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SimulationNCT06473090

Comparison of Using a Video vs. a Text to Improve Secure Communication During a Crisis in Anesthesia

A study testing Video group and Text group in people with Simulation and Education, run by Université Paris-Sud.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Simulation, Education, Communication
What is being tested?
Video group and Text group
Could I receive a placebo?
No, everyone receives an active treatment
How many people
80 participants
Where
No sites listed yet
Study dates
26 Jun 2024to 1 Aug 2025
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 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • technical problem video
  • declines active participation in the session

Trial locations and contacts

No sites are listed yet.

Antonia Blanié, MD PhD contact

33 145 21 34 47

antonia.blanie@aphp.fr

Fabien Marquion contact

fmarquion@ch-versailles.fr

About this study

Official title: 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:

Read more
  • 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.

Read the 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.

Being tested
Video group, Text group
Keywords
Communication, education, simulation, anesthesia, video
Medical subject headings
Communication

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Video groupOther

    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.

  • Text groupOther

    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

Study groups in NCT06473090
Study groupRoleWhat they receive
Video groupExperimentalParticipants 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.
Receives: Other: Video group
Text groupActive comparatorParticipants 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
Receives: Other: Text group

What is being measured

The primary outcome is the main question the study is designed to answer.

  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).

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

Secondary outcomes (7)
  1. Satisfaction

    to evaluate satisfaction with the educational tool ((rated between 1 to 10 on a Likert scale, Kirkpatrick level 1)

    Measured: 1 minute and the end of the session by all residents

  2. perception of learning

    the perception of learning in terms of secure communication (rated between 1 to 10 on a Likert scale, Kirkpatrick level 2).

    Measured: 1 minute and the end of the session by all residents

  3. Closed-loop-communication

    to evaluate the proportion of Closed loop communication per verbal order.

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

  4. SBAR (situation, background, assessment, recommandation) tool

    to evaluate Number of correctly performed SBAR tool (1 correct event = 1 point)

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

  5. closed-loop communication

    to evaluate Number of correctly or partially performed closed-loop communications ( correct event = 1 point, partial = ½ point)

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

  6. verbal orders

    to evaluate Number of directive verbal orders (using a name or the pronoun "you") (1 correct event = 1 point)

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

  7. medication dosages

    1. Number of correct medication dosages (medication with route of administration and dosage) (1 correct event = 1 point).

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Jun 2024
  2. Study start26 Jun 2024 (estimated)
  3. Primary completion1 Jul 2025 (estimated)
  4. Study completion1 Aug 2025 (estimated)

Resources

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
Other
Allocation
Randomised
Intervention model
Parallel groups
Model description
Parallel assignment, blinded, randomized study
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
80 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06473090
Sponsor's protocol ID
LabForSims-007
Status last verified
Jun 2024
First submitted
12 Jun 2024
Last updated
25 Jun 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Video group and Text group in people with Simulation and Education, run by Université Paris-Sud.

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 2 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 25 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.

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?

Contact Antonia Blanié, MD PhD (33 145 21 34 47, antonia.blanie@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

communication events (time frame: 30 minutes by video after the end of the session by an external evaluator). 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 25 Jun 2024.

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