Stress ReactionNCT05798052
Effects of Stress on Team Coordination and Performance
A study testing Psychological stressors added to simulated clinical scenarios. in people with Stress Reaction and Stress, Psychological, run by Ottawa Hospital Research Institute at 1 site in Canada.
Trial summary
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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Stress Reaction, Stress, Psychological, Stress, Physiological
- What is being tested?
- Psychological stressors added to simulated clinical scenarios.
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 1 siteCanada
- Study dates
- Apr 2023to Apr 2024
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- none
Trial locations and contacts
1 site in 1 country.
Canada1 site
University of Ottawa Skills and Simulation Centre
Ottawa, Ontario, K1Y 4E9
About this study
Official title: Managing Medical Crisis - The Effects of Stress on Team Communication, Coordination and Performance
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. Such 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. The study will be a within-subject experimental design, 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).
Read the 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).
- Being tested
- Psychological stressors added to simulated clinical scenarios.
- Keywords
- teamwork, coordination
- Medical subject headings
- Fractures, Stress, Stress, Psychological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Psychological stressors added to simulated clinical scenarios.Behavioural
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).
| Study group | Role | What they receive |
|---|---|---|
| Low-High stress group | Other | Complete the first simulated clinical scenario in the low stress condition, then complete the second simulated scenario in the high stress condition. Receives: Behavioral: Psychological stressors added to simulated clinical scenarios. |
| High-Low stress groups | Other | Complete the first simulated clinical scenario in the high stress condition, then complete the second simulated scenario in the low stress condition. Receives: Behavioral: Psychological stressors added to simulated clinical scenarios. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Team performance
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
Measured: Over 3 months at the end of the data collection phase.
Secondary outcomes (3)
Ratio of information management to task management
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
Measured: Over 3 months at the end of the data collection phase.
Frequency of chances between implicit and explicit coordination
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,
Measured: Over 3 months at the end of the data collection phase.
Team heedfulness score
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
Measured: Over 3 months at the end of the data collection phase.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2023
- Study startApr 2023 (estimated)
- Primary completionDec 2023 (estimated)
- Study completionApr 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stress ReactionStudies of the same condition, open and under way.
- More trials run by Ottawa Hospital Research InstituteThe sponsor's other registered studies.
- 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Teams will be assigned to manage simulated clinical scenarios in two order: low stress then high stress, high stress then low stress.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 108 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ottawa Hospital Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- University of Ottawa
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05798052
- Sponsor's protocol ID
- 2020752-01H
- Status last verified
- Apr 2023
- First submitted
- 8 Mar 2023
- Last updated
- 4 Apr 2023
- 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 4 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Managing Medical Crisis - The Effects of Stress on Team Communication, Coordination and Performance
- ClinicalTrials.gov ID
- NCT05798052
- Acronym / sponsor ID
- 2020752-01H
- Keywords
- teamwork, coordination
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 108 participants (estimated)
- Lead sponsor
- Ottawa Hospital Research InstituteUniversity, hospital or other
- Collaborators
- University of Ottawa
- Study start
- Apr 2023 (estimated)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Apr 2024 (estimated)
- First posted
- 4 Apr 2023 (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.
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. Such 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. The study will be a within-subject experimental design, 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).
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Teams will be assigned to manage simulated clinical scenarios in two order: low stress then high stress, high stress then low stress.
| Arm | Type | Receives |
|---|---|---|
| Low-High stress group | Other | Behavioral: Psychological stressors added to simulated clinical scenarios.Complete the first simulated clinical scenario in the low stress condition, then complete the second simulated scenario in the high stress condition. |
| High-Low stress groups | Other | Behavioral: Psychological stressors added to simulated clinical scenarios.Complete the first simulated clinical scenario in the high stress condition, then complete the second simulated scenario in the low stress condition. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- none
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 |
|---|---|---|
| Psychological stressors added to simulated clinical scenarios.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). | Behavioural | High-Low stress groups, Low-High stress group |
Primary outcome
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
3 secondary outcomes
Ratio of information management to task management
Time frame: Over 3 months at the end of the data collection phase.
Frequency of chances between implicit and explicit coordination
Time frame: Over 3 months at the end of the data collection phase.
Team heedfulness score
Time frame: Over 3 months at the end of the data collection phase.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2023.
- 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 Psychological stressors added to simulated clinical scenarios. in people with Stress Reaction and Stress, Psychological, run by Ottawa Hospital Research Institute 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 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: status not confirmed, as of the sponsor's last update on 4 Apr 2023. 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. 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?
Results are not available in the source record.
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?
Team performance (time frame: Over 3 months at the end of the data collection phase.). 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 4 Apr 2023.