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Human resource change in Research investigators and Seoul Fire Department
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This study aims to improve the survival rate of out-of-hospital cardiac arrest patients by 2% through a bundle of three intervention measures including: 1) dispatcher-assisted CPR, 2) multi-tiered response team CPR, and 3) feedback CPR.
The project aims to implement gold standard emergency medical services (EMS) cardiopulmonary resuscitation (CPR) programs, which will result in increased bystander CPR, reduced EMS response time, and high quality CPR during prehospital resuscitation through a bundled approach including 1) dispatcher-assisted CPR (DA-CPR), 2) multi-tiered response team CPR, and 3) feedback CPR.
The DA-CPR program aims to contribute to improved bystander CPR rate and reduced EMS response time interval through rigorous monitoring of cardiac arrest detection at primary call receiving stage as well as increased number of dispatcher-assisted CPR instruction initiation in the target time of 90 seconds. The Team CPR protocol will render synergetic efforts among participating EMS personnel from both basic life support (BLS) and advanced life support (ALS) units within the new tiered dispatch system and subsequently deliver uninterrupted CPR to out-of-hospital cardiac arrest (OHCA) patients before hospital arrival. The feedback CPR monitoring and quality assurance program will contribute to high quality CPR delivered to the patients on the scene as well as during transport.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Before intervention | No Intervention | The before intervention group will include patients from January, 2013 through December, 2014, as to refer to the historic control population who did not receive any of study interventions. | |
| After intervention | Experimental | The main study phase was planned to begin in January, 2016 through December, 2017, for a total of two years. Patients during the main study phase will have received one or more study interventions as applicable. However, because we could not continue our project in 2017, we changed after period. We included implementation period (2015) in after period. Therefore, final after period begins in January 2015 to December 2016. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bundled EMS CPR approach including dispatcher-assisted CPR, 3-person team CPR, and feedback CPR monitoring device | Procedure | Gold standard EMS CPR refers to our bundled approach to providing high quality EMS CPR through one or more intervention(s) as applicable including 1) dispatcher-assisted CPR, 2) multi-tiered team CPR, and 3) feedback CPR. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Survival to Hospital Discharge | Number of EMS-assessed out-of-hospital cardiac arrest patients who survive to hospital discharge will be recorded. | At hospital discharge, up to 28 weeks from hospital admission |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Good Neurological Recovery at Discharge | Number of EMS-assessed out-of-hospital cardiac arrest patients who survive to hospital discharge and has cerebral performance category 1 or 2 will be recorded. | At hospital discharge, up to 28 weeks from hospital admission |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National University Hospital | Seoul | 110-744 | South Korea |
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| ID | Title | Description |
|---|---|---|
| FG000 | Conventional EMS CPR (2013-2014, 2 Years) | Conventional EMS CPR group will include patients from January, 2013 through December, 2014, as to refer to the historic control population who did not receive any of study interventions. |
| FG001 | Bundled EMS CPR (2015-2016, 2 Years) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 8, 2015 |
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The main study phase will begin in January, 2015 through December, 2016, for a total of two years. Patients during the main study phase will have received one or more study interventions as applicable. Bundled EMS CPR approach including dispatcher-assisted CPR, 3-person team CPR, and feedback CPR monitoring device: Gold standard EMS CPR refers to our bundled approach to providing high quality EMS CPR through one or more intervention(s) as applicable including 1) dispatcher-assisted CPR, 2) multi-tiered team CPR, and 3) feedback CPR. |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Conventional EMS CPR (2013-2014, 2 Years) | Conventional EMS CPR group will include patients from January, 2013 through December, 2014, as to refer to the historic control population who did not receive any of study interventions. |
| BG001 | Bundled EMS CPR (2015-2016, 2 Years) | The main study phase will begin in January, 2015 through December, 2016, for a total of two years. Patients during the main study phase will have received one or more study interventions as applicable. Bundled EMS CPR approach including dispatcher-assisted CPR, 3-person team CPR, and feedback CPR monitoring device: Gold standard EMS CPR refers to our bundled approach to providing high quality EMS CPR through one or more intervention(s) as applicable including 1) dispatcher-assisted CPR, 2) multi-tiered team CPR, and 3) feedback CPR. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
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| Age, Continuous | Median | Inter-Quartile Range | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Public place | Count of Participants | Participants |
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| Witnessed | Count of Participants | Participants |
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| Bystander CPR | Count of Participants | Participants |
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| Initial shockable rhythm | Count of Participants | Participants |
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| Multi-tier response | Count of Participants | Participants |
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| Feedback CPR | Using feed-back CPR device - CPR using equipment to measure CPR quality (depth and rate) | Count of Participants | Participants |
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| Prehospital ROSC | Number of participants with prehospital return of spontaneous circulation (ROSC before arriving hospital) | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Number of Participants With Survival to Hospital Discharge | Number of EMS-assessed out-of-hospital cardiac arrest patients who survive to hospital discharge will be recorded. | Posted | Count of Participants | Participants | At hospital discharge, up to 28 weeks from hospital admission |
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| Secondary | Number of Participants With Good Neurological Recovery at Discharge | Number of EMS-assessed out-of-hospital cardiac arrest patients who survive to hospital discharge and has cerebral performance category 1 or 2 will be recorded. | Posted | Count of Participants | Participants | At hospital discharge, up to 28 weeks from hospital admission |
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At hospital discharge, up to 28 weeks from hospital admission
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Conventional EMS CPR | Conventional EMS CPR group will include patients from January, 2013 through December, 2014, as to refer to the historic control population who did not receive any of study interventions. | 5,607 | 6,201 | 0 | 6,201 | 0 | 6,201 |
| EG001 | Bundled EMS CPR | The main study phase will begin in January, 2015 through December, 2016, for a total of two years. Patients during the main study phase will have received one or more study interventions as applicable. Bundled EMS CPR approach including dispatcher-assisted CPR, 3-person team CPR, and feedback CPR monitoring device: Gold standard EMS CPR refers to our bundled approach to providing high quality EMS CPR through one or more intervention(s) as applicable including 1) dispatcher-assisted CPR, 2) multi-tiered team CPR, and 3) feedback CPR. | 5,762 | 6,469 | 0 | 6,469 | 0 | 6,469 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Jeong Ho Park | Seoul National University Hospital | +821035426282 | timthe@gmail.com |
| Feb 21, 2020 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D058687 | Out-of-Hospital Cardiac Arrest |
| ID | Term |
|---|---|
| D006323 | Heart Arrest |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Bystander CPR with dispatcher assistace |
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| Bystander CPR without dispatcher assistace |
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| Multi-tier with ambulance |
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| Multi-tier with fireengine |
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