Abstract

BackgroundThere is little systematic operational guidance about how best to develop complex interventions to reduce the gap between practice and evidence. This article is one in a Series of articles documenting the development and use of the Theoretical Domains Framework (TDF) to advance the science of implementation research.MethodsThe intervention was developed considering three main components: theory, evidence, and practical issues. We used a four-step approach, consisting of guiding questions, to direct the choice of the most appropriate components of an implementation intervention: Who needs to do what, differently? Using a theoretical framework, which barriers and enablers need to be addressed? Which intervention components (behaviour change techniques and mode(s) of delivery) could overcome the modifiable barriers and enhance the enablers? And how can behaviour change be measured and understood?ResultsA complex implementation intervention was designed that aimed to improve acute low back pain management in primary care. We used the TDF to identify the barriers and enablers to the uptake of evidence into practice and to guide the choice of intervention components. These components were then combined into a cohesive intervention. The intervention was delivered via two facilitated interactive small group workshops. We also produced a DVD to distribute to all participants in the intervention group. We chose outcome measures in order to assess the mediating mechanisms of behaviour change.ConclusionsWe have illustrated a four-step systematic method for developing an intervention designed to change clinical practice based on a theoretical framework. The method of development provides a systematic framework that could be used by others developing complex implementation interventions. While this framework should be iteratively adjusted and refined to suit other contexts and settings, we believe that the four-step process should be maintained as the primary framework to guide researchers through a comprehensive intervention development process.

Highlights

  • There is little systematic operational guidance about how best to develop complex interventions to reduce the gap between practice and evidence

  • The UK Medical Research Council’s (MRC) guidance for developing complex interventions informed by theory [10,11,12,13] is useful as a general approach to designing an implementation intervention, but it does not provide detailed guidance about how to achieve this

  • We have illustrated a four-step systematic method for developing an intervention designed to change clinician behaviour based on a theoretical framework

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Summary

Introduction

There is little systematic operational guidance about how best to develop complex interventions to reduce the gap between practice and evidence. Implementation interventions have had limited and varied effects [2]. This may be due, in part, to a lack of explicit rationale for the intervention choice and the use of inappropriate methods to design the interventions [3,4,5]. The design of implementation interventions requires a systematic approach with a strong rationale for design and explicit reporting of the intervention development process [6,7,8]. The UK Medical Research Council’s (MRC) guidance for developing complex interventions informed by theory [10,11,12,13] is useful as a general approach to designing an implementation intervention, but it does not provide detailed guidance about how to achieve this

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