European Quality of Care Pathways Study on the Effect of Care Pathways on Interprofessional Teamwork (EQCP-TEAM)
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| First Received Date ICMJE | September 15, 2011 | ||||||||||||||||
| Last Updated Date | September 15, 2011 | ||||||||||||||||
| Start Date ICMJE | May 2009 | ||||||||||||||||
| Estimated Primary Completion Date | December 2013 (final data collection date for primary outcome measure) | ||||||||||||||||
| Current Primary Outcome Measures ICMJE |
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. |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||||||||||||||
| Change History | No Changes Posted | ||||||||||||||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||||||||||
| Descriptive Information | |||||||||||||||||
| Brief Title ICMJE | European Quality of Care Pathways Study on the Effect of Care Pathways on Interprofessional Teamwork (EQCP-TEAM) | ||||||||||||||||
| Official Title ICMJE | The Impact of Care Pathways on Interprofessional Teamwork: an International Cluster Randomized Controlled Trial | ||||||||||||||||
| Brief 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. |
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| 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. |
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| Study Type ICMJE | Interventional | ||||||||||||||||
| Study Phase | Not Provided | ||||||||||||||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Health Services Research |
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| Condition ICMJE |
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| Intervention ICMJE | 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. |
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| Study Arm (s) |
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| Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||||||||||
| Recruitment Status ICMJE | Enrolling by invitation | ||||||||||||||||
| Estimated Enrollment ICMJE | 475 | ||||||||||||||||
| Estimated Completion Date | December 2013 | ||||||||||||||||
| Estimated Primary Completion Date | December 2013 (final data collection date for primary outcome measure) | ||||||||||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||||||||||
| Ages | Not Provided | ||||||||||||||||
| Accepts Healthy Volunteers | No | ||||||||||||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||||||||||
| Location Countries ICMJE | Belgium | ||||||||||||||||
| Administrative Information | |||||||||||||||||
| NCT Number ICMJE | NCT01435538 | ||||||||||||||||
| Other Study ID Numbers ICMJE | EPA-EQCP-003 | ||||||||||||||||
| Has Data Monitoring Committee | Yes | ||||||||||||||||
| Responsible Party | Dr. Kris Vanhaecht, European Pathway Association | ||||||||||||||||
| Study Sponsor ICMJE | Dr. Kris Vanhaecht | ||||||||||||||||
| Collaborators ICMJE |
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| Investigators ICMJE |
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| Information Provided By | European Pathway Association | ||||||||||||||||
| Verification Date | September 2011 | ||||||||||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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