European Quality of Care Pathways Study on Proximal Femur Fracture (EQCP-PFF) (EQCP-PFF)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00962910
Recruitment Status : Completed
First Posted : August 20, 2009
Last Update Posted : October 13, 2017
Katholieke Universiteit Leuven
University of Eastern Piedmont
Information provided by (Responsible Party):
Dr. Kris Vanhaecht, European Pathway Association

Brief Summary:

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

Detailed Description:

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
Allocation: Randomized
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

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Pathway
A care pathway will be implemented in this experimental group.
Other: PFF evidence based pathway
A care pathway, as complex intervention, will be implemented.
Other Names:
  • pathway
  • care pathway
  • clinical pathway
  • critical pathway
  • integrated care pathway

No Intervention: Usual Care
Usual Care will be provided.

Primary Outcome Measures :
  1. Mortality [ Time Frame: 6 month ]

Secondary Outcome Measures :
  1. Length of stay [ Time Frame: in hospital ]
  2. Pain score [ Time Frame: in hospital ]

Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Inclusion criteria on cluster level are:

    1. Written agreement to participate in the study;
    2. Agreement that a care pathway for PFF will not be developed and used within the time frame of the study when randomized in the control group.
  • Inclusion criteria on patient level are:

    1. Written informed consent;
    2. All consecutive admissions with PFF;
    3. Minimum age of 65 years;
    4. Closed fracture;
    5. Eligible for surgical intervention;
    6. ASA-score of 1, 2 or 3;
    7. Each patient was included only once in the study at initial hospitalization, even if the patient has been hospitalized more than once.

Exclusion Criteria:

  • Exclusion criteria on patient level:

    1. Patients with severe dementia (DSM IV);
    2. Bone metastatic diseases (pathologic fractures);
    3. Second fracture on the same hip (i.e. peri-prosthetic fracture)

Inclusion criteria on multidisciplinary team level:

  1. Team members are involved in direct patient care responsibilities for PFF;
  2. Minimum representation of the core disciplines according to PFF literature;

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00962910

Sponsors and Collaborators
European Pathway Association
Katholieke Universiteit Leuven
University of Eastern Piedmont
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

Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Dr. Kris Vanhaecht, Dr. Kris Vanhaecht, Secretary General, European Pathway Association, ivzw, European Pathway Association Identifier: NCT00962910     History of Changes
Other Study ID Numbers: EPA-EQCP002
First Posted: August 20, 2009    Key Record Dates
Last Update Posted: October 13, 2017
Last Verified: October 2017

Keywords provided by Dr. Kris Vanhaecht, European Pathway Association:
Femoral Fractures
Critical Pathway
Cluster Randomized Controlled Trial

Additional relevant MeSH terms:
Fractures, Bone
Femoral Fractures
Wounds and Injuries
Leg Injuries