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RACE-CARS - RAndomized Cluster Evaluation of Cardiac ARrest Systems

Primary Purpose

Cardiac Arrest

Status

Enrolling by invitation

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Rapid cardiac arrest recognition that triggers immediate priority EMS/first responder dispatch by 911 operators

Systematic bystander resuscitation instruction by 911 operators

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

Optimized first responder performance including earlier use of AEDs.

About this trial

This is an interventional health services research trial for Cardiac Arrest focused on measuring cardiac arrest, cardiopulmonary resuscitation, telephone CPR, dispatch CPR, out-of-hospital cardiac arrest, defibrillation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Duke

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention (Enhanced Standard of Care)

Control (Standard of Care)

Arm Description

Mass community CPR/AED training, optimize 911 medical dispatch, improve first responder performance

Usual care, continuing standard quality improvement effort

Outcomes

Primary Outcome Measures

Survival with good neurologic outcomes as measured by a CPC score of 1 or 2 at discharge

Cerebral Performance Category (CPC)

Secondary Outcome Measures

Percent of patients who receive CPR from a bystander as measured by EMS report

Rate of Defibrillation before paramedics arrive as measured by bystander interview

Full Information

NCT ID

NCT04660526

First Posted

December 3, 2020

Last Updated

April 19, 2023

Sponsor

Duke University

Collaborators

National Heart, Lung, and Blood Institute (NHLBI)

1. Study Identification

Unique Protocol Identification Number

NCT04660526

Brief Title

RACE-CARS - RAndomized Cluster Evaluation of Cardiac ARrest Systems

Official Title

RAndomized Cluster Evaluation of Cardiac ARrest Systems

Study Type

Interventional

2. Study Status

Record Verification Date

April 2023

Overall Recruitment Status

Enrolling by invitation

Study Start Date

July 1, 2022 (Actual)

Primary Completion Date

June 2027 (Anticipated)

Study Completion Date

June 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Duke University

Collaborators

National Heart, Lung, and Blood Institute (NHLBI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cardiac Arrest

Keywords

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

7. Study Design

Primary Purpose

Health Services Research

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

20000 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Intervention (Enhanced Standard of Care)

Arm Type

Experimental

Arm Description

Mass community CPR/AED training, optimize 911 medical dispatch, improve first responder performance

Arm Title

Control (Standard of Care)

Arm Type

No Intervention

Arm Description

Usual care, continuing standard quality improvement effort

Intervention Type

Other

Intervention Name(s)

Rapid cardiac arrest recognition that triggers immediate priority EMS/first responder dispatch by 911 operators

Intervention Description

EMS first responders will recognize cardiac arrest and respond immediately, increasing time to dispatch

Intervention Type

Other

Intervention Name(s)

Systematic bystander resuscitation instruction by 911 operators

Intervention Description

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

Intervention Type

Other

Intervention Name(s)

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

Intervention Description

Training of lay people regarding CPR and AED use.

Intervention Type

Other

Intervention Name(s)

Optimized first responder performance including earlier use of AEDs.

Intervention Description

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

Primary Outcome Measure Information:

Title

Survival with good neurologic outcomes as measured by a CPC score of 1 or 2 at discharge

Description

Cerebral Performance Category (CPC)

Time Frame

up to 12months

Secondary Outcome Measure Information:

Title

Percent of patients who receive CPR from a bystander as measured by EMS report

Time Frame

Baseline

Title

Rate of Defibrillation before paramedics arrive as measured by bystander interview

Time Frame

Baseline

Other Pre-specified Outcome Measures:

Title

Percent of cardiac arrest patients whose cardiac arrests are recognized by 911-dispatcher through telephone call

Time Frame

Follow-up, up to 4 years

Title

Percent of cardiac arrest patients with responders who receive CPR instructions by 911-dispatcher through telephone call

Time Frame

Follow-up, up to 4 years

Title

Survival rate as measured by medical record abstraction

Time Frame

Follow-up, up to 4 years

Title

Change in Neurologic disability as measured by Modified Rankin Score

Description

The Modified Rankin Score is a 6 point likert scale, with 0 being "No symptoms" and 6 being "Dead"

Time Frame

3 months, 12 months

Title

Change in Quality of life as measured by the SF-36

Description

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).

Time Frame

3 months, 12 months

Title

Change in Quality of life as measured by the EQ-5D-5L

Description

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.

Time Frame

3 months, 12 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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: 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Christopher Granger, MD

Organizational Affiliation

Duke University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Duke

City

Durham

State/Province

North Carolina

ZIP/Postal Code

27705

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

RACE-CARS - RAndomized Cluster Evaluation of Cardiac ARrest Systems

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