RACE-CARS - RAndomized Cluster Evaluation of Cardiac ARrest Systems

N/AActive Not RecruitingNCT04660526

Duke University20,000 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

NONE

Enrollment

20,000

Conditions

Cardiac Arrest

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Survival with good neurologic outcomes as measured by a CPC score of 1 or 2 at discharge

Cerebral Performance Category (CPC)

Time frame: up to 12months

Secondary Outcomes

Percent of patients who receive CPR from a bystander as measured by EMS report

Time frame: Baseline

Rate of Defibrillation before paramedics arrive as measured by bystander interview