grant

RACE-CARS DCC 2/2

Organization DUKE UNIVERSITYLocation DURHAM, UNITED STATESPosted 1 Jul 2020Deadline 30 Jun 2027
NIHUS FederalResearch GrantFY202518 year old18 years of ageActive Follow-upAdherenceAgreementAsystoleCardiacCardiac ArrestCardiac ElectroversionCardioversionCaringCategoriesCell Communication and SignalingCell SignalingCerebrumClinicalClinical ResearchClinical StudyClinical TrialsClinical Trials Data Monitoring CommitteesCluster randomization trialCluster randomized trialCollaborationsCommunitiesCountryCountyDataData BasesData CollectionData Coordinating CenterData Coordination CenterData Monitoring CommitteesData ReportingData SetData and Safety Monitoring BoardsDatabasesDoctor of PhilosophyDocumentationDoseED careER careEffectivenessElectric CountershockElectric DefibrillationElementsEmergenciesEmergency CareEmergency Department careEmergency Room careEmergency SituationEmergency health careEmergency medical careEmergency medical serviceEmergency responseEnrollmentEnsureFeedbackHeart ArrestHeterogeneityHospitalsInstitute of MedicineInstitute of Medicine (U.S.)InstructionInterventionIntervention StrategiesIntracellular Communication and SignalingInvestigatorsLeadershipLinkManualsManuscriptsMeasuresMedicalMonitorNAS/IOMNHLBINational Heart, Lung, and Blood InstituteNervous System PhysiologyNeurologicNeurologic functionNeurologic outcomeNeurologicalNeurological functionNeurological outcomeNorth CarolinaObservation researchObservation studyObservational StudyObservational researchOutcomePatient outcomePatient-Centered OutcomesPatient-Focused OutcomesPatientsPerformancePersonsPh.D.PhDPhasePhonePopulationPopulation DensityPreparationPrincipal InvestigatorProceduresProcessProtocolProtocols documentationPublic HealthQOLQuality ControlQuality of lifeRaceRacesRandomization trialRandomizedRegistriesReportingResearch DesignResearch InstituteResearch PersonnelResearch ProposalsResearch ResourcesResearchersResourcesResuscitationRoleSafety Monitoring BoardsSecureSignal TransductionSignal Transduction SystemsSignalingSocio-economic statusSocioeconomic StatusStandardizationStatistical Data AnalysesStatistical Data AnalysisStatistical Data InterpretationStudy TypeSurvival RateSurvivorsSystemTechniquesTelephoneTestingTrainingUnited StatesVariantVariationWorkactive followupage 18 yearsbiological signal transductioncardiovascular emergencycare as usualcare providerscare servicescare systemscerebralcoaching callscommunity interventioncommunity level interventioncommunity-based interventiondata basedata depositiondata integrationdata managementdata qualitydata representationdata representationsdata submissiondefibrillationdesigndesigningdissemination trialeffective interventioneffective therapyeffective treatmenteighteen year oldeighteen years of ageelectronic dataemergency serviceenrollexperiencefirst responderfollow upfollow-upfollowed upfollowupfunctional statusimplementation interventionimplementation trialimprovedimproved outcomeincremental costintervention programnervous system functionoperationoperationsout-of-hospital cardiac arrestout-of-hospital sudden cardiac arrestpatient oriented outcomesphone coachpreparationsprimary end pointprimary endpointprogramsracialracial backgroundracial originrandomisationrandomizationrandomized trialrandomly assignedresponsesecondary outcomesocial rolesocio-economic positionsocioeconomic positionstandard carestandard treatmentstatistical analysisstatisticsstudy designtelephone based coachingtelephone coachingtelephone counselingtreatment as usualtrial designusual care
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Full Description

Project Abstract
Approximately 350,000 people suffer out-of-hospital cardiac arrest (OHCA) each year, with an average survival

rate with good neurological function of only 9.0%. In response to the clear public health imperative signaled by

these statistics, the Institute of Medicine in 2015 called for studies on implementation of interventions for

OHCA at the community, emergency medical services (EMS), and hospital levels. The lack of consistent use of

effective interventions across the country is largely due to the lack of high quality evidence from randomized

trials on how to implement these interventions at the systems (community) level. The proposed Regional

Approaches to Cardiovascular Emergencies- Cardiac ARreSt (RACE-CARS) cluster-randomized trial has been

designed to develop new systems-based high quality clinical trial evidence on how to improve outcomes for

OHCA. The premise for RACE-CARS is based on prior observations showing substantial regional

heterogeneity in care correlated with variations in outcomes. In 11 North Carolina counties, we observed

improved rates of bystander CPR and first responder defibrillation, associated with a 37% increase in survival

with good neurologic outcome over a 4-year period.

RACE-CARS, a 7-year pragmatic, cluster randomized (1:1) trial of 50 counties in NC, will test whether

implementation of a customized set of strategically targeted community-based interventions can improve

survival to hospital discharge with good neurologic function in OHCA relative to control/standard care. Our

intervention program will consist of 4 main elements: (1) optimized medical 911-dispatch performance with

rapid recognition of cardiac arrest and dispatch of emergency response, (2) enhanced 911-dispatch telephone

coaching of bystander CPR, (3) improved first responder performance with AED use, and (4) comprehensive

public training of CPR and AED use. Quality of life and neurological functional status will be assessed at 6 and

12 months. RACE-CARS will leverage our statewide emergency care network, which has successfully

collaborated on improving quality of emergency cardiovascular care over the past 14 years, and ongoing data

collection of the majority of cardiac arrests in NC using the CARES registry. We will enroll ~20,000 patients

with cardiac arrest over the study period, to give us >90% power to detect a 30% increase in bystander CPR,

and 50% increase in bystander or first responder defibrillation, and > 85% power to detect a 33% increase in

survival with good neurologic outcome. While all the intervention approaches have evidence for improved

outcomes in prior observational studies, RACE CARS is unique in combining these efforts into a pragmatic

randomized systems-based implementation trial that can be adjusted to the needs and abilities/resources of

regions that vary according to population density, demographic and socioeconomic status.

1

Grant Number: 5U24HL146938-06
NIH Institute/Center: NIH

Principal Investigator: Hussein Al-Khalidi

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