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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01435538
Other study ID # EPA-EQCP-003
Secondary ID
Status Completed
Phase N/A
First received September 15, 2011
Last updated October 12, 2017
Start date May 2009
Est. completion date January 2017

Study information

Verified date October 2017
Source European Pathway Association
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 984
Est. completion date January 2017
Est. primary completion date June 2014
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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 Design


Intervention

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.

Locations

Country Name City State
Belgium Katholieke Universiteit Leuven Leuven

Sponsors (3)

Lead Sponsor Collaborator
Dr. Kris Vanhaecht Katholieke Universiteit Leuven, University of Eastern Piedmont

Country where clinical trial is conducted

Belgium, 

References & Publications (1)

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Relational Coordination 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 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). For average period of 3 months
Secondary Work engagement 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
Secondary Team Climate Team climate is an indicator to measure the team vision, participative safety, support for innovation and task orientation. For average period of 3 months
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