Ventricular FibrillationNCT02707185
Physicians in Training and Critical Care Nurses Performance in Medical Code Events: Effect of Simulation-Based Training
A study testing Simulation-Based Training in people with Ventricular Fibrillation, run by St. Luke's-Roosevelt Hospital Center at 1 site in United States.
Trial summary
METHODS: Subjects: All internal medicine (IM), emergency medicine (EM), anesthesia (A), surgery (S) residents and all hospital ICU nurses (approximately 400 subjects) will be undergoing evaluation and training in CPR techniques according to their department training policy. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Ventricular Fibrillation
- What is being tested?
- Simulation-Based Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 157 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2012to Dec 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Physicians in training and nurses
Who cannot join
- Physicians in training and nurses refusing to have their data included in final analysis
Trial locations and contacts
1 site in 1 country.
United States1 site
St. Luke's Roosevelt Roosevelt
New York, New York, 10019
About this study
METHODS:
Subjects:
Read more
All internal medicine (IM), emergency medicine (EM), anesthesia (A), surgery (S) residents and all hospital ICU nurses (approximately 400 subjects) will be undergoing evaluation and training in CPR techniques according to their department training policy.
Study Assessment Tool:
An objective assessment tool has been developed and tested in medical code scenarios during training sessions recently done in the simulation lab. The tool has five domains: Airway, Breathing, Circulation, Communications/Leadership, and Defibrillation. Each domain consists of 3-8 tasks and skills (attachment A).
Design:
- Phase I: In groups of five to six subjects, residents and nurses will undergo baseline assessment in CPR techniques in the simulation lab. Subject will be presented with a clinical scenario that includes cardiopulmonary arrest. Subjects will be scored by observers based on the previously described assessment tool and will be video recorded.
- Phase II: All study subjects who completed phase I assessment will undergo standardized debriefing and demonstration of proper CPR techniques after reviewing their individual baseline videotape followed by repeated demonstration in CPR techniques during a clinical scenario with cardiopulmonary arrest in the simulation lab. Knowledge retention will be assessed periodically.
- Phase III: Rates of survival to hospital discharge and survival at 24 hours in hospitalized patients after cardiopulmonary arrest collected by the CPR committee and QA department longitudinally for one year after completion of project training (phase II) will be reviewed and compared to the same period one year earlier (CPR outcome data are being collected since 2005 at St. Luke's-Roosevelt Hospitals).
- Conditions
- Ventricular Fibrillation
- Being tested
- Simulation-Based Training
- Medical subject headings
- Ventricular Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Simulation-Based TrainingBehavioural
An objective assessment tool has been developed and tested in medical code scenarios during training sessions recently done in the simulation lab. The tool has five domains: Airway, Breathing, Circulation, Communications/Leadership, and Defibrillation. Each domain consists of 3-8 tasks and skills.
| Study group | Role | What they receive |
|---|---|---|
| Physicians | Other | Physician in training:
All internal medicine (IM), emergency medicine (EM), anesthesia (A), surgery (S) residents and all hospital ICU nurses. Receives: Behavioral: Simulation-Based Training |
| Nurses | Other | Nurses in Training Receives: Behavioral: Simulation-Based Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Performance scale
Change in performance scale at 1 year as compared to baseline
Measured: Baseline and 1 year
Rates of survival
Rates of survival to hospital discharge after cardiopulmonary arrest one year after completion of the simulation based training in CPR
Measured: 1 year
Secondary outcomes (2)
Survey questionnaire
Change in survey questionnaire score at 1 year as compared to baseline. The questionnaire consists of 4 parts, including: adequacy of training, sense of preparedness, supervision and feedback, and general information. With the exception of the section on general information, responses are scored on a 5 point Likert scale.
Measured: Baseline and 1 year
Perceptions of preparedness
Change in perceptions of preparedness at 1 year as compared to baseline. The method of assessment for this outcome measure is the Likert Scale
Measured: Baseline and 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2016 (estimated)
- Study startJun 2012
- Primary completionDec 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ventricular FibrillationStudies of the same condition, open and under way.
- 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
- None (open label)
- Enrolment
- 157 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Luke's-Roosevelt Hospital Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hassan Khouli, MD, Principal investigator, St. Luke's-Roosevelt Hospital Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02707185
- Sponsor's protocol ID
- 10-080
- Other IDs
- MCT STUDY
- Status last verified
- Mar 2016
- First submitted
- 10 May 2011
- Last updated
- 14 Mar 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physicians in Training and Critical Care Nurses Performance in Medical Code Events: Effect of Simulation-Based Training
- ClinicalTrials.gov ID
- NCT02707185
- Acronym / sponsor ID
- 10-080
- Conditions
- Ventricular Fibrillation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 157 participants (actual)
- Lead sponsor
- St. Luke's-Roosevelt Hospital CenterUniversity, hospital or other
- Study start
- Jun 2012
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 14 Mar 2016 (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.
METHODS:
Subjects:
All internal medicine (IM), emergency medicine (EM), anesthesia (A), surgery (S) residents and all hospital ICU nurses (approximately 400 subjects) will be undergoing evaluation and training in CPR techniques according to their department training policy.
Study Assessment Tool:
An objective assessment tool has been developed and tested in medical code scenarios during training sessions recently done in the simulation lab. The tool has five domains: Airway, Breathing, Circulation, Communications/Leadership, and Defibrillation. Each domain consists of 3-8 tasks and skills (attachment A).
Design:
- Phase I: In groups of five to six subjects, residents and nurses will undergo baseline assessment in CPR techniques in the simulation lab. Subject will be presented with a clinical scenario that includes cardiopulmonary arrest. Subjects will be scored by observers based on the previously described assessment tool and will be video recorded.
- Phase II: All study subjects who completed phase I assessment will undergo standardized debriefing and demonstration of proper CPR techniques after reviewing their individual baseline videotape followed by repeated demonstration in CPR techniques during a clinical scenario with cardiopulmonary arrest in the simulation lab. Knowledge retention will be assessed periodically.
- Phase III: Rates of survival to hospital discharge and survival at 24 hours in hospitalized patients after cardiopulmonary arrest collected by the CPR committee and QA department longitudinally for one year after completion of project training (phase II) will be reviewed and compared to the same period one year earlier (CPR outcome data are being collected since 2005 at St. Luke's-Roosevelt Hospitals).
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Physicians | Other | Behavioral: Simulation-Based TrainingPhysician in training: All internal medicine (IM), emergency medicine (EM), anesthesia (A), surgery (S) residents and all hospital ICU nurses. |
| Nurses | Other | Behavioral: Simulation-Based TrainingNurses in Training |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Physicians in training and nurses
Key exclusion criteria (1 listed)
- Physicians in training and nurses refusing to have their data included in final analysis
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 |
|---|---|---|
| Simulation-Based TrainingAn objective assessment tool has been developed and tested in medical code scenarios during training sessions recently done in the simulation lab. The tool has five domains: Airway, Breathing, Circulation, Communications/Leadership, and Defibrillation. Each domain consists of 3-8 tasks and skills. | Behavioural | Nurses, Physicians |
Primary outcome
Performance scale
Time frame: Baseline and 1 year
Change in performance scale at 1 year as compared to baseline
Rates of survival
Time frame: 1 year
Rates of survival to hospital discharge after cardiopulmonary arrest one year after completion of the simulation based training in CPR
2 secondary outcomes
Survey questionnaire
Time frame: Baseline and 1 year
Perceptions of preparedness
Time frame: Baseline and 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2016.
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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.
Hassan Khouli, MD principal investigator
St. Luke's-Roosevelt Hospital Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Simulation-Based Training in people with Ventricular Fibrillation, run by St. Luke's-Roosevelt Hospital Center 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: finished, as of the sponsor's last update on 14 Mar 2016. 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. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 scale (time frame: Baseline and 1 year). 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 14 Mar 2016.