Abstract

BackgroundOptimization of the clinical care process by integration of evidence-based knowledge is one of the active components in care pathways. When studying the impact of a care pathway by using a cluster-randomized design, standardization of the care pathway intervention is crucial. This methodology paper describes the development of the clinical content of an evidence-based care pathway for in-hospital management of chronic obstructive pulmonary disease (COPD) exacerbation in the context of a cluster-randomized controlled trial (cRCT) on care pathway effectiveness.MethodsThe clinical content of a care pathway for COPD exacerbation was developed based on recognized process design and guideline development methods. Subsequently, based on the COPD case study, a generalized eight-step method was designed to support the development of the clinical content of an evidence-based care pathway.ResultsA set of 38 evidence-based key interventions and a set of 24 process and 15 outcome indicators were developed in eight different steps. Nine Belgian multidisciplinary teams piloted both the set of key interventions and indicators. The key intervention set was judged by the teams as being valid and clinically applicable. In addition, the pilot study showed that the indicators were feasible for the involved clinicians and patients.ConclusionsThe set of 38 key interventions and the set of process and outcome indicators were found to be appropriate for the development and standardization of the clinical content of the COPD care pathway in the context of a cRCT on pathway effectiveness. The developed eight-step method may facilitate multidisciplinary teams caring for other patient populations in designing the clinical content of their future care pathways.

Highlights

  • Optimization of the clinical care process by integration of evidence-based knowledge is one of the active components in care pathways

  • This paper describes the development of the clinical content of a care pathway for in-hospital management of chronic obstructive pulmonary disease (COPD) exacerbation

  • The clinical content of an evidence-based care pathway for COPD exacerbation was developed based on the process design methodology developed by Berry et al [16], and the guideline development methods of the American College of Chest Physicians (ACCP) [17], the World Health Organization (WHO) [18] and the Healthcare Infection Control Practices Advisory Committee (HICPAC) [19]

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Summary

Introduction

Optimization of the clinical care process by integration of evidence-based knowledge is one of the active components in care pathways. When studying the impact of a care pathway by using a cluster-randomized design, standardization of the care pathway intervention is crucial This methodology paper describes the development of the clinical content of an evidence-based care pathway for in-hospital management of chronic obstructive pulmonary disease (COPD) exacerbation in the context of a cluster-randomized controlled trial (cRCT) on care pathway effectiveness. Care pathways induce change at different levels of the organization (that is, patient, team, hospital); variability at individual level outcomes may reflect the impact of higher-level complexity processes. To deal with these multilevel effects, cluster randomized designs are strongly recommended when studying the impact of care pathways [10,11]. Standardization in complex interventions refers to adaptation of the care pathway components to the context level, without compromising the integrity of the intervention being evaluated across multiple sites [10,14,15]

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