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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
European Pathway Association
About
Eligibility
Locations
Arms
Outcomes
Full info

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

65 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

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;

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

    First Posted
    August 19, 2009
    Last Updated
    October 12, 2017
    Sponsor
    European Pathway Association
    Collaborators
    KU Leuven, University of Eastern Piedmont
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    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

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

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