Medical KnowledgeNCT01992120
Utility of High-Fidelity Simulation In the Education and Assessment of Residents in the Recognition and Management of the Sepsis Syndrome
A study testing Debriefing of high-fidelity sepsis simulation scenarios in people with Medical Knowledge and Clinical Performance, run by NYU Langone Health at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 20 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Medical Knowledge, Clinical Performance
- What is being tested?
- Debriefing of high-fidelity sepsis simulation scenarios
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2013to Jul 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- English-speaking internal medicine resident trainees
Who cannot join
- Anyone not meeting inclusion criteria
Trial locations and contacts
1 site in 1 country.
United States1 site
VA Harbor Simulation Center
New York, New York, 10010
About this study
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.
Read the 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.
- Conditions
- Medical Knowledge, Clinical Performance
- Being tested
- Debriefing of high-fidelity sepsis simulation scenarios, Placebo: Debriefing of high-fidelity non-sepsis simulation scenarios
- Keywords
- Simulation, Sepsis, High-fidelity, Severe Sepsis, Septic Shock, Education
- Medical subject headings
- Sepsis, Shock, Septic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Debriefing of high-fidelity sepsis simulation scenariosOther
Also called Education, High-fidelity simulation, Debriefing
Educational intervention
Placebo: Debriefing of high-fidelity non-sepsis simulation scenariosOther
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Other: Placebo: Debriefing of high-fidelity non-sepsis simulation scenarios |
What is being measured
The primary outcome is the main question the study is designed to answer.
Performance on a written assessment of the recognition and management of early sepsis in the hospitalized patient.
Written test
Measured: 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
Measured: 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.
Written self-assessment survey
Measured: 2-4 months after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2013 (estimated)
- Study startNov 2013
- Primary completionJul 2014
- Study completionJul 2014
Why it stopped: Key Personnel left institution
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Medical KnowledgeStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Collaborators
- VA Office of Research and Development
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01992120
- Sponsor's protocol ID
- VA01419
- Status last verified
- Dec 2015
- First submitted
- 30 Oct 2013
- Last updated
- 8 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Utility of High-Fidelity Simulation In the Education and Assessment of Residents in the Recognition and Management of the Sepsis Syndrome
- ClinicalTrials.gov ID
- NCT01992120
- Acronym / sponsor ID
- VA01419
- Conditions
- Medical Knowledge, Clinical Performance
- Keywords
- Simulation, Sepsis, High-fidelity, Severe Sepsis, Septic Shock, Education
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Key Personnel left institution
- Enrolment
- 40 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Collaborators
- VA Office of Research and Development
- Study start
- Nov 2013
- Primary completion
- Jul 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 25 Nov 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Debriefing of high-fidelity sepsis simulation scenarios | Experimental | Other: Debriefing of high-fidelity sepsis simulation scenariosFirst 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 |
| Debriefing of high-fidelity non-sepsis simulation scenarios | Placebo comparator | Other: Placebo: Debriefing of high-fidelity non-sepsis simulation scenariosFirst 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 |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- English-speaking internal medicine resident trainees
Key exclusion criteria (1 listed)
- Anyone not meeting inclusion criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Debriefing of high-fidelity sepsis simulation scenariosAlso: Education, High-fidelity simulation, DebriefingEducational intervention | Other | Debriefing of high-fidelity sepsis simulation scenarios |
| Placebo: Debriefing of high-fidelity non-sepsis simulation scenarios | Other | Debriefing of high-fidelity non-sepsis simulation scenarios |
Primary outcome
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
1 secondary outcome
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
Results and safety
The study was stopped early (reason given: Key Personnel left institution). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Debriefing of high-fidelity sepsis simulation scenarios in people with Medical Knowledge and Clinical Performance, run by NYU Langone Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 8 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Key Personnel left institution). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Performance on a written assessment of the recognition and management of early sepsis in the hospitalized patient. (time frame: 2-4 months after intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Dec 2015.