Overview
In this chapter we present the discussion and conclusion of our study. Here, the
explicit intention is to move beyond simple iteration. We therefore present our
closing argument in four main parts.
First, we return to the original research questions posed in the aim and
objectives of this study and address them guided by our empirical findings. In
this manner, we forward our conceptualisation of context, mechanism, agency and
ensuing outcome, and develop insights from the local implementation of the three
focal interventions selected from the 1000 Lives+ national programme:
ILQI, RSC and RHAI. Second, we acknowledge the limitations of our study and set
out our stance regarding the generalisability of our findings. Next, we consider
the contribution of this study to the study of patient safety, outline the
future outputs from this project and suggest areas for future research. Finally,
we consider the implications of the research for health-care practice and
patient safety.
Which contextual factors matter: how, why and for whom?
In this study, we sought to ascertain which contextual factors matter, how, why
and for whom, in order that processes and outcomes of future patient safety
programmes may be improved. Our study therefore deviated, quite markedly, from
the traditional focus of realist inquiry, and the newly established RAMESES
publication standards for realist syntheses (www.ramesesproject.org).
Most significantly, our unit of analysis was the process of local implementation
of the 1000 Lives+ programme, as opposed to the evaluation of the
1000 Lives+ programme per se.
Before we could begin to address this issue, the notion of context demanded
clarification. As Bate699 has
recently commented, context is everything. However, there has been very limited
systematic and independent analysis of the relationship between organisational
factors, which shape the local context of health care, and the outcomes of
patient safety interventions.124,216–223 In this study, guided by the
established approach to realist inquiry,228,241,242,247 we specified four main levels of contextual
hierarchy: infrastructural system, institutional setting, interpersonal
relations and individual. All levels except the individual are divided into
substrata (see ). Through this depiction we sought to capture and convey the
accumulated sense of contextual constraints and enablements, structural and
cultural, which impact differently positioned actors within the Welsh
health-care field to shape their scope and perceived discretion to act. Context
was, therefore, conceptualised as ‘situated’. By this we mean
that context is stratified, conditioned, relational and temporally dynamic.
Importantly, our view of context was reflected in our findings. At the level of
the functional team, context was perceived to be distinct from that of the wider
organisation. Indeed, it resonated with that of a bounded health-care managerial
or clinical micro-work system.163,164,166,700–704 Accordingly, we suggest that this finding challenges the use of
the health-care organisation as a unit of analysis for patient safety
programmes, as adopted in this study and as advocated in the ‘four
high-priority’ features of organisational context.5,223,705 Indeed, our
use of a comparative case-study design across major, district general and small
community hospital sites within each participant health board was somewhat
confounded.
In phase 1 of our analysis, despite the bureaucratic mandate to engage with the
1000 Lives+ programme that was evident at the field level of analysis
(see Chapter 4), our
examination of the normalisation of 1000 Lives+ at the
suborganisational level (see Chapter
5) surfaced a complex pattern. At this level, discrete
pockets of high adherence sat alongside areas of enforced but somewhat
disengaged adoption. As such, even within case sites, it was not uncommon to
find disparity between adjacent wards. In essence, two polarised types of
situated context emerged. In the first type, 1000 Lives+ was
normalised and absorbed into daily practice, becoming integral to care. In the
second type of situated context, engagement with 1000 Lives+ was
merely adsorbed (attached to but not fully integrated with) onto daily practice.
It was then perceived to be an additional burden above and beyond the routine
demands of health-care provision. The local implementation of the 1000
Lives+ programme was, therefore, positioned across a spectrum
between these polarised stances. This highlights the transitional and fragile
state of its progressive institutionalisation across NHS Wales. We therefore
contend that focus directed at the level of the ‘micro-work
system’163–170,706–711 may offer greater insight into the impact of
patient safety improvement programmes at the point of patient-centred care.
Indeed, this may even help to challenge Pawson’s iron law of evaluation:
the expected value of any net impact assessment of any large-scale social
program is zero.241
Contextual organisational factors pertinent to the health outcomes of
hospital patient safety interventions
In this section we build on our conceptualisation of a situated context.
Informed by our realist analysis of the local implementation of the 1000
Lives+ programme’s three focal interventions
– ILQI, RSC and RHAI – we identify and analyse the
supraorganisational and organisational factors in the Welsh health-care
field which are pertinent to the health outcomes of these hospital patient
safety interventions.
What supraorganisational factors matter: how, why and for
whom?
In this study, we have drawn on the long-held view that multiple
institutional logics co-exist.331 As illustrated in and , at the higher-order
societal level, the balance between these logics shapes what is expected
and accepted behaviour for broader society. Moreover, at the level of
the Welsh health-care institutional field, their expression orchestrates
the rituals, routines and practices constituting day-to-day professional
work.38 The interplay
between logics and their inherent tensions give rise to the
institutional complexity that all health-care practitioners
confront.712
Consequently, each individual – whether positioned as a policy
lead in the Welsh Government, a health board chief executive or
board-level director, or a hospital doctor, nurse or other aligned
professional group – has to negotiate individually, and as part
of a functional team, the consequences of countervailing, co-existent
and complementary logics. Existence within such a system demands nuanced
institutional work. This is typically executed through role and
professional position-based power to attain a state of force majeure, or
to broker a workable sense of reconciliation and compromise.713
Our findings indicate that the precise balance of the institutional
logics moulding the Welsh health-care institutional field impacts
patient safety in a particular way. First, the paradigmatic logic of
bureaucratic command and control, which fosters mandated engagement with
1000 Lives+ via coercive institutional isomorphism,
structures the health-care policy context for elite individuals such as
policy leads, members of public sector partner agencies tasked with the
strategic oversight of patient safety and board-level personnel in NHS
Wales’ seven health boards.
Although this logic was dominant at the level of the infrastructural
system, as illustrated in and , professional logic was found to
dominate contextual strata at sub-board organisational levels across
each health board. This gave rise to conflict between logics. In the
example of the mandated completion of the WHO checklist, cited in
Chapter 7,
while the moral and pragmatic legitimacy of the 1000 Lives+
programme was promoted by the logic of policy leads and health-care
managers, it was challenged by the logic of some groups of health-care
clinical professionals. Importantly, it was not the central issue of
patient care that promoted such contestation, but the means through
which it was imposed. Mandated engagement was perceived in a pejorative
light as a means of management control that eroded professional
autonomy: a core component of professional logic.335,336 This created tensions that provoked decoupling from the
goals and practices advocated by the 1000 Lives+
programme.
What organisational factors matter: how, why and for whom?
Our findings set out in Chapter
4 illustrated that the paradigmatic logic of
bureaucratic command and control inculcated a pervasive performance
measurement and management ethos across the Welsh health-care field.
Mandated engagement with 1000 Lives+ was, therefore,
legitimised as a core policy lever for health-care transformation. This
clearly impacted on board-level actors in NHS Wales’ seven
health boards. Specifically, it caused their actions to be directed to
the (i) co-optation, negotiation and legitimisation of the distributed
leadership of change across the relational structure of their personal
managerial and professional networks; and (ii) the formalisation of
patient safety governance processes, specifically the statutory Quality
and Safety Committee, aligned to the Welsh National Quality and Safety
Forum.
Such mandated engagement was, however, hindered by the challenges posed
by the structural reconfiguration of NHS Wales. Indeed, our findings
highlight that the emergence of health boards has (i) added management
tiers, which now distort communication channels formerly shaped by
proximity and close relational ties for health-care managers and
health-care clinical professionals alike; and (ii) disrupted the
relational structures of clinical micro-work systems due to clinical
service reconfiguration across formerly distinct organisations.
Furthermore, the profound challenges posed by the economic downturn
impact patient safety and NHS Wales’ organisations engaged with
1000 Lives+ have to do ‘more with less’.
Reflecting on such issues at the level of the functional team added
further insight into the nature of situated context. For example, the
organisational factors impacting the focal intervention ILQI, set out in
Chapter 6,
were found to be closely integrated with the 1000 Lives+
programme’s position as a legitimised core policy lever for
health-care transformation across NHS Wales. Formalised through the
Welsh Government’s tier 1 targets, this structural constraint
drove board-level engagement and severely limited the scope for
decoupling. Moreover, it was compounded by demands for heightened
transparency with respect to the publication of health board and
discrete hospital site RAMI data (see Tables 14–20) and board
papers conveying the use of patient stories.
In addition, in the aftermath of the Francis Report,714 cultural constraints and enablements
centred on heightening awareness of systemic failings and the need to
foster a culture of high-quality compassionate care. This gave rise to
the institutionalised division of delegated strategic oversight of
patient safety – and thus 1000 Lives+ and ILQI
– to the directors of medicine, nursing, and therapies and
health science. Given the board-level status and professional
role-positions of such actors, the inherent change agenda overarching
the 1000 Lives+ programme and, thus, the ILQI were executed
from a position of high negotiating strength.
Structural elaboration was, therefore, displayed across each case site.
Indeed, an objective outcome of the ILQI was the normalisation of the
three practices examined in Chapter 6. In addition, the relational
structure at each site had evolved, promoting the diffusion of the ILQI,
and thus the 1000 Lives+ programme, while engendering a
culture of organisational learning. However, cultural change was
restricted by medical disengagement – notably via challenge to
the moral and pragmatic legitimacy of some components of the 1000
Lives+ programme. The two key issues we identified were
the burden of documentation and weak feedback from boards to wards.
The organisational factors impacting at the level of the functional team
for the focal intervention RSC and the associated WHOSSC, set out in
Chapter 7,
were, once again, shaped by the bureaucratic processes of formalisation
emergent from the infrastructural system of the Welsh
Government’s Department of Health and Social Care. However, in
this regard, the overarching policy mandate of the 1000
Lives+ programme was augmented by the compulsion to
undertake the WHOSSC forwarded by professional Royal Colleges.
Cultural constraints and enablements centred on the institutional system
emblematic of the theatre departments. Two critical features surfaced in
this study were a sense of separation from the broader health board that
was compounded by distinctive functional and dominant professional
cultures.
In essence, the local implementation of the RSC and the WHOSSC demanded
skilful brokerage of institutional change across two groups of theatre
department staff. The first group were consultant surgeons who lacked
the burden of managerial accountability for the implementation of the
RSC and WHOSSC, and who, therefore, were, quite simply, participants in
its local operationalisation. This group of actors viewed the change
with a degree of disdain: ’It was all quite an interesting
shambles actually. The senior people decided that they were above it all
basically’. The second group were consultant surgeons, supported
by theatre managers, who were explicitly tasked with the strategic
oversight of the local implementation of the RSC and the WHOSSC. Given
the professional role-positions of such theatre department actors and
the inherent change agenda overarching the 1000 Lives+
programme, the RSC and the WHOSSC were executed through negotiated
compromise through multimodal institutional work.
Once again, as set out in Chapter
7, structural elaboration was evident across
each case site. This was illustrated by the integration of the WHOSSC
into governance processes. However, the openly acknowledged decoupling
from such governance processes distorted coherence and commitment to the
RSC and the WHOSSC by diminishing it to a tick-box exercise. Such a
contested change highlights the time demanded to bring discordant
professional logics into alignment. It also underscores the complexity
of the prolonged period of creative institutional work required to
promote the desired coalescence and unification at the cultural system
level.
In contrast, the organisational factors impacting the focal intervention
RHAI centred on the complex array of established alternative frameworks
and ongoing surveillance of their effectiveness via the WHAIP. This was
compounded by different but interlocking professional roles across the
local IPAC team. Accordingly, in such a situated context, no appreciable
change to practice was required and deinstitutionalisation did not
occur. The 1000 Lives+ programme and RHAI were, therefore,
blunted through adherence to alternative frameworks of perceived
heightened professional legitimacy via institutional maintenance
work.
Mechanisms that interact with contextual organisational factors to
generate the health outcomes of hospital patient safety
interventions
In this section, first, we reflect on the notion of a mechanism. Then we set
out how our findings have identified critical mechanism substructures which
impact the local implementation of the 1000 Lives+ programme.
From mechanism to causal configuration
In realist inquiry, mechanisms are considered to be the engines of
explanation embodied in an agent’s reasoning and their selective
attention to the disparate resources offered through a social
programme.228,241,242 However, consideration of social
actors’ contextually situated reflexive reasoning remains
underdeveloped.256
One reason for this arises from the inherent problems associated with
unpacking and conceptualising reasoning, specifically as justifications
for choices may operate within different, and often contradictory,
stances.321
The notion of ‘a mechanism’, in the sense of a unitary
phenomenon, obscures its inherent structure and operation within a
broader causal configuration. Hence, in this study, mechanism, while
centred on agents’ reasoning, is theorised as part of a causal
configuration emergent from a cluster of contextual factors and
organisational components. These typically encompass a complex array of
social structures, practices, relations, rules and resources. Yet,
collectively, it is these factors which possess the powers, capacities
and potentials to do certain things when operating in a spatio-temporal
relationship with other objects.306,309,310 Conceptualised in this
manner, mechanisms, and their attendant causal I-CMAO (CMO)
configurations, may be embedded in another or configured in a series, so
that the outcome of one configuration becomes the context for the next
in the chain of implementation steps.307 This aspect of realist inquiry remains
underdeveloped, as it demands the formulation of I-CMAO configurations,
which pervade and connect contextual strata, in the form of
bidirectional (top-down and bottom-up) nested causal cascades or
metamechanisms.316–318
In this study, our aim was to contribute to these conceptual challenges
by examining the nuanced demarcation between context and mechanism
across defined yet linked contextual strata, each involved in the
operationalisation of the 1000 Lives+ programme within the
Welsh health-care field. Hence, to examine the process of the local
implementation of this complex and ambitious patient safety programme,
we drew on two fundamental institutional processes –
bureaucratisation and normalisation – which, we argue, operate
as sociocultural and organisational metamechanisms. Bureaucratisation
and normalisation, therefore, act as the underpinning carriers347 of the processes of
health-care institutional change and ensuing practice-based change
advocated by 1000 Lives+. In essence, it is through
successful embedding within these fundamental metamechanisms that the
patient safety programme becomes institutionalised.
Our findings from Chapters
4–8 illustrated three mechanism substructures,
which collectively compose core components of the causal configuration
for the local implementation of the 1000 Lives+ programme and
further enrich our appreciation of the complex interplay of context and
mechanism.
Mechanism substructure I: institutional isomorphism –
mimetic, coercive and normative – coupling and
decoupling
Institutional theory has arguably become the dominant approach for the
study of macro-organisational phenomena.715 Indeed, in institutionally informed
health-care research it is acknowledged that institutions are primary
and mould the context in which the varied health-care actors’
interests operate.716
Dominant institutional logics are, therefore, a critical field-level
mechanism717 that
focus attention on the manner through which the attendant
‘culture’718 influences lower-level organisational change.719
As set out in Chapter
4, our findings indicated that, within the Welsh
health-care field, institutionally prescribed values were orchestrated
at field level and echoed at the organisational level of the Welsh
Government and NHS Wales, though they manifested in a distinctive manner
in functional subgroups. This stance has been identified in other
complex, institutionally dense organisations.720 However, it was the discrete
professions embedded within this institutional field that operated as
the ‘pre-eminent institutional agents’, enacting
isomorphic institutionalism through mimetic, coercive or normative
means.404,721 Furthermore, our
findings highlight that such institutional work engendered legitimacy
which impacted strategy and culture as well as associated structures and
processes, in part, due to the statutory accountabilities and governance
structures enmeshed with patient safety practices across NHS Wales.
Voronov et al.722 have identified the important role of
‘glocalisation’ – fidelity to global norms with
aligned adaptation to local conditions – in institutional
maturation and change. In our study, this effect was apparent in the
transmission of the IHI patient safety practices via mimetic isomorphic
forces, driven by the dominance of the IHI’s position and their
acceptance by elite institutional actors with close professional ties to
policy leads within the Welsh Government. Indeed, our data highlighted
that for social actors embedded within the policy domain of the Welsh
Government, mimetic isomorphic forces drove acts of imitative
entrepreneurship even for those who expressed questions over the
legitimacy of the 1000 Lives+ programme. Mimetic isomorphism
also arose through the institutional work of ‘believers’
in the 1000 Lives+ programme’s ethos and values,
thereby catalysing co-optation and engagement of others. Yet despite the
salience and assumed core values enshrined in the notion of patient
safety, this institutional mechanism, as previously illustrated by Van
Wijk et al.,723 was marred by the disruptive distributed brokerage of
change.
Coercive institutionalism was apparent throughout our study. It emerged
from dominating organisational structures tied to health-care policy,
health board performance and the ‘legitimating
rhetoric’724
of governance – external and internal – of patient
safety. Yet this, too, was challenged by professional, predominantly
medical, power-based structures of membership and specialism
identity.725
In addition, isomorphic institutionalism through normative means was
apparent in some long-established interventions, which had previously
operated under the banner of the 1000 Lives campaign and, indeed, the
Safer Patients Initiative, together with others associated with the 1000
Lives+ programme. However, as illustrated in
Chapter 5,
such normalisation was fragmented and isolated in discrete pockets.
Normalisation of the 1000 Lives+ programme was also associated
with clear leadership of change, internal health-care practice
maturation emergent from the MI-PDSA approach, and complex
‘boundary brokerage’34,91,726 to
signal an identity for the programme, its adherents and associated
health-care practices. The creative institutional work required to
change beliefs, values and, through time, associated norms of practice
was frequently displayed by actors occupying hybrid professional roles,
including nurse-managers, associate directors with dual management and
clinical portfolios, and board-level clinical practitioners. This
finding parallels that of Reay et al.222,408
Our findings illustrated that, while the local implementation of the 1000
Lives+ programme fostered strong institutional coupling
that was moulded by the institutional isomorphism inherent to its
bureaucratisation and normalisation, the operationalisation of 1000
Lives+ in everyday practice was distorted by adaptive and
maladaptive decoupling.
Adaptive decoupling arose in the focal intervention RHAI, as already
established alternative IPAC guidelines and the ongoing surveillance of
their effectiveness via the WHAIP were perceived to offer more rigor
and, thus, heightened legitimacy across the core professional groups
examined in our study. Hence given the embedded nature of such
alternatives, and their aligned clinical practices, the 1000
Lives+ programme was simply circumvented.
In contrast, maladaptive decoupling was apparent in the local
implementation of the focal intervention RSC, centred on the WHOSSC.
Given the Welsh health-care policy commitment to this practice, as well
as its world-wide professional advocacy,439,565,727 it is
worth considering the means through which such maladaptive decoupling
manifested, that is, the simple and common failure to identify the
members of the theatre team in the checklist. This practice reduced the
possibility of individuals being blamed for any failures, undermining
belief in the WHOSSC as a meaningful practice. Indeed, such disruptive
institutional work diminished the legitimacy and moral foundation of the
practice and hindered the remoulding of underlying belief systems.
Perceived as a threat to the entrenched professional dominance of
surgeons, the resistance rendered the WHOSSC down to a tick-box exercise
which was interpreted by respondents to demonstrate that it was having
little effect on reducing error ’. . .across NHS
Wales we’ve had disasters even with the checklist being used:
wrong site surgery, instruments left in, etcetera . . .
In other words it’s not being used properly’.
Mechanism substructure II: alignment of institutional logics
– countervailing, co-existent and complementary – and
ensuing coherence, cognitive participation and reflexive
monitoring
At the level of the Welsh health-care institutional field, the nature of
the alignment of institutional logics - be they complementary,
co-existent or countervailing – impact patient safety. As
discussed in Contextual organisational factors pertinent to the
health outcomes of hospital patient safety interventions,
What supra-organisational factors matter: how, why and for
whom?, and as illustrated in and , this centred on the
interplay of the logic of the bureaucratic state and professional logic.
However, previous studies have illustrated that, within health care,
professional logic does not manifest in unitary manner.37,38,222,373,728 Rather, different
interprofessional logics and attendant institutions are displayed, each
connected by some semblance of an overarching ‘logic of
care’.373
Our findings illustrated the dynamic and complex nature of this
relationship. When a complementary alignment of professional logics
arose, as in the case of the focal intervention ILQI, coherence,
cognitive participation and reflexive monitoring of the health-care
practices advocated by the 1000 Lives+ programme was
fostered, thereby aiding its normalisation in daily practice. In
contrast, a countervailing alignment of logics, or their mere
co-existence, was found to have stymied normalisation. Such varied
permutations may be found both between different health-care
professional groups, and within a discrete health-care professional
group, and are typically dependent on two factors. The first is
variation in individual practitioners’ reflexive theorisation,
encompassing their discernment of the patient safety practice in
question, deliberation over the issues and dedication to a chosen action
guided by their situational logic. The second factor is variation in the
situational logic apparent at the level of the functional team.
Normalisation, a pivotal stage of institutionalisation, was therefore
found to be dependent on the actions of those who were the
‘believers’: perceiving meaning in 1000
Lives+ due to alignment with the beliefs and values of
their professional logics. When such coherence manifested, it promoted
cognitive participation and reflexive theorisation in the individual
and, importantly, at the level of the functional team, building
commitment and co-ordinated engagement with the programme across the
bounded clinical micro-work systems. Underscoring the fundamental role
of leadership and effective teamwork to orchestrate the actions of the
functional team, such processes were central to local innovation and
adaptation of the health-care practices advocated by 1000
Lives+ and appeared to be a viable means of developing
micro-competences across the functional team.
Mechanism substructure III: relational structure – role
position-practices and profession – and the power to change
health-care practice
Across Chapters
4–8, our findings highlight the role of the
relational structure of the functional team in the local implementation
of the 1000 Lives+ programme. This mechanism substructure
places attention on the human relationships. By this we mean the ties
that bind the functional team, its orchestrating situational logic,
ethos and values, and the presence of hierarchical or distributed
leadership.729,730 These factors
collectively impact team-level performance and, in turn, patient safety.
Hence relational structure is moulded by the interplay of role
position-practices and profession within the multidisciplinary team, and
the power to change health-care practices is aligned to leadership
functions across managerial and clinical micro-work systems.
In Chapters
4–8, those in professional role-position
practices shaped by high levels of social capital – typically
board-level managers and consultant medical or surgical health-care
practitioners – were found to have had a valued role to play in
reconfiguring other actors’ belief systems to support the local
implementation of 1000 Lives+. Our findings therefore echo
those that recognise the role of managerial, medical and nurse
leadership in patient safety, especially in the brokerage of change
across different functional teams.34,731,732 Despite this, there
were some such actors who, as the following comment illustrates, overtly
rejected the 1000 Lives+ programme: ’The 1000
Lives+ national programme and the campaign –
it’s command and control rather than a grass roots culture
change – it hasn’t been created by the people.
It’s not of the people. It’s an imposition. It’s
control. It’s from Cardiff. It’s very much a Cardiff
thing that is being pushed to everyone else because: “we know
better”. Outside Cardiff, it feels remote and distant and not
part of us, it’s something that we all recognise as important,
clearly, but we don’t necessarily own it’.
However, such demonstrable leadership was not the exclusive jurisdiction
of high-status actors. Social actors across an array of managerial and
clinical roles, who expressed their belief in the 1000 Lives+
programme and actively engaged in creative institutional work to imbue a
similar sense of meaning in others, were undeniably central to the local
implementation of 1000 Lives+ and the ongoing discourse of
patient safety across NHS Wales. This was expressed in the view that
’Clinical leadership is key – credible clinical
leadership – and that’s all about empowerment of Band 7
nurses’, underscoring the empowerment and emancipation of those
in roles traditionally subordinate to the profession of medicine.
Therefore, in supporting staff at all levels, an important outcome of
the 1000 Lives+ programme was the progressive erosion of
entrenched professional barriers that prohibit challenge and scope for
health-care practice change.
Mediation and reflexive theorisation
In defining such mechanism substructures, our findings help to reveal how the
structural constraints and enablements of context are mediated to social
actors engaged in the local implementation of the 1000 Lives+
programme. As expanded in Chapter
2, these influences give rise to four potential
second-order emergents, which foster the accompanying situational logics of
protection, correction/compromise, opportunism and elimination, thereby
guiding the generative mechanisms in play.
Our findings illustrated that the focal intervention ILQI drew professional
logic into alignment with that of the bureaucratic state. This fostered the
systematisation of 1000 Lives+ and ILQI across the cultural
system level of NHS Wales and promoted the reproduction of such practices
across each health board. Consequently, at board level, ILQI operated under
a situational logic of protection that guided sociocultural interaction,
agency, strategic negotiation and ensuing modes of institutional work.
The focal intervention RSC, centred on the local implementation of the
WHOSSC, confronted a more contested terrain, with the coalescence and
cohesion manifest between the views of theatre managers, consultant surgeons
tasked with the implementation of the WHOSSC, and theatre nurses, stymied by
the countervailing stance adopted by some surgeons. These constraining
contradictions (necessary incompatibilities) between the dominant logic of
the bureaucratic state and aligned professional health-care management logic
versus that of professional medical logic held by surgeons opposed to the
introduction of the WHOSSC therefore created a situational logic of
correction/compromise. This logic guided sociocultural interaction, agency,
strategic negotiation and ensuing modes of institutional work along its
disrupted path.
The focal intervention RHAI emerged into a context moulded by internal and
necessary linkages of a complementary nature to existing structures.
Nonetheless, a situational logic of protection of the status quo ante
manifested. Reflexive monitoring was found to be anchored to the past, to
preferred and more highly rated organisational and professional processes
currently in use. Under these conditions, there was only superficial
interest in and action to engage with RHAI.
Development and hypothesis testing of relationships between contextual
organisational factors, mechanisms and the health outcomes of hospital
patient safety interventions
In this study, we sought to develop and test hypothesis regarding the nature
of the relationships between contextual organisational factors, mechanisms
and the health outcomes of hospital patient safety interventions. Yet given
the ontological commitment to critical realism, set out in Chapter 2 (see
Addressing the challenges of realist enquiry,
Realist social theory) and Chapter 3 (see Comparative case
study approach, Ontological and epistemological
alignment to realist analysis), such hypothesis testing was
markedly different from that commonly adopted in positivistic studies. In
essence, our approach centred on the progressive explanation and refinement
of our understanding of the local implementation of the 1000
Lives+ programme, and the three focal interventions
considered in more depth, all framed through our I-CMAO configurations.
Across Chapters
4–8, this approach revealed the nuanced relationships
associated with the bureaucratisation and normalisation of the 1000
Lives+ programme, as illustrated in the explanatory
schematics and accompanying data tables. What emerged from our data was the
role of structural and cultural conditioning on the individual, embedded at
the level of the functional team – managerial and clinical –
and their ensuing disposition and scope to act to effect institutional
change in support of patient safety. Such social structure, understood as
the internal and necessary relations between social positions and
positioned-practices, gave rise to emergent causal powers as the material
cause of social activity.733–735
Perceived through our non-reductionist critical realist ontological stance,
patient safety is, therefore, an emergent property of the micro-level
organisation of health care.
In examining the bureaucratisation and normalisation of the 1000
Lives+ programme, together with the local implementation of
the three focal interventions selected, the underpinning role of the MI-PDSA
approach, depicted in –, was revealed. 1000 Lives+, together
with this core resource, were found to have become ’part of the
patient safety language of NHS Wales’ . . .
’PDSA cycles and all of that stuff it’s created a language
that they like: it’s language that they all understand’.
That, supported by the 1000 Lives+ dedicated website, and aligned
resources from Improving Quality Together and Patient Safety Wales, now
provide the means to spread such practices across NHS Wales.
However, although innovation through identifying failings and honing local
knowledge and skills to change health-care practice was evident throughout
our study, there were those who challenged the evidence that the programme
was working: ‘The evidence-base for the 1000 Lives+
national programme has been systematically attacked by the other factions
– for one side, it’s evidence and truth; for the other,
it’s spin and fluff – and reality is caught in the
middle’.
Limitations of the study
Although we contend that our realist analysis framework presents an innovative
and suitable means to address the research questions posed, we must acknowledge
inherent limitations. There are three main sets of limitations to this work: (1)
those posed by the processs of realist analysis itself, (2) those consequent on
any qualitative social science research, and (3) those posed by a lack of the
type of quantitative data which would have added further validity to our
findings.
The most significant limitation in producing a narrative which is true to the
tenets of critical realism is in the abstraction, abduction and retroduction
inherent to the data analysis. Abstraction draws out the various components
within the situated context, facilitating the conceptualisation of their
interplay, through combination and interaction, so that the researcher may gain
new insight.310 Abduction
involves the production of an elementary account of a basis process or
mechanism.363 Retroduction
builds on this analytical stage. The aim is to reconstruct the basic conditions
for such phenomena to be what they are, so fostering knowledge of the
transfactual conditions, structures and mechanisms in play.363 In this study, this process was aided by the
hierarchical bureaucratisation of the Welsh health-care institutional field,
which facilitated the explication of the internal and necessary relationships
underpinning structural and cultural emergent properties.
To be adequate, as noted by Herepath,342 this approach must abstract from particular conditions,
excluding those which are believed to have no significant effect, in order to
focus on those which do and identify relations of different types:
‘substantial’, ‘formal’, ‘external or
contingent’ and ‘internal or necessary’.310 Only once this step has been
achieved may it be possible to combine or synthesise the various separate
understandings into a unity that reconstitutes, or provides a better
understanding of, the concrete.736 Thus, an explanatory structure is devised through a combination
of theory and experimental observation.228
Inevitably, such analysis is open to the criticism that, as it must be influenced
by the investigator’s perspective, beliefs and experience, the data
represent only individual interpretation. To counter such criticism we made
considerable efforts to ensure the data collected were as robust as possible. We
achieved this triangulation of data collection by accessing documentary evidence
and conducting on-site observation, as well as interviewing a large and varied
number of individuals.
A further limitation of our study is our inability to derive detailed linkage of
quantitative data to the qualitative data relating to each specific intervention
studied. Paradoxically, given the engagement in the study of all seven of the
health boards in NHS Wales, detailed linkage of quantitative data was prohibited
as it would have proved impossible to ensure anonymisation at organisational,
hospital case site and individual level. The best we were able to do was to
accommodate for this deficit by giving illustrative public source data for each
health board, as set out in Tables
14–20 (RAMI data), Tables 25 and 26 (‘never
events’ across NHS Wales’ health boards) and Tables
31 and 32 (MRSA per 100,000 bed-days and
S. aureus per 100,000 bed-days).
Possible applications
As this study centred on the local implementation of the 1000
Lives+ national patient safety programme across NHS Wales, a
substate nation with devolved oversight of health-care policy, it is
pertinent to consider to what extent our findings may be applicable to other
developed or developing health-care systems.
There is, of course, a global debate on patient safety, and patient safety
programmes have been widely integrated into developed health-care systems on
a world-wide scale. In that sense, some of the processes and practices seen
in our study of the implementation of 1000 Lives+ in NHS Wales
may well be identified in other settings and, therefore, offer insights into
other similar processes and practices elsewhere. Nevertheless, the extent to
which our findings may be directly transferable to other health-care systems
implementing major programmatic changes is limited by a number of
factors.
First, as presented in Chapter
4, NHS Wales is shaped by a distinctive health-care
policy trajectory in which engagement with the 1000 Lives+
programme is mandated and monitored. This created a health-care
institutional field moulded by coercive isomorphism in addition to the
normative and mimetic modes more typical to studies of the diffusion of
patient safety practices.358
Furthermore, the study period overlapped the period of transition following
the reconfiguration of health services in Wales. As such, health boards,
through the merger of other former NHS Wales’ hospital trusts with
primary care organisations, were newly established. Each organisation,
therefore, confronted a strategic agenda burdened by the managerial demands
of reconfiguration, including change to management cadres and clinical
director roles, together with the politicised and public constraints
fostered through the ongoing reconfiguration of hospital service provision
across each territory. Though such circumstances are far from unique in
developed health-care systems, they were distinctively shaped by the
particular context of health care in Wales, and these factors do limit the
degree to which the lessons learned from this study may be transferable to
other settings.
Another limitation of applicability is that, although in our research
protocol our case site selection criteria encompassed a major hospital, an
intermediate hospital and a small local community hospital within each
health board, to offer a desirable mix of different organisational features
the strategic oversight of the 1000 Lives+ programme and its
leadership was predominantly centred within the major hospital sites.
Indeed, the 1000 Lives+ programme was, ostensibly, acute in its
focus, with fewer interventions applicable to small case hospitals. This
limited our scope to explore the implementation of each focal intervention
across the range of organisations. Our findings are, therefore, more broadly
applicable to large and intermediate hospital settings.
Case study participants were initially selected by the research
team’s local contact at each case site and, thus, a degree of bias
must be acknowledged. However, we sought to mitigate this issue through our
use of a snowball sampling strategy, as discussed in Chapter 3. As evidenced by
the candid and occasionally very blunt comments embedded in Chapters
4–8, the research team is confident that the data
collected accurately represented the views of those interviewed, although,
as a degree of self-selection was involved, we cannot discount the
possibility that others who were not interviewed might have held different
views.
Despite these caveats, however, we would argue that, at the micro-level of
functional teams in wards and departments, the processes and practices of
implementation identified in this study may well mirror those to be found in
similar circumstances in other health-care systems, and that our findings
may thus have relevance and offer lessons to be learned elsewhere.
Contribution of the study to patient safety research
This study offers conceptual, methodological and empirical contributions to
patient safety research. In conceptual terms, we developed a theoretically
grounded and evidence-based realist model of which organisational factors
matter, how they matter and why they matter. To do this, we introduced
conceptual resources from sociological institutionalism and Archerian critical
realism to address challenges associated with applying realist inquiry. Our
model incorporates four elaborations of the established approach to realist
inquiry.
First, so that we may understand precisely ‘what’ is working, for
whom, how and in what circumstances, we include intervention as a separate
analytical category in our realist analysis. Second, we forward a view of
‘situated context’ as stratified, conditioned, relational and
temporally dynamic. This involves identifying the dominant structural and
cultural emergent properties in play and separating context from its mediation.
Third, we apportion mediation and reflexive theorisation to mechanism. In this
manner, we distinguish the conceptual elements of mechanism from its ensuing
outcomes, which include the agential emergent properties, expressed through the
unfolding strategic negotiation of change, and the mode of institutional work
enacted, to deliver sustainable outcomes, be they elaborative or reproductive.
This fine-grained realist analysis therefore explicates the fundamental role of
beliefs and values – institutional logics – on the propensity to
act, to reveal the contested nature of institutional change, health-care
practice evolution, and thus social elaboration or, indeed, reproduction.
Finally, in our realist analysis framework, outcome is not perceived as a
simple, single aspect of change, such as a defined health outcome. Rather, we
reveal structural and ideational differentiation, together with the regrouping
inherent to the power play of the diverse array of agents embroiled in the
institutionalisation of a complex patient safety improvement programme.
In methodological terms, this is one of the first studies of patient safety to
apply realist philosophy of social science across inception, design, fieldwork,
analysis and writing. This has generated a number of features that may inform
and challenge the field of patient safety research.
First, in contrast to the majority of health services research studies, this
study has taken seriously, and explicated, realist epistemology and ontology.
These foundations of our research conditioned its design, conduct and reporting.
They helped shape our concern for ontological depth and contextual strata, and
they directed us towards the identification and explanation of the underlying
generative mechanisms which shape structure, agency, social relations and the
ensuing practices that are reproduced and/or transformed. In terms of analysis,
this is one of the first health services research studies to conduct
abstraction, abduction and retroduction363 to devise an explanatory structure through a combination of
theory and experimental observation. While we have earlier noted the challenges
posed by this approach, we believe that this study has demonstrated the value of
the analytical approach in helping to reconstruct the basic conditions for focal
phenomena to be what they are, so fostering knowledge of the conditions,
structures and mechanisms in play. In addition, the conclusions of our realist
analysis are recognised to be both provisional and fallible.
In terms of empirical contribution, for each of the three focal interventions of
1000 Lives+ programme, this study offers a nuanced explanation of how
local conditions relating to each level of our stratified model of context
differentially combine with mechanisms (the engines of explanation embodied in
people’s reasoning) to derive outcomes in terms of structural and
cultural reproduction or change. Reflecting social reality, these causal
configurations are complex and nested. To aid our elucidation of these
configurations we augment our textual description with a series of graphics.
This approach to presentation of our findings allows us to clearly specify how
particular configurations of factors across multiple layers of context (e.g.
logics, power relations) combine with two metamechanisms (bureaucratisation and
normalisation) and three submechanisms (isomorphism, logic alignment and
relational structure) to generate outcomes that are variously viewed as more or
less successful by multiple stakeholders.
We believe these findings will provide a valuable resource for policy-makers,
managers and practitioners, locally, nationally and internationally, and will
enable stakeholders to develop improvement interventions that are more likely to
‘work’ (for specified stakeholders) in their local contingent
circumstances. They may also serve as a diagnostic tool to be used as a
precursor to the design of more differentiated and context-sensitive
interventions in future.
Future project outputs
This report addresses gaps in conceptual, methodological and empirical
knowledge about the influence of context on the local implementation of
patient safety programmes so that we may discern which contextual factors
matter – how, why and for whom – in order that processes and
outcomes of future improvement programmes may be improved. Future research
outputs will seek to contribute to a broad range of academic and
professional literatures.
Active dissemination of emergent findings to academic audiences has commenced
via participation in relevant national and international conferences
[Academy of Management (US); British Academy of Management; European Group
for Organizational Studies; Health Services Research Network; International
Organisational Behaviour in Healthcare; International Research Society for
Public Management]. Dissemination will now continue through the submission
of papers to leading academic journals. The first of such papers is
currently under review.
As well as disseminating our findings to academic audiences, we intend to
work with case site organisations in NHS Wales and, potentially, to reach
out to a wider audience in NHS England, through a series of interactive
seminars for health-care policy and professional audiences. These
discussions will be disseminated through publications targeted specifically
at NHS professional audiences including, for example, the Health
Service Journal.
Future research
While the work conducted in this study could be developed in a number of
ways, we believe that three options are most promising.
First, although this study adopted the organisation as the primary unit of
analysis, we now consider that the micro-work system – managerial
and clinical – could be a more fruitful unit of analysis from which
to develop further insight into the implementation of patient safety
programmes. Indeed, this offers the potential to examine the complexity
inherent to the delivery of patient-centred care across discrete care
pathways, thereby spanning organisational boundaries between primary,
secondary and, potentially, tertiary-based functional teams. Such an
approach, we believe, will help to explicate the true demands of leadership,
followership, and empowered and emancipated team working, which underpin
health-care practice innovation and commitment to the delivery of health
care of the highest quality for all.
Second, this study has placed great significance on the role of, and
interplay between, logics operating across the multiple strata of our model
of context. In our case based in Wales, a critical dynamic occurs between
the field level, where the paradigmatic logic of bureaucratic command and
control shapes the activity of elite actors, while actors at sub-board
organisational levels are influenced primarily by professional logics. It
will, therefore, be important to compare the processes and outcomes from
that context with (i) settings with similar institutional arrangements
(possibly Scotland), and (ii) arenas with alterative arrays of dominant
logics across contextual strata (possibly England, where the dominant
paradigmatic logic is competition augmented by devolution and
transparency).
Furthermore, given the mandated nature of engagement with the 1000
Lives+ programme in our study, and the tensions thereby
fostered for some health-care clinical professionals, it will also be
important to compare future patient safety interventions which emerge at the
level of the functional team so that their insights may be effectively
harnessed and their diffusion aided within, and across, health-care
organisations.
Finally, this study has illustrated the complex interplay that lies behind
the 1000 Lives+ programme’s summary I-CMAO configuration.
Indeed, it has exposed that distinctive ‘cultures of care’
emerged and operated throughout the local implementation of the 1000
Lives+ programme. These ranged from ‘discrete pockets
of high adherence’ to situated contexts of ‘enforced but
somewhat disengaged adoption’. This finding demonstrates the time
and institutional work needed to achieve change amid competing priorities,
contested professional values and notions of control. Future research should
address the relational dynamics of the functional team within a situated
context to refine our understanding of high-performing micro-work systems
and thus penetrate beyond the illusory notion of a cohesive culture of
care.
Priorities for practice
Below, we set out the implications of our findings for realist informed research
and the design and operationalisation of complex patient safety
interventions.
Realist analysis
The realist analysis undertaken in this study is different from established
approaches to realist inquiry. It is neither a realist evaluation of the
success or failure of the 1000 Lives+ patient safety programme,
nor a realist synthesis of extant data to inform the future redesign of the
1000 Lives+ patient safety programme and associated policy in NHS
Wales. Rather, as set out in in the introduction to this report, our
approach to realist analysis defines an alternative means to analyse the
complex interplay of this patient safety intervention within a specified
‘situated’ context. This creates challenges and
opportunities for the field.
The challenges posed are primarily conceptual and methodological, and arise
from the need to integrate distinct research traditions – realist
inquiry, critical realism and institutional theory – with the
information to be assimilated from aligned medical, health-care policy and
health-care organisational and professional fields. However, we would argue
that the opportunities offered by the adoption of our approach, and the
generation of I-CMAO configurations within other studies, arise from the
more nuanced understanding to be gained of the organisation and operation of
developed health-care safety practices at the level of the functional team.
This, we consider, possesses the potential to enrich our understanding of
the emergence of patient safety as a dynamic capability within
high-performing health-care teams, thereby informing the design of patient
safety interventions.
Realist analysis: refinement of the concepts of context and
mechanism
Our conceptual refinement of the situated context of care suggests that
future patient safety research will need to consider context as more than a
mere amorphous residual. While it may not be practicable for all research
designs to actively embrace our stratified, conditioned, relational and
temporally dynamic approach, a heightened awareness and account of context
will foster cumulative insight and contribute to appreciation of the locus
of change within complex health-care systems or discrete organisations.
Similarly, in future realist informed research, apportioning both the
mediation of contextual forces and reflexive theorisation to mechanism will
help to refine our understanding of what drives social agents – be
they organisations, professions or individuals – to actively embrace
and normalise a new patient safety practice or reject and retard such
change. This will help to clarify the role of that such mechanisms play
within larger and more complex causal configurations.
Realist analysis: refinement of agency and outcome
This study suggests that the combination of Archerian critical realism and
institutional theory offers a robust means to examine mechanism across
aligned or conflicted institutional logics in different organisational and
professional jurisdictions. This feature of an I-CMAO configuration,
therefore, helps to further inform our understanding of the
operationalisation of patient safety practices, specifically by offering
insight into the actions that unfold within and across functional teams.
Accordingly, both patient safety research and the implementation of such
interventions will benefit from an enhanced understanding of practice,
centred on the unfolding strategic negotiation of change and mode of
institutional work enacted to deliver sustainable outcomes.
Design of patient safety improvement programmes
This study demonstrates that complex patient safety interventions, though
targeted at whole-systems or multisite health-care organisations, do not
embed and normalise into practice in such a totalising manner. Rather,
acceptance and adherence is piecemeal and fragmented. This suggests that
their design may be more logically framed at the level of the functional
team and associated discrete high-risk health-care practice. This has marked
implications for the leadership of localised change and support provided,
and the emancipation of front-line health-care professionals may further the
development of innovative patient safety practices at the point of care.
Oversight of the implementation and operationalisation of patient safety
improvement programmes
This study has demonstrated a significant cause for concern by capturing the
ready acceptance of gaming,405 under a legitimacy façade, that obscures the failure
to adhere to recommended patient safety practices. Such actions are diverse
– ranging from hollow engagement with WalkRounds and disconnected
recording of the WHOSSC in computer-based systems to the overt
‘performance’ of observed hand-washing – but they
suggest the need for (i) clearly visible and meaningful leadership of
patient safety and (ii) integration of the oversight of patient safety
programmes into corporate governance and organisational development
programmes, with ensuing accountability for performance and staff
development. To this end, as outlined in Chapter 5 (specifically in the sections
Putative mechanisms fostering and normalisation of
1000+
Lives, Cognitive participation and
Collective action), cognitive participation is an
essential component of collective action to ensure that systemic and
organisational factors giving rise to patient neglect are addressed, while
knowledge sharing and trust are enhanced.
