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RACE-CARS - RAndomized Cluster Evaluation of Cardiac ARrest Systems

Not Applicable
Conditions
Cardiac Arrest
Interventions
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.
Registration Number
NCT04660526
Lead Sponsor
Duke University
Brief Summary

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.

Detailed Description

Not available

Recruitment & Eligibility

Status
ENROLLING_BY_INVITATION
Sex
All
Target Recruitment
20000
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.
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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:

    1. injuries incompatible with life,
    2. the presence of rigor mortis or lividity,
    3. signs of decomposition, or
    4. 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

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Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Intervention (Enhanced Standard of Care)Optimized first responder performance including earlier use of AEDs.Mass community CPR/AED training, optimize 911 medical dispatch, improve first responder performance
Intervention (Enhanced Standard of Care)Systematic bystander resuscitation instruction by 911 operatorsMass community CPR/AED training, optimize 911 medical dispatch, improve first responder performance
Intervention (Enhanced Standard of Care)Comprehensive community training of lay people in CPR and AED use.Mass community CPR/AED training, optimize 911 medical dispatch, improve first responder performance
Intervention (Enhanced Standard of Care)Rapid cardiac arrest recognition that triggers immediate priority EMS/first responder dispatch by 911 operatorsMass community CPR/AED training, optimize 911 medical dispatch, improve first responder performance
Primary Outcome Measures
NameTimeMethod
Survival with good neurologic outcomes as measured by a CPC score of 1 or 2 at dischargeup to 12months

Cerebral Performance Category (CPC)

Secondary Outcome Measures
NameTimeMethod
Rate of Defibrillation before paramedics arrive as measured by bystander interviewBaseline
Percent of patients who receive CPR from a bystander as measured by EMS reportBaseline

Trial Locations

Locations (1)

Duke

🇺🇸

Durham, North Carolina, United States

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