Emergency Response System Improvements for Cardiac Arrest

Recruiting at 1 trial location

Overseen By Kimberly T. Ward, MPH

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Duke University

Disqualifiers: Traumatic etiology, DNR, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

20000 Participants Needed

Trial Summary

What is the purpose of this trial?

RACE-CARS is a real-world cluster-randomized trial designed to evaluate a multifaceted community and health systems intervention aimed to improve outcomes of out-of-hospital cardiac arrest. RACE-CARS will enroll 50 counties in North Carolina that are estimated to have a total of approximately 20,000 patients with cardiac arrest over a 4-year intervention period. County "clusters" will be randomized in a 1:1 ratio to intervention versus usual care. The trial duration is 7 years, which includes a 6-month start-up (including recruitment and randomization) period, a 12-month intervention training phase, a 4-year intervention period, a 12-month follow-up for to assess quality of life in survivors of OHCA, and a 6-month close-out and data analysis period.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the treatment Comprehensive community training of lay people in CPR and AED use, Optimized first responder performance including earlier use of AEDs, Rapid cardiac arrest recognition that triggers immediate priority EMS/first responder dispatch by 911 operators, Systematic bystander resuscitation instruction by 911 operators?

Research shows that rapid defibrillation with AEDs (devices that can restart the heart) significantly improves survival rates in cardiac arrest cases. Studies indicate that training laypeople and first responders, like police and firefighters, to use AEDs can lead to quicker defibrillation and better outcomes. Additionally, dispatcher assistance can help laypeople effectively use AEDs, potentially increasing survival rates. ^{1 2 3 4 5}

Is the emergency response system improvement for cardiac arrest safe for humans?

Research on layperson use of automated external defibrillators (AEDs) in public access defibrillation programs shows no significant safety issues, even when used by minimally trained responders. These programs are generally considered safe and are supported by organizations like the American Heart Association. ^{1 2 4 6 7}

How does the treatment for improving emergency response systems for cardiac arrest differ from other treatments?

This treatment is unique because it focuses on a comprehensive community approach, training laypeople in CPR and AED use, optimizing first responder performance, and ensuring rapid recognition and dispatch by 911 operators, which is not typically emphasized in standard treatments. It aims to improve survival rates by reducing response times and increasing the availability of life-saving interventions before professional medical help arrives. ^{1 2 8 9 10}

Research Team

Christopher Granger, MD

Principal Investigator

Duke University

Eligibility Criteria

The RACE-CARS trial is for patients who experience non-traumatic out-of-hospital cardiac arrest (OHCA) and are pulseless when first responders arrive or become pulseless in their presence. It's not for cases where resuscitation isn't attempted due to severe injuries, signs of death, decomposition, or a valid DNR order.

Inclusion Criteria

I was revived by a defibrillator before EMS arrived.

My cardiac arrest was not caused by an injury.

You don't have a pulse when the first responders arrive.

Exclusion Criteria

Private EMS transport that did not involve 911 dispatch (example: interfacility transport between nursing home and hospital)

I have not had a cardiac arrest without attempted resuscitation due to severe injuries or signs of death.

I was revived from a suspected heart attack without needing shocks or CPR from first responders.

Timeline

Start-up

Recruitment and randomization of county clusters

6 months

Intervention Training

Training phase for community CPR/AED, 911 dispatch optimization, and first responder performance improvement

12 months

Intervention

Implementation of the intervention across 50 counties

4 years

Follow-up

Assessment of quality of life in survivors of out-of-hospital cardiac arrest

12 months

Close-out and Data Analysis

Final data collection and analysis period

6 months

Treatment Details

Interventions

• Comprehensive community training of lay people in CPR and AED use.
• Optimized first responder performance including earlier use of AEDs.
• Rapid cardiac arrest recognition that triggers immediate priority EMS/first responder dispatch by 911 operators
• Systematic bystander resuscitation instruction by 911 operators

Trial Overview This study tests a system-wide intervention in 50 North Carolina counties to improve cardiac arrest outcomes. It includes rapid EMS dispatch, optimized first responder actions like early AED use, community CPR/AED training, and systematic bystander instruction by 911 operators.

Participant Groups

Group I: Intervention (Enhanced Standard of Care) Experimental Treatment 4 Interventions

Mass community CPR/AED training, optimize 911 medical dispatch, improve first responder performance

Group II: Control (Standard of Care) Active Control 1 Intervention

Usual care, continuing standard quality improvement effort

Who Is Running the Clinical Trial?

Duke University

Lead Sponsor

Trials

2,495

Recruited

5,912,000+

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials

3,987

Recruited

47,860,000+

References

1. Ireland pubmed.ncbi.nlm.nih.gov

AED use in businesses, public facilities and homes by minimally trained first responders. [2019]

2. United States pubmed.ncbi.nlm.nih.gov

Get the data. [2007]

3. England pubmed.ncbi.nlm.nih.gov

Performance of police first responders in utilizing automated external defibrillation on victims of sudden cardiac arrest. [2019]

4. United States pubmed.ncbi.nlm.nih.gov

Dispatcher assistance and automated external defibrillator performance among elders. [2019]

5. Ireland pubmed.ncbi.nlm.nih.gov

Results from the first 12 months of a fire first-responder program in Australia. [2019]

6. Ireland pubmed.ncbi.nlm.nih.gov

Adverse events associated with lay emergency response programs: the public access defibrillation trial experience. [2013]

7. United States pubmed.ncbi.nlm.nih.gov

Lay rescuer automated external defibrillator ("public access defibrillation") programs: lessons learned from an international multicenter trial: advisory statement from the American Heart Association Emergency Cardiovascular Committee; the Council on Cardiopulmonary, Perioperative, and Critical Care; and the Council on Clinical Cardiology. [2013]

8. England pubmed.ncbi.nlm.nih.gov

Cardiac arrest in the community. How to improve survival rates. [2019]

9. United States pubmed.ncbi.nlm.nih.gov

Community-based automated external defibrillator only resuscitation for out-of-hospital cardiac arrest patients. [2017]

10. Ireland pubmed.ncbi.nlm.nih.gov

Factors associated with the arrival of smartphone-activated first responders before the emergency medical services in Out-of-Hospital cardiac arrest dispatch. [2023]