NCT01992120

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2013

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 30, 2013

Completed
2 days until next milestone

Study Start

First participant enrolled

November 1, 2013

Completed
24 days until next milestone

First Posted

Study publicly available on registry

November 25, 2013

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2014

Completed
Last Updated

December 8, 2015

Status Verified

December 1, 2015

Enrollment Period

8 months

First QC Date

October 30, 2013

Last Update Submit

December 7, 2015

Conditions

Keywords

SimulationSepsisHigh-fidelitySevere SepsisSeptic ShockEducation

Outcome Measures

Primary Outcomes (2)

  • Performance on a written assessment of the recognition and management of early sepsis in the hospitalized patient.

    Written test

    2-4 months after intervention

  • 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

Secondary Outcomes (1)

  • Self-assessment of knowledge and ability in the recognition and management of early sepsis in the hospitalized patient.

    2-4 months after intervention

Study Arms (2)

Debriefing of high-fidelity sepsis simulation scenarios

EXPERIMENTAL

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

Debriefing of high-fidelity non-sepsis simulation scenarios

PLACEBO COMPARATOR

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

Interventions

Educational intervention

Also known as: Education, High-fidelity simulation, Debriefing
Debriefing of high-fidelity sepsis simulation scenarios
Debriefing of high-fidelity non-sepsis simulation scenarios

Eligibility Criteria

Age20 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • English-speaking internal medicine resident trainees

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

VA Harbor Simulation Center

New York, New York, 10010, United States

Location

MeSH Terms

Conditions

SepsisShock, Septic

Interventions

Educational StatusCrisis Intervention

Condition Hierarchy (Ancestors)

InfectionsSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and SymptomsShock

Intervention Hierarchy (Ancestors)

Socioeconomic FactorsPopulation CharacteristicsPsychotherapyBehavioral Disciplines and Activities

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 30, 2013

First Posted

November 25, 2013

Study Start

November 1, 2013

Primary Completion

July 1, 2014

Study Completion

July 1, 2014

Last Updated

December 8, 2015

Record last verified: 2015-12

Locations