Pediatric Cardiac Arrest (Simulated)EXPRESSNCT01682629
Examining the Effect of a Scripted Debriefing on Resuscitation Performance in Pediatrics
A study testing Debriefing Script and High Physical Realism Simulation in people with Pediatric Cardiac Arrest (Simulated), run by KidSIM Simulation Program at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Pediatric Cardiac Arrest (Simulated)
- What is being tested?
- Debriefing Script and High Physical Realism Simulation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 443 participants
- Where
- 1 siteCanada
- Study dates
- Apr 2009to Feb 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
- 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
Who cannot join
- experienced instructors, defined as having taught three or more courses for healthcare professionals where simulation was followed by debriefing
- N/A
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Examining Pediatric Resuscitation Education Using Simulation and Scripted Debriefing: A Multicenter, Randomized Controlled Trial
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 :
Read more
- 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;
- 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:
- 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;
- 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;
- Conditions
- Pediatric Cardiac Arrest (Simulated)
- Being tested
- Debriefing Script, High Physical Realism Simulation
- Keywords
- Pediatric, Cardiac, Arrest, Simulation, Debriefing, Realism
- Medical subject headings
- Heart Arrest
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Non-Scripted Debriefing, Low Realism Simulation | No intervention | A debriefing script was designed for novice instructors to facilitate a 20-minute debriefing session. In this arm, novice instructors were provided the scenario learning objectives but NO SCRIPT, and asked to observe the simulation and conduct a 20 minute debriefing. The simulation scenario itself was conducted with an infant simulator. The low realism group had the simulator with the compressor turned off, thus eliminating the functionality of physical findings. |
| Scripted debriefing, Low Realism | Experimental | In this arm, novice instructors were provided the scenario learning objectives WITH A DEBRIEFING SCRIPT, and asked to observe the simulation and conduct a 20 minute debriefing USING THE SCRIPT. The lo realism group had the simulator with the compressor turned on, thus eliminating the functionality of physical findings. Receives: Other: Debriefing Script |
| non-Scripted Debriefing, High Realism Simulation | Experimental | In this arm, novice instructors were provided the scenario learning objectives WITHOUT A DEBRIEFING SCRIPT, and asked to observe the simulation and conduct a 20 minute debriefing WITHOUT USING THE SCRIPT. The hi realism group had the simulator with the compressor turned on, thus activating the functionality of physical findings. Receives: Other: High Physical Realism Simulation |
| Scripted Debriefing, High Realism Simulation | Experimental | In this arm, novice instructors were provided the scenario learning objectives WITH A DEBRIEFING SCRIPT, and asked to observe the simulation and conduct a 20 minute debriefing USING THE SCRIPT. The hi realism group had the simulator with the compressor turned on, thus activating the functionality of physical findings. Receives: Other: Debriefing Script; Other: High Physical Realism Simulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline of one hour (post debreifing) - note: reporting change in timeframe for all 3 outcome measures
Secondary outcomes (2)
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.
Measured: Baseline of one hour (post debreifing) - note: reporting change in timeframe for all 3 outcome measures
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.
Measured: Baseline of one hour (post debreifing) - note: reporting change in timeframe for all 3 outcome measures
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2012 (estimated)
- Study startApr 2009
- Primary completionFeb 2011
- Study completionFeb 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Pediatric Cardiac Arrest (Simulated)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 443 participants (actual)
Sponsor and investigators
- Lead sponsor
- KidSIM Simulation Program
- Sponsor type
- Research network
- Collaborators
- American Heart Association
- Responsible party
- Sponsor
- Investigators
- Vinay Nadkarni, MD, Study chair, Children's Hospital of PhiladelphiaElizabeth Hunt, MD, Study director, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01682629
- Sponsor's protocol ID
- 1-Robertson
- Acronym
- EXPRESS
- Status last verified
- Sep 2012
- First submitted
- 5 Sep 2012
- Last updated
- 11 Sep 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 18675032Eppich 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. doi: 10.1097/01.mop.0000193309.22462.c9.
PubMed 16721146Eppich 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.
PubMed 18475092Issenberg 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. doi: 10.1001/jama.282.9.861.
PubMed 10478693Donoghue 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.
PubMed 19262421Nelson 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.
PubMed 19088657Rudolph 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. doi: 10.1016/j.anclin.2007.03.007.
PubMed 17574196Donoghue 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.
PubMed 20047787LeFlore JL, Anderson M. Alternative educational models for interdisciplinary student teams. Simul Healthc. 2009 Fall;4(3):135-42. doi: 10.1097/SIH.0b013e318196f839.
PubMed 19680079Cheng 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.
PubMed 21613969Issenberg 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. doi: 10.1080/01421590500046924.
PubMed 16147767Rudolph 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. No abstract available.
PubMed 19088618
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Examining Pediatric Resuscitation Education Using Simulation and Scripted Debriefing: A Multicenter, Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01682629
- Acronym / sponsor ID
- EXPRESS / 1-Robertson
- Conditions
- Pediatric Cardiac Arrest (Simulated)
- Keywords
- Pediatric, Cardiac, Arrest, Simulation, Debriefing, Realism
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 443 participants (actual)
- Lead sponsor
- KidSIM Simulation ProgramResearch network
- Collaborators
- American Heart Association
- Study start
- Apr 2009
- Primary completion
- Feb 2011 (actual)
- Study completion
- Feb 2011 (actual)
- First posted
- 11 Sep 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 :
- 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;
- 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:
- 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;
- 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 design
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Non-Scripted Debriefing, Low Realism Simulation | No intervention | –A debriefing script was designed for novice instructors to facilitate a 20-minute debriefing session. In this arm, novice instructors were provided the scenario learning objectives but NO SCRIPT, and asked to observe the simulation and conduct a 20 minute debriefing. The simulation scenario itself was conducted with an infant simulator. The low realism group had the simulator with the compressor turned off, thus eliminating the functionality of physical findings. |
| Scripted debriefing, Low Realism | Experimental | Other: Debriefing ScriptIn this arm, novice instructors were provided the scenario learning objectives WITH A DEBRIEFING SCRIPT, and asked to observe the simulation and conduct a 20 minute debriefing USING THE SCRIPT. The lo realism group had the simulator with the compressor turned on, thus eliminating the functionality of physical findings. |
| non-Scripted Debriefing, High Realism Simulation | Experimental | Other: High Physical Realism SimulationIn this arm, novice instructors were provided the scenario learning objectives WITHOUT A DEBRIEFING SCRIPT, and asked to observe the simulation and conduct a 20 minute debriefing WITHOUT USING THE SCRIPT. The hi realism group had the simulator with the compressor turned on, thus activating the functionality of physical findings. |
| Scripted Debriefing, High Realism Simulation | Experimental | Other: Debriefing Script, Other: High Physical Realism SimulationIn this arm, novice instructors were provided the scenario learning objectives WITH A DEBRIEFING SCRIPT, and asked to observe the simulation and conduct a 20 minute debriefing USING THE SCRIPT. The hi realism group had the simulator with the compressor turned on, thus activating the functionality of physical findings. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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
- 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
Key exclusion criteria (2 listed)
- experienced instructors, defined as having taught three or more courses for healthcare professionals where simulation was followed by debriefing
- N/A
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Debriefing ScriptA 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. | Other | Scripted Debriefing, High Realism Simulation, Scripted debriefing, Low Realism |
| High Physical Realism SimulationHigh 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. | Other | Scripted Debriefing, High Realism Simulation, non-Scripted Debriefing, High Realism Simulation |
Primary outcome
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.
2 secondary outcomes
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
Multiple Choice Test (Knowledge)
Time frame: Baseline of one hour (post debreifing) - note: reporting change in timeframe for all 3 outcome measures
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2012.
- Background: PubMed 18675032Hunt 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.
- Background: PubMed 16721146Eppich 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. doi: 10.1097/01.mop.0000193309.22462.c9.
- Background: PubMed 18475092Eppich 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.
- Background: PubMed 10478693Issenberg 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. doi: 10.1001/jama.282.9.861.
- Background: PubMed 19262421Donoghue 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.
- Background: PubMed 19088657Nelson 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.
- Background: PubMed 17574196Rudolph 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. doi: 10.1016/j.anclin.2007.03.007.
- Background: PubMed 20047787Donoghue 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.
- Background: PubMed 19680079LeFlore JL, Anderson M. Alternative educational models for interdisciplinary student teams. Simul Healthc. 2009 Fall;4(3):135-42. doi: 10.1097/SIH.0b013e318196f839.
- Background: PubMed 21613969Cheng 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.
- Background: PubMed 16147767Issenberg 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. doi: 10.1080/01421590500046924.
- Background: PubMed 19088618Rudolph 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. No abstract available.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vinay Nadkarni, MD study chair
Children's Hospital of Philadelphia
Elizabeth Hunt, MD study director
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Debriefing Script and High Physical Realism Simulation in people with Pediatric Cardiac Arrest (Simulated), run by KidSIM Simulation Program at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Sep 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01682629, which also lists 12 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2012.