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Role PlayingAPSIMPNCT03983798

Learning Process of Medical Students During Simulation Training in Psychiatry

An observational study of Role Playing and Psychology, run by Institut Mutualiste Montsouris at 2 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Role Playing, Psychology, Learning
What is being tested?
Simulation training in psychiatry
How many people
72 participants
Where
2 sitesFrance
Study dates
16 Oct 2018to 10 Jul 2019
Phase
Observational
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 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

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

Who may be able to join

  • 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

Who cannot join

  • •Refusal of agreement

Trial locations and contacts

2 sites in 1 country.

France2 sites
  • Institut mutualiste montsouris

    Paris, 75014

  • Institut Mutualiste Montsouris

    Paris, Île-de-France Region, 75014

Other trials in France

About this study

Official title: Learning Process of 5th Year Medical Students During Simulation Training in Psychiatry: a Multicentric Mixed Method Study

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.

Read more

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.

Read the detailed description

Since the end of the nineties, pedagogical transformations question traditional pedagogical system which supports a passive learning from master to student, trying to overcome classical " teaching paradigm" to " learning paradigm ". Despite several critics, the notion of " professional competence " emerges as one of the essential purpose of learning. Competence might be defined as " complex ability that professional built, starting from a specialized knowledge base, developed and controlled by a collegial peer who constitute the profession ", implying " a reflexive practice inside and after action " which creates or increases new competence in return.

However in french context, this paradigmatic revolution didn't really happened yet, including in psychiatry. Moreover, there are no engineering didactic work on specific skills required by a physician (psychiatrist or not) should have in care of a patient with psychiatric disorders. For instance, skills required when a surgeon has to deliver a "clear, loyal and adjusted" information to a patient with a schizophrenia ; and try to get his or her agreement so as to operate a intestinal blockage? As a matter of facts, no integrated competence referential will be able to be a reference in this work.

In a report which is nowadays a reference for the faculties of medicine all over the world, the Royal College of Physicians and Surgeons of Canada (CRMCC) define a framework of essential skills that each physician have to control: medical expertise, erudition ; communicational and relational abilities; collaboration ; professionalism ; management; health promotion. In the French context, skills that each medical student have to provide fo the psychiatric speciality are defined by 33 questions of national classifying exam (ECN). The " Psychiatry and Addictology Referential " points to medical students the reference knowledge to provide to respond to these questions during the challenge of ECN. But this referential doesn't explain skills, abilities and attitudes required with a patient with psychiatric disorders.

The places of providing essential skills defined by CRMCC applied in French psychiatry (as relational and communicational skills for instance) are thus often situated in others spaces. Realization of well supervised clerkship in psychiatry constitutes for example one of the privilege way of skills acquisition. Nonetheless in French context, all the undergraduate students can benefit from psychiatry during their clerkship; especially because of the rarefaction of well supervised internship (decreasing demography of psychiatrist), associated with increase number of medical student over the past few years. Moreover, realization of an only internship can not include all the diversity of main family situation that should be known by each physician; mainly because of dichotomy of internship between adult and child and adolescent psychiatry, specific populations specific who go to different service according to there trouble (emergencies, closed unit, expert diagnosis centers…). Providing pedagogical tools allowing acquisition of basic skills, abilities and attitudes (complementary to knowledge and know-repeat) to care patient with psychiatric disorders seems thus interesting, for improving medical training.

Besides, assessment modalities determine for students work methodology and time involved in each learning, following Hawthorne effect. Assessments support learning assessed, involving long term memory, following " testing effect " ; and hierarchize planning of ulterior learning activities. Trials of ECN in this current shape will probably value acquisition of declarative knowledge for students who would like to succeed in the competition; to the detriment of know-how and life skills. These skills to care patients who suffer from psychiatric disorders won't be neither provided during a specialty residency, unless it might be especially oriented to psychiatry. Thus, it seems important to wider summative assessment modalities in psychiatry during undergraduate medical studies, so as to value acquisition of the wall skills required for a physician in care of a patient with psychiatric disorders. Which implies precise explanation of skills, abilities and attitudes needed, to balance success of ECN with their acquisition. In that context, simulation can offer a good response to this double aim : formative et summative. However, if some theorical approach are references to understand learning process in simulation, very few learning tool are validated in simulation, and none, to our knowledge, did a modelisation on learning process in psychiatric simulation for medical students.

Objectives:

This study aims to explore learning process in a simulation training using simulated patients in psychiatry for 5th year medical students.

This study is one of the 3 studies included in a PhD on learning process during simulation training in psychiatry.

The results of this 3 studies will aim at building a formative and summative assessment tool of competences specific to this pedagogic context

Methodology:

A 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. Each participant will be offered to complete 6 hours of psychiatric simulation training, dealing with mood disorders, anxious disorders, eating disorders, borderline disorders, substance abuse and schizophrenia.

Study design is a mixted method study, following grounded theory including:

  • Quantitative features:
  • Pre/post test concept map
  • Self-reported questionnaires : " Learning Effectiveness Inventory Scale "
  • Sociodemographical data and others questions
  • Qualitative : Grounded Theory
  • Semi-structured interview of learners
  • Portfolio completed during clinical clerkship, after simulation on each pathology studied
  • Pre/post test concept map (for clinical reasonning features)
  • Video-record of simulation
  • Audio-record of briefing and debriefing
Being tested
Simulation training in psychiatry
Keywords
Simulation training, Patient simulation, Psychiatric, Medical students, Educational, Medical

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Simulation training in psychiatryOther

    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.

Study groups in NCT03983798
Study groupRoleWhat they receive
Simulation training in psychiatryConvenient 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.
Receives: Other: Simulation training in psychiatry

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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).

    Measured: 6 weeks

  2. 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).

    Measured: 6 weeks

Secondary outcomes (5)
  1. 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.

    Factors supporting or preventing 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).

    Measured: 6 weeks

  2. 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.

    Factors supporting or preventing learning process assessed on written port-folio with open questions on factors supporting or preventing from learning process on each simulation , 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).

    Measured: 6 weeks

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

    Quantitative and qualitative analysis of concept map to understand cognitive reasoning.There are no consensual and validated method to assess cognitiv reasoning with concept map for the time being. There is 3 method tried to assess mind map. We plan to compute these method with qualitative approach.

    Measured: Before and immediately after simulation

  4. Satisfaction about learning: Self-questionnaire

    Self-questionnaire: "Simulation Learning Effectiveness Inventory" (SLEI), divided in 7 different section with 32 questions. Each question is quoted on a 5-points Lickert scale (1 for not at all; 5 for "totaly agree"). Results are reported individually for each question, or by a mean on 5-points Lickert scale for each section: course; ressource; debrief; clinical ability; confidence; problem solving; collaboration.

    (Chen SL, Huang TW, Liao I-c, Liu C. Development and validation of the Simulation Learning Effectiveness Inventory. Journal of advanced nursing. 2015;71(10):2444-53.)

    Measured: Immediately after the end of simulation

  5. Sociodemographic and other questions

    Age, gender, previous experience in simulation, in psychiatry and in psychiatric simulation, first, second and third specialty choice

    Measured: Immediately after the end of simulation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Jun 2019
  2. Study start16 Oct 2018
  3. Primary completion2 Jan 2019
  4. Study completion10 Jul 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
72 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03983798
Sponsor's protocol ID
PSY-04-2018
Acronym
APSIMP
Status last verified
Jul 2019
First submitted
16 Oct 2018
Last updated
15 Oct 2019
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 28815750
  • 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.

    PubMed 847061
  • 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.

    PubMed 26073864

Questions about this trial

What is this clinical trial studying?

An observational study of Role Playing and Psychology, run by Institut Mutualiste Montsouris at 2 sites in France.

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 5 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 15 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in France. 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?

Learning process assessed by qualitative approach ( constructivist Grounded Theory) through semi-structured interviews. (time frame: 6 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03983798, which also lists 3 linked publications.

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 15 Oct 2019.

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