RACE-CARS - RAndomized Cluster Evaluation of Cardiac ARrest Systems
- Conditions
- Cardiac Arrest
- Interventions
- Other: Rapid cardiac arrest recognition that triggers immediate priority EMS/first responder dispatch by 911 operatorsOther: Systematic bystander resuscitation instruction by 911 operatorsOther: 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
- 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.
-
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 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 operators Mass 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 operators Mass community CPR/AED training, optimize 911 medical dispatch, improve first responder performance
- Primary Outcome Measures
Name Time Method Survival with good neurologic outcomes as measured by a CPC score of 1 or 2 at discharge up to 12months Cerebral Performance Category (CPC)
- Secondary Outcome Measures
Name Time Method Rate of Defibrillation before paramedics arrive as measured by bystander interview Baseline Percent of patients who receive CPR from a bystander as measured by EMS report Baseline
Trial Locations
- Locations (1)
Duke
🇺🇸Durham, North Carolina, United States