RACE-CARS - RAndomized Cluster Evaluation of Cardiac ARrest Systems

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Cardiac Arrest
• Intervention / Treatment: Other: Rapid cardiac arrest recognition that triggers immediate priority EMS/first responder dispatch by 911 operators; Other: Systematic bystander resuscitation instruction by 911 operators; Other: Comprehensive community training of lay people in CPR and AED use.; Other: Optimized first responder performance including earlier use of AEDs.

• Study Type: Interventional
• Enrollment (Estimated): 20000
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Durham, North Carolina, United States, 27705
      • Duke

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention (Enhanced Standard of Care); Mass community CPR/AED training, optimize 911 medical dispatch, improve first responder performance	Other: Rapid cardiac arrest recognition that triggers immediate priority EMS/first responder dispatch by 911 operators; EMS first responders will recognize cardiac arrest and respond immediately, increasing time to dispatch; Other: Systematic bystander resuscitation instruction by 911 operators; 911 operators will be able to describe how to administer CPR over the phone.; Other: Comprehensive community training of lay people in CPR and AED use.; Training of lay people regarding CPR and AED use.; Other: Optimized first responder performance including earlier use of AEDs.; First responders will recognize where AEDs are located and use them appropriately
No Intervention: Control (Standard of Care); Usual care, continuing standard quality improvement effort

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Survival with good neurologic outcomes as measured by a CPC score of 1 or 2 at discharge	Cerebral Performance Category (CPC)	up to 12months

Secondary Outcome Measures

Outcome Measure	Time Frame
Percent of patients who receive CPR from a bystander as measured by EMS report	Baseline
Rate of Defibrillation before paramedics arrive as measured by bystander interview	Baseline

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percent of cardiac arrest patients whose cardiac arrests are recognized by 911-dispatcher through telephone call		Follow-up, up to 4 years
Percent of cardiac arrest patients with responders who receive CPR instructions by 911-dispatcher through telephone call		Follow-up, up to 4 years
Survival rate as measured by medical record abstraction		Follow-up, up to 4 years
Change in Neurologic disability as measured by Modified Rankin Score	The Modified Rankin Score is a 6 point likert scale, with 0 being "No symptoms" and 6 being "Dead"	3 months, 12 months
Change in Quality of life as measured by the SF-36	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).	3 months, 12 months
Change in Quality of life as measured by the EQ-5D-5L	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.	3 months, 12 months

Collaborators and Investigators

• Sponsor: Duke University
• Collaborators: National Heart, Lung, and Blood Institute (NHLBI)
• Investigators: Principal Investigator: Christopher Granger, MD, Duke University

Publications and helpful links

General Publications

• Krychtiuk KA, Starks MA, Al-Khalidi HR, Mark DB, Monk L, Yow E, Kaltenbach L, Jollis JG, Al-Khatib SM, Bosworth HB, Ward K, Brady S, Tyson C, Vandeventer S, Baloch K, Oakes M, Blewer AL, Lewinski AA, Hansen CM, Sharpe E, Rea TD, Nelson RD, Sasson C, McNally B, Granger CB; RACE-CARS NC Counties. RAndomized Cluster Evaluation of Cardiac ARrest Systems (RACE-CARS) trial: Study rationale and design. Am Heart J. 2024 Nov;277:125-137. doi: 10.1016/j.ahj.2024.07.013. Epub 2024 Jul 30.

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2022
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): June 30, 2027

Study Registration Dates

• First Submitted: December 3, 2020
• First Submitted That Met QC Criteria: December 3, 2020
• First Posted (Actual): December 9, 2020

Study Record Updates

• Last Update Posted (Actual): July 16, 2026
• Last Update Submitted That Met QC Criteria: July 15, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: cardiac arrest; out-of-hospital cardiac arrest; cardiopulmonary resuscitation; telephone CPR; dispatch CPR; defibrillation
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Heart Diseases; Heart Arrest; Out-of-Hospital Cardiac Arrest; Therapeutics; Resuscitation; Emergency Treatment; Cardiopulmonary Resuscitation
• Other Study ID Numbers: Pro00105633; 5UH3HL146935-06 (U.S. NIH Grant/Contract); 5U24HL146938-06 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No