Protocol for the process evaluation of a complex intervention designed to increase the use of research in health policy and program organisations (the SPIRIT study)

This protocol provides a worked example of how to embed process evaluation in the design and evaluation of a complex intervention trial. It tackles complexity in the intervention and its implementation settings. To our knowledge, it is the only detailed example of the methods for a process evaluation of an intervention conducted as part of a randomised trial in policy organisations. We identify strengths and weaknesses, and discuss how the methods are functioning during early implementation. Using 'insider' consultation to develop methods is enabling us to optimise data collection while minimising discomfort and burden for participants. Embedding the process evaluation within the trial design is facilitating access to data, but may impair participants' willingness to talk openly in interviews. While it is challenging to evaluate the process of conducting a randomised trial of a complex intervention, our experience so far suggests that it is feasible and can add considerably to the knowledge generated.