RACE-CARS - RAndomized Cluster Evaluation of Cardiac ARrest Systems

Cardiac Arrest Clinical Trial

Official title:

RAndomized Cluster Evaluation of Cardiac ARrest Systems

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04660526
• Other study ID #: Pro00105633
• Secondary ID: 1UG3HL146935-01A
• Status: Enrolling by invitation
• Phase: N/A
• Start date: July 1, 2022
• Est. completion date: June 30, 2027

Study information

• Verified date: April 2024
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 20000
• Est. completion date: June 30, 2027
• Est. primary completion date: June 30, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cardiac Arrest
• Heart Arrest

Intervention

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
• Systematic bystander resuscitation instruction by 911 operators
911 operators will be able to describe how to administer CPR over the phone.
• Comprehensive community training of lay people in CPR and AED use.
Training of lay people regarding CPR and AED use.
• Optimized first responder performance including earlier use of AEDs.
First responders will recognize where AEDs are located and use them appropriately

Locations

Country	Name	City	State
United States	Duke	Durham	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Duke University	National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Percent of cardiac arrest patients whose cardiac arrests are recognized by 911-dispatcher through telephone call		Follow-up, up to 4 years
Other	Percent of cardiac arrest patients with responders who receive CPR instructions by 911-dispatcher through telephone call		Follow-up, up to 4 years
Other	Survival rate as measured by medical record abstraction		Follow-up, up to 4 years
Other	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
Other	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
Other	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
Primary	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	Percent of patients who receive CPR from a bystander as measured by EMS report		Baseline
Secondary	Rate of Defibrillation before paramedics arrive as measured by bystander interview		Baseline