Educational ActivitiesSIM_LCJRNCT06035822
Assessment of Nursing Students' Performance During Guided Debriefing With the Lasater Clinical Judgement Rubric
A study testing Debriefing with TeamGAINS in people with Educational Activities, run by University of Vic - Central University of Catalonia at 1 site in Spain.
Trial 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… Read more about this study
- Who is it for?
- Ages 20 years and olderHealthy volunteers can take part
- Conditions the study is for
- Educational Activities
- What is being tested?
- Debriefing with TeamGAINS
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 89 participants
- Where
- 1 siteSpain
- Study dates
- 1 Apr 2017to 30 Jun 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- The inclusion criterion applied was all students enrolled in the Practicum VI subject in the 2017-2018 academic year.
Who cannot join
- The exclusion criterion was students who did not wish to participate in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessment of Nursing Students' Performance During Guided Debriefing With the Lasater Clinical Judgement Rubric: a Randomized Clinical Trial
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:
Read more
- 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.
- Conditions
- Educational Activities
- Being tested
- Debriefing with TeamGAINS
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Debriefing with TeamGAINSOther
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
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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). |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: The evaluation instrument is applied during the debriefing analysis carried out at the end of the intervention, lasting one hour.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2023
- Study start1 Apr 2017
- Primary completion31 Dec 2019
- Study completion30 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Educational ActivitiesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 89 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Vic - Central University of Catalonia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Montserrat Faro, University of Vic - Central University of Catalonia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06035822
- Sponsor's protocol ID
- SIM_DEB_LCJR
- Acronym
- SIM_LCJR
- Status last verified
- Nov 2023
- First submitted
- 6 Sep 2023
- Last updated
- 5 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Nursing Students' Performance During Guided Debriefing With the Lasater Clinical Judgement Rubric: a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06035822
- Acronym / sponsor ID
- SIM_LCJR / SIM_DEB_LCJR
- Conditions
- Educational Activities
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 89 participants (actual)
- Lead sponsor
- University of Vic - Central University of CataloniaUniversity, hospital or other
- Study start
- 1 Apr 2017 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 30 Jun 2021 (actual)
- First posted
- 13 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Debriefing with TeamGAINS | Experimental | Other: Debriefing with TeamGAINSThe 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). |
| 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). |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- The inclusion criterion applied was all students enrolled in the Practicum VI subject in the 2017-2018 academic year.
Key exclusion criteria (1 listed)
- The exclusion criterion was students who did not wish to participate in the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Debriefing with TeamGAINSThe 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 | Other | Debriefing with TeamGAINS |
Primary outcome
Number of participants who have improved their performance from structured debriefing and good clinical reasoning.
Time frame: The evaluation instrument is applied during the debriefing analysis carried out at the end of the intervention, lasting one hour.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Debriefing with TeamGAINS in people with Educational Activities, run by University of Vic - Central University of Catalonia at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants who have improved their performance from structured debriefing and good clinical reasoning. (time frame: The evaluation instrument is applied during the debriefing analysis carried out at the end of the intervention, lasting one hour.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2023.