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OpenTrials
Completed

NCT Number: NCT03600298

Simulation Training of Closed-Loop Communication (CLC)

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.

Completed

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Key information

Age range

20 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital Bern

Bern, 3010, Switzerland

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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.

Treatment and study plan

simulation

Other

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.

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

    rate of Closed-Loop Communication following the simulation as assessed by external raters

  2. 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

    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).

  3. 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

    rate of Closed-Loop Communication following the simulation as assessed by external raters

Sponsors and collaborators

Lead sponsor

Insel Gruppe AG, University Hospital Bern

Other

Registry information

Official study title

Does Simulation Enhance Closed-Loop Communication in the Clinical Setting of a Pediatric Intensive Care Unit?

Important dates

Study start
2017
Primary completion
2017
Study completion
2018
First posted
Jul 26, 2018
Registry last updated
Jul 26, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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