European Quality of Care Pathways Study on Proximal Femur Fracture (EQCP-PFF) (EQCP-PFF)
Primary Purpose
Femoral Fractures
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
PFF evidence based pathway
Sponsored by

About this trial
This is an interventional health services research trial for Femoral Fractures focused on measuring Femoral Fractures, Critical Pathway, Cluster Randomized Controlled Trial, Safety, Efficiency
Eligibility Criteria
Inclusion Criteria:
Inclusion criteria on cluster level are:
- Written agreement to participate in the study;
- 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:
- Written informed consent;
- All consecutive admissions with PFF;
- Minimum age of 65 years;
- Closed fracture;
- Eligible for surgical intervention;
- ASA-score of 1, 2 or 3;
- 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:
- Patients with severe dementia (DSM IV);
- Bone metastatic diseases (pathologic fractures);
- Second fracture on the same hip (i.e. peri-prosthetic fracture)
Inclusion criteria on multidisciplinary team level:
- Team members are involved in direct patient care responsibilities for PFF;
- Minimum representation of the core disciplines according to PFF literature;
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Pathway
Usual Care
Arm Description
A care pathway will be implemented in this experimental group.
Usual Care will be provided.
Outcomes
Primary Outcome Measures
Mortality
Secondary Outcome Measures
Length of stay
Pain score
Full Information
NCT ID
NCT00962910
First Posted
August 19, 2009
Last Updated
October 12, 2017
Sponsor
European Pathway Association
Collaborators
KU Leuven, University of Eastern Piedmont
1. Study Identification
Unique Protocol Identification Number
NCT00962910
Brief Title
European Quality of Care Pathways Study on Proximal Femur Fracture (EQCP-PFF)
Acronym
EQCP-PFF
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 Type
Interventional
2. Study Status
Record Verification Date
October 2017
Overall Recruitment Status
Completed
Study Start Date
May 2009 (undefined)
Primary Completion Date
May 2014 (Actual)
Study Completion Date
January 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
European Pathway Association
Collaborators
KU Leuven, University of Eastern Piedmont
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Femoral Fractures
Keywords
Femoral Fractures, Critical Pathway, Cluster Randomized Controlled Trial, Safety, Efficiency
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
514 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Pathway
Arm Type
Experimental
Arm Description
A care pathway will be implemented in this experimental group.
Arm Title
Usual Care
Arm Type
No Intervention
Arm Description
Usual Care will be provided.
Intervention Type
Other
Intervention Name(s)
PFF evidence based pathway
Other Intervention Name(s)
pathway, care pathway, clinical pathway, critical pathway, integrated care pathway
Intervention Description
A care pathway, as complex intervention, will be implemented.
Primary Outcome Measure Information:
Title
Mortality
Time Frame
6 month
Secondary Outcome Measure Information:
Title
Length of stay
Time Frame
in hospital
Title
Pain score
Time Frame
in hospital
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Inclusion criteria on cluster level are:
Written agreement to participate in the study;
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:
Written informed consent;
All consecutive admissions with PFF;
Minimum age of 65 years;
Closed fracture;
Eligible for surgical intervention;
ASA-score of 1, 2 or 3;
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:
Patients with severe dementia (DSM IV);
Bone metastatic diseases (pathologic fractures);
Second fracture on the same hip (i.e. peri-prosthetic fracture)
Inclusion criteria on multidisciplinary team level:
Team members are involved in direct patient care responsibilities for PFF;
Minimum representation of the core disciplines according to PFF literature;
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kris Vanhaecht, PhD
Organizational Affiliation
KU Leuven
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Walter Sermeus, PhD
Organizational Affiliation
KU Leuven
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Massimiliano Panella, PhD
Organizational Affiliation
Amedeo Avogadro University of Eastern Piemont
Official's Role
Principal Investigator
12. IPD Sharing Statement
Citations:
PubMed Identifier
34766330
Citation
Handoll HH, Cameron ID, Mak JC, Panagoda CE, Finnegan TP. Multidisciplinary rehabilitation for older people with hip fractures. Cochrane Database Syst Rev. 2021 Nov 12;11(11):CD007125. doi: 10.1002/14651858.CD007125.pub3.
Results Reference
derived
PubMed Identifier
29884319
Citation
Panella M, Seys D, Sermeus W, Bruyneel L, Lodewijckx C, Deneckere S, Sermon A, Nijs S, Boto P, Vanhaecht K. Minimal impact of a care pathway for geriatric hip fracture patients. Injury. 2018 Aug;49(8):1581-1586. doi: 10.1016/j.injury.2018.06.005. Epub 2018 Jun 4.
Results Reference
derived
PubMed Identifier
22640531
Citation
Vanhaecht K, Sermeus W, Peers J, Lodewijckx C, Deneckere S, Leigheb F, Boonen S, Sermon A, Boto P, Mendes RV, Panella M; EQCP study group. The impact of care pathways for patients with proximal femur fracture: rationale and design of a cluster-randomized controlled trial. BMC Health Serv Res. 2012 May 24;12:124. doi: 10.1186/1472-6963-12-124.
Results Reference
derived
Links:
URL
http://www.E-P-A.org
Description
European Pathway Association
Learn more about this trial
European Quality of Care Pathways Study on Proximal Femur Fracture (EQCP-PFF)
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