Simulation Training of Closed-Loop Communication (CLC)

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.

Study Overview

• Status: Completed
• Conditions: Behavioral Changes; Pediatric Intensive Care Unit; Closed Loop Communication; In-situ Simulation
• Intervention / Treatment: Other: Simulation

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 Type: Interventional
• Enrollment (Actual): 15
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Switzerland
  • Bern, Switzerland, 3010
    • University Hospital Bern

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 63 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Other: Pediatric intensive care unit-nurses; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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

Collaborators and Investigators

• Sponsor: University Hospital Inselspital, Berne
• Investigators: Study Director: Thomas Riva, MD, University of Bern

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2017
• Primary Completion (Actual): December 31, 2017
• Study Completion (Actual): January 25, 2018

Study Registration Dates

• First Submitted: June 28, 2018
• First Submitted That Met QC Criteria: July 24, 2018
• First Posted (Actual): July 26, 2018

Study Record Updates

• Last Update Posted (Actual): July 26, 2018
• Last Update Submitted That Met QC Criteria: July 24, 2018
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: Ulmer-Riva2017

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No