NCT05269576

Brief Summary

The hypothesis of our work is that with the simulation techniques applied in the Medical School of the Autonomous University of Barcelona (UAB), students accelerate the learning curve of clinical skills, acquire transversal skills in medicine, and obtain a higher quality learning.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
84

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2020

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 12, 2020

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

February 13, 2022

Completed
23 days until next milestone

First Posted

Study publicly available on registry

March 8, 2022

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 22, 2022

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 22, 2022

Completed
Last Updated

March 22, 2022

Status Verified

March 1, 2022

Enrollment Period

1.8 years

First QC Date

February 13, 2022

Last Update Submit

March 7, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • to know the effectiveness of simulation in 3rd year medical students, through the objective evaluation of clinical and transversal competences with Mini Clinical Evaluation Exercise (Mini-CEX)

    Evaluation of competencies through Mini-CEX, which is done in 3 different moments of each course: at the beginning; after clinicar care practice or simulation session; and at the end of the course after clinical care practice and simulation session.

    Through study completion, an average of 6 months.

Secondary Outcomes (10)

  • To know the effect of clinical care practice in 3rd year medical students

    Through study completion, an average of 6 months.

  • To compare the effect of simulation with that of clinical practice

    Through study completion, an average of 6 months.

  • Qualitative analysis of the simulation by analyzing its objectives by questionnaire

    Through study completion, an average of 6 months.

  • Contrast the evaluation of the objectives between student who did the simulation, observer students and teacher, by questionnaire

    Through study completion, an average of 6 months.

  • Contrast the evaluation of the objectives between the different cases of each session by questionnare

    Through study completion, an average of 6 months.

  • +5 more secondary outcomes

Study Arms (1)

Single arm that receive two different interventions (clinical practice and clinical simulation).

EXPERIMENTAL

An analysis is carried out to the entire group prior to intervention. A second analysis is carried out to the entire group after one of the two interventions. Finally, a last analysis is carried out to the entire group after complete both types of interventions. We apply the study in a group of medicine students of 3rth course of the degree. We examine their competencies at the beginning of the course. Re-examination is done after they do a period of clinical practice or a period of clinical simulation. At the end of the course, all the students done both interventions (clinical practice and clinical simulation), moment when we do the last examination of their competencies.

Other: Clinical practiceOther: Clinical simulation

Interventions

Period of 5 days where medical students carry out hospital clinical practices with real patients supervised by professionals who teach them at the same time.

Single arm that receive two different interventions (clinical practice and clinical simulation).

Clinical simulation classes through 2 sessions of 5 simulated cases each day. All students actively participate in one or two of the simulation cases and observed and discussed all the cases in the debriefings of all of them.

Single arm that receive two different interventions (clinical practice and clinical simulation).

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • \- Students in the 3rd year of medicine at the UAB (Autonomous University of Barcelona) who, at the beginning of the study, have not carried out any type of hospital clinical practice or clinical simulation.

You may not qualify if:

  • Students with prior experience in hospital clinical practice or clinical simulation
  • Students who have not attended clinical practices or simulation classes

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Autonomous University of Barcelona

Bellaterra, Barcelona, 08193, Spain

RECRUITING

Related Publications (7)

  • McGaghie WC, Issenberg SB, Cohen ER, Barsuk JH, Wayne DB. Does simulation-based medical education with deliberate practice yield better results than traditional clinical education? A meta-analytic comparative review of the evidence. Acad Med. 2011 Jun;86(6):706-11. doi: 10.1097/ACM.0b013e318217e119.

  • Cook DA, Hatala R, Brydges R, Zendejas B, Szostek JH, Wang AT, Erwin PJ, Hamstra SJ. Technology-enhanced simulation for health professions education: a systematic review and meta-analysis. JAMA. 2011 Sep 7;306(9):978-88. doi: 10.1001/jama.2011.1234.

  • Norcini JJ, Blank LL, Duffy FD, Fortna GS. The mini-CEX: a method for assessing clinical skills. Ann Intern Med. 2003 Mar 18;138(6):476-81. doi: 10.7326/0003-4819-138-6-200303180-00012.

  • Norcini JJ, Blank LL, Arnold GK, Kimball HR. The mini-CEX (clinical evaluation exercise): a preliminary investigation. Ann Intern Med. 1995 Nov 15;123(10):795-9. doi: 10.7326/0003-4819-123-10-199511150-00008.

  • Norcini JJ, Blank LL, Arnold GK, Kimball HR. Examiner differences in the mini-CEX. Adv Health Sci Educ Theory Pract. 1997;2(1):27-33. doi: 10.1023/A:1009734723651.

  • Hatala R, Ainslie M, Kassen BO, Mackie I, Roberts JM. Assessing the mini-Clinical Evaluation Exercise in comparison to a national specialty examination. Med Educ. 2006 Oct;40(10):950-6. doi: 10.1111/j.1365-2929.2006.02566.x.

  • Leblanc VR. Review article: simulation in anesthesia: state of the science and looking forward. Can J Anaesth. 2012 Feb;59(2):193-202. doi: 10.1007/s12630-011-9638-8. Epub 2011 Dec 17.

Study Officials

  • Fernando Martínez-López, MD

    Universitat Autonoma de Barcelona

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Fernando Martínez-López, MD

CONTACT

Sandra Montmany-Vioque, phD, MD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Masking Details
The investigator and the outcomes assessor didn't know the moment of the interventions in each participant of the group.
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD. Principal investigator. Anesthesiology coordinator.

Study Record Dates

First Submitted

February 13, 2022

First Posted

March 8, 2022

Study Start

September 12, 2020

Primary Completion

June 22, 2022

Study Completion

September 22, 2022

Last Updated

March 22, 2022

Record last verified: 2022-03

Data Sharing

IPD Sharing
Will not share

At the moment, there is no project to share the study data. We are open to doing it so as soon as we see possibilities of working together with other similar groups.

Locations