Normalisation process theory: a framework for developing, evaluating and implementing complex interventions
Open accessAbstract
BACKGROUND: The past decade has seen considerable interest in the development and evaluation of complex interventions to improve health. Such interventions can only have a significant impact on health and health care if they are shown to be effective when tested, are capable of being widely implemented and can be normalised into routine practice. To date, there is still a problematic gap between research and implementation. The Normalisation Process Theory (NPT) addresses the factors needed for successful implementation and integration of interventions into routine work (normalisation). DISCUSSION: In this paper, we suggest that the NPT can act as a sensitising tool, enabling researchers to think through issues of implementation while designing a complex intervention and its evaluation. The need to ensure trial procedures that are feasible and compatible with clinical practice is not limited to trials of complex interventions, and NPT may improve trial design by highlighting potential problems with recruitment or data collection, as well as ensuring the intervention has good implementation potential. SUMMARY: The NPT is a new theory which offers trialists a consistent framework that can be used to describe, assess and enhance implementation potential. We encourage trialists to consider using it in their next trial.
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Tools were developed to assist implementation practitioners and researchers in thinking through and measuring important elements of implementation processes.
“From this, tools were developed to assist implementation practitioners and researchers [13–16] in thinking through and measuring important elements of implementation processes.”
From Using Normalization Process Theory in feasibility studies and process evaluations of complex healthcare interventions: a systematic review (2018) · cites this paper as [13]
The Abstract (page unavailable) describes NPT as a sensitising tool that helps researchers think through implementation issues, and the Summary says it can be used to assess implementation potential. The cited paper does not describe a tool for measuring elements of implementation processes or say that such measurement tools were developed. (LLM, conf=0.83)
Experimental — accuracy not yet measuredNPT has been developed from qualitative research and identifies four key processes that underlie the adoption of new interventions: coherence of intervention, cognitive participation, collective action, and reflexive monitoring.
“The theory has been developed from qualitative research and identifies four key processes that underlie the adoption of new interventions (coherence of intervention; cognitive participation; collective action; reflexive monitoring).”
From Study protocol for the Multimodal Approach to Preventing Suicide in Schools (MAPSS) project: A regionally based feasibility trial of an integrated response to suicide risk among UK secondary school pupils (2024) · cites this paper as [38]
The Normalisation Process Theory section identifies the four named components and links them to the work of incorporating interventions into routine practice. Our copy does not say that NPT was developed from qualitative research; its discussion of qualitative methods in the Complex interventions section concerns intervention research generally, not NPT’s origins. (LLM, conf=0.86)
Experimental — accuracy not yet measuredPrevious research has shown that NPT can be applied effectively to qualitative data in healthcare contexts and, more recently, in school-based research.
“Previous research has shown that NPT can be applied effectively to qualitative data in healthcare contexts and, more recently, in school-based research [38, 40, 41].”
From Study protocol for the Multimodal Approach to Preventing Suicide in Schools (MAPSS) project: A regionally based feasibility trial of an integrated response to suicide risk among UK secondary school pupils (2024) · cites this paper as [38]
In “Undertake an NPT analysis of the intervention” (page unavailable), the paper describes using NPT in a primary-care study and identifies observation and interviews as possible data sources. This supports the healthcare portion of the claim, but the paper does not report applying NPT to school-based research. (LLM, conf=0.84)
Experimental — accuracy not yet measuredNormalisation Process Theory (NPT) provides a framework for understanding the barriers and facilitating processes that underlie the implementation and integration of complex interventions into systems.
“NPT provides a framework for understanding the barriers and facilitating processes that underlie the implementation and integration of complex interventions into systems.”
The method of obtaining CYP assent by ticking a box at the beginning of the survey has been used successfully in previous trials by the Principal Investigators, in the pilot study, and is recommended in good practice guidance.
“This method has been used successfully in previous trials by the Principal Investigators, in the pilot study, and is recommended in good practice guidance.38”
From Study protocol for the Multimodal Approach to Preventing Suicide in Schools (MAPSS) project: A regionally based feasibility trial of an integrated response to suicide risk among UK secondary school pupils (2024) · cites this paper as [38]
The Cognitive participation section discusses simplifying an informed-consent process in a primary-care trial, but does not describe CYP assent by ticking a survey box. Searches for that method and for good-practice guidance found no passage addressing its use in the investigators’ previous trials or pilot study. (LLM, conf=0.76)
Experimental — accuracy not yet measured
Alternative approaches to CHI optimisation include strategies proposed by the MRC framework 2000 and 2008, the normalisation process theory (NPT) and the process modelling in implementation research (PRIME) approach.
“Alternative approaches to CHI optimisation include strategies proposed by the MRC framework 2000 [1] and 2008 [3], the normalisation process theory (NPT) [11, 12] and the process modelling in implementation research (PRIME) approach [13].”
From Optimisation of complex health interventions prior to a randomised controlled trial: a scoping review of strategies used (2016) · cites this paper as [12]
These findings suggest the need for closer proximity between innovation design and evaluation, so that critical insights might usefully feed back into design and implementation, ensuring interventions are 'minimally disruptive' for recipients.
“Additionally, these findings suggest the need for closer proximity between innovation design and evaluation, so that critical insights might usefully feed back into design and implementation [11,13] ensuring interventions are ‘minimally disruptive’ for recipients [42].”
From Exploring barriers to participation and adoption of telehealth and telecare within the Whole System Demonstrator trial: a qualitative study (2012) · cites this paper as [11]
The MRC framework has been highly influential, with many additional publications on applying, extending, and revising the framework.
“It has been highly influential, with many additional publications on applying, extending, and revising the framework [92-94].”
From Web-Based Interventions for Behavior Change and Self-Management: Potential, Pitfalls, and Progress (2012) · cites this paper as [94]
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- Authors
- Murray, E., Treweek, S., Pope, C., MacFarlane, A., Ballini, L., Dowrick, C., Finch, T., Kennedy, A., Mair, F., O'Donnell, C., Ong, B. N., Rapley, T., Rogers, A., & May, C.
- Affiliations
- The Royal Free Hospital (GB)
- University of Dundee (GB)
- University of Southampton (GB)
- National University of Ireland (IE)
- Agenzia Sanitaria e Sociale Regionale (IT)
- University of Liverpool (GB)
- Newcastle University (GB)
- University of Manchester (GB)
- University of Glasgow (GB)
- Keele University (GB)
- Corresponding author
- Murray, Elizabeth
- ORCID
- Venue
- BMC Medicine
- Published
- 2010-10-20
- Volume
- 8
- Issue
- 1
- Pages
- 63-63
- ISSN
- 1741-7015 (ISSN-L)
- PMC
- PMC2978112
- OpenAlex
- W2144185507
- Cited by
- 1,478
- References
- 35
- Citations by year
- 2026: 141 · 2025: 155 · 2024: 205 · 2023: 143 · 2022: 128 · 2021: 147 · 2020: 188 · 2019: 64 · 2018: 68 · 2017: 62 · 2016: 61 · 2015: 39 · 2014: 29 · 2013: 18 · 2012: 20
- FWCI
- 26.76
- Type
- journal article
- Language
- en
- Open access
- gold
- doi.org
- Licence
- Locations
- BMC Medicine (publishedVersion, cc-by)
- PubMed Central (publishedVersion, cc-by)
- PubMed (publishedVersion)
- Discovery Research Portal (University of Dundee) (acceptedVersion, cc-by)
- Arrow@dit (Dublin Institute of Technology) (acceptedVersion)
- LSHTM Research Online (London School of Hygiene and Tropical Medicine) (acceptedVersion)
- Aberdeen University Research Archive (Aberdeen University) (submittedVersion)
- Northumbria Research Link (Northumbria University) (submittedVersion)
- Research Explorer (The University of Manchester) (submittedVersion, cc-by)
- Arrow@dit (Dublin Institute of Technology) (submittedVersion)
- ARAN (University of Galway Research Repository) (Ollscoil na Gaillimhe – University of Galway) (submittedVersion, cc-by-nc-nd)
- DOAJ (DOAJ: Directory of Open Access Journals) (submittedVersion, cc-by-sa)
- ePrints Soton (University of Southampton) (submittedVersion)
- UCL Discovery (University College London) (submittedVersion)
- University of Limerick Institutional Repository (University of Limerick) (submittedVersion, cc-by-nc-sa)
- Lenus, The Irish Health Repository (Dr Steevens Hospital Library) (submittedVersion)
- Newcastle University ePrints (Newcastle Univesity) (cc-by)
- Funders
- National Institute for Health and Care Research (RP-PG-0407-10386)
- NIHR School for Primary Care Research
- 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 › Sociology and Political Science › Delphi Technique in Research
- Keywords
- Normalisation Process Theory, complex interventions, implementation potential, research-practice gap, trial design, implementation research, intervention development, healthcare implementation
- MeSH terms
- Clinical Trials as Topic, Humans, Models, Theoretical, Planning Techniques, Research Design, Evidence-Based Medicine
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