Clinical trial NCT04660526: RACE-CARS - RAndomized Cluster Evaluation of Cardiac ARrest Systems
Official title: RAndomized Cluster Evaluation of Cardiac ARrest Systems
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Cardiac Arrest
Keywords: cardiac arrest
cardiopulmonary resuscitation
telephone CPR
dispatch CPR
out-of-hospital cardiac arrest
defibrillation
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2020-12-09
Enrollment: 20000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.


Eligibility criteria: 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

Primary outcomes:
measure: Survival with good neurologic outcomes as measured by a CPC score of 1 or 2 at discharge
timeFrame: up to 12months
Secondary outcomes:
measure: Percent of patients who receive CPR from a bystander as measured by EMS report
timeFrame: Baseline
measure: Rate of Defibrillation before paramedics arrive as measured by bystander interview
timeFrame: Baseline
Other outcomes:
measure: Percent of cardiac arrest patients whose cardiac arrests are recognized by 911-dispatcher through telephone call
timeFrame: Follow-up, up to 4 years
measure: Percent of cardiac arrest patients with responders who receive CPR instructions by 911-dispatcher through telephone call
timeFrame: Follow-up, up to 4 years
measure: Survival rate as measured by medical record abstraction
timeFrame: Follow-up, up to 4 years
measure: Change in Neurologic disability as measured by Modified Rankin Score
timeFrame: 3 months, 12 months
measure: Change in Quality of life as measured by the SF-36
timeFrame: 3 months, 12 months
measure: Change in Quality of life as measured by the EQ-5D-5L
timeFrame: 3 months, 12 months
Locations:
city: Durham
country: United States
facility: Duke
state: North Carolina
Study officials:
affiliation: Duke University
name: Christopher Granger, MD
role: PRINCIPAL_INVESTIGATOR
References: