Pediatric Intensive Care UnitNCT03600298
Simulation Training of Closed-Loop Communication (CLC)
A study testing Simulation in people with Pediatric Intensive Care Unit and Closed Loop Communication, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
Trial summary
Open interventional before and after study on the effect of on-site full-scale simulation with a subsequent course follow-up and a three month follow-up observation pertaining to behavioural changes in communication of the paediatric intensive care unit staff that is participating in the on-site simulation training. Read more about this study
- Who is it for?
- Ages 20 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Pediatric Intensive Care Unit, Closed Loop Communication, In-situ Simulation
- What is being tested?
- Simulation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Apr 2017to 25 Jan 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 20 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Employees, with written informed consent, working in the paediatric intensive care unit of the Children's Bern University Hospital
- Employees novices to in-situ simulation
Who cannot join
- employees, working in the paediatric intensive care unit of the Children's Bern University Hospital who are not fluent in German or Swiss German.
- employees, working in the paediatric intensive care unit of the Children's Bern University Hospital who are unable to be observed during phases I and II and during the follow up phase (see below).
- No vulnerable participants will be included.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Does Simulation Enhance Closed-Loop Communication in the Clinical Setting of a Pediatric Intensive Care Unit?
Open interventional before and after study on the effect of on-site full-scale simulation with a subsequent course follow-up and a three month follow-up observation pertaining to behavioural changes in communication of the paediatric intensive care unit staff that is participating in the on-site simulation training.
Read the detailed description
Closed-Loop Communication (CLC) is a proposed, taught and practiced Crisis Resource Management (CRM) strategy thought to be effective for enhancing patient safety by enforcing reiteration and clarity, thus reducing ambiguity during verbal communication among health care providers. The transfer of this CRM strategy into clinical practice seems to require recurring exposure. Teaching and training is needed to help health care providers develop routine in communicating. This training is most effective if practiced in the clinical setting that is familiar to the health care provider (in situ simulation). As trainees become more proficient, the ultimate goal is to integrate Closed-Loop Communication into daily habits of verbal interaction in every health care setting. One way to practice the utilization of Closed-Loop Communication is simulation. The investigators seek to investigate if simulation participants can incorporate CRM strategies such as Closed-Loop Communication into their communication repertoire. This shall serve as an example of attitude transfer following a simulation based learning experience.The primary study objective is to measure the success of simulation training for increasing Closed-Loop Communication as a behavioural change in the clinical setting.
- Conditions
- Pediatric Intensive Care Unit, Closed Loop Communication, In-situ Simulation, Behavioral Changes
- Being tested
- Simulation
- Medical subject headings
- Teach-Back Communication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SimulationOther
Intervention phase: Study participants will be subjected to on-site simulation training focusing on communication, including CRM and non-technical skills in the PICU setting.
| Study group | Role | What they receive |
|---|---|---|
| Pediatric intensive care unit-nurses | Other | Phase I: During the month leading up to the simulation two trained observers / raters will observe the rate of Closed-Loop Communication in the pediatric intensive care unit (PICU) among study participants.
Intervention phase: Study participants will be subjected to on-site simulation training focusing on communication, including CRM and non-technical skills in the PICU setting.
Phase II + III: During the follow up phase, trained raters will again observe the study-participating PICU staff relative to their communication behaviour in the month following simulation training (Phase II) and again three months later (Phase III). Receives: Other: Simulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of difference regarding employment of Closed-Loop communications measured by counting the call-outs for each participant in a defined timeframe in Phase I, II and III of the study
measurement of difference regarding the employment of Closed-Loop Communication in the clinical setting after three months of the simulation training focusing on crisis resource management (CRM) in communication and assessed by external raters and compared to baseline before such training. Based on a study by Härgestam et al. (2013) we classified the call-outs as command (com), question (que), observation (obs) or suggestion (sug). Furthermore, after our experience during the pilot phase we added the category information (inf), since we could not sort a number of call-outs into the existing four categories
Measured: 3 months
Secondary outcomes (3)
Rate of Closed-Loop Communication measured by counting the call-outs for each participant in a defined timeframe in Phase I, II and III of the study
rate of Closed-Loop Communication following the simulation as assessed by external raters
Measured: 3 months
Measurement of difference regarding employment of Closed-Loop communications measured by counting the reaction to call-outs for each participant in a defined timeframe in Phase I, II and III of the study
measurement of difference regarding the employment of Closed-Loop Communication while reacting to a call-outs in the clinical setting after three months of the simulation training focusing on crisis resource management (CRM) in communication and assessed by external raters and compared to baseline before such training. Inspired by the study by Boyd et al (2014) the reaction to the call-out will be as follows categorized: no response (no-check), call-back (check), verbal response (verb-res.), nonverbal response (noverb-res.) and closed-loop (check-close).
Measured: 3 months
Rate of Closed-Loop Communication measured by counting the reactions to call-outs for each participant in a defined timeframe in Phase I, II and III of the study
rate of Closed-Loop Communication following the simulation as assessed by external raters
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2018
- Study start1 Apr 2017
- Primary completion31 Dec 2017
- Study completion25 Jan 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 Pediatric Intensive Care UnitStudies 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Open interventional before and after study on the effect of on-site full-scale simulation with a subsequent course follow-up and a three month follow-up observation pertaining to behavioural changes in communication of the paediatric intensive care unit staff that is participating in the on-site simulation training
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Insel Gruppe AG, University Hospital Bern
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Thomas Riva, MD, Study director, University of Bern
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03600298
- Sponsor's protocol ID
- Ulmer-Riva2017
- Status last verified
- Jul 2018
- First submitted
- 28 Jun 2018
- Last updated
- 26 Jul 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Ulmer FF, Lutz AM, Muller F, Riva T, Butikofer L, Greif R. Communication Patterns During Routine Patient Care in a Pediatric Intensive Care Unit: The Behavioral Impact of In Situ Simulation. J Patient Saf. 2022 Mar 1;18(2):e573-e579. doi: 10.1097/PTS.0000000000000872.
PubMed 34224500
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Simulation Enhance Closed-Loop Communication in the Clinical Setting of a Pediatric Intensive Care Unit?
- ClinicalTrials.gov ID
- NCT03600298
- Acronym / sponsor ID
- Ulmer-Riva2017
- Conditions
- Pediatric Intensive Care Unit, Closed Loop Communication, In-situ Simulation, Behavioral Changes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Insel Gruppe AG, University Hospital BernUniversity, hospital or other
- Study start
- 1 Apr 2017 (actual)
- Primary completion
- 31 Dec 2017 (actual)
- Study completion
- 25 Jan 2018 (actual)
- First posted
- 26 Jul 2018 (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.
Open interventional before and after study on the effect of on-site full-scale simulation with a subsequent course follow-up and a three month follow-up observation pertaining to behavioural changes in communication of the paediatric intensive care unit staff that is participating in the on-site simulation training.
Detailed description
Closed-Loop Communication (CLC) is a proposed, taught and practiced Crisis Resource Management (CRM) strategy thought to be effective for enhancing patient safety by enforcing reiteration and clarity, thus reducing ambiguity during verbal communication among health care providers. The transfer of this CRM strategy into clinical practice seems to require recurring exposure. Teaching and training is needed to help health care providers develop routine in communicating. This training is most effective if practiced in the clinical setting that is familiar to the health care provider (in situ simulation). As trainees become more proficient, the ultimate goal is to integrate Closed-Loop Communication into daily habits of verbal interaction in every health care setting. One way to practice the utilization of Closed-Loop Communication is simulation. The investigators seek to investigate if simulation participants can incorporate CRM strategies such as Closed-Loop Communication into their communication repertoire. This shall serve as an example of attitude transfer following a simulation based learning experience.The primary study objective is to measure the success of simulation training for increasing Closed-Loop Communication as a behavioural change in the clinical setting.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Open interventional before and after study on the effect of on-site full-scale simulation with a subsequent course follow-up and a three month follow-up observation pertaining to behavioural changes in communication of the paediatric intensive care unit staff that is participating in the on-site simulation training
| Arm | Type | Receives |
|---|---|---|
| Pediatric intensive care unit-nurses | Other | Other: SimulationPhase I: During the month leading up to the simulation two trained observers / raters will observe the rate of Closed-Loop Communication in the pediatric intensive care unit (PICU) among study participants. Intervention phase: Study participants will be subjected to on-site simulation training focusing on communication, including CRM and non-technical skills in the PICU setting. Phase II + III: During the follow up phase, trained raters will again observe the study-participating PICU staff relative to their communication behaviour in the month following simulation training (Phase II) and again three months later (Phase III). |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Employees, with written informed consent, working in the paediatric intensive care unit of the Children's Bern University Hospital
- Employees novices to in-situ simulation
Key exclusion criteria (3 listed)
- employees, working in the paediatric intensive care unit of the Children's Bern University Hospital who are not fluent in German or Swiss German.
- employees, working in the paediatric intensive care unit of the Children's Bern University Hospital who are unable to be observed during phases I and II and during the follow up phase (see below).
- No vulnerable participants will be included.
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 |
|---|---|---|
| SimulationIntervention phase: Study participants will be subjected to on-site simulation training focusing on communication, including CRM and non-technical skills in the PICU setting. | Other | Pediatric intensive care unit-nurses |
Primary outcome
Measurement of difference regarding employment of Closed-Loop communications measured by counting the call-outs for each participant in a defined timeframe in Phase I, II and III of the study
Time frame: 3 months
measurement of difference regarding the employment of Closed-Loop Communication in the clinical setting after three months of the simulation training focusing on crisis resource management (CRM) in communication and assessed by external raters and compared to baseline before such training. Based on a study by Härgestam et al. (2013) we classified the call-outs as command (com), question (que), observation (obs) or suggestion (sug). Furthermore, after our experience during the pilot phase we added the category information (inf), since we could not sort a number of call-outs into the existing four categories
3 secondary outcomes
Rate of Closed-Loop Communication measured by counting the call-outs for each participant in a defined timeframe in Phase I, II and III of the study
Time frame: 3 months
Measurement of difference regarding employment of Closed-Loop communications measured by counting the reaction to call-outs for each participant in a defined timeframe in Phase I, II and III of the study
Time frame: 3 months
Rate of Closed-Loop Communication measured by counting the reactions to call-outs for each participant in a defined timeframe in Phase I, II and III of the study
Time frame: 3 months
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 26 Jul 2018.
- Derived from this study: PubMed 34224500Ulmer FF, Lutz AM, Muller F, Riva T, Butikofer L, Greif R. Communication Patterns During Routine Patient Care in a Pediatric Intensive Care Unit: The Behavioral Impact of In Situ Simulation. J Patient Saf. 2022 Mar 1;18(2):e573-e579. doi: 10.1097/PTS.0000000000000872.
Related trials for Pediatric Intensive Care Unit
Not yet recruitingObservational study
PICS-p Longitudinal Cohort Study
Physical Functional Impairment, Cognitive Impairment
Not yet recruitingObservational study
pSOFA Score in Predicting Mortality in Pediatric Intensive Care
Critical Illness, Multiple Organ Dysfunction Syndrome
Recruiting
Probiotic Role in Prevention of Ventilator Associated Pneumonia in Critically- Ill Children Admitted at Pediatric Intensive Care Unit
Probiotic, Ventilator Associated Pneumonia
Not yet recruitingPhase 3
Impact on Delirium of the Use of DEXmedetomidine as First-line Sedation in PEDIAtric Intensive Care
Delirium in the Intensive Care Unit
RecruitingObservational study
A Korean Point Prevalence Study of Acute Rehabilitation for Kids in the PICU (PARK-PICU)
Pediatric Intensive Care Units
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.
Thomas Riva, MD study director
University of Bern
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Simulation in people with Pediatric Intensive Care Unit and Closed Loop Communication, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
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 2 inclusion and 3 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 26 Jul 2018. 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 Switzerland. 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?
Measurement of difference regarding employment of Closed-Loop communications measured by counting the call-outs for each participant in a defined timeframe in Phase I, II and III of the study (time frame: 3 months). 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 NCT03600298, 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 26 Jul 2018.