Understanding the implementation of complex interventions in health care: the normalization process model
Open accessAbstract
Background: The Normalization Process Model is a theoretical model that assists in explaining the processes by which complex interventions become routinely embedded in health care practice. It offers a framework for process evaluation and also for comparative studies of complex interventions. It focuses on the factors that promote or inhibit the routine embedding of complex interventions in health care practice. Methods: A formal theory structure is used to define the model, and its internal causal relations and mechanisms. The model is broken down to show that it is consistent and adequate in generating accurate description, systematic explanation, and the production of rational knowledge claims about the workability and integration of complex interventions. Results: The model explains the normalization of complex interventions by reference to four factors demonstrated to promote or inhibit the operationalization and embedding of complex interventions (interactional workability, relational integration, skill-set workability, and contextual integration). Conclusion: The model is consistent and adequate. Repeated calls for theoretically sound process evaluations in randomized controlled trials of complex interventions, and policy-makers who call for a proper understanding of implementation processes, emphasize the value of conceptual tools like the Normalization Process Model.
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The development of NPT first involved the iterative development of a robust generic theory of implementation.
“The development of NPT first involved the iterative development of a robust generic theory of implementation [5–9, 11, 12].”
From Using Normalization Process Theory in feasibility studies and process evaluations of complex healthcare interventions: a systematic review (2018) · cites this paper as [6]
The Background describes successive development of the Normalization Process Model from empirical studies into a robust applied theory. But the Conclusion explicitly says the model is not a general theory: its scope is the implementation of complex interventions in healthcare, so this paper does not support calling it a generic theory of implementation. (LLM, conf=0.86)
Experimental — accuracy not yet measuredNormalization Process Theory (NPT) identifies, characterises and explains key mechanisms that promote and inhibit the implementation, embedding and integration of new health techniques, technologies and other complex interventions.
“Normalization Process Theory (NPT) identifies, characterises and explains key mechanisms that promote and inhibit the implementation, embedding and integration of new health techniques, technologies and other complex interventions.”
From Using Normalization Process Theory in feasibility studies and process evaluations of complex healthcare interventions: a systematic review (2018) · cites this paper as [6]
The Background and Abstract Results sections say the Normalization Process Model identifies factors that promote or inhibit implementation and explains how complex interventions become embedded in health care practice. The cited paper calls this the Normalization Process Model, not Normalization Process Theory (NPT), and describes its scope as complex interventions in health care rather than the broader formulation in the claim. The copy provides no page numbers. (LLM, conf=0.88)
Experimental — accuracy not yet measuredNPT has been built up from studies of practice in many different healthcare systems.
“NPT is a theory of implementation that focuses on what people—both individuals and groups—do rather than what they believe or intend, and it has been built up from studies of practice in many different healthcare systems.”
From Using Normalization Process Theory in feasibility studies and process evaluations of complex healthcare interventions: a systematic review (2018) · cites this paper as [6]
The Background says the model was derived from empirical studies, supporting the claim that it was built up from studies of practice. It does not say those studies took place in many different healthcare systems, so that scope is unsupported by this paper. (LLM, conf=0.84)
Experimental — accuracy not yet measuredTheories are conceptual toolkits that can be used flexibly to deal with practical problems.
“we have argued that theories are conceptual toolkits that can be used flexibly to deal with practical problems.”
From Using Normalization Process Theory in feasibility studies and process evaluations of complex healthcare interventions: a systematic review (2018) · cites this paper as [6]
The Conclusion describes applied theories as tools for description, explanation and investigation, and presents the model as a practical tool. It also says such tools must be used within defined limits; it does not support an unqualified claim that theories can be used flexibly across practical problems. The indexed passages provide no page numbers. (LLM, conf=0.82)
Experimental — accuracy not yet measuredDesigning specific interventions for different under-represented groups through a common framework may improve the subsequent uptake in services.
“Designing specific interventions for different under-represented groups through a common framework may improve the subsequent uptake in services [14].”
From Development and evaluation of culturally sensitive psychosocial interventions for under-served people in primary care (2014) · cites this paper as [14]
The Background (page not provided) describes a common framework for identifying factors that promote or inhibit implementation and for assessing whether an intervention will become routine in health care practice. It does not address designing interventions for different under-represented groups or show that doing so improves service uptake. (LLM, conf=0.84)
Experimental — accuracy not yet measured
NPT is a theory of implementation that focuses on what people-both individuals and groups-do rather than what they believe or intend.
“NPT is a theory of implementation that focuses on what people—both individuals and groups—do rather than what they believe or intend, and it has been built up from studies of practice in many different healthcare systems.”
From Using Normalization Process Theory in feasibility studies and process evaluations of complex healthcare interventions: a systematic review (2018) · cites this paper as [6]
In the first iteration of NPT (the Normalization Process Model), collective action is important in routinely incorporating complex interventions into everyday practice.
“In the first iteration of the theory—the Normalization Process Model (NPM) [5, 6]—we identified the importance of collective action in routinely incorporating complex interventions into everyday practice.”
From Using Normalization Process Theory in feasibility studies and process evaluations of complex healthcare interventions: a systematic review (2018) · cites this paper as [6]
Collective action was organised around interactions between users and the properties of intervention components.
“We showed how collective action was organised around interactions between users and the properties of intervention components.”
From Using Normalization Process Theory in feasibility studies and process evaluations of complex healthcare interventions: a systematic review (2018) · cites this paper as [6]
None of implementation takes place in a vacuum, and all of it is negotiated in diverse contexts.
“As we have pointed out [22, 23, 27], none of these takes place in a vacuum, and all of it is negotiated in diverse contexts.”
From Implementation, context and complexity (2016) · cites this paper as [22]
The precursor to NPT, the normalization process model (NPM), originated from a large body of work on eHealth and was developed to explain the observation that many eHealth initiatives failed to embed into routine practice.
“The precursor to NPT, normalization process model (NPM), originated from a large body of work on eHealth and was developed to explain the observation that many eHealth initiatives failed to embed into routine practice [112,113].”
From Web-Based Interventions for Behavior Change and Self-Management: Potential, Pitfalls, and Progress (2012) · cites this paper as [112]
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- Authors
- May, C., Finch, T., Mair, F., Ballini, L., Dowrick, C., Eccles, M., Gask, L., MacFarlane, A., Murray, E., Rapley, T., Rogers, A., Treweek, S., Wallace, P., Anderson, G., Burns, J., & Heaven, B.
- Affiliations
- Newcastle University (GB)
- University of Glasgow (GB)
- Agenzia Sanitaria e Sociale Regionale (IT)
- University of Liverpool (GB)
- University of Manchester (GB)
- Ollscoil na Gaillimhe – University of Galway (IE)
- The Royal Free Hospital (GB)
- University of Dundee (GB)
- Corresponding author
- May, Carl
- ORCID
- Venue
- BMC Health Services Research
- Published
- 2007-09-19
- Volume
- 7
- Issue
- 1
- Pages
- 148-148
- ISSN
- 1472-6963 (ISSN-L)
- PMC
- PMC2089069
- OpenAlex
- W2122402281
- Cited by
- 768
- References
- 25
- Citations by year
- 2026: 20 · 2025: 43 · 2024: 67 · 2023: 53 · 2022: 57 · 2021: 67 · 2020: 107 · 2019: 39 · 2018: 41 · 2017: 41 · 2016: 40 · 2015: 35 · 2014: 38 · 2013: 25 · 2012: 28
- FWCI
- 23.04
- Type
- journal article
- Language
- en
- Open access
- gold
- doi.org
- Locations
- BMC Health Services Research (publishedVersion, cc-by)
- PubMed Central (publishedVersion, cc-by)
- PubMed (publishedVersion)
- Research Explorer (The University of Manchester) (publishedVersion)
- ePrints Soton (University of Southampton) (acceptedVersion)
- Northumbria Research Link (Northumbria University) (acceptedVersion)
- LSHTM Research Online (London School of Hygiene and Tropical Medicine) (acceptedVersion)
- BIBSYS Brage (BIBSYS (Norway)) (submittedVersion)
- DOAJ (DOAJ: Directory of Open Access Journals) (submittedVersion, cc-by-sa)
- ENLIGHTEN (Jurnal Bimbingan dan Konseling Islam) (submittedVersion)
- UCL Discovery (University College London) (submittedVersion)
- NORA - Norwegian Open Research Archives (submittedVersion, other-oa)
- Newcastle University ePrints (Newcastle Univesity)
- Funders
- National Institute for Health and Care Research
- European Commission
- Economic and Social Research Council
- Health Technology Assessment Programme
- Topics
- Health Sciences › Health Professions › General Health Professions › Health Policy Implementation Science
- Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Clinical practice guidelines implementation
- Social Sciences › Decision Sciences › Management Science and Operations Research › Evaluation and Performance Assessment
- Keywords
- complex interventions, intervention implementation, process evaluation, relational integration, contextual integration, health care practices, causal mechanisms
- MeSH terms
- Humans, Models, Theoretical, Practice Patterns, Physicians', Randomized Controlled Trials as Topic, Evidence-Based Medicine, Guideline Adherence
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