European Quality of Care Pathways Study on Proximal Femur Fracture (EQCP-PFF) (EQCP-PFF)
|ClinicalTrials.gov Identifier: NCT00962910|
Recruitment Status : Completed
First Posted : August 20, 2009
Last Update Posted : October 13, 2017
Care pathways, a complex intervention to (re)organise, standardize and evaluate care processes, are used worldwide and in different kinds of settings. Although their international use, the impact is unclear. The European Quality of Care Pathways Study is the first international cluster Randomized Controlled Trial on the effect of care pathways for proximal femur fracture patients (PFF).
The hypothesis is that teams who work with care pathways for PFF patients deliver care that is more compliant to evidence based key interventions, have better patient outcomes and higher scores on team indicators than teams who do not work with care pathways.
|Condition or disease||Intervention/treatment||Phase|
|Femoral Fractures||Other: PFF evidence based pathway||Not Applicable|
Healthcare is changing towards more patient focused care. The organization of the care process related to quality, efficiency and accessibility is one of the main areas of interest within the next years for clinicians, healthcare managers and policy makers. A main method to (re)organize a care process is the development and implementation of a care pathway. Care pathways, also known as clinical pathways or critical pathways, are used worldwide for a variety of patient groups. The European Pathway Association (E-P-A) defines a care pathway as: "A complex intervention for the mutual decision making and organization of predictable care for a well-defined group of patients during a well defined period. Defining characteristics of pathways includes: an explicit statement of the goals and key elements of care based on evidence, best practice and patient expectations; the facilitations of the communication and coordination of roles, and sequencing the activities of the multidisciplinary care team, patients and their relatives; the documentation, monitoring, and evaluation of variances and outcomes; and the identification of relevant resources".
Some prospective studies have been performed and published on the impact of pathways on quality and efficiency of care. The European Quality of Care Pathways (EQCP)-study will involve proximal femur fracture (PFF) to evaluate pathway effectiveness. Literature shows that adherence to international guidelines with regard to inhospital management of PFF is low for both pre-operative and post-operative care. Currently, some non-randomized trials (controlled clinical trials, cohort and case-control studies) and protocols about the impact of a care pathway for inpatient management of proximal femur fracture are published. The studies are conducted between 1992 and 2004, and the methodology is often doubtful. However, the studies indicate that care pathways for PFF improves performance with regard to pre-operative and post-operative interventions (i.e. time before surgery and time before mobilisation after surgery), and that they diminish length of stay (acute and total), in-hospital mortality, 30-day mortality, 1-year mortality, readmission rate and some post-operative complications like pressure sores or ulcers.
In the context of the high volume of PFF patients, high costs and high risk, and the complex coordination of care among multiple caregivers, a care pathway could enhance the quality of care in these patients by improving patient outcomes, promoting patient safety, increasing patient satisfaction, improving multidisciplinary teamwork and optimizing the use of resources.
The goal of the European Quality of Care Pathways (EQCP) study is:
- To evaluate the care pathway effectiveness in acute hospitals and their immediate link with primary care;
- To evaluate the effect of care pathways on team processes and team perceived organization of care.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||514 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Health Services Research|
|Official Title:||The European Quality of Care Pathways Study: The Impact of a Care Pathway for Proximal Femur Fracture (PFF) : an International Cluster Randomized Controlled Trial." (Www.E-P-A.Org)|
|Study Start Date :||May 2009|
|Actual Primary Completion Date :||May 2014|
|Actual Study Completion Date :||January 2017|
A care pathway will be implemented in this experimental group.
Other: PFF evidence based pathway
A care pathway, as complex intervention, will be implemented.
No Intervention: Usual Care
Usual Care will be provided.
- Mortality [ Time Frame: 6 month ]
- Length of stay [ Time Frame: in hospital ]
- Pain score [ Time Frame: in hospital ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00962910
|Study Director:||Kris Vanhaecht, PhD||Katholieke Universiteit Leuven|
|Principal Investigator:||Walter Sermeus, PhD||Katholieke Universiteit Leuven|
|Principal Investigator:||Massimiliano Panella, PhD||Amedeo Avogadro University of Eastern Piemont|