Femoral FracturesEQCP-PFFNCT00962910
European Quality of Care Pathways Study on Proximal Femur Fracture (EQCP-PFF)
A study testing PFF evidence based pathway in people with Femoral Fractures, run by European Pathway Association.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Femoral Fractures
- What is being tested?
- PFF evidence based pathway
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 514 participants
- Where
- No sites listed yet
- Study dates
- May 2009to Jan 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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.
- Written informed consent;
- All consecutive admissions with PFF;
- Minimum age of 65 years;
- Closed fracture;
Show all 11Show fewer
- 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.
- Team members are involved in direct patient care responsibilities for PFF;
- Minimum representation of the core disciplines according to PFF literature;
Who cannot join
- Patients with severe dementia (DSM IV);
- Bone metastatic diseases (pathologic fractures);
- Second fracture on the same hip (i.e. peri-prosthetic fracture)
About this study
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)
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.
Read the 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.
- Conditions
- Femoral Fractures
- Being tested
- PFF evidence based pathway
- Keywords
- Femoral Fractures, Critical Pathway, Cluster Randomized Controlled Trial, Safety, Efficiency
- Medical subject headings
- Femoral Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PFF evidence based pathwayOther
Also called pathway, care pathway, clinical pathway, critical pathway
A care pathway, as complex intervention, will be implemented.
| Study group | Role | What they receive |
|---|---|---|
| Pathway | Experimental | A care pathway will be implemented in this experimental group. Receives: Other: PFF evidence based pathway |
| Usual Care | No intervention | Usual Care will be provided. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality
Measured: 6 month
Secondary outcomes (2)
Length of stay
Measured: in hospital
Pain score
Measured: in hospital
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2009 (estimated)
- Study startMay 2009
- Primary completionMay 2014
- Study completionJan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Femoral FracturesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 514 participants (actual)
Sponsor and investigators
- Lead sponsor
- European Pathway Association
- Sponsor type
- University, hospital or other
- Collaborators
- KU Leuven, University of Eastern Piedmont
- Responsible party
- Principal investigator, Dr. Kris Vanhaecht, European Pathway Association
- Investigators
- Kris Vanhaecht, PhD, Study director, KU LeuvenWalter Sermeus, PhD, Principal investigator, KU LeuvenMassimiliano Panella, PhD, Principal investigator, Amedeo Avogadro University of Eastern Piemont
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00962910
- Sponsor's protocol ID
- EPA-EQCP002
- Acronym
- EQCP-PFF
- Status last verified
- Feb 2024
- First submitted
- 19 Aug 2009
- Last updated
- 7 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 34766330Panella 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.
PubMed 29884319Vanhaecht 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.
PubMed 22640531
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT00962910
- Acronym / sponsor ID
- EQCP-PFF / EPA-EQCP002
- Conditions
- Femoral Fractures
- Keywords
- Femoral Fractures, Critical Pathway, Cluster Randomized Controlled Trial, Safety, Efficiency
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 514 participants (actual)
- Lead sponsor
- European Pathway AssociationUniversity, hospital or other
- Collaborators
- KU Leuven, University of Eastern Piedmont
- Study start
- May 2009
- Primary completion
- May 2014 (actual)
- Study completion
- Jan 2017 (actual)
- First posted
- 20 Aug 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pathway | Experimental | Other: PFF evidence based pathwayA care pathway will be implemented in this experimental group. |
| Usual Care | No intervention | –Usual Care will be provided. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (11 listed)
- Team members are involved in direct patient care responsibilities for PFF;
- Minimum representation of the core disciplines according to PFF literature;
Key exclusion criteria (3 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PFF evidence based pathwayAlso: pathway, care pathway, clinical pathway, critical pathwayA care pathway, as complex intervention, will be implemented. | Other | Pathway |
Primary outcome
Mortality
Time frame: 6 month
2 secondary outcomes
Length of stay
Time frame: in hospital
Pain score
Time frame: in hospital
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2024.
- Derived from this study: PubMed 34766330Handoll 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.
- Derived from this study: PubMed 29884319Panella 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.
- Derived from this study: PubMed 22640531Vanhaecht 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.
- European Pathway AssociationLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kris Vanhaecht, PhD study director
KU Leuven
Walter Sermeus, PhD principal investigator
KU Leuven
Massimiliano Panella, PhD principal investigator
Amedeo Avogadro University of Eastern Piemont
Questions about this trial
What is this clinical trial studying?
A study testing PFF evidence based pathway in people with Femoral Fractures, run by European Pathway Association.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mortality (time frame: 6 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00962910, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Feb 2024.