cardiac arrest registry to enhance survival (cares) reference manual aug 07.pdf · the cares...

Cardiac Arrest Registry to Enhance Survival (CARES)

CARES REFERENCE MANUAL

August 2007

Bryan McNally, MD, MPH (Principle Investigator) Arthur Kellermann, MD, MPH (Co-Investigator)

Allison Park, MPH (Program Coordinator) Lorie Click MN, MPH (Epidemiologist)


I. INTRODUCTION

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INTRODUCTION

Sudden cardiac death (SCD) is the leading cause of death among adults in the United States and Western countries. It is estimated that approximately 400,000 deaths occur every year. Most of these deaths are due to a fatal heart rhythm disturbance called ventricular fibrillation. Nationally, only about 35 communities actively monitor and report their survival rates from out-of-hospital cardiac arrest (OOHCA). The range of survival in these communities for ventricular fibrillation is anywhere - from 2% to 35%, a striking difference, since the approach to the care of these patients is uniform and there is no evidence that patients in one part of the country are different biologically from another. The CARES (Cardiac Arrest Registry to Enhance Survival) Program is a collaborative effort of the Centers for Disease Control and Prevention (CDC), the American Heart Association (AHA) and the Emory University Department of Emergency Medicine, Section of Prehospital and Disaster Medicine. The CDC and the AHA are working together to reduce the death rate from heart disease and stroke by 25% from the years 2000-2010. One of the CDC’s initiatives is to develop a model national registry to accurately measure our progress in the treatment of out-of- hospital sudden cardiac death (SCD). Using the Utstein style of statistics for OOHCA, CARES is capable of identifying and tracking all cases of cardiac arrest in a defined geographic area. The ultimate goals of CARES is to help local EMS administrators and medical directors identify who is affected, when and where cardiac arrest events occur, which elements of the system are functioning properly and which elements are not, and how changes can be made to improve cardiac arrest outcomes. CARES utilizes an internet database system that reduces time involved in registering events, tracking patient outcomes with hospitals, and response intervals associated with First Responder and EMS response. Multiple reporting features can be generated and monitored continuously through secure online access by CARES participants and allow for longitudinal, internal benchmarking. Presently, the odds of surviving an episode of out of hospital cardiac arrest in the United States vary by a factor of 10 to 20, depending on the community in which it occurs. Disparities in outcome this extreme are unacceptable and are what the CARES project will be able to identify and allow communities to improve upon. As more communities participate in CARES, confidential, external benchmarking can occur between similar systems across the United States. The CARES Reference Manual provides a comprehensive review of the implementation, operations, and reporting of CARES. Please use this manual as a resource and guide for furthering your understanding of CARES, and please do not hesitate to contact the CARES staff for additional questions and updates. Thank you for your interest in the CARES Program and your consideration of participating in the program in an effort to improve out-of-hospital cardiac arrest survival in your community.

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Cardiac Arrest Registry to Enhance Survival (CARES) OPERATIONAL OVERVIEW

Overview The goal of the CARES project is to establish a model of unifying all essential data elements from three, independent sources, which currently record fractured data of a single, cardiac arrest event. The CARES system is building this model by establishing a relationship with emergency medical services (EMS) agencies, hospitals, and computer-aided dispatch (CAD) systems. Through these sources, access to specific data elements and participation allow for understanding of data flow and the ability to develop an efficient and automatic data collection and outcome reporting system. The collection and reporting system is provided by a restricted-access, secure, internet database developed by Scanhealth, Inc. and managed locally by the CARES project staff. All participants can view their individual statistics and de-identified, community-aggregate statistics. EMS agencies EMS providers initiate a CARES event based on criteria set forth initially by the project coordinator and the data dictionary. A contact person at each EMS agency (CARES liason) ensures adherence to the criteria and provides routine communication with the project coordinator for issues, concerns, and questions. The data can be submitted in three ways: completion of the CARES form, direct entry into the website database, or exporting electronic data from field software programs. Hospitals Hospitals receive notification to provide outcome data through an email, which is automatically generated by the database. The hospital contact person was identified by obtaining the cooperation and support from the Georgia Hospital Association (GHA). Through establishing a relationship with the hospital, orientation to the project and website was conducted, HIPAA concerns were addressed, and adequate identification of patients within their system was obtained. CAD system CAD data is collected through automatic export/import and/or direct entry into the website database. Once contact and agreement is made with each CAD system administrator, time elements are sent and/or entered after matching the event based on date, approximate time, and location of the event. In various combinations, multiple CAD systems provide response times for EMS and First Responders. All event and First Responder information is identified by EMS during the initial CARES report. Review The CARES database is monitored daily by the project staff, which continues to address key issues. These include CARES form and dictionary revisions for EMS and hospital users, updates in website data entry and report formats, identifying and meeting with additional communities for project participation (ie, Kansas City, MO), summary analysis of pitfalls and solutions for project ‘tool kit’, and advising agencies with system improvement in areas related to the CARES project.

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CARES NETWORK

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ILLUSTRATIONS OF CARES IMPACT, OBSTACLES, AND SOLUTIONS

FIGURE 1. IMPORTANCE OF EACH DATA ELEMENT IN MODEL

Hospital Completes Utstein report by

providing: • Survival to discharge • Report transferred patients • Neurological status

CAD system Provides accurate response

intervals by using: • 911 call received • First Responder dispatch • EMS dispatch • First Responder arrival • EMS arrival

EMS • Likely phase of survival • Date and time of event • Location type • Bystander interventions • Etiology of event • Rhythm analysis (Utstein) • IDs CAD, First Resp, and

Hospitals involved w/ event

CARES Event (Cardiac Arrest)

• Identified occurrence • Of time-sensitive event • With meaningful outcome statistics

Feedback

Feedback

Feedback

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FIGURE 2. OBSTACLES OF UNIFYING DATASETS FROM EACH AGENCY

Hospital • Matching record # w/ EMS • Linking data electronically • Coop of Hospital personnel • HIPPA concerns

CAD system • Matching record # w/ EMS • Linking data electronically • Cooperation of CAD vendor • Coop of CAD personnel

EMS • Defining data elements • Collecting data from field • Establishing compliance • Ensure specificity/sensitivity• Put data into electronic form • Meaningful feedback stats • 100% regional participation


• Identified occurrence • Of time-sensitive event • With meaningful outcome statistics

Feedback

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FIGURE 3. SOLUTIONS TO UNIFYING DATASETS FROM EACH AGENCY

Hospital • Access Pt info via website • Ease of semi-auto process to

reduce anxiety of labor involved

• Limit required follow-up entries to essential cases

• Extension of Public Health agency w/ HIPAA-compliant website

CAD system • Auto-match record by date,

address and approx time • Use of export/import

program by Scanhealth • Devlp universal setup and

allow consumer demand to drive competitive market

• Est easy, semi-automatic process of data entry

EMS • Standardized data elements • Creating CARES Form • Integrate data in PCR/Tablet• Estab query of EMS records • Scan or Web-enter data • Utstein, Time, Bystander,

and Demographic reports


• Identified occurrence • Of time-sensitive event • With meaningful outcome statistics • Resulting in longitudinal survey of

system performance • With comparative analysis

Feedback

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Principal Investigator/Program Director (Las, first, middle): McNally, Bryan F.

CARES GRANT PROPOSAL DOCUMENT Modified Application Review Criterion: Significance: Out of hospital cardiac arrest is a leading cause of death in the U.S. The registry of this cooperative agreement will help communities identify their outcomes, improve their processes of care, and increase public attention to the frequency and consequences of this condition, creating opportunities to promote awareness and prevention. Approach: The conceptual approach is built on the public health model, uses readily available data sources, and will incorporate consensus standards for data collection, including NEDSS, SENDSS, and the Utstein Criteria for cardiac arrest reporting. Innovation: Few communities nationwide regularly monitor cardiac arrest outcomes and performance statistics. By creating an alliance between an academic medical center, local EMS, the CDC and the American Heart Association, we can demonstrate how data can rapidly drive process improvement and save lives. Investigator: Our proposal includes a fellowship trained and highly experienced P.I. who holds dual MD, MPH degrees and has significant field experience in EMS, with a senior Co-investigator who holds dual MD MPH degrees is one of the nation’s most highly regarded EM investigators with a track record of successful cardiac arrest research. We have also secured the commitment of the nation’s most highly regarded cardiac arrest researcher, Dr. Mickey Eisenberg of the University of Washington to advise the team. Environment: Metro Atlanta is a challenging setting for this sort of project, in that it has multiple agencies and jurisdictions, competing healthcare systems, and a large population to cover. However, it benefits from close proximity to the CDC, the American Heart Association regional affiliate, and Emory University. If the registry is successful here, it can succeed anywhere. Methods: Our plans for identification of subjects and securing data are straightforward. The involvement and support of the Georgia Office of EMS, which has regulatory authority over EMS activities statewide, insures cooperation. Evaluation: The registry promises to spotlight an important health problem, cardiac arrest, and identify opportunities to improve care and increase community rates of survival. It will help us both identify and reduce disparities in out of hospital care and improve outcomes, particularly for minority and disadvantaged populations. It should facilitate cooperation between agencies, jurisdictions and organizations for the benefit of individual patients and public health. Details of our proposal follow, organized in the PHS 398 format.

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http://www.cdc-cafunding.org/newapplications/applicationreview.htm


A) SPECIFIC AIMS 1. Plan, implement, and support the operation of emergency medical service (EMS)-based

cardiac arrest registry. 2. Demonstrate the availability of additional resources and supports from, and partnership

with, national or local organizations, and key stakeholders. Demonstrate a willingness by selected first responders or EMS agencies, 9-1-1 dispatching centers, and hospitals to participate in the cardiac arrest registry prototype.

3. Convene a national expert panel to revise and refine required and supplementary data elements for cardiac arrest registry through workshops.

4. Develop a plan for the selection of a defined geographic area (community, county, metropolitan area, or state) to participate in the cardiac arrest registry prototype development.

5. Collaborate with CDC on the feasibility of developing a data system that is compliant or compatible with the National Electronic Disease Surveillance System (NEDSS).

6. Develop a data collection mechanism and train hospital personnel in the data collection process.

7. Develop and maintain a real-time data system, including quality assurance mechanisms for data collection and management, to provide timely, complete and quality data.

8. Plan and implement a methodology for assessments of hospital reporting compliance, validity of diagnosis, reliability and completeness of all reporting parameters, and hospital costs required for data collection.

9. Develop and maintain the capability to securely export data. 10. Submit data elements to a CDC-designated independent auditor with the content and

format specified by the auditor. The required format for data export may be revised during the project period, for example, due to potentially new federal legislative and regulatory requirements.

11. Ensure secure electronic storage, to the extent possible, of all collected data including text and codes.

12. Participate in an independent outside audit of data completeness and quality, conducted by a CDC-approved organization/entity. Audit results will be furnished to CDC.

13. Provide a relevant and realistic plan to use cardiac arrest registry data to improve the delivery of care to patients with cardiac arrest.

CDC Activities (to be done in conjunction with Emory) 14. Provide consultation and technical assistance for effective program planning and

management through conference calls, annual site visits, and annual meetings for recipients.

15. Collaborate in establishing or endorsing program requirements for completeness, timeliness, and accuracy of data.

16. Assist in obtaining CDC and local IRB approval. 17. Ensure the completion of all requirements and quality of the project.

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B) BACKGROUND AND SIGNIFICANCE

Sudden cardiac arrest is the leading cause of death among adults in the United States and Western countries. It is estimated that approximately 400,000 deaths occur every year. Most of these deaths are due to a fatal heart rhythm disturbance called ventricular fibrillation. The average age for cardiac arrest is late 60s but it can happen in persons in the third and fourth decade of life and even rarely among teenagers and young adults. Most events happen in men. The ratio of men to women for sudden cardiac arrest is 2:1.

The incidence of cardiac arrest is not static. A recent CDC clinical investigation found

evidence that between 1989 to 1998, sudden cardiac death as a percentage of all cardiac deaths increased by 12.4%. Even more alarmingly, the proportion of out-of-hospital SCD increased by 23.5%.

Approximately half the time, the cardiac arrest event occurs in someone with a history of

heart disease. However, frequently the cardiac arrest event is the first sign of an underlying problem with heart disease. Collapse can occur without any premonitory symptoms whatsoever. Over 75% of the events happen in homes; approximately 15% occur in public locations and 10% in nursing homes.

During ventricular fibrillation, the pulse is quickly lost and the blood pressure falls to zero and the victim loses consciousness. He or she is clinically dead at this moment. Unless the heart is quickly restarted, death will be irreversible. If, however, CPR is quickly initiated to maintain blood flow and oxygenation of the brain and heart, and if a device called a defibrillator can be brought to the victim within a few minutes to deliver an electric shock to the heart to restart its normal rhythm, there is a good chance of full recovery. A good metaphor is to think of life being “snatched from the jaws of death”. Success or failure comes down to a matter of minutes and seconds. If treatment is not provided quickly, the victim will die.

To reinforce the importance of time, the American Heart Association created the

concept of the “chain of survival”. The first link in this chain is the need for a bystander or witness to the event to quickly call 911 and activate the EMS system. The second link is rapid provision of CPR, ideally through a bystander. The third link is early defibrillation. This may be provided by the first arriving paramedic, a firefighter with an automated external defibrillator (AED), or in some public areas such as an airport concourse, a bystander using a public access AED. The fourth and final link is rapid advanced life support care (such as administration of cardiac medications and endotracheal intubation. Additional definitive care, potentially including such measures as thrombolytic therapy, angioplasty, or coronary artery bypass grafting, invasive monitoring, IV pressor support, and respiratory support via a ventilator, is provided once the patient reaches the hospital emergency department, and subsequently the cardiac cath lab or an intensive care unit.

Nationally, only about 35 communities actively monitor and report their survival rates

from out-of-hospital cardiac arrest. The range of reported rates of survival for all cardiac rhythms varies in these communities ranges from 1% to 20% a striking difference, since the approach to care of these patients is uniform and there is no evidence that patients in one part

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of the country are different biologically from another. The range of survival in these communities for the cardiac dysrhythmia ventricular fibrillation (the one associated with the highest likelihood of survival) is equally striking - from 2% to 35%.

Communities with relatively high survival rates for out of hospital cardiac arrest are

characterized by certain characteristics, all of which are associated with components of the American Heart Association’s “Chain of Survival”. First, through use of 911, they provide a ready means for the public to contact authorities and activate the EMS system. Second, they report high percentages of bystander CPR (through public training programs and provision of dispatcher assisted telephone CPR). Third, they feature rapid-response EMS systems in which first responding firefighters or EMTs equipped with an automated external defibrillator or paramedics equipped with a manual defibrillator arrive within minutes to administer one or more defibrillatory shocks. Finally, paramedics also have the capability to provide the fourth link in the “chain of survival” provision of advanced life support, such as skilled airway maneuvers and other treatments while the patient is quickly transported to a hospital for definitive care.

Of all these links and time intervals, the one that appears to be the most important for

predicting survival to hospital discharge is the time interval from collapse to the first attempt at defibrillation. With each minute that defibrillation is delayed, the chances of successful resuscitation decrease by 2-10%.

The importance of minimizing time to provision of prehospital cardiac care cannot be

overemphasized. Several studies have demonstrated that if a victim cannot be successfully resuscitated at the scene, his or her chances of successful resuscitation in a hospital ED and subsequently survival to hospital discharge are extremely poor - approximately 0.5%. The odds that the victim will survive with an acceptable neurological outcome are even less. On the strength of this finding, many cities have made extensive efforts to shorten the time from collapse to defibrillation in out-of-hospital cardiac arrest. A variety of initiatives have been implemented, including providing automated external defibrillators (AEDs) to first responding firefighters or police officers, strategic placement of AEDs in public places such as airport concourses, and provision of AEDs for home use by family members of high risk cardiac patients.

In contrast to the efforts made to strengthen provision of emergency cardiac care, little effort has been made to strengthen the information systems needed to measure various components of a community’s approach to cardiac arrest. Many cities do not even know their success rate for resuscitating victims of out of hospital cardiac arrest.

The justification for enhanced data collection is straightforward. None of the factors that

influence cardiac arrest survival can be understood or improved without a basic data collection system that identifies cardiac arrest events, links data reported by various components of the EMS system (e.g., 911, fire department based first responders, ambulances and hospitals) and identifies patient outcomes. In the absence of basic data on each link of the “chain of survival”, EMS administrators and medical directors cannot determine where or how to focus their quality improvement efforts.

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The nationwide scope of this problem was recently highlighted in a series of front-page

stories in the national newspaper, USA Today. The third article in the series was entitled “Many lives are lost across USA because emergency services fail.” This story can be found at http://www.usatoday.com/news/nation/ems-day1-cover.htm. A copy is included in Appendix A.

In conjunction with the series, USA Today released the results of a survey conducted

by the Henry J. Kaiser Family Foundation. It revealed that 38 of the country’s 50 largest cities either could not, or would not, report their community’s rate of cardiac arrest survival.

USA Today identified three major reasons why emergency services in most U.S. cities save few people in life-or-death situations. The second is particularly germane to this proposal: • “Many cities’ emergency services are undermined by the culture. Infighting and turf wars

between fire departments and ambulance services cause deadly delays. • Most cities don’t measure their performance effectively, if at all. They don’t know

how many lives they are losing, so they can’t determine ways to increase survival rates. (Emphasis added).

• Many cities lack the strong leadership needed to improve emergency medical services. Leadership – by the mayor, the city council and community health officials – can make a dramatic difference. Boston, for example, more than doubled its survival rate over 10 years under the direction of a strong mayor who demanded change and enlisted city officials, businesses and many residents in the drive to save lives”

A central thesis of the USA Today series is that the current lack of epidemiological and

outcomes data represents a major obstacle to improving prehospital emergency cardiac care at the local level. Performance metrics and basic outcome data are essential in order for local EMS system administrators, medical directors and government officials to identify effective way(s) to boost rates of survival from cardiac arrest. What is needed is a simple yet robust cardiac arrest registry that can be readily implemented at the community level, utilizing consistent data elements and equally consistent data definitions. Lack of data is perhaps the most ubiquitous yet readily surmountable obstacle to enhancing care of cardiac arrest victims and thereby improving rates of survival from this devastating condition.

When communities have the wherewithal to collect data, there is a standard approach to analyzing it. A number of years ago, a group of international leaders in the field of cardiac arrest research met at the Utstein Abby in Denmark and proposed a set of uniform reporting rules and criteria for studying episodes and outcomes of out-of-hospital cardiac arrest. These “Utstein criteria” as they quickly became known, primarily focus on cases of witnessed cardiac arrest due to ventricular fibrillation or pulseless ventricular tachycardia - the individuals that have the best chance of being salvaged. To be officially classified a survivor; a patient must leave the hospital alive, ideally without significant anoxic brain damage. By classifying events using the Utstein criteria, the relatively few communities that presently collect outcome data can directly compare their performance with each other.

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http://www.usatoday.com/news/nation/ems-day1-cover.htm


Despite the paucity of community outcome data for cardiac arrest, there is a strong

professional consensus that it is needed. In 1991, an American Heart Association “Scientific Statement” by a panel of world experts in the field of sudden cardiac arrest included the following words: “…The Future chain of survival will be highly dependent on multi-center cooperative studies of cardiac arrest death in both in-hospital and out-of-hospital settings (emphasis added). In addition to scientific research, the training of those responsible for implementing and maintaining the chain of survival must become a priority. For emergency medical services the challenge is to develop programs that will allow recognition, access, bystander CPR, defibrillation and advanced care to occur as quickly as possible. Ideally systems should deliver these interventions within moments after collapse. Achievement of such a goal requires the deployment of multiple, properly directed programs, within an EMS system. Each program should lend strength to the chain of survival, thereby enhancing successful recovery and long term survival.”

This proposal represents the first effort since these recommendations were made nearly 13 years ago to devise a simple yet systematic approach to data collection and analysis. Developing and implementing it in metropolitan Atlanta will enable us to demonstrate its feasibility, evaluate its impact, and use these findings to promote nationwide adoption of cardiac arrest registries to enhance the “chain of survival” and raise awareness of the impact of out of hospital cardiac arrest on a national basis. C) PRELIMINARY DATA

Both of the Emory researchers directly involved in this study (BM, AK) have expertise and experience with EMS operations, data collection and process improvement, particularly as it pertains to EMS.

The Principal Investigator, Bryan McNally, MD, MPH, has a strong background in Emergency Medicine and Public Health, with a special interest in EMS systems. He began his medical training as an EMT and later a paramedic while working in Harlem and Washington Heights for the former New York City Emergency Medical Service (NYC-EMS). In this capacity, he gained familiarity with the data collection methods used to prospectively study cardiac arrest survival in New York City from 1990-1992. During his subsequent residency training in the specialty of emergency medicine, he had the opportunity to work regularly with Dr. Gary Lombardi and Dr. John Gallagher, Principal Investigator of the NYC cardiac arrest study. Following residency, he completed fellowship training in Emergency Medical Services (EMS) with Boston City EMS, and concurrently earned his Master’s degree in public health. His EMS research during his fellowship training including a process improvement project involving the management of violent patients in the out-of-hospital environment, and an epidemiological study of pedestrian injuries in the City of Boston that required the use of geomapping to determine dangerous locations for pedestrian injury. Working with Fellowship supervisor, Dr. Peter Moyer, he helped to maintain the Boston EMS cardiac arrest database, and witnessed first hand the effectiveness of using epidemiological data to guide and inform a

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high-functioning EMS system. Data-driven decision making and strong physician leadership are the two central reasons that Boston has one of the best rates of cardiac arrest survival in the country.

Study Co-investigator, Arthur Kellermann, MD, MPH, is Professor and Chair of the

Department of Emergency Medicine at Emory University. An accomplished clinical and epidemiological investigator, Dr. Kellermann has extensive experience conducting prehospital and in-hospital research on cardiac resuscitation. Over the course of his 19-year academic career, he has worked with a wide variety of EMS agencies and individuals to study various aspects of the chain of survival, concentrating on early provision of CPR, early defibrillation, and when to terminate Advanced Cardiac Life Support (ACLS) efforts in the field.

Many of the observations that follow were derived from federally funded research:

• Effective prehospital cardiac care is vital to the survival of a victim of out-of-hospital cardiac

arrest. If the victim is not successfully resuscitated in the field, his or her chances of survival to hospital discharge with good neurological outcome are virtually nil. The overall survival rate for failed prehospital resuscitations is approximately 0.5%; most of these have a poor neurological outcome. Racing from the scene with a patient in refractory cardiac arrest is dangerous, costly, and ill advised. Everything possible should be done to enhance the likelihood of field resuscitation by optimizing each link in the “chain of survival”. Conversely, protocols to enable paramedics to pronounce refractory cardiac arrest patients dead in the field should be encouraged.

• It is possible to train EMS dispatchers to provide telephone CPR instructions to laypersons.

The resulting CPR is comparable in quality to that provided on a “no notice” basis by persons with prior CPR training. Combining prior CPR training and dispatcher CPR instructions produces better CPR than either technique alone.

• Three firefighters working as a team can provide CPR more effectively than two, primarily

because two can perform bag-valve mask ventilations much better than one. • Firefighters using an early generation automated external defibrillator (late 1980s)

sometimes became so focused on the machine that they failed to return to the patient to resume CPR. Instead, they analyzed the rhythm over and over again. On the strength of this observation, later generations of AEDs were designed to include a voice prompt to remind rescuers that if a shock is not indicated, they should recheck the victim’s pulse and resume CPR.

• A population-based study of cardiac arrest treatment in Memphis, TN revealed that African

American victims of cardiac were much less likely to receive bystander CPR than whites. The disparity in rates of bystander CPR was most notable in cardiac arrest events that occurred in the home. This suggests that the problem is due to a lack of CPR education, not a lack of desire to help. More focused efforts are needed to train African Americans to perform CPR, as well as more widespread adoption of dispatcher-assisted CPR programs.

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• In another aspect of that study, Kellermann and colleagues equipped 20 first responding Memphis Fire Department engine companies with an AED and trained them in its use. This enabled them to give defibrillatory shocks shortly following arrival on the scene of a cardiac arrest. Paramedic units follow all first responders in Memphis. Rather than use the conventional “before-after” design employed by other researchers, Kellermann adopted a quasi-experimental approach. A second (control) group of 20 engine companies were trained to perform 3 rescuer CPR. To minimize selection bias, the two groups of engine companies exchanged the AEDs every 75 days. This way, over the 2-year study interval, each group carried the devices roughly half the time. The engine companies equipped with AEDs achieved a cardiac arrest save rate roughly twice that of historical controls. However, the control (CPR only) engine companies also doubled their save rate versus the historical rate. This suggests that much of the benefit in cardiac arrest survival was not due to introduction of AEDs, but rather the “Hawthorne Effect”. This represents a strong argument for collecting process and outcome data to enhance a community’s response to sudden cardiac arrest.

• Working with Braslow and Brennan, nationally renowned EMS educators, Kellermann’s

research team conducted two experimental studies of a new CPR training technique – video self-instruction CPR. Using a pilot, 30 minute self-instruction video and a simple cardboard manikin. Kellermann’s group showed that volunteers can teach themselves, in 30 minutes, CPR of comparable quality to that taught by a professional instructor in a 4 hour course. When experimental (video CPR) and control (Instructor taught CPR) subjects were retested a month later, they performed CPR of comparable quality. The study was first done with new Emory medical students who had not yet learned CPR. It was later replicated in a group of older, African American Churchgoers in Atlanta. This technique promises to make CPR education much more widely accessible than ever before.

• In an editorial “debate” published in JAMA, Kellermann took issue with Dr. Mickey

Eisenberg’s assertion that automated external defibrillators are so effective, and so safe, that they should not only be widely deployed in public places, but be made available to sale “over the counter”. Kellermann argued that scientific data on the benefit of public access defibrillation are scant, and only demonstrate their effectiveness in highly selected environments like airport concourses and casinos. He noted that there is no data to support the notion of promoting the sale of AEDs for the home. He argued that money used to purchase home AEDs could be better spent on smoking cessation, blood pressure control and exercise – interventions known to reduce the risk of coronary artery disease, and therefore of cardiac arrest.

Recent cardiac arrest statistics collected by Grady EMS and Rural-Metro EMS provide a glimpse at the dismal survival rate for Fulton County Georgia as summarized (in appendix B). Note that presently, EMS planners in Atlanta cannot report Utstein style statistics due to the gaps in obtaining patient outcomes after reaching the hospital. Support for the creation of a more legitimate (Utstein template) cardiac arrest database are supported by the medical directors of both EMS agencies, Dr. Eric Ossmann, Medical Director of Grady EMS and Dr. James Capes, Medical Director of Rural-Metro-EMS (see letters of support)

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Atlanta was a “group 3” city in the USA Today article – “no data”. (Appendix C) D) EXPERIMENTAL/RESEARCH DESIGN AND METHODS

1. Plan, implement, and support the operation of emergency medical service (EMS)-based cardiac arrest registry.

In response to the CDC’s RFP, the Department of Emergency Medicine, Emory University School of Medicine is prepared to join forces with the CDC, the Atlanta Affiliate of the American Heart Association, the Office of EMS/Georgia Division of Public Health, and a range of local stakeholders to create a prototype emergency medical service (EMS)-based cardiac arrest registry. CARES will create a model cardiac arrest registry capable of identifying and tracking all cases of cardiac arrest in a defined geographic area. During the first year of development, the system will be confined to Fulton County, the most populous county in the state of Georgia. In year two, it will be expanded to a multi-county area of metropolitan Atlanta, GA. At that point, if the Georgia Division of Public Health and its regional EMS offices wish to adopt the registry and its data collection and dissemination methods, we will offer to expand the system statewide. We will also work collaboratively with the CDC to share the templates and data elements with other metropolitan areas and regional or state EMS systems that wish to improve their performance in the treatment of out-of-hospital cardiac arrest. Because the data system we are devising is intended to be universally applicable to EMS operations nationwide, it will be designed to be compatible with the National Electronic Disease Surveillance System (NEDSS) and use generally agreed upon standardized data elements and definitions. The ultimate goals of this cardiac arrest registry will be to help local EMS administrators and medical directors identify who is affected, when and where cardiac arrest events occur, which elements of the system are functioning properly and which elements are not, and how changes can be made to improve cardiac arrest outcomes. Because the data will be submitted and analyzed on a prospective basis, we envision a registry that will virtually monitor performance and outcomes on a “real time” basis. Because the model is backed by the American Heart Association and developed in conjunction with the CDC, we will be able to transcend the parochial concerns that so frequently limit data sharing and collective action across multiple agencies and jurisdictions. Creating the capacity for ongoing analysis, interpretation and dissemination of data is a central element of the CARES model. The registry we envision will enable local officials to quickly identify weak or missing links in the American Heart Association’s “chain of survival” model, whether they involve delays or failure to contact 911, prolonged call processing times, delayed dispatch of fire first responders or paramedic staffed ambulances, problems with unit response times from dispatch to arrival on scene, or problems with the provision of early defibrillation and/or advanced life support care. By quickly identifying whether or not the patient was initially resuscitated, whether or not the patient survived to hospital admission, whether or not the patient survived to hospital discharge, and the broad level of functional status at discharge will provide additional insight into system performance and the outcomes it achieves.

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CARES will quickly and efficiently measure each aspect of care in the “chain of survival” and determine how readily it bears on the outcome of out of hospital cardiac arrest. By capturing basic demographic and geographic data on each victim, we will be able to identify local disparities in such factors as rates of bystander CPR, 911 dispatching effectiveness, Fire Dept. first responder and ambulance response times, and outcomes. This will not only help us determine which links in the chain of survival need the most immediate attention, but which areas of the community or which demographic subgroups are experiencing the most deficient care and suffering the worst outcomes. Real time data collection will allow for an evaluation of the delivery of care in the form of regular analytical reports regarding each key component, while measuring the effects of feedback on various process and outcome improvement initiatives. CARES will provide participating agencies and communities with a uniform data collection mechanism to “benchmark” their cardiac arrest care. This will enable them to objectively measure their performance, and document the impact of successful improvements. Once a working model is perfected, it will be widely shared to improve care and outcomes on a regional, state, and ultimately national level. Recommendations will be provided to all of the communities that participate in the cardiac arrest registry in an effort to improve survival statistics. A quality improvement committee will be responsible for prioritizing and implementing the necessary initiatives that have been identified as priorities from the collected surveillance data. This committee will be made up of the “key stakeholders” needed to impact change locally, regionally and statewide. The quality improvement committee will be directed by a physician with both emergency medicine and public health experience working very closely with an epidemiologist with public health expertise. The experiences learned in Georgia will be used as a model to expand the CARES proposal to include disseminating using the NEDSS and the eventual creation of a national cardiac arrest registry A uniform, simple and sustainable cardiac arrest registry is essential to help communities assess their provision of care to victims of sudden cardiac arrest and measure the outcomes that are achieved. It is arguably the most important step in improving out of hospital care, and ultimately the community’s rate of survival from this common and devastating event. Decades of research have established that the likelihood that a victim who sustains a witnessed cardiac arrest from ventricular fibrillation will survive with good neurological function largely depends on receiving bystander CPR and rapid defibrillation within 4-8 minutes of collapse. The longer these vital interventions are delayed, the more likely the cardiac arrest event will be irreversible and the victim will die. Presently, the odds of surviving an episode of out of hospital cardiac arrest in the United States vary by a factor of 10 to 20, depending on the community in which it occurs. Disparities in outcome this extreme are unacceptable. Businessmen have known for years that processes cannot be improved without first measuring them. Applying this axiom to emergency care will save lives. In the nation’s 50 largest cities, about 9,000 people collapse each year from sudden cardiac arrest. Only 6-10%, or as few as 540, are successfully resuscitated, if all of these cities increased their survival rates to 20%, as

19


a few cities have done, an additional 1,800 lives could be saved each year. If smaller communities achieved this benchmark as well, the number of additional “saves” would be even larger than that.

2. Demonstrate the availability of additional resources and supports from, and partnership with, national or local organizations, and key stakeholders. Demonstrate a willingness by selected first responders or EMS agencies, 9-1-1 dispatching centers, and hospitals to participate in the cardiac arrest registry prototype.

There is a broad consensus that a uniform cardiac arrest registry will be an important tool to improve processes and outcomes of care in the treatment of out of hospital cardiac arrest. While creation of the registry and the mechanisms to collect, analyze, interpret and communicate findings will be an evolutionary process in year one, and necessarily involve input from a wide range of stakeholders, we have secured formal pledges of support a number of organizations that are central to the effort. Their letters are included in the letters of support section. They include, but are not limited to: The Georgia State EMS Office – EMS in Georgia is a public health function. Under state law, this office has overall statutory authority for ensuring the quality of EMS care statewide through regulations, provider training and certification, vehicle inspection, awarding of ambulance zones, trip report analysis, and complaint investigations. Georgia EMS Region III – State EMS oversight is exercised through a series of state-designated geographic regions. Georgia EMS Region III encompasses the City of Atlanta, Fulton County, and their surrounding counties – a metropolitan area of more than 3 million people. Its involvement and participation in this process insures cooperation and data sharing by the large number of 911 centers, Fire Department First Responders (county and municipal), ambulance services (public and private) and hospitals. Department of Emergency Medicine, School of Medicine, Emory University – One of the largest and most highly respected academic EM programs in the world, Emory is widely known and highly respected for bridging the disciplines of clinical emergency medicine and public health. Department faculty members provide medical direction to many of the key components of Atlanta’s EMS system, including the Fulton County Office of EMS and Fulton County 911 (Art Yancey, MD), Atlanta Fire Department (Jim Augustine, MD), Grady EMS (Eric Ossmann, MD), Rural/Metro EMS (Pat Capes, MD), and Emory Flight Air EMS Service (Alex Isakov, MD). Furthermore, the department includes a number of specialty “opinion leaders” who serve in key leadership positions of various national EM organizations, including the American College of Emergency Physicians (1 board member), the Society for Academic Emergency Medicine (2 board members), the Emergency Medicine Section of the National Medical Association (President Elect), and the Emergency Medicine Resident’s Association (President elect and a past President). Because the PI and Co-investigators for this project are respectively, Assistant Professor and Professor and Chair of the department, no letter is included.

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Grady Emergency Medical Service (EMS) – Grady EMS has provided ambulance care the citizens of Atlanta for more than 100 years. It is currently the state-designated 911 provider of advanced life support care for the “central zone” of Fulton County, an area largely defined by the city limits of Atlanta. In light of this capacity, Grady EMS has independent access to key parameters needed for the registry. The recent acquisition of automated trip report technology will greatly enhance their capacity to cooperate with this program. Rural/Metro EMS (Fulton County) – A national, for-profit ambulance company, RuralMetro holds the contract to serve as the state-designated 911 provider of advanced life support care for the “north” and “south” zones of Fulton County, areas generally defined by Fulton County north and south of the city limits of Atlanta. In this capacity, Rural/Metro EMS has independent access to key parameters needed for the registry. American Heart Association, Atlanta Chapter – the American Heart Association is highly respected as a neutral, nonprofit organization wholly dedicated to reducing death and disability from heart disease. The AHA created and promulgated the concept of the “chain of survival” – the model that underlies the design of our proposed registry. The AHA’s support and involvement will go a long way towards bringing different and sometimes competing stakeholders, such as various hospital systems, to the table. The AHA’s involvement also greatly enhances the prospects for national dissemination of the registry. Centers for Disease Control and Prevention – although no letter of support is included, the nature of this cooperative agreement insures the CDC’s active participation as a partner in the effort. This will bring additional pressure on various community partners to participate and insure a substantial degree of media coverage and popular support. It also greatly enhances the prospects for nationwide dissemination of the registry. NAEMSP – The National Association of EMS Physicians is the preeminent organization for EMS medical directors in the United States. Their endorsement of this project and interest in its success reflects the organization’s recognition of the value of this effort. It also ensures that the NAEMSP will assist in disseminating the results of this project. ACEP – The American College of Emergency Physicians is the leading organization for emergency physicians in the United States. It has more than 22,000 members nationwide. ACEP’s endorsement of this project and interest in its success reflects the specialty’s recognition of the value of this effort. It also ensures that ACEP will assist in disseminating the results of this project. In addition to the funding provided by this cooperative agreement, we are working in partnership with the Atlanta chapter of the American Heart Association to pursue funds from a variety of local donors, including private individuals, the Healthcare Georgia Foundation, and the Woodruff Foundation.


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Working in concert with the CDC, we will convene a national expert panel to provide input into the registry, the selection and definition of data elements, and coding conventions. This group will monitor what is learned on the initial two years of implementation of the RESTART initiative, and make recommendations for any changes or modifications that are needed before efforts are made to expand the registry to other states. Dr. Mickey Eisenberg, arguably the best-known and most widely respected researcher in this field has agreed to serve as a program advisor. Recently retired after a distinguished career at the University of Washington and King County EMS service in Seattle Washington, Dr. Eisenberg has a wealth of knowledge and practical experience with population-based cardiac arrest registries. If his travel schedule allows, he will chair the national expert panel workshops. If not, other senior members of the panel will assume this role. Working with the CDC, we will identify and invite participants in this panel from the physician, EMS administrator, 911, hospital administrator, emergency physician, cardiology, and Fire communities. Organizational representation (possibly overlapping with areas of expertise described above) will be sought from the American Heart Association (AHA), American Public Health Association (APHA), American College of Emergency Physicians (ACEP), National Association of EMS Physicians (NAEMSP), the International Association of Fire Fighters (IAFF), the Division of Chronic Disease Prevention and Health Promotion, Centers for Disease Control and Prevention (CDC), the Office of EMS in the National Highway Safety Administration (NHTSA) and the National EMS Information System (NEMSIS). Finally, a specific effort will be made to involve experts from the cardiac arrest research community who were involved in formulating the guidelines for uniform reporting of data using the Utstein Style. Ideally, the initial meeting of this panel will be scheduled to coincide with a CDC sponsored meeting, or a national conference for either the NAEMSP or ACEP. This will facilitate convening the panel while limiting participant expenses and the demand on their time.


During the first year of the study, we will concentrate on developing the model database, and implementing it to create a uniform cardiac arrest registry to capture all events that occur in Fulton County, GA (population – 816,638 in 2001). The major EMS providers working in this county include (Grady EMS, Rural Metro EMS and the Atlanta Fire Department/Hartsfield Airport EMS Service). In the second year of the project, the Project CARES registry will be expanded to encompass the eight counties that make up Region III of the State Wide Emergency Medical Service Regions {Fulton, Douglas, Cobb, Gwinnett, Dekalb, Clayton, Rockdale, and Newton Counties}). Region III represents a population base of nearly 3.2 million people. Maps are included in Appendix D.


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The National Electronic Disease Surveillance System (NEDSS) is an initiative that promotes the use of data and information system standards to advance the development of efficient, integrated, and interoperable surveillance systems at federal, state and local levels. It is a major component of the Public Health Information Network (PHIN). This broad initiative was designed to:

• Rapidly detect outbreaks and monitor the health of the nation • Facilitate the electronic transfer of appropriate information from clinical information

systems in the health care system to public health departments • Reduce provider burden in the provision of information • Enhance both the timeliness and quality of information provided

Surveillance Systems (and in the case of CARES, disease registries) collect and monitor data for disease trends and/or outbreaks so that public health personnel can protect the nation's health. The vision of NEDSS is to have integrated surveillance systems that can transfer appropriate public health, laboratory, and clinical data efficiently and securely over the Internet. NEDSS will revolutionize public health by gathering and analyzing information quickly and accurately. This will help to improve the nation's ability to identify and track emerging infectious diseases and potential bioterrorism attacks as well as to investigate outbreaks and monitor disease trends. We will work with appropriate CDC officials in formatting the cardiac arrest registry to insure that it is NEDSS compliant.


The data elements would be used to form the cardiac arrest registry using “Utstein style” template endpoints, as listed below. Whenever possible, EMS and hospital personnel will be trained to use utilizing standardized forms that can be electronically read in an effort to more efficiently collect the needed data. Failing that, we will ask participating agencies to fax copies of their trip reports to our office for transcription and analysis. The very basic outcome data we require from hospitals will be sought by developing relationships with the CCU supervisor or appropriate “point of contact” individuals for each facility. HIPAA may create an additional complexity to crafting these arrangements, but we are confident any obstacles can be overcome. Based on our prior work, we have identified the following data elements as candidates for inclusion in our prototype cardiac arrest registry. Before a final decision is made on the inclusion or exclusion of particular elements, data definitions, and coding conventions, consensus will be sought with our CDC collaborators and advisory panel members.

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Call and Patient Data: Incident Date: MM/DD/YYYY Incident Number: 00000000 Hospital: Pull Down Name Unique Identifier # 000000000 DOB: MM/DD/YYYY Gender: Pulldown Reviewed By: Pulldown Name EMS Service: Pulldown Name EMS Provider # 1 Enter Badge Number EMS Provider # 2 Enter Badge Number Initial Disposition. Code Pulldown menu Was Arrest Witnessed? Pulldown menu Was etiology of event considered cardiac? Pulldown menu Did event occur before arrival of EMS? Pulldown menu. Address of cardiac arrest. Pulldown menu ( address of arrest for GIS purposes) Setting of cardiac arrest (Pulldown menu) (e.g., Residence, nursing

home, outdoors, airport, sporting arena) Was bystander CPR performed? Pulldown menu. Was an AED used? Pulldown menu Who delivered first shock. Pulldown menu. (options include bystander as

well as police, fire, pmedic, nurse First Responder Service and Unit # Pulldown menu 000 Number of AED shocks delivered. 000

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Number of manual shocks delivered 000 Rhythm upon arrival of paramedics Pulldown menu. Primary airway adjunct used: Pulldown menu - ETT, combi, LMA, BVM) IV meds given (identify all) Pulldown window - epi, lido, amio, atropine,

others… Disposition of patient on scene. Pulldown menu (dead in field, DOA, survived to

ED admission) Destination of transport Pulldown menu (hospital). Number of days in the hospital 000 Did patient survive to hospital discharge? Y/N Disposition from hospital Pulldown menu (hospital disposition – home,

other hospital, rehab, skilled nursing facility, morgue)

Glascow outcome score on discharge. 0

Times

Collapse Time* HH:MM Call Time HH:MM Dispatch Time First. Resp. HH:MM Dispatch Time Ambulance HH:MM First Responder time on scene HH:MM Ambulance time on scene HH:MM Time from collapse* to CPR MM Time from collapse* to first shock MM ALS termination Time (if pronounced dead) HH:MM

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Transport Time (if transported) HH:MM * Collapse time will be estimated as one minute prior to call time, unless otherwise specified in the call narrative or EMS trip report. To help us compile and maintain these data elements, we will recruit a project coordinator with a strong background in public health and/or EMS, and expertise in epidemiology and biostatistics. The primary responsibility of this individual will be to coordinate the mechanics of data collection, including securing electronic or fax information from emergency dispatch (911 computer aided dispatch data, fire first responder and emergency medical service (EMS) data, and hospital outcome data. The coordinator will also work with CDC personnel to maintain an accurate and secure information network.

7. Develop and maintain a real-time data system, including quality assurance mechanisms

for data collection and management, to provide timely, complete and quality data. Quality assurance mechanisms will be in place to insure the timely collection of all data fields. A systematic data management plan will be developed and followed to insure the acquisition and maintenance of high quality data. We will work to establish and maintain a close relationship with Emergency Medical Dispatch personnel, EMS providers, and hospital staff to facilitate reporting and sharing of accurate information. Periodically, the project coordinator and PI will independently sample data elements from the registry and compare them to original source documents to confirm accuracy. The project coordinator will also be responsible for querying the database and producing regular reports for the working group meetings described in objective 7 above. These reports will be formatted to identify strengths and weaknesses in the “chain of survival” while monitoring the impact of interventions attempting to improve these links.

8. Plan and implement a methodology for assessments of hospital reporting compliance,

validity of diagnosis, reliability and completeness of all reporting parameters, and hospital costs required for data collection.

The project coordinator will insure that a relationship exists between each hospital (all 911 receiving hospitals in Fulton County serviced by Grady EMS and Rural Metro EMS -- the ALS ambulance providers that are presently responsible for transporting all 911 initiated cardiac arrest calls in the county) and the RESTART project to allow for reliable and complete reporting of all out-of-hospital cardiac arrests. All 911 receiving hospitals will be involved with providing final patient outcome statistics. Because we will identify events via 911 and EMS, hospitals will only be required to give basic outcome and length of stay information, a process that involves minimal cost. The method of data collection will comply with all state and federal regulations and local IRBs (Emory University IRB, Georgia Division of Public Health IRB and the CDC’s IRB) and will be gathered as an ongoing quality improvement initiative that requires the exchange of minimal but necessary patient care information to ultimately improve EMS patient care throughout the community without comprising the identity of any individual.

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9. Develop and maintain the capability to securely export data. To preserve patient confidentiality, we will use high encryption methodology to transmit data. The Georgia Division of Public Health already uses a highly secure Web based interface, known as the “State Electronic Notifiable Diseases Surveillance System” or SENDSS, to transmit the personal identifiers of patients with reportable health conditions (http://www.ph.dhr.state.ga.us/epi/sendss.shtml). On a weekly or monthly basis, batched cardiac registry records (minus personal identifiers) will be transmitted to the CDC and the Office of EMS, Georgia Division of Public Health. We anticipate transmitting data in HL7 format, which is generally preferable to other record lay-outs such as a “flat” ASCII delimited file or a database format such as Access. This will require greater effort initially to develop procedures for receiving and processing the data, but it will allow greater flexibility in the future for adding additional reporting regions to a statewide or national data repository. In the initial phase of the project, analysis of registry data will be conducted by team members at Emory, working in concert with medical epidemiologists at the CDC. Development of a fully integrated data repository for cardiac arrest events will provide an ideal model for a national cardiac arrest “data warehouse”. The system we develop in concert with the CDC will utilize the architecture of the National Electronic Disease Surveillance System (NEDSS).

10. Submit data elements to a CDC-designated independent auditor with the content and format specified by the auditor. The required format for data export may be revised during the project period, for example, due to potentially new federal legislative and regulatory requirements.

All 911 receiving hospitals will be involved with providing final patient outcome statistics. We will abide by all federal regulations for patient related research and will be compliant with all standards that involve patient confidentiality. RESTART staff will submit all data that is requested of them to a CDC-designated independent auditor and will be respectful of any future legislative and regulatory requirements that might require revision of our data management plan.


Transmitted data will be stripped of individual patient identifiers. If deemed necessary, a separate encrypted database will be used to link a unique patient identifier associated with each prehospital cardiac arrest event and the patient’s respective hospital medical record number. This will insure patient confidentiality.


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http://www.ph.dhr.state.ga.us/epi/sendss.shtml


We agree to participate in one or more independent, outside audits to insure the completeness and quality of the data in the cardiac arrest registry.


The CARES project Principal Investigator and Co-investigator will work closely with key stakeholders in the EMS community to provide necessary feedback to the respective provider agencies to insure that data are being reported in an accurate and timely manner, and that our findings and recommendations are quickly disseminated to appropriate individuals for action. Like most communities, Fulton County and Region III EMS have EMS Boards, quality improvement committees and other working groups that have standing responsibilities to oversee care and identify opportunities for process improvement. Rather than create an independent, potentially competing body, we will work with these groups by providing them with regular reports that are formatted to safeguard the confidentiality of patients and EMS providers, yet provide the feedback and outcome data needed to spur corrective action. Once we have acquired experience with the registry and determined its impact on decision makers and processes of care, we will disseminate our findings through presentations and demonstrations at state, regional and national meetings of the American College of Emergency Physicians, the National Association of EMS Physicians, the American Public Health Association, the American Heart Association, and other professional or service organizations. We will also make formal presentations to interested individuals at the CDC and other federal agencies. We will prepare formal descriptions of our findings to peer reviewed journals such as Annals of Emergency Medicine, the Journal of the American Medical Association, the American Journal of Preventive Medicine and the American Journal of Public Health. Since the registry and data transmission procedures we propose were or will be developed with public funding, they are nonproprietary. This will enable us and the CDC to offer the registry and data collection procedures to communities nationwide at little or no cost to interested parties. Human Subjects Considerations: From the perspective of the Georgia Division of Public Health and the participating local health departments, this project is likely to be deemed “non-research” public health practice. Thus, the receipt, analysis, and reporting of results can be conducted under the state’s authority to conduct public health surveillance. As such, these “non-research” activities would not be considered human subjects research and would not require state institutional review board oversight.i In addition, because these surveillance activities will be conducted under the state’s authority to collect such information for public health purposes, they would be exempt from the authorization requirements of the Health Insurance Portability and Accountability Act.ii

After reviewing the exemption categories outlined in on the NIH OHRP’s website, we believe that our project is covered by Exemption 5 – “Research and demonstration projects which are

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conducted by or subject to the approval of department or agency heads, and which are designed to study, evaluate or otherwise examine (a) public benefit or service programs; (b) procedures for obtaining benefits or services under those programs; (c) possible changes in our alternatives to those programs or procedures; or (d) possible chances in methods or levels of payment for benefits or services under those programs.” Clearly a registry devised to improve the provision of emergency medical services is applicable under provisions a, b, and c of this exemption. Furthermore, our proposal may also qualify under Exemption 4 – “Research involving the collection or study of existing data, documents, records, pathological specimens or diagnostic specimens, if these sources are publicly available or if the information is recorded by the investigator in such a manner that subjects cannot be identified, directly or through identifiers linked to the subjects.” From the perspective of Emory University, the project may or may not ultimately be deemed human subjects research, but we intend to apply for a formal IRB exemption as well as exemption from HIPAA authorization requirements, on the grounds that the project has enormous public health importance, represents minimal risk to subjects and cannot be feasibly conducted if individual patient authorization is required. We will not export individual identifiers, but a formal request for exempt status may be necessary because of the relative infrequency of cardiac arrest events, and the detail that will be included in the registry and sent to the CDC and the Georgia Division of Public Health, including incident location and/or geocode coordinates), the date and time of the event, and the destination hospital. The Georgia Division of Public Health is currently working with the Emory University Office of Research Compliance to identify procedures for managing public health authorities, human subjects protections, and privacy protections for public health-academic collaboration in situations where the Division deems the activity to represent public health practice (non-research) and the University deems the activity to be research. Patients will not be contacted at any point in the process. Special populations - The system we propose to develop will include all individuals in the geographic area proposed for study. Fulton County alone includes hundreds of thousands of residents of inner-city areas, suburban communities and even rural areas; low income and minority groups; women; the elderly; and individuals with special health care needs. Any are likely to be a victim of cardiac arrest. Risks to the subjects - The project is non-interventional in nature; it therefore poses no appreciable risk to patients. Likewise, the “chain of survival” treatment guidelines promulgated by the American Heart Association and other patient care groups reflect the most current, evidence-based health services research. If any impact is made on care, it should be positive rather than negative. Adequacy of protection against risks - The principles on which this project is based incorporate rigorously studied and clinically validated concepts of public health surveillance, performance improvement, and clinical epidemiology. Any impact on clinical decision-making and patient

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management is likely to be positive rather than negative. For this reason, we believe any risks to individual patients of introducing these systems into practice are negligible. In fact, they are highly likely to improve care, and clinical outcomes. Potential benefits of the proposed research to the subjects and others - The project we propose will strengthen coordination between EMS entities, the public and health care systems. If a functional, multi-agency and multi-jurisdictional cardiac arrest registry can favorably influence cardiac arrest care and outcomes in metro Atlanta, a region historically associated with poor rates of cardiac arrest survival, it can make a positive impact everywhere. Population sample – As a matter of practice as well as federal law, EMS services and emergency departments treat non-selected patient populations. Everyone who sustains an out of hospital cardiac arrest is treated, without regard for age, race, gender, ethnicity, or ability to pay. Women and minority inclusion in clinical research – Women and minority subjects will be included in the study in exact proportion to the incidence of cardiac arrest in these populations. Based on the demographics of metro Atlanta, the project will primarily affect White and African American patients, although the region has rapidly growing Hispanic and Asian/Pacific Island minorities. Subject selection criteria – All patients requiring care for out of hospital cardiac arrest care will be included. Rationale for exclusion of any group – No groups will be excluded. Description of the proposed outreach programs for recruiting women and minorities in clinical research as subjects – No outreach programs will be needed. Proposed sample composition – All patients requiring care for cardiac arrest in the geographic confines of the study area will be eligible for entry into the registry. There is no sample per se. Inclusion of children – Children are rarely victims of cardiac arrest due to heart disease. However, to the degree that these cases occur, they will be included in the registry. i CDC. Guidelines for Defining Public Health Research and Public Health Non-Research [accessed July 2003] Available at URL: http://www.cdc.gov/od/ads/opspoll1.htm ii Centers for Disease Control and Prevention. HIPAA Privacy Rule and public health: guidance from CDC and the U.S. Department of Health and Human Services. MMWR 2003;52(Supl):6-8. [accessed July 2003] Available at URL: http://www.cdc.gov/mmwr/PDF/wk/su5201.pdf

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http://www.cdc.gov/od/ads/opspoll1.htm


II. DATA COLLECTION

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1 - Street Address (Where Arrest Occurred)

1 - City 1 - State 1 - Zip Code

Cardiac Arrest Registry

14 - Location Type

Farm

Mine / Quarry

Industrial Place

Recreation/Sport

Street/HwyPublic Building

Educational Inst. Airport

Home/ Residence

Nursing HomeResidence/InstitutionPhysician Office/Clinic

Hospital

Jail

Other

SH3001 (1 of 1), Rev 3, 04/06 Copyright 2006 ScanHealth, Inc. (Page 1)

Arrest Information

First Responding Agency Dispatch Times

Presumed Cardiac EtiologyTraumaRespiratoryDrowning

17 - Presumed Cardiac Arrest Etiology

ElectrocutionOther

Yes

No

16 - Arrest After Arrival of EMS

Witnessed Arrest

Unwitnessed Arrest

15 - Arrest Witnessed

3 - Last Name2 - First Name

5 - Date of Birth 6 - GenderMaleFemale

13 - EMS Notified

: :

YesNo

18 - Resuscitation Attempted by EMS

Ventricular FibrillationVentricular TachycardiaAsystoleIdioventricular/PEA

23 - First Arrest Rhythm of Patient

Unknown Shockable RhythmUnknown Unshockable Rhythm

Dead in Field

Pronounced Dead in ED

Ongoing Resuscitation in ED

27 - End of the Event

First Cardiac Arrest Rhythm Strip (Apply with ScotchTape on Top and Sides)

Resuscitation Information

First Cardiac Arrest Rhythm of Patient and ROSC Information

13 - Time of 1st CPR

: :13 - ROSC Time

:13 - CPR Stopped/Termination Time

Resuscitation not initiated at scene due toobvious signs of death, DNR, resuscitationconsidered futile, or resuscitation is notrequired

Resuscitation terminated at scene due tomedical control order, protocol/policyrequirements completed

Transported to Hospital with or withoutROSC

26 - Out of Hospital DispositionYesNo

24 - ROSC

YesNo

25 - Sustained ROSC

YesNoAED Present but not Used

21 - Was an AED Used During Resuscitation

Bystander

First Responder Fire/Police AEDEMS AED or Monitor/Defibrillator

22 - Who First Applied Monitor/Defibrillator, AED

AED Malfunctioned

:13 - Time of 1st Defibrillation

# 0f AED Shocks

# 0f Manual Shocks

BystanderBystander Family MemberFirst Responder Fire/PoliceResponding EMS PersonnelMedical ProviderOther

Don't Attach Below this LIne

Hospital Destination

Not Applicable

Bystander Family Member

: :13 - EMS Arrived at Scene

Part A : Non - HealthEMS™ Users start here, otherwise skip to part B

Part B : To be completed by all Users9 - Call #8 - Date of Arrest

/ /10 - Booklet ID (HealthEMS™ Users Only)7 - EMS Agency ID

4 - AgeDaysMonthsYears

11 - Fire/First Responder 12 - Destination Hospital

AsianBlack/African-American

American-Indian/AlaskaNative Hawaiian/Pacific IslanderWhite

Unknown28 - Race/Ethnicity

ALS First Responder Monitor/Defibrillator

Hispanic/Latino

20 - Who Initiated CPR

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Cardiac Arrest Registry to Enhance Survival - CARES

Condensed Data Dictionary and Coding Manual:

Essential Instructions for Abstracting and Coding Data Elements

EMS AGENCY

August 2007

Bryan McNally, MD, MPH (Principal Investigator) Arthur Kellermann, MD, MPH (Co-Investigator)


CARES Condensed EMS Data Dictionary

Monday, October 2, 2006

CARES PROJECT – EMS DATA SET ESSENTIAL DATA ELEMENTS

Item # Data Item Best / Alternate Data Source Comments (page)

1 Address of Cardiac Arrest EMS Trip Sheet 3 2-6, 28 Patient Information EMS Trip Sheet 3-4

7 EMS Agency ID EMS Trip Sheet 4 8 Date of Cardiac Arrest EMS Trip Sheet 4 9 Cardiac Arrest Call Number EMS Trip Sheet 5

10 Booklet ID Number HealthEMS® Trip Sheet only 5 11 Fire/First Responder Service Dispatch/CAD Record, Trip Sheet 5 12 Hospital Destination EMS Trip Sheet 5 13 Time Elements (dispatch, ROSC, CPR, etc..) EMS Trip Sheet (Estimate) 6 14 Location Type EMS Trip Sheet 6 15 Arrest, Witnessed EMS Trip Sheet / Crew member(s) 6 16 Arrest After Arrival of Responding EMS EMS Trip Sheet / Crew member(s) 7 17 Presumed Cardiac Arrest Etiology EMS Trip Sheet / Crew member(s) 7 18 Resuscitation Attempted by EMS Personnel EMS Trip Sheet 7 20 Who Initiated CPR EMS Trip Sheet / Crew member(s) 8 21 Was an AED Used During Resuscitation EMS Trip Sheet 8 22 Who First Applied AED, Monitor/Defibrillator EMS Trip Sheet 9 23 First Arrest Rhythm of Patient EMS Trip Sheet / Crew member(s) 9 24 Return of Spontaneous Circulation (ROSC) EMS Trip Sheet / Crew member(s) 9 25 Sustained Return of Spontaneous Circulation EMS Trip Sheet 9 26 Out of Hospital Disposition EMS Trip Sheet / Crew member(s) 10 27 End of Event Crew member(s) / EMS Trip Sheet 10

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CARES PROJECT DATA SET - ESSENTIAL VARIABLES GENERAL INSTRUCTIONS

• For the CARES project, EMS is defined as the providers that respond to the 911 call AND are capable of transporting the patient to the hospital. All other responding providers that are involved in patient care but DO NOT transport the patient to the hospital will be considered “First Responders”.

• To minimize missing and unknown data, please complete a cardiac arrest registry form for each and every arrest patient with presumed cardiac etiology, regardless of whether the patient was transported as long as resuscitation efforts were initiated. This will help to establish a meaningful cardiac arrest database.

1. ADDRESS - REQUIRED General Instructions for Coding

• This is the address where EMS was directed to respond to the arrest event, whether or not the arrest occurred enroute the hospital.

• All elements of the address are crucial to identify the response intervals from the CAD system. • All addresses should include two lines. • The address should be fully spelled out using standard USPS abbreviations (see Appendix B) • Uppercase letters are preferred on all lines of the address. • Do not use punctuation • Spell city names in their entirety.

Examples: Standardized Address Definition 102 MAIN ST SW APT 12 ATLANTA GA 30303

Spelled out fully, use capital letters, use standard abbreviations, do not use punctuation, place a space between letters and numbers

UNKNOWN ATLANTA GA 30303-1231

Street address unknown, city and zip+4 known. Hyphen is OK in zip code+4

1600 CENTRAL PL BLDG 14 UNKNOWN GA

Street address and state known, city and zip code unknown

2, 3. PATIENT NAME – WHERE AVAILABLE Description

• Patient name is essential for location outcome information from the hospital. • If patient name is unknown, list as “John/Jane Doe”. • This information can be obtained from the patient care report (PCR). • This information is protected in confidence and should not be withheld based on HIPAA

concerns; please contact the CARES Project Coordinator (CPC) or your agencies CARES liason for questions.

• When the CARES data is complete and verified with matching hospital data the patient name will be “scrubbed” from the registry to de-identify the record completely.

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4. PATIENT AGE/PATIENT UNITS – WHERE AVAILABLE Description

• Allows for categorization of the patient according to their age at the time of cardiac arrest when used in conjunction with patient age units.

Instructions for Coding

• The actual or estimated age of a patient should be recorded. If a child is less than one year, enter the number of months, or days. If older than one year do not enter months.

• If the patients age is not know it should be estimated and recorded. • Both “Patient Age” must be filled in and “Patient Age Units” must be coded. • If a child is less than one year, enter the number of months, or days. If older than one year do not

enter months. Code Definition

001 One day, one month or one year when combined with “Patient Age Units”. 011 Eleven days, 11 months or 11 years when combined with “Patient Age Units” 120 One hundred and 20 days or 120 years. If the age is 120 days the age could also be recorded

as 004 with the “month” code for “Patient Age Units” 999 Unknown, must correspond with “9” for “Patient Age Units”.

5. DATE OF BIRTH – WHERE AVAILABLE

• All dates are entered with 8 digits in the following form, MMDDYYYY. • Do not leave any component, month, day, or year, of the date blank.

Code Example Definition

MMDDCCYY 07252004 July 25, 2004 6. GENDER - REQUIRED Description

• The sex of the patient may be an important risk factor for cardiac arrest and resuscitation interventions.


• The patient sex as recorded in the patient record or by self report. • Coded as male or female.

Code Definition

1 Male 2 Female

Monday, October 2, 2006 36


7. EMS AGENCY ID – REQUIRED • The Emergency Medical Service (EMS) that provided out-of-hospital care to the patient

in cardiac arrest. • EMS Agency ID used is the three digit code recognized by the local/state EMS office. • This field should appear automatically for the online version of data entry. • EMS personnel respond to a medical emergency in an official capacity as part of an

organized medical response team. By this definition, physicians, nurses, or paramedics who witness a cardiac arrest and initiate CPR but are not part of the organized rescue team are characterized as bystanders and are not part of the EMS system.

8. DATE VARIABLES - REQUIRED



MMDDCCYY 07252004 July 25, 2004 9. CALL NUMBERS - REQUIRED

• Number that EMS agencies use to identify the call as a unique event within their system. • Enter all six digits for call number. • If less than 6 digits, start with initial ‘0’s’

Code Examples Definition IIIIII 012345 Call number 12345 IIIIII 123456 Call number 123456

10. BOOKLET ID NUMBERS – WHERE APPLICABLE

• This number is only for EMS agencies that use a HealthEMS® ePCR form for standard patient documentation

• Enter all nine digits for booklet ID number. • If less than nine digits, start with initial ‘0’s’


Monday, October 2, 2006 37



11. FIRE/FIRST RESPONDER – WHERE APPLICABLE

• Corresponds to the 3 digit Georgia State EMS list for officially recognized First Responder organization.

• See Appendix B for listing of State list specific to First Responder agencies for Fulton County. 12. DESTINATION HOSPITAL – REQUIRED (IF TRANSPORTED)

• The hospital that the patient was transported to. • The hospital name should correspond to the hospital code for the particular jurisdiction. • Hospital codes will be found in Appendix C.

13. TIME VARIABLES – WHERE AVAILABLE General Instructions for Coding

• These are approximations to help identify the time set in the CAD system. These are not used for establishing statistical intervals.

• Time should be recorded in military time in the following form, HH:MM:SS for all EMS dispatch times.

• Time should be recorded in military time in the following form, HH:MM for all resuscitation times, (Time of first CPR, CPR stopped/termination time, Time of 1st defib) HH:MM (not seconds).

Examples: Code Examples Definition HH:MM:SS 01:23:45 Twenty three minutes and 45 seconds after 1 o’clock in the morning HH:MM 16:30 Four thirty in the afternoon

38



ARREST INFORMATION 14. LOCATION TYPE - REQUIRED General Instructions for Coding

• Location that the cardiac arrest occurred, not necessarily, the origin of the transport if the subject was moved after the arrest.

• If any doubt exists about the general categories listed below, refer to the detailed definitions in (Appendix D).

Code Definition Example

01 Home/Residence Front Yard 02 Public Building Krogers 03 Street/Hwy Corner of Peachtree and 14th Street 04 Nursing Home/Assisted Living Center Shady Grove Nursing Home 05 Residence/Institution. Shady Grove Children’s Home 06 Physician Office / Medical Clinic Shady Grove Free Clinic 07 Educational Institution Shady Grove High School 08 Hospital Shady Grove Community Hospital 09 Recreation/Sport Facility Shady Grove Softball Field 10 Industry Shady Grove Mattress Factory 11 Farm Clover Leaf Cattle Farm 12 Mine/Quarry Hard Rock Limestone Quarry 13 Jail Shady Grove County Jail 14 Airport Shady Grove International Airport 15 Other In flight between Shady Grove airport and Atlanta airport 15. ARREST WITNESSED - REQUIRED

• A witnessed arrest is one that is seen or heard by another person, or an arrest that is monitored. If the patient was found after an uncertain period of time and not either seen or heard to collapse, then the arrest is considered an unwitnessed arrest.

16. ARREST AFTER EMS ARRIVAL - REQUIRED

• Did the arrest occur after the arrival of EMS personnel?

Code Definition YES Yes, patient was both awake and responsive or had a pulse upon arrival of EMS but

monitored rhythm or loss of pulse as assessed by EMS indicated cardiac arrest during EMS treatment.

NO No, patient was in cardiac arrest when EMS arrived.

39



17. PRESUMED CARDIAC ARREST ETIOLOGY - REQUIRED

• An arrest is presumed to be of cardiac etiology unless it is known or likely to have been caused by trauma, submersion, drug overdose, presumed poisoning/overdose, asphyxia, exsanguinations, or any other non-cardiac cause as best determined by rescuers.

• This field allows for categorization based on evidence to suggest that the arrest was caused by a non-cardiac etiology. This will allow for the best chance of identifying patients that are otherwise presumed to have a primary cardiac etiology and help establish an true cardiac etiology survival rate (Utstein) for a community.

Code Definition

1 Presumed cardiac etiology 2 Trauma 3 Respiratory 4 Drowning 5 Electrocution 7 Other, when etiology is documented but is not listed in options.

Examples: Code Definition

1 EMS was call to the home of James Doe who complained of shortness of breath. Mr. Doe was awake and alert when EMS arrived and the first monitored cardiac rhythm was sinus tachycardia of 150 bpm. After 2 minutes of monitored sinus tachycardia, Mr. Doe went into ventricular fibrillation. Resuscitation was begun, etc.

4 EMS was called to home of John Doe for possible cardiac arrest. When EMS arrived Mr. Doe was unconscious in the swimming pool. Mr. Doe’s wife saw him running and then suddenly fall into the pool. Mr. Doe did not have a pulse when he was removed from the pool.

RESUSCITATION INFORMATION 18. RESUSCITATION ATTEMPTED BY EMS - REQUIRED

• A resuscitation attempt is defined as the act of attempting to maintain or restore life by establishing or maintaining airway (or both), breathing, and circulation through CPR, defibrillation, and other related emergency care techniques.

• When EMS personnel perform CPR or attempt defibrillation, it is recorded as resuscitation attempted by EMS personnel.

Code Definition

YES Yes, EMS personnel performed CPR or attempted defibrillation. NO No, EMS personnel did NOT perform CPR or attempt defibrillation

40



20. WHO INITIATED CPR - REQUIRED

• Cardiopulmonary resuscitation, CPR, is an attempt to restore spontaneous circulation by performing chest compressions with or without ventilation.

• Bystander CPR is CPR performed by a person who is not responding as an organized emergency response system approach to a cardiac arrest. Physicians, nurses, and paramedics may be described as medical provider if they are not part of the emergency response system involved in the victim’s resuscitation.

• Identifies the initial person to perform CPR. CPR or defibrillation being delivered defines a treated cardiac arrest patient.

Code Definition

1 Bystander (layperson not known to be a family member) 2 Bystander Family Member (layperson known to be family member) 3 First Responder Fire/Police 4 Responding EMS personnel 5 Medical provider (off duty on scene, not part of responding EMS personnel) 6 Other 7 CPR not attempted 8 Missing 9 Unknown

21. WAS AN AED USED DURING RESUSCITATION - REQUIRED

• The machine would need to have the pads applied to the patient with a minimum of one analysis

performed, regardless of whether or not a shock is indicated. • # of AED shocks used to indicate defibrillation attempts with an AED or monitor that is in AED

mode. • # of Manual shocks used to indicate defibrillation attempt with trained personnel monitoring

rhythm.

Code Definition YES Yes, AED was present and attached for one analysis. NO No, AED was neither present nor used. AED Present but not Used AED was available (ie, on wall or floor) but not attached to the patient

for one analysis. AED Malfunctioned AED was attached but malfunctioned during analysis attempt.

41



22. WHO FIRST APPLIED MONITOR/DEFIBRILLATOR, AED

• Identifies the individual who was responsible for using the AED during the resuscitation. • To determine the frequency of lay person, first responder and EMS use of AEDs during

resuscitations

Code Definition Not Applicable If field #20 was “NO” or “AED PRESENT BUT NOT USED” Bystander Bystander applied AED Bystander, family member AED Bystander, family member applied AED First Responder Fire/Police AED First Responder Fire or Police applied AED EMS AED or Monitor/Defibrillator EMS applied AED or Monitor/Defibrillator ALS First Responder Monitor/Defibrillator

If First Responder was equipped with monitor/defibrillator AND provided ALS personnel to monitor rhythm for rhythm analysis.

FIRST CARDIAC ARREST RHYTTHM OF PATIENT AND ROSC INFORMATION 23. FIRST ARREST RHYTHM OF PATIENT - REQUIRED

• The first monitored rhythm is the first cardiac rhythm present when a manual (monitor/defibrillator) or AED (automated external defibrillator) is attached to a patient after cardiac arrest.

• The initial rhythm that the patient was found to be in as indicated by EMS personnel. For the purposes of uniform reporting, the Utstein group classifies a deflection on the surface ECG < 1mm amplitude (calibrated 10 mm/mv) as asystole; 1 mm or more is ventricular fibrillation

• The first monitored rhythm recording (strip) needs to be attached at the bottom of the cardiac arrest registry sheet.

24. ANY RETURN OF SPONTANEOUS CIRCULATION (ROSC) - REQUIRED

• ROSC is defined as documentation in the trip sheet of a brief (approximately > 30 seconds) restoration of spontaneous circulation that provides evidence of more than an occasional gasp, occasional fleeting palpable pulse, or arterial waveform.

25. SUSTAINED RETURN OF SPONTANEOUS CIRCULATION - REQUIRED

• Sustained ROSC is deemed to have occurred when chest compressions are not required for 20 consecutive minutes and signs of circulation persist.

• If a patient has a subsequent loss of spontaneous circulation after “Sustained ROSC” this subsequent arrest is NOT coded as a new event. After the cardiac arrest event that resulted in the initial 911 call all subsequent arrests after ROSC are considered part of the initiating event.

42



26. OUT OF HOSPITAL DISPOSITION - REQUIRED

• This variable will be used to quantify the number of patients who had resuscitation terminated in the field and which patients were transported to the hospital.

• The final destination of the patient at the end of the EMS call.

Code Definition 1 Resuscitation not initiated at scene due to obvious signs of death, DNR, resuscitation

considered futile, or resuscitation is not required (eg. The patient shows signs of circulation). 2 Resuscitation terminated at scene due to medical control order, protocol/policy requirements

completed, return of spontaneous circulation 3 Transported to Hospital with or without return of spontaneous circulation.

27. END OF EVENT - REQUIRED

• Important: This field propagates the request for additional data from the hospital (if “ongoing resuscitation in the ED” has been selected.

• The event defined by this variable is the resuscitation attempt. • A resuscitation event is deemed to have ended when death is declared or spontaneous circulation

is restored and sustained for 20 minutes or longer.

Code Definition 1 Dead in Field; patient expired without being transported. 2 Pronounced Dead in ED; patient was in cardiac arrest when EMS arrived and, following

transfer of patient to hospital, EMS had knowledge that resuscitation efforts were terminated by ED staff.

3 Ongoing resuscitation in ED; whether or not the patient had a pulse upon arrival, the patient was continuing in receive care by hospital staff at time of EMS departure from hospital. Note: this includes patients with sustained ROSC, who have no impairment whatsoever, but had experienced cardiac arrest during this event.

28. RACE/ETHNICITY - REQUIRED

• Assign race/ethnicity of patient as considered by patient, family, or healthcare provider.

Code Definition 1 American-Indian/Alaska 2 Asian 3 Black/African-American 4 Hispanic/Latino 5 Native Hawaiian/ Pacific Islander 6 White 9 Unknown

43



Appendix A

Detailed LOCATION Definitions Code Definition

01 Home/Residence - Includes apartment, boarding house, farmhouse, home premises, residential house, and non-institutional place of residence, private driveway, private garage, private garden, private home, and private walkway, swimming pool within a private residence or garden, and yard of home. Excludes home under construction but not occupied or institutional place of residence. (See Industry)

02 Public Building -Includes any building used by the general public, including airport, bank café, casino, church, cinema, clubhouse, courthouse, dance hall, parking garage, hotel, market, movie theater, music hall, nightclub, office building, opera house, post office, public hall, broadcasting station, restaurant, commercial shop, bus or railway station, store, or theater. Excludes home garage (see Home/Residence) or industrial building or workplace. Excludes state, public and private schools (see Educational Institution) and physician’s offices. (See Physician Office/Medical)

03 Street/Hwy - Includes all public roadways. 04 Nursing Home/Assisted Living Center -Includes all medical residential institutions that are licensed by

the State as a nursing home or assisted-living center. 05 Residence/Institution - Children’s home, dormitory, orphanage. 06 Physician Office / Medical Clinic - Doctor offices, free standing clinics (other than one meeting the

definition of “Hospital”. 07 Educational Institution - Includes state, public and private schools. Excludes playground, gymnasium,

and other recreational locations within educational institutions. (See Recreation/Sports Facility). 08 Hospital - Hospitals, Medical Centers or other recognized medical facilities of similar type. 09 Recreation/Sport Facility - Includes amusement park, baseball field, basketball courts, beach resort,

cricket ground, football field, golf course, gymnasium, hockey field, holiday camps, ice palace, lake resort, mountain resort, playgrounds including school playground, public parks, racecourses, resorts of all types, riding school, rifle range, seashore resorts, skating rink, sports ground, sports palace, stadium, public swimming pool, tennis court, vacation resort. Excludes occurrences in private house, private garden, private swimming pool, and private yard. (See Home/Residence).

10 Industry - Includes building under construction, dockyard, dry dock, factory building or premises, garage (place of work), industrial yard, loading platform in factory or store, industrial plant, railway yard, shop (place of work), warehouse, and workhouse.

11 Farm - Includes farm buildings and land under cultivation. Excludes farmhouse and home premises of farm (See Home/Residence).

12 Mine/Quarry - Includes gravel pit, sand pit, or tunnel under construction. 13 Jail - Facility where persons are in custody of the judicial system. 14 Airport – Any location designated for routine travel by flight. 15 Other - Is to be used when location is not included in the above categories.

44



APPENDIX B Georgia First Responder Codes

Region County Name of Service PCR # 3 Fulton Atlanta Fire Department 802 3 Fulton City of Alpharetta - Alpharetta Fire Department 801 3 Cobb City of Austell Fire Department 803 3 Fulton City of College Park Fire Department 808 3 Fulton City of East Point Fire Department - First Responder 811 3 Clayton City of Forest Park Fire/EMS Services 867 3 Fulton City of Hapeville Fire Department 871 3 Clayton City of Morrow Fire Department 870 3 Clayton Clayton County Emergency Medical Services 858 3 Cobb Cobb County Fire and Emergency Services 806 3 Dekalb Dekalb County Department of Fire and Rescue Services 810 3 Douglas Douglas County Fire Department/ Emergency Medical Services 156 3 Cobb Elite Emergency Medical Services, LLC 362 3 Dekalb Emory University First Responder Unit EMS 833 3 Fulton Event & Motorsports EMS ( MFR) 882 3 Fulton Fulton County Fire Department 815 3 Cobb Georgia EMS Ambulance 319 3 Gwinnett Gwinnett County Fire and Emergency Services 872 3 Cobb Marietta Fire and Emergency Services 820 3 Newton Med One Emergency Medical Services, Inc. 375 3 Fulton MedStat Emergency Medical Service, Inc. 234 3 Clayton Riverdale Fire Services 850 3 Fulton Roswell Fire and Rescue Department 825 3 Cobb Six Flags First Aid 851 3 Cobb Smyrna Fire Rescue 826 3 Fulton Union City Fire Department 830

45



APPENDIX C Georgia Destination Hospitals

Destination Destination

Code Atlanta Medical Center 709 Children’s at Egleston 416 Children’s at Scottish Rite 518 Dekalb Medical Center 720 Emory Adventist Hospital 641 Emory Crawford Long Hospital 705 Emory Eastside Medical Center 534 Emory University Hospital 706 Fayette Community Hospital 200 Grady Memorial Hospital - Atlanta 710 Gwinnett Medical Center 366 Henry General Hospital 532 Hughes Spalding Children's Hospital 750 Joan Glancy Memorial Hospital 226 Newnan Hospital 515 Newton General Hospital 322 North Fulton Medical Center 327 Northlake Regional Medical Center 173 Northside Hospital 634 Northside Hospital Forsyth 346 Peidmont Hospital 617 Rockdale Hospital 240 South Fulton Medical Center 630 Southern Regional Medical Cent 547 St Josephs Hospital of Atlanta 714 Tanner Medical Center – Carrollton 435 Tanner Medical Center - Villa Rica 244 VA Medical Center - Atlanta 715 Wellstar Cobb Hospital & Medical Center 546 Wellstar Douglas General Hospital 312 Wellstar Kennestone Hospital 615 Wellstar Paulding Memorial Medical Center 151

46



APPENDIX D

US Postal Service Standard Abbreviation Address Abbreviation Address Abbreviation Apartment APT Plaza PLZ Avenue AVE Park PARK Building BLDG Parkway PKWY Boulevard BLVD Road RD Circle CIR Room RM Court CT South S Department DEPT Southeast SE Drive DR Southwest SW East E Square SQ Floor FL Street ST North N Suite STE Northeast NE Unit UNIT Northwest NW West W

47


Condensed Data Dictionary and Coding Manual:

Essential Instructions for Abstracting and Coding Data Elements

HOSPITAL

August 2007

Bryan McNally, MD, MPH (Principal Investigator) Arthur Kellermann, MD, MPH (Co-Investigator)


CARES Condensed Hospital Data Dictionary

EMERGENCY ROOM OUTCOME CARES Description

• The final disposition of the patient from the emergency department. • This variable will be used to quantify the outcome of the patient from emergency

department specifically. It will be used to differentiate outcome in the field (EMS resuscitation) and the outcome from the hospital (hospital survival) from the outcome in the emergency department.


• This variable should not be left missing or blank. All the information from the EMS trip sheet and patient medical record should be used to complete this data field.

Code Definition 1 Resuscitation terminated in ED 2 Admitted to ICU/CCU 3 Admitted to floor 4 Transferred to another acute care facility from the emergency department

Examples:

Code Definition 1 Patient was received in the ED after successful resuscitation in the field by EMS

personnel. Patient blood pressure was liable upon receiving in the ED and continued to deteriorate…..Patient was pronounced dead in the ED 20 minutes after arrival.

2 Patient was received in the ED after successful resuscitation in the field by EMS personnel. Patient blood pressure was adequate upon receiving in the ED and continued to improve after the addition of Dopamine…..Patient was transported to the CCU……

4 Patient was received in the ED with ongoing resuscitation by EMS personnel. Patient was stabilized in the ED after the addition of Dopamine…..Patient was transported to Pine Valley Tertiary Care Hospital for further intervention.

50


HOSPITAL OUTCOME CARES Description

• The final disposition of the patient from the hospital. • This variable will be used to quantify the outcome of the patient from the hospital.


• This variable should not be left missing or blank. All the information from patient medical record and discharge summary should be used to complete this data field.

Code Definition

1 Died in the Hospital 2 Discharged Alive 3 Transferred to another acute care facility 8 Patient has not been disposed 9 Unknown, not able to access medical record, or hospital discharge summary to

determine outcome at 30 days from admission Examples: Code Definition

1 Patient was admitted to CCU after successful resuscitation from sudden cardiac arrest. Patient became unstable after 2 days in the CCU. Blood pressure could not be maintained after pharmacological support. Patient arrested at 04:30 after being admitted to the CCU Resuscitation attempts were unsuccessful and patient was pronounced dead at 6:00.

2 Patient was received in the ED after successful resuscitation in the field by EMS personnel. Patient blood pressure was adequate upon receiving in the ED and continued to improve after the addition of Dopamine…..Patient was transported to the CCU……Patient remained stable and Dopamine was weaned off in 12 hours. Patient was transferred to the floor and discharged home after one week in the hospital.

51


DISPOSITION FROM THE HOSPITAL CARES Description

• This variable will be used to determine the frequency that patients are discharged or transferred to various facilities.



Code Definition

1 Home/residence 2 Rehabilitation facility 3 Skilled nursing facility 9 Unknown, not able to access medical record, or hospital discharge summary to

determine outcome at 30 days from admission. Examples: Code Definition

1 After two weeks in the CCU following sudden cardiac arrest, and a week on the floor, the patient was discharged home with follow up orders….

2 After 3 weeks in the CCU, and 5 weeks on the floor patient was transported to Sunshine Rehabilitation Hospital for further treatment.

9 After being transported to Rosedale Community Hospital following successful resuscitation by EMS following cardiac arrest, Registry personnel have not been able to obtain access to the patient medical record or the hospital discharge summary

52


NEUROLOGICAL OUTCOME AT DISCHARGE FROM HOSPITAL Utstein/CARES Description

• Survival without higher neurological outcome is suboptimal; therefore it is important to attempt to assess neurological outcome at discharge.

• This variable will be used to determine the frequency of neurological outcome in resuscitation survivors at the time of discharge.


• The level of cerebral performance of the patient at the time of discharge from the hospital. The following simple, validated neurological score is referred to as the Cerebral Performance Category, CPC.

• 1 = Good Cerebral Performance – Conscious, Alert, able to work and lead a normal life. • 2 = Moderate Cerebral Disability – Conscious and able to function independently (dress,

travel, prepare food) may have hemiplegia, seizures, or permanent memory or mental changes.

• 3 = Severe Cerebral Disability – Conscious, dependent on others for daily support, functions only in an institution or at home with exceptional family effort.

• 4 = Coma, vegetative state. • This variable should not be left missing or blank. All the information from patient

medical record and discharge summary should be used to complete this data field.

Code Definition 1 Good Cerebral Performance – Conscious, Alert, able to work and lead a normal life. 2 Moderate Cerebral Disability – Conscious and able to function independently (dress,


3 Severe Cerebral Disability – Conscious, dependent on others for daily support, functions only in an institution or at home with exceptional family effort.

4 Coma, vegetative state. 9 Unknown, not able to access medical record, or hospital discharge summary to

determine outcome at 30 days from admission. Examples:

Code Definition 1 After two weeks in the CCU following sudden cardiac arrest, and a week on the floor,

the patient was discharged home with follow up order about when to return to normal daily activities.

2 After 3 weeks in the CCU, and 5 weeks on the floor patient was transported to Sunshine Rehabilitation Hospital to educate family on how to provide complete activities of daily living.


53


Complete Data Set for EMS, Hospital, and CAD Participants and

Instructions for Abstracting and Coding Data Elements

August 2007

Bryan McNally, MD, MPH (Principle Investigator) Arthur Kellermann, MD, MPH (Co-Investigator)


CARES Data Dictionary and Coding Manual

CARES PROJECT DATA SET ESSENTIAL DATA ELEMENTS

No. Data Item Best Data Source/Alternate Data Source Comments (page)

EMS Dataset 1 Street Address (Where Arrest Occurred) EMS Trip Sheet 3

2-6, 28 Patient Information EMS Trip Sheet 4-6

7 EMS Agency ID EMS Trip Sheet 6 8 Date of Cardiac Arrest EMS Trip Sheet 7 9 Cardiac Arrest Call Number EMS Trip Sheet 8

10 Booklet ID Number EMS Trip Sheet 8 11 Fire/First Responder Service EMS Trip Sheet / EMS Crew Member 9 12 Hospital Destination EMS Trip Sheet 10 13 Time Elements (dispatch, ROSC, CPR, etc..) EMS Trip Sheet 10-12 14 Location Type EMS Trip Sheet 13-14 15 Arrest, Witnessed EMS Trip Sheet / EMS Crew Member 14-15 16 Arrest After Arrival of Responding EMS EMS Trip Sheet / EMS Crew Member 15 17 Presumed Cardiac Arrest Etiology EMS Trip Sheet / EMS Crew Member 16 18 Resuscitation Attempted by EMS Personnel EMS Trip Sheet 17 20 Who Initiated CPR EMS Trip Sheet / EMS Crew Member 18 21 Was an AED Used During Resuscitation EMS Trip Sheet / EMS Crew Member 19 22 Who First Applied AED, Monitor/Defibrillator EMS Trip Sheet / EMS Crew Member 20 23 First Arrest Rhythm of Patient EMS Trip Sheet / EMS Crew Member 21 24 Return of Spontaneous Circulation (ROSC) EMS Trip Sheet 22 25 Sustained Return of Spontaneous Circulation EMS Trip Sheet 23 26 Out of Hospital Disposition EMS Trip Sheet / EMS Crew Member 24 27 End of Event EMS Trip Sheet / EMS Crew Member 25

Hospital Dataset

25 Emergency Room Outcome ED Patient Record 26 26 Hospital Outcome Medical Record/Discharge Summary 27 27 Disposition from Hospital Medical Record/Discharge Summary 28 28 Neurological Status at Hospital Discharge Medical Record/Discharge Summary 29

Computer Aided Dispatch (CAD) Dataset

33 Call Number (Call #) Computer Aided Dispatch 30 34 Agency CAD ID Computer Aided Dispatch 31 35 Call Received Time Computer Aided Dispatch 31 36 Dispatched Time Computer Aided Dispatch 32 37 On Scene Time Computer Aided Dispatch 33 38 First Responder Call Received Time Computer Aided Dispatch 34 39 First Responder En Route Time Computer Aided Dispatch 35 40 First Responder On Scene Time Computer Aided Dispatch 36

Thursday, October 05, 2006 56


CARES PROJECT: EMS DATA SET 1. STREET ADDRESS (Where Arrest Occurred) WSCAD/Utstein/NEMSIS/CARES Description

• The address of the patient when the 911 call is made. • The address can be used to map the location of the cardiac arrest using GIS technology

and to identify patterns and clusters of cardiac arrest events. Instructions for Coding

• The address of arrest should include two lines. On the first line, record the number and street address of the location where the subject had the cardiac arrest. On the second (last line) record the city and state of the cardiac arrest and the zip code.

• The address should be fully spelled out using standard USPS abbreviations. These abbreviations include but are not limited to: AVE (avenue), BLVD (boulevard), CIR (circle), CT (court), DR (drive), PLZ (plaza), PARK (park), PKWY (parkway), RD (road), SQ (square), ST (street), APT (apartment), BLDG building), FL (floor), STE (suite), UNIT (unit), RM (room), DEPT (department), N (north), NE (northeast), NW (northwest), S (south), SE (southeast), SW (southwest), E (east), W (west).

• The ability to use GIS technology and to map cardiac arrest events is dependent upon the accuracy of the cardiac arrest address. For this reason, USPS standards are recommended for the coding of the address. The full document of these standards can be found at the USPS website (http://pe.usps.gov/cpim/ftp/pubs/Pub28/pub28.pdf). Address standards that are important for CARES are listed below.

• A standardized address is one that is fully spelled out, abbreviated by using the Postal Service standard abbreviations.

• Uppercase letters are preferred on all lines of the address. • Do not use the # sign if there is an address unit designator such as APT, SUITE or RM. • Punctuation should not be used in the address. • Spell city names in their entirety.

Example: Code Definition 102 MAIN ST SW APT 12 ATLANTA GA 30303

Use capital letters, use standard abbreviations, do not use punctuation, place a space between letters and numbers



2. PATIENT NAME – WHERE AVAILABLE Description

• Patient name is essential for location outcome information from the hospital. • If patient name is unknown, list as “John/Jane Doe”. • This information can be obtained from the patient care report (PCR). • This information is protected in confidence and should not be withheld based on HIPAA

concerns; please contact the CARES Project Coordinator (CPC) or your agencies CARES liason for questions.

• When the CARES data is complete and verified with matching hospital data the patient name will be “scrubbed” from the registry to de-identify the record completely.

4. PATIENT AGE WSCAD/Utstein/CARES Description

• Allows for categorization of the patient according to their age at the time of cardiac arrest when used in conjunction with patient age units.


• The actual or estimated age of a patient should be recorded. If a child is less than one year, enter the number of months, or days. If older than one year do not enter months.

• If the patients age is not know it should be estimated and recorded. • Both “Patient Age” and “Patient Age Units” must be coded.

Code Definition

001 One day, one month or one year when combined with “Patient Age Units”. 011 Eleven days, 11 months or 11 years when combined with “Patient Age Units” 120 One hundred and 20 days or 120 years. If the age is 120 days the age could also be

recorded as 004 with the “month” code for “Patient Age Units” 888 Missing, the trip sheet is not available or gets lost before coding complete. (Coded as

“888” only after every effort has been made to locate trip sheet or obtain information from other sources such as medical record). Must correspond with “8” for “Patient Age Units”.

999 Unknown, must correspond with “9” for “Patient Age Units”.



4. PATIENT AGE UNITS WSCAD/CARES Description

• Detailed pediatric age groups will provide information about cardiac arrest associated with congenital heart defects that may be inherited (such as prolong QT Syndrome and Wolf-Parkinson-White Syndrome). This information will improve screening of other family members that may be at risk of having these defects.

• Units in which the patient age is recorded. Instructions for Coding

• If a child is less than one year, enter the number of months, or days. If older than one year do not enter months.

Code Definition

1 Years 2 Months 3 Days

5. DATE OF BIRTH __



MMDDCCYY 07252004 July 25, 2004 6. GENDER Utstein/NEMSIS/CARES Description

• The sex of the patient may be an important risk factor for cardiac arrest and resuscitation interventions.


• The patient sex as recorded in the patient record or by self report. Code Definition

1 Male 2 Female



28. RACE/ETHNICITY – REQUIRED

• Assign race/ethnicity of patient as considered by patient, family, or healthcare provider.

Code Definition 1 American-Indian/Alaska 2 Asian 3 Black/African-American 4 Hispanic/Latino 5 Native Hawaiian/ Pacific Islander 6 White 9 Unknown

7. EMS AGENCY ID CARES, Utstein Description

• The Emergency Medical Service (EMS) that provided out-of-hospital care to the patient in cardiac arrest.

• EMS personnel respond to a medical emergency in an official capacity as part of an organized medical response team. By this definition, physicians, nurses, or paramedics who witness a cardiac arrest and initiate CPR but are not part of the organized rescue team are characterized as bystanders and are not part of the EMS system.


• Use the official code of the state EMS Service List. • The name of the EMS service is documented on the trip sheet. • The service name should be identified on the official list and then coded.

Code Definition 006 Specific EMS Service code. See Appendix A for Georgia listing. 888 Missing EMS Service code. Missing means that the service has an official

code in the jurisdiction but it was not recorded on the trip sheet. 999 Unknown EMS Service code. Unknown means that the service does not

have an official code in the jurisdiction. Examples: Code Definition 003 Code from Official EMS Service List 999 Quick Response EMS responded to the cardiac arrest but the service is not

on the jurisdiction official list.



8. DATE OF CARDIAC ARREST WSCAD/Utstein/NEMSIS/CARES Description

• Date cardiac arrest occurred • Allows the calculation of survival time based on consecutively timed events from this

index date. Instructions for Coding

• Use the date of event as recorded in the EMS trip sheet • Since this variable is required to be complete there can be no missing or unknown data.

Use all of the information on the EMS trip sheet and medical record to obtain the date of arrest.

Code Definition MMDDCCYY The date of cardiac arrest is the month, day and year that the event

occurred as recorded on the EMS trip sheet. The first two digits are the month, the third and forth digits are the day and the last 4 digits are the year.

Examples: Code Definition 07252004 July 25, 2004



9. CALL # WSCAD/Utstein/NEMSIS/CARES Description

• Incident number used by the EMS agency on the scene of the cardiac arrest • The Call number will be used to identify each unique event within the CARES database

and, where applicable, trace and link dispatch information (CAD data), including first responders, or additional ALS or BLS units.


• Use the Call number as recorded in the EMS trip sheet • This is essential information for follow up and linking data. This number must be

recorded and should not be missing on the EMS trip sheet. Code Definition XXXXXXXXXXX This is recorded as given on the EMS trip sheet. There are 6 characters

designated for this field. When the incident number is less than 6 characters, do not use preceding 0. If letters are used in the incident number they should be recorded as capital letters.

99999999999 Use only when every effort has been made to identify the incident number.

Examples: Code Definition 564512 Numeric incident number with eleven digits. 363348 Incident number from EMS trip sheet, 363348. AB6468 Four digit incident number that includes preceding letters.

10. BOOKLET ID NUMBERS – WHERE APPLICABLE

• This number is only for EMS agencies that use a HealthEMS® Epcr form for standard patient documentation

• Enter all nine digits for booklet ID number. • If less than nine digits, start with initial ‘0’s’




11. FIRE/ FIRST RESPONDER SERVICE CARES, Utstein Description

• Fire/first responder service that provided out-of-hospital care to the patient in cardiac arrest.


• Use the official code for Fire/First Responder designated on state Service List. • The name and/or code of the Fire/First Responder Service may be documented on the

EMS trip sheet. • The service name should be identified on the official list and then coded.

Code Definition 006 Specific fire/first responder service code. See Appendix A for Georgia listing. 888 Missing fire/first responder service code. Missing means that the service has an

official code in the jurisdiction but it was not recorded on the trip sheet. 999 Unknown fire/first responder service code. Unknown means that the service does not

have an official code in the jurisdiction. Examples: Code Definition 003 Code from Fire/First Responder Service List 999 Quick Response First was the first responder to the cardiac arrest but the service is

not on the Official Georgia list.



12. DESTINATION HOSPITAL CARES Description

• The hospital that the patient was transported to. Instructions for Coding

• The destination hospital should be documented on the EMS trip sheet. The hospital name should correspond to the hospital code for the particular jurisdiction.


Code Definition

000 Actual hospital code from list given in Appendix B 888 Missing, hospital is given on the EMS trip sheet but is missing from the official list of

codes for the jurisdiction 999 Unknown, use only after exhausting all sources for destination hospital.

Examples:

Code Definition 037 Shady Grove Hospital 888 First Class Hospital, is given as the receiving hospital but this hospital does not have a

code on the official list in the appendix of the Coding Manual. 13. TIME VARIABLES WHERE AVAILABLE General Instructions for Coding

• These are approximations to help identify the time set in the CAD system. These are not used for establishing statistical intervals.

• Time should be recorded in military time in the following form, HH:MM:SS for all EMS dispatch times.

• Time should be recorded in military time in the following form, HH:MM for all resuscitation times, (Time of first CPR, CPR stopped/termination time, Time of 1st defib) HH:MM (not seconds).

EMS NOTIFIED AND EMS ARRIVED AT SCENE Utstein/CARES General Instructions for Coding

• Estimated time EMS was notified of the event and time EMS arrived at scene of event.



TIME OF FIRST BYSTANDER CPR Utstein/CARES Description

• Estimated time that bystander began CPR. • This variable should be used with caution since errors in time can have important

ramifications for the evaluation response to and resuscitation of out-of-hospital cardiac arrest.


• All times collected for the CARES Registry should be coded in a uniform manner. Uniformity of this data collection will allow accurate calculation of resuscitation time intervals and survival time which is the fundamental purpose of the CARES Registry.

TIME OF FIRST DEFIBRILLATION Utstein/CARES Description

• Time the time that the first manual/AED shock was delivered. • The time that the first AED shock was delivered can be obtained when an AED

(automated external defibrillator) is attached to a patient after cardiac arrest. It may be possible to determine the first defibrillation from a storage data card, hard drive, or other device used by the AED to record data. If the AED has no data-recording device or a manual defibrillator was used, then the time of first defibrillation can be obtained from the EMS patient care narrative.


• Use the time as documented in the EMS trip sheet or computerized AED documentation. • All times collected for the CARES Registry should be coded in a uniform manner.

Uniformity of this data collection will allow accurate calculation of resuscitation time intervals and survival time which is the fundamental purpose of the CARES Registry.

TIME OF RETURN OF SPONTANEOUS CIRCULATION Utstein/CARES Description

• This time marks the return of any palpable pulse in the absence of ongoing chest compressions. Date that EMS arrived at the scene of a possible cardiac arrest

• Allows the calculation of survival time based on consecutively timed events.

Instructions for Coding • Use the time as documented on the EMS patient care record. • All times collected for the CARES Registry should be coded in a uniform manner.




TIME WHEN CPR STOPPED/TERMINATION TIME Utstein/CARES Description

• Numerous psychological and situational factors influence the time at which CPR is stopped, and this time point often is imprecise. Nevertheless, this information may be useful (eg. For developing guidelines on when to stop CPR). Duration of CPR is an important quality assurance issue (eg. Provision of CPR for 1-2 hours may be inappropriate).


• Use the time as documented on the EMS trip sheet. • All times collected for the CARES Registry should be coded in a uniform manner.


Examples: Code Examples Definition HH:MM:SS 01:23:45 Twenty three minutes and 45 seconds after 1 o’clock in the morning HH:MM 16:30 Four thirty in the afternoon



14. LOCATION TYPE WSCAD/Utstein/NEMSIS/CARES Description

• Location that the cardiac arrest occurred, not necessarily the origin of the transport if the subject was moved after the arrest.

• This field allows categorization of cardiac arrest according to type of location; this may allow for a greater understanding of high frequency arrest locations that can be targeted for prevention or response programs.

• These data are located on the EMS trip sheet. • If location is “missing” on the EMS trip sheet check the ED admission for information.

Instructions for Coding Code Definition

01 Home/Residence – Includes apartment, boarding house, farmhouse, home premises, residential house, and non-institutional place of residence, private driveway, private garage, private garden, private home, and private walkway, swimming pool within a private residence or garden, and yard of home. Excludes home under construction but not occupied or institutional place of residence. (See Industry)

02 Public Building –Includes any building used by the general public, including airport, bank café, casino, church, cinema, clubhouse, courthouse, dance hall, parking garage, hotel, market, movie theater, music hall, nightclub, office building, opera house, post office, public hall, broadcasting station, restaurant, commercial shop, bus or railway station, store, or theater. Excludes home garage (see Home/Residence) or industrial building or workplace. Excludes state, public and private schools (see Educational Institution) and physician’s offices. (See Physician Office/Medical)

03 Street/Hwy – Includes all public roadways. 04 Nursing Home –Includes all medical residential institutions that are licensed by the State

as a nursing home or assisted-living center. 05 Residence/Institution – Children’s home, dormitory, orphanage. 06 Physician Office / Clinic – Doctor offices, free standing clinics (other than one meeting

the definition of “Hospital”. 07 Educational Institution – Includes state, public and private schools. Excludes

playground, gymnasium, and other recreational locations within educational institutions. (See Recreation/Sports Facility).

08 Hospital – Hospitals, Medical Centers or other recognized medical facilities of similar type.

09 Recreation/Sport – Includes amusement park, baseball field, basketball courts, beach resort, cricket ground, football field, golf course, gymnasium, hockey field, holiday camps, ice palace, lake resort, mountain resort, playgrounds, public parks, racecourses, resorts of all types, riding school, rifle range, skating rink, sports ground, stadium, public swimming pool, tennis court. Excludes occurrences in private house, private garden, private swimming pool, and private yard. (See Home/Residence).

10 Industrial Place – Includes building under construction, dockyard, dry dock, factory building or premises, garage (place of work), industrial yard, loading platform in factory or store, industrial plant, railway yard, shop (place of work), warehouse, and workhouse.



11 Farm – Includes farm buildings and land under cultivation. Excludes farmhouse and home premises of farm (See Home/Residence).

12 Mine/Quarry – Includes gravel pit, sand pit, or tunnel under construction. 13 Jail – Facility where persons are in custody of the judicial system. 14 Airport – Any location designated for routine travel by flight. 15 Other – Is to be used when location is not included in the above categories.


09 Subject had a cardiac arrest at the baseball field while watching a Little League game.

03 Subject had cardiac arrest while driving to work on Peachtree Street. 14 Subject had cardiac arrest in flight between Nashville airport and Atlanta airport

15. ARREST WITNESSED NEMSIS, WSCSD, Utstein Description

• A witnessed arrest is one that is seen or heard by another person, or an arrest that is monitored. If the patient was found after an uncertain period of time and not either seen or heard to collapse, then the arrest is considered an unwitnessed arrest.

• To be able to determine a true Utstein survival rate in a given community it is necessary to identify those patients who have a chance at survival. An unknown downtime prevents classifying a patient as potentially viable and should be categorized as an unwitnessed arrest to prevent creating a false Utstein survival rate.


• A witnessed arrest is recorded in the EMS trip sheet. • Avoid missing data by using all of the information on the EMS trip sheet to determine if

the arrest was witnessed. Code Definition

1 Witnessed arrest 2 Unwitnessed arrest 8 Missing, the trip sheet is not available or gets lost before coding complete. (Coded as “8”

only after every effort has been made to locate trip sheet or obtain information from other sources such as medical record).

9 Unknown, unable to determine from the patient care report (trip sheet) whether or not the arrest was witnessed.




1 John Doe had a sudden cardiac arrest at home while watching Georgia football. The arrest was witnessed by Mr. Doe’s cousin.

2 Suzie Doe was found in the kitchen by her husband. He did not see or hear her fall but immediately called 911. EMT arrived and found Mrs. Smith in cardiac arrest.

1 EMS was call to the home of James Doe who complained of shortness of breath. Mr. Doe was awake and alert when EMS arrived and the first monitored cardiac rhythm was sinus tachycardia of 150 bpm. After 2 minutes of monitored sinus tachycardia, Mr. Doe went into ventricular fibrillation. Resuscitation was begun, etc

2 EMS was called to the corner of Peachtree and 14th Street for a possible cardiac arrest. Upon arrival a woman was found lying on the sidewalk with no pulse. The couple who had called 911 was interviewed and stated they found the woman while walking to their car.

2 EMS was called to the YMCA for a possible cardiac arrest. Upon arrival a man was found lying on the gym floor with no pulse. Several other people were playing basketball when the event occurred but no one heard or saw the man collapse.

16. ARREST AFTER ARRIVAL OF EMS Utstein/CARES Description

• Did the arrest occur after the arrival of EMS personnel. • Those patients who experience a cardiac arrest after the arrival of EMS personnel are in

the best of circumstances to be resuscitated by trained EMS personnel with the equipment to provide immediate defibrillation.


• This information can be obtained from the EMS trip sheet. • All of the information on the trip sheet should be used to avoid missing data.

Code Definition 1 Yes, patient was both awake and responsive or had a pulse upon arrival of EMS

but monitored rhythm or loss of pulse as assessed by EMS indicated cardiac arrest during EMS treatment.

2 No, patient was in cardiac arrest when EMS arrived. Examples:

Code Definition 1 EMS was call to the home of James Doe who complained of shortness of

breath. Mr. Doe was awake and alert when EMS arrived and the first monitored cardiac rhythm was sinus tachycardia of 150 bpm. After 2 minutes of monitored sinus tachycardia, Mr. Doe went flat line. Resuscitation was begun, etc.

2 Patient had no pulse when EMS arrived.



17. PRESUMED CARDIAC ARREST ETIOLOGY Utstein, CARES Description

• An arrest is presumed to be of cardiac etiology unless it is known or likely to have been caused by trauma, submersion, drug overdose, presumed poisoning/intoxication, asphyxia, exsanguinations, or any other non-cardiac cause as best determined by rescuers.

• This field allows for categorization based on evidence to suggest that the arrest was caused by a non-cardiac etiology. This will allow for the best chance of identifying patients that are otherwise presumed to have a primary cardiac etiology and help establish an Utstein survival rate for a community


• Use the etiology of cardiac arrest as recorded in the EMS trip sheet • Avoid missing data by using all of the information on the EMS trip sheet to determine

presumed etiology. Code Definition

1 Presumed cardiac etiology 2 Trauma 3 Respiratory 4 Drowning 5 Electrocution 7 Other, when etiology is documented but is not listed in options.


1 EMS was call to the home of James Doe who complained of shortness of breath. Mr. Doe was awake and alert when EMS arrived and the first monitored cardiac rhythm was sinus tachycardia of 150 bpm. After 2 minutes of monitored sinus tachycardia, Mr. Doe went into ventricular fibrillation. Resuscitation was begun, etc.

4 EMS was called to home of John Doe for possible cardiac arrest. When EMS arrived Mr. Doe was unconscious in the swimming pool. Mr. Doe’s wife saw him running and then suddenly fall into the pool. Mr. Doe did not have a pulse when he was removed from the pool.



18. RESUSCITATION ATTEMPTED BY EMS PERSONNEL Utstein Description

• A resuscitation attempt is defined as the act of attempting to maintain or restore life by establishing or maintaining airway (or both), breathing, and circulation through CPR, defibrillation, and other related emergency care techniques.

• When EMS personnel perform CPR or attempt defibrillation, it is recorded as resuscitation attempted by EMS personnel.

• For the CARES project, EMS for is defined as the providers that respond to the 911 call AND transport the patient to the hospital. All other responding providers that are involved in patient care but DO NOT transport the patient to the hospital will be considered “First Responders”.


• This information will be found on the EMS trip sheet. • Avoid missing data by using all of the information on the EMS trip sheet.

Code Definition 1 Yes, EMS personnel performed CPR or attempted defibrillation. 2 No, EMS personnel did NOT perform CPR or attempt defibrillation

Examples:

Code Example 2 Paramedic unit responds to the scene and finds the first responder doing CPR on a

patient with dependent lividity. Resuscitation is terminated due to the futile nature of the event.



20. WHO INITIATED CPR Utstein/WSCAD Description

• Cardiopulmonary resuscitation, CPR, is an attempt to restore spontaneous circulation by performing chest compressions with or without ventilation.

• Bystander CPR is CPR performs by a person who is not responding as an organized emergency response system approach to a cardiac arrest. Physicians, nurses, and paramedics may be described as performing bystander CPR if they are not part of the emergency response system involved in the victim’s resuscitation.

• Identifies the initial person to perform CPR. CPR or defibrillation being delivered defines a treated cardiac arrest patient


• Use the date of event as recorded in the EMS trip sheet • Avoid missing data by using all of the information on the EMS trip sheet to estimate date

of arrest. Code Definition

1 Bystander (layperson not known to be a family member) 2 Bystander Family Member (layperson known to be family member) 3 First Responder Fire/Police 4 Responding EMS personnel 5 Medical provider (off duty on scene, not part of responding EMS personnel) 6 Other


1 After attending the symphony, couple saw a woman suddenly collapse to the sidewalk. Since there was no pulse the man began chest compressions while the woman called 911.

3 Police responded to a 911 call at a single family dwelling at 123 Happy Lane. When police arrived wife stated she saw her husband collapse while he was washing dishes. Since there was no pulse police began chest compressions.

5 After attending a movie, a group of nurses heard someone call for help in the parking lot. A man was found on the ground with no pulse and no respirations. CPR was initiated by the nurses.



21. WAS AN AED USED DURING RESUSCITATION WSCAD/CARES Description

• To determine the incidence of automated external defibrillator (AED) use in the community.


• The machine would need to have the pads applied to the patient with a minimum of one analysis performed, regardless of whether or not a shock is indicated.

• # of AED shocks used to indicate defibrillation attempts with an AED or monitor that is in AED mode.

• # of Manual shocks used to indicate defibrillation attempt with trained personnel monitoring rhythm.

Code Definition

1 Yes 2 No 3 AED present but not used. 4 AED malfunctioned


1 EMS responded to a possible cardiac arrest at Lenox Mall. Upon arrival female was found on the floor with mall security at her side and an AED in use. Pads had been applied and one shock had been given.

3 EMS responded to a possible cardiac arrest at Peachtree-DeKalb Airport. Upon arrival a man was found on the ground beside a small aircraft. Airport personnel were running to the man’s side carrying an AED. EMS personnel began evaluation and resuscitation.

4 After the fitness instructor applied the AED to the collapsed jogger in the health club, she reported to the responding EMS After the fitness instructor applied the AED to the collapsed jogger in the health club, she reported to the responding EMS personnel that the AED did not work. She believes the batteries on the device were dead.



22. WHO FIRST APPLIED MONITOR/DEFIBRILLATOR, AED? CARES Description

• Identifies the individual who was responsible for using the AED during the resuscitation. • To determine the frequency of lay person, first responder and EMS use of AEDs during

resuscitations Instructions for Coding

Code Definition 1 Not applicable AED not used 2 Bystander (layperson not known to be a family member) 3 Bystander Family Member (layperson known to be family member) 4 First Responder Fire/Police 5 Responding EMS personnel 6 If First Responder was equipped with monitor/defibrillator AND provided ALS personnel

to monitor rhythm for rhythm analysis. Examples:

Code Definition 2 EMS responded to a possible cardiac arrest at Lenox Mall. Upon arrival female

was found on the floor with mall security at her side and an AED in use. Pads had been applied and one shock had been given

4 Police responded to a 911 call at a single family dwelling at 123 Happy Lane. When police arrived wife stated she saw her husband collapse while he was washing dishes. Since there was no pulse police began chest compressions. AED was applied. First monitored rhythm was ventricular fibrillation and shock was given

5 EMS was called to the YMCA for a possible cardiac arrest. Upon arrival a man was found lying on the gym floor with no pulse. Several other people were playing and watching a basketball game when the event occurred. Several bystanders saw the man collapse and were at his side. EMS applied AED.



23. FIRST ARREST RHYTHM OF PATIENT Utstein/NEMSIS Description

• The first monitored rhythm is the first cardiac rhythm present when a manual (monitor/defibrillator) or AED (automated external defibrillator) is attached to a patient after cardiac arrest. If the AED does not have a rhythm display, then it may be possible to determine the first monitored rhythm from a storage data card, hard drive, or other device used by the AED to record data. If the AED has no data-recording device, then the first monitored rhythm should be classified simply as “shockable” or “nonshockable”. This data point can be updated later if the AED has downloadable capability.

• The initial rhythm that the patient was found to be in as indicated by EMS personnel. For the purposes of uniform reporting, the Utstein group classifies a deflection on the surface ECG < 1mm amplitude (calibrated 10 mm/mv) as asystole; 1 mm or more is ventricular fibrillation


• In order to obtain the first monitored rhythm from the AED, it must have a working recording cartridge. The recording cartridge provides an electronic copy of the recorded rhythms and respective defibrillations that may be delivered. This cartridge must be retrieved after the arrest for review by the principle investigators or registry medical director.

• If the AED does not have a recording cartridge, record whether the AED provided a shock to a “shockable rhythm” from reviewing the EMS patient care report.

• For manual defibrillators, the first monitored rhythm should be recorded in the patient care narrative by EMS paramedics.

• If an AED without recorded rhythm is used during the event, selection should only be made from “Unknown shockable AED rhythm” or “Unknown unshockable AED rhythm.”

Code Definition

00 Ventricular fibrillation 01 Ventricular tachycardia 02 Asystole 03 Idioventricular/Pulseless Electrical Activity (PEA) 06 Unknown shockable AED rhythm 07 Unknown unshockable AED rhythm

Example: Code Definition

00 Monitor/Defibrillator was available to rhythm interpretation by First Responder or EMS. Ventricular Fibrillation was the presenting rhythm interpreted by trained personnel.

06 An AED was used by bystander or First Responder that did not provide observation of rhythm for interpretation. The AED advised to deliver a shock. This is the first arrest rhythm regardless of actual rhythm observed after EMS interpretation.



24. RETURN OF SPONTANEOUS CIRCULATION (ROSC) Utstein Description

• Signs of the return of spontaneous circulation (ROSC) include breathing (more than an occasional gasp), coughing, or movement. For healthcare personnel, signs of ROSC also may include evidence of palpable pulse or a measurable blood pressure. For the purposes of the Utstein registry template, “successful resuscitation” or ROSC is defined for all rhythms as the restoration of a spontaneous perfusing rhythm that results in more than an occasional gasp, fleeting palpable pulse, or arterial waveform. Previous reports that focus on outcomes from ventricular fibrillation have variably defined “successful defibrillation” as the termination of fibrillation to any rhythm (including asystole) and the termination of fibrillation to an organized electrical rhythm at 5 seconds after defibrillation (including pulseless electrical activity, PEA). Neither of these definitions of successful defibrillation would qualify as ROSC unless accompanied by evidence of restored circulation. By consensus, the phrase “any ROSC” is intended to represent a brief (approximately > 30 seconds) restoration of spontaneous circulation that provides evidence of more than an occasional gasp, occasional fleeting palpable pulse, or arterial waveform.


Code Definition 1 Yes, documentation in the trip sheet of a brief (approximately > 30 seconds) restoration

of spontaneous circulation that provides evidence of more than an occasional gasp, occasional fleeting palpable pulse, or arterial waveform.

2 No, documentation in the trip sheet that there was NO brief (approximately > 30 seconds) restoration of spontaneous circulation and no evidence of more than an occasional gasp, occasional fleeting palpable pulse, or arterial waveform.

Examples:

Code Definition 1 “… after defibrillation cardiac arrest patient had a palpable carotid pulse that was

sustained and a return of monitored arterial wave form.” 2 …after defibrillation cardiac arrest patient had very faint carotid pulse that faded after

approximately 10 seconds. Monitored rhythm remained as asystole.



25. SUSTAINED ROSC Utstein Description

• Sustained ROSC is deemed to have occurred when chest compressions are not required for 20 consecutive minutes and signs of circulation persist.


• If a patient has a subsequent loss of spontaneous circulation after “Sustained ROSC” this subsequent arrest is NOT coded as a new event. After the cardiac arrest event that resulted in the initial 911 call all subsequent arrests after ROSC are considered part of the initiating event.

Code Definition

1 Yes, chest compressions were not required for 20 consecutive minutes and signs of circulation persist.

2 No, chest compressions were required before 20 consecutive minutes pasted and signs of circulation did not persist.

Examples:

Code Definition 1 “…after defibrillation patient monitored rhythm returned to sinus tachycardia with a

palpable carotid pulse. There was no further fibrillation or asystole. Patient remained stable and was transported…”

2 “…after defibrillation patient monitored rhythm returned to sinus tachycardia with a palpable carotid pulse. After 10 minutes, the patient became flaccid and asystolic. Chest compressions were restarted…”



26. OUT OF HOSPITAL DISPOSITION CARES Description

• This variable will be used to quantify the number of patients who had resuscitation terminated in the field and which patients were transported to the hospital.

• The final destination of the patient at the end of the EMS call.

Instructions for Coding • This variable should not be left missing or blank. All the information from the EMS trip

sheet and patient medical record should be used to complete this data field. Code Definition

1 Resuscitation not initiated at scene due to obvious signs of death, DNR, resuscitation considered futile, or resuscitation is not required (eg. The patient shows signs of circulation).

2 Resuscitation terminated at scene due to medical control order, protocol/policy requirements completed, return of spontaneous circulation

3 Transported to Hospital with or without return of spontaneous circulation. 8 Missing, the trip sheet is not available or gets lost before coding complete. (Coded as

“8” only after every effort has been made to locate trip sheet or obtain information from other sources such as medical record


2 Paramedics contact medical control physician after providing standard advanced cardiac life support for nearly 30 minutes. A medical control order is given to terminate resuscitation efforts when further treatment efforts have been deemed to be medically futile.

1 EMS responded to a possible cardiac arrest at the corner of Peachtree and Ponce de Leon. When EMS personnel arrived on the scene a man was found lying on the ground with dependent lividity.

3 “…after defibrillation patient monitored rhythm returned to sinus tachycardia with a palpable carotid pulse. There was no further fibrillation or asystole. Patient remained stable and was transported to Shady Grove Hospital…”



27. END OF THE EVENT Utstein/NEMSIS Description

• The reason that CPR or the resuscitation efforts were discontinued. • A resuscitation event is deemed to have ended when death is declared or spontaneous

circulation is restored and sustained for 20 minutes or longer. Instructions for Coding

Code Definition 1 Dead in Field 2 Pronounced Dead in ED 3 Ongoing Resuscitation in ED

Examples:

Code Definition 1 Dead in Field; patient expired without being transported. 2 Pronounced Dead in ED; patient was in cardiac arrest when EMS arrived and, following

transfer of patient to hospital, EMS had knowledge that resuscitation efforts were terminated by ED staff.

3 Ongoing resuscitation in ED; whether or not the patient had a pulse upon arrival, the patient was continuing in receive care by hospital staff at time of EMS departure from hospital. Note: this includes patients with sustained ROSC, who have no impairment whatsoever, but had experienced cardiac arrest during this event.



HOSPITAL DATASET 29. EMERGENCY ROOM OUTCOME CARES Description

• The final disposition of the patient from the emergency department. • This variable will be used to quantify the outcome of the patient from emergency

department specifically. It will be used to differentiate outcome in the field (EMS resuscitation) and the outcome from the hospital (hospital survival) from the outcome in the emergency department.



• If “Transferred to another acute care facility from the emergency department” (Code 4) is selected, the destination hospital and data of transfer should be documented using the corresponding drop-down menu and/or “Hospital Comments” section.

Code Definition 1 Resuscitation terminated in ED 2 Admitted to ICU/CCU 3 Admitted to floor 4 Transferred to another acute care facility from the emergency department

Examples:

Code Definition 1 Patient was received in the ED after successful resuscitation in the field by EMS

personnel. Patient blood pressure was liable upon receiving in the ED and continued to deteriorate…..Patient was pronounced dead in the ED 20 minutes after arrival.

2 Patient was received in the ED after successful resuscitation in the field by EMS personnel. Patient blood pressure was adequate upon receiving in the ED and continued to improve after the addition of Dopamine…..Patient was transported to the CCU……

4 Patient was received in the ED with ongoing resuscitation by EMS personnel. Patient was stabilized in the ED after the addition of Dopamine…..Patient was transported to Pine Valley Tertiary Care Hospital for further intervention.



30. HOSPITAL OUTCOME CARES Description

• The final disposition of the patient from the hospital. • This variable will be used to quantify the outcome of the patient from the hospital.



• If “Transferred to another acute care facility” (Code 3) is selected, the destination hospital and data of transfer should be documented using the corresponding drop-down menu and/or “Hospital Comments” section.

Code Definition

1 Died in the Hospital 2 Discharged Alive 3 Transferred to another acute care hospital 8 Patient has not been disposed 9 Unknown, not able to access medical record, or hospital discharge summary to

determine outcome at 30 days from admission Examples: Code Definition

1 Patient was admitted to CCU after successful resuscitation from sudden cardiac arrest. Patient became unstable after 2 days in the CCU. Blood pressure could not be maintained after pharmacological support. Patient arrested at 04:30 after being admitted to the CCU Resuscitation attempts were unsuccessful and patient was pronounced dead at 6:00.

2 Patient was received in the ED after successful resuscitation in the field by EMS personnel. Patient blood pressure was adequate upon receiving in the ED and continued to improve after the addition of Dopamine…..Patient was transported to the CCU……Patient remained stable and Dopamine was weaned off in 12 hours. Patient was transferred to the floor and discharged home after one week in the hospital.



31. DISCHARGE FROM THE HOSPITAL CARES Description

• This variable will be used to determine the frequency that patients are discharged or transferred to various facilities.



Code Definition

1 Home/residence 2 Rehabilitation facility 3 Skilled nursing facility 9 Unknown, not able to access medical record, or hospital discharge summary to

determine outcome at 30 days from admission. Examples: Code Definition

1 After two weeks in the CCU following sudden cardiac arrest, and a week on the floor, the patient was discharged home with follow up orders.

2 After 3 weeks in the CCU, and 5 weeks on the floor patient was transported to Sunshine Rehabilitation Hospital for further treatment.




32. NEUROLOGICAL OUTCOME AT DISCHARGE FROM HOSPITAL Utstein/CARES Description

• Survival without higher neurological outcome is suboptimal; therefore it is important to attempt to assess neurological outcome at discharge.

• This variable will be used to determine the frequency of neurological outcome in resuscitation survivors at the time of discharge.


• The level of cerebral performance of the patient at the time of discharge from the hospital. The following simple, validated neurological score is referred to as the Cerebral Performance Category, CPC.

• 1 = Good Cerebral Performance – Conscious, Alert, able to work and lead a normal life. • 2 = Moderate Cerebral Disability – Conscious and able to function independently (dress,


• 3 = Severe Cerebral Disability – Conscious, dependent on others for daily support, functions only in an institution or at home with exceptional family effort.

• 4 = Coma, vegetative state. • This variable should not be left missing or blank. All the information from patient

medical record and discharge summary should be used to complete this data field.

Code Definition 1 Good Cerebral Performance; CPC 1 2 Moderate Cerebral Disability; CPC 2 3 Severe Cerebral Disability; CPC 3 4 Coma, vegetative state; CPC 4 9 Unknown, not able to access medical record, or hospital discharge summary to

determine outcome at 30 days from admission. Examples:

Code Definition 1 At discharge, patient was conscious, alert, able to work and lead a normal life. 2 At discharge, patient was conscious and able to function independently (dress, travel,

prepare food) may have hemiplegia, seizures, or permanent memory or mental changes. 9 After being transported to Rosedale Community Hospital following successful

resuscitation by EMS following cardiac arrest, Registry personnel have not been able to obtain access to the patient medical record or the hospital discharge summary



CAD DATASET General Instructions for Coding

• Multiple CAD system may be used to contribute to this dataset. • CARES staff should be notified of time synchronization issues and sources of each time element

to set up specified user accounts. 33. CALL # CARES Description

• Call number assigned within computer aided dispatch (CAD) system when the 911 call was received.

• Allows the tracking of times associated with CARES events.

Instructions for Coding • Use format as documented on the computer aided dispatch (CAD) records. • All Call #s collected for the CARES Registry should be coded in a uniform manner.

Code Definition XXXXXXXXX The call number associated with the CARES event within the CAD system.

Examples: Code Definition 200500001 The first record within the CAD system in 2005.



34. AGENCY CAD ID CARES Description

• The state ID code associated with the CAD system.

Instructions for Coding • Use the official code of the state CAD Service List. • The service name should be identified on the official list and then coded.

35. CALL RECEIVED TIME Utstein/CARES Description

• Initial time the CAD system received the 911 call. • Allows the calculation of survival time based on consecutively timed events.

Instructions for Coding • Use the time 911 call received as documented on the CAD records. • Avoid missing time data since the intervals calculated between consecutive events is

fundamental purpose of the CARES Registry. • All times collected for the CARES Registry should be coded in a uniform manner.


Code Definition HH:MM:SS Time should be recorded based on military time. The first two digits represent the

hour 00- 24. The second two digits represent the minutes 00-59. The last two digits are seconds 00-59. A colon should separate the hour, minutes and seconds.

99:99:99 When the hour, minutes or seconds of the event are unknown. Examples: Code Definition 01:23:45 Twenty three minutes and 45 seconds after 1 o’clock in the morning 16:30:15 Four thirty and 15 seconds in the afternoon



36. DISPATCHED TIME Utstein/CARES Description

• Time the Responding EMS Unit was notified • Allows the calculation of survival time based on consecutively timed events.

Instructions for Coding • Use the time as documented on the computer aided dispatch (CAD) records • Avoid missing time data since the intervals calculated between consecutive events is








37. ON SCENE TIME Utstein/CARES Description

• Time that Responding EMS Unit arrived at scene. • Allows the calculation of survival time based on consecutively timed events.









38. FIRST RESPONDER CALL RECEIVED TIME Utstein/CARES Description

• Initial time the CAD system received the 911 call. • Allows the calculation of survival time based on consecutively timed events.

Instructions for Coding • Use the time 911 call received as documented on the CAD records. • Avoid missing time data since the intervals calculated between consecutive events is








39. FIRST RESPONDER EN ROUTE TIME Utstein/CARES Description

• Time the Responding First Responder Unit was notified • Allows the calculation of survival time based on consecutively timed events.









40. FIRST RESPONDER ON SCENE TIME Utstein/CARES Description

• Time that the First Responder Unit arrived at scene. • Allows the calculation of survival time based on consecutively timed events.









III. DATA REPORTS

91

Local administrators will be able to generate the following individual reports for any interval for their specific agency. In a format determined among CARES participants, external

benchmarking of these same reports can occur in a region or among similar systems. These external, aggregate reports may be conducted quarterly or annually and only of enough data

exists in the CARES system to maintain confidentiality of data.

UTSTEIN REPORT The Utstein report generated by CARES is a three-page document that describes the events in three categories and three subcategories. The categories are “Witnessed Arrest (bystander)”,

“Unwitnessed Arrest”, and “Witnessed Arrest by EMS”. The events are further categorized in each of these sections based on the initial arrest rhythms “Asystole”, “Ventricular Fibrillation / Ventricular Tachycardia (pulseless)”, and “Other”. An example Utstein report is given on the

following three pages.

RESPONSE INTERVALS All response intervals reports are generated on the CARES website in a continuous fashion as the data is entered. Examples of bar and pie charts reflecting EMS and First Responder intervals are

given within the following section.

COMMUNITY RESPONSE

Bystander interventions are included on the Utstein report in the top-right corner along with summary survival statistics. These interventions include AED use and CPR. An example of this data table is listed above and its location can be identified on the first page of the Utstein report.

DEMOGRAPHICS

Age range, gender percentages, and percentages based on location type are generated on the website in table format.

MAPPING OF ARREST EVENTS (FUTURE)

Current developments of reporting include mapping application to identify the location of events and community-wide AED placement.

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Utstein Survival ReportCares Demo

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October 04, 2006 ©2000-2006 ScanHealth, Inc. ScanHealth - myCARES™ 1 of 393

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EMS CAD TimesSample Data

http://www.gotomeeting.com/

https://mycares.net/setup_dashboard_form.jsp

https://mycares.net/menu.jsp

https://mycares.net/menu.jsp?Menuid=0

https://mycares.net/logout.jsp

https://mycares.net/setup_main.jsp

https://mycares.net/secure/criteria_form.jsp?reportid=0

https://mycares.net/secure/reports_main.jsp

First Responder CAD TimesSample Data

http://www.gotomeeting.com/

https://mycares.net/setup_dashboard_form.jsp

https://mycares.net/menu.jsp

https://mycares.net/menu.jsp?Menuid=0

https://mycares.net/logout.jsp

https://mycares.net/setup_main.jsp

https://mycares.net/secure/criteria_form.jsp?reportid=0

https://mycares.net/secure/reports_main.jsp

DemographicsSample Data


IV. HIPAA / DATA CONFIDENTIALITY AGREEMENTS

100

CARES (Cardiac Arrest Registry to Enhance Survival)

EMS Data Use Agreement

This Data Use Agreement for a Limited Data Set (“Data Use Agreement”) is effective on the ______ day of __________________ (“Effective Date”) by and between ____________________________ (“Participating EMS Agency”), and Emory University, through its School of Medicine (“Recipient”).

Recipient has in place a policy regarding the use of Limited Data Sets for research and public health purposes in accordance with regulations issued under the Health Insurance Portability and Accountability Act of 1996, as amended (“HIPAA”). Under this policy, entities and/or individuals may provide a Limited Data Set to a researcher or other appropriate individual for purposes of research or public health. The Limited Data Set consists of health information has been stripped of all of the following identifiers:

• Names.

• Addresses, including any email, web URL and postal addresses, except zip codes and names of towns, cities and states.

• Numerical identifiers (including telephone numbers; fax numbers; email addresses; IP addresses; social security numbers; medical record numbers; health plan beneficiary numbers; account numbers; certificate/license numbers; vehicle identification and serial numbers, including license plate numbers; device identifiers and serial numbers).

• Biometric identifiers (including finger and voice prints).

• Full-face photographic images.

A Limited Data Set may contain the following information: (a) dates and ages; (b) gender; (c) race; (d) ethnicity; (e) marital status; (f) town, city and state of residence; (g) zip codes; and (h) a unique identifying number, characteristic or code.

Participating EMS agency is a Covered Entity as defined in HIPAA, and Participating EMS Agency is willing to provide Recipient with a Limited Data Set of Protected Health Information for public health and research purposes.

In order to protect the interest of both parties and to comply with the requirements of HIPAA, Recipient and Participating EMS Agency agree as follows:

1. Capitalized terms used but not defined in this Data Use Agreement shall have the definitions set forth in HIPAA and the regulations promulgated under HIPAA. In the event of any inconsistency between the provisions of this Data Use Agreement and mandatory provisions of HIPAA, HIPAA shall control.

2. The Recipient of the Limited Data Set is Emory University, through its School of Medicine, Department of Emergency Medicine, Section of Prehospital and Disaster Medicine, through the individual requestor identified below.

Name & Title of Requestor: Bryan McNally, MD, MPH

Address & Phone No. of Requestor: Suite 340, 531 Asbury Circle-Annex, Atlanta, Georgia 30322

Entity by Whom Requestor is Employed: Emory University, through its School of Medicine

C:\Documents and Settings\med7paj\My Documents\CARES\CARES Admin Forms\Reference Manual\EMS Data Use Agreement.doc

3. The Recipient requests that the Participating EMS Agency provide it with the Limited Data Set described below for the uses and purposes described below. The Recipient agrees and affirms that all information requested to be provided in the Limited Data Set, and all uses and purposes for which the Limited Data Set is requested, are permitted by and are in accordance with the Limited Data Set policy described above.

(a) Description of Limited Data Set Requested: EMS Outcome measures for patients that have experienced an out of hospital cardiac arrest event include:

1) Address of Cardiac Arrest.

2) Name, Age, Date of Birth, Gender, Race/Ethnicity

3) EMS Agency ID

4) Date of Cardiac Arrest

5) Call Number (and Booklet Number, where applicable)

6) ID of First Responder(s) Involved in Incident

7) ID of Destination Hospital

8) Time Elements Including “Time of First CPR”, “ROSC Time”, “CPR Termination Time”, “Time of First Defibrillation”, and approximate times of “EMS Notified” and “EMS Arrived at Scene”

9) Location Type

10) Witnessed Status of Arrest and Whether Arrest was Witnessed Prior to or After the Arrival of EMS

11) Presumed Etiology of Arrest

12) Indication of whether Resuscitation of Arrest was Initiated

13) Generalized Identity of Who Initiated CPR

14) If an AED was Used and Who First Applied the AED

15) First Arrest Rhythm of the Patient

16) Whether Return of Spontaneous Circulation (ROSC) Occurred in the Prehospital Setting and Whether ROSC was Sustained

17) The Out of Hospital Disposition

18) Knowledge of the End of the Event

The descriptors for these data elements are simple and do not require detailed responses.

(b) The Limited Data Set is being requested for the following purpose(s):

__X__ Research and Public Health purposes. Briefly describe:


Sudden cardiac death (“SCD”) is the leading cause of death among adults in the United States and Western countries. It is estimated that approximately 400,000 deaths occur every year. Most of these deaths are due to a fatal heart rhythm disturbance called ventricular fibrillation.

CARES is a model SCD registry capable of identifying and tracking all cases of cardiac arrest in a defined geographic area. The registry shall consist of de-identified protected health information (“PHI”) as defined under the privacy standards of HIPAA. During the first year of development, the system will be confined to Fulton County, the most populous county in the state of Georgia. In year two, it will be expanded to a multi-county area of metropolitan Atlanta, GA. Recipient is working collaboratively with the CDC and the American Heart Association with the goal of generating data to help emergency medical systems (“EMS”) improve their performance in the treatment of out-of-hospital cardiac arrest. The ultimate goals of this project are to develop a registry for nationwide use to help local EMS administrators and medical directors identify who is affected, when and where cardiac arrest events occur, which elements of the system are functioning properly and which elements are not, and how changes can be made to improve cardiac arrest outcomes. The registry shall include the location of the medical incident and not the address of the particular person involved.

A uniform, simple and sustainable cardiac arrest registry is essential to help communities across the United States assess their provision of care to victims of SCD and measure the outcomes that are achieved. It is a critical step in improving out of hospital care, and ultimately the community’s rate of survival from this common and devastating event.

(c) Description of Persons who will be Permitted to Use or Receive the Limited Data Set (e.g., PI and research staff; specific study sponsor, etc.):

• Bryan McNally MD, MPH_(Principal Investigator of CARES),

• Lorie Click RN, MSN, MPH_(Epidemiologist for CARES),

• Allison Park, MPH (Data Manager for CARES)

4. The Recipient agrees that it, and its employees and agents will:

(a) Not use or further disclose the information contained in the Limited Data Set other than as permitted in this Data Use Agreement or as required by law;

(b) Use appropriate safeguards to prevent the use or disclosure of the information contained in the Limited Data Set other than as permitted in this Data Use Agreement and will not link the information obtained under this Data Use Agreement to any other available data sets to determine the identity of any and all individuals involved;

(c) Report to EMS Agency and to Emory University Privacy Officer any use or disclosure of the information contained in the Limited Data Set that is not permitted by this Data Use Agreement of which it becomes aware. Such reports can be made to the Emory University Privacy Officer, Office of Research Compliance, Ste. 510, 1784 N. Decatur Rd., Atlanta, GA 30322;

(d) Ensure that any of its agents or subcontractors to whom it provides the Limited Data Set agrees in writing to the same restrictions and conditions that apply to the Recipient. The Recipient may do this by providing its agents and subcontractors with a copy of this Data Use Agreement and having them agree in writing that they have received and reviewed the Agreement and agree to abide by its terms (see Subcontractor/Agent Signature Block below); and


(e) Not identify the information or contact the individuals who are the subject of the information.

5. This Data Use Agreement will be effective on the Effective Date set forth above and shall continue in effect as long as the Recipient retains the data, unless otherwise terminated by applicable law or regulation.

Recipient: Participating EMS Agency:

Signature:___________________________ Name of EMS Agency: _________________

Date:_______________________________ Address: ________________________

Signature:________________________

Title:_____________________________

Date:_____________________________

Acknowledgement and Agreement of Recipient’s Agents & Subcontractors:

The undersigned subcontractor/agent of the Recipient who will be receiving access to the Limited Data Set described herein agrees that it has received a copy of and reviewed this Data Use Agreement governing its use of the Limited Data Set and that it will ensure that it and its employees and agents abide by its terms.

Name of Subcontractor/Agent:_______________________ Date:_________

Authorized Signature:___________________________________________________

Name and Title of Authorized Signatory:_____________________________________


Hospital Data Use Agreement

This Data Use Agreement for a Limited Data Set (“Data Use Agreement”) is effective on the ______ day of __________________ (“Effective Date”) by and between ____________________________ (“Participating Hospital”), and Emory University, through its School of Medicine (“Recipient”).


• Names.






Participating Hospital is a Covered Entity as defined in HIPAA, and Participating Hospital is willing to provide Recipient with a Limited Data Set of Protected Health Information for public health and research purposes.

In order to protect the interest of both parties and to comply with the requirements of HIPAA, Recipient and Participating Hospital agree as follows:






CARES C:\Documents and Settings\med7paj\My Documents\CARES\CARES Admin Forms\Reference Manual\Hospital Data Use Agreement.doc

3. The Recipient requests that the Participating Hospital provide it with the Limited Data Set described below for the uses and purposes described below. The Recipient agrees and affirms that all information requested to be provided in the Limited Data Set, and all uses and purposes for which the Limited Data Set is requested, are permitted by and are in accordance with the Limited Data Set policy described above.

(a) Description of Limited Data Set Requested: EMS Outcome measures for patients that have experienced an out of hospital cardiac arrest event include:

1) Emergency Department Outcome.

2) Hospital Outcome

3) Discharge Status and Destination

4) Neurological Outcome at Time of Discharge from the Hospital

5) If Transferred from one Hospital to Another, the Name of Receiving Hospital and Date of Transfer










• Lorie Click, RN, MSN, MPH_(Epidemiologist for CARES),

• Allison Park, MPH_(Program Co-coordinator for CARES),




(c) Report to Participating Hospital and to Emory University Privacy Officer any use or disclosure of the information contained in the Limited Data Set that is not permitted by this Data Use Agreement of which it becomes aware. Such reports can be made to the Emory University Privacy Officer, Office of Research Compliance, Ste. 510, 1784 N. Decatur Rd., Atlanta, GA 30322;

(d) Ensure that any of its agents or subcontractors to whom it provides the Limited Data Set agrees in writing to the same restrictions and conditions that apply to the Recipient. The Recipient may do this by providing its agents and subcontractors with a copy of this Data Use Agreement and having them agree by receiving and reviewing the Agreement and agree to abide by its terms; and




Recipient: Participating Hospital:

Signature:___________________________ Name of Hospital: _______________________

Date:_______________________________ Address: ______________________________

Signature:______________________________

Title:__________________________________

Date:_________________________________







CAD (Computer-Aided Dispatch) Data Use Agreement

This Data Use Agreement for a Limited Data Set (“Data Use Agreement”) is effective on the ______ day of __________________ (“Effective Date”) by and between ____________________________ (“Participating CAD”), and Emory University, through its School of Medicine (“Recipient”).


• Names.






Participating CAD is a Covered Entity as defined in HIPAA, and Participating EMS Agency is willing to provide Recipient with a Limited Data Set of Protected Health Information for public health and research purposes.

In order to protect the interest of both parties and to comply with the requirements of HIPAA, Recipient and Participating Hospital agree as follows:






C:\Documents and Settings\med7paj\My Documents\CARES\CARES Admin Forms\Reference Manual\CAD Data Use Agreement.doc

3. The Recipient requests that the Participating CAD provide it with the Limited Data Set described below for the uses and purposes described below. The Recipient agrees and affirms that all information requested to be provided in the Limited Data Set, and all uses and purposes for which the Limited Data Set is requested, are permitted by and are in accordance with the Limited Data Set policy described above.

(a) Description of Limited Data Set Requested: Response measures for patients that have experienced an out of hospital cardiac arrest event include:

1) Call Received Time.

2) Time EMS and First Responders were Dispatched

3) Time EMS and First Responders Arrived on scene of incident

4) CAD identification code and case/incident number









• Lorie Click RN, MSN, MPH_(Epidemiologist for CARES),

• Allison Park, MPH (Data Manager for CARES)

C:\Documents and Settings\med7paj\My Documents\CARES\CARES Admin Forms\Reference Manual\CAD Data Use Agreement.doc




(c) Report to Participating CAD and to Emory University Privacy Officer any use or disclosure of the information contained in the Limited Data Set that is not permitted by this Data Use Agreement of which it becomes aware. Such reports can be made to the Emory University Privacy Officer, Office of Research Compliance, Ste. 510, 1784 N. Decatur Rd., Atlanta, GA 30322;

(d) Ensure that any of its agents or subcontractors to whom it provides the Limited Data Set agrees in writing to the same restrictions and conditions that apply to the Recipient. The Recipient may do this by providing its agents and subcontractors with a copy of this Data Use Agreement and having them agree in writing that they have received and reviewed the Agreement and agree to abide by its terms (see Subcontractor/Agent Signature Block below); and



Recipient: Participating EMS Agency:

Signature:___________________________ Name of EMS Agency: _________________

Date:_______________________________ Address: ________________________

Signature:________________________

Title:_____________________________

Date:_____________________________







V. GETTING STARTED / NEXT STEPS

114

Cardiac Arrest Registry to Enhance Survival (CARES) Emergency Medical Services Information for New Data Source

EMS Agency Information: Agency Name:___________________________________________________ Address:________________________________________________________ City:__________________ State:_______ Zip Code:_________________ Zone / Territory:_____________________________ State ID Code:_______ County:______________________ EMS Region:__________________ EMS Director Name:_______________________________________________ Email:__________________________________________________________ Phone(s): Work - __________________ Cell - _______________________ Medical Director Name:__________________________________________ Email:__________________________________________________________ Phone(s): Work - __________________ Cell - _______________________ EMS Data Manager:______________________________________________ Email:__________________________________________________________ Phone(s): Work - __________________ Cell - _______________________

CARES EMS Application Version 1 (09/2006) 115

Current Involvement in Cardiac Arrest Survival Statistics: Do you collect and measure Utstein-style statistics? Yes No

If yes, since:_________ If yes, who do you use to collect this information? (circle) Dedicated staff Quality-Assurance/Training Other If yes, do you benchmark yourself against other cities using Utstein ? Yes No

Do you collect and compare survival outcomes to: (circle) Response Intervals Bystander Interventions Other:________(specify) Has any of your data/statistics been made available to the public? Yes No If yes, please indicate the website and/or publication(s) below: ________________________________________________________________ ________________________________________________________________ ________________________________________________________________


Documentation: Method of documenting patient care reports (PCR): (circle one) Paper (scanned) Paper (not scanned) Laptop/software Other:_________ (specify) If Laptop, list hardware:___________________________________________________ And software:_____________________________________________________ PCR Vendor Name:__________________________________________________ PCR Vendor Address:________________________________________________ Contact Person Name:_______________________________________________ Email:_____________________________________________________________ Phone:___________________ ____________________ ___________________ May we contact your PCR Vendor directly? Yes No If No, may we set up a conference call with you and your PCR Vendor? Yes No Describe the ability of your software program / scanned PCR to query event records to capture all cardiac arrest events, with presumed cardiac etiology where resuscitation is attempted: Also, check the following that apply:

We have a feature to query events documented as “cardiac arrest”: □

We can query events where CPR was performed: □

We can rule out arrest events that are NOT “presumed cardiac” in etiology: □ NOTE: PLEASE ATTACH A BLANK OR SAMPLE COPY OF YOUR PATIENT CARE REPORT (PCR)


Hosptials: List all hospitals that receive cardiac arrest patients from your EMS agency’s 9-1-1 Zone/Territory

1. Hospital Name:_____________________________ State ID Code:________ Address:_______________________________________________________ City:________________________ State:________ Zip Code:___________

Contact Person:_________________________________________________ Email:_________________________________________________________

Phone(s) Work - __________________ Cell - _______________________ County:________________

2. Hospital Name:______________________________ State ID Code:________ Address:_______________________________________________________ City:________________________ State:________ Zip Code:___________













First Responders: List all First Responders that respond to cardiac arrest patients in your EMS agency’s 9-1-1 Zone/Territory

1. First Responder Name:________________________ State ID Code:________ Address:_______________________________________________________ City:________________________ State:________ Zip Code:___________
















Dispatch System: Describe the configuration of your CAD system(s) and relay of information from the time a 9-1-1 call is made: Example: Zone consists of one city zone within one county. 9-1-1 calls in “City A” reach “City A” CAD system. “City A” CAD system screens the event using Emergency Medical Dispatch (EMD) criteria and dispatches City A Fire Department as the First Responder. The call is then forwarded from “City A” CAD to “County A” CAD system via electronic data transfer (CAD-to-CAD interface). “County A” CAD dispatches the EMS responder. If the event occurs outside of “City A” and in the county zone, “County A” CAD receives the call, screens with EMD, dispatches County A Fire Department as the First Responder, and dispatches the EMS responder. Do you manage your own CAD system? (circle one) Yes No If yes, does your CAD system dispatch the EMS responders? (circle one) Yes No If yes, does your CAD system receive the call from the 9-1-1 caller? Yes No If no, what CAD times does your EMS agency have access to? (circle all that apply) EMS Times Some First Responder Times All First Responder Times


List all Computer-Aided Dispatch (CAD) systems that partially or completely manage the 9-1-1 calls in your EMS Zone/Territory: 1. CAD System:________________________ State ID Code:______________ Address:_______________________________________________________ City:________________________ State:________ Zip Code:___________



This CAD system handles the following times:

Call Received Dispatched Arrived Onscene

and dispatches the following responders: First Responder EMS Responder

2. CAD System:________________________ State ID Code:______________ Address:_______________________________________________________ City:________________________ State:________ Zip Code:___________










This CAD system handles the following times: Call Received Dispatched Arrived Onscene









Comments: Please describe any situation that you feel may me relevant or important to the development and implementation of CARES in your community.


Dear Hospital Representative, You are receiving this email because of your current contribution to providing patient outcomes data on prehospital cardiac arrest patients. Recently, we have become involved in a project to improve our ability to monitor cardiac arrest survival in our community. The Center for Disease Control and Prevention (CDC) in a cooperative agreement with the Association of American Medical Colleges (AAMC) is funding Emory University to establish a regional model for collecting and reporting prehospital cardiac arrest statistics. The Cardiac Arrest Registry to Enhance Survival (CARES) project was established in Atlanta, Georgia in October 2004 and is expanding throughout the United States. We anticipate this program will allow us to collect this information in a more efficient and automated fashion. We are grateful for the relationship we have with our local hospitals that receive these patients, and would like to invite you to XXXXXX on XXXXX to meet the CARES staff. Bryan McNally, MD, MPH, Emergency Medicine physician and principal investigator, and Allen Stokes, BSc, NREMT-P, paramedic and research coordinator, will be here to discuss CARES in detail, describe your participation, and answer any questions you may have. We have attached information regarding CARES, which we ask you to review prior to this meeting. Specifically, we would like to invite Please RSVP to XXXXX. We look forward to working with you on this project and believe that CARES will be an important tool in allowing us to make a difference in our community. Thank you,

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Cardiac Arrest Registry to Enhance Survival (CARES)

1-Day Agenda for Site Visit

7:00am CARES Team Arrival 9:00am – 10:00am Introduction of CARES Bryan McNally, MD, MPH Allison Park, MPH 10:00am – 11:00am Description of PCR / Data System and

Orientation of CARES Internet Database (EMS Data Manager), (EMS Agency here)

Allison Park, MPH 11:00am – 11:30am Break / Tour Facility EMS Agency Host 11:30am – 12:30pm Conference w/ Scanhealth. and PCR Vendor Tim McMahan, Scanhealth, Inc. - phone Tony Gjerdahl, Scanhealth, Inc. - phone (PCR Vendor Contact), (Vendor here) - phone (EMS Director), (EMS Agency here) Bryan McNally, MD, MPH Allison Park, MPH 12:30pm – 2:00pm Lunch 2:00pm – 3:30pm Hospital Outcomes Data and Orientation of CARES Internet Database Allison Park, MPH 3:30pm – 4:00pm Break / Questions Bryan McNally, MD, MPH Allison Park, MPH 4:00pm – 5:30pm CAD Vendor Meeting TBA 6:00pm – 7:30pm Dinner Meeting for Timeline / Finalization 8:00pm CARES Team Departure

CARES SEQUENCE FOR BECOMING OPERATIONAL

Initial contact made between CARES and EMS agency DATE:____________

CARES Reference Manual sent to EMS agency DATE:____________

CARES EMS Application information discussed by phone DATE:____________

CARES EMS Application completed, returned, and reviewed DATE:____________

Establish tentative date for CARES site visit DATE:____________

Letters mailed from EMS Agency to participating Hospitals DATE:____________

Hospitals RSVP to EMS Agency DATE:____________

Date of CARES site visit adjusted (as needed) DATE:____________

IRB / HIPAA questions resolved w/ Hospitals prior to visit DATE:____________

CARES Staff conducts site visit DATE:____________

Data Use Agreements signed and returned to CARES staff DATE:____________

Establish tentative “Go Live” date DATE:____________

All website user accounts created and operational DATE:____________

Orientation of EMS personnel conducted by EMS Agency DATE:____________

Orientation of Hospital staff by CARES (online/go-to-meeting) DATE:____________

Test cases entered into CARES database DATE:____________

Resolve website system issues and generate test reports DATE:____________

Entry of real EMS CARES data DATE:____________

Entry of real Hospital data DATE:____________

Entry of real CAD data DATE:____________

Generate first Agency-specific reports DATE:____________

Generate first external benchmarking reports DATE:____________

(optional) Advance system of data collection (CAD, EMS) DATE:____________

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VI. APPENDIX

129

C.A.R.E.S. Program(Cardiac Arrest Registry to Enhance Survival)

Bryan McNally, MD, MPHPrincipal Investigator

Allison Park, MPHProgram Coordinator

Objectives

• CARES Program Overview• CARES Database

– EMS Component– 911 Component

– Hospital Component• Feedback Reports

• Review / Questions

CARES Program Overview

• Identify and collect prehospital cardiac arrest events to improve survival outcomes.

• Establish a method for uniform consolidation of EMS, 911, and hospital information.

• Present reports of response intervals and patient outcomes to involved agencies in useful format.

CARES Program Database

• Sansio– Mainframe housed in Duluth, MN

• Internet database system– https://mycares.net– HIPAA compliant security

• Unifies EMS, 911, and Hospital data– Any EMS system throughout US

EMS Component• Collection methods

– Scanned CARES form• Scanalyzer/Analyzer Software

– Direct entry online– Integration of CARES data fields

onto EMS tablet/laptop software• Query to ensure capture of data

– Manual or through PCR documentation systems

• EMS initiates event and signals other two components

– Generates email to Hospital component

– Matches event with daily 911 import

911 Component

• Call number on CARES form identifies Computer-Aided Dispatch (CAD) record.

• Times are forwarded to database daily using auto-extraction tool.

• Unmatched CAD times are identified and matched manually.– Likely matches ranked based on Date, Time, and

Address.– Matches confirmed by EMS agency liaison

Hospital Component

• Hospital follow-up only required on patients where outcome is unknown– ‘ongoing resuscitation’

• Hospital contacts set up through CARES administrator.

• EMS CARES form generates email to primary contact to selected Hospital destination.

• When all three data components form a complete record of the event, the data is de-identified of all patient information (name, address, DOB, etc…)

Feedback Reports• Bystander intervention / community statistics

– AED/CPR use– Gender, age (mean and range), and location type

• Response time intervals– 911 to EMS arrival– Dispatch to EMS arrival

• Utstein flow diagram– Survival to discharge– Neurological status (CPC)

• Call volume– Total volume for agency as a function of time.– Hospital Destination

DemographicsSample Data

EMS CAD Times Sample Data

First Responder CAD TimesSample Data

Utstein Flow Diagram

Call Volume & Misc Variables

• Call volume for this agency during each month of participation.

• Any combination of variables, including call volume to specific hospitals, can be queried.

• Can be used to track ‘resuscitation awards’

Review / Questions

• The CARES Project:– Uses experiences to establish ‘painless’ model.– Integrates EMS, 911, and Hospital components.– Provides useful feedback to community

stakeholders.– Provides direction and consultation for

developing further uses for data registry.• Questions?

American Heart Association Racing the Clock to Restart Hearts Program

In partnership with Emory University’s Department of Emergency Medicine, the Centers for Disease Control (CDC) and many of Atlanta’s leading health professionals, the American Heart Association (AHA), with the support of the Georgia Association of Emergency Medical Services (GAEMS), is undertaking a three million dollar pilot program in Fulton County to demonstrate the life-saving effectiveness of a four-step coordinated approach called the Chain of Survival. The two-year program will also demonstrate to the nation the benefit of using a cardiac arrest information registry to target, track and improve intervention activities in the chain of survival. In addition to saving lives and turning knowledge into effective community action, this program will serve as a state model, demonstrating to the rest of the state that a community with the will to improve its cardiac emergency care system can be successful by targeting intervention improvements based on the use of tools and techniques implemented in Atlanta. The administrator of the program is Mike Willingham, EMS Community Relations Director with the AHA. The American Heart Association, by creating this very important position working with the Heart and Stroke Initiatives Team, recognized the importance of EMS on the final dispositions of cardiac arrest patients. Mike is a National Registry Paramedic, a Georgia Paramedic Instructor, and a member of the GAEMS. Please contact Mike with any questions about the program or if you need any support from the EMS Division of the AHA. The American Heart Association welcomes the Georgia Association of Emergency Medical Services as a partner in our quest to improve survival from sudden cardiac arrest. Mike Willingham, CCEMT-P EMS Community Relations Director American Heart Association Office: 678-385-2054 Fax: 678-385-2054 [email protected]

151

IDENTIFICATION OF SPECIFIC AIMS ACCOMPLISHED AS INDICATED IN THE CARES RESEARCH PROPOSAL (McNally, pg 15)

SPECIFIC AIMS RESULTS

1. Plan, implement, and support the operation of emergency medical service (EMS)-based cardiac arrest registry.

• Met w/ administrators at 14, Atlanta area EMS agencies to establish training and operation of systematic data collection and ensured accountability of all events.

2. Demonstrate the availability of additional

resources and supports from, and partnership with, national or local organizations, and key stakeholders. Demonstrate a willingness by selected first responders or EMS agencies, 9-1-1 dispatching centers, and hospitals to participate in the cardiac arrest registry prototype.

• Through the desire to see aggregate statistics as well as justification for resource needs, all EMS, 9-1-1, and First Responder agencies have been willing to participate. In addition, hospitals recognize the importance of meaningful outcomes data and value the ease of low-volume data entry.


• A national panel of EMS experts knowledgeable about Utstein criteria, sudden cardiac death research and EMS data collection met in Naples, Florida, at NAMESP Conference 01/05


• Atlanta area model is start-up system. • Kansas City, MO model is advanced system of

collecting this data using full-time staff. • Next, look to establish another advanced system for

high-yield data.


• The present system of data collection is complaint with standardized data elements when available (Utstein and NEMSIS). The mycares registry is NEDSS complaint too.


• Hospital-specific user accounts are set up for outcomes data entry at https://mycares.net.

7. Develop and maintain a real-time data system, including quality assurance mechanisms for data collection and management, to provide timely, complete and quality data.

• Events can be queried based on any combination of data variables.

• Each EMS agency has tailored method of assuring high sensitivity and specificity of CARES events.

8. Plan and implement a methodology for assessments of hospital reporting compliance, validity of diagnosis, reliability and completeness of all reporting parameters, and hospital costs required for data collection.

• The CARES Project coordinator has administrator privileges, which gives oversight of all hospital participants to determine data entry compliance. Presently we are querying hospital data to ensure the reliable and complete data entry.

9. Develop and maintain the capability to securely export data.

• Security of data export is assured by database developers, who are familiar with transfer of medical records information.

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10. Submit data elements to a CDC-designated independent auditor with the content and format specified by the auditor. The required format for data export may be revised during the project period, for example, due to potentially new federal legislative and regulatory requirements.

• Michael Matters, PhD. (Informatics Fellow) from the Chronic Disease branch of the CDC completed an independent audit of the CARES program. See attached summary document.


• Data is directly converted on electronic format upon entry into the website database.


• Review of bioinformatics system conducted by CDC fellow, Mike Matters, PhD.


• Low bystander CPR and AED use has been identified in nearly all EMS agencies, which provides insight into need for community CPR programs and strategic AED placement.

CDC Activities (to be done in conjunction with Emory)

14. Provide consultation and technical assistance for

effective program planning and management through conference calls, annual site visits, and annual meetings for recipients.

• Provide information to AHA for fund-raising initiatives.

15. Collaborate in establishing or endorsing program requirements for completeness, timeliness, and accuracy of data.

• Data schedule developed to ensure timely feedback to key stakeholders in the community (ie, full participation in region is required for aggregate statistics).

16. Assist in obtaining CDC and local IRB approval.

• IRB approval has been obtained by both Emory and the CDC.

17. Ensure the completion of all requirements and quality of the project.

• Plan to continue meeting quarterly with our CDC partners to insure that all requirements are being accomplished in a satisfactory manner. As the program expands geographically we will continue to keep CDC staff informed of the progress that we make in transforming the pilot phase of this program into an eventual model for a National Cardiac Arrest Registry.

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CARES Staff Contact Information

Bryan McNally, MD, MPH Principal Investigator Assistant Professor

Department of Emergency Medicine Emory University School of Medicine 351 Asbury Cir – Annex N340 Atlanta, Georgia 30322 Office: 404.712.2772 Fax: 404.778.2630 Email: [email protected]

Arthur Kellermann, MD, MPH Co-investigator Professor and Chairman of Emergency Medicine


Allison Park, MPH Senior Research Project Coordinator


Lorie Click, MN, MPH Epidemiologist

Department of Emergency Medicine Emory University School of Medicine 49 Jesse Hill Jr. Dr. SE Atlanta, Georgia 30303 Office: 404.616.6022 Fax: Email: [email protected]

mailto:[email protected]


