Simulation Training of Closed-Loop Communication (CLC)

Behavioral Changes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03600298
• Other study ID #: Ulmer-Riva2017
• Status: Completed
• Phase: N/A
• Start date: April 1, 2017
• Est. completion date: January 25, 2018

Study information

• Verified date: July 2018
• Source: University Hospital Inselspital, Berne
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: January 25, 2018
• Est. primary completion date: December 31, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Behavioral Changes
• Closed Loop Communication
• In-situ Simulation
• Pediatric Intensive Care Unit
• Problem Behavior

Intervention

Other:
• Simulation
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.

Locations

Country	Name	City	State
Switzerland	University Hospital Bern	Bern

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Inselspital, Berne

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	3 months
Secondary	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	3 months
Secondary	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).	3 months
Secondary	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	3 months