RACE-CARS - RAndomized Cluster Evaluation of Cardiac ARrest Systems

NCT04660526 | Enrolling By Invitation DMC

• 3 other identifiers: Pro001056331UG3HL146935-01A11U24HL146938-01A1
• Study Type: interventional
• Target: 20,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Cardiac Arrest

Keywords

cardiac arrest; cardiopulmonary resuscitation; telephone CPR; dispatch CPR; out-of-hospital cardiac arrest; defibrillation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• 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 Outcomes (6)

• 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

Study Arms (2)

Intervention (Enhanced Standard of Care)

EXPERIMENTAL

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; 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.

Control (Standard of Care)

NO INTERVENTION

Usual care, continuing standard quality improvement effort

Interventions

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

Intervention (Enhanced Standard of Care)

Systematic bystander resuscitation instruction by 911 operators OTHER

911 operators will be able to describe how to administer CPR over the phone.

Intervention (Enhanced Standard of Care)

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

Training of lay people regarding CPR and AED use.

Intervention (Enhanced Standard of Care)

Optimized first responder performance including earlier use of AEDs. OTHER

First responders will recognize where AEDs are located and use them appropriately

Intervention (Enhanced Standard of Care)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Duke University: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

Duke

Durham, North Carolina, 27705, United States

Location

Related Publications (1)

• 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.

  PMID: 39084483 DERIVED

MeSH Terms

Conditions

Heart Arrest; Out-of-Hospital Cardiac Arrest

Interventions

Cardiopulmonary Resuscitation

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Resuscitation; Emergency Treatment; Therapeutics

Study Officials

• Christopher Granger, MD

  Duke University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 3, 2020
• First Posted: December 9, 2020
• Study Start: July 1, 2022
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2027
• Last Updated: May 6, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)