Simulation Training of Closed-Loop Communication (CLC)

NCT03600298 | Completed DMC

• 1 other identifier: Ulmer-Riva2017
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pediatric Intensive Care Unit; Closed Loop Communication; In-situ Simulation; Behavioral Changes

Outcome Measures

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

  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 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

  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

  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

  3 months

Study Arms (1)

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).

Other: Simulation

Interventions

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.

Pediatric intensive care unit-nurses

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Insel Gruppe AG, University Hospital Bern: lead

Study Sites (1)

University Hospital Bern

Bern, 3010, Switzerland

Location

Related Publications (1)

• 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.

  PMID: 34224500 DERIVED

MeSH Terms

Conditions

Teach-Back Communication

Condition Hierarchy (Ancestors)

Communication; Behavior

Study Officials

• Thomas Riva, MD

  University of Bern

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: June 28, 2018
• First Posted: July 26, 2018
• Study Start: April 1, 2017
• Primary Completion: December 31, 2017
• Study Completion: January 25, 2018
• Last Updated: July 26, 2018

Record last verified: 2018-07

Locations

CH (1)