- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06473090
Comparison of Using a Video vs. a Text to Improve Secure Communication During a Crisis in Anesthesia
Comparison of Using a Video vs. Text to Improve Learning of Secure Communication During a Crisis in Anesthesia: A Multicenter Randomized Controlled Study in Simulation
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Introduction Effective resolution of a crisis situation in anesthesia and critical care requires both technical and non-technical skills (1). Non-technical skills (NTS) include leadership, task distribution, teamwork, and communication. Moreover, communication issues are common in the operating room (2). Poor team communication in the OR is associated with increased postoperative morbidity and mortality (3). Thus, experts recommend that the healthcare team in a crisis situation use secure and standardized communication to improve the quality and safety of care (to reduce morbidity and mortality and limit the incidence of adverse events) (1). 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 (1).
To improve healthcare professionals' communication, it is essential to use effective educational tools. Traditionally, lectures or reading articles were the standard methods. More recently, simulation has shown its value in acquiring these skills (1)(4). However, given the large number of professionals and the limited number of trainers, other educational tools must be developed to allow training for as many professionals as possible.
The use of video as a tool for knowledge and skills transfer seems promising. Nowadays, many teenagers and adults regularly watch videos on digital platforms. Animated images offer many advantages over text. Research in psychology shows that 93% of human communication is non-verbal (5). Additionally, the human brain deciphers different elements of an image simultaneously, whereas spoken or written language is decoded linearly and sequentially, which takes more time (5). Consequently, the use of images for knowledge transfer would be particularly relevant as learning is more effective when visual, oral, or written information is provided simultaneously rather than sequentially (5). In the healthcare field, using images related to written or spoken text has proven particularly effective for knowledge transmission (6). Illustrated text allows participants to develop more complex cognitive structures than those who do not benefit from images (7).
Objective: The objective of this study 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.
Materials and Methods 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 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 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. 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 (1)(5).
The 2 high-fidelity simulation scenarios will be crisis scenarios in anesthesia promoting verbal orders and communication (including cardiac arrest, malignant hyperthermia...). They will serve as the evaluation basis. Each scenario will involve 2 to 3 learner participants (residents and/or nurse anesthetists). The first scenario will be followed by a debriefing focusing on technical skills, and the second scenario will be followed by a debriefing focusing on both technical and non-technical skills.
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). The number of verbal orders per scenario will also be counted by the 2 experts. A correct closed-loop communication is defined as completing the following 3 steps: 1° the sender formulates the order / 2° the receiver acknowledges receipt of the message / 3° the sender closes the loop by verifying the message is correctly received. The verbal order is only the first step when the sender formulates the order aloud.
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 (rated between 1 to 10 on a Likert scale, Kirkpatrick level 2). Participants' characteristics will also be collected via an online questionnaire right after the session.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Antonia Blanié, MD PhD
- Phone Number: 33 145 21 34 47
- Email: antonia.blanie@aphp.fr
Study Contact Backup
- Name: Fabien Marquion
- Email: fmarquion@ch-versailles.fr
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- anesthesia residents and/or nurse anesthetists who have used one of the educational supports and then actively participated in the simulation scenarios.
Exclusion Criteria:
- technical problem video
- declines active participation in the session
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 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 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. |
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. |
|
Active Comparator: 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. 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 |
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 |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
communication events
Time Frame: 30 minutes by video after the end of the session by an external evaluator
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Satisfaction
Time Frame: 1 minute and the end of the session by all residents
|
to evaluate satisfaction with the educational tool ((rated between 1 to 10 on a Likert scale, Kirkpatrick level 1)
|
1 minute and the end of the session by all residents
|
|
perception of learning
Time Frame: 1 minute and the end of the session by all residents
|
the perception of learning in terms of secure communication (rated between 1 to 10 on a Likert scale, Kirkpatrick level 2).
|
1 minute and the end of the session by all residents
|
|
Closed-loop-communication
Time Frame: 30 minutes by video after the end of the session by an external evaluator
|
to evaluate the proportion of Closed loop communication per verbal order.
|
30 minutes by video after the end of the session by an external evaluator
|
|
SBAR (situation, background, assessment, recommandation) tool
Time Frame: 30 minutes by video after the end of the session by an external evaluator
|
to evaluate Number of correctly performed SBAR tool (1 correct event = 1 point)
|
30 minutes by video after the end of the session by an external evaluator
|
|
closed-loop communication
Time Frame: 30 minutes by video after the end of the session by an external evaluator
|
to evaluate Number of correctly or partially performed closed-loop communications ( correct event = 1 point, partial = ½ point)
|
30 minutes by video after the end of the session by an external evaluator
|
|
verbal orders
Time Frame: 30 minutes by video after the end of the session by an external evaluator
|
to evaluate Number of directive verbal orders (using a name or the pronoun "you") (1 correct event = 1 point)
|
30 minutes by video after the end of the session by an external evaluator
|
|
medication dosages
Time Frame: 30 minutes by video after the end of the session by an external evaluator
|
d) Number of correct medication dosages (medication with route of administration and dosage) (1 correct event = 1 point).
|
30 minutes by video after the end of the session by an external evaluator
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Antonia Blanié, MD PhD, Université Paris-Saclay
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
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
Other Study ID Numbers
- LabForSims-007
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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