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

NCT ID: NCT00962468

Last Updated: 2017-10-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 342 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-05-31
• Study Completion Date: 2016-07-31

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.

Conditions

Pulmonary Disease, Chronic Obstructive

Keywords

Pulmonary Disease, Chronic Obstructive; Critical Pathway; Cluster Randomized Controlled Trial; Safety; Efficiency

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Pathway

A care pathway will be implemented in this experimental group.

Group Type: EXPERIMENTAL

COPD evidence based care pathway

Intervention Type: OTHER

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

Usual care

Usual care will be provided.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

COPD evidence based care pathway

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

Intervention Type: OTHER

Other Intervention Names

pathway; care pathway; clinical pathway; critical pathway; integrated care pathway

Eligibility Criteria

Inclusion Criteria

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.

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.

1. Team members are involved in direct patient care responsibilities for COPD;

2. Minimum representation of the core disciplines according to COPD literature;

Exclusion Criteria

1. Admission required to intensive care unit;

2. Need for Invasive Positive Pressure Ventilation (IPVV).

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

KU Leuven

OTHER

Sponsor Role: collaborator

University of Eastern Piedmont

OTHER

Sponsor Role: collaborator

European Pathway Association

OTHER

Sponsor Role: lead

Responsible Party

Dr. Kris Vanhaecht

Dr. Kris Vanhaecht, Secretary General, European Pathway Association, ivzw

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Kris Vanhaecht, PhD

Role: STUDY_DIRECTOR

KU Leuven

Walter Sermeus, PhD

Role: PRINCIPAL_INVESTIGATOR

KU Leuven

Massimiliano Panella, PhD

Role: PRINCIPAL_INVESTIGATOR

Amedeo Avogadro University of Eastern Piemont

References

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.

Reference Type: DERIVED

PMID: 21092098 (View on PubMed)

Related Links

http://www.E-P-A.org

European Pathway Association

Other Identifiers

EPA-EQCP001

Identifier Type: -

Identifier Source: org_study_id