Trial Outcomes & Findings for Effects of a New Dispatcher-Assisted Basic Life Support Training Program (NCT NCT02142387)
NCT ID: NCT02142387
Last Updated: 2020-05-01
Results Overview
The study end points are survival to hospital discharge. Survival to discharge will be measured as proportions of patients who were discharged from a hospital with their spontaneous circulation recovered. This information will be collected from medical record review.
COMPLETED
NA
18822 participants
from date of discharge, assessed up to 3 months
2020-05-01
Participant Flow
Participant milestones
| Measure |
New DA-BLS Training Program
A one-hour training course that includes a 30-minute video-based self-instruction (VSI) training session, a short role-play, and a debriefing. The video consists of a bystander CPR simulation with dispatcher instructions using the trainee's own phone and practice session following demonstration by a simulated layperson. After watching the video clip, all trainees are divided into two groups and conduct a role-play as dispatchers and laypersons for 15 minutes. Finally, there is a 15-minute debriefing session with several assignments. The program focuses on cooperation with a dispatcher, from recognition of cardiac arrest to performing DA-CPR, with hands-on practice so that laypersons can provide bystander CPR immediately in a real situation.
|
Current Basic Life Support (BLS) Training Program
A one-hour training program that was developed by the Korea Center for Disease and Prevention (CDC) and it was based on the American Heart Association (AHA) guideline (http://www.cdc.go.kr/board.es?mid=a20503050000\&bid=0021\&tag=\&act=view\&list\_no=127655). The program consists of a 30-minute VSI, and a 30-minute practice debriefing session. It focuses on detailed techniques for performing high-quality chest compressions including the correct hands and body position of the bystanders.
|
|---|---|---|
|
Overall Study
STARTED
|
2551
|
16271
|
|
Overall Study
COMPLETED
|
1486
|
8641
|
|
Overall Study
NOT COMPLETED
|
1065
|
7630
|
Reasons for withdrawal
| Measure |
New DA-BLS Training Program
A one-hour training course that includes a 30-minute video-based self-instruction (VSI) training session, a short role-play, and a debriefing. The video consists of a bystander CPR simulation with dispatcher instructions using the trainee's own phone and practice session following demonstration by a simulated layperson. After watching the video clip, all trainees are divided into two groups and conduct a role-play as dispatchers and laypersons for 15 minutes. Finally, there is a 15-minute debriefing session with several assignments. The program focuses on cooperation with a dispatcher, from recognition of cardiac arrest to performing DA-CPR, with hands-on practice so that laypersons can provide bystander CPR immediately in a real situation.
|
Current Basic Life Support (BLS) Training Program
A one-hour training program that was developed by the Korea Center for Disease and Prevention (CDC) and it was based on the American Heart Association (AHA) guideline (http://www.cdc.go.kr/board.es?mid=a20503050000\&bid=0021\&tag=\&act=view\&list\_no=127655). The program consists of a 30-minute VSI, and a 30-minute practice debriefing session. It focuses on detailed techniques for performing high-quality chest compressions including the correct hands and body position of the bystanders.
|
|---|---|---|
|
Overall Study
<19 years old
|
49
|
326
|
|
Overall Study
non-cardiac etiology
|
504
|
3431
|
|
Overall Study
CPR not performed
|
74
|
473
|
|
Overall Study
witnessed by paramedic
|
139
|
917
|
|
Overall Study
incomplete data
|
1
|
9
|
|
Overall Study
occurred not at home
|
298
|
2474
|
Baseline Characteristics
Effects of a New Dispatcher-Assisted Basic Life Support Training Program
Baseline characteristics by cohort
| Measure |
Districts Which Implement New DA-BLS Training Program
n=1486 Participants
A one-hour training course that includes a 30-minute video-based self-instruction (VSI) training session, a short role-play, and a debriefing. The video consists of a bystander CPR simulation with dispatcher instructions using the trainee's own phone and practice session following demonstration by a simulated layperson. After watching the video clip, all trainees are divided into two groups and conduct a role-play as dispatchers and laypersons for 15 minutes. Finally, there is a 15-minute debriefing session with several assignments. The HEROS program focuses on cooperation with a dispatcher, from recognition of cardiac arrest to performing DA-CPR, with hands-on practice so that laypersons can provide bystander CPR immediately in a real situation. Moreover, the HEROS program emphasizes practice for providing the correct address of the scene and switching to speakerphone mode, especially for the elderly.
|
Districts Which Keep Current BLS Training Program
n=8641 Participants
A one-hour training program that was developed by the Korea CDC and it was based on the AHA guideline (http://www.cdc.go.kr/board.es?mid=a20503050000\&bid=0021\&tag=\&act=view\&list\_no=127655). The program consists of a 30-minute VSI, and a 30-minute practice debriefing session. It focuses on detailed techniques for performing high-quality chest compressions including the correct hands and body position of the bystanders.
|
Total
n=10127 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
74 years
n=5 Participants
|
74 years
n=7 Participants
|
74 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
623 Participants
n=5 Participants
|
3487 Participants
n=7 Participants
|
4110 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
863 Participants
n=5 Participants
|
5154 Participants
n=7 Participants
|
6017 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1486 Participants
n=5 Participants
|
8641 Participants
n=7 Participants
|
10127 Participants
n=5 Participants
|
|
witnessed by laypersons
|
681 Participants
n=5 Participants
|
3993 Participants
n=7 Participants
|
4674 Participants
n=5 Participants
|
|
DA-CPR
|
1139 Participants
n=5 Participants
|
6717 Participants
n=7 Participants
|
7856 Participants
n=5 Participants
|
|
bystander CPR
|
859 Participants
n=5 Participants
|
5281 Participants
n=7 Participants
|
6140 Participants
n=5 Participants
|
|
shockable rhythm
|
187 Participants
n=5 Participants
|
1080 Participants
n=7 Participants
|
1267 Participants
n=5 Participants
|
|
level of ED
Level 1
|
12 Participants
n=5 Participants
|
1086 Participants
n=7 Participants
|
1098 Participants
n=5 Participants
|
|
level of ED
Level 2
|
1276 Participants
n=5 Participants
|
6533 Participants
n=7 Participants
|
7809 Participants
n=5 Participants
|
|
level of ED
Level 3
|
198 Participants
n=5 Participants
|
1022 Participants
n=7 Participants
|
1220 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: from date of discharge, assessed up to 3 monthsThe study end points are survival to hospital discharge. Survival to discharge will be measured as proportions of patients who were discharged from a hospital with their spontaneous circulation recovered. This information will be collected from medical record review.
Outcome measures
| Measure |
Districts Which Implement Newer DA-BLS Training Program
n=1486 Participants
the out of hospital cardiac arrest victims who were given bystander CPR by whom trained as newer dispatcher-assisted BLS training program, which more focuses on cooperation with a dispatcher, from recognition to perform DA-CPR and hands-on practice.
BLS CPR program with dispatcher assisted CPR simulation: the training program more focuses on cooperation with a dispatcher, from recognition to perform DA-CPR and hands-on practice.
|
Districts Which Keep Traditional BLS Training Program
n=8641 Participants
Control group commonly uses a one-hour training program which was developed by the Korea CDC. It focuses on detailed techniques of performing high-quality chest compressions.
|
|---|---|---|
|
Number of Participants Surviving to Hospital Discharge
|
85 Participants
|
551 Participants
|
SECONDARY outcome
Timeframe: from date of cardiac arrest occurred, assessed up to 1 weekThe return of spontaneous circulation will be measured as proportion of the patients who were recovered their circulation at emergency department. This information will be collected from the medical review.
Outcome measures
| Measure |
Districts Which Implement Newer DA-BLS Training Program
n=1486 Participants
the out of hospital cardiac arrest victims who were given bystander CPR by whom trained as newer dispatcher-assisted BLS training program, which more focuses on cooperation with a dispatcher, from recognition to perform DA-CPR and hands-on practice.
BLS CPR program with dispatcher assisted CPR simulation: the training program more focuses on cooperation with a dispatcher, from recognition to perform DA-CPR and hands-on practice.
|
Districts Which Keep Traditional BLS Training Program
n=8641 Participants
Control group commonly uses a one-hour training program which was developed by the Korea CDC. It focuses on detailed techniques of performing high-quality chest compressions.
|
|---|---|---|
|
Number of Participants With Return of Spontaneous Circulation (ROSC)
|
544 Participants
|
3118 Participants
|
SECONDARY outcome
Timeframe: from date of discharge, assessed up to 3 monthsThe Cerebral Performance Categories (CPC) score will be used to measure neurological recovery status: CPC 1 (good cerebral performance), CPC 2 (moderate cerebral disability), CPC 3 (severe cerebral disability), CPC 4 (coma or vegetative state), CPC 5 (brain death). We defined the good neurological recovery as CPC 1 or CPC 2. This information will be collected from medical record review.
Outcome measures
| Measure |
Districts Which Implement Newer DA-BLS Training Program
n=1486 Participants
the out of hospital cardiac arrest victims who were given bystander CPR by whom trained as newer dispatcher-assisted BLS training program, which more focuses on cooperation with a dispatcher, from recognition to perform DA-CPR and hands-on practice.
BLS CPR program with dispatcher assisted CPR simulation: the training program more focuses on cooperation with a dispatcher, from recognition to perform DA-CPR and hands-on practice.
|
Districts Which Keep Traditional BLS Training Program
n=8641 Participants
Control group commonly uses a one-hour training program which was developed by the Korea CDC. It focuses on detailed techniques of performing high-quality chest compressions.
|
|---|---|---|
|
Number of Participants With Good Neurological Recovery
|
42 Participants
|
316 Participants
|
Adverse Events
Newer DA-BLS Training Program
Current BLS Training Program
Serious adverse events
| Measure |
Newer DA-BLS Training Program
n=1486 participants at risk
A 30-minute video-based self-instruction (VSI) training session, a short role-play, and a debriefing. The video consists of a bystander CPR simulation with dispatcher instructions using the trainee's own phone and practice session following demonstration by a simulated layperson. After watching the video clip, all trainees are divided into two groups and conduct a role-play as dispatchers and laypersons for 15 minutes. Finally, there is a 15-minute debriefing session with several assignments. The HEROS program focuses on cooperation with a dispatcher, from recognition of cardiac arrest to performing DA-CPR, with hands-on practice so that laypersons can provide bystander CPR immediately in a real situation. Moreover, the HEROS program emphasizes practice for providing the correct address of the scene and switching to speakerphone mode, especially for the elderly.
|
Current BLS Training Program
n=8641 participants at risk
A one-hour training program that was developed by the Korea CDC and it was based on the AHA BLS provider course (http://www.cdc.go.kr/board.es?mid=a20503050000\&bid=0021\&tag=\&act=view\&list\_no=127655). The program consists of a 30-minute VSI, and a 30-minute practice debriefing session. It focuses on detailed techniques for performing high-quality chest compressions including the correct hands and body position of the bystanders.
|
|---|---|---|
|
Cardiac disorders
death
|
94.3%
1401/1486 • from date of discharge, assessed up to 3 months
1,401 cardiac arrest patients are died in the districts which implement new DA-BLS Training program. 8,090 cardiac arrest patients are died in the districts which keep current BLS Training program.
|
93.6%
8090/8641 • from date of discharge, assessed up to 3 months
1,401 cardiac arrest patients are died in the districts which implement new DA-BLS Training program. 8,090 cardiac arrest patients are died in the districts which keep current BLS Training program.
|
Other adverse events
Adverse event data not reported
Additional Information
Dr. Gwan Jin Park
Laboratory of Emergency Medical Services, Seoul National University Hospital Biomedical Research Institute
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place