RACE-CARS - RAndomized Cluster Evaluation of Cardiac ARrest Systems

Part of paid clinical trials in Durham, North Carolina.

Sponsor
Duke University
Study ID
NCT04660526
Status
Enrolling By Invitation

Conditions

  • Cardiac Arrest

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Rapid cardiac arrest recognition that triggers immediate priority EMS/first responder dispatch by 911 operators — OTHER
    EMS first responders will recognize cardiac arrest and respond immediately, increasing time to dispatch
  • Systematic bystander resuscitation instruction by 911 operators — OTHER
    911 operators will be able to describe how to administer CPR over the phone.
  • Comprehensive community training of lay people in CPR and AED use. — OTHER
    Training of lay people regarding CPR and AED use.
  • Optimized first responder performance including earlier use of AEDs. — OTHER
    First responders will recognize where AEDs are located and use them appropriately

Study Details

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.

Key Dates

Start date
Jul 1, 2022
Status verified
May 2026
Primary completion
Jun 30, 2026
Completion
Jun 30, 2027

Study Design

Enrollment
20,000 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH

Arms

  • Experimental: Intervention (Enhanced Standard of Care)
    Mass community CPR/AED training, optimize 911 medical dispatch, improve first responder performance
  • No Intervention: Control (Standard of Care)
    Usual care, continuing standard quality improvement effort

Primary Outcome Measure

Survival with good neurologic outcomes as measured by a CPC score of 1 or 2 at discharge [ Time Frame: up to 12months ]

Locations (1)

FacilityCityStateZIPSite coordinators
DukeDurhamNorth Carolina27705-

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By research site
Duke· Durham, NC

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