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Pulmonary Disease, Chronic ObstructiveEQCP-COPDNCT00962468

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

A study testing COPD evidence based care pathway in people with Pulmonary Disease, Chronic Obstructive, run by European Pathway Association.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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?
Any age
Conditions the study is for
Pulmonary Disease, Chronic Obstructive
What is being tested?
COPD evidence based care pathway
Could I receive a placebo?
No, everyone receives an active treatment
How many people
342 participants
Where
No sites listed yet
Study dates
May 2009to Jul 2016
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 Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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.
  • Written informed consent;
  • All consecutive admissions with COPD exacerbation;
  • Hospitalization for at least 48 hours;
  • Moderate, severe or very severe COPD;
Show all 9Show fewer
  • Each patient will be included only once in the study at initial hospitalization, even if the patient had been hospitalized more than once.
  • Team members are involved in direct patient care responsibilities for COPD;
  • Minimum representation of the core disciplines according to COPD literature;

Who cannot join

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

About this study

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)

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.

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".

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.
Being tested
COPD evidence based care pathway
Keywords
Pulmonary Disease, Chronic Obstructive, Critical Pathway, Cluster Randomized Controlled Trial, Safety, Efficiency
Medical subject headings
Pulmonary Disease, Chronic Obstructive

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • COPD evidence based care pathwayOther

    Also called pathway, care pathway, clinical pathway, critical pathway

    A care pathways, as complex intervention, will be implemented.

Study groups in NCT00962468
Study groupRoleWhat they receive
PathwayExperimentalA care pathway will be implemented in this experimental group.
Receives: Other: COPD evidence based care pathway
Usual careNo interventionUsual care will be provided.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Readmission rate

    Measured: 6 month

Secondary outcomes (2)
  1. Mortality

    Measured: 1 year

  2. Length of stay

    Measured: in hospital

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Aug 2009 (estimated)
  2. Study startMay 2009
  3. Primary completionMar 2014
  4. Study completionJul 2016

Resources

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
342 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00962468
Sponsor's protocol ID
EPA-EQCP001
Acronym
EQCP-COPD
Status last verified
Oct 2017
First submitted
19 Aug 2009
Last updated
13 Oct 2017
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 21092098

Questions about this trial

What is this clinical trial studying?

A study testing COPD evidence based care pathway in people with Pulmonary Disease, Chronic Obstructive, 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 9 inclusion and 2 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 13 Oct 2017. 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?

Readmission rate (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 NCT00962468, which also lists 1 linked publication.

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 13 Oct 2017.

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