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European Quality of Care Pathways Study on Chronic Obstructive Pulmonary Disease (COPD) (EQCP-COPD)

Primary Purpose

Pulmonary Disease, Chronic Obstructive

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
COPD evidence based care 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 Pulmonary Disease, Chronic Obstructive focused on measuring Pulmonary Disease, Chronic Obstructive, Critical Pathway, Cluster Randomized Controlled Trial, Safety, Efficiency

Eligibility Criteria

undefined - undefined (Child, Adult, 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 COPD 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 COPD exacerbation;
  3. Hospitalization for at least 48 hours;
  4. Moderate, severe or very severe COPD;
  5. Each patient will be included only once in the study at initial hospitalization, even if the patient had been hospitalized more than once.

Exclusion Criteria:

Exclusion criteria on patient level:

  1. Admission required to intensive care unit;
  2. Need for Invasive Positive Pressure Ventilation (IPVV).

Inclusion criteria on multidisciplinary team level:

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

    Readmission rate

    Secondary Outcome Measures

    Mortality
    Length of stay

    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
    NCT00962468
    Brief Title
    European Quality of Care Pathways Study on Chronic Obstructive Pulmonary Disease (COPD)
    Acronym
    EQCP-COPD
    Official Title
    The European Quality of Care Pathways Study: The Impact of a Care Pathway for Exacerbation of Chronic Obstructive Pulmonary Disease (COPD) : 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
    March 2014 (Actual)
    Study Completion Date
    July 2016 (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 COPD patients. The hypothesis is that teams who work with care pathways for COPD 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". Very few 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 exacerbation of Chronic Obstructive Pulmonary Disease (COPD) to evaluate pathway effectiveness. Literature shows that adherence to international guidelines with regard to inhospital management of COPD exacerbation is low, especially in non pharmacological treatment.11-19 Currently, only three non-randomized trials about the impact of a care pathway for inpatient management of COPD exacerbation are published. The studies are conducted between 1995 and 2001, and the methodology is doubtful. However the studies indicate that a COPD exacerbation care pathway improves performance with regard to diagnostic assessment and use of standing orders, and that it diminishes the number of rehospitalisation, shortens length of stay (LOS) and reduces mortality. In the context of the high volume of hospitalized COPD 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
    Pulmonary Disease, Chronic Obstructive
    Keywords
    Pulmonary Disease, Chronic Obstructive, 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
    342 (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)
    COPD evidence based care pathway
    Other Intervention Name(s)
    pathway, care pathway, clinical pathway, critical pathway, integrated care pathway
    Intervention Description
    A care pathways, as complex intervention, will be implemented.
    Primary Outcome Measure Information:
    Title
    Readmission rate
    Time Frame
    6 month
    Secondary Outcome Measure Information:
    Title
    Mortality
    Time Frame
    1 year
    Title
    Length of stay
    Time Frame
    in hospital

    10. Eligibility

    Sex
    All
    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 COPD 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 COPD exacerbation; Hospitalization for at least 48 hours; Moderate, severe or very severe COPD; Each patient will be included only once in the study at initial hospitalization, even if the patient had been hospitalized more than once. Exclusion Criteria: Exclusion criteria on patient level: Admission required to intensive care unit; Need for Invasive Positive Pressure Ventilation (IPVV). Inclusion criteria on multidisciplinary team level: Team members are involved in direct patient care responsibilities for COPD; Minimum representation of the core disciplines according to COPD 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
    21092098
    Citation
    Vanhaecht K, Sermeus W, Peers J, Lodewijckx C, Deneckere S, Leigheb F, Decramer M, Panella M; EQCP Study Group. The impact of care pathways for exacerbation of Chronic Obstructive Pulmonary Disease: rationale and design of a cluster randomized controlled trial. Trials. 2010 Nov 19;11:111. doi: 10.1186/1745-6215-11-111.
    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 Chronic Obstructive Pulmonary Disease (COPD)

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