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Completed

NCT Number: NCT01682629

Examining the Effect of a Scripted Debriefing on Resuscitation Performance in Pediatrics

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;

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Key information

Conditions

Pediatric Cardiac Arrest (Simulated) Cardiovascular Diseases Heart Arrest Heart Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

BC Children's Hospital

Vancouver, British Columbia, V6H3N1, Canada

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

(Novice Instructors):

  • senior residents (general pediatric, emergency medicine, pediatric subspecialty) in year three of training or above
  • nursing staff, respiratory therapists or paramedics with greater than 5 years of clinical experience
  • recent PALS certification within the past 2 years

Inclusion criteria

(Team composition)

  • 1 or 2 pediatric nurses, 2 physicians (residents/fellows in pediatrics, anesthesia, family medicine, emergency medicine, pediatric emergency medicine, pediatric critical care or pediatric anesthesia) and/or 1 pediatric respiratory therapist or 1 pediatric transport paramedic

Exclusion criteria

(Novice Instructors):

  • experienced instructors, defined as having taught three or more courses for healthcare professionals where simulation was followed by debriefing

Exclusion criteria

(Team composition)

  • N/A

Treatment and study plan

Debriefing Script

Other

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 Simulation

Other

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.

Primary outcomes

  1. Behavioural Assessment Tool Score (Percentage 0-100%)

    Time frame: Baseline of one hour (post debreifing) - note: reporting change in timeframe for all 3 outcome measures

    Behavioral Assessment Tool The Behavioral Assessment Tool (BAT) was used to assess the team leader's crisis resource management skills during the pre and post-simulation scenarios. Each behavior is rated on a five-point Likert scale, where a score of one represents poor behavioral performance in the category and a score of five reflects excellent performance. Each behavior is supplement by descriptive anchors for poor (1), average (3) and excellent performance (5). Previous work done by LeFlore et al has focused on establishing reliability and validity of the tool in varying contexts. In a study of nurse practitioner students, data demonstrated a Cronbach's alpha of 0.97 with an intraclass correlation coefficient of 0.84 (p<0.001). In a different study assessing alternative educational models for interdisciplinary student teams, the BAT was used to assess behavioral performance and the Cronbach's alpha was 0.956.

Secondary outcomes

  1. Clinical Performance Tool Score (Percentage 0-100%)

    Time frame: Baseline of one hour (post debreifing) - note: reporting change in timeframe for all 3 outcome measures

    The Clinical Performance Tool, with 21 individual items, designed for evaluation of Pediatric Advanced Life Support scenarios, was utilized to assess clinical performance of the team. A total score (maximum 42 points) was converted into a percentage (0-100%) for analysis.

  2. Multiple Choice Test (Knowledge)

    Time frame: Baseline of one hour (post debreifing) - note: reporting change in timeframe for all 3 outcome measures

    For the 20 question test, 15 questions designed to test medical knowledge were chosen from the existing American Heart Association Pediatric Advanced Life Support (PALS) question bank that have undergone rigorous validation, while 5 new questions were developed to assess knowledge of crisis resource management principles. As the study design required a "Test A and Test B", stems for the same questions were modified slightly (eg. different age of patient, different vital signs, different history) between the two different tests, but overall content and purpose of questions were structured to be the same.

Sponsors and collaborators

Lead sponsor

KidSIM Simulation Program

Network

Collaborators

  • American Heart Association

Registry information

Official study title

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

Acronym: EXPRESS

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Sep 11, 2012
Registry last updated
Sep 11, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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