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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
Sponsor:
Collaborator:
VA Office of Research and Development
Information provided by (Responsible Party):
NYU Langone Health

Brief Summary:
The primary objective of the proposed study will be to determine if a multi-modality teaching curriculum utilizing high-fidelity simulation and didactic lecture will result in sustained improvement by internal medicine residents in written knowledge and clinical performance when compared to residents receiving a curriculum utilizing only didactic lecture. The investigators hypothesis is that the addition of high-fidelity simulation to a traditional didactic lecture curriculum will result in sustained and superior written knowledge and practical performance when compared to a group receiving only didactic lecture on the same topic. Specifically, the investigators will be assessing internal medicine resident knowledge and performance in the area of sepsis in the hospitalized patient, and will shape the investigators teaching curriculum around this focus.

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

Detailed Description:

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Debriefing of high-fidelity sepsis simulation scenarios

First visit:

  • Subjects will fill out a self-assessment focusing on perceptions of their knowledge and ability in the recognition and management of sepsis in hospitalized patient
  • Subjects will be specifically exposed to high-fidelity simulated sepsis scenarios and be debriefed on their performance in these scenarios (intervention)
  • Subjects will take a written test focusing on early recognition and management of sepsis
  • Subjects will receive a didactic teaching session focusing on recognition and management of early sepsis in the hospitalized patient

In the second visit:

  • Subjects will be exposed to a number of high-fidelity simulated sepsis scenarios and be scored on their performance in management of these scenarios
  • Subjects will take a written test of knowledge focusing on early recognition and management of sepsis
  • Subjects will then be debriefed specifically on their performance in the simulation scenarios
Other: Debriefing of high-fidelity sepsis simulation scenarios
Educational intervention
Other Names:
  • Education
  • High-fidelity simulation
  • Debriefing

Placebo Comparator: Debriefing of high-fidelity non-sepsis simulation scenarios

First visit:

  • Subjects will fill out a self-assessment survey of their perceptions of their knowledge and ability in the recognition and management of sepsis in the hospitalized patient
  • Subjects will be exposed to high-fidelity simulation scenarios (non-sepsis) and be debriefed in terms of their performance in these scenarios
  • Subjects will take a written test of knowledge focusing on early recognition and management of sepsis
  • Subjects will receive a didactic teaching session focusing on recognition and management of early sepsis in the hospitalized patient

In the second visit:

  • Subjects will be exposed to a number of high-fidelity simulated sepsis scenarios and be scored on their performance in management of the scenarios
  • Subjects will take a written test of knowledge focusing on early recognition and management of sepsis
  • Subjects will then be debriefed specifically on their performance in the simulation scenarios
Other: Placebo: Debriefing of high-fidelity non-sepsis simulation scenarios



Primary Outcome Measures :
  1. 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

  2. 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


Secondary Outcome Measures :
  1. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • English-speaking internal medicine resident trainees

Exclusion Criteria:

  • Anyone not meeting inclusion criteria

Information from the National Library of Medicine

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


Locations
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United States, New York
VA Harbor Simulation Center
New York, New York, United States, 10010
Sponsors and Collaborators
NYU Langone Health
VA Office of Research and Development
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Responsible Party: NYU Langone Health
ClinicalTrials.gov Identifier: NCT01992120    
Other Study ID Numbers: VA01419
First Posted: November 25, 2013    Key Record Dates
Last Update Posted: December 8, 2015
Last Verified: December 2015
Keywords provided by NYU Langone Health:
Simulation
Sepsis
High-fidelity
Severe Sepsis
Septic Shock
Education
Additional relevant MeSH terms:
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Sepsis
Toxemia
Systemic Inflammatory Response Syndrome
Infection
Inflammation
Pathologic Processes
Shock