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

Pediatric Cardiac Arrest (Simulated) Clinical Trial

— EXPRESS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01682629
• Other study ID #: 1-Robertson
• Status: Completed
• Phase: N/A
• First received: September 5, 2012
• Last updated: September 10, 2012
• Start date: April 2009
• Est. completion date: February 2011

Study information

• Verified date: September 2012
• Source: Express Collaborative
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial 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;

Recruitment information / eligibility

• Status: Completed
• Enrollment: 443
• Est. completion date: February 2011
• Est. primary completion date: February 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A and older

Eligibility

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)

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Single Blind (Outcomes Assessor)

Related Conditions & MeSH terms

• Heart Arrest
• Pediatric Cardiac Arrest (Simulated)

Intervention

Other:
• Debriefing Script
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
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.

Locations

Country	Name	City	State
Canada	BC Children's Hospital	Vancouver	British Columbia

Sponsors (2)

Lead Sponsor	Collaborator
Express Collaborative	American Heart Association

Country where clinical trial is conducted

Canada, 

References & Publications (12)

Cheng A, Nadkarni V, Hunt EA, Qayumi K; EXPRESS Investigators. A multifunctional online research portal for facilitation of simulation-based research: a report from the EXPRESS pediatric simulation research collaborative. Simul Healthc. 2011 Aug;6(4):239-43. doi: 10.1097/SIH.0b013e31821d5331. — View Citation

Donoghue A, Nishisaki A, Sutton R, Hales R, Boulet J. Reliability and validity of a scoring instrument for clinical performance during Pediatric Advanced Life Support simulation scenarios. Resuscitation. 2010 Mar;81(3):331-6. doi: 10.1016/j.resuscitation.2009.11.011. Epub 2010 Jan 4. — View Citation

Donoghue AJ, Durbin DR, Nadel FM, Stryjewski GR, Kost SI, Nadkarni VM. Effect of high-fidelity simulation on Pediatric Advanced Life Support training in pediatric house staff: a randomized trial. Pediatr Emerg Care. 2009 Mar;25(3):139-44. doi: 10.1097/PEC.0b013e31819a7f90. — View Citation

Eppich WJ, Adler MD, McGaghie WC. Emergency and critical care pediatrics: use of medical simulation for training in acute pediatric emergencies. Curr Opin Pediatr. 2006 Jun;18(3):266-71. Review. — View Citation

Eppich WJ, Brannen M, Hunt EA. Team training: implications for emergency and critical care pediatrics. Curr Opin Pediatr. 2008 Jun;20(3):255-60. doi: 10.1097/MOP.0b013e3282ffb3f3. Review. — View Citation

Hunt EA, Fiedor-Hamilton M, Eppich WJ. Resuscitation education: narrowing the gap between evidence-based resuscitation guidelines and performance using best educational practices. Pediatr Clin North Am. 2008 Aug;55(4):1025-50, xii. doi: 10.1016/j.pcl.2008.04.007. Review. — View Citation

Issenberg SB, McGaghie WC, Hart IR, Mayer JW, Felner JM, Petrusa ER, Waugh RA, Brown DD, Safford RR, Gessner IH, Gordon DL, Ewy GA. Simulation technology for health care professional skills training and assessment. JAMA. 1999 Sep 1;282(9):861-6. — View Citation

Issenberg SB, McGaghie WC, Petrusa ER, Lee Gordon D, Scalese RJ. Features and uses of high-fidelity medical simulations that lead to effective learning: a BEME systematic review. Med Teach. 2005 Jan;27(1):10-28. Review. — View Citation

LeFlore JL, Anderson M. Alternative educational models for interdisciplinary student teams. Simul Healthc. 2009 Fall;4(3):135-42. doi: 10.1097/SIH.0b013e318196f839. — View Citation

Nelson KL, Shilkofski NA, Haggerty JA, Saliski M, Hunt EA. The use of cognitive AIDS during simulated pediatric cardiopulmonary arrests. Simul Healthc. 2008 Fall;3(3):138-45. doi: 10.1097/SIH.0b013e31816b1b60. — View Citation

Rudolph JW, Simon R, Raemer DB. Which reality matters? Questions on the path to high engagement in healthcare simulation. Simul Healthc. 2007 Fall;2(3):161-3. doi: 10.1097/SIH.0b013e31813d1035. — View Citation

Rudolph JW, Simon R, Rivard P, Dufresne RL, Raemer DB. Debriefing with good judgment: combining rigorous feedback with genuine inquiry. Anesthesiol Clin. 2007 Jun;25(2):361-76. Review. — View Citation

* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Behavioural Assessment Tool Score (Percentage 0-100%)	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.	Baseline of one hour (post debreifing) - note: reporting change in timeframe for all 3 outcome measures	No
Secondary	Clinical Performance Tool Score (Percentage 0-100%)	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.	Baseline of one hour (post debreifing) - note: reporting change in timeframe for all 3 outcome measures	No
Secondary	Multiple Choice Test (Knowledge)	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.	Baseline of one hour (post debreifing) - note: reporting change in timeframe for all 3 outcome measures	No