- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05798052
Effects of Stress on Team Coordination and Performance
Managing Medical Crisis - The Effects of Stress on Team Communication, Coordination and Performance
Study Overview
Status
Intervention / Treatment
Detailed Description
Healthcare teams often encounter challenging circumstances where they must deliver high-quality care. For a team to function effectively, its members must not only be individually competent, but they also need to collaborate and cooperate using their respective expertise. Effective teamwork has been demonstrated to have a positive effect on patient outcomes and adherence to treatment guidelines. As a result, team training interventions have become increasingly prevalent in healthcare. These interventions predominantly focus on generic team competencies that can be transported across different situations and team compositions. A recent meta-analysis found that team training resulted in large effect sizes for the learning and transfer of cognitive and skills-based outcomes, but weaker effects on teamwork performance and medical errors. As such, there are calls to better understand the factors that affect teamwork. Teams often work under high stress situations, where they need to make high stakes decisions under conditions of uncertainty, time-sensitivity and variable levels of control. Research shows that such emergency situations provoke stress responses in individuals, which can impair attention, memory, reasoning, and decision-making. However, it remains unclear how individual-level stress responses influence team communication, coordination, and performance. The aims of this study are to a) compare team coordination, communication, and performance in low stress versus high stress simulated emergency situations; and b) characterize the relationship between teams' stress profiles and the teams' performance and coordination.
Methods: The study will be a randomized control trial, with teams serving as their own controls. Teams of emergency medicine residents and nurses will participate in two simulation scenarios: one in a low stress condition, and the other in a high stress condition (counterbalanced across the teams). Based on previous similar studies on the impact of stress on individual performance, where large effects sizes are seen (.7 -.75)8, the study will recruit a minimum of 17 teams (two-tailed test, alpha set at .05 and power set at .80). In both low and high stress scenario versions, the underlying mechanism of disease or injury will be identical, as will be the expected clinical management of the situation. Known stressors will be added to the scenarios, ensuring ecological validity (stressors that occur in real life). The stressors will include a) socio-evaluative stressors (presence of other with ability to negatively judge); b) increases in the severity of the situation (unstable patient); c) increases in the stakes (e.g. woman in early stages of pregnancy), d) noise, as well as e) unexpected brief complications (e.g. brief equipment challenge).
The participants' subjective (State-Trait Anxiety Inventory- STAI11, cognitive appraisal) and physiological stress (heart rate variability) responses will be measured. Stress responses will be compared at baseline, immediately before, and immediately after each scenario, as well as during for the physiological measures. The team performance will be assessed using the Team Emergency Assessment Measure (TEAM).
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Ontario
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Ottawa, Ontario, Canada, K1Y 4E9
- University of Ottawa Skills and Simulation Centre
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Teams of postgraduate residents enrolled at the University of Ottawa, and The Ottawa Hospital emergency medicine nurses scheduled to attend simulation education sessions organized within their department.
Exclusion Criteria:
- none
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Low-High stress group
Complete the first simulated clinical scenario in the low stress condition, then complete the second simulated scenario in the high stress condition.
|
In both low and high stress scenario versions, the underlying mechanism of disease or injury will be identical, as will be the expected clinical management of the situation.
Known stressors9,10 will be added to the scenarios, ensuring ecological validity (stressors that occur in real life).
The stressors will include a) socio-evaluative stressors (presence of other with ability to negatively judge); b) increases in the severity of the situation (unstable patient); c) increases in the stakes (e.g.
woman in early stages of pregnancy), d) noise, as well as e) unexpected brief complications (e.g.
brief equipment challenge).
|
Other: High-Low stress groups
Complete the first simulated clinical scenario in the high stress condition, then complete the second simulated scenario in the low stress condition.
|
In both low and high stress scenario versions, the underlying mechanism of disease or injury will be identical, as will be the expected clinical management of the situation.
Known stressors9,10 will be added to the scenarios, ensuring ecological validity (stressors that occur in real life).
The stressors will include a) socio-evaluative stressors (presence of other with ability to negatively judge); b) increases in the severity of the situation (unstable patient); c) increases in the stakes (e.g.
woman in early stages of pregnancy), d) noise, as well as e) unexpected brief complications (e.g.
brief equipment challenge).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Team performance
Time Frame: Over 3 months at the end of the data collection phase.
|
Team performance will be assessed using the Team Emergency Assessment Measure (TEAM), which was developed to assess the quality of medical emergency team performance.
It consists of 12 items.
The first 11 items assess leadership, team coordination, team communication, and situation awareness on 5-point Likert scale.
The 12th item is an overall measure of a team's performance and scored on a 10-point Likert-scale.
Higher scores indicate better performance.
The teams performance during the scenarios will be video-recorded and then scored by blinded raters
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Over 3 months at the end of the data collection phase.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Ratio of information management to task management
Time Frame: Over 3 months at the end of the data collection phase.
|
Using a structured observation system of team coordination during non-routine events (Co-ACT, Framework for Observing Coordination Behaviour in Acute Care Teams), the investigators will characterize how and when the teams engage in coordination and communication activities that have been linked with high performing teams, but that have yet to be integrated into common healthcare team training approaches.
The ratio of information management versus task management will be calculate as the amount of time in which the team members communicate and coordinate actions related to information management versus the amount of time communicating and coordinating actions related to task management.
The teams performance during the scenarios will be video-recorded and then scored by blinded raters
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Over 3 months at the end of the data collection phase.
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Frequency of chances between implicit and explicit coordination
Time Frame: Over 3 months at the end of the data collection phase.
|
Using a structured observation system of team coordination during non-routine events (Co-ACT, Framework for Observing Coordination Behaviour in Acute Care Teams), the investigators will characterize how and when the teams engage in coordination and communication activities that have been linked with high performing teams, but that have yet to be integrated into common healthcare team training approaches.
The frequency of changes between implicit coordination and explicit coordination will be calculated as the number of times, in a given scenario, the team switches from implicit coordination to explicit coordination, and vice-versa.
The teams performance during the scenarios will be video-recorded and then scored by blinded raters,
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Over 3 months at the end of the data collection phase.
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Team heedfulness score
Time Frame: Over 3 months at the end of the data collection phase.
|
Using a structured observation system of team coordination during non-routine events (Co-ACT, Framework for Observing Coordination Behaviour in Acute Care Teams), the investigators will characterize how and when the teams engage in coordination and communication activities that have been linked with high performing teams, but that have yet to be integrated into common healthcare team training approaches.
The degree of heedfulness in the teams will be calculated as the total time that team members engage in heedful behaviours (Noticing and communicating, Anticipating, Maintaining standards, Backup Behaviour, Closed-Loop Communication).
The teams performance during the scenarios will be video-recorded and then scored by blinded raters
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Over 3 months at the end of the data collection phase.
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Subjective Stress responses
Time Frame: Through study completion, and average of 1 year
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As a manipulation check, the investigators will compare the team subjective stress scores between the low stress and high stress scenarios.
Subjective stress will be assessed with the Y Form of the State-Trait Anxiety Inventory (STAI), a 20-item tool designed to measure an individual's momentary level of anxiety by self-report.
The STAI has been shown to be sensitive to manipulations of acute stress in simulated settings.
Each inventory is scored between 20 and 80, and has population anxiety reference ranges available.
Higher scores indicate greater levels of anxiety.
In this study, participants will complete the STAI at baseline, immediately before, and immediately after each scenario.
|
Through study completion, and average of 1 year
|
Cognitive appraisal
Time Frame: Through study completion, an average of 1 year
|
As a manipulation check, cognitive appraisal will be assessed immediately before and after each scenario.
Primary appraisal will be examined by asking the participants to answer the questions 'How demanding do you expect the upcoming task to be?' before the scenario and 'How demanding was the task you just completed?' after the scenario.
Secondary appraisal will be measured by asking the participants to answer the question: 'How able are [were] you to cope with this task?' Participants will indicate their answers on an anchored 10-point Likert scale.
The index of cognitive appraisal is calculated as the ratio of the primary appraisal (demands) to the secondary appraisal (resources).
If the resources are assessed as being equal to or greater than the task demands, the situation is appraised as a 'challenge' (ratio ≤ 1).
If the task demands are appraised as being greater than the resources, the situation is appraised as a 'threat' (ratio > 1).
I
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Through study completion, an average of 1 year
|
Heart rate variability - rMSSD
Time Frame: During the simulation sessions, throughout the study: 5 minutes at start of each session (Baseline), 5 minutes prior to start of each scenario, for the duration of each scenario (divided into sequential 5 min periods), 5 minutes following each scenario
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As manipulation check, the investigators will compare the team physiological stress scores between the low stress & high stress scenarios by heart rate variability (HRV) monitoring.
Continuous heart rate (R-R intervals) will be measured with the POLAR® H10 device, a non-invasive chest strap with a transducer worn directly against the sternum paired with a smart device application (EliteHRV).
The participants HRV will be recorded for 5 minutes at the start of the session (Baseline), 5 minutes prior to start of each scenario (Pre-scenario - to capture anticipatory stress responses), for the duration of each scenario (divided into sequential 5 minute periods), as well as 5 minutes following each scenario (post-scenario, to observe stress recovery rates).
For each participant, the investigators will analyse the participant's root mean square of successive R-R interval differences (rMSSD).
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During the simulation sessions, throughout the study: 5 minutes at start of each session (Baseline), 5 minutes prior to start of each scenario, for the duration of each scenario (divided into sequential 5 min periods), 5 minutes following each scenario
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Heart rate variability - pNN50
Time Frame: During the simulation sessions, throughout the study: 5 minutes at start of each session (Baseline), 5 minutes prior to start of each scenario, for the duration of each scenario (divided into sequential 5 min periods), 5 minutes following each scenario
|
As manipulation check, the investigators will compare the team physiological stress scores between the low stress & high stress scenarios by heart rate variability (HRV) monitoring.
Continuous heart rate (R-R intervals) will be measured with the POLAR® H10 device, a non-invasive chest strap with a transducer worn directly against the sternum paired with a smart device application (EliteHRV).
The participants HRV will be recorded for 5 minutes at the start of the session (Baseline), 5 minutes prior to start of each scenario (Pre-scenario - to capture anticipatory stress responses), for the duration of each scenario (divided into sequential 5 minute periods), as well as 5 minutes following each scenario (post-scenario, to observe stress recovery rates).
For each participant, the investigators will analyse the participant's percentage of successive R-R intervals that differ by more than 50Ms (pNN50).
|
During the simulation sessions, throughout the study: 5 minutes at start of each session (Baseline), 5 minutes prior to start of each scenario, for the duration of each scenario (divided into sequential 5 min periods), 5 minutes following each scenario
|
Collaborators and Investigators
Collaborators
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
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
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2020752-01H
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
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