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Care pathway implementation is characterised by a dual complexity. A care pathway itself represents a complex intervention with multiple interacting and interdependent intervention components and outcomes. The organisations in which care pathways are being implemented represent complex systems that need to be directed at change through an in-depth understanding of their external and internal context in which they are functioning in. This study sets out a new evidence-based and pragmatic framework that unpacks how intervention mechanisms, intervention fidelity and care context are converge and represent interacting processes that determine success or failure of the care pathway. We recommend researchers looking to increase the effectiveness of care pathway implementation and accelerate improvement of desired outcomes to adopt this framework from inception to implementation of the intervention. [ABSTRACT FROM AUTHOR]

Background: Specific factors that facilitate or prevent the implementation of enhanced recovery protocols for colorectal cancer surgery have been described in previous qualitative studies. This study aims to perform a concurrent qualitative and quantitative evaluation of factors associated with successful implementation of a care pathway (CP) for patients undergoing surgery for colorectal cancer., Methods: This comparative mixed methods multiple case study was based on a sample of 10 hospitals in 4 European countries that implemented a specific CP and performed pre- and post-implementation measurements. In-depth post-implementation interviews were conducted with healthcare professionals who were directly involved. Primary outcomes included protocol adherence and improvement rate. Secondary outcomes included length of stay (LOS) and self-rated protocol adherence. The hospitals were ranked based on these quantitative findings, and those with the highest and lowest scores were included in this study. Qualitative data were summarized on a per-case basis using extended Normalization Process Theory (eNPT) as theoretical framework. The data were then combined and analyzed using joint display methodology., Results: Data from 381 patients and 30 healthcare professionals were included. Mean protocol adherence rate increased from 56 to 62% and mean LOS decreased by 2.1 days. Both measures varied greatly between hospitals. The two highest-ranking hospitals and the three lowest-ranking hospitals were included as cases. Factors which could explain the differences in pre- and post-implementation performance included the degree to which the CP was integrated into daily practice, the level of experience and support for CP methodology provided to the improvement team, the intrinsic motivation of the team, shared goals and the degree of management support, alignment of CP development and hospital strategy, and participation of relevant disciplines, most notably, physicians., Conclusions: Overall improvement was achieved but was highly variable among the 5 hospitals evaluated. Specific factors involved in the implementation process that may be contributing to these differences were conceptualized using eNPT. Multidisciplinary teams intending to implement a CP should invest in shared goals and teamwork and focus on integration of the CP into daily processes. Support from hospital management directed specifically at quality improvement including audit may likewise facilitate the implementation process., Trial Registration: NCT02965794 . US National Library of Medicine, ClinicalTrials.gov . Registered 4 August 2014.

Adherence to evidence-based recommendations is variable and generally low. This is also followed in colorectal surgery, despite the availability of the ERAS ® protocol. The aim of the study was to evaluate the effect of implementing a care pathway for perioperative care in colorectal cancer surgery on outcomes and protocol adherence. So, we performed an international pre-test-post-test multicenter study, performed in ten hospitals in four European countries. The measures used included length of stay, morbidity and mortality, and documentation and adherence on intervention and patient level. Unadjusted pre-test-post-test differences were analyzed following an analysis adjusted for patient-mix variables. Importance-performance analysis was used to map the relationship between importance and performance of individual interventions. In total, 381 patients were included. Length of stay decreased from 12.6 to 10.7 days (p = 0.0230). Time to normal diet and walking also decreased significantly. Protocol adherence improved from 56 to 62% (p < 0.00001). Adherence to individual interventions remained highly variable. Importance-performance analysis showed 30 interventions were scored as important, of which 19 had an adherence < 70%, showing priorities for improvement. Across hospitals, change in protocol adherence ranged from a 13% decrease to a 22% increase. Implementing a care pathway for colorectal cancer surgery reduced length of stay, time to normal diet and walking. Documentation and protocol adherence improved after implementing the care pathway. However, not in all participating hospitals protocol adherence improved. Only in 25% of patients, protocol adherence of ≥ 70% was achieved, suggesting a large group is at risk for underuse. Importance-performance analysis showed which interventions are important, but have low adherence, prioritizing improvement efforts.

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.