RACE-CARS - RAndomized Cluster Evaluation of Cardiac ARrest Systems (NCT04660526) | Clinical Trial Compass
By InvitationNot Applicable
RACE-CARS - RAndomized Cluster Evaluation of Cardiac ARrest Systems
United States20,000 participantsStarted 2022-07-01
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Exclusion criteria
. injuries incompatible with life,
. the presence of rigor mortis or lividity,
. signs of decomposition, or
. the presence of a valid DNR.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is listed as 'enrolling by invitation' — can you help me understand how someone becomes eligible to be part of this study, and whether it's even an option for my situation?
2Since this is a cluster-based trial studying emergency cardiac arrest response systems rather than a drug or device given directly to a patient, can you explain what that means for how I or my community would actually be involved?
3The main thing this study is measuring is survival with good brain function after cardiac arrest — can you walk me through what the 'CPC score' scale means in practice, and what scores of 1 or 2 actually look like in terms of daily functioning?
4This trial doesn't have a traditional phase listed, which suggests it's evaluating a healthcare system or process rather than a new treatment — does that mean the risks are different compared to a typical drug trial, and what should I realistically expect?
5If this study is focused on improving community or hospital systems for responding to cardiac arrest, are there standard-of-care treatments or programs already available to me that I should be considering alongside or instead of any involvement in this research?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Survival with good neurologic outcomes as measured by a CPC score of 1 or 2 at discharge