Abstract
BackgroundThe 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).DiscussionIn 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.SummaryThe 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.
Highlights
The past decade has seen considerable interest in the development and evaluation of complex interventions to improve health
We argue that the implementation and sustainability of interventions can be considered from the very beginning of their development and evaluation by using Normalisation Process Theory (NPT)
Use of NPT to develop a complex intervention Define the context efficacious an intervention is shown to be in an experimental environment, its long-term impact depends both on its effectiveness in the “real world” and on how widely it is implemented
Summary
It is important to distinguish clearly between the intervention (which would continue if it were subsequently implemented) and the evaluation of the intervention (which would not continue). Using NPT within ImPACT emphasised the importance of understanding the varied contexts of primary care (e.g., number of partners, communication between GPs, models of team working, use of guidelines), how to gain participation (e.g., through the use of champions) and maintain this (e.g., through peer support), highlighting the potential benefits of participation in the trial and the ‘fit’ with routine practice Such insights were subsequently used in the design of another large implementation study. NPT will not solve these problems, but it can help to identify how links between participants may be affected by the intervention and how the intervention might be modified to support these interactions This is, we believe, a clear strength of NPT compared to other approaches to implementation, which tend to focus principally on the needs of one professional group or level at a time, with less consideration given to the wider system issues. We consider that NPT is a strong candidate framework and encourage trialists, both those designing trials of complex interventions and those designing clinical trials, to consider using it in their trial
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