RACE-CARS - RAndomized Cluster Evaluation of Cardiac ARrest Systems

Duke University

Status: Invitation-only

Conditions: Cardiac Arrest

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

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04660526

1UG3HL146935-01A1 (U.S. NIH Grant/Contract)

1U24HL146938-01A1 (U.S. NIH Grant/Contract)

Pro00105633

Details and patient eligibility

About

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.

Enrollment: 20,000 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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:

  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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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20,000 participants in 2 patient groups

Intervention (Enhanced Standard of Care)

Experimental group

Description:

Mass community CPR/AED training, optimize 911 medical dispatch, improve first responder performance

Treatment:

Other: Rapid cardiac arrest recognition that triggers immediate priority EMS/first responder dispatch by 911 operators

Other: Optimized first responder performance including earlier use of AEDs.

Other: Systematic bystander resuscitation instruction by 911 operators

Other: Comprehensive community training of lay people in CPR and AED use.

Control (Standard of Care)

No Intervention group

Description:

Usual care, continuing standard quality improvement effort