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

February 5, 2024 updated by: Dr. Kris Vanhaecht, European Pathway Association

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)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

514

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

61 years and older (Older Adult)

Accepts Healthy Volunteers

No

Description

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;

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Mortality
Time Frame: 6 month
6 month

Secondary Outcome Measures

Outcome Measure
Time Frame
Length of stay
Time Frame: in hospital
in hospital
Pain score
Time Frame: in hospital
in hospital

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

European Pathway Association

Collaborators

KU Leuven
University of Eastern Piedmont

Investigators

  • Study Director: Kris Vanhaecht, PhD, KU Leuven
  • Principal Investigator: Walter Sermeus, PhD, KU Leuven
  • Principal Investigator: Massimiliano Panella, PhD, Amedeo Avogadro University of Eastern Piemont

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2009

Primary Completion (Actual)

May 1, 2014

Study Completion (Actual)

January 1, 2017

Study Registration Dates

First Submitted

August 19, 2009

First Submitted That Met QC Criteria

August 19, 2009

First Posted (Estimated)

August 20, 2009

Study Record Updates

Last Update Posted (Estimated)

February 7, 2024

Last Update Submitted That Met QC Criteria

February 5, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EPA-EQCP002

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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