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High-fidelity Simulation in Health Care Education

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ClinicalTrials.gov Identifier: NCT00690144
Recruitment Status : Unknown
Verified June 2010 by National Taiwan University Hospital.
Recruitment status was:  Recruiting
First Posted : June 4, 2008
Last Update Posted : June 29, 2010
Sponsor:
Information provided by:
National Taiwan University Hospital

Tracking Information
First Submitted Date  ICMJE May 28, 2008
First Posted Date  ICMJE June 4, 2008
Last Update Posted Date June 29, 2010
Study Start Date  ICMJE July 2007
Estimated Primary Completion Date June 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 3, 2008)
performance of clinical reasoning and skills in simulated settings [ Time Frame: before and after the simulation-based training ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00690144 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 3, 2008)
clinical performance of reasoning and skills [ Time Frame: before and after the simulation-based training ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE High-fidelity Simulation in Health Care Education
Official Title  ICMJE Prospective Study Focusing on Impact of High-fidelity Simulation in Health Care Education
Brief Summary The purpose of this study is to determine whether the use of high-fidelity simulation in health care education is an effective training and evaluation model.
Detailed Description High-fidelity simulation has many advantages in medical education. Simulation-based critical care training is especially valuable due to error-prone work settings and the high cost of patient adverse events. This study was conducted to assess the effectiveness of implementing the high-fidelity simulation in critical care training, and the feasibility of high-fidelity simulation as an evaluation tool.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Healthy
Intervention  ICMJE Device: High-fidelity high-fidelity mannequin simulator (SimMan, Laerdal, Stavanger, Norway).
Critical care training using high-fidelity simulation. The case scenarios were simulated by a high-fidelity mannequin simulator (SimMan, Laerdal, Stavanger, Norway).
Study Arms  ICMJE Experimental: simulation group
the trainees in the simulation group receive simulation-based training
Intervention: Device: High-fidelity high-fidelity mannequin simulator (SimMan, Laerdal, Stavanger, Norway).
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: June 3, 2008)
500
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 2011
Estimated Primary Completion Date June 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • healthcare trainees, including medical students, nursing students, residents, nursing staff and emergency medical technicians.

Exclusion Criteria:

  • any trainees unwilling to receive simulation-based training
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Taiwan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00690144
Other Study ID Numbers  ICMJE 200803078R
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Matthew Huei-Ming Ma, MD, PhD, National Taiwan University Hospital
Study Sponsor  ICMJE National Taiwan University Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Matthew Huei-Ming Ma, MD, PhD National Taiwan University Hospital
PRS Account National Taiwan University Hospital
Verification Date June 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP