Positive CommunicationComPerfNCT03375073
Positive Communication and Clinical Performance in Anaesthetic Care.
A study testing Positive communication during medical transmission in people with Positive Communication and Clinical Performance, run by University Grenoble Alps at 1 site in France.
Trial summary
The emotional and cognitive impact of positive communication between caregivers remains uninvestigated. The investigators hypothesize that positive communication during medical transmission can increase clinical performance for managing a subsequent stressful unexpected adverse event. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Positive Communication, Clinical Performance, Anaesthesiology
- What is being tested?
- Positive communication during medical transmission
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteFrance
- Study dates
- 29 Nov 2017to 29 Sep 2018
- 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
- Anaesthetic teams composed with :
- 1 resident in anaesthesiology and critical care AND
- 1 anaesthetic nursing student in second year OR 1 anaesthetic nurse graduated less than 5 years ago
- Non-inclusion criteria
- Refusal to be videotaped
- No consent to participate
- Anaesthetic nurses working in a paediatric operating room.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Positive Communication Within Healthcare Team and Clinical Performance: a Prospective, Randomised and Controlled Simulation Trial.
The emotional and cognitive impact of positive communication between caregivers remains uninvestigated. The investigators hypothesize that positive communication during medical transmission can increase clinical performance for managing a subsequent stressful unexpected adverse event.
Read the detailed description
When caregivers deal with acute stressful adverse events, cognitive overload and negative emotions can impair cognitive abilities and decrease clinical performance. The beneficial effect of positive communication on patients' emotions has widely been studied. However, the emotional and cognitive impact of positive communication between caregivers remains uninvestigated. The primary purpose of this trial is to study the impact of positive communication between anaesthetic teams during medical transmissions on clinical performance for managing a subsequent stressful unexpected adverse event. Secondary outcomes are to study the impact of positive communication on physiological (heart rate variability) and psychological (psychometric scales) levels of stress.
- Being tested
- Positive communication during medical transmission
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Positive communication during medical transmissionOther
Use of positive communication for medical transmission to the anaesthetic team who takes over the patient.
| Study group | Role | What they receive |
|---|---|---|
| Positive communication | Experimental | Positive communication during medical transmission Receives: Other: Positive communication during medical transmission |
| Non-optimized communication | No intervention | Medical transmission with non-optimized communication. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical performance of the anaesthetic team
Clinical performance in a simulated scenario of laryngospasm occurring in a 7 year old child under general anaesthesia. Clinical performance will be scored from 0 to 100 by two independent blinded assessors, using video records and a pre-established scenario-specific checklist. The primary endpoint will be the mean of the two assessments for each performance.
Measured: Each anaesthetic team will be involved once in the scenario. The scenario will last about 6 min (transmission not included). Both assessment of clinical performance will be made within 20 weeks of each simulation session
Secondary outcomes (2)
Heart rate variability
Standard deviation of the average of RR intervals (SDNN in milliseconds) in participants
Measured: Before the scenario (during 5 min), during medical transmission (2 min), during the scenario before the laryngospasm (2 min), during the laryngospasm (4 min), during the debriefing (20 min), after the debriefing (5 min)
Self-reported stress
Stress level self reported by participants on visual analogical scale (VAS from 0 to 100); One end of the scale represents the maximum conceivable symptom strength (i. e., 100%), the other end no symptoms whatsoever (i. e., 0%).
Measured: Before the scenario (at 5 min), after medical transmission (at 7 min), after the scenario (at 13 min), after debriefing (at 33 min)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2017
- Study start29 Nov 2017
- Primary completion29 Jun 2018
- Study completion29 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Positive CommunicationStudies of the same condition, open and under way.
- 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled trial, with a 1:1 allocation ratio
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Grenoble Alps
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pierre ALBALADEJO, University Grenoble Alps
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03375073
- Sponsor's protocol ID
- CESAR001
- Acronym
- ComPerf
- Status last verified
- Apr 2019
- First submitted
- 22 Nov 2017
- Last updated
- 18 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Bertrand B, Evain JN, Piot J, Wolf R, Bertrand PM, Louys V, Terrisse H, Bosson JL, Albaladejo P, Picard J. Positive communication behaviour during handover and team-based clinical performance in critical situations: a simulation randomised controlled trial. Br J Anaesth. 2021 Apr;126(4):854-861. doi: 10.1016/j.bja.2020.12.011. Epub 2021 Jan 7.
PubMed 33422288
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Positive Communication Within Healthcare Team and Clinical Performance: a Prospective, Randomised and Controlled Simulation Trial.
- ClinicalTrials.gov ID
- NCT03375073
- Acronym / sponsor ID
- ComPerf / CESAR001
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- University Grenoble AlpsUniversity, hospital or other
- Study start
- 29 Nov 2017 (actual)
- Primary completion
- 29 Jun 2018 (actual)
- Study completion
- 29 Sep 2018 (actual)
- First posted
- 15 Dec 2017 (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.
The emotional and cognitive impact of positive communication between caregivers remains uninvestigated. The investigators hypothesize that positive communication during medical transmission can increase clinical performance for managing a subsequent stressful unexpected adverse event.
Detailed description
When caregivers deal with acute stressful adverse events, cognitive overload and negative emotions can impair cognitive abilities and decrease clinical performance. The beneficial effect of positive communication on patients' emotions has widely been studied. However, the emotional and cognitive impact of positive communication between caregivers remains uninvestigated. The primary purpose of this trial is to study the impact of positive communication between anaesthetic teams during medical transmissions on clinical performance for managing a subsequent stressful unexpected adverse event. Secondary outcomes are to study the impact of positive communication on physiological (heart rate variability) and psychological (psychometric scales) levels of stress.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized controlled trial, with a 1:1 allocation ratio
| Arm | Type | Receives |
|---|---|---|
| Positive communication | Experimental | Other: Positive communication during medical transmissionPositive communication during medical transmission |
| Non-optimized communication | No intervention | –Medical transmission with non-optimized communication. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 1 resident in anaesthesiology and critical care AND
- 1 anaesthetic nursing student in second year OR 1 anaesthetic nurse graduated less than 5 years ago
- Non-inclusion criteria
- Refusal to be videotaped
- No consent to participate
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Positive communication during medical transmissionUse of positive communication for medical transmission to the anaesthetic team who takes over the patient. | Other | Positive communication |
Primary outcome
Clinical performance of the anaesthetic team
Time frame: Each anaesthetic team will be involved once in the scenario. The scenario will last about 6 min (transmission not included). Both assessment of clinical performance will be made within 20 weeks of each simulation session
Clinical performance in a simulated scenario of laryngospasm occurring in a 7 year old child under general anaesthesia. Clinical performance will be scored from 0 to 100 by two independent blinded assessors, using video records and a pre-established scenario-specific checklist. The primary endpoint will be the mean of the two assessments for each performance.
2 secondary outcomes
Heart rate variability
Time frame: Before the scenario (during 5 min), during medical transmission (2 min), during the scenario before the laryngospasm (2 min), during the laryngospasm (4 min), during the debriefing (20 min), after the debriefing (5 min)
Self-reported stress
Time frame: Before the scenario (at 5 min), after medical transmission (at 7 min), after the scenario (at 13 min), after debriefing (at 33 min)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2019.
- Derived from this study: PubMed 33422288Bertrand B, Evain JN, Piot J, Wolf R, Bertrand PM, Louys V, Terrisse H, Bosson JL, Albaladejo P, Picard J. Positive communication behaviour during handover and team-based clinical performance in critical situations: a simulation randomised controlled trial. Br J Anaesth. 2021 Apr;126(4):854-861. doi: 10.1016/j.bja.2020.12.011. Epub 2021 Jan 7.
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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 Positive communication during medical transmission in people with Positive Communication and Clinical Performance, run by University Grenoble Alps at 1 site in France.
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 7 inclusion and 0 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: finished, as of the sponsor's last update on 18 Apr 2019. 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 France. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Clinical performance of the anaesthetic team (time frame: Each anaesthetic team will be involved once in the scenario. The scenario will last about 6 min (transmission not included). Both assessment of clinical performance will be made within 20 weeks of each simulation session). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03375073, which also lists 1 linked publication.
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 18 Apr 2019.