake a critica reaist anaysis of the institutionaisation of the 1000 Lives + nationa programme s RSC and WHOSSC. Again, our case study considered sites A, B, C and D. Our anaysis focuses on three groups of key actors, theatre managers, consutant surgeons and anaesthetists, and theatre nurses, tasked with the impementation of the RSC under the auspices of the 1000 Lives + nationa programme. Queen s Printer and Controer of HMSO This work was produced by Herepath et a. under the terms of a commissioning contract issued by the Secretary of State for Heath. This issue may be freey reproduced for the purposes of private research and study and extracts (or indeed, the fu report) may be incuded in professiona journas provided that suitabe acknowedgement is made and the reproduction is not associated with any form of advertising. Appications for commercia reproduction shoud be addressed to: NIHR Journas Library, Nationa Institute for Heath Research, Evauation, Trias and Studies Coordinating Centre, Apha House, University of Southampton Science Park, Southampton SO16 7NS, UK. 111