HEROS: Effects of a New Dispatcher-Assisted Basic Life Support Training Program

• Sponsor: Seoul National University Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT02142387
• Collaborator: (none)
• Enrollment: 18,822
• Location: 1
• Arms: 2
• Actual Duration (Months): 59
• Patients Per Site Per Month: 319.2

Study Details

Study Description

Brief Summary

Despite aggressive cardiopulmonary resuscitation (CPR) training, the outcome of cardiac arrest is not good. The problem is method of education. So, the investigators want to add the dispatcher-assisted CPR simulation into conventional CPR training. In this study, the study is aimed to investigate the effect of newer CPR training program.

Condition or Disease	Intervention/Treatment	Phase
Out of Hospital Cardiac Arrest	Other: BLS CPR program with dispatcher assisted CPR simulation	N/A

Detailed Description

The training program focuses on working in team with dispatcher, performing all steps from recognizing cardiac arrest to performing CPR, together with the dispatcher. The one hours training session is split into four parts:

1. Video self-instruction manikin practice (30 min), including a brief introduction to automated external defibrillator (AED).

2. Practice in pairs (15 min). Practicing the dispatcher and rescuer role in a simulation to enhance learning.

3. Debriefing. Questions, answers and reflection (15 min).

4. Homework. Leaflet with tasks like learn how to activate the speaker function on your own phone.

The main difference between dispatcher-assisted basic life support (DA-BLS) and traditional BLS training is that DA-BLS provides the scenes and interactive experiences on calling emergency medical service (EMS) and receiving CPR instruction via telephone speaker function, following up the skill training by scenario simulation training.

Study Design

• Study Type: Interventional
• Actual Enrollment: 18822 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Clinical Effects of a New Dispatcher-Assisted Basic Life Support Training Program in a Metropolitan City: A Before-and-After Intervention Study
• Actual Study Start Date: Jan 1, 2014
• Actual Primary Completion Date: Dec 1, 2017
• Actual Study Completion Date: Dec 1, 2018

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 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 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.	Other: 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.
No Intervention: Current Basic Life Support (BLS) training program A one-hour training program that was developed by the Korea Center for Disease Control 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.

Outcome Measures

Primary Outcome Measures

1. Number of Participants Surviving to Hospital Discharge [from date of discharge, assessed up to 3 months]

   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.

Secondary Outcome Measures

1. Number of Participants With Return of Spontaneous Circulation (ROSC) [from date of cardiac arrest occurred, assessed up to 1 week]

   The 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.

2. Number of Participants With Good Neurological Recovery [from date of discharge, assessed up to 3 months]

   The 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 19 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• All out-of-hospital cardiac arrest (OHCA) patients with presumed cardiac etiology who are 19 years of age or older and assessed and treated by EMS providers after dispatched by the EMS dispatch center will be included.

Exclusion Criteria:

• We will exclude patients with non-cardiac etiology, prolonged cardiac arrest with a suspected duration more than 30 minutes, cases such as livor mortis or rigor mortis, and decapitated or decomposed body, and patients who have "Do-Not-Resuscitate" card documented by doctor.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Seoul National University Hospital	Seoul		Korea, Republic of	110-744

Sponsors and Collaborators

• Seoul National University Hospital

Investigators

• Study Chair: Sang Do Shin, MD, MPH, PHD, Seoul National University Hospital

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Feb 8, 2020

More Information

Publications

None provided.

• Responsible Party: Sang Do Shin, professor, Seoul National University Hospital
• ClinicalTrials.gov Identifier: NCT02142387
• Other Study ID Numbers: SNUH-heros-01
• First Posted: May 20, 2014
• Last Update Posted: May 1, 2020
• Last Verified: Apr 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by Sang Do Shin, professor, Seoul National University Hospital: cardiac arrest; dispatcher-assisted bystander cardiopulmonary resuscitation; survival
• Additional relevant MeSH terms: Heart Arrest; Out-of-Hospital Cardiac Arrest

Study Results

Participant Flow

Arm/Group Title	New DA-BLS Training Program	Current Basic Life Support (BLS) Training Program
Arm/Group Description	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.	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.
Period Title: Overall Study
STARTED	2551	16271
COMPLETED	1486	8641
NOT COMPLETED	1065	7630

Baseline Characteristics

Arm/Group Title	Districts Which Implement New DA-BLS Training Program	Districts Which Keep Current BLS Training Program	Total
Arm/Group Description	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.	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 of all reporting groups
Overall Participants	1486	8641	10127
Age (years) [Median (Inter-Quartile Range) ]
Median (Inter-Quartile Range) [years]	74	74	74
Sex: Female, Male (Count of Participants)
Female	623 41.9%	3487 40.4%	4110 40.6%
Male	863 58.1%	5154 59.6%	6017 59.4%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	0 0%	0 0%	0 0%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	0 0%	0 0%	0 0%
White	0 0%	0 0%	0 0%
More than one race	0 0%	0 0%	0 0%
Unknown or Not Reported	1486 100%	8641 100%	10127 100%
witnessed by laypersons (Count of Participants)
Count of Participants [Participants]	681 45.8%	3993 46.2%	4674 46.2%
DA-CPR (Count of Participants)
Count of Participants [Participants]	1139 76.6%	6717 77.7%	7856 77.6%
bystander CPR (Count of Participants)
Count of Participants [Participants]	859 57.8%	5281 61.1%	6140 60.6%
shockable rhythm (Count of Participants)
Count of Participants [Participants]	187 12.6%	1080 12.5%	1267 12.5%
level of ED (Count of Participants)
Level 1	12 0.8%	1086 12.6%	1098 10.8%
Level 2	1276 85.9%	6533 75.6%	7809 77.1%
Level 3	198 13.3%	1022 11.8%	1220 12%

Outcome Measures

1. Primary Outcome

Title	Number of Participants Surviving to Hospital Discharge
Description	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.
Time Frame	from date of discharge, assessed up to 3 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Districts Which Implement Newer DA-BLS Training Program	Districts Which Keep Traditional BLS Training Program
Arm/Group Description	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.	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.
Measure Participants	1486	8641
Count of Participants [Participants]	85 5.7%	551 6.4%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Districts Which Implement Newer DA-BLS Training Program, Districts Which Keep Traditional BLS Training Program
	Comments
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.34
	Comments
	Method	Chi-squared
	Comments

2. Secondary Outcome

Title	Number of Participants With Return of Spontaneous Circulation (ROSC)
Description	The 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.
Time Frame	from date of cardiac arrest occurred, assessed up to 1 week

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Districts Which Implement Newer DA-BLS Training Program	Districts Which Keep Traditional BLS Training Program
Arm/Group Description	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.	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.
Measure Participants	1486	8641
Count of Participants [Participants]	544 36.6%	3118 36.1%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Districts Which Implement Newer DA-BLS Training Program, Districts Which Keep Traditional BLS Training Program
	Comments
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.7
	Comments
	Method	Chi-squared
	Comments

3. Secondary Outcome

Title	Number of Participants With Good Neurological Recovery
Description	The 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.
Time Frame	from date of discharge, assessed up to 3 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Districts Which Implement Newer DA-BLS Training Program	Districts Which Keep Traditional BLS Training Program
Arm/Group Description	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.	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.
Measure Participants	1486	8641
Count of Participants [Participants]	42 2.8%	316 3.7%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Districts Which Implement Newer DA-BLS Training Program, Districts Which Keep Traditional BLS Training Program
	Comments
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.11
	Comments
	Method	Chi-squared
	Comments

Adverse Events

Time Frame	from date of discharge, assessed up to 3 months
Adverse Event Reporting Description	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.
Arm/Group Title	Newer DA-BLS Training Program		Current BLS Training Program
Arm/Group Description	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.		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.
All Cause Mortality
	Newer DA-BLS Training Program		Current BLS Training Program
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1401/1486 (94.3%)		8090/8641 (93.6%)
Serious Adverse Events
	Newer DA-BLS Training Program		Current BLS Training Program
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1401/1486 (94.3%)		8090/8641 (93.6%)
Cardiac disorders
death	1401/1486 (94.3%)		8090/8641 (93.6%)
Other (Not Including Serious) Adverse Events
	Newer DA-BLS Training Program		Current BLS Training Program
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/1486 (0%)		0/8641 (0%)

Limitations/Caveats

This new DA-BLS training program was only used in the community health center. And it was difficult to identify whether laypersons who had performed bystander CPR actually received this new program.

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.