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.
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.
- Conditions
- Pulmonary Disease, Chronic Obstructive
- 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 group | Role | What they receive |
|---|---|---|
| Pathway | Experimental | A care pathway will be implemented in this experimental group. Receives: Other: COPD evidence based care 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.
Readmission rate
Measured: 6 month
Secondary outcomes (2)
Mortality
Measured: 1 year
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.
- First posted20 Aug 2009 (estimated)
- Study startMay 2009
- Primary completionMar 2014
- Study completionJul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pulmonary Disease, Chronic ObstructiveStudies 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
- 342 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
- 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
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2017. 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 Exacerbation of Chronic Obstructive Pulmonary Disease (COPD) : an International Cluster Randomized Controlled Trial." (Www.E-P-A.Org)
- ClinicalTrials.gov ID
- NCT00962468
- Acronym / sponsor ID
- EQCP-COPD / EPA-EQCP001
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Keywords
- Pulmonary Disease, Chronic Obstructive, Critical Pathway, Cluster Randomized Controlled Trial, Safety, Efficiency
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 342 participants (actual)
- Lead sponsor
- European Pathway AssociationUniversity, hospital or other
- Collaborators
- KU Leuven, University of Eastern Piedmont
- Study start
- May 2009
- Primary completion
- Mar 2014 (actual)
- Study completion
- Jul 2016 (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 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.
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: COPD evidence based care pathwayA care pathway will be implemented in this experimental group. |
| Usual care | No intervention | –Usual care will be provided. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (9 listed)
- 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;
Key exclusion criteria (2 listed)
- Admission required to intensive care unit;
- Need for Invasive Positive Pressure Ventilation (IPVV).
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 |
|---|---|---|
| COPD evidence based care pathwayAlso: pathway, care pathway, clinical pathway, critical pathwayA care pathways, as complex intervention, will be implemented. | Other | Pathway |
Primary outcome
Readmission rate
Time frame: 6 month
2 secondary outcomes
Mortality
Time frame: 1 year
Length of stay
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 13 Oct 2017.
- Derived from this study: PubMed 21092098Vanhaecht 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.
- 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 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.