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The national action plan to improve community cardiac arrest survival

Though I call this a national plan many of the elements can actually apply at the state level depending on state resources.

National Action PlanDifficulty of Implementation
1. Political leadershipVery difficult
2. National lead agencyDifficult
3. National Performance standardsVery difficult
4. National Institute of Resuscitation ResearchDifficult
5. Exception for informed consent and national approval processDifficult
6. HIPAA (Health Insurance Portability and Accountability Act)
laws to enable EMS research
Difficult
7. Cardiac arrest as a reportable diseaseVery Difficult
8. Compassionate resuscitation guidelinesVery difficult
9. Comprehensive research centers in EMSVery Difficult
10. Incentives for CPR training and purchase of AEDsVery Difficult

Table: National action plan to improve cardiac arrests survival

1. Political leadership:
Just as with the local action plan the national plan needs political leadership. There are no vacuums in politics and for new programs and new mandates to materialize there must be someone or some group to spearhead its creation. Several national organizations could promote such efforts. One national organization, the National Association of EMS Physicians (NAEMSP) has an active legislative committee and is probably best positioned to lobby on behalf of EMS programs. The International Association of Fire Fighters (IAFF), the International Association of Fire Chiefs (IAFC), and the National Association of EMTs (NAEMT) are also logical organizations to help lead the lobbying effort. I do not pretend to have political sophistication but I know enough to realize that good ideas require champions and keen understanding of the political process if they are to be realized.

2. National lead agency:
Some agency at the federal (or state) level has to champion emergency medical services and help create the mandate, standards, and garner resources. The idea for a lead federal agency gained momentum with a 2006 report of the Institute of Medicine. The report, Emergency Medical Services at the Crossroads, was part of a trio of reports – the other two were on the crisis in emergency departments (Hospital-Based Emergency Care: At the Breaking Point) and deficiencies in emergency care for children (Emergency Care for Children: Growing Pains). The trio of reports has the potential for huge impact.

The report of interest to us, Emergency Medical Services at the Crossroads, covers the entire spectrum of prehospital care. It convincingly documents the major challenges. These include fragmentation of services, incompatible communication equipment, lack of coordination with hospitals, lack of uniform training and supervision, lack of accurate data, irrational funding mechanisms, lack of readiness for disasters, and limited evidence base (in other words there is lack of quality information on what works and what does not). In short, things are a mess. Clearly cardiac arrest is a major component of prehospital emergency care and therefore receives a fair amount of attention in the report. Keeping in mind that the report was not written solely to improve resuscitation rates but rather to improve prehospital care in general, many of the recommendations are relevant to cardiac arrest and resuscitation. One of the 20 specific recommendations is to “Establish a lead federal agency for prehospital emergency care, ideally housed in the Department of Health and Human Services.” I like to think the IOM recommendation will have an impact? The IOM is a respected institution and its reports have high credibility. Congress often listens to the IOM. Perhaps not immediately as it sometimes takes time for the ideas to incubate and percolate up through the political process.

EMS has long been an orphan in the federal system relegated far down the administrative ladder of the Department of Transportation in the National Highway Traffic and Safety Administration (NHTSA). It is an historical anomaly that DOT is the agency currently charged with defining EMT curriculum (this stems from the 1968 National Academy of Sciences report on the tragedy of trauma and the development of EMT curriculum). While it will undoubtedly be helpful to have a lead federal agency (hopefully high within the Department of Health and Human Services) it does not address the fundamental ambiguous nature of EMS. The IOM clearly nails it when it states that EMS operates at the intersection of health care (the hospital system), public health, and public safety. It has responsibilities in all three spheres and yet is poorly integrated in each sphere. As the IOM states, “EMS has a foot in many doors but no clear home.” This ambiguity is important in that it diffuses any focus on solving the problem. If there are too many agencies there will be too many opportunities to ignore the problem as well as pass the buck.

This lead agency should require communities to publicly disclose how they measure up to cardiac arrest performance standards (see next recommendation). A good analogy is state and federal requirements for reporting of hospital-acquired infection rates and complications with major surgery. This lead agency might promote a bit of friendly EMS competition. How about an award for any community that achieves 50% survival (discharged from hospital) for witnessed VF? This could be a really big thing. The 50% figure is not entirely arbitrary as it was the number published by Pantridge and Geddes in the very first prehospital cardiac care program in 1966. Plus several communities are already pushing that figure. The rules should be simple: One calendar year with all consecutive cases (witnessed VF- minimum of 50) with clinical data confirmed by an outside reviewer.

3. National performance standards:
There are regrettably few if any national performance standards for resuscitations. The National Fire Protection Association Standard 1710 posits response time standards but these standards are voluntary in most of the country. The national lead agency for EMS is the logical agency to champion resuscitation standards. What are some possible standards for urban EMS systems? Bystander CPR more than 50% of witnessed cardiac arrests. Telephone CPR administered more than 25% of all cardiac arrests. Time from call pick up to arrival of EMTs at patient’s side less than 5 minutes greater than 90% of all calls. Time from call pick up to first shock less than 6 minutes greater than 90% of calls. Time for call pick up to paramedic arrival at patient’s side less than 10 minutes 90% of time. Voice and rhythm recording of all resuscitations. Medical director review and critique of EVERY resuscitation. Discharge survival from witnessed VF of greater than 25%. Similar to NFPA response time standards for career and voluntary departments there could be urban and rural standards. These standards should be mandatory. In other words every EMS organization must report their performance annually to the national lead agency for EMS.

I realize any federal performance standard is likely to engender a storm of resistance. There is the issue of unfunded mandates and the issue of centralized versus local control. And will there be consequences if a community falls short of the standards? Should they be linked to federal dollars such as national highway funding or Medicare reimbursement (most EMS services bill Medicare for transportation to the local hospital)? Most importantly, the data contained in the annual reporting to the national agency must be publicly available. Civic groups and the press should scrutinize the data. They should celebrate the standards when they are achieved and they should demand explanations when they fall short. A little friendly community competition may not be a bad thing. Perhaps a national weekly would like to publish its annual guide to the top 10 cardiac-safe cities in America.

4. National Institute of Resuscitation Research (NIRR):
Establishing a new institute within the National Institutes of Health is probably as likely as pigs flying. Nevertheless concerted efforts by resuscitation researchers placed this topic on the national agenda and did convince the National Heart Lung and Blood Institute to fund the Resuscitation Outcomes Consortium (ROC) (Figure 10.1). Additional funding comes from the Institute of Circulatory and Respiratory Health of the Canadian Institutes of Health Research, the Canadian Defense Research and Development, the Heart and Stroke Foundation of Canada, and the American Heart Association. These agencies have committed 10 million dollars per year for at least 5 years beginning in late 2004. ROC is a 10-site collaborative undertaking that will research new therapies for cardiac resuscitation and traumatic injury. The 10 sites are scattered throughout the US and Canada (See Map) with the University of Washington serving as the coordinating site. Initial cardiac resuscitation trials will focus on comparing immediate defibrillation for VF versus two minutes of CPR prior to defibrillation as well as a trial of an impedance threshold device to improve cardiac output during CPR. Another benefit of the consortium is a cardiac arrest registry in each of the 10 sites. This common data set will allow quality data to be both collected and compared across sites.

Figure Sites for the Resuscitation Outcomes Consortium Trial

ROC, perhaps because nothing like it has occurred, has had its share of growing pains. The inconsistent research infrastructure in the 10 communities combined with considerable delays in regulatory approval for the proposed studies have led to a three year delay in starting the first cardiac resuscitation trial. Despite these frustrations, ROC is a good initiative but something more massive is in order. Creation of a NIRR would allow the research agenda to cross traditional lines. EMS and resuscitation research involves basic science, clinical science, health services, epidemiology, and economics and ethics.

One of the first tasks of the NIRR should be to establish a clearinghouse for clinical research in resuscitation. It would be useful if the leading research issues could be parsed out to the leading investigators and some monitoring system created. There is no reason why so many researchers keep demonstrating the same thing. If I read another article on the association of witnessed collapse, VF, time to CPR, and time to defibrillation with survival I think I will go berserk and stomp on the journal while I shout, “Thank you for reinventing the wheel.” There are so many unresolved issues that perhaps it is time to establish a national research agenda. Some of these issues are the role of antiarrhythmic therapy, the optimal timing of defibrillation, how to achieve cerebral resuscitation, optimizing therapy for cardiomyopathy associated arrest, improving access to AEDs, how to prevent refibrillation during resuscitation, optimal timing of hypothermia, and countless other clinical questions. It would not take much to reap big dividends. If cardiac arrest survival nationally improved by a mere 2% it would mean 3000 more Americans would survive cardiac arrest annually. The IOM report, cited above, also recommends a national institute or program to coordinate and stimulate EMS resuscitation research. While on the topic of national EMS research agendas, the National Highway Traffic Safety Administration published a National EMS Research Agenda in December, 2001 (a pdf version of the report may be found at the NHTSA web site: http://www.nhtsa.dot.gov) with eight very reasoned and reasonable recommendations to move the EMS research agenda forward.

The International Liaison Committee on Resuscitation (comprised of members of the American Heart Association, the European Resuscitation Council, and 5 other organizations) has also weighed in with a research agenda. In November 2007 this Committee put forth 46 research priorities in resuscitation. Among the researchable questions are: What is the optimal compression to ventilation ratio? What are the safety and efficacy of compression-only CPR? Do beta-blocking drugs improve survival from cardiac arrest? Does timing of drug delivery influence outcome? What is the optimal blood glucose concentration during and after CPR? What are the safety and efficacy of resuscitative and postresuscitative hypothermia?

5. Exception from informed consent and national approval process:
It is extremely difficult to conduct interventional research in the prehospital world. I am not referring to funding but rather to the prohibitively difficult to implement human research guidelines. Everyone recognizes it is not possible for a patient in cardiac arrest to give informed consent to experimental therapy. Nor is it possible to request this permission from a family member. But I also hope everyone recognizes that the only way to improve therapy is to measure the benefit of a new therapy against the existing standard of care. Clearly there must be strict guidelines to preserve the safety and privacy of patients and there must be a thorough and independent review of the new therapy to make sure the potential benefits outweigh the risks. Federal regulations for exemption from informed consent (EFIC) applies to situations where it is impossible to obtain consent from the patient or a relative, such as in cardiac arrest, is simply too restrictive. Current and proposed guidelines overly inhibit new ideas and therapies being tested.

6. HIPAA (Health Insurance Portability and Accountability Act) laws and EMS research:
Current HIPAA regulations make it very difficult for EMS agencies to determine what happens to a patient once left at the hospital. This is most regrettable and undoubtedly was not the intent of the drafters of HIPAA. I suspect those who drafted the legislation never anticipated this difficulty since HIPAA was passed by Congress in part to address privacy matters relating to health insurance companies. Nevertheless, most hospitals interpret HIPAA strictly and will not release this information without the written consent of the patient. Many in epidemiology and health services research consider HIPAA to be well intentioned but misguided. A recent study in JAMA surveyed 1527 researchers about the effect of HIPAA on research -- 68% reported that the law had a negative impact, often adding uncertainty, cost, or delay to research. Only a quarter perceived that the law enhanced patient confidentiality. Short of changing the law there are local options that may correct the problem. In Washington State and in many states clinical information may be obtained for QI purposes (without permission of the patient) so long as the information remains confidential and all data are pooled. In other words, it is impossible to identify an individual. As someone in the University of Washington Human Subject Committee put it, "No one, absolutely no one can link the information to a live human being." Not all hospitals in our region are accommodating and several hide behind the wall of HIPAA wasting countless hours of their time and EMS time. The revised law should make it clear that EMTs and paramedics and medical directors who provide care or supervise care to a patient are entitled to follow up information about that patient. As health care providers they must adhere to all professional standards of confidentiality. The IOM also recommends a revision in HIPAA laws so information can more freely flow between EMS agencies and hospitals.

7. Cardiac arrest as a reportable disease:
This is a nice concept but problematic for many reasons. The first is how to define cardiac arrest. Should it be all out of hospital deaths or only those with EMS attempted resuscitation? Should it be cardiac etiology arrests or all etiologies? And what data elements should be reported? The National EMS Information System (NEMSIS) is an effort to define the elements that all EMS systems should collect. NEMSIS was conceived in 2001 by the National Highway Traffic Safety Association (NHTSA), National Association of EMS Physicians, and the Health Resources and Services Administration (HRSA) Maternal and Child Health Bureau. By 2003 49 states signed (New York has not signed) a memorandum of understanding to recognize the need for a national data set and to define desirable data elements to be collected and the first draft of the data dictionary was written. Considerably progress has been made since the first draft and there are new versions as well as establishment of technical assistance center. The Centers for Disease Control as well as the University of Utah and North Carolina have joined the above federal agencies in the project. A national EMS database has the potential to help develop training curricula, evaluate care and outcomes, facilitate research, and allow cross community comparisons. The main challenge to the adoption of NEMSIS is that most localities view it as an unfunded mandate. NEMSIS requires considerable resources to change and upgrade management systems and there are no federal dollars to make this happen. Furthermore many see NEMSIS as an encyclopedia of data with little focus. In other words every tiny detail of care is collected into the data set but the direct relevance to patient outcomes or furthering research seems remote to many observers. Despite these problems a national data base will draw attention to the problem and allow new predictors of survival to be identified.

8. Establish compassionate resuscitation guidelines:
I think a compassionate resuscitation modeled after a program in King County is both humane and simply the right thing to do. This program allows resuscitation to be withheld if two conditions are met: 1) The patient is in the end stages of a terminal disease, and 2) Relatives state that the patient does not wish to be resuscitated. This information can be followed by the EMS personnel even if a written advanced directive is not available. If there is any doubt about the situation the EMS personnel are instructed to begin CPR. End of life issues are sometimes contentious. Perhaps the best way to move this agenda forward is for national EMS organizations to take the lead and draft model policies for compassionate resuscitation.

9. Comprehensive research centers in EMS:
Not every EMS agency should do research. But a few centers in the United States have excellent resuscitation research track records and should be supported. The National Institutes of Health has a model whereby it provides center grants (usually 5 years long and renewable) as well as mid-career investigator awards of five years. The latter award provides support for established clinicians to further their research program as well as the opportunity to mentor junior investigators. So much of research involves infrastructure it seems a waste of resources to duplicate this infrastructure in multiple sites. There are economies of scale in research as in many activities. A federal agency (such as the National Heart Lung and Blood Institute) could invite proposals for comprehensive research centers in EMS. Am I being self serving in this recommendation? Yes, of course I am. Clearly I think good research centers deserve to be supported. But my voice on this issue is not an isolated one. The National Research EMS Agenda (mentioned in recommendation 4 above) has as its second recommendation the establishment of at least five Centers of Excellence to facilitate EMS research.

10. Incentives for CPR training and purchase of AEDs:
Since CPR and defibrillation are so critical why not offer incentives for each? How about a $10 tax write-off for evidence of CPR training or offer a modest tax credit for the purchase of an AED on Federal income tax? I’m not trying to provide a windfall for defibrillator manufacturers but there should be some way to boost the number of AEDs that are in homes and businesses.