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

October 12, 2017 updated by: Dr. Kris Vanhaecht

The Impact of Care Pathways on Interprofessional Teamwork: an International Cluster Randomized Controlled Trial

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.

Study Overview

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.

Study Type

Interventional

Enrollment (Actual)

984

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Leuven, Belgium, 3000
        • Katholieke Universiteit Leuven

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Care pathway teams.
In this experimental arm, the interprofessional teams will develop and implement a care pathways.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Relational Coordination
Time Frame: For average period of 3 months
Relational coordination describes the quality of communication and functional relations within a interprofessional team with shared goals and interdependent tasks.
For average period of 3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Perceived Organisation of Care
Time Frame: For average period of 3 months
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).
For average period of 3 months
Work engagement
Time Frame: For average period of 3 months
Work engagement is a measure to analyse the level of competence, emotional exhaustion and mental detachement measured with the Burnout Inventory.
For average period of 3 months
Team Climate
Time Frame: For average period of 3 months
Team climate is an indicator to measure the team vision, participative safety, support for innovation and task orientation.
For average period of 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Director: Kris Vanhaecht, PhD, KU Leuven
  • Principal Investigator: Walter Sermeus, PhD, KU Leuven
  • Principal Investigator: Massimiliano Panella, PhD, Amedeo Avogadro University of Eastern Piemont
  • Principal Investigator: Svin Deneckere, MSc, KU Leuven

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2009

Primary Completion (Actual)

June 1, 2014

Study Completion (Actual)

January 1, 2017

Study Registration Dates

First Submitted

September 15, 2011

First Submitted That Met QC Criteria

September 15, 2011

First Posted (Estimate)

September 16, 2011

Study Record Updates

Last Update Posted (Actual)

October 13, 2017

Last Update Submitted That Met QC Criteria

October 12, 2017

Last Verified

October 1, 2017

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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