Advancements in new technologies of health and medical care – and in their social organisation - promise to benefit the health and well-being of patients and society. However, getting new technologies into practice beyond the context of research projects that demonstrate the (clinical) efficacy or effectiveness of new practices and procedures remains a problem. Researchers are now investing much effort in understanding and resolving issues of ‘implementation’ in relation to health care interventions and practices, and this is reflected in a fast growing field of ‘implementation science’. Understanding the science behind implementation processes has also become an important concern for healthcare policy and practice. Following Linton
‘Implementation involves all activities that occur between making an adoption commitment and the time that an innovation either becomes part of the organizational routine, ceases to be new, or is abandoned (…) [and the] behavior of organizational members over time evolves from avoidance or non-use, through unenthusiastic or compliant use, to skilled or consistent use. (p 65)’
There is a vast literature on implementation in service organisations
], however efforts at implementing new technologies and practices remain problematic. The gap between research evidence and practice remains wide
], and concerns about the large numbers of ‘pilot’ studies of new interventions that never lead to sustainable services are repeatedly expressed
]. This is particularly the case for ‘e-health’ technologies - defined as practicing and delivering health care using information and communication technology
] - despite significant promises for improving health care quality and efficiency
In attempting to address such problems of implementation, the application of theory to designing health care interventions
], planning and evaluating them
], and developing effective strategies for their implementation
] offers much potential.
However, obstacles to the use of theory for such purposes are numerous, and include the identification of relevant and useful theoretical perspectives from the huge body of literature on implementation that spans diverse academic disciplines (for example, psychology, sociology, business, healthcare management). Such theoretical diversity includes approaches that emphasise attitudes and behaviours
]; diffusion and adoption of innovations through social networks
]; and Science and Technology Studies (STS) approaches
] that emphasise technology design and its relations with human actors. Reviews such as those of Greenhalgh and colleagues
] (of literature relevant to the diffusion of innovations in service organisations) and Grol and colleagues
] (of theories useful for planning and studying initiatives for improving patient care) begin to address this difficulty by mapping the terrain of implementation theories that may be useful for guiding both intervention development and approaches to implementation, and summarising their key processes and emphases.
Advances in theory-based intervention development and implementation have been made particularly with regard to changing healthcare professionals’ behaviour and practice to facilitate the uptake of evidence-based-practice strategies
]. Drawing on psychological theories of behaviour, Michie and colleagues
] explicitly set out to develop theory-based explanations of factors that affect professional practice in a format that would be accessible to non-academic users, and associated work has included guidance for designing questionnaires based on the Theory of Planned Behavior
]. Models focused on psychological theory however, tend to over-emphasise the personal agency of individuals and underplay the importance of context. For example, implementation failures are often attributed to slow behaviour change by professionals, when there are likely to be other good and predictable socio-organisational reasons for such failure
]. Nonetheless, such approaches show promise in facilitating the uptake of new interventions and/or ways of working, particularly where the roles and actions of individuals in making an implementation ‘effective’ are an appropriate focus for implementation efforts.
We would argue, however, that in practice, many interventions being implemented in healthcare settings are subject to more complex influences than those known to directly affect the behaviour of individuals. New practices get taken up and become ‘workable’ due to a complex interplay between features of the intervention/practice itself, the actions of individuals involved in the process, and aspects of the physical and social environment in which implementation activities are undertaken. Normalization Process Theory (NPT)
] approaches the problem of implementation with a view to understanding such dynamics. It emphasises the processes by which new technologies and practices become normalised,
focusing on the work that this requires of people working both individually and collaboratively. What really matters here is the extent to which new technologies and practices can – and do – become embedded
in both the contexts in which they are to be used, and in the everyday practices of the individuals whose work is affected by these innovations. NPT is concerned with the generative processes
] that underpin three core problems: implementation
(bringing a practice or practices into action); embedding
, (when a practice or practices may be routinely incorporated into the everyday work of individuals and groups); and integration
(when a practice or practices are reproduced and sustained in the social matrices of an organization or institution). In NPT it is postulated that practices become routinely embedded in social contexts as the result of people working, individually and collectively, to enact them, and that the production and reproduction of a practice requires continuous investment by individuals to carry action forward in time and space. There are four sets of processes that characterise different kinds of ‘normalisation work’, and which require particular kinds of investments from individuals and organisations
Coherence: the process of sense-making and understanding that individuals and organisations have to go through in order to promote or inhibit the routine embedding of a practice to its users. These processes are energized by investments of meaning made by participants.
Cognitive participation: the process that individuals and organisations have to go through in order to enrol individuals to engage with the new practice. These processes are energized by investments of commitment made by participants.
Collective action: the work that individuals and organisations have to do to enact the new practice. These processes are energized by investments of effort made by participants.
Reflexive monitoring: the informal and formal appraisal of a new practice once it is in use, in order to assess its advantages and disadvantages and which develops users’ comprehension of the effects of a practice. These processes are energized by investments in appraisal made by participants.
A considerable body of research now supports NPT as an adequate and useful theory for explaining processes of the normalization of practices associated with complex interventions. This evidence spans diverse settings in which new technologies and practices have been the focus of its application, such as telecare
], clinical decision support systems
], infertility management
], maternity services
]and the management and treatment of depression
The development of structured tools for assessing implementation processes, which take account of this complex interplay between interventions, individual actions, and context, would represent an advance in applying theory to understand and address implementation problems in practice. Existing assessment tools that focus on organisational factors relevant to ‘readiness’ for interventions in healthcare
] do not adequately reflect the complexity of normalisation processes as characterised by the NPT – for example, the dynamic and iterative relationships between the types of work involved in making sense of a new practice, enacting it (collectively) and appraising its outcome and value. They are therefore limited in the extent to which they offer practical ways of facilitating
implementation processes in ways that lead to the embedding of new practices within contexts of use.
A further challenge for the development of theory-based measures that capture the complexity of implementation activities concerns the various ways in which outcomes of such activities may be defined. In contrast to psychological theories of implementation behaviour, which focus on explaining and/or quantifying individuals’ uptake of a new practice, NPT focuses on more subtle – and gradual – processes, such as ‘embedding’, ‘integrating’ and ‘normalisation’. NPT does not offer a ‘definition’ of the term ‘normalisation’, for it can be appropriately used to refer to a process or a ‘state’, depending on the context and the frame of reference – that is, for the most part ‘normalisation’ is considered to be an ongoing cycle of activity aimed at making a new practice ‘fit in’ with the work of individuals and their context of practice, but when a practice ceases to be ‘new’ or no longer requires additional effort, it may be framed as having become ‘normalised’. Further work needs to be done to develop ways of defining and measuring outcomes of efforts to implement new practices, that reflect the complexity and context-dependent nature of what it means to have ‘successfully’ or ‘effectively’ implemented a new practice.
Thus the development of structured assessment tools for understanding the complex processes involved in integrating complex interventions, including e-health
], into practice remains a priority. Recently, theory-based tools for assisting implementers in planning and ‘thinking through’ particular interventions with reference to the social and organisational contexts in which they are to be implemented have been offered
]. Although promising however, such tools do not provide measurements
to be used during implementations to assess progress towards successful implementation (however defined by stakeholders). Such tools would offer the potential to identify (and quantify) problems with an implementation during the process, but so far work in this area remains limited.
The objective of this study then was to advance work on translating theory into structured assessment instruments for research and practical purposes in these contexts, by drawing on the findings of a study
] that undertook the development and preliminary testing of a Technology Adoption Readiness Scale (TARS) for measuring normalisation processes in the context of e-health service interventions. This paper therefore aims to (1) describe the process and outcome of a project to develop a theory-based instrument for measuring processes involved in the implementation of e-health interventions; and (2) identify key issues and methodological challenges for further advancing work in this field. First however, a fuller explanation of the theoretical development of NPT is required.
Normalization process theory: Theoretical development
NPT was initially developed as an applied theoretical model to assist clinicians and researchers to understand and evaluate the factors that inhibit and promote the routine incorporation of complex healthcare interventions in practice. Since then, it has been developed as a middle-range theory of socio-technical change
], which characterizes the mechanisms involved in the embedding of practices within their immediate and broader social contexts.
The development of NPT
] focused on addressing two key criteria for theory to be ‘useful’: that it must be both adequately described and fit for purpose. Thus, the theory has been developed to offer transparent and transferable explanations for the phenomena of interest (processes of embedding new practice and ways of working) revealed by empirical investigation
]. In doing so, we have followed sociological approaches to theory building
] to undertake four kinds of conceptual work required to make a theory ‘fit for purpose’: describing, explaining, making knowledge claims, and investigating observed phenomena (see Table
: Requirements of Theory).
Table 1 Requirements of a Theory (from May et al. 2007)
Considerable work has been undertaken to critique NPT in terms of its potential for describing key processes that underpin the success or otherwise of implementation, and to ensure that NPT’s core constructs can be operationalised in a stable and consistent way by multiple user constituencies, including testing out NPT in qualitative studies of a variety of practices and in a diverse range of contexts
]. Recent work has also extended the practical utility of NPT for a wide range of academic and non-academic users. An online ‘users’ manual’ for NPT (
), that provides descriptions, guidance on use of the theory, and applied examples, along with work to frame NPT as a tool for designing, developing and implementing
] and make NPT accessible to diverse user groups who are interested in understanding and solving practical problems of implementation.
The development of good practice for designing and administering structured instruments to assess the processes of normalization
described and explicated in the formal specification of the theory is the next step for further extending the utility of NPT. In terms of enhancing the NPT’s ‘fitness for purpose’, this is important for facilitating investigation
as a key component of theory (Table
). The development of NPT derived ‘assessment’ measures would represent a step beyond current work undertaken with NPT to operationalise it as a tool for planning interventions
], towards exploring investigative questions about the theory’s scope for use in predicting
– or more appropriately providing assessment of ‘potential for achieving’
]– the normalization of complex interventions in practice.
Development of technology adoption readiness scale (TARS)
An instrument development study was undertaken as part of a larger study that used a multi-method approach to understanding barriers to the uptake and integration of e-health into healthcare professionals’ practice
]. The TARS study aimed to develop a structured instrument to measure processes
of normalisation in relation to the routine use of a specific e-health system. As NPT is the basis for the instrument, these normalisation processes are seen to reflect staff perceptions of factors related to the collaborative work required for the normalisation of particular e-Health systems in a given context.
The primary purpose of this instrument then was to enable users to quantify a range of processes proposed by the NPT to contribute to the successful normalisation of a new intervention – in this case, e-health. As such, the instrument could be used both by practitioners charged with implementing an e-health intervention (and thus used in a ‘diagnostic’ capacity for identifying and resolving problems early on in an implementation), and by research teams or practitioners undertaking service evaluations (thus as an evaluative tool). Although the ultimate aim of a programme of work we are undertaking on measure development based on NPT is to develop ‘predictive’ tools based on the theory, development of an instrument for this purpose was beyond the scope of this study.
This project was undertaken in two stages, each of which is described here in turn. The first stage was the development of the instrument and the second stage was a preliminary test of the utility of the instrument in two different NHS settings in which staff were using particular e-health systems. The focus of this project was on development rather than the empirical determination of psychometric properties, thus the final discussion in this paper will focus primarily on the processes and experiences of translating empirically derived theoretical constructs into structured tools and the implications of this for undertaking applied assessments in health care settings.
Phase 1: Item development and conceptual validation
In this phase, we aimed to draw on the NPT to develop a comprehensive set of general items –TARS items - reflecting factors affecting the routine use of e-health ready for application in specific settings.