NCT06473090

Brief Summary

Poor team communication in the OR is associated with increased postoperative morbidity and mortality. Thus, experts recommend that the healthcare team in a crisis situation use secure and standardized communication to improve the quality and safety of care. Secure and standardized communication involves clear, concise, and unambiguous language. Methods of secure communication include closed-loop communication (CLC), precise and complete communication (direct, full dosage), and the use of the SBAR tool. To improve healthcare professionals' communication, it is essential to use effective educational tools. Traditionally, lectures or reading articles were the standard methods. The use of video as a tool for knowledge and skills transfer seems promising. The objective is to compare the learning of secure communication in crisis situations in anesthesia after using two different educational supports: a text versus an educational video. A prospective, multicenter, controlled, and randomized study will be conducted during high-fidelity simulation sessions in anesthesia, comparing a group using a text-type educational support versus a group using an educational video. It will take place in simulation centers. Voluntary participants will be anesthesia and critical care residents and/or nurse anesthetists who have used one of the educational supports and then actively participated in the simulation scenarios. After their consent, participants will be randomized into two groups:

  • Text group: Participants will read a text-type educational support for 15 minutes at the beginning of the session before their involvement in 2 high-fidelity crisis simulation scenarios.
  • Video group: Participants will watch a 15-minute educational video at the beginning of the session before their involvement in the 2 high-fidelity simulation scenarios. The primary endpoint will be to compare the total number of correct secure communication events during the crisis between the 2 groups, which includes: a) Number of correctly performed SBAR b) Number of correctly or partially performed closed-loop communications (CLC) c) Number of directive verbal orders d) Number of correct medication dosages. This evaluation will be based on video recordings of the 2 scenarios assessed by 2 independent, blinded experts (external evaluation of a team's secure communication skills (Kirkpatrick level 2). This composite score is based on various secure communication methods described in the literature and recommended by experts. The number of verbal orders per scenario will also be recorded. The secondary endpoint will be to evaluate each item independently, the proportion of CLC per verbal order, satisfaction with the educational tool (Kirkpatrick level 1), and the perception of learning in terms of secure communication (1 to 10 Likert scale, Kirkpatrick level 2). Participants' characteristics will also be collected.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2024

Status
not yet recruiting

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

June 12, 2024

Completed
13 days until next milestone

First Posted

Study publicly available on registry

June 25, 2024

Completed
1 day until next milestone

Study Start

First participant enrolled

June 26, 2024

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2025

Completed
Last Updated

June 25, 2024

Status Verified

June 1, 2024

Enrollment Period

1 year

First QC Date

June 12, 2024

Last Update Submit

June 18, 2024

Conditions

Keywords

Communicationeducationsimulationanesthesiavideo

Outcome Measures

Primary Outcomes (1)

  • communication events

    The primary endpoint will be to compare the total number of correct secure communication events during the crisis between the 2 groups, which includes: a) Number of correctly performed SBAR (1 correct event = 1 point) b) Number of correctly or partially performed closed-loop communications (CLC) (1 correct event = 1 point, partial = ½ point) c) Number of directive verbal orders (using a name or the pronoun "you") (1 correct event = 1 point) d) Number of correct medication dosages (medication with route of administration and dosage) (1 correct event = 1 point). This evaluation will be based on video recordings of the 2 scenarios assessed by 2 independent, blinded experts. This composite score is based on various secure communication methods described in the literature and recommended by experts (1). It corresponds to an external evaluation of a team's secure communication skills (Kirkpatrick level 2).

    30 minutes by video after the end of the session by an external evaluator

Secondary Outcomes (7)

  • Satisfaction

    1 minute and the end of the session by all residents

  • perception of learning

    1 minute and the end of the session by all residents

  • Closed-loop-communication

    30 minutes by video after the end of the session by an external evaluator

  • SBAR (situation, background, assessment, recommandation) tool

    30 minutes by video after the end of the session by an external evaluator

  • closed-loop communication

    30 minutes by video after the end of the session by an external evaluator

  • +2 more secondary outcomes

Study Arms (2)

Video group

EXPERIMENTAL

Participants will watch a 15-minute educational video at the beginning of the session before their involvement in the 2 high-fidelity simulation scenarios. The educational video used was developed by experts (in Human Factors and Obstetric Anesthesia) and validated by SFAR and CARO. It depicts poor use of NTS (including CLC) during a maternal cardiac arrest anesthesia scenario and then proper use of NTS during the same scenario.

Other: Video group

Text group

ACTIVE COMPARATOR

Participants will read a text-type educational support for 15 minutes at the beginning of the session before their involvement in 2 high-fidelity crisis simulation scenarios. The text-type educational support, written in French by the same team of experts, covers all the NTS mentioned in the video and has already been used in a previous study

Other: Text group

Interventions

Participants will watch a 15-minute educational video at the beginning of the session before their involvement in the 2 high-fidelity simulation scenarios. The educational video used was developed by experts (in Human Factors and Obstetric Anesthesia) and validated by SFAR and CARO. It depicts poor use of NTS (including CLC) during a maternal cardiac arrest anesthesia scenario and then proper use of NTS during the same scenario.

Video group

Participants will read a text-type educational support for 15 minutes at the beginning of the session before their involvement in 2 high-fidelity crisis simulation scenarios. The text-type educational support, written in French by the same team of experts, covers all the NTS mentioned in the video and has already been used in a previous study

Text group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • anesthesia residents and/or nurse anesthetists who have used one of the educational supports and then actively participated in the simulation scenarios.

You may not qualify if:

  • technical problem video
  • declines active participation in the session

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Communication

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Antonia Blanié, MD PhD

    Université Paris-Saclay

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Antonia Blanié, MD PhD

CONTACT

Fabien Marquion

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
The evaluation will be based on video recordings of the 2 scenarios assessed by 2 independent, blinded experts.
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: Parallel assignment, blinded, randomized study
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 12, 2024

First Posted

June 25, 2024

Study Start

June 26, 2024

Primary Completion

July 1, 2025

Study Completion

August 1, 2025

Last Updated

June 25, 2024

Record last verified: 2024-06

Data Sharing

IPD Sharing
Will not share