- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07346937
Evaluating the Impact of In-Situ Simulation on Interprofessional Healthcare Team Training
Evaluating the Impact of In-Situ Simulation on Interprofessional Healthcare Team Training: A Randomized Trial
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Janete Santos, PhD
- Phone Number: +351 220 426 569
- Email: investigaclinica@med.up.pt
Study Contact Backup
- Name: Maria do Céu F Campos
- Email: mariaceucampos@gmail.com
Study Locations
-
-
-
Matosinhos Municipality, Portugal, 4464-513
- ULS Matosinhos - Hospital Pedro Hispano
-
Contact:
- Maria do Céu F Campos
- Phone Number: +351 964 131 846
- Email: mariaceucampos@gmail.com
-
Contact:
- Rita Resende, MD
- Email: ritaresende@yahoo.com
-
Porto, Portugal, 4200-319
- Faculty of Medicine, University of Porto
-
Contact:
- Maria do Céu F Campos
- Phone Number: +351 964 131 846
- Email: mariaceucampos@gmail.com
-
Contact:
- Abel Nicolau, PhD
- Email: anicolau@med.up.pt
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Professionals working in the surgical center of ULSM-HPH with at least 6 months of experience in the role.
- Availability to participate in the simulation group assigned to them.
Exclusion Criteria:
- Professionals who do not work in the surgical center.
- Participants who cannot complete all phases of the study due to scheduling or health restrictions.
- Pregnant professionals.
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: In Situ Simulation
Half of the teams will carry out the scenario in an in-situ context, at the ULS Matosinhos - Pedro Hispano Hospital (ULSM-HPH).
|
Simulation scenario carried out in situ. The training team will consist of 3 facilitators (who will always be the same throughout the study), with each scenario having only 2 facilitators and the principal investigator. Each group will be subjected to the same simulation scenario, the process of which is approximately 60 minutes, divided into: Briefing - 10 min; Scenario Development - 15 minutes; Debriefing - 30/35 min. |
|
Active Comparator: Simulation Center
Half of the teams will carry out the scenario in a Simulation Center context, at the Faculty of Medicine, University of Porto (SIMFMUP).
|
Simulation scenario carried out in the Simulation Center. The training team will consist of 3 facilitators (who will always be the same throughout the study), with each scenario having only 2 facilitators and the principal investigator. Each group will be subjected to the same simulation scenario, the process of which is approximately 60 minutes, divided into: Briefing - 10 min; Scenario Development - 15 minutes; Debriefing - 30/35 min. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Simulation Effectiveness (SET-M)
Time Frame: Immediately after the simulation session (Day 1)
|
Measured with Simulation Effectiveness Tool - Modified (SET-M). SET-M is a 19-item tool with a three-point Likert scale that measures effectiveness by capturing student feedback on three domains. The higher the score, the more effective the simulation training. |
Immediately after the simulation session (Day 1)
|
|
Simulation Effectiveness (ICCAS)
Time Frame: Immediately after the simulation session (Day 1)
|
Measured with the Interprofessional Collaborative Competencies Attainment Survey (ICCAS). ICCAS is a 20-item self-report tool with a seven-point Likert scale that evaluates the participants' competencies in six dimensions before and after the simulation. Participants complete the tool after simulation training, but rate their abilities twice: once as they recall them before training, and after that training is done. The higher the score, the more effective the simulation training. |
Immediately after the simulation session (Day 1)
|
|
Simulation Design Evaluation
Time Frame: Immediately after the simulation session (Day 1)
|
Evaluated using Simulation Design Scale (SDS) - Student version. SDS is a 20-item tool with a five-point Likert scale designed to evaluate five design features of instructor-developed simulations. The instrument has two parts: the presence of specific features in the simulation and the importance of those features to the learner. The higher the score, the higher the evaluation of the design feature. |
Immediately after the simulation session (Day 1)
|
|
Simulation Debriefing Assessment
Time Frame: Immediately after the simulation session (Day 1)
|
Measured with the Debriefing Assessment for Simulation in Healthcare (DASH) Short version for students and for instructors. DASH for students has students evaluating the instructors in 6 elements with a seven-point Likert scale, while DASH for instructors is a self-assessment tool with the same structure. The higher the score, the higher the debriefing skill. |
Immediately after the simulation session (Day 1)
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Maria do Céu F Campos, Universidade do Porto
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- In-Situ Simulation
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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 in Situ Simulation
-
Jean François BrichantEnrolling by invitation
-
Rigshospitalet, DenmarkCopenhagen Trial Unit, Center for Clinical Intervention ResearchCompletedSimulation | Education | Obstetrics | 'In Situ Simulation'Denmark
-
University Hospital Inselspital, BerneCompletedBehavioral Changes | Pediatric Intensive Care Unit | Closed Loop Communication | In-situ SimulationSwitzerland
-
National Taiwan University HospitalRecruitingAdult Non-trauma Cardiac Arrest Resuscitation | Effectiveness of In-situ Simulation (ISS) Training | Effectiveness of Off-site Simulation (OSS) Training | Improvement of Teamwork in Emergency Care SettingsTaiwan
-
University of AarhusCorporate HR, MidtSim, Central Denmark RegionCompletedMedical Education | Pediatrics | In-hospital Cardiac Arrest | Simulation-based Training | in Situ SimulationDenmark
-
Centre Hospitalier Universitaire de BesanconCompletedEducation | in Situ Simulation | in Hospital Cardiac Arrest | Clinical AuditFrance
-
Assistance Publique - Hôpitaux de ParisURC-CIC Paris Descartes Necker CochinWithdrawnPedagogical and Psycho-social Impact of in Situ SimulationFrance
-
Hospices Civils de LyonUnknownTime | Benefit of in Situ Simulation for This Kind of Training | Installation of the Patient Until the PercutaneousFrance
-
Women's College HospitalUnknownSimulation Team Training in Ambulatory SurgeryCanada
-
University of Texas Southwestern Medical CenterCompleted
Clinical Trials on In Situ Simulation
-
University of Sao PauloCompletedExclusive Breastfeeding | Breastfeeding Self-EfficacyBrazil
-
Rigshospitalet, DenmarkCopenhagen Trial Unit, Center for Clinical Intervention ResearchCompletedSimulation | Education | Obstetrics | 'In Situ Simulation'Denmark
-
Mehmet Akif Ersoy UniversityCompleted
-
Prehospital Center, Region ZealandCompletedDrowning | Drowning, Near | Drowning and Nonfatal Submersion | Drowning and Submersion While in Natural Water | Drowning/SubmersionDenmark
-
National University Hospital, SingaporeCompleted
-
Selçuk GörücüNot yet recruitingPatient SafetyTurkey (Türkiye)
-
Memorial University of NewfoundlandWithdrawnLaceration | Sutured Laceration
-
National Taiwan University HospitalRecruitingAdult Non-trauma Cardiac Arrest Resuscitation | Effectiveness of In-situ Simulation (ISS) Training | Effectiveness of Off-site Simulation (OSS) Training | Improvement of Teamwork in Emergency Care SettingsTaiwan
-
Selçuk GörücüNot yet recruitingPatient Safety | Peripheral Intravenous Catheter-Related İnfiltration
-
Hospices Civils de LyonUnknown