ClinicalTrials.gg
CompletedNCT03470818FlippedSimUpdated Nov 29, 2022

Applying Flipped Learning Concepts to Simulation: the Effect on the Retention of Non-technical Skills

An interventional study of Preparatory instructional videos (flipped classroom model) and Sham video in Crisis Resource Management and Flipped Classroom, sponsored by Centre hospitalier de l'Université de Montréal (CHUM). Completed at 1 site in Canada. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-11-29.

Primary conditionAnxiety Disorders(the registry's first term)UnverifiedIs this wrong?The registry often attaches Anxiety Disorders to studies about something else, and this study's title and listed conditions do not name it. No better condition is named, so the registry's term is kept.

Sponsored by Centre hospitalier de l'Université de Montréal (CHUM) · Not applicable, Interventional, and Other

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Phase
Not applicable
Study type
Interventional
Enrollment
64
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

The primary objective of this study is to assess if letting learners know in advance what medical illnesses will be practiced in an upcoming simulation session and providing them with instruction regarding that medical content ahead of time (flipped classroom model) will allow them to focus on the application of Crisis Resource Management (CRM) principles during a simulation session and result in an increase retention of theses skills. Secondary objectives of this study are to assess the relationship between the study intervention and learners' emotional responses and its impact on the retention of non-technical skills, in occurrence CRM

Read the detailed description

The term "flipped classroom" refers to courses where basic educational content has been removed from the in-class schedule and has instead been provided in advance for learners to review prior to face-to-face interaction with the instructor. Consequently, during class time, learners use time ordinarily spent in lecture to instead practice applying their knowledge.

Although this methodology has been mainly described in classroom-based instruction, the underlying theory can conceptually apply to simulation training in the context of medical education. Too often, and especially with junior learners, time during simulation instruction is spent giving feedback directed at performance gaps caused by a lack of medical knowledge (e.g. medication dose, treatment plan, etc.). Unfortunately, teaching medical knowledge during debriefings takes away from the time spent practicing and discussing non-technical skills (NTS) such as communication, leadership, etc. If the objectives of a simulation session are directed towards increasing competencies in NTS (e.g., Crisis Resource Management [CRM]), efforts should be made to maximize the time spent on the application of these skills. Ensuring that learners possess the medical knowledge required to accomplish the task work of a case (e.g. diagnosis, treatment, etc.) beforehand could help focus their attention on teamwork competencies and result in educational gains.

The benefit of applying a flipped classroom model to simulation-based CRM instruction is anchored in two hypotheses:

  1. The Cognitive Load Theory Hypothesis: Applying a flipped classroom model to CRM training could decrease the load imposed on learners' cognitive processes. According to this theory, working memory has a finite capacity and can only take on a certain load. When it is overloaded, new information cannot be processed and learning is impeded. Temporally separating the instructional content could help learners concentrate on the intended learning objectives of a simulation exercise designed to practice CRM skills. This could lead to enhanced proficiency and retention of these skills.
  2. The Control Value Theory of Achievement Emotions Hypothesis: Achievement emotions are defined as emotions induced by learning activities or their outcomes. They are generated when performances of students are appraised according to a standard of excellence. Central to this theory is that "[...] individuals experience specific achievement emotions when they feel in control of, or out of control of, achievement activities and outcomes that are subjectively important to them [...]". Negative emotions, such as anxiety, have been shown to reduce the cognitive resources available for learning. Providing preparatory instruction could regulate learners' stress response and reduce its impact on learning. In fact, increasing learners' knowledge of what will happen during simulation training can enhance their perceived control over the learning experience and limit the emergence of anticipatory anxiety. The act of sharing information prior to simulation training may also been seen as a gesture of transparency on the instructor's behalf. This has the potential to realign the perceived role of the instructor to a coaching instead of a judging role. A shared understanding of the upcoming learning experience may lessen socioevaluative anxiety by emphasizing the formative nature of the activity.

This study specifically tries to provide an answer to this research question: "Does providing preparatory instruction regarding the medical content of a simulation case to junior medical residents allow learners to focus more on Crisis Resource Management (CRM) principles thus resulting in an increase retention of Crisis Resource Management (CRM) skills three months after a technology-enhanced simulation session aimed at the acquisition of CRM competencies?"

The research question and underlying hypotheses will be tested in a between-subjects experimental design using a mixed-method approach. Subjects will be randomly allocated to an intervention (i.e. "flipped simulation") or a control group.

02

Conditions studied

  • Crisis Resource Management
  • Flipped Classroom

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Keywords

  • Medical Education
  • Flipped Classroom
  • Anxiety
  • Simulation
  • Achievement Emotions
03

In context

Anxiety Disorders Unverified

7,207 studies on the registry are indexed under Anxiety Disorders; 1,682 are open to participants now.

This study's enrollment of 64 is below the median of 80 across 6,062 interventional studies indexed under Anxiety Disorders.

Browse Anxiety Disorders studies →

Lead sponsor

Centre hospitalier de l'Université de Montréal (CHUM) is the lead sponsor of 376 studies on the registry; 110 are open to participants now.

Compared within Anxiety Disorders, the registry's first condition term, which may not be this study's main condition. Counted across the registry records on this site, refreshed daily. How we classify →

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • First year residents in any surgical or medical specialty (including family medicine) that are required to achieve competencies in CRM skills per residency program requirements

Exclusion criteria

Exclusion Criteria:

  • endocrine disorders affecting cortisol metabolism (i.e., hypo/hyperthyroidism, Cushing's syndrome/disease, adrenal insufficiency, etc.)
  • therapy (except for topical)
  • Use of drugs interfering with physiologic stress response (i.e., antidepressant medication, benzodiazepines, beta-blockers, calcium channel blockers, etc.)
  • Pregnancy
  • Knowledge of the simulation scenarios before study inclusion
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
64 participants (actual)

Study arms

  • Experimental
    Intervention group

    Preparatory instructional videos (flipped classroom model) 32 participants Application of a flipped classroom model Prior to the simulation session, the intervention group will have received the study intervention. This consists in the provision of preparatory instruction about the medical knowledge required to complete the task work of the upcoming simulated acute care clinical situation. The format used to convey this off-loaded educational content will be short (approximately 15 minutes) narrated video PowerPoint presentations; every relevant medical situation incorporated in the simulation case will have a dedicated video presentation. These videos will be available to the intervention group participants on a web-based platform one week prior to the simulation session

    Other: Preparatory instructional videos (flipped classroom model)

  • Sham comparator
    Control group

    Sham videos Participants in the control group will also be called to watch an online video prior to the simulation activity. However, this video presentation will not have any form of information regarding the upcoming simulation case; it will be an introductory video discussing the capacities of the simulation facility. This will limit any unwanted "snowball" effect where discussion between research participants could lead the control group participants to inquire about a video presentation that they would not exposed to.

    Other: Sham video

Interventions

  • OtherPreparatory instructional videos (flipped classroom model)

    The intervention consists in the provision of preparatory instruction about the medical knowledge required to complete the task work of the upcoming simulated acute care clinical situation. The format used to convey this off-loaded educational content will be short (approximately 15 minutes) narrated video PowerPoint presentations; every relevant medical situation incorporated in the simulation case will have a dedicated video presentation. These videos will be available to the intervention group participants on a web-based platform one week prior to the simulation session

  • OtherSham video

    Participants in the control group will be called to watch an online video prior to the simulation activity. However, this video presentation will not have any form of information regarding the upcoming simulation case; it will be an introductory video discussing the capacities of the simulation facility. This will limit any unwanted "snowball" effect where discussion between research participants could lead the control group participants to inquire about a video presentation that they would not exposed to.

06

What researchers measure

Primary outcomes

  1. Overall Crisis Resource Management skills

    The between group difference in Crisis Resource Management skills three months post instruction measured by the overall Ottawa Crisis Resource Management Global Rating Scale mean score Scale ranges: 1 - 7 Higher scores are associated with better performance

    Time frame: Three months

Secondary outcomes

  1. Specific Crisis Resource Management skills

    Difference in mean scores on the Ottawa Crisis Resource Management Global Rating Scale subcategories for the instructional and assessment sessions Scale ranges: 1 - 7 Higher scores are associated with better performance

    Time frame: 3 months

  2. Stress response with salivary cortisol

    Between group difference in stress response (i.e. Peak minus baseline State Trait Anxiety Inventory score) during the instructional session and the learning assessment at 3 months

    Time frame: Baseline and 3 months

  3. Stress response with State Trait Inventory Index

    Between group difference in stress response (i.e. Peak minus baseline State Trait Anxiety Inventory score) during the instructional session and the learning assessment at 3 months

    Time frame: Baseline and 3 months

  4. Stress response difference with State Trait Anxiety Inventory

    Between group difference in the mean change in stress response between the instructional session and the learning assessment at 3 months as measured by the State Trait Anxiety Inventory (i.e. State Trait Anxiety Inventory stress response for the assessment session minus the State Trait Anxiety Inventory stress response for the instructional session)

    Time frame: 3 months

  5. Stress response difference with salivary cortisol

    Between group difference in the mean change in stress response between the instructional session and the learning assessment at 3 months as measured by cortisol levels (i.e. Cortisol stress response for the assessment session minus the cortisol stress response for the instructional session)

    Time frame: 3 months

  6. Emotional response assessed with the Achievement Emotion Questionnaire

    Between group difference in the incidence of specific achievement emotions before, during and after the Crisis Resource Management simulation training and the learning assessment at 3 months as specified in the Achievement Emotion Questionnaire

    Time frame: Baseline and 3 months

  7. Qualitative assessment

    Differences in the qualitative themes obtained through semi-structure interviews for each groups.

    Time frame: Baseline and 3 months

07

Study locations

1 site
  • Centre Hospitalier de l'Université de Montréal
    Montréal, Quebec H2X 3E4, Canada
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Jan 2018 to primary completion in Dec 2021, 47 months.

Of 3,841 non-industry interventional studies with no phase under Anxiety Disorders, half reached primary completion within 12 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 28. This study's 47 months is above that.

Counting every sponsor, half of 3,943 studies reached it within 12 months; a quarter within 5 and three quarters within 28.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 7, 2018
First posted
Mar 20, 2018
StartActual
Jan 19, 2018
Primary completionActual
Dec 31, 2021
CompletionActual
Dec 31, 2021
Last update
Nov 29, 2022
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Nov 29, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03470818
Responsible party
Sponsor
First posted
Mar 20, 2018
Start date
Jan 19, 2018
Primary completion
Dec 31, 2021
Completion
Dec 31, 2021
Last update
Nov 29, 2022

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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