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| ID | Type | Description | Link |
|---|---|---|---|
| 1UG3HL146935-01A1 | U.S. NIH Grant/Contract | View source | |
| 1U24HL146938-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention (Enhanced Standard of Care) | Experimental | Mass community CPR/AED training, optimize 911 medical dispatch, improve first responder performance |
|
| Control (Standard of Care) | No Intervention | Usual care, continuing standard quality improvement effort |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| 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 |
| Measure | Description | 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 |
| 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 |
Inclusion Criteria:
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:
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
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| Name | Affiliation | Role |
|---|---|---|
| Christopher Granger, MD | Duke University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duke | Durham | North Carolina | 27705 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39084483 | Derived | 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. |
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| Systematic bystander resuscitation instruction by 911 operators | Other | 911 operators will be able to describe how to administer CPR over the phone. |
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| Comprehensive community training of lay people in CPR and AED use. | Other | Training of lay people regarding CPR and AED use. |
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| Optimized first responder performance including earlier use of AEDs. | Other | First responders will recognize where AEDs are located and use them appropriately |
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| 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 |
| ID | Term |
|---|---|
| D006323 | Heart Arrest |
| D058687 | Out-of-Hospital Cardiac Arrest |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D016887 | Cardiopulmonary Resuscitation |
| ID | Term |
|---|---|
| D012151 | Resuscitation |
| D004638 | Emergency Treatment |
| D013812 | Therapeutics |
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