Clinical trial NCT01435538: European Quality of Care Pathways Study on the Effect of Care Pathways on Interprofessional Teamwork (EQCP-TEAM)
Official title: The Impact of Care Pathways on Interprofessional Teamwork: an International Cluster Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Obstructive Pulmonary Disease
Proximal Femur Fracture
Keywords: interprofessional teamwork
care pathways
team communication
team coordination
Chronic Obstructive Pulmonary Disease Teams
Proximal Femur Fracture Teams
Lead sponsor: European Pathway Association
Sponsor class: OTHER
Collaborators: name: KU Leuven
name: University of Eastern Piedmont
First posted: 2011-09-16
Enrollment: 984
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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.

Eligibility criteria: 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).

Primary outcomes:
measure: Relational Coordination
timeFrame: For average period of 3 months
Secondary outcomes:
measure: Perceived Organisation of Care
timeFrame: For average period of 3 months
measure: Work engagement
timeFrame: For average period of 3 months
measure: Team Climate
timeFrame: For average period of 3 months
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: Katholieke Universiteit Leuven
Study officials:
affiliation: KU Leuven
name: Kris Vanhaecht, PhD
role: STUDY_DIRECTOR
affiliation: KU Leuven
name: Walter Sermeus, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Amedeo Avogadro University of Eastern Piemont
name: Massimiliano Panella, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: KU Leuven
name: Svin Deneckere, MSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.