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 byusing 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.
The 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.
A 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.
The 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.