CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 443 enrolled
Drug / intervention
Debriefing Script +1 moreother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01682629
NCT01682629N/ACompleted

Examining Pediatric Resuscitation Education Using Simulation and Scripted Debriefing: A Multicenter, Randomized Controlled Trial

KidSIM Simulation Program·interventional·Posted Sep 11, 2012·Updated Sep 11, 2012

In Brief

A clinical study evaluating Debriefing Script and High Physical Realism Simulation for Pediatric Cardiac Arrest (Simulated). Completed, enrolled 443 participants across 1 site.

Detailed Summary

The investigative team's purpose for conducting this research is to improve effective and efficient translation and implementation of evidence based advanced life support practice to providers of care for children. This specific project aims to accomplish 2 major goals. The investigators aim to evaluate the utility of a debriefing script specifically designed to facilitate debriefing when used by novice Pediatric Advanced Life Support instructors during low and high realism simulation-based learning. Secondly, the investigators hope to evaluate the effectiveness of high realism simulation vs. low realism simulation in achieving PALS-based educational outcomes, such as knowledge and skill acquisition. The investigators hypothesize that SCRIPTED debriefing by novice instructors following low and high fidelity simulation-based learning will : 1. Improve the cognitive performance and knowledge of multidisciplinary team members as assessed by a cognitive performance tool and multiple choice testing compared with more traditional, NON-SCRIPTED debriefing; 2. Improve the behavioural, teamwork and communication skills of multidisciplinary team members as assessed by a validated assessment tool compared with more traditional, NON-SCRIPTED debriefing; The investigators hypothesize that HIGH REALISM simulation-based learning will: 1. Improve the cognitive performance and knowledge of multidisciplinary team members as assessed by a cognitive performance tool and multiple choice testing compared with more traditional, LOW REALISM simulation; 2. Improve the behavioural, teamwork and communication skills of multidisciplinary team members as assessed by a validated assessment tool compared with more traditional, LOW REALISM simulation;

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesCanada

Timeline

N/ACompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedSep 11, 2012
Enrollment StartApr 1, 2009
Primary CompletionFeb 1, 2011
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 13.8 years ago

Interventions

Debriefing Scriptother

A debriefing script was designed for novice instructors to facilitate a 20-minute debriefing session. It was developed in iterative steps: (a) review of PALS learning objectives; (b) categorization of script content; (c) development of scripted language; (d) formatting into a cognitive aid and (e) pilot testing script for usability with subsequent edits before implementation in the study. All novice instructors received the scenario 2 weeks prior to the study session. Instructors randomized to scripted debriefing were also given the script with no instruction on how to use it except on the day of the study, to use and follow the script as closely as possible during the debriefing session. All instructors held a clipboard while observing the simulation session; to hold the debriefing script and/or take notes. This allowed for blinding of the video reviewers as to which study arm the team had been randomized. Debriefing sessions were limited to 20-minutes in duration.

High Physical Realism Simulationother

High vs. Low Physical Realism Simulators A pre-programmed infant simulator was used for all simulation sessions. To create "high" physical realism (HiR), full simulator functions were activated ("turned on") including vital sign monitoring, audio feedback, breath sounds, chest rise, heart sounds, palpable pulses, and vocalization. "Low" physical realism (LoR) groups had the identical simulator but the compressor was "turned off", thus eliminating physical findings described above. In addition, the LoR simulator was connected to a monitor, but it only displayed the cardiac rhythm, and not pulse oximetry, respiratory rate, blood pressure, temperature and audio feedback present in the HiR group. All other aspects of the simulated resuscitation environment were standardized for all groups.