title: The impact of care pathways for exacerbation of Chronic Obstructive Pulmonary Disease: rationale and design of a cluster randomized controlled trial.
abstract: BACKGROUND
  Hospital treatment of chronic obstructive pulmonary disease (COPD) frequently does not follow published evidences. This lack of adherence can contribute to the high morbidity, mortality and readmissions rates. The European Quality of Care Pathway (EQCP) study on acute exacerbations of COPD (NTC00962468) is undertaken to determine how care pathways (CP) as complex intervention for hospital treatment of COPD affects care variability, adherence to evidence based key interventions and clinical outcomes.
  
  
  METHODS
  An international cluster Randomized Controlled Trial (cRCT) will be performed in Belgium, Italy, Ireland and Portugal. Based on the power analysis, a sample of 40 hospital teams and 398 patients will be included in the study. In the control arm of the study, usual care will be provided. The experimental teams will implement a CP as complex intervention which will include three active components: a formative evaluation of the quality and organization of care, a set of evidence based key interventions, and support on the development and implementation of the CP. The main outcome will be six-month readmission rate. As a secondary endpoint a set of clinical outcome and performance indicators (including care process evaluation and team functioning indicators) will be measured in both groups.
  
  
  CONCLUSIONS
  The EQCP study is the first international cRCT on care pathways. The design of the EQCP project is both a research study and a quality improvement project and will include a realistic evaluation framework including process analysis to further understand why and when CP can really work.
  
  
  BACKGROUND
  NCT00962468.
authors.affiliation: European Pathway Association, Kapucijnenvoer 35/4, B-3000 Leuven, Belgium. kris.vanhaecht@med.kuleuven.be
authors.forename: Kris
authors.initials: K
authors.lastname: Vanhaecht
authors.forename: Walter
authors.initials: W
authors.lastname: Sermeus
authors.forename: Jan
authors.initials: J
authors.lastname: Peers
authors.forename: Cathy
authors.initials: C
authors.lastname: Lodewijckx
authors.forename: Svin
authors.initials: S
authors.lastname: Deneckere
authors.forename: Fabrizio
authors.initials: F
authors.lastname: Leigheb
authors.forename: Marc
authors.initials: M
authors.lastname: Decramer
authors.forename: Massimiliano
authors.initials: M
authors.lastname: Panella
mesh_terms: D002985:Clinical Protocols; D006801:Humans; D029424:Pulmonary Disease, Chronic Obstructive / Q000628:therapy*; D012107:Research Design; D016896:Treatment Outcome