Normalisation Process Theory: Its consolidation and application in implementation research and practice

Carl May; Tracy Finch; Tim Rapley

doi:10.3310/nihropenres.14315.1

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Research Article

Normalisation Process Theory: Its consolidation and application in implementation research and practice

[version 1; peer review: awaiting peer review]

Carl May ¹, Tracy Finch², Tim Rapley³

PUBLISHED 30 Jun 2026

Author details Author details

¹ Department of Health Services Research and Policy, London School of Hygiene and Tropical Medicine, London, England, WC1H 9SH,, UK
² School of Healthcare and Nursing Sciences, Northumbria University Department of Health Services Research and Policy, Newcastle upon Tyne, England, NE1 8ST, UK
³ School of Communities and Education, Northumbria University, Newcastle upon Tyne, NE1 8ST, UK

Carl May
Roles: Conceptualization, Formal Analysis, Funding Acquisition, Investigation, Methodology, Project Administration, Writing – Original Draft Preparation

Tracy Finch
Roles: Conceptualization, Formal Analysis, Funding Acquisition, Investigation, Writing – Review & Editing

Tim Rapley
Roles: Conceptualization, Formal Analysis, Funding Acquisition, Investigation, Methodology, Resources, Writing – Review & Editing

OPEN PEER REVIEW

REVIEWER STATUS AWAITING PEER REVIEW

Abstract

Background

Normalization Process Theory (NPT) has developed over twenty-five years into a widely used explanatory theory of implementation processes in health services. Over this period, its core constructs, contextual elaboration, and methodological tools have been presented in separate publications. No single account has integrated these into a unified theoretical architecture or mapped the contribution of the practical toolkit that NPT has generated.

Methods

We present a consolidated account of NPT. We show that it comprises three analytically distinct but interrelated elements: a classificatory framework, a process model, and an explanatory theory. We describe the theory’s three core propositions, define its constructs relating to implementation contexts, mechanisms, and outcomes, and situate NPT within the broader landscape of implementation science.

Results

NPT specifies generative mechanisms, contextual conditions, and observable outcomes that are present in implementation processes and can be used to analyze them. It provides a theoretical foundation for qualitative and quantitative evaluation and research. It can also be presented in a Context–Mechanism–Outcome structure that positions NPT as a ready-made program theory for realist evaluation. The theory can also be operationalized through a suite of practical tools to support implementation, comprising the NPT Online Toolkit, the Trial Gatekeeper, the ItFits Toolkit, the NoMAD survey instrument, the NPT Coding Manual, and the NPT Taxonomy of Implementation Strategies. These tools support intervention design, feasibility assessment, prospective process evaluation, real-time investigation, retrospective analysis, and evidence synthesis.

Conclusions

This paper provides an integrated account of NPT for the first time. It consolidates its framework, process model, explanatory propositions, contextual constructs, and implementation toolkit in a single publication, it offers a definitive reference for researchers and practitioners applying NPT to understand, design, and evaluate implementation processes in health services.

Plain Language Summary

When something new is brought into healthcare—a new test, a new way of supporting people with long-term conditions, a new piece of technology—it often doesn’t catch on. Staff may try it for a while, then quietly drop it. Patients may notice it appear and then disappear. Why does this happen so often, and what would it take for new and better ways of working to actually stick?

Normalization Process Theory, or NPT, was developed to answer that question. It looks at the everyday work that people—staff, patients, managers, families—have to do together to make a new practice part of normal care. This paper, for the first time, brings the whole theory together in one place. Until now, it has been spread across lots of separate research papers, which has made it hard for people to use it well.

The theory says that four kinds of work matter. People need to make sense of what the new thing is and why it’s worth doing. They need to get the right people on board. They need to actually do the work, day in and day out. And they need to keep checking whether it is making a difference. If any of these break down, the new practice will struggle to take root.

The paper also asks an important question: who benefits from a change, and who carries the extra work? Too often, new practices add hidden burdens onto patients and carers, or onto staff who are already stretched. Thinking about fairness, and about race and inequality, has to be part of how new practices are designed—not an afterthought.

Keywords

implementation science, process evaluation, implementation theory,

Corresponding author: Carl May

Competing interests: The authors have developed NPT.

Grant information: This project is funded by the National Institute for Health and Care Research (NIHR) under NIHR-SD1-0509-10017 (NIHR Senior Investigator Award to CRM), NIHR IS-CLA-0113-10054 (NIHR Wessex CLARHC), NIHR200163 (NIHR North Thames ARC), NIHR200173 (NIHR North-East North Cumbria ARC), and NIHR 202038 (SPHERE Trial). The views expressed are those of the author(s) and not necessarily those of the NIHR or the Department of Health and Social Care.
The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.

Copyright: © 2026 May C et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

How to cite: May C, Finch T and Rapley T. Normalisation Process Theory: Its consolidation and application in implementation research and practice [version 1; peer review: awaiting peer review]. NIHR Open Res 2026, 6:79 (https://doi.org/10.3310/nihropenres.14315.1) First published: 30 Jun 2026, 6:79 (https://doi.org/10.3310/nihropenres.14315.1) Latest published: 30 Jun 2026, 6:79 (https://doi.org/10.3310/nihropenres.14315.1)

Introduction

Normalization Process Theory (NPT) identifies, characterizes, and explains the mechanisms that motivate and shape implementation processes’.¹ It tells us how innovations in practice, and in the organization and delivery of care can become routinely embedded in everyday work through the collective and collaborative action of people working within organizational fields. Over twenty-five years of development, NPT has generated a substantial body of empirical research and a suite of practical tools for implementation research and practice. It is now one of the most widely applied theoretical frameworks in implementation science. Yet NPT has never been presented as a whole. In the literature, it is presented as a set of components distributed across multiple papers,^1–9 none of which offers the complete theory. This means that researchers and practitioners who wish to work with NPT must assemble it themselves from sources that were written at different stages of the theory’s development, that use evolving terminology, and that do not always make their relationships to one another explicit. The consequence of this is that a theory whose propositions, constructs, and tools are dispersed across publications written over more than two decades invites partial and inconsistent application. Researchers may work with the 2009 mechanisms,⁶ while overlooking the 2016 contextual constructs.⁹ They may apply the NoMAD survey instrument,^10,11 without understanding the propositional structure it operationalizes. They may cite NPT as a ‘framework’ when their study requires it to function as an explanatory theory or treat its constructs as a coding frame when their research question demands engagement with its causal propositions. These are not failures of individual scholarship—they are consequences of a theory that has not yet been consolidated in a form that makes its complete architecture visible and accessible. This paper provides that consolidation.

Our purpose in this paper is to present NPT as an integrated theoretical whole: to show what the theory is, how it works, and what it can (and cannot) do. We start by defining the structure of the theory, and the assumptions on which it is founded, and the core mechanisms that motivate and shape implementation processes. We then develop the structure of the theory by describing constructs that enable analysis of the contexts and outcomes of implementation processes, in concert with these, we show how NPT can be configured as a Context–Mechanism–Outcome scheme that creates as a program theory for realist evaluation.¹² We then describe NPT’s engagement with problems of equity and racialization in implementation, through Patient-Centered Equity Design,¹³ and its potential integration with Critical Race Theory. Finally, we map the suite of practical tools—the NPT Online Toolkit,¹⁴ the Trial Gatekeeper,¹⁵ the ItFits Toolkit,¹⁶ the NoMAD survey instrument,^10,11 the NPT Coding Manual,¹⁷ and the NPT Taxonomy of Implementation Strategies¹⁸—that operationalize NPT across the lifecycle of implementation research. The paper also sets out the limits of what NPT claims to explain. NPT is a middle-range theory of implementation processes. It does not offer a theory of individual behavior change, a higher-order account of sociotechnical transition, or a dynamic theory of health system reform. We identify the theoretical resources that address each of these domains and describe their relationship to NPT’s explanatory scope.

What follows is neither a review of NPT’s development, nor a summary of studies that have applied it. In this paper, we present, for the first time, the complete theory—its propositions, constructs, configurations, equity commitments, and methodological tools—in a single, integrated account. Our aim is to provide a definitive reference for researchers and practitioners working with NPT, and a foundation from which the theory can continue to be tested, challenged, and extended.

Patient and public involvement

There are how many hundreds of protocols, empirical reports, reviews, and policy implementation plans informed by Normalization Process Theory since its primary publication in 2009.⁵ This paper charts the development and consolidation of Normalization Process Theory within the frame of NIHR funded research. Patient and public involvement for empirical research was delivered through PPI groups supported by NIHR Wessex CLAHRC, NIHR North Thames ARC, and NIHR North-East North Cumbria ARC. Members of those groups commented helpfully on the application of theory and methods to empirical research studies. An example is the SPHERE trial of health and wellbeing coaching for people living with HIV in which implementation design was informed by NPT. From the point of inception, the development and delivery of this NIHR funded programme grant incorporated multiple service users and third sector organizations. This relationship was acknowledged in the study protocol,¹⁰⁰ built into the logic model and theory of change of the trial,¹⁰¹ and supported by a ‘Positive Voices’ survey of people living with HIV undertaken in collaboration with third sector and advocacy organizations representing people living with HIV.¹⁰² Throughout the life of the research, people living with HIV have contributed to the design of the work, recruitment of participants, and interpretation of results.

The place of NPT in implementation science

NPT occupies a distinctive position in implementation science. It has been developed iteratively over a period of 25 years through sustained empirical engagement with the implementation of complex interventions and service innovations. NPT is a mechanism-based theory of how implementation processes work and how they are accomplished in practice. The development of NPT began with work that sought to explain problems in the adoption of telemedicine systems in the UK.^2–4 This work led to the adoption of the concept of normalization, drawn from the phenomenological writings of Peter L Berger,¹⁹ and led to an empirically grounded contingency framework of implementation activity.³ This formed the point of departure for the development of a theory of telemedicine adoption. This theory effectively described features of the technology adoption landscape but failed to explain their operation. A second attempt to explain the routine incorporation of complex interventions in health service settings was much more successful.^5,20,21 This theory-building activity coincided with the emergence of implementation science as a field of research and development,^22–27 and its definition by Eccles and Mittman, as:

The scientific study of methods to promote the systematic uptake of research findings and other evidence-based practices into routine practice, with the aim of improving the quality and effectiveness of health services and care.²⁸

Implementation science is a rapidly expanding field in which a diverse array of theoretical tools competes for attention and application. Many of these are weak and descriptive, and repackage concepts derived from already established theories, models and frameworks. Quite different intellectual trajectories were visible in the field as it has developed, and these have generated strong theory-informed approaches that have been widely applied. First, is the application of psychological theories,^29–42 often focusing on clinical guideline dissemination and implementation, and frequently rooted in the Theory of Planned Behavior.^43–45 More recently, a major program of theory synthesis initiated by Michie has led to the COM-B Model, the Behavior change Wheel, and the Theoretical Domains Framework.^46–52 Second, sociologically informed approaches to conceptualization in implementation science have often focused on a much wider range of intervention types. Important here are Greenhalgh and colleagues’ model of diffusion of service innovations,⁵³ updated by Damschroder et al as the Consolidated Framework for Implementation Research.⁵⁴ Both have their reference points rooted in Rogers’ Diffusion of Innovations Theory.⁵⁵ Aaron et al’s⁵⁶ Exploration, Adoption and Preparation, Implementation, Sustainment model has overlapping concepts with Greenhalgh et al and Damschroder et al. However, it offers a staged model of implementation delivery, this was a significant advance for practitioners seeking to implement evidence in practice. An equally important but more eclectically founded contribution is Kitson et al’s Promoting Action on Research Implementation in Health Services framework,^57–59 which emphasized the role of facilitation in knowledge translation and implementation.

NPT occupies a distinctive position alongside other implementation frameworks, models, and theories.⁶⁰ It offers an empirically grounded explanatory theory that focuses on the mechanisms that are implicated in implementation processes, and the work through which new practices become routinely embedded in everyday work. To work with this, we have followed this definition of mechanism: ‘it is a process in a concrete system which is capable of bringing about or preventing some change in the system’.⁶¹ NPT’s key publication in 2009,⁶ positioned it as an analytic structure for understanding implementation as a collective and collaborative accomplishment, and that tells us about the dynamics of agency under conditions of constraint. It is informed by the ‘analytic’ approach to sociology proposed by Hedström,⁶¹ and described by Vaughan.⁶²

In the development of NPT, we have sought to identify, characterize and explain processes and their outcomes by revealing the mechanisms that motivate and shape real-world implementation projects.

NPT as framework, model, and theory

In implementation science, the terms framework, model, and theory are often used interchangeably. Nilsen⁶³ has developed a taxonomy of conceptualization in implementation science in which three terms—framework, model, and theory—are defined. However, our use of these terms in NPT predates Nilsen’s taxonomy. In NPT they are used to describe different elements of theory construction.⁶ In our work, the purpose of theory is to provide a rational and reproducible explanation, not merely of what happens or how elements are connected, but why particular patterns of implementation work arise and under what conditions they are likely to succeed. We use these terms as follows:

▪ As a framework, NPT provides a taxonomy of constructs that identify and classify the kinds of work associated with implementation.
▪ As a model, NPT maps the patterned interactions among those constructs, showing their relative position and significance within implementation processes.
▪ As a theory, NPT specifies the generative social mechanisms that produce observable implementation outcomes.

The formulation of NPT meant that each of its elements built on and extended the previous one. The three terms therefore mark a developmental trajectory rather than alternative descriptions of the same thing. The development of Normalization Process Theory can therefore be understood as the progressive elaboration of conceptual tools for analyzing implementation processes, moving from a framework to model, and then from model to explanatory theory.

By identifying a set of social mechanisms that motivate and shape implementation processes, it was possible to offer a set of theoretical propositions about how practices become embedded in everyday settings. NPT characterized the generative mechanisms through which implementation processes unfold and specified how these mechanisms produce observable outcomes. This phase yielded a set of empirical generalizations,⁶⁴ concerning the conditions under which practices are successfully implemented, embedded, and sustained.

The structure of NPT

NPT is a middle-range theory of the kind proposed by Robert K. Merton.⁶⁵ Middle-range theories begin with a clearly delimited set of empirical observations, from which specific hypotheses or propositions can be derived that can then be tested against further observations. NPT is formed around three such propositions. These provide a structure for the theory. They are:

▪ Context conditions shape enabled agency.

Practices become routinely embedded in social contexts as the result of people working, individually and collectively, to implement them. Embedding is operationalized through four contextual conditions (strategic intention, adaptive execution, negotiated capacity, and reframing organizational logics). This proposition shows how the conditions under which mechanisms can work—strategic intention shapes whether coherence-building is even attempted; organizational logics determine whether collective action is structurally possible. Without this proposition, NPT cannot find an answer to the problem of why an apparently identical intervention produces different outcomes in different settings and at different times.

▪ Implementation work is motivated and shaped by generative mechanisms.

Without specification of mechanisms (coherence; cognitive participation; collective action; and reflexive monitoring), NPT is merely descriptive. It describes implementation mechanisms that operate interdependently and recursively. Without this proposition NPT cannot find an answer to the problem of why implementation processes might stall or reverse after initial success.

▪ Continuous translational action shapes implementation outcomes.

The production and reproduction of a practice require continuous investment by agents in ensembles of action that they carry forward in time and space. This third proposition shows that implementation mechanisms are not terminal. Continuous translational action is operationalized through four implementation outcomes (intervention performance, relational restructuring, normative restructuring, and sustainment). Because embedding requires continuous investment rather than a single episode, without this proposition NPT cannot explain normalization success and failure. Implementation is a dynamic and often recursive process in which practices become embedded through the ongoing co-ordination of actors, resources, and organizational structures. We define implementation processes as follows¹:

▪ An implementation process occurs when one group of actors seek to translate their strategic intentions into the everyday practices of others.
▪ An essential feature of an implementation process is that participating actors are subject to calls for collective action and collaborative work.
▪ The aim of collective action and collaborative work is to secure some degree of embedding in practice of an intervention or innovation, so that it is integrated into its setting.

The concept of continuous translational action describes the purposive, goal-directed work through which actors carry strategic intentions forward across organizational contexts and social time. Continuous translational action matters because embedding is never completely achieved but requires constant attention and investment from people working together. After all, it is hard to think of an implementation process that is accomplished by individuals working without connections to others. Focusing on the ways that people work together helps us to distinguish practice implementation from individual behavior change by focusing our attention on collective action. Importantly, translational action in NPT is distinct from translation in actor-network theory, where Latour⁶⁶ uses the term to describe the process by which actors, objects, and interests are enrolled into networks. NPT’s translational action is more concrete and more tractable. The propositions and definitions discussed above reflect iterative attempts to understand and explain what happens in practice when new technologies, interventions, or organizational innovations are implemented in health services. It also reflects iterative empirical work to uncover their composition and to develop a taxonomy of intervention components. This taxonomy is divided into four parts:

▪ Objects and procedures. These are the technical components of an intervention: the treatment modalities, hardware, software, and administrative processes that actors must enact in practice. They constitute the material focus of collective action: the things around which enactment is organized, workflows are reconfigured, and skill sets are allocated.
▪ Interaction strategies. These are the relational demands that the intervention places on its participants: changes in who talks to whom, how roles and responsibilities are negotiated, and how trust is built and maintained across the workforce. They shape the conditions for cognitive participation: who gets enrolled, how legitimacy is established, and whether actors sustain their commitment over time.
▪ Rules and resources. Implementation always depends on normatively framed uses of time, infrastructure, and governance. These dependencies must be made visible and actively mobilized: they cannot be left to informal or hidden work. Negotiating this capacity is a core implementation task: without it, collective action cannot be sustained, and interventions stall regardless of their technical merit.
▪ Institutional logics. These are the shared professional and organizational assumptions, priorities, and values that define what counts as legitimate, high-quality, or equitable practice. Because they constitute the cognitive and structural environment into which interventions are introduced, they enable or constrain embedding. Where an intervention requires new ways of working, these logics must be actively reframed if normalization is to occur.

This taxonomy provides a structured way of thinking about what interventions consist of. NPT treats them as analytically distinct but interdependent. In any given setting, the relative salience of each component will vary. Understanding which dimensions are most at risk of under-resourcing or resistance is what NPT’s mechanisms are designed to reveal.

The core of implementation work

NPT began with a taxonomy—or framework—of forms of work associated with implementation across US, UK, Australian, and European health services. Empirical research into the implementation of complex healthcare interventions identified recurrent, observable elements within implementation processes. These elements were derived from qualitative studies that examined how health professionals worked to implement, embed, and integrate new practices into routine care. In this phase, the emphasis was on identifying and classifying the kinds of work that participants undertook during implementation. In building this framework, empirical observations of implementation work were first translated into characterizations of agency and investment and then characterized as a set of mechanisms that motivate and shape implementation processes. This analytic work led to a set of propositions that characterized implementation as the routine incorporation (or normalization) of complex interventions through the collective action of actors working with them. NPT⁶ proposes a set of implementation mechanisms that are revealed through interrogating purposive investment of personal and group resources to achieve goals. These form the implementation core. They are:

▪ Coherence-building. In implementation processes, people work together in everyday settings to understand and operationalize implementation around interventions and their components.

Coherence-building is generative of a shared understanding of an intervention’s purpose, value, and operational demands, asking what it is for, how it differs from existing practice, what it requires of each participant, and why it is worth doing. When coherence is achieved, cognitive burden and coordinative uncertainty are reduced, raising the threshold for collective action. When coherence is absent or contested, actors cannot enroll others into work they cannot explain, cannot sustain collective action around tasks whose purpose they dispute, and cannot appraise effects against criteria they have never agreed. Coherence is not a precondition that, once met, can be taken for granted—it requires ongoing maintenance, and can be eroded by changes in personnel, organizational context, or the intervention itself.

▪ Cognitive participation. In implementation processes, people work together to create networks of participation and communities of practice.

Cognitive participation is generative of the relational infrastructures in which implementation is set—the networks, distributed roles, and working commitments. This includes the work of key drivers who advocate for and animate the intervention, the processes through which others are enrolled and come to see participation as legitimate, and the ongoing effort to maintain commitment against competing demands and obdurate organizations. When participation is secured, the social conditions for collective action are established. The legitimacy of the intervention is realized and there is sufficient shared commitment to sustain the work when it becomes difficult. When participation is fragile or absent, the collective action pathway breaks down regardless of the strength of coherence. An intervention cannot be enacted if the people needed to enact it have not committed to it, or if key drivers disengage. Cognitive participation is also the mechanism most sensitive to changes in personnel. Changes in staff can rapidly destabilize networks of participation that take considerable effort to build.

▪ Collective action. In implementation processes, people work together to enact interventions and their components.

Collective action is generative of the processes through which actors operationalize an intervention in the real world—doing the work the intervention requires under real-world conditions—includes not only the technical tasks specified in an intervention protocol but the informal, often invisible work of making things fit: adapting to local constraints, and integrating the intervention’s demands and the existing organization of work. When collective action is realized and sustained, the intervention is enacted in ways that generate effects that can meaningfully be appraised. Disruption of collective action generates misleading evidence of poor performance, which actors may attribute to design failure when the cause is enactment failure—this is one of the most important failure pathways in implementation, in which an intervention is abandoned not because it does not work but because it was never properly enacted.

▪ Reflexive monitoring. In implementation processes, people work together to appraise interventions and their components.

Reflexive monitoring is generative of the processes through which actors come to value what they have done. They form individual and collective judgements about whether those effects are worthwhile and use those judgements to modify both their own behavior and the intervention itself. Reflexive monitoring is not passive. It is purposive, is undertaken by individuals and groups and generates the feedback loops through which the conditions for normalization are realized. Here, problems are identified and addressed, sceptics are converted by evidence or experience, and the intervention is progressively refined. When monitoring is absent, implementation proceeds without error-correction, making normalization unlikely. When it produces sustained negative appraisal, it can undermine investment across all other mechanisms. Actors who conclude that an intervention does not work will withdraw cognitive participation, cease collective action, and ultimately contest the coherence that originally motivated their involvement. This recursive potential is what distinguishes NPT from linear stage models of implementation: these mechanisms drive embedding forward, but in the wrong conditions they create friction or failure.

Contexts and outcomes in implementation processes

NPT theorizes context not as a place but as an unfolding set of social accomplishments in which implementation processes are interwoven.⁹ An early paper⁶⁷ established its foundation in sociological theory rather than implementation science. It proposed that social action and its contexts cannot be analytically divided without systematic distortion of what is being explained, and that structural changes in the organization of care had made the consequences of that division practically as well as theoretically untenable. This process is defined by the ways that continuous translational action interacts with other, coterminous, patterns of social relations and organizational arrangements. Here, context is not where implementation happens, rather it unfolds over time and across settings through which participants in implementation processes simultaneously act within and act upon. This approach employed new two new analytical concepts—intervention plasticity and contextual elasticity—to characterize the relationship between qualities of intervention components and their contexts in terms that NPT’s original account could not capture.

▪ Intervention plasticity: describes the extent to which intervention components are malleable and adaptation is allowed, the degree to which they can be molded by their users to fit the specific conditions of the contexts into which they are introduced.⁹ (In the NPT coding manual this is characterized as adaptive execution).¹⁷
▪ Contextual elasticity describes the extent to which contexts can be stretched or compressed to make space for intervention components, the degree to which the normative and relational structures of implementation environments can accommodate change.⁹ (In the NPT coding manual this is characterized as negotiated capacity.¹⁷

Together, these concepts explain a set of implementation outcomes that NPT’s original formulation could describe but not explain: why tightly coupled and rigidly specified interventions so often fail in dynamic organizational environments, and why loosely coupled interventions that give users significant discretion over how they are operationalized more often achieve sustained embedding. This work also introduced concepts that describe the effects of interventions on their contexts, and which help us define the outcomes of implementation processes. These are

▪ Normative restructuring: this describes changes to the conventions, rules, and resources that provide the scaffolding for everyday behavior.^9,17
▪ Relational restructuring: this describes changes to the interpersonal interactions and group processes that make collective action possible.^9,17

These are adaptive consequences of responses to the turbulence and emergence that characterize complex adaptive systems, it defines implementation processes as non-linear progressions toward a stable endpoint but ongoing, recursive, and often contested accomplishments that continuously reshape both the interventions being implemented and the contexts in which they are enacted. The practical consequence of this development for NPT is that continuous translational action involves negotiations with contexts through which participants adapt both what they are implementing and the conditions into which they are implementing it. These are negotiations whose outcomes depend not only on the quality of the intervention or the commitment of the implementers but on the plasticity of intervention components, the elasticity of implementation environments, and the adaptive work that participants do to hold open the space in which implementation can proceed. This is what it means, in NPT’s terms, for implementation to be understood as a dynamic accomplishment rather than a linear process.

The concept of negotiated continuous translational action connects directly to NPT’s recent description as a Context–Mechanism–Outcome (CMO) theory compatible with realist evaluation.⁶⁸ In CMO terms, translational action describes the way actors draw on contextual resources to engage generative implementation mechanisms. The outcome of this work, when it is sustained, is normalization: the routine incorporation of a practice within its setting. Framing implementation as continuous translational action positions NPT as a strong (and ready-made) program theory for realist research that conforms to a Context–Mechanism–Outcome (CMO) configuration.¹² The fit is not perfect, however. In Pawson and Tilley’s development of realist evaluation,^69,70 mechanisms are mental rather than material phenomena. In Dalkin et al’s extension of realist evaluation, they disaggregate the mechanism into two components: the resources an intervention provides, and the reasoning of those who encounter them. Evidence of all of NPT’s mechanisms and constructs is not hidden in this sense: for example, coherence, cognitive participation, collective action, and reflexive monitoring are observable through the work practices they generate. In its CMO configuration.⁶⁸ NPT rests on the addition of constructs relating to implementation contexts, and these are:

▪ Strategic intention. Actors shape the formulation and planning of interventions and their components.¹⁷
▪ Adaptive execution. Actors engage in practical reasoning and collective action to identify and enact workable solutions so that an intervention and its components can be operationalized under real-world constraints.^9,17
▪ Negotiated capacity. Actors mobilize existing relational and organizational resources to integrate an intervention into established ways of working, negotiating the division of labor and reconfiguring roles, responsibilities, and practices accordingly.^9,17
▪ Reframing organizational logics. Existing social structural and social cognitive mechanisms constitute the implementation environment, enabling or constraining the embedding of an intervention and shaping the conditions under which it is sustained or abandoned.¹⁷

The CMO configuration also rests on the addition of four constructs describing implementation outcomes. These provide a structure for assessing the practical effects of implementation mechanisms at work, and their shaping effects on continuing translational action.

▪ Intervention performance. Practice changes as the result of interventions and their components being operationalized, enacted, reproduced, over time and across settings.^9,17
▪ Relational restructuring. Working with interventions and their components changes the ways actors are organized and relate to each other.^9,17
▪ Normative restructuring. Working with interventions and their components changes the norms, rules and resources that govern action.^9,17
▪ Sustainment (normalization). Implementation processes are normalized when interventions and their components have become incorporated in practice.^2,6

Within NPT, contexts are seen as emergent and dynamic environments in which implementation work unfolds variably across social time and social space.⁹ Outcomes capture the fluid but observable effects of the work that are realized through these mechanisms. The relationship between contexts and mechanisms in NPT is not one of simple precedence or succession. Context constructs do not merely precede or enable mechanisms—they are the conditions in which mechanisms operate and by which their effects are shaped. In this sense, the context constructs and the implementation mechanisms are analytically distinct but empirically intertwined: understanding why a mechanism operates as it does in a given setting requires attending to the contextual conditions that both enable and constrain it.

Strategic Intentions change contexts

A consequence of theoretical consideration of context is the theorization of Strategic Intentions: who they belong to, and how they shape contexts and action. As we have seen, context in NPT is not simply ‘background’ or ‘setting’ in the way those terms are often used in implementation research Context in NPT refers to the patterns of social relations and structures that constitute the implementation environment.

The construct of Strategic Intention refers to the ways that actors shape the formulation and planning of interventions and their components. It is about the work that goes into deciding what an intervention will be, what it will do, who it is for, and how it will be introduced—before active implementation begins. This includes decisions made by commissioners, managers, policy makers, clinical leaders, and frontline practitioners about the design and purpose of the intervention, the rationale for introducing it, the goals it is meant to achieve, and the strategies through which it will be delivered. This matters because interventions themselves change the contexts in which they are operationalized. How an intervention is framed, what problems it is understood to solve, whose priorities it is designed to serve, and what assumptions are embedded in its design all shape the conditions under which it will subsequently be enacted. An intervention that has been designed with a clear rationale that actors find credible arrives in a different implementation environment from one introduced without adequate planning or with a rationale that practitioners find unconvincing or contradictory to their values. This has important implications:

The construct of Strategic Intentions also captures the extent to which the intervention has been formed in ways that anticipate the conditions of its use. An intervention in which components are clearly specified, their purpose is understandable and has been informed by knowledge of the setting into which it will be introduced naturally creates a more hospitable context for the operation of implementation mechanisms than one that arrives incompletely specified or whose rationale is obscure. Nor are Strategic Intentions the sole the province of senior decision-makers. Frontline practitioners engage in their own strategic work around interventions, including decisions about whether to adopt them, how to adapt them to local conditions, and how to advocate for or against them. The construct therefore captures distributed agency, not just top-down planning.

Finally, the alignment of Strategic Intentions matters. An intervention may be planned with goals that differ from the goals of the practitioners who will deliver it, or with assumptions about capacity and resources that do not match real-world conditions. Differences in interpretation of existing context are transmitted through the strategic intentions of trial investigators, commissioners and clinicians, between managers and frontline staff, between researchers and practitioners create tensions that subsequently manifest in the mechanisms. Low coherence, weak cognitive participation, and contextual integration failures in collective action can often be traced back to misalignment at the level of Strategic Intentions.

The relationships between Strategic Intentions, Adaptive Execution, and Negotiated Capacity are also worth noting. Where Strategic Intention reflects the formulation and planning of an intervention, Adaptive Execution concerns the workarounds and modifications that actors make in practice to make the intervention workable, and Negotiated Capacity concerns the work that actors must do to ensure the integration of an intervention into existing structures and workflow. These constructs bracket the intervention in time: Strategic Intentions shapes what is introduced, Adaptive Execution shapes what it becomes through use, and Negotiated Capacity shapes how it fits. The construct of Organizational Reframing reflects the immediate changes that the operationalization of strategic intentions brings to action.

Implementation outcomes represent re-contextualization

Because context in NPT is an unfolding set of social accomplishments: they are patterns of social relations and structures that are themselves produced and reproduced through action. This matters for how outcomes are understood. It means that the outcomes of implementation processes are more than endpoints that succeed or follow from those processes. They are changes to the very stuff that context is made of. NPT’s outcome constructs describe this. Relational Restructuring describes changes to the interpersonal interactions and group processes that are brought about by implementing interventions, and Normative Restructuring describes changes to the conventions, rules, and resources that provide it scaffolding. These describe continuing translational action. The outcomes of implementation are therefore changes to context itself. This also explains why context constructs and outcome constructs map onto each other so clearly in NPT’s architecture. Strategic Intentions shapes what is introduced into a context—and Intervention Performance the extent to which the technical problems of practice that result from the intervention that is implemented. The context that existed before implementation and the context that exists after are not the same. The intervening construct is continuous translational action, and this leads to recontextualization. Sustainment (normalization) is the endpoint of this logic. An intervention that has become normalized is one that has so thoroughly re-contextualized in its setting that its practice is no longer distinguishable from routine. The intervention has ceased to be a foreign object in a pre-existing context and has become part of what that context is. This is why NPT defines normalization as incorporation rather than adoption. Adoption implies the context receives something from outside, whereas incorporation implies the thing has become constitutive of the context itself.

NPT and the problem of equity

Implementation science as a field has been subject to significant criticism for its failure to account for problems of inequity and inequality.^71–77 This is an important criticism, and NPT is open to challenge on these grounds. Recent work inspired by NPT has engaged with inequity and racialization in implementation processes. Patient-Centered Equity Design (P-CED)¹³ offers both a theoretical basis for understanding how inequities are implemented and propagated within health services, and content for an equity audit instrument. This situates NPT constructs in a program of prefigurative design,⁷⁸ underpinned by social justice theory.⁷⁹ The model organizes its equity content around four generative design principles that map directly onto NPT’s implementation mechanisms.

▪ Coherence-building is the site at which interventions construct their implicit model of the patient: whose knowledge counts as legitimate, whose experience is treated as evidence, and whose sense of an intervention’s purpose and value is solicited.

Implementation projects that fail to build coherence around a genuinely inclusive account of users reproduce inequity. They do this by embedding narrow or idealized assumptions about what patients and caregivers are, know, and can do. The C-PED approach identifies this as misidentification.

▪ Cognitive participation is the mechanism through which participation barriers are either recognized and addressed or quietly reproduced.

Enrolment and legitimation processes that are designed without attending to the relational inequalities and power asymmetries that shape who gets recruited, whose commitment is sought, and whose legitimation is treated as necessary, participation becomes structurally selective.

▪ Collective action is where the distribution of treatment and administrative burdens is concretely realized.

Interventions that increase workload for patients and caregivers without providing corresponding capacity, support, or recognition transfer the costs of implementation onto those least able to bear them. Designing for reduced workload and restored agency is therefore an equity intervention in its own right.

▪ Reflexive monitoring is the mechanism through which accountability for equity is either institutionalized or evaded.

When evaluation does not track whose experience of an intervention is captured, whose feedback shapes reconfiguration, and who benefits and who is burdened by the changes that follow, then monitoring reproduces the invisibility of inequity rather than correcting it.

Patient-Centered Equity Design addresses the structural and relational mechanisms through which inequities are produced and reproduced within health services, but it does not fully confront the specifically racialized character that appears in some of those processes. Critical Race Theory (CRT)⁸⁰ extends the analysis of equity by asserting that race is a foundational organizing principle of institutional life: it shapes which problems get named, whose knowledge is treated as legitimate, and whose interests are served by the structures that implementation processes reproduce. Where P-CED asks whether interventions and their implementation processes produce or challenge inequity, CRT asks the sharper question: whose implementation is this, and at whose expense? Here, combining CRT with NPT in implementation design and evaluation is therefore not simply an addition. It recasts the mechanisms themselves as the possible sites of racialized practice. It involves a series of critical questions.

▪ Coherence-building asks whose sense-making counts.
▪ Cognitive participation asks who gets enrolled and on what terms.
▪ Collective action asks whose labor is mobilized and whose burden increases.
▪ Reflexive monitoring asks whose appraisal of an intervention’s effects shapes reconfiguration.

Intervention designs that treat these as race-neutral technical processes may inadvertently normalize racially inequitable practices,⁸¹ leaving the deepest sources of inequity untouched. Integrating CRT with NPT and P-CED offers a more fully equity-sensitive framework for implementation science — one that can answer the question CRT demands: who benefits, and who is burdened?

Using NPT to analyse implementation: A worked example

The following worked example focuses on NPTs characterization of implementation processes rather than the Patient-Centered Equity Design questions outlined above. These could usefully be applied to any study. To illustrate the practical application of Normalization Process Theory and its CMO configuration, in Table 1 we provide a comparative worked example drawing on six published papers from two NPT-informed cluster randomized trials: the MOVE study (maternal and child health nurse domestic violence screening, Australia),^82–84 and the WISE study (whole-system self-management support, England).^85–87 Both trials used NPT prospectively across intervention design, implementation, and process evaluation. The analysis applies abductive reasoning^88,89 to each study, drawing on the full NPT propositional scheme, and results in eight synthesis propositions about the conditions under which mechanisms activate, stall, or fail entirely.

Table 1. Worked example of NPT analysis - comparison of the MOVE and WISE Trials.

NPT PROPOSITIONS, DEFINITIONS, MECHANISMS	MOVE TRIAL (Australia^82–84)—Analysis		WISE TRIAL (UK^85–87) —Analysis
Proposition 1: Context conditions shape embedded agency. Practices become routinely embedded as the result of people working, individually and collectively, to implement them.	Context and embedding: Government policy framework change was the primary contextual disruptor. FV liaison worker intensity was the primary enabling condition. Team-level variation in embedding reflected systematic variation in contextual conditions, not individual difference.	Abductive inference: The ‘dose’ of relational support to front-line workers is a key implementation lever. Randomization may inadvertently create systematic contextual variation that NPT predicts to be mechanistically significant.	Context and embedding: Two decisive contextual conditions: (1) QOF created a financially incentivized biomedical work environment that made non-QOF activities structurally illegitimate; (2) PCT dissolution during the trial removed the organizational infrastructure supporting training roll-out.	Abductive inference: QOF operated as a structural implementation barrier with far greater determinative force than any intervention-level factor. In pay-for-performance environments, non-incentivized practices face a near-insurmountable embedding barrier regardless of intervention quality.
Context: strategic intention: actors shape the formulation and planning of interventions.	MOVE: Strongly developed through six months of participatory action research aligning researcher and nurse intentions before implementation. Government mandate created strategic tension navigated via checklist design.	Abductive inference: Participatory design is a strategic intention mechanism: it aligns multiple actors’ intentions before implementation begins and generates ownership that top-down mandates cannot replicate.	WISE: Strong at PCT executive level but did not cascade to commissioning or middle management. WISE not embedded in PCT annual planning cycle or commissioning directorate—a ‘nobody’s baby’ problem. GP strategic intentions are dominated by QOF contractual obligations.	Abductive inference: Strategic intention requires vertical alignment within organizations. Executive buy-in that does not cascade with commissioning and middle management creates strategic aspiration without an implementation pathway mode of failure absent in MOVE, where participatory design aligned the relevant front-line actors.
Context: Adaptive execution: actors identify and enact workable solutions under real-world constraints.	MOVE: Multiple documented adaptations: self-completion format; timing shift to 3–4 months; ‘planting a seed’ multiple-asking strategy; 15-minute extension to routine visit. All sanctioned by participatory design process giving nurses legitimacy to adapt.	Abductive inference: Adaptive execution was enabled by design-phase ownership. Participatory design conferred legitimacy to adapt that top-down training cannot provide.	WISE: Adaptive execution operated primarily at training design level (Kennedy 2010 documents multiple training revisions), not at clinical practice level. Individual nurses made limited adaptations (e.g., using PRISMS for one pressing concern). One practice integrated PRISMS distribution through reception. Otherwise, adaptation was minimal.	Abductive inference: The research team adapted; the clinicians largely did not. Adaptive execution requires both legitimacy and structural opportunity—in QOF-governed practices there is limited legitimate space to adapt consultation content without disrupting incentivized task completion.
Context: Negotiated capacity: actors mobilize relational and organizational resources to integrate an intervention into established ways of working.	MOVE: Most variable contextual condition. Key drivers: local government funding for 3-month visit, FV liaison worker intensity, team leader maintenance of FV on team meeting agendas. Uneven liaison allocation created systematic variation in implementation quality.	Abductive inference: Negotiated capacity requires active resource mobilization, not just goodwill. Resource ‘presence’ and resource ‘adequacy’ are distinct.	WISE: Failed at every level. PCT: WISE in wrong management directorate, trainers had no operational authority. Practice: practice managers drove training participation—insufficient to negotiate clinical capacity change. Nurses: QOF tasks exhausted available consultation capacity; PRISMS in a 10-minute consultation was structurally impossible.	Abductive inference: WISE demonstrates negotiated capacity failure as rational calculation. When actors correctly perceive that enacting an intervention will generate demands exceeding available capacity, avoidance is rational. Implementation theory needs to account for this pattern—it is distinct from resistance and from inertia.
Context: Reframing organizational logics: existing structural and cognitive mechanisms enable or constrain the embedding of an intervention.	MOVE: Partial reframing. Checklist positioned DV screening within a maternal health wellbeing frame, compatible with MCH nursing identity. Child-centered organizational accountability was not reframed. Family-centered care logic operated bidirectionally.	Abductive inference: MOVE reframed mode and timing of screening but not the deeper organizational priority structure. Full normalization may require institutional reframing beyond what a single trial can achieve.	WISE: Reframing failed at professional level. WISE was absorbed into nurses’ existing patient-centered identity claim without generating practice change. The QOF logic was not reframed — WISE aspired to create a parallel patient-centered logic but had no financial or governance mechanism to give it institutional force.	Abductive inference: Where an intervention does not establish its own institutional logic, it is absorbed and neutralized by the dominant logic. The ‘we already do it’ response dissolves the intervention’s distinctiveness. Interventions depending on new institutional logic require either financial incentivization or a sufficiently distinct, measurable practice identity to resist absorption.
Proposition 2: Implementation work is motivated and shaped by generative mechanisms.	Mechanism activation: Asymmetric mechanism intensity: collective action strongest, reflexive monitoring weakest. Coherence and cognitive participation were disrupted when they coincided with government framework change.	Abductive inference: Collective action can sustain implementation even when reflexive monitoring is weak, provided coherence is sufficient — but absent monitoring limits embedding reach and error-correction.	Mechanism activation: All four mechanisms were weak or absent at professional level. Coherence failed (WISE not seen as different from existing practice). Cognitive participation failed (QOF dominated; SMS not seen as legitimate professional work). Collective action minimal. Reflexive monitoring entirely absent — nothing to measure or audit.	Abductive inference: WISE represents near-total mechanism failure at professional level, contrasting with MOVE’s partial success. This suggests that both a compatible implementation object and a legitimate professional role identity are necessary conditions for any mechanism activation.
Intervention: Objects and procedures: the technical components of an intervention that actors must operationalize in practice.	MOVE objects: Maternal health checklist was the central object; 96% uptake. Self-completion, timing at 3–4 months, and maternal health framing were design features critical to its success. Clinical guidelines (74%) and pathway (67%) were secondary objects.	Abductive inference: Object design encodes social relations. The checklist redistributed disclosure responsibility from nurse to woman. Object design is itself a relational and political process.	WISE objects: Three objects: PRISMS form (patient needs assessment), guidebooks (patient information), online directory (local resources). Differential uptake: guidebooks used most, PRISMS rarely, directory infrequently. Kennedy 2010 documents PRISMS introduced at end of consultation, equivalent to a prescription.	Abductive inference: Object design must account for workflow integration, not just conceptual fit. PRISMS required consultation restructuring, patient pre-completion infrastructure, and GP willingness to address patient-generated agendas — none established. The object was logically coherent but contextually incompatible.
Intervention: Interaction strategies: the relational demands the intervention places on participants.	MOVE interaction strategies: Nurse mentors (38% → 52% uptake), FV liaison workers (effective where intensive), nurse consultants (high coherence from design participation). Formal relational structures competed with informal proximate peer networks.	Abductive inference: The solo nature of MCH practice was a structural barrier to nurse mentor utilization. Formal relational infrastructure must compete with — and may lose to — existing informal structures.	WISE interaction strategies: Lay trainers (PCT-employed), whole-practice training, practice champion model. Training is appreciated as team building but relational infrastructure is not sustained. Trainers had no managerial backing. Follow-up access refused. GP–nurse–patient chain required for PRISMS never established.	Abductive inference: The lay trainer model was structurally vulnerable: trainers had no commissioning authority, management champion, or formal accountability mechanism. Interaction strategies require institutional anchorage to persist beyond initial enrolment.
Intervention: Rules and resources: normatively framed uses of time, infrastructure, training, supervision, and governance.	MOVE resources: Time was the most-cited barrier (>77% experienced barriers at 4-week visit). Additional local government funding required for 3-month visit (only 3 of 4 teams secured it). FV liaison worker unevenly distributed. One-off government training was criticized as inadequate.	Abductive inference: Resource adequacy, not just resource presence, is the critical variable. Uneven distribution created systematic variation in implementation quality.	WISE resources: 10-minute consultation time structurally insufficient for PRISMS and QOF monitoring combined. QOF financially incentivized biomedical tasks only. No audit mechanism for WISE activities made them ‘hidden work’ invisible to management, unrecognized, and unrewarded. PCT funded locum cover for training attendance but no ongoing resource support.	Abductive inference: Activities that are not auditable are invisible to practice management and accountability systems. Invisibility means neither recognition nor resources follow — a self-reinforcing cycle of deprioritisation. QOF inclusion of SMS indicators would be the most powerful implementation lever available.
Intervention: Institutional logics: the shared assumptions, priorities, and values that define legitimate practice.	MOVE logics: Family-centered care logic operated bidirectionally: enabled maternal health framing but constrained privacy for DV screening. Child-centered organizational accountability was not reframed.	Abductive inference: Institutional logics operate bidirectionally. Linear barrier/enabler frameworks cannot capture this. The same logic can simultaneously enable and constrain different aspects of an intervention.	WISE logics: QOF-biomedical logic functioned almost entirely as a constraint — not bidirectional. Patient-centered logic was rhetorically endorsed but not operationally enacted: nurses claimed patient-centeredness as professional identity while delivering task-driven care. This espoused–enacted logic gap actively undermined WISE coherence.	Abductive inference: NPT should attend not only to what actors say they believe but to logics governing behavior. In WISE, self-reported patient-centeredness eliminated nurses’ perceived need to change: if they believed they were already patient-centered, WISE offered no compelling case for investment.
Mechanism: Coherence-building: shared understanding of purpose, value, and operational demands of an intervention.	MOVE coherence: Strong among nurse consultants (design participants). Disrupted by KAS framework change and staff turnover. Improved progressively with checklist use. Comfort with asking about violence: 65.5% vs 46.2% comparison (p = 0.04) by impact survey.	Abductive inference: Coherence is linked to participation in design. It requires ongoing maintenance and is vulnerable to staff turnover and concurrent organizational change.	WISE coherence: Coherence failed on multiple sub-constructs. Differentiation: nurses did not perceive WISE as different from existing practice (‘teaching us to suck eggs’; Kennedy IJNS 2014). Communal specification failed: limited post-training communication stifled collective sense-making. Kennedy 2010 documents the same problem in formative evaluation: DVD exemplar prompted ‘this is what we do already’ responses.	Abductive inference: Absence of differentiation is a specific coherence failure mode not prominent in MOVE. Where an intervention is perceived as insufficiently novel it activates no curiosity, generates no specific work, and is absorbed into existing practice without change. This is distinct from active resistance — it is passive non-implementation through perceived redundancy.
Mechanism: Cognitive participation: creation of networks of participation and communities of practice around an intervention.	MOVE participation: >95% endorsement of FV work importance. Checklist = powerful participation device (96% use). Nurse mentor role underutilized (38% → 52%). Heavy workloads and solo practice structure limited enacted participation.	Abductive inference: Critical distinction between endorsement (believing work is important) and enacted participation (doing it consistently). MOVE achieved the former more reliably than the latter.	WISE participation: Cognitive participation achieved at organizational level (PCT commitment) but failed at professional level. Legitimation was absent: many nurses did not perceive their role as requiring SMS adoption. Practice managers often drove training sign-up rather than clinical champions — the wrong actor to generate professional legitimation.	Abductive inference: Top-down initiation without professional legitimation creates a participation gap: the organizational level enrolls; the professional level does not. WISE lacked the mechanism for translating organizational commitment into professional practice change. Contrast with MOVE: nurse consultants’ direct design involvement created a legitimation pathway.
Mechanism: Collective action: operationalization of an intervention’s components in real-world practice.	MOVE collective action: Strongest mechanism. Checklist activated interactional workability. ‘Planting a seed’ emerged as an adaptive strategy. Relational integration partial (nurse mentor underused; liaison worker effective where intensive). Inter-organizational collective action weak throughout (referrals <1%).	Abductive inference: Collective action was strong at nurse-client level but weak at inter-organizational level. This asymmetry maps directly onto asymmetric outcomes: safety planning ↑↑, referrals flat.	WISE collective action: Minimal across all sub-constructs. Interactional workability: PRISMS generated patient needs that could not then be addressed within consultation time — it increased workload without providing capacity. Contextual integration: QOF tasks dominated; practice systems could not integrate PRISMS forms. Only guidebook distribution achieved routine collective action, and this was absorbed into existing information-giving rather than generating new practice.	Abductive inference: ‘Pandora’s box dynamics’: PRISMS was avoided precisely because activation of patient needs would exceed available capacity. Collective action failure is not always due to lack of will or skill — it may reflect rational avoidance when enacting an intervention would create more burden than existing capacity can absorb. This is an important theoretical extension of NPT’s collective action construct.
Mechanism: Reflexive monitoring: individual and collective appraisal of an intervention’s effects used to modify behavior.	MOVE monitoring: Weakest mechanism. ~65% of intervention nurses received no useful feedback. No chart audits performed. Clinical supervision initially lower in intervention arm (48.1% vs 76.0%, p = 0.004). Team leaders acknowledged failure to monitor despite guideline recommendations.	Abductive inference: Absent reflexive monitoring limited error-correction and explains why referral pathway failures were not identified. Reflexive monitoring is the most consistently underdeveloped mechanism in complex nursing interventions.	WISE monitoring: Essentially absent across all levels. PCT: ‘no outcomes to measure, not audited.’ Professional level: no chart audits, no systematic feedback, no formal SMS appraisal. Kennedy IS 2014: ‘there was nothing tangible to measure or audit.’ Individual appraisal is limited to occasional nurse reflection on guidebook usefulness. Positive PRISMS experiences did not feed back into team practice.	Abductive inference: WISE provides the clearest case for reflexive monitoring being structurally absent rather than merely neglected. There were no QOF incentives, audit tools, reporting mechanisms, or accountability frameworks for SMS. The monitoring absence in WISE was more complete than in MOVE, where individual clinical supervision existed. This depth of absence may be specific to non-incentivized interventions in QOF-dominated environments.
Proposition 3: Continuous translational action shapes implementation outcomes.	Translational action: 36-month safety planning trajectory (RR 2.95 yr1 → RR 4.22 yr3) is the strongest evidence for this proposition: sustained and increasing after trial withdrawal, driven by continued checklist use (81%).	Abductive inference: Once embedded in routine practice, translational action can become self-sustaining. This is rare empirical evidence for NPT’s third proposition.	Translational action: No evidence of sustained translational action. Guidebooks were used passively. PCT dissolution removed organizational support. Follow-up training sessions were repeatedly cancelled by practices. No practice reported changed clinical behavior at 6 months post-training.	Abductive inference: WISE illustrates the failure mode of proposition 3: without initial embedding, there is no translational action to sustain. Two half-day training sessions were insufficient to initiate the continuous investment NPT requires.
Outcome: Intervention performance: practice changes because of interventions being operationalized and enacted over time.	MOVE: Safety planning: sustained improvement (RR 2.95 yr1 → RR 4.22 yr3, p = 0.003). Checklist screening: 63.1% vs 23.5% usual care. Routine screening: no significant difference. Referrals: <1% both arms throughout. No harm from screening.	Abductive inference: Performance pattern reflects asymmetric mechanism activation: strong at nurse-client level (safety planning), weak at inter-organizational level (referrals).	WISE: RCT: no effect on patient outcomes at 12 months (Kennedy et al. BMJ 2013). Process evaluation confirms: guidebook distribution occurred; PRISMS not routinely used; online directory rarely accessed. No change in patient self-management behavior or consultation quality demonstrated.	Abductive inference: WISE is a case of implementation failure producing trial failure. The mechanism chain from training to changed practice to patient outcome was never activated. The null result is explained by mechanism analysis: the evidence base for components was sound but the implementation context was incompatible.
Outcome: Relational restructuring: working with interventions changes the ways actors are organized and relate to each other.	MOVE: Significant at nurse-client level: checklist redistributed disclosure responsibility from nurse to woman. Partial within teams (enhanced safety practices; increased FV discussion). Inter-organizational restructuring is minimal.	Abductive inference: Most significant restructuring was at micro (nurse-client) level, not organizational level. Micro-level relational restructuring was more consequential for outcomes than any macro-level change.	WISE: No significant relational restructuring achieved. Whole-practice training created temporary team cohesion (valued as team building) but not durable structural change. GP–nurse role demarcation unchanged. Trainer-practice relationship severed when follow-up access refused.	Abductive inference: WISE illustrates the difference between an interaction (training session) and a relationship (sustained change in how actors work together). NPT’s relational integration sub-construct requires the latter. Enjoyable training is insufficient to produce relational restructuring.
Outcome: Normative restructuring: working with interventions changes the norms, rules, and resources governing action.	MOVE: Partial within teams. FV screening progressively more accepted as routine expectation in intervention teams. Government mandate created normative obligation without relational infrastructure. Government mandate and relational infrastructure are complementary sources of normative change.	Abductive inference: Normative change driven by mandate alone is insufficient without the relational infrastructure to sustain it. MOVE provided the infrastructure the mandate lacked.	WISE: Normative restructuring not achieved. Nurses’ norms concerning legitimate consultation work remained biomedical and QOF-driven throughout. Persistent nurse ambivalence about patient capacity for self-management (‘patients don’t want to take responsibility’) indicated that professional normative orientation to the patient population was not shifted.	Abductive inference: WISE reveals a normative-structural interaction: norms about patient capacity are themselves produced by the structural conditions of QOF-governed care. Changing practitioner norms without changing the structural conditions that produce them may be insufficient for sustainable normalization.
Sustainment (normalization): implementation processes are normalized when interventions have become incorporated in routine practice.	MOVE: Partial and domain specific. Checklist (81% continued use), safety planning, and maternal health visit normalized. Nurse mentor, FV liaison, and referral pathway are not fully normalized. The 36-month safety planning trajectory is the strongest normalization evidence in this corpus.	Abductive inference: Normalization occurs at multiple levels simultaneously and does not travel consistently across components. Sustainment claims should be disaggregated by component and level of analysis.	WISE: No normalization achieved for PRISMS or the whole-systems SMS approach. Guidebook distribution achieved partial embedding only as ‘minimally disruptive’ information-giving—absorbed into existing practice rather than constituting a new practice. Kennedy 2010 explicitly flagged that guidebook uptake reflected fit with existing routines, not adoption of WISE.	Abductive inference: The ‘absorbed but not transformed’ pattern: a component can be normalized into existing practice without carrying the intended relational transformation. Guidebook normalization in WISE created the appearance of uptake while obscuring intervention failure. This is a form of pseudo-normalization that may actively impede full implementation by satisfying superficial uptake criteria.

The MOVE Trial (Australia)^82–84: MOVE was a domestic violence screening model developed for maternal and child health (MCH) nurses in north-west metropolitan Melbourne, Australia. The intervention comprised four components: a self-completion maternal health checklist administered at the 3–4-month MCH visit; nurse mentors within each team; Family Violence liaison workers providing specialist case support; and a set of clinical guidelines. Taken together, these formed elements of a care pathway. The checklist was the central implementation object, designed to redistribute the burden of disclosure from nurse-initiated questioning to a woman-completed form, situating screening within a positive maternal wellbeing frame. The comparator was government-mandated face-to-face screening at the 4-week visit. During the trial, the state government introduced a new universal domestic violence screening framework, creating an unanticipated concurrent contextual change affecting both arms. The cluster randomized controlled trial across four MCH nursing teams found no statistically significant difference between arms in rates of routine screening.⁸⁴ However, checklist-based screening was substantially higher in the intervention arm (63.1% vs 23.5%), and safety planning was significantly more frequent, continuing to increase over three years to a risk ratio of 4.22 (p = 0.003). No adverse effects were identified. The mixed-methods process evaluation was informed by NPT and explained why implementation succeeded in some domains (safety planning) but not others (routine screening, referrals).⁸³

The WISE Trial (UK)⁸⁵^–⁸⁷: WISE (Whole System Informing Self-Management Engagement)^85–87 was designed to improve self-management support for people with long-term conditions in NHS primary care, developed and tested in a socio-economically deprived inner-city Primary Care Trust (PCT) in north-west England, focusing on diabetes, COPD, and IBS. The intervention operated across three levels: organizationally, the PCT employed two lay trainers; at practice level, whole teams attended two three-hour training sessions; and at patient level, participants received information about changes to their practice’s approach. Three tools were central: the PRISMS form, patient guidebooks, and an online directory of local self-care resources. NPT structured both the intervention’s development and its process evaluation. The organizational context was significantly shaped by the NHS Quality and Outcomes Framework, a pay-for-performance system that financially incentivizes auditable biomedical activities while structurally deprioritizing self-management support. During the trial, the PCT was also disbanded as part of broader NHS reorganization. The cluster randomized trial recruited 5,599 patients across 43 general practices and found no effect on any patient-level outcome at twelve months.⁹⁰ The pre-specified process evaluation examined why SMS failed to embed in daily clinical practice, encompassing organizational stakeholders, practice staff, and patients.

Abductive analysis: Table 1 shows how abductive analysis created local empirical observations to generate empirical generalizations.⁶⁴ In abductive analysis, a theoretical framework informs the treatment of empirical material. This differs from deductive coding (applying pre-specified categories to data) and inductive coding (generating categories without prior theoretical commitment). Both of these analytic strategies have been widely used in NPT-informed research and evaluation.^91–93 Each NPT construct is applied to the MOVE and WISE papers in two steps: (i) relevant empirical material is identified and summarized under the construct heading, and (ii) an abductive inference is drawn about how the construct operates, under what conditions, and with what consequences. Because both studies used NPT in their process evaluation the coding has an additional reflexive dimension. Here, NPT-structured findings reveal the conditions under which its constructs are most and least illuminating.

Using NPT Tools in Implementation Research

Normalization Process Theory has enabled the development of a suite of tools designed to operationalize it through the lifecycle of implementation research. These translate the NPT’s core mechanisms into practical instruments that can support intervention design, implementation planning, process evaluation, and explanatory analysis. In Table 2, we show how these tools shift from constructs, through implementation strategies, to implementation measurement. NPT tools can be applied across five research domains: intervention design and feasibility, prospective process evaluation, cross-sectional real-time investigation, retrospective analysis, and evidence synthesis.

▪ Intervention design and feasibility studies: Early-stage research is supported by the NPT Online Toolkit,¹⁴ the Trial Gatekeeper,¹⁵ and the ItFits Toolkit.¹⁶ These provide a mechanism-informed basis for testing (i) whether a proposed intervention has a realistic prospect of successful implementation, (ii) whether prospective users understand and see value in it; whether it can be integrated into routine work, and (iii) whether existing contextual conditions are likely to enable or obstruct embedding. Where conditions are absent or cannot be established, these tools can support a decision to redesign or discontinue before resources are committed to full evaluation.
▪ Prospective process evaluation and real-time cross-sectional investigation: Research in these domains is supported by the NoMAD survey instrument.^10,11 This provides construct-level scores for coherence, participation, collective action, and reflexive monitoring. Administered repeatedly across the implementation period, it tracks how normalization mechanisms evolve and identifies where targeted support may be needed. The NPT Coding Manual¹⁷ sits alongside NoMAD and provides construct definitions that can guide qualitative analysis of interviews, observations, and documentary materials within a Context–Mechanism–Outcome configuration. The ItFits Apply-and-Review module further supports real-time management, enabling implementation plans to be sustained, adjusted, or restarted as contextual conditions evolve.
▪ Retrospective analysis and evidence synthesis: Research in these domains is important to answer why questions. The NPT Coding Manual¹⁷ and the NPT Taxonomy of Implementation Strategies¹⁸ enable post-hoc mapping of implementation processes onto NPT constructs to explain why normalization succeeded, stalled, or failed. For evidence synthesis, the shared theoretical vocabulary of NPT provides a common coding framework across studies. NoMAD^10,11 data can be aggregated to identify which mechanism domains most consistently predict success across settings, while the Coding Manual supports synthesis at the level of CMO configurations, enabling transferable propositions to be generated from qualitative findings across multiple studies.

Table 2. NPT core constructs, implementation strategies, and NoMAD survey questions.

NPT core constructs		NPT coding manual construct descriptions⁶⁸	NPT Implementation strategies¹⁸	NoMAD Survey questions
Implementation contexts: Contexts are patterns of social relations and structures that unfold over time and across settings. They make up the implementation environment.		Strategic Intention: How actors shape the formulation and planning of interventions and their components	Ensure collaborative work to build a coherent and inclusive implementation plan for the intervention	--
		Adaptive Execution: How actors find and enact workarounds that make an intervention and its components a workable proposition in practice	Determine which components of the intervention can be adapted to better fit the target setting	--
		Negotiated Capacity: How actors integrate interventions into existing ways of working	Engage stakeholders to ensure the intervention can be integrated in workflows in its target setting	--
		Reframing organizational logics: How existing social structural and social cognitive resources shape the implementation environment	Identify features of the target setting that are likely to support implementation	--
Implementation mechanisms: Mechanisms are revealed through purposive social action—collaborative work—that involves the investment of personal and group resources to achieve goals	Coherence building⁶ How people work together in everyday settings to understand and operationalize implementation	Coherence building – Differentiation: How actors distinguish interventions and their components from their current ways of working	Clearly articulate how the new intervention improves upon current practices	I can see how the [intervention] differs from usual ways of working
		Coherence building - Communal specification: How actors collectively agree about the purpose of interventions and their components	Establish and agree shared goals for the implementation process	Staff in this organization have a shared understanding of the purpose of this [intervention]
		Coherence building - Individual specification: How individual actors understand what interventions and their components require of them	Define and communicate individual roles and responsibilities related to the intervention	I understand how the [intervention] affects the nature of my own work
		Coherence building – Internalization: How actors construct the potential value of interventions and their components for their work	Clearly identify the value of the intervention to staff	I can see the potential value of the [intervention] for my work
Cognitive participation⁶ How people work together to create networks of participation and communities of practice around interventions and their components.	Cognitive participation – Initiation: How key actors drive interventions and their components forward	Select and support key individuals who will drive the intervention forward	There are key people who drive the [intervention] forward and get others involved
	Cognitive participation – Enrolment: How actors join in with interventions and their components	Be clear about how, why, and for who the intervention is the right thing to do	I’m open to working with colleagues in new ways to use the [intervention]
	Cognitive participation – Legitimation: How actors agree that interventions and their components are the right thing to do and should be part of their work	Eliminate obstacles to participation in the implementation process	I believe that participating in the [intervention] is a legitimate part of my role
	Cognitive participation – Activation: How actors continue to support interventions and their components	Develop strategies to maintain commitment among the implementation team	I will continue to support the [intervention]
Collective action⁶ How people work together to enact interventions and their components	Collective action - Interactional workability How actors do the work required by interventions and their components	Ensure that the intervention does what it is supposed to do with minimal disruption of other activities	I can easily integrate the [intervention] into my existing work
	Collective action - Relational integration: How does using interventions and their components affect the confidence that actors have in each other?	Foster positive and trusting interactions within the team	The [intervention] disrupts working relationshipsI have confidence in other people’s ability to use the [intervention]
	Collective action – Skill-set workability: How is the work of interventions and their components appropriately allocated to actors	Ensure staff have the skills required for effective implementation	Work is assigned to those with skills appropriate to the [intervention] Sufficient training is provided to enable staff to use the [intervention]
	Collective action – Contextual integration: How is the work of interventions and their components supported by host organizations	Demonstrate organizational commitment and support for interventions	Sufficient resources are available to support the [intervention] Management adequately supports the [intervention]
Reflexive monitoring⁶ How people work together to appraise interventions and their components	Reflexive monitoring – Systematization: How actors access information about the effects of interventions and their components	Deploy systems to track progress and outcomes of the intervention	I am aware of reports about the effects of the [intervention]
	Reflexive Monitoring – Communal appraisal: How actors collectively assess interventions and their components as worthwhile	Create opportunities to continually improve the implementation process	The staff agree that the [intervention] is worthwhile
	Reflexive Monitoring – Individual appraisal: How individual actors assess interventions and their components as worthwhile	Create safe spaces for personal feedback about the implementation process	I value the effects the [intervention] has had on my work
	Reflexive Monitoring – Reconfiguration: How actors modify their work in response to their appraisal of interventions and their components	Revise implementation process based on staff feedback	Feedback about the [intervention] can be used to improve it in the future I can modify how I work with the [intervention]
Implementation outcomes: The practical effects of implementation mechanisms at work		Intervention performance: What practices have changed as the result of interventions and their components being operationalized, enacted, reproduced, over time and across settings	Train staff to understand and contribute to the evaluation process	--
		Relational restructuring: How has working with interventions and their components changed the ways actors are organized and relate to each other	Update team structures to take account of change brought about by the implementation process	--
		Normative restructuring: How has working with interventions and their components changed the norms, rules and resources that govern action?	Update organizational policies and guidelines to take account of changes brought about by the implementation process	--
		Sustainment (normalization): How have interventions and their components become incorporated in practice?	Be clear about how to decide if implementation has been successful, and for whom.	--

Taken together, these tools take NPT beyond a middle-range explanatory theory and enable it to inform practical methodological frameworks for implementation research. By linking theoretical constructs to specific research instruments, NPT tools allow investigators to examine implementation processes systematically across the full trajectory of intervention development, evaluation, and scale-up.

What NPT does not do

It is important that this paper is clear not only about what NPT does, but also what it does not do. NPT is open to challenge for not including individual behavior change, sociotechnical change, and service organization.

NPT does not offer a theory of individual behavior change. For this we can turn to a theory from analytic sociology, by Hedström,⁶¹ or to a theory from cognitive psychology, by Michie et al.⁴⁸ Both operationalize similar but non-equivalent constructs to explain social action and individual behavior. They exist in parallel, as is shown below. Hedström’s DBO-A theory is founded on concepts drawn from sociological rational choice theory and behavioral economics,⁶¹ and Michie et al’s COM-B model synthesizes constructs from cognitive psychological theory.⁴⁸ They are useful conceptual tools and can be linked to collective action theories to explain individual behavior. They complement NPT by explaining the individual-level mechanisms that NPT deliberately brackets, because it focuses on collective action and collaborative work.

NPT does not offer a higher order theory of sociotechnical change. It is concerned with micro-meso-level collective action and collaborative work. In contrast, Geels’ widely used Multi-Level Perspective (MLP),^94–96 conceptualizes large-scale sociotechnical transitions as emerging from dynamic interactions across three levels:

i. Niches, in which radical innovations are developed and protected from mainstream selection pressures.
ii. Regimes, comprising the stable configurations of technology, institutions, practices and actor networks that govern existing systems.
iii. Landscapes, representing slow-moving macro-level conditions that can destabilize incumbent regimes.

Transitions occur when landscape pressures create windows of opportunity for niche innovations to challenge and reconfigure established sociotechnical arrangements. NPT theorizes implementation within existing organizational fields but lacks an account of how macro-level pressures—austerity, digitization, pandemic disruption—shape the conditions under which mechanisms operate. MLP’s niche-regime-landscape architecture could help NPT explain why identical implementation processes succeed in some historical moments and fail in others.

NPT does not offer a dynamic theory of health system change. A powerful theory that performs this function and conceptualizes health systems as institutional configurations shaped by the interplay of three dimensions: money, authority and expertise is offered by Tuohy.^97–99 Different healthcare systems embed a distinctive mix of market, state and professional logics that constrain the possibilities for reform and produce path-dependent patterns of change. Fundamental restructuring is episodic rather than continuous, occurring through politically contingent windows of opportunity whose outcomes are shaped by existing structural arrangements. In relation to this, NPT treats organizational context as shaping implementation but does not attempt to explain why contexts have the structural features they do. Operationalizing Tuohy’s money-authority-expertise framework could enable NPT to explain how macro-level institutional configurations systematically promote or inhibit its mechanisms. This may support comparative analyses of path-dependent implementation success and failure between different healthcare systems.

Conclusion

This paper has presented, for the first time, NPT as a unified theoretical whole. It presents NPT’s propositions, constructs, contextual elaborations, equity commitments, and methodological tools in a single account, makes their relationships explicit. NPT’s propositions show that context conditions shape embedded agency, that implementation work is motivated and shaped by generative mechanisms, and that continuous translational action shapes implementation outcomes. The theory itself provides a rigorous account of the mechanisms that motivate and shape implementation processes, and constructs that describe implementation constructs and outcome. Its Context–Mechanism–Outcome configuration is both a ready-made program theory for realist evaluation and the foundation for a practical framework for intervention design, prospective evaluation, and evidence synthesis. At a critical level, it integrates Patient-Centered Equity Design and the resources of Critical Race Theory to ask whose implementation is being served, at whose expense, and through which mechanisms inequity is produced and reproduced in practice. The paper is also explicit about what we do not claim that NPT explains. It is not a theory of individual behavior change, sociotechnical transition, or health system reform. These are not gaps in its ambition but evidence of its appropriate theoretical scope. NPT is a middle-range theory and these boundaries matter because they are analytically productive. NPT explains the collective and collaborative work through which practices become embedded: it requires complementary theories to explain individual behavior, macro-level transition, and institutional dynamics, and enables researchers to federate these resources rather than expecting any single theory to do work it was not built to do.

Implementation science has shifted in the quarter-century since NPT’s foundations were laid. Its center of gravity has moved from cataloguing barriers and facilitators toward understanding mechanisms, sustainability, and equity. NPT has contributed to that shift, and this consolidation is offered as the platform from which the theory can continue to be tested, challenged, and extended. The questions that motivated its development are not answered by consolidating it. How are new practices routinely incorporated in everyday work? Under what conditions do implementation processes succeed or fail? Who bears the burden of that work, and who benefits from it? These questions have not become less important. The consolidation presented here provides the most complete theoretical and methodological basis yet available for pursuing them.

Ethics approval and consent to participate

Not applicable.

Availability of data and materials

No data are associated with this article.

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Author details Author details

¹ Department of Health Services Research and Policy, London School of Hygiene and Tropical Medicine, London, England, WC1H 9SH,, UK
² School of Healthcare and Nursing Sciences, Northumbria University Department of Health Services Research and Policy, Newcastle upon Tyne, England, NE1 8ST, UK
³ School of Communities and Education, Northumbria University, Newcastle upon Tyne, NE1 8ST, UK

Carl May
Roles: Conceptualization, Formal Analysis, Funding Acquisition, Investigation, Methodology, Project Administration, Writing – Original Draft Preparation

Tracy Finch
Roles: Conceptualization, Formal Analysis, Funding Acquisition, Investigation, Writing – Review & Editing

Tim Rapley
Roles: Conceptualization, Formal Analysis, Funding Acquisition, Investigation, Methodology, Resources, Writing – Review & Editing

Competing interests

The authors have developed NPT.

Grant information

This project is funded by the National Institute for Health and Care Research (NIHR) under NIHR-SD1-0509-10017 (NIHR Senior Investigator Award to CRM), NIHR IS-CLA-0113-10054 (NIHR Wessex CLARHC), NIHR200163 (NIHR North Thames ARC), NIHR200173 (NIHR North-East North Cumbria ARC), and NIHR 202038 (SPHERE Trial). The views expressed are those of the author(s) and not necessarily those of the NIHR or the Department of Health and Social Care.
The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.

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May C, Finch T and Rapley T. Normalisation Process Theory: Its consolidation and application in implementation research and practice [version 1; peer review: awaiting peer review]. NIHR Open Res 2026, 6:79 (https://doi.org/10.3310/nihropenres.14315.1)

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[1] 1. May C, Rapley T, Finch T: Normalization Process Theory.Nilsen P, Birken S, editors. International Handbook of Implementation Science. London: Edward Elgar; 2020; 144–167.

[2] 2. May C, Harrison R, Finch T, et al.: Understanding the normalization of telemedicine services through qualitative evaluation. Journal of the American Medical Informatics Association. 2003; 10(6): 596–604. PubMed Abstract | Publisher Full Text | Free Full Text

[3] 3. May C, Mort M, Williams T, et al.: Health technology assessment in its local contexts: studies of telehealthcare. Social Science & Medicine. 2003; 57(4): 697–710. Publisher Full Text

[4] 4. May CR, Harrison R, MacFarlane A, et al.: Why do telemedicine systems fail to normalize as stable models of service delivery?. J Telemed Telecare. 2003; 9(1): 25–26. Publisher Full Text

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Normalisation Process Theory: Its consolidation and application in implementation research and practice

Abstract

Background

Methods

Results

Conclusions

Plain Language Summary

Keywords

Introduction

Patient and public involvement

The place of NPT in implementation science

NPT as framework, model, and theory

The structure of NPT

The core of implementation work

Contexts and outcomes in implementation processes

Strategic Intentions change contexts

Implementation outcomes represent re-contextualization

NPT and the problem of equity

Using NPT to analyse implementation: A worked example

Table 1. Worked example of NPT analysis - comparison of the MOVE and WISE Trials.

Using NPT Tools in Implementation Research

Table 2. NPT core constructs, implementation strategies, and NoMAD survey questions.

What NPT does not do

Conclusion

Ethics approval and consent to participate

Availability of data and materials

References

Comments on this article Comments (0)

Open Peer Review

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Reviewer Status

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Normalisation Process Theory: Its consolidation and application in implementation research and practice

Abstract

Background

Methods

Results

Conclusions

Plain Language Summary

Keywords

Introduction

Patient and public involvement

The place of NPT in implementation science

NPT as framework, model, and theory

The structure of NPT

The core of implementation work

Contexts and outcomes in implementation processes

Strategic Intentions change contexts

Implementation outcomes represent re-contextualization

NPT and the problem of equity

Using NPT to analyse implementation: A worked example

Table 1. Worked example of NPT analysis - comparison of the MOVE and WISE Trials.

Using NPT Tools in Implementation Research

Table 2. NPT core constructs, implementation strategies, and NoMAD survey questions.

What NPT does not do

Conclusion

Ethics approval and consent to participate

Availability of data and materials

References

Comments on this article Comments (0)

Open Peer Review

Comments on this article Comments (0)

Open Peer Review

Reviewer Status

Comments on this article

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Are you an NIHR-funded researcher?

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