NCT03983798

Brief Summary

In french context, simulation training is not well implemented in medical school, mainly in psychiatry. We aim to build a formative and summative assessment tool of competences specific to this pedagogic context, so as to support its development. This studies aims to explore learning process and factors supporting or preventing from learning of medical students during simulation in psychiatry. A convenient sample of 72 voluntary participants, allocated among 6 groups of around 12 students, will be recruited at Paris Descartes, Paris Diderot and Brest Universities between september of 2018 and june of 2019. Each participant will complete 6 hours of psychiatric simulation training, dealing with mood disorders, anxious disorders, eating disorders, borderline disorders, substance abuse and schizophrenia. Participant will be offered to complete a portfolio about learning process during the trimester they are involved, a concept gap before and after each training and the " Learning Effectiveness Inventory Scale "at the end of simulation. A purposive sample of students will have to complete a face-to-face semi-interview (until reaching data saturation). Video record of simulation and audio-record of debriefing will be analysed to enhance triangulation process of analysis.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
72

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2018

Shorter than P25 for all trials

Geographic Reach
1 country

2 active sites

Status
completed

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

First Submitted

Initial submission to the registry

October 16, 2018

Completed
Same day until next milestone

Study Start

First participant enrolled

October 16, 2018

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 2, 2019

Completed
5 months until next milestone

First Posted

Study publicly available on registry

June 12, 2019

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 10, 2019

Completed
Last Updated

October 15, 2019

Status Verified

July 1, 2019

Enrollment Period

3 months

First QC Date

October 16, 2018

Last Update Submit

October 11, 2019

Conditions

Keywords

Simulation trainingPatient simulationPsychiatricMedical studentsEducationalMedical

Outcome Measures

Primary Outcomes (2)

  • Learning process assessed by qualitative approach ( constructivist Grounded Theory) through semi-structured interviews.

    Learning process assessed by semi-structured face-to-face interview from a purposive sample of participants, until reaching data saturation. There are no scale, no score, we have just to follow this qualitative method of analysis (Glaser BG, Strauss AL. The discovery of grounded theory: Strategies for qualitative research. Chicago: Aldine; 1967).

    6 weeks

  • Learning process assessed by qualitative approach ( constructivist Grounded Theory) through written port-folio.

    Learning process assessed on written port-folio with open questions on learning process on each simulation session, until reaching data saturation.There are no scale, no score, we have just to follow this qualitative method of analysis (Glaser BG, Strauss AL. The discovery of grounded theory: Strategies for qualitative research. Chicago: Aldine; 1967).

    6 weeks

Secondary Outcomes (5)

  • Factors supporting or preventing learning of 5th year medical students during simulation training in psychiatry assessed by qualitative approach ( constructivist Grounded Theory) through semi-structured interviews.

    6 weeks

  • Factors supporting or preventing learning of 5th year medical students during simulation training in psychiatry assessed by qualitative approach ( constructivist Grounded Theory) through written port-folio.

    6 weeks

  • Evolution of concept map on main psychiatric disorders studied during psychiatric simulation.

    Before and immediately after simulation

  • Satisfaction about learning: Self-questionnaire

    Immediately after the end of simulation

  • Sociodemographic and other questions

    Immediately after the end of simulation

Study Arms (1)

Simulation training in psychiatry

Convenient sample of 72 voluntary medical students, allocated among 6 groups of around 12 students, will be recruited at Paris Descartes, Paris Diderot and Brest Universities between september of 2018 and June of 2019.

Other: Simulation training in psychiatry

Interventions

Each participant will complete 6 hours of psychiatric simulation training, dealing with mood disorders, anxious disorders, eating disorders, borderline disorders, substance abuse and schizophrenia. Simulation training will be supplemented by brief lecture on concept map and portfolio at the beginning of the first hour. Curriculum integration of simulation training in psychiatric course assure that each pathology studied is supplemented by a one-hour lecture and 1 to 3 hours clinical cases and MCQ training. A part of the medical students are supplemented by clinical practice ; whereas the other won't benefit from clinical practice.

Simulation training in psychiatry

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Voluntary medical students recruited at Paris Descartes, Paris Diderot and Brest Universities

You may qualify if:

  • Age \> to 18 years old
  • Undergraduate medical student of Paris Descartes, Paris Diderot or Brest University
  • During university year 2018-2019
  • French or English langage
  • Agreement

You may not qualify if:

  • Refusal of agreement

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Institut mutualiste montsouris

Paris, 75014, France

Location

Institut Mutualiste Montsouris

Paris, Île-de-France Region, 75014, France

Location

Related Publications (3)

  • Lavoie P, Michaud C, Belisle M, Boyer L, Gosselin E, Grondin M, Larue C, Lavoie S, Pepin J. Learning theories and tools for the assessment of core nursing competencies in simulation: A theoretical review. J Adv Nurs. 2018 Feb;74(2):239-250. doi: 10.1111/jan.13416. Epub 2017 Sep 20.

    PMID: 28815750BACKGROUND
  • Bandura A. Self-efficacy: toward a unifying theory of behavioral change. Psychol Rev. 1977 Mar;84(2):191-215. doi: 10.1037//0033-295x.84.2.191. No abstract available.

    PMID: 847061BACKGROUND
  • Chen SL, Huang TW, Liao IC, Liu C. Development and validation of the Simulation Learning Effectiveness Inventory. J Adv Nurs. 2015 Oct;71(10):2444-53. doi: 10.1111/jan.12707. Epub 2015 Jun 15.

    PMID: 26073864BACKGROUND

MeSH Terms

Interventions

Psychiatry

Intervention Hierarchy (Ancestors)

Behavioral SciencesBehavioral Disciplines and Activities

Study Officials

  • Marie-Aude PIOT, MD, PhD

    Institut Mutualiste Montsouris

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 16, 2018

First Posted

June 12, 2019

Study Start

October 16, 2018

Primary Completion

January 2, 2019

Study Completion

July 10, 2019

Last Updated

October 15, 2019

Record last verified: 2019-07

Locations