Simulation Training of Closed-Loop Communication (CLC)

• ClinicalTrials.gov Identifier: NCT03600298
• Recruitment Status: Completed
• First Posted: July 26, 2018
• Last Update Posted: July 26, 2018
• Sponsor: University Hospital Inselspital, Berne
• Information provided by (Responsible Party): University Hospital Inselspital, Berne

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Pediatric Intensive Care Unit; Closed Loop Communication; In-situ Simulation; Behavioral Changes	Other: Simulation	Not Applicable

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

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 15 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Intervention 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)
• Primary Purpose: Treatment
• Official Title: Does Simulation Enhance Closed-Loop Communication in the Clinical Setting of a Pediatric Intensive Care Unit?
• Actual Study Start Date: April 1, 2017
• Actual Primary Completion Date: December 31, 2017
• Actual Study Completion Date: January 25, 2018

Arms and Interventions

Arm

Intervention/treatment

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.

Outcome Measures

Primary Outcome Measures :

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 Outcome Measures :

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

Eligibility Criteria

• Ages Eligible for Study: 20 Years to 65 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

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.

Contacts and Locations

Locations

Switzerland

University Hospital Bern

Bern, Switzerland, 3010

Sponsors and Collaborators

University Hospital Inselspital, Berne

Investigators

• Study Director: Thomas Riva, MD; University of Bern

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Ulmer FF, Lutz AM, Müller F, Riva T, Bütikofer 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.

• Responsible Party: University Hospital Inselspital, Berne
• ClinicalTrials.gov Identifier: NCT03600298
• Other Study ID Numbers: Ulmer-Riva2017
• First Posted: July 26, 2018
• Last Update Posted: July 26, 2018
• Last Verified: July 2018

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Problem Behavior; Behavioral Symptoms