Chronic Obstructive Pulmonary DiseaseEQCP-TEAMNCT01435538
European Quality of Care Pathways Study on the Effect of Care Pathways on Interprofessional Teamwork (EQCP-TEAM)
A study testing Care pathway. in people with Chronic Obstructive Pulmonary Disease and Proximal Femur Fracture, run by Dr. Kris Vanhaecht at 1 site in Belgium.
Trial summary
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease, Proximal Femur Fracture
- What is being tested?
- Care pathway.
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 984 participants
- Where
- 1 siteBelgium
- Study dates
- May 2009to Jan 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
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- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Being tested
- Care pathway.
- Keywords
- interprofessional teamwork, care pathways, team communication, team coordination, Chronic Obstructive Pulmonary Disease Teams, Proximal Femur Fracture Teams
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Proximal Femoral Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Care pathway.Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Care pathway teams. | Experimental | In this experimental arm, the interprofessional teams will develop and implement a care pathways. Receives: Behavioral: Care pathway. |
| Usual care teams. | No intervention | In the no intervention arm, the interprofessional teams will deliver usual care without implementing the intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relational Coordination
Relational coordination describes the quality of communication and functional relations within a interprofessional team with shared goals and interdependent tasks.
Measured: For average period of 3 months
Secondary outcomes (3)
Perceived Organisation of Care
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).
Measured: For average period of 3 months
Work engagement
Work engagement is a measure to analyse the level of competence, emotional exhaustion and mental detachement measured with the Burnout Inventory.
Measured: For average period of 3 months
Team Climate
Team climate is an indicator to measure the team vision, participative safety, support for innovation and task orientation.
Measured: For average period of 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2011 (estimated)
- Study startMay 2009
- Primary completionJun 2014
- Study completionJan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 984 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr. Kris Vanhaecht
- Sponsor type
- University, hospital or other
- Collaborators
- KU Leuven, University of Eastern Piedmont
- Responsible party
- Sponsor-investigator, Dr. Kris Vanhaecht, European Pathway Association
- Investigators
- Kris Vanhaecht, PhD, Study director, KU LeuvenWalter Sermeus, PhD, Principal investigator, KU LeuvenMassimiliano Panella, PhD, Principal investigator, Amedeo Avogadro University of Eastern PiemontSvin Deneckere, MSc, Principal investigator, KU Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01435538
- Sponsor's protocol ID
- EPA-EQCP-003
- Acronym
- EQCP-TEAM
- Status last verified
- Oct 2017
- First submitted
- 15 Sep 2011
- Last updated
- 13 Oct 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 21190951Handoll 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.
PubMed 34766330Deneckere 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.
PubMed 22607698
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Care Pathways on Interprofessional Teamwork: an International Cluster Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01435538
- Acronym / sponsor ID
- EQCP-TEAM / EPA-EQCP-003
- Keywords
- interprofessional teamwork, care pathways, team communication, team coordination, Chronic Obstructive Pulmonary Disease Teams, Proximal Femur Fracture Teams
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 984 participants (actual)
- Lead sponsor
- Dr. Kris VanhaechtUniversity, hospital or other
- Collaborators
- KU Leuven, University of Eastern Piedmont
- Study start
- May 2009
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jan 2017 (actual)
- First posted
- 16 Sep 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Care pathway teams. | Experimental | Behavioral: Care pathway.In this experimental arm, the interprofessional teams will develop and implement a care pathways. |
| Usual care teams. | No intervention | –In the no intervention arm, the interprofessional teams will deliver usual care without implementing the intervention. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (9 listed)
- 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:
Key exclusion criteria (2 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | Care pathway teams. |
Primary outcome
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.
3 secondary outcomes
Perceived Organisation of Care
Time frame: For average period of 3 months
Work engagement
Time frame: For average period of 3 months
Team Climate
Time frame: For average period of 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2017.
- Background: PubMed 21190951Deneckere 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.
- Derived from this study: PubMed 34766330Handoll 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.
- Derived from this study: PubMed 22607698Deneckere 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.
- European Pathway AssociationLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kris Vanhaecht, PhD study director
KU Leuven
Walter Sermeus, PhD principal investigator
KU Leuven
Massimiliano Panella, PhD principal investigator
Amedeo Avogadro University of Eastern Piemont
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Care pathway. in people with Chronic Obstructive Pulmonary Disease and Proximal Femur Fracture, run by Dr. Kris Vanhaecht at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Relational Coordination (time frame: For average period of 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01435538, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2017.