RACE-CARS - RAndomized Cluster Evaluation of Cardiac ARrest Systems

Study Overview
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Brief Summary
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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.

Official Title
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RAndomized Cluster Evaluation of Cardiac ARrest Systems

Conditions
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Cardiac Arrest

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


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: OHCA of non-traumatic etiology Patients who are pulseless on arrival of a first responder; or patients who become pulseless in the presence of a first responder; OR patients who have a pulse on arrival of EMS, where a successful defibrillation was previously administered by a bystander or first responder. Exclusion Criteria: Untreated cardiac arrests, including arrests in which resuscitation efforts are not initiated or are terminated immediately upon arrival of EMS because the patient is not a viable candidate for resuscitation due to: injuries incompatible with life, the presence of rigor mortis or lividity, signs of decomposition, or the presence of a valid DNR. Private EMS transport that did not involve 911 dispatch (example: interfacility transport between nursing home and hospital). Arrest of clear and obvious traumatic etiology Bystander suspected cardiac arrest, where ROSC was achieved without the need for defibrillation or first responder CPR

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention (Enhanced Standard of Care)<br>Mass community CPR/AED training, optimize 911 medical dispatch, improve first responder performance | Other: Rapid cardiac arrest recognition that triggers immediate priority EMS/first responder dispatch by 911 operators<br>* EMS first responders will recognize cardiac arrest and respond immediately, increasing time to dispatch<br>Other: Systematic bystander resuscitation instruction by 911 operators<br>* 911 operators will be able to describe how to administer CPR over the phone.<br>Other: Comprehensive community training of lay people in CPR and AED use.<br>* Training of lay people regarding CPR and AED use.<br>Other: Optimized first responder performance including earlier use of AEDs.<br>* First responders will recognize where AEDs are located and use them appropriately<br>|
| No Intervention: Control (Standard of Care)<br>Usual care, continuing standard quality improvement effort | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survival with good neurologic outcomes as measured by a CPC score of 1 or 2 at discharge | Cerebral Performance Category (CPC) | up to 12months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent of patients who receive CPR from a bystander as measured by EMS report |  | Baseline | 
| Rate of Defibrillation before paramedics arrive as measured by bystander interview |  | Baseline | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cardiac arrest, cardiopulmonary resuscitation, telephone CPR, dispatch CPR, out-of-hospital cardiac arrest, defibrillation