The impact of care pathways for patients with proximal femur fracture: rationale and design of a cluster-randomized controlled trial

Kris Vanhaecht,Jan Peers,Massimiliano Panella,Svin Deneckere,Steven Boonen,Fabrizio Leigheb,An Sermon,Cathy Lodewijckx,Paulo Boto,Walter Sermeus,Rita Veloso Mendes

doi:10.1186/1472-6963-12-124

Abstract

BackgroundProximal 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/DesignAn 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.DiscussionThe 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.Trial registration numberNCT00962910

Highlights

Proximal femur fracture (PFF) is associated with considerable morbidity and mortality
The results suggest that mortality in hip fracture patients may not be the best parameter to assess quality of care as they may ignore important improvements in other outcomes that can be achieved by care pathways
The project The European Quality of Care Pathways (EQCP) study is an international multicentre research project launched by the European Pathway Association (E-P-A) [35]

Summary

Introduction

Proximal femur fracture (PFF) is associated with considerable morbidity and mortality. Fracture of the proximal femur constitutes one of the most devastating complications of osteoporosis. Within the European Union, more than 400,000 women and 100,000 men sustain a hip fracture every year [1]. The worldwide annual number of hip fractures amounts to about 1,800,000. Because the number of elderly people is rising, a continued increase in incidence of fractures is expected [1]. People with a proximal femur fracture experience a clinically important decline in functional status with considerable loss in quality of life [2,3]. Within one year after sustaining a hip fracture, close to 20% of individuals will have to be institutionalized because of the fracture and because of its functional consequences

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