Utility of High-Fidelity Simulation In the Education and Assessment of Residents in the Recognition and Management of the Sepsis Syndrome

Clinical Performance Clinical Trial

Official title:

Utility of High-Fidelity Simulation In the Education and Assessment of Residents in the Recognition and Management of the Sepsis Syndrome

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01992120
• Other study ID #: VA01419
• Status: Terminated
• Phase: N/A
• First received: October 30, 2013
• Last updated: December 7, 2015
• Start date: November 2013
• Est. completion date: July 2014

Study information

• Verified date: December 2015
• Source: New York University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 40
• Est. completion date: July 2014
• Est. primary completion date: July 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 20 Years to 60 Years

Eligibility

Inclusion Criteria:

• English-speaking internal medicine resident trainees

Exclusion Criteria:

• Anyone not meeting inclusion criteria

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject)

Related Conditions & MeSH terms

• Clinical Performance
• Medical Knowledge
• Sepsis
• Systemic Inflammatory Response Syndrome
• Toxemia

Intervention

Other:
• Debriefing of high-fidelity sepsis simulation scenarios
Educational intervention
• Placebo: Debriefing of high-fidelity non-sepsis simulation scenarios

Locations

Country	Name	City	State
United States	VA Harbor Simulation Center	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
New York University School of Medicine	VA Office of Research and Development

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Performance on a written assessment of the recognition and management of early sepsis in the hospitalized patient.	Written test	2-4 months after intervention	No
Primary	Performance on a practical assessment of the recognition and management of early sepsis in the hospitalized patient.	Graded performance in simulated sepsis scenario utilizing high-fidelity simulation	2-4 months after intervention	No
Secondary	Self-assessment of knowledge and ability in the recognition and management of early sepsis in the hospitalized patient.	Written self-assessment survey	2-4 months after intervention	No