ABSTRACT
Background and aim: Care pathways are complex interventions, consisting of multiple 'active ingredients', to structure care processes around patient needs. Numerous studies have reported improved outcomes after implementation of care pathways. The structure-process-outcome framework and the context-mechanism-outcome framework both suggest that outcomes can only be achieved through a certain process within a context or structure. To understand how and why care pathways are effective, understanding of both this process and context is necessary. The aim of this article is to propose a study protocol to evaluate the implementation process of evidence-based care pathways, including the influence of the context. This protocol is explained by applying it to the implementation of a colorectal cancer surgery pathway in an international setting.
Methods: The Medical Research Council (MRC) guidance on process evaluations for complex interventions is used as the basis for the protocol. The key components of process evaluation are intervention, context, implementation, mechanisms of impact and outcomes. In process evaluations, these components are studied using quantitative and qualitative methods. Among them are patient record analysis, questionnaires, on-site visits and interviews.
Discussion: To guide our methodological choices, the MRC guidance for process evaluations of complex interventions, and published protocols for process evaluations of complex interventions were used. Our protocol is now tailored for the process evaluation of evidence-based care pathways and provides researchers and clinicians methods and tools, as well as a worked example, that can be used to study the process of care pathway implementation. As a result, healthcare professionals will be informed on context factors and implementation processes that can facilitate the implementation of care pathways, improving quality and effectiveness of care processes.