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

NCT00962468 | Completed DMC

• 1 other identifier: EPA-EQCP001
• Study Type: interventional
• Target: 342
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Pulmonary Disease, Chronic Obstructive

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Readmission rate

  6 month

Secondary Outcomes (2)

• Mortality

  1 year

• Length of stay

  in hospital

Study Arms (2)

Pathway

EXPERIMENTAL

A care pathway will be implemented in this experimental group.

Other: COPD evidence based care pathway

Usual care

NO INTERVENTION

Usual care will be provided.

Interventions

COPD evidence based care pathway OTHER

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

Also known as: pathway, care pathway, clinical pathway, critical pathway, integrated care pathway

Pathway

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;
• Each patient will be included only once in the study at initial hospitalization, even if the patient had been hospitalized more than once.

You may not qualify if:

• Admission required to intensive care unit;
• Need for Invasive Positive Pressure Ventilation (IPVV).
• Team members are involved in direct patient care responsibilities for COPD;
• Minimum representation of the core disciplines according to COPD literature;

Sponsors & Collaborators

• European Pathway Association: lead
• KU Leuven: collaborator
• University of Eastern Piedmont: collaborator

Related Publications (1)

• 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.

  PMID: 21092098 DERIVED

Related Links

• European Pathway Association

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Critical Pathways

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Patient Care Planning; Comprehensive Health Care; Patient Care Management; Health Services Administration

Study Officials

• Kris Vanhaecht, PhD

  KU Leuven

  STUDY DIRECTOR

• Walter Sermeus, PhD

  KU Leuven

  PRINCIPAL INVESTIGATOR

• Massimiliano Panella, PhD

  Amedeo Avogadro University of Eastern Piemont

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. Kris Vanhaecht, Secretary General, European Pathway Association, ivzw

Study Record Dates

• First Submitted: August 19, 2009
• First Posted: August 20, 2009
• Study Start: May 1, 2009
• Primary Completion: March 1, 2014
• Study Completion: July 1, 2016
• Last Updated: October 13, 2017

Record last verified: 2017-10