The California Resuscitation Outcomes Consortium (CAL-ROC): A novel collaboration to facilitate the implementation of randomized clinical trials in the prehospital setting

Abstract

Background: Few large randomized clinical trials (RCTs) have been conducted to inform the prehospital phase of care for out-of-hospital cardiac arrest (OHCA). We describe the development of a consortium to facilitate large-scale prehospital RCTs through a novel research collaboration, leveraging pre-existing prehospital and hospital data capture infrastructure.

Consortium description: We developed a consortium consisting of 173 emergency medical services (EMS) Provider Agencies and four academic "hubs." The consortium is an innovative collaboration consisting of a diverse set of EMS experts from across California and designed to overcome logistical, cost, and regulatory challenges associated with prehospital research. All participating agencies share data via a state EMS database, California EMS Information System (CEMSIS), and contribute data to the national Cardiac Arrest Registry to Enhance Survival (CARES) database. Data from CEMSIS and CARES will be linked to capture RCT outcomes. We abstracted two years of data from the CARES database to characterize the population served by the consortium and facilitate sample size calculations for future trials. We estimate that the consortium will have the ability to enroll a diverse population of patients with OHCA, at a rate of approximately 19,000 per year across all sites, for a future trial of cardiac arrest therapies.

Conclusion: This collaboration uses pre-existing data infrastructure to capture prehospital and hospital outcome data to facilitate large-scale prehospital RCTs for time-critical emergencies.

Keywords: Cardiac arrest; Clinical trials; Emergency medical services; Out-of-hospital cardiac arrest.

Fig. 1

a. Map of Emergency Medical Services Agencies Participating in the Consortium b. Organizational and Regulatory Structure of California Emergency Medical Services.

Fig. 2

CAL-ROC Organizational Structure; CCC = Clinical Coordinating Center, DCC = Data Coordinating Center, DSMB = Data Safety Monitoring Board, EMS = Emergency Medical Services, FDA = Food and Drug Administration, sIRB = single Institutional Review Board, TLI = The Lundquist Institute, UC = University of California.

Fig. 3

CAL-ROC Data Flow; CARES = Cardiac Arrest to Enhance Survival database, CEMSIS = California Emergency Medical Services Information System, DCC = Data Coordinating Center, EMS = Emergency Medical Services.