The impact of care pathways for patients with proximal femur fracture: rationale and design of a cluster-randomized controlled trial.
BACKGROUND
Proximal femur fracture (PFF) is associated with considerable morbidity and mortality. The European Quality of Care Pathway (EQCP) study on PFF (NCT00962910) was designed to determine how care pathways (CP) for hospital treatment of PFF affect consistency of care, adherence to evidence-based key interventions, and clinical outcome.


METHODS
An international cluster-randomized controlled trial (cRCT) will be performed in Belgium, Ireland, Italy and Portugal. Based on power analyses, a sample of 44 hospital teams and 437 patients per arm will be included in the study. In the control arm, usual care will be provided. Experimental teams will implement a care pathway which will include three active components: a formative evaluation of quality and organization of the care setting, a set of evidence-based key interventions, and support of the development and implementation of the CP. Main outcome will be the six-month mortality rate.


CONCLUSIONS
The EQCP study constitutes the first international cRCT on care pathways. The EQCP project was designed as both a research and a quality improvement project and will provide a real-world framework for process evaluation to improve our understanding of why and when CP can really work.


BACKGROUND
NCT00962910.
Health Services Research Group, School of Public Health, KU Leuven, University of Leuven, Kapucijnenvoer 35, 3000, Leuven, Belgium. kris.vanhaecht@med.kuleuven.be
Kris
K
Vanhaecht
Walter
W
Sermeus
Jan
J
Peers
Cathy
C
Lodewijckx
Svin
S
Deneckere
Fabrizio
F
Leigheb
Steven
S
Boonen
An
A
Sermon
Paulo
P
Boto
Rita Veloso
RV
Mendes
Massimiliano
M
Panella
D000368:Aged; D019091:Critical Pathways; D005264:Femoral Fractures / Q000401:mortality / Q000628:therapy*; D006801:Humans; D010043:Outcome and Process Assessment, Health Care; D011787:Quality of Health Care; D012107:Research Design