The document introduces Normalization Process Theory (NPT), a conceptual model for evaluating the implementation and integration of new health technologies and complex interventions. NPT focuses on the work done by individuals and groups to embed interventions in practice. The NPT Toolkit provides managers, clinicians and researchers with a simplified framework based on NPT to assess implementation processes. It includes questions related to coherence, participation, action and appraisal, and allows users to gauge these implementation factors using a visual interface. The toolkit is meant as an aid for critical thinking, not a validated measurement instrument.

1. A toolkit for evaluating health technologies and complex interventions using Normalization Process Theory Carl May, Tracy Finch, Luciana Ballini, Anne MacFarlane, Elizabeth Murray, Frances Mair, Shaun Treweek, Tim Rapley www.normalizationprocess.org © The authors 2010/ contact berg206@gmail.com

2. this presentation introduces basic concepts of Normalization Process Theory (NPT) and the NPT Toolkit purpose of the NPT toolkit is to provide managers, clinicians and researchers with a robust conceptual model of implementation and integration processes around new health technologies and complex interventions

3. quick introduction to NPT

4. normalization process theory explains factors that promote and inhibit implementation , and explains how complex interventions in health care become embedded and integrated in practice

5. theory lite? theories are abstract and need to be translated for everyday users constructs and components of NPT can be translated into simple statements for managers, clinicians, and researchers simplified statements are heuristic devices to think through implementation problems, not to measure them

6. what is a complex intervention? a complex intervention is any deliberately initiated attempt to introduce new, or modify existing, patterns of collective action in health care or some other formal organizational setting. deliberate initiation means that an intervention is: institutionally sanctioned; formally defined; consciously planned; and intended to lead to a changed outcome . initiators of a complex intervention may seek to modify the ways that people think, act and organize themselves in health care , or they may seek to initiate a process with the intention of creating a new outcome.

7. complex interventions elements of complex interventions directed at actors often seek to change behaviour and its intended outcomes (e.g. strategies for making ‘expert patients’; or new professional roles) elements of complex interventions aimed at objects often seek to change expertise and actions ( e.g. novel therapeutic agents and medical devices; or decision-making tools and clinical guidelines) elements of complex interventions aimed at contexts often to seek to change the procedures enacted to achieve goals. (e.g. digital delivery, or organisational structures) most complex interventions engage with multiple actors, objects, and contexts simultaneously

8. normalization process theory explains how interventions become routinely embedded in their contexts explains routine embedding by reference to four mechanisms (coherence; cognitive participation; collective action; reflexive monitoring). explains how the work, (individually and collective), of implementing interventions requires investment in action.

9. four constructs of NPT reflexive Monitoring : defines and organizes assessment of the outcomes of a practice cognitive Participation : defines and organizes the people implicated in a complex intervention collective Action : defines and organizes the enacting of a practice coherence : defines and organizes the components of a practice

10. normalization process theory focuses on the work that people do processes of individual and communal coherence and sense making. processes of cognitive participation . processes of collective action . processes of individual and communal reflexive monitoring .

11. it’s all about the work what is the work? who does the work? how does the work get get done? why did the work happen like that?

12. quick introduction to the NPT toolkit

13. www.normalizationprocess.org is an on-line resource to help clinicians, managers, and researchers think through problems of implementation, embedding, and integration is not a validated survey instrument is a resource that can be used when planning or appraising the implementation and integration of a new technology or complex intervention

14. www.normalizationprocess.org provides clinicians, managers, and researchers with a toolkit to think through key issues around implementation, embedding, and integration

15. components of coherence work differentiation defines an [intervention] and organises its relationships with other practices and contexts; communal specification or co-ordination forms and organises shared beliefs and knowledge about the purpose of the [intervention]; individual specification forms and organises personal beliefs and knowledge about the demands of the [intervention]; internalization defines the value of the [intervention] to its users.

16. toolkit items assessing coherence work [participants] distinguish the [intervention] from current ways of working [participants] collectively agree the purpose of the [intervention] [participants] individually understand what the [intervention] requires of them? [participants] construct potential value of the [intervention] for their work

17. toolkit users can use slide-bars to begin to work through their subjective assessment of coherence work

18. components of participation work initiation brings an [intervention] into practice; legitimation forms and organises shared beliefs about the legitimacy of participating in the [intervention]; enrolment forms and organises the ways that participants join in the [intervention] activation forms and organises the ways that participants continue to support the [intervention]

19. toolkit items assessing participation work [participants] work to initiate the [intervention] [participants] agree that the [intervention] is a legitimate part of their work [participants] join in delivering the [intervention] [participants] continue supporting the [intervention]

20. toolkit users can use slide-bars to begin to work through their subjective assessment of participation work

21. components of collective action skill-set work of allocation and performance of the tasks related to an [intervention]; relational integration in which confidence and accountability of an [intervention] are formed and organised; interactional work in which the [intervention] is a vehicle for deciding and disposing of operational problems; contextual integration in which material and interpersonal resources are realised and policies and procedures executed to support the [intervention].

22. toolkit items assessing enacting work [participants] perform the tasks required by the [intervention] [participants] maintain trust in each others’ work and expertise through the [intervention] the work of the [intervention] is allocated appropriately to [participants] the [intervention] is supported adequately by its host organization

23. toolkit users can use slide-bars to begin to work through their subjective assessment of collective action

24. components of appraisal work systematizing forms and organises knowledge about the effects of the [intervention] communal appraisal people work together to assess whether the effects of the [intervention] are worthwhile for others individual appraisal people assess whether the effects of an [intervention] are worthwhile for themselves reconfiguration organizes changes in the ways that the [intervention] is enacted

25. questions assessing appraisal work [participants] access information about the effects of the [intervention] [participants] collectively appraise the [intervention] as worthwhile for others [participants] individually appraise the [intervention] as worthwhile for themselves [participants] modify their work in response to their appraisal of the [intervention]

26. toolkit users can use slide-bars to begin to work through their subjective assessment of monitoring work

27. interpreting results interpreting the report reports consist of a primary graph that represents all 16 items, and four graphs that describe responses for each of the theory's four constructs. to properly interpret graphic results users need to familiarize themselves with the core constructs of NPT. health warning the toolkit is not a scientific instrument. The bars do not provide objective scores for variables. they are heuristic tools to think through an implementation or integration process. instruments to measure NPT constructs need to be constructed using a different set of techniques.

28. the results page provides a global picture of implementation work in relation to NPT

29. the results page provides specific feedback on implementation and embedding – relating these to the four constructs of NPT

30. www.normalizationprocess.org NPT focuses attention on factors already empirically demonstrated to be important in promoting or inhibiting implementation, embedding, and integration of complex interventions the toolkit provides a simplified version of NPT suitable for use as an aid to critical thinking

31. key papers May C, Finch T. Implementation, embedding, and integration: an outline of Normalization Process Theory . Sociology 2009; 43:535-54. Available here May C, et al . Development of a theory of implementation and integration: Normalization Process Theory . Implementation Science 2009; art4. Available here .

32. normalization process theory This work was supported by the UK Economic and Social Research Council (Grant 189250003) .

33. Carl May Professor of Healthcare Innovation Faculty of Health Sciences University of Southampton Southampton, UK [email_address]