Utility of High-Fidelity Simulation In the Education and Assessment of Residents in the Recognition and Management of the Sepsis Syndrome
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|ClinicalTrials.gov Identifier: NCT01992120|
Recruitment Status : Terminated (Key Personnel left institution)
First Posted : November 25, 2013
Last Update Posted : December 8, 2015
|Condition or disease||Intervention/treatment||Phase|
|Medical Knowledge Clinical Performance||Other: Debriefing of high-fidelity sepsis simulation scenarios Other: Placebo: Debriefing of high-fidelity non-sepsis simulation scenarios||Not Applicable|
This is a randomized prospective single-blinded pilot study. Residents from the internal medicine residency program will be assigned a unique number to de-identify them, and then randomized, stratified by post-graduate year (PGY) level, by random number generator to intervention and control groups. Only de-identified information will be used in subsequent analysis, and no individual results will be used. Residents will not know to which group they have been randomized.
Both the intervention and control groups will take a pre-course survey assessing their level of training, area of specialty/interest, and level of confidence in the recognition and management of sepsis.
Both the intervention and control groups will then be put through 2-4 simulated scenarios using high-fidelity simulation. In the intervention group, these scenarios will be sepsis syndrome scenarios. In the control group, non-sepsis scenarios will be administered.
Immediately following the scenarios, a written knowledge quiz focusing on recognition and management of sepsis will be administered to subjects in both groups.
Following the quiz, there will be a debrief session for subjects in both groups of the simulation scenarios, pointing out what was done correctly and what was not.
There will then be a brief didactic teaching session focusing on recognition and management of sepsis administered to subjects in both groups.
2-4 months later, subjects in both groups will be brought back to the simulation lab and tested on a new identical set of simulated sepsis scenarios. This will be videotaped and scored by an impartial volunteer who will score performance according to a check-list of critical actions. Following the simulated scenarios, the written quiz administered at the first visit will be given again. Subjects in both groups will then get debriefed on their performance.
Data can then be compared between the control and intervention group in terms of written and practical performance. Other potential analyses include before and after performance in the intervention group, comparison between the intervention and control groups, as well as subanalysis by PGY level. Student's paired and unpaired t-test will be the model for statistical analysis, and the investigators will utilize a statistician for data analysis.
In developing and implementing a multi-modality sepsis teaching curriculum, and demonstrating its superiority to a didactic-only curriculum, the investigators hope to justify the permanent implementation of a multi-modality teaching module to educate residents (and other healthcare personnel) which will lead to improved recognition and management of sepsis and improved patient outcomes.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||40 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Utility of High-Fidelity Simulation In the Education and Assessment of Residents in the Recognition and Management of the Sepsis Syndrome|
|Study Start Date :||November 2013|
|Actual Primary Completion Date :||July 2014|
|Actual Study Completion Date :||July 2014|
Experimental: Debriefing of high-fidelity sepsis simulation scenarios
In the second visit:
Other: Debriefing of high-fidelity sepsis simulation scenarios
Placebo Comparator: Debriefing of high-fidelity non-sepsis simulation scenarios
In the second visit:
Other: Placebo: Debriefing of high-fidelity non-sepsis simulation scenarios
- Performance on a written assessment of the recognition and management of early sepsis in the hospitalized patient. [ Time Frame: 2-4 months after intervention ]Written test
- Performance on a practical assessment of the recognition and management of early sepsis in the hospitalized patient. [ Time Frame: 2-4 months after intervention ]Graded performance in simulated sepsis scenario utilizing high-fidelity simulation
- Self-assessment of knowledge and ability in the recognition and management of early sepsis in the hospitalized patient. [ Time Frame: 2-4 months after intervention ]Written self-assessment survey
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01992120
|United States, New York|
|VA Harbor Simulation Center|
|New York, New York, United States, 10010|