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NCT Number: NCT04660526

RACE-CARS - RAndomized Cluster Evaluation of Cardiac ARrest Systems

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Cardiac Arrest Cardiovascular Diseases Heart Arrest Heart Diseases Out-of-Hospital Cardiac Arrest

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Duke

Durham, North Carolina, 27705, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  1. 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

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

    Time frame: Baseline

  2. Rate of Defibrillation before paramedics arrive as measured by bystander interview

    Time frame: Baseline

Other outcomes

  1. Percent of cardiac arrest patients whose cardiac arrests are recognized by 911-dispatcher through telephone call

    Time frame: Follow-up, up to 4 years

  2. Percent of cardiac arrest patients with responders who receive CPR instructions by 911-dispatcher through telephone call

    Time frame: Follow-up, up to 4 years

  3. Survival rate as measured by medical record abstraction

    Time frame: Follow-up, up to 4 years

  4. Change in Neurologic disability as measured by Modified Rankin Score

    Time frame: 3 months, 12 months

    The Modified Rankin Score is a 6 point likert scale, with 0 being "No symptoms" and 6 being "Dead"

  5. Change in Quality of life as measured by the SF-36

    Time frame: 3 months, 12 months

    The SF-36 is Is a health-related quality-of-life questionnaire consisting of thirty six questions that measure eight health domains to assess physical and mental health. Physical health-related domains include General Health (GH), Physical Functioning (PF), Role Physical (RP), and Body Pain (BP).

  6. Change in Quality of life as measured by the EQ-5D-5L

    Time frame: 3 months, 12 months

    The EQ-5D-5L is Quality of Life instrument measure with one question for each of the five dimensions that include mobility, self-care, usual activities, pain/discomfort, and anxiety/depression.

Sponsors and collaborators

Lead sponsor

Duke University

Other

Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

Registry information

Official study title

RAndomized Cluster Evaluation of Cardiac ARrest Systems

Important dates

Study start
2022
Primary completion
2026
Study completion
2027
First posted
Dec 9, 2020
Registry last updated
Jul 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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