- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01435538
European Quality of Care Pathways Study on the Effect of Care Pathways on Interprofessional Teamwork (EQCP-TEAM) (EQCP-TEAM)
The Impact of Care Pathways on Interprofessional Teamwork: an International Cluster Randomized Controlled Trial
Study Overview
Status
Intervention / Treatment
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Leuven, Belgium, 3000
- Katholieke Universiteit Leuven
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
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:
- 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
- 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
- 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
- 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
- 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
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
Sponsor
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
General Publications
- Handoll HH, Cameron ID, Mak JC, Panagoda CE, Finnegan TP. Multidisciplinary rehabilitation for older people with hip fractures. Cochrane Database Syst Rev. 2021 Nov 12;11(11):CD007125. doi: 10.1002/14651858.CD007125.pub3.
- Deneckere S, Robyns N, Vanhaecht K, Euwema M, Panella M, Lodewijckx C, Leigheb F, Sermeus W; EQCP-studygroup. Indicators for follow-up of multidisciplinary teamwork in care processes: results of an international expert panel. Eval Health Prof. 2011 Sep;34(3):258-77. doi: 10.1177/0163278710393736. Epub 2010 Dec 29.
- Deneckere S, Euwema M, Lodewijckx C, Panella M, Sermeus W, Vanhaecht K. The European quality of care pathways (EQCP) study on the impact of care pathways on interprofessional teamwork in an acute hospital setting: study protocol: for a cluster randomised controlled trial and evaluation of implementation processes. Implement Sci. 2012 May 18;7:47. doi: 10.1186/1748-5908-7-47.
Helpful Links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- EPA-EQCP-003
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.
Clinical Trials on Chronic Obstructive Pulmonary Disease
-
Spire, Inc.ResMedCompletedSevere Chronic Obstructive Pulmonary Disease | Moderate Chronic Obstructive Pulmonary DiseaseUnited States
-
Karaganda Medical UniversityCompletedChronic Obstructive Pulmonary Disease | Chronic Obstructive Pulmonary Disease Moderate | Chronic Obstructive Pulmonary Disease SevereKazakhstan
-
Randall DebattistaUniversity of Malta, Faculty of Health SciencesNot yet recruitingChronic Obstructive Pulmonary Disease Moderate | Acute Exacerbation of COPD | Chronic Obstructive Pulmonary Disease Severe
-
Cukurova UniversityCompletedAnesthesia | Chronic Obstructive Pulmonary Disease Moderate | Lungcancer | Chronic Obstructive Pulmonary Disease Severe | Chronic Obstructive Pulmonary Disease MildTurkey
-
National Taipei University of Nursing and Health...TerminatedChronic Pulmonary Disease | Chronic Obstructive Pulmonary Disease Exacerbation | Chronic Obstructive Pulmonary Disease With ExacerbationTaiwan
-
Taipei Medical UniversityUnknownChronic Obstructive Pulmonary Disease Severe | Chronic Obstructive Pulmonary Disease End StageTaiwan
-
Kırıkkale UniversityRecruitingCOPD (Chronic Obstructive Pulmonary Disease)Turkey
-
Hopital FochAir Liquide SARecruitingChronic Obstructive Pulmonary Disease SevereFrance
-
Fundación para la Investigación del Hospital Clínico...Not yet recruitingCOPD, Chronic Obstructive Pulmonary DiseaseSpain
-
Canandaigua VA Medical CenterRecruitingChronic Obstructive Pulmonary Disease ModerateUnited States
Clinical Trials on Care pathway.
-
European Pathway AssociationKU Leuven; University of Eastern PiedmontCompletedPulmonary Disease, Chronic Obstructive
-
European Pathway AssociationKU Leuven; University of Eastern PiedmontCompleted
-
European Pathway AssociationKU LeuvenCompleted
-
Helsinki University Central HospitalRecruitingEncephalitis | Traumatic Brain Injury | Hypoxia-Ischemia, Brain | Brain Hemorrhage | Stroke, Acute IschemicFinland
-
Medical College of WisconsinPediatric Emergency Care Applied Research Network; Nemours Children's Health...RecruitingSickle Cell CrisisUnited States
-
University Hospital, GrenobleUniversity Hospital, Angers; Poitiers University Hospital; Union hospital, Toulouse and other collaboratorsWithdrawnObstructive Sleep Apnea | Obesity Hypoventilation SyndromeFrance
-
St Luke's Hospital, SingaporeNational University, SingaporeCompleted
-
Ilyse KenisKU Leuven; University Ghent; Kom Op Tegen KankerUnknownOncologic DisordersBelgium
-
Norwegian University of Science and TechnologyThe Research Council of Norway; St. Olavs Hospital; Nordmøre and Romsdal Hospital... and other collaboratorsCompleted
-
Majed AljeraisyCompletedHeart Failure | Asthma | Acute Kidney Injury | Venous Thromboembolism | Community Acquired PneumoniaSaudi Arabia