RAndomized Cluster Evaluation of Cardiac ARrest Systems
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Duke University
- Enrollment
- 20,000
- Locations
- 2
- Primary Endpoint
- Survival with good neurologic outcomes as measured by a CPC score of 1 or 2 at discharge
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Health Services Research
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Intervention (Enhanced Standard of Care)
Mass community CPR/AED training, optimize 911 medical dispatch, improve first responder performance
Intervention: Systematic bystander resuscitation instruction by 911 operators (Other)
Intervention (Enhanced Standard of Care)
Mass community CPR/AED training, optimize 911 medical dispatch, improve first responder performance
Intervention: Rapid cardiac arrest recognition that triggers immediate priority EMS/first responder dispatch by 911 operators (Other)
Control (Standard of Care)
Usual care, continuing standard quality improvement effort
Intervention (Enhanced Standard of Care)
Mass community CPR/AED training, optimize 911 medical dispatch, improve first responder performance
Intervention: Optimized first responder performance including earlier use of AEDs. (Other)
Intervention (Enhanced Standard of Care)
Mass community CPR/AED training, optimize 911 medical dispatch, improve first responder performance
Intervention: Comprehensive community training of lay people in CPR and AED use. (Other)
Outcomes
Primary Outcomes
Survival with good neurologic outcomes as measured by a CPC score of 1 or 2 at discharge
Time Frame: up to 12months
Cerebral Performance Category (CPC)
Secondary Outcomes
- 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)