European Quality of Care Pathways Study on the Effect of Care Pathways on Interprofessional Teamwork (EQCP-TEAM)

This study is enrolling participants by invitation only.
Sponsor:
Collaborators:
Katholieke Universiteit Leuven
University of Eastern Piedmont
Information provided by (Responsible Party):
Dr. Kris Vanhaecht, European Pathway Association
ClinicalTrials.gov Identifier:
NCT01435538
First received: September 15, 2011
Last updated: NA
Last verified: September 2011
History: No changes posted
  Purpose

Care pathways are complex interventions to support the interprofessional team in the redesign of their care process. This international cluster randomised trial will analyse the impact of the development and implementation of care pathways on the interprofessional teamwork.


Condition Intervention
Chronic Obstructive Pulmonary Disease
Proximal Femur Fracture
Behavioral: Care pathway.

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: The Impact of Care Pathways on Interprofessional Teamwork: an International Cluster Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by European Pathway Association:

Primary Outcome Measures:
  • Relational Coordination [ Time Frame: For average period of 3 months ] [ Designated as safety issue: Yes ]
    Relational coordination describes the quality of communication and functional relations within a interprofessional team with shared goals and interdependent tasks.


Secondary Outcome Measures:
  • Perceived Organisation of Care [ Time Frame: For average period of 3 months ] [ Designated as safety issue: Yes ]
    The perceived organisation of care is a team indicator to measure the actual organisation of the care process. It is measured in a valid and reliable way by using the Care Process Self Evaluation Tool (CPSET).

  • Work engagement [ Time Frame: For average period of 3 months ] [ Designated as safety issue: Yes ]
    Work engagement is a measure to analyse the level of competence, emotional exhaustion and mental detachement measured with the Burnout Inventory.

  • Team Climate [ Time Frame: For average period of 3 months ] [ Designated as safety issue: Yes ]
    Team climate is an indicator to measure the team vision, participative safety, support for innovation and task orientation.


Estimated Enrollment: 475
Study Start Date: May 2009
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Care pathway teams.
In this experimental arm, the interprofessional teams will develop and implement a care pathways.
Behavioral: Care pathway.
The intervention group will implement a care pathway for PFF or COPD containing three active components: a formative evaluation of the actual teams' performance, a set of evidence based key interventions and a training in pathway-development.
No Intervention: Usual care teams.
In the no intervention arm, the interprofessional teams will deliver usual care without implementing the intervention.

Detailed Description:

Background Although care pathways are often said to promote teamwork, high-level evidence that supports this statement is lacking. The objective of the European Quality of Care Pathway (EQCP) study is therefore to study the impact of care pathways on interprofessional teamwork.

Methods/design An international post-test-only cluster Randomized Controlled Trial (cRCT), combined with process evaluations, will be performed in Belgium, Ireland, Italy and Portugal. Teams caring for Proximale Femur Fracture (PFF) patients and patients hospitalized with an exacerbation of Chronic Obstructive Pulmonary Disease (COPD) will be randomized into an intervention and control group. The intervention group will implement a care pathway for PFF or COPD containing three active components: a formative evaluation of the actual teams' performance, a set of evidence based key interventions and a training in pathway-development. The control group will provide usual care. As effect measures a set of team input, process and output indicators will be used. Main outcome indicator is the team process indicator relational coordination. Next to these, process measures will be used to evaluate the implementation process. In total, 132 teams agreed to participate, of which 68 were randomly assigned to the intervention group and 64 to the control group. Based on power analysis, a sample of 475 team members per arm is required. To analyze results, multilevel analysis will be performed.

Discussion The EQCP-study on teamwork is the first cluster-randomized controlled trial on the impact of care pathways on interprofessional teamwork. Results from our study will enhance understanding on the active components of care pathways. Through this, preferred implementation strategies can be defined.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Inclusion on cluster level requires the written agreement to participate form the hospital management, the medical head of the division and the head nurse
  • Next to this, they have to agree that they will not develop and implement a care pathway for COPD- exacerbation of PFF within the time frame of the study when randomized in the control group
  • Finally, the participating hospitals need an expected volume of more than one hundred COPD-exacerbation or PFF patients annually.
  • To have a comparable sample across all clusters, the following inclusion criteria on individual level are set:

    1. All professionals that according to the medical head of the division and head nurse are member of the interprofessional team caring for COPD-exacerbation or PFF patients from admission until discharge out of the acute hospital ward
    2. To be part of the interprofessional care team is further conceptualized as being part of the group of clinicians and staff who have a shared clinical purpose and direct care responsibilities for the respective patient group during the set time period
    3. All individual participants need to be member of the team during one specific week, where patients are being followed for the two other trials of the EQCP-project (8). This specific week is chosen by the study coordinator and can be defined as an average week, with normal staff ratios
    4. Because we want to study interprofessional teamwork, each cluster is asked to minimally include the orthopedic surgeons/pneumologists, head nurse, nurses, physiotherapists and social workers in their sample. Based on their own judgment, the chief medical doctor, in consensus with the head nurse, can decide to include other professional groups in their sample
    5. In some hospitals COPD-exacerbation or PFF patients are being admitted at multiple nursing wards, e.g. due to capacity problems or other organizational issues. If that is the case, then the clusters are asked to only include these team members that are working on the ward where the respective patient groups are being admitted most frequently.

Exclusion Criteria:

  • All team members that are not working (e.g. on leave) during the chosen week
  • All team members who are only temporarily part of the team (e.g. student nurses in training).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01435538

Locations
Belgium
Katholieke Universiteit Leuven
Leuven, Belgium, 3000
Sponsors and Collaborators
Dr. Kris Vanhaecht
Katholieke Universiteit Leuven
University of Eastern Piedmont
Investigators
Study Director: Kris Vanhaecht, PhD Katholieke Universiteit Leuven
Principal Investigator: Walter Sermeus, PhD Katholieke Universiteit Leuven
Principal Investigator: Massimiliano Panella, PhD Amedeo Avogadro University of Eastern Piemont
Principal Investigator: Svin Deneckere, MSc Katholieke Universiteit Leuven
  More Information

Additional Information:
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Dr. Kris Vanhaecht, Secretary General, European Pathway Association
ClinicalTrials.gov Identifier: NCT01435538     History of Changes
Other Study ID Numbers: EPA-EQCP-003
Study First Received: September 15, 2011
Last Updated: September 15, 2011
Health Authority: Belgium: Institutional Review Board

Keywords provided by European Pathway Association:
interprofessional teamwork
care pathways
team communication
team coordination
Chronic Obstructive Pulmonary Disease Teams
Proximal Femur Fracture Teams

Additional relevant MeSH terms:
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Femoral Fractures
Respiratory Tract Diseases
Fractures, Bone
Wounds and Injuries
Leg Injuries

ClinicalTrials.gov processed this record on October 19, 2014