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Open Access Highly Accessed Study protocol

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

Kris Vanhaecht123*, Walter Sermeus12, Jan Peers12, Cathy Lodewijckx14, Svin Deneckere1, Fabrizio Leigheb5, Steven Boonen6, An Sermon7, Paulo Boto8, Rita Veloso Mendes8, Massimiliano Panella125 and EQCP study group

Author Affiliations

1 Health Services Research Group, School of Public Health, KU Leuven, University of Leuven, Kapucijnenvoer 35, 3000, Leuven, Belgium

2 European Pathway Association, Kapucijnenvoer 35, 3000, Leuven, Belgium

3 Western Norway Research Group on Integrated Care, Helse Fonna, 5504, Haugesund, Norway

4 Department of Pulmonology, University Hospitals Leuven, Herestraat 49, 3000, Leuven, Belgium

5 Department of Clinical and Experimental Medicine, Amedeo Avogadro University of Eastern Piedmont, Via Duomo, 13100, Vercelli, Italy

6 Department of Geriatrics and Leuven University Center for Metabolic Bone Diseases, University Hospitals Leuven, KU Leuven, University of Leuven, Herestraat 49, 3000, Leuven, Belgium

7 Department of Orthopedics & Traumatology, University Hospitals Leuven, Herestraat 49, 3000, Leuven, Belgium

8 National School of Public Health, Avenido Padre Cruz 1600-560, Lisbon, Portugal

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BMC Health Services Research 2012, 12:124  doi:10.1186/1472-6963-12-124

Published: 24 May 2012

Abstract

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/Design

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.

Discussion

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.

Trial registration number

NCT00962910