Crisis Resource ManagementFlippedSimNCT03470818
Applying Flipped Learning Concepts to Simulation: the Effect on the Retention of Non-technical Skills
A study testing Preparatory instructional videos (flipped classroom model) in people with Crisis Resource Management and Flipped Classroom, run by Centre hospitalier de l'Université de Montréal (CHUM) at 1 site in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Crisis Resource Management, Flipped Classroom
- What is being tested?
- Preparatory instructional videos (flipped classroom model)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 64 participants
- Where
- 1 siteCanada
- Study dates
- 19 Jan 2018to 31 Dec 2021
- Phase
- Interventional
- 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
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Canada1 site
Centre Hospitalier de l'Université de Montréal
Montreal, Quebec, H2X 3E4
About this study
Official title: Applying Flipped Classroom Concepts to Simulation: the Effect of Pre-teaching Medical Content on Resident Acquisition and Retention of Non-technical Skills
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:
- 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.
- Conditions
- Crisis Resource Management, Flipped Classroom
- Being tested
- Preparatory instructional videos (flipped classroom model), Sham video
- Keywords
- Medical Education, Flipped Classroom, Anxiety, Simulation, Achievement Emotions
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Preparatory instructional videos (flipped classroom model)Other
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 videoOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | 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 Receives: Other: Preparatory instructional videos (flipped classroom model) |
| Control group | Sham comparator | 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. Receives: Other: Sham video |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Three months
Secondary outcomes (7)
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
Measured: 3 months
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
Measured: Baseline and 3 months
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
Measured: Baseline and 3 months
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)
Measured: 3 months
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)
Measured: 3 months
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
Measured: Baseline and 3 months
Qualitative assessment
Differences in the qualitative themes obtained through semi-structure interviews for each groups.
Measured: Baseline and 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2018
- Study start19 Jan 2018
- Primary completion31 Dec 2021
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Crisis Resource ManagementStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre hospitalier de l'Université de Montréal (CHUM)
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03470818
- Sponsor's protocol ID
- 16.081
- Acronym
- FlippedSim
- Status last verified
- Nov 2022
- First submitted
- 7 Mar 2018
- Last updated
- 29 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Applying Flipped Classroom Concepts to Simulation: the Effect of Pre-teaching Medical Content on Resident Acquisition and Retention of Non-technical Skills
- ClinicalTrials.gov ID
- NCT03470818
- Acronym / sponsor ID
- FlippedSim / 16.081
- Conditions
- Crisis Resource Management, Flipped Classroom
- Keywords
- Medical Education, Flipped Classroom, Anxiety, Simulation, Achievement Emotions
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Centre hospitalier de l'Université de Montréal (CHUM)University, hospital or other
- Study start
- 19 Jan 2018 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 20 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Other: Preparatory instructional videos (flipped classroom model)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 |
| Control group | Sham comparator | Other: Sham videoSham 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Preparatory 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 | Other | Intervention group |
| Sham videoParticipants 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. | Other | Control group |
Primary outcome
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
7 secondary outcomes
Specific Crisis Resource Management skills
Time frame: 3 months
Stress response with salivary cortisol
Time frame: Baseline and 3 months
Stress response with State Trait Inventory Index
Time frame: Baseline and 3 months
Stress response difference with State Trait Anxiety Inventory
Time frame: 3 months
Stress response difference with salivary cortisol
Time frame: 3 months
Emotional response assessed with the Achievement Emotion Questionnaire
Time frame: Baseline and 3 months
Qualitative assessment
Time frame: Baseline and 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Preparatory instructional videos (flipped classroom model) in people with Crisis Resource Management and Flipped Classroom, run by Centre hospitalier de l'Université de Montréal (CHUM) at 1 site in Canada.
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 1 inclusion and 5 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 29 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. 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. Some participants in this study may receive a placebo. 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?
Overall Crisis Resource Management skills (time frame: Three months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Nov 2022.