NCT06035822

Brief Summary

I invite you to participate in the study entitled Use of debriefing as a training tool in simulation, of which Montserrat Faro-Basco is not the main researcher. The study is linked to the doctoral thesis Debriefing in clinical simulation, essential for the development of reflective professionals, which the same researcher is carrying out as part of the UVic-UCC Doctoral Program in Educational Innovation and Intervention. The aim of this study is: \- Analysis of the effectiveness of the structured debriefing session with the TeamGAINS tool The procedure to follow will consist of the recording of the debriefing for the subsequent analysis of the behaviors and attitudes of the participants in the session (teacher and students), through its viewing. Participation in this activity is voluntary and does not involve any harm or danger to your physical or mental health. You can refuse to participate at any time in the study without having to give reasons for this, or receiving any type of penalty. The data obtained will be confidential, anonymity will be kept, these data will be organized with a number assigned to each participant, there will be no record of the identity of the participants. The data will be in charge of the research team of this study for the subsequent development of reports and publications of the study results in scientific journals. The collected information will not be used for any purpose other than those indicated.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
89

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2017

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2019

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2021

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

September 6, 2023

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 13, 2023

Completed
Last Updated

December 5, 2023

Status Verified

November 1, 2023

Enrollment Period

2.8 years

First QC Date

September 6, 2023

Last Update Submit

November 28, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • Number of participants who have improved their performance from structured debriefing and good clinical reasoning.

    The debriefing sessions were recorded with two fixed video cameras, which were activated at the beginning of the debriefing. The purpose of the recordings was that the two facilitators and the two external evaluators could later view them in order to be able to analyze and evaluate the participants' interventions during the debriefing, applying the LCJR instrument, which allowed the assessment of the student's performance and clinical reasoning.

    The evaluation instrument is applied during the debriefing analysis carried out at the end of the intervention, lasting one hour.

Study Arms (2)

Debriefing with TeamGAINS

EXPERIMENTAL

The Intervention Group debriefings (n=15) were conducted by the research teacher, who is trained in clinical simulation methodology, is a clinical simulation instructor, and is trained in the use of the TeamGAINS tool (Kolbe et al., 2013). The intervention consisted of using the TeamGAINS tool as a debreifing script, during the debriefing, in accordance with the objectives of the clinical simulation scenario (CSC).

Other: Debriefing with TeamGAINS

Debriefing free

NO INTERVENTION

The Control Group debriefings (n=15) were conducted by a teacher trained in clinical simulation methodology, with no experience in the use of any debriefing guide. The intervention consisted of the debriefer applying his or her simulation experience and training to perform the debriefings freely, in accordance with the objectives of the clinical simulation scenario (CSC).

Interventions

The IG debriefings were conducted by the research teacher, who is trained in clinical simulation methodology, is a clinical simulation instructor, and is trained in the use of the TeamGAINS tool, using this tool as a debriefing script, in accordance with the objectives Clinical Simulation Scenario

Debriefing with TeamGAINS

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

c. Sagrada Familia, 7

Vic, Barcelona, 08500, Spain

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
The students did not know whether they were a control group or an intervention group
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: The assignment of the 30 groups to the intervention or control group was randomized. Fifteen were assigned to the intervention group (IG) and were given the High-Fidelity Simulation (HFS) intervention with a debriefing script, and 15 were assigned to the control group (CG) and were given the HFS intervention without a debriefing script.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator Dr. Montserrat Faro-Basco

Study Record Dates

First Submitted

September 6, 2023

First Posted

September 13, 2023

Study Start

April 1, 2017

Primary Completion

December 31, 2019

Study Completion

June 30, 2021

Last Updated

December 5, 2023

Record last verified: 2023-11

Locations