- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03470818
Applying Flipped Learning Concepts to Simulation: the Effect on the Retention of Non-technical Skills (FlippedSim)
Applying Flipped Classroom Concepts to Simulation: the Effect of Pre-teaching Medical Content on Resident Acquisition and Retention of Non-technical Skills
Study Overview
Status
Conditions
Intervention / Treatment
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:
- 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.
- 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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Quebec
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Montréal, Quebec, Canada, H2X 3E4
- Centre Hospitalier de l'Université de Montréal
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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:
- endocrine disorders affecting cortisol metabolism (i.e., hypo/hyperthyroidism, Cushing's syndrome/disease, adrenal insufficiency, etc.)
- Corticosteroid 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
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 |
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 |
|
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. |
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Overall Crisis Resource Management skills
Time Frame: Three months
|
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 |
Three months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Specific Crisis Resource Management skills
Time Frame: 3 months
|
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 |
3 months
|
|
Stress response with salivary cortisol
Time Frame: Baseline and 3 months
|
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
|
Baseline and 3 months
|
|
Stress response with State Trait Inventory Index
Time Frame: Baseline and 3 months
|
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
|
Baseline and 3 months
|
|
Stress response difference with State Trait Anxiety Inventory
Time Frame: 3 months
|
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)
|
3 months
|
|
Stress response difference with salivary cortisol
Time Frame: 3 months
|
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)
|
3 months
|
|
Emotional response assessed with the Achievement Emotion Questionnaire
Time Frame: Baseline and 3 months
|
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
|
Baseline and 3 months
|
|
Qualitative assessment
Time Frame: Baseline and 3 months
|
Differences in the qualitative themes obtained through semi-structure interviews for each groups.
|
Baseline and 3 months
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 16.081
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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