NCT05798052

Brief 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. 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).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
108

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2023

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 8, 2023

Completed
24 days until next milestone

Study Start

First participant enrolled

April 1, 2023

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 4, 2023

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2023

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2024

Completed
Last Updated

April 4, 2023

Status Verified

April 1, 2023

Enrollment Period

8 months

First QC Date

March 8, 2023

Last Update Submit

April 3, 2023

Conditions

Keywords

teamworkcoordination

Outcome Measures

Primary Outcomes (1)

  • 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

    Over 3 months at the end of the data collection phase.

Secondary Outcomes (3)

  • Ratio of information management to task management

    Over 3 months at the end of the data collection phase.

  • Frequency of chances between implicit and explicit coordination

    Over 3 months at the end of the data collection phase.

  • Team heedfulness score

    Over 3 months at the end of the data collection phase.

Other Outcomes (4)

  • Subjective Stress responses

    Through study completion, and average of 1 year

  • Cognitive appraisal

    Through study completion, an average of 1 year

  • Heart rate variability - rMSSD

    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

  • +1 more other outcomes

Study Arms (2)

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.

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.

Behavioral: Psychological stressors added to simulated clinical scenarios.

Interventions

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).

High-Low stress groupsLow-High stress group

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Ottawa Skills and Simulation Centre

Ottawa, Ontario, K1Y 4E9, Canada

Location

MeSH Terms

Conditions

Fractures, StressStress, Psychological

Condition Hierarchy (Ancestors)

Fractures, BoneWounds and InjuriesBehavioral SymptomsBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Assessors, who are blinded to the study hypotheses and manipulations, will score video-recordings of the teams, in terms of their performance and their coordination patterns.
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
CROSSOVER
Model Details: Teams will be assigned to manage simulated clinical scenarios in two order: low stress then high stress, high stress then low stress.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 8, 2023

First Posted

April 4, 2023

Study Start

April 1, 2023

Primary Completion

December 1, 2023

Study Completion

April 1, 2024

Last Updated

April 4, 2023

Record last verified: 2023-04

Data Sharing

IPD Sharing
Will not share

Locations