- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02707185
Physicians in Training and Critical Care Nurses Performance in Medical Code Events: Effect of Simulation-Based Training
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 Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
New York
-
NYC, New York, United States, 10019
- St. Luke's Roosevelt Roosevelt
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Physicians in training and nurses
Exclusion Criteria:
- Physicians in training and nurses refusing to have their data included in final analysis
Study Plan
How is the study designed?
Design Details
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
OTHER: Physicians
Physician in training: All internal medicine (IM), emergency medicine (EM), anesthesia (A), surgery (S) residents and all hospital ICU nurses. |
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.
|
OTHER: Nurses
Nurses in Training
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Performance scale
Time Frame: Baseline and 1 year
|
Change in performance scale at 1 year as compared to baseline
|
Baseline and 1 year
|
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
|
1 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Survey questionnaire
Time Frame: Baseline and 1 year
|
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.
|
Baseline and 1 year
|
Perceptions of preparedness
Time Frame: Baseline and 1 year
|
Change in perceptions of preparedness at 1 year as compared to baseline.
The method of assessment for this outcome measure is the Likert Scale
|
Baseline and 1 year
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 10-080
- MCT STUDY (OTHER_GRANT: NEW YORK STATE ECRIP 2009)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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