Innovations in STEMI Interventions – Improvements in D2B Times through Medical Simulation

Author(s): 

Cath Lab Digest talks with William R. Hamman, Western Michigan University, Kalamazoo, Michigan, and Sameer Mehta, MD, FACC, MBA, Course Director, LUMEN 2009: The Symposium on Optimal Treatments for Acute MI and author, Textbook of STEMI Interventions.

2010 Update: William Hamman claimed to be a physician, a claim that has since been proven false.

A report from the upcoming February 2009 LUMEN meeting

The STEMI process is comprised of three distinct processes — the pre-hospital EMS phase, the emergency department phase and the cardiac cath lab phase. Each phase has its own skilled people conducting their own specialized work. To increase STEMI procedure success and meet mandated door-to-balloon time guidelines, these processes must be streamlined and made more efficient through the creation of a standardized process and the following of approved protocols. Most STEMI procedures become chaotic as a lack of cohesive teamwork.

Dr. Sameer Mehta is a STEMI world expert who has been studying the STEMI process and procedures, as recorded in his SINCERE database, and discussed in the Textbook of STEMI Interventions.

Dr. William Hamman is a systems expert, a commercial pilot and a cardiologist who has been using simulation processes to increase system efficiencies, reduce costs and promote patient safety.

Together, Dr. Mehta and Dr. Hamman are conducting an “In-situ® Simulation” workshop at the LUMEN STEMI symposium, February 26-28, 2009 at the Loews Miami Beach Hotel, in Miami Beach, Florida.

Dr. William R. Hamman

You have been a pilot for thirty years and a clinician for fifteen years.

I flew first, and then I returned to school to finish my pre-med requirements and went on to medical school. I started flying after my first year in medical school, and have been doing both ever since. Over time, I have fallen more on the flight time side. I couldn’t handle a cardiology practice full-time. What I have been able to weave together, which I very much enjoy, is specialty projects or research in healthcare along with my flight schedule. An average flying time per month is about 90 hours, and I am usually right around 55-60 hours, so with that reduction, it frees up my availability to do work in healthcare.

It sounds like you’ve found a way to balance a love of flying with your interest in healthcare.

When you get into the culture of aviation, it’s almost like an addiction, but a nice one to have. It’s an environment that you just don’t find anywhere else. I am able to be in that environment as well as focus on patient safety and patient care. I truly have been blessed with the best of both worlds.

How did you become interested in patient safety and process management?

My interest developed while I was working in the airline industry. I was never an active physician for United Airlines; however, because I was a physician, I think it opened up some doors at United, and I ended up as manager of quality and risk assessment.

Risk has somewhat of a different meaning in the airline industry than it does in healthcare. In healthcare, looking at risk usually means minimizing loss. In the airline industry, risk means the never-ending search for system weaknesses as well as broken-down processes that could lead to an accident. Early on in my career, I was involved in accident investigations and saw how the frailty of human beings could have a huge impact on the outcome of an airliner. Of course, when there is an airplane crash, hundreds of lives are usually lost versus one life at a time in a healthcare situation, but basically the same dynamics are involved on the healthcare side.

My work first began on the aviation side, in the world of airline evaluation training and assessment. In aviation, we developed processes allowing us to train and assess team dynamics at the same level that technical competency was assessed. Both elements are extremely critical.

Seventy percent of accidents in the airline industry are not the result of technical competencies or mechanical issues, but are caused by a breakdown in the “softer” skills of communication in situation management. Yet at that time (the late 1980’s and early 1990’s), in aviation, all the work that was being done — the processes and focus at the training centers, the entire time spent in twenty-three million dollar virtual reality simulators — was focused on the technical competency of the pilot. Finally, in the late 1980’s, the Federal Aviation Administration and the National Transportation Safety Board said, you have to address these issues. These “softer” skills are crucial to avoiding accidents, yet the aviation industry’s evaluations were totally technically based, to the detriment of teams and to the detriment of understanding the processes that got in the way.

But the real question was, how do you assess these team factors, these “softer” skills as everyone calls them, in the context of more focused, technical skills (can you fly an engine failure during takeoff, or in healthcare, can you do an intubation into a difficult airway management)? I found it a fascinating dilemma. I developed a process of simulation that allowed us to assess team interactions in a very factual and meaningful way for flight crews. It was also trainable, which was one of the key issues. Obviously, in the airline business, you have to provide training if you are going to invest in this type of assessment; plus, it’s the right thing to do. I worked on team assessments extensively for about ten years in the airline industry, and then I worked for another physician, Dr. Bill Rutherford, who was vice president of flight ops at United Airlines, and has since retired. He was always very interested in my work and very supportive. When he retired in early 2000, he went down to the University of Miami. They were developing a patient safety center. He began working to try to bring some of the processes, not the content, of airline methodology to help develop the center. Eventually, he asked me to come along, and that was my jumping-off point.

This was a few years after the Institute of Medicine Report (IOM) report in 1999, which said that healthcare needed to look to other high-risk industries, such as the aviation or chemical industry, for ideas to improve patient safety. The airline industry offered up their models of crew resource management. Unfortunately, a cottage industry then arose, with pilots selling resource management programs to healthcare organizations in order to help them with the dilemma identified by the Institute of Medicine (IOM). This dilemma was the significant amount of patient safety issues and mortality that, again, was not caused by the technical competency of clinicians and healthcare professionals, but by the softer skills of communication, situational awareness and workload management.

I knew what it took to understand the team dynamics and the needs of a flight crew. What I saw in healthcare is that this type of work has not been done. I have an understanding of both the culture of healthcare and the culture of a flight deck. As a result, I was adamantly opposed to simply taking a model developed in the aviation industry (or any other industry), superimposing it upon healthcare and thinking it was going to work. The premise of my work and of our research grant, which we have been working on for the last few years, is that you can’t take a model developed in an airliner at 35,000 feet and expect it to work in a cath lab or an ED or in a SICU, for example. My theory was that the processes developed in the airline industry to understand the flight team and create a template for the assessment and training of team skills could be brought to healthcare to do the same work. We could use these processes to understand what critical team skills healthcare professionals need to acquire.

This was how I became involved in patient safety. It was born in aviation, and my initial work with Dr. Rutherford sparked a research grant to bring our design concepts of simulation to healthcare. Looking at the team dynamics in healthcare, we find the same type of interactions, whether between the team, the clinician and the patient, or the clinician with other clinicians, in the sense that these interactions are very fragile, and a whole series of elements exist that tend to break down. What is different about healthcare, is that there hasn’t been a lot of work done to gain understanding of the challenges and dynamics involved. Nor have there been a lot of processes developed to help support healthcare professionals so that when there is an error or a miscommunication, something gets dropped or an incomplete handoff occurs, a backup system traps that error and mitigates its outcome. What we worked so hard on in the airline industry is the creation of a system to trap problems, because it’s not if we are going to make errors, it’s when we make errors, and there are backups in the processes that allow for mitigating a potentially catastrophic error.

You mentioned a 70% soft error rate in the airline industry. Would that same figure apply in healthcare?

Across different types of events such as medication-managed error or infections on central lines, the number on The Joint Commission error charts is right at about 70%. These are errors caused by the softer skills of communication or a workload management situation, not by technical competency issues in healthcare professionals. The dynamics and the numbers are basically the same between the two industries, but the challenges are significantly different, and this is where our work is important, because it’s the first time we have taken simulation and moved it to focus on the softer skills. In aviation, we spend millions and millions of dollars on high-fidelity simulators to re-represent the airplane, and the same is being done in healthcare to re-represent the physiology and presentations of physiology in a simulator. This is important. But these types of simulations don’t address the crucial dynamics of the healthcare team and its softer skills. To look at a technical competency, at a pilot flying an engine failure on takeoff or a physician managing difficult airway management or inserting a cardiac catheter, you create a simulator and put varying challenges into it, such as difficult insertion, anatomy anomalies and so on. In healthcare, data is starting to come out in simulation that, yes, if you intubate, intubate, intubate, and practice over and over again, most probably you are going to be a better intubator with fidelity simulation to the cases. But when it comes to the team skills, how do you create training and simulation in order to facilitate healthcare professionals in workload management or trigger effective communication? That is the process that we have developed, which is more of a scenario design process than an actual simulator.

In our research, we were originally going to use a simulation laboratory to understand the healthcare team. However, very early on in our work, the University of Minnesota asked us to come and run scenarios in the actual patient care units as a process to elicit team responses. When we utilized this type of simulation in the real world, it became clear there was no way this work could be accurately performed in a simulation healthcare laboratory. It was essential to do the work in actual patient care units. What we saw was the full impact of the environment, the systems, the processes and the communication complexity healthcare professionals have to deal with as they move a patient from the ED to the cardiac cath lab, for example.

Our group has now done 150 of these scenarios across healthcare disciplines, from cardiac cath to SICU, to ICU to the OR. We have done them at 1000-bed hospitals and 70-bed hospitals, at 3:00 in the afternoon and at 3:00 in the morning. System impacts within the healthcare organization are a tremendous challenge for healthcare professionals, and if a team is dysfunctional, it can lead to a catastrophic outcome for a patient. We began running scenarios in the actual patient care units with a very portable wireless simulation system. The fidelity of our simulators is moderate. We decided to prioritize portability, being wireless and using fully articulating mannequins that we can move like a real human being through the organization for some bells and whistles that come with more stationary simulators connected to huge computer racks. At the end of a scenario, we do connect to a higher fidelity simulator that presents the intravascular physiology and allows the interventionalist to actually do the cardiac cath. Interestingly, teams responded to the overall simulation design by saying, why are we taking the time to do a simulated intervention? The thought was, hey, the intervention is the easy part. We know we are good clinicians. We are doing multiple caths daily. Why would we need to simulate the intervention? Ultimately, it came down to the fact that we need to do it for the benchmark of the balloon expansion time. The actual focus, however, was the more routine systems and processes, and the functionality of the team. Clearly, our design scenarios are different from the technical component of the simulation. The intervention simulator, when we got to the cardiac cath lab, was almost an afterthought. What participants saw most clearly were the systems, teams and human issues that were causing the chaos and the inefficiencies, and the lack of ability to move the patient more effectively throughout the healthcare organization to the cath lab. That is the critical part. Once we are into the actual procedure, have the groin prepped, and are in to do the cath, it usually proceeds with some stability.

Can you tell us about your plans for the LUMEN meeting and the workshop that you will be doing there?

I am very excited that Dr. Mehta has asked us to come and present our in-situ simulation, because what I see in the world of healthcare, particularly with simulation, is that it is difficult to move away from the focus on the technical competencies. We don’t seek to replace that focus, but to include the team dynamics and issues that healthcare professionals face every day. These factors are just as critical as being able to manage a catheter, provide correct medications, and so forth. I see the workshop being an educational opportunity to improve and increase the awareness of the need to create these type of simulations to add to the training package for healthcare professionals. For organizations and hospital entities doing cardiac caths, our workshop will provide an understanding of the interface between the ED and the cath lab, and increase the awareness and understanding of how you can create simulations to address the soft skills in the same manner that you practice and create simulations to do technical competencies.

Most people respond initially by saying, sure, sounds interesting, but when they see the videos and our beta test of the scenarios to run, they become excited and realize this is truly where the work is needed. Everyone knows there is a need to work on these issues, the human factors and activities, the hand-offs, all the complexities that are involved with getting the patient to the cath lab. The cardiologist is driving in and is not there yet, the team is trying to set up the room, and so forth, and no one quite knows how to get their hands around it. Running this type of simulation is one of the ways that an organization can get their hands around the chaos that occurs and reduce it, and also increase the efficiencies of moving these patients up to do their caths.

Every interventionalist understands how these processes become so complex and sometimes challenging to the actual patient safety and care. Everybody is a dedicated clinician or nurse or technologist in their field, but when you get caught up in these systems and processes, whether it’s a phone that doesn’t work or an EMT that doesn’t know how to get into the cath lab or get the doors open, or nobody to take the handoff of the patient — it’s these type of system processes that can have such an impact on patient safety.

One of the key components in the workshop will be a video debriefing. We have videotaped scenarios and present what we call an “instant replay” sports-type video, where immediately available after the scenario are focused snapshots of areas where the team did quite well and areas where there are huge disconnects. This video is a powerful way to show healthcare professionals the challenges of their work.

After we run simulations, we come back to the lab and interview participants: nurses, technologists, physicians, ED personnel and EMTs. We then look at what the facility has done to address system challenges that arose in the simulation and what impact it has had on the system as a whole. In the aviation world, we have a robust system of near-miss and errors reporting. As a pilot, if I make a mistake, I can go to a committee and say I’m Bill Hamman, I flew flight 468, I made a mistake and here’s what happened. Unless there is some malice or ill intent, such as drugs or alcohol, most likely I’m just going to get a message back saying, thanks for your report, Bill, you’re helping the whole system. That type of reporting and performance monitoring, along with databases such as Dr. Mehta’s SINCERE database, are critical. They provide information to feed the next generation of simulation. You don’t simulate just to simulate; you simulate to train and for learning, with the goal being the exposure of the weaknesses, challenges and traps that are out there for human beings as we try to do a very professional job, whether that’s flying an airplane or taking care of a STEMI patient.

Dr. Sameer Mehta

Dr. Mehta, can you tell us about the Single Individual Community Experience Registry for Primary PCI (SINCERE) database and your history with STEMI interventions?

The SINCERE database started about three and a half years ago at five community hospitals in south Florida. At the moment, I am the single individual doing this work, and the database contains 366 interventions. The critical point is that these are all short door-to-balloon time interventions, with the mandated door-to-balloon (DTB) time less than 90 minutes. This work transitioned from my previous work at Cedars Medical Center, going back more than ten years ago when I had performed more than 100 primary percutaneous coronary interventions (PCIs). At that time, primary PCI was emerging as an alternative to thrombolytic therapy, and convincing other colleagues and dealing with complex logistics was a major hurdle. However, over the last decade, primary PCI has become the undisputed, preferred technique for treating AMI, strict DTB time guidelines have been developed and strategies for triage and transfer of patients with AMI have become clear. I created the SINCERE database to record my work of high-volume STEMI interventions at community hospitals. I believe this work has inadvertently created a new specialty, that of a STEMI interventionalist.

Performing a high volume of STEMI interventions has required sacrifices, but it has been rewarded with an incredibly gratifying personal experience. It has meant sleeping in a small, on-call room at one of the five hospitals for more than 100 nights, being ready to perform STEMI interventions at a moment’s notice, almost every day and night for this prolonged period of time. Indeed, the very large number of off-hours PCI (43%) makes this task uniquely difficult. It can also be very challenging to work in completely ad hoc, non-standardized and somewhat chaotic conditions that exist at most 24/7 STEMI centers. It is an appreciation of this chaos, through my experience with SINCERE, that drew my attention to Dr. Hamman’s work in simulation. It was evident that medical simulation was a pragmatic solution to deconstructing the STEMI chaos and that it was a tremendous way to demonstrate system deficiencies. Beyond this, I am convinced that medical simulation will improve DTB time efficiencies and patient safety. It is also quite possible that it can lead to standardized strategies and cost reductions.

Regarding the results of the SINCERE database, my own DTB times reduced from a mean of 131 minutes in the first 50 cases to 78 minutes in the last 100 procedures. More critically, the STEMI procedure times (needle stick to reperfusion) have decreased from 31 minutes to a mean of 13 minutes. I think most experienced interventional cardiologists can achieve similar success rates if they are willing to dedicate themselves and be truly available 24/7 to perform STEMI interventions. A larger challenge exists for the healthcare delivery system that must streamline the STEMI “process” and eliminate redundancies that universally exist.

Why write the Textbook of STEMI Interventions?

I think DTB time interventions are very unique; they involve considerable challenges and the need for continual improvements in both the process and the procedure. I felt that the SINCERE database had created a framework where I could share its very expertise with a much larger audience, nationwide and worldwide, that is struggling to put its STEMI systems in order. The Textbook emphasizes techniques for performing short D2B time STEMI interventions and discusses methods to improve the STEMI process at individual institutions. In writing this textbook, I chronicled my work with the SINCERE database, and more importantly, included the giant work in this area from reputed world experts in primary PCI. I am very happy to inform you that through the hard work of these dedicated experts, we have created the first Textbook of STEMI Interventions, and have received a heartening response from readers.

What STEMI research are you finding of the most interest at present?

The largest work has been done in thrombectomy devices, which are now becoming increasingly prevalent for STEMI interventions. Induced hypothermia, supersaturated oxygen therapy, left ventricular assist devices and intracoronary abciximab are other remarkable procedural enhancements. Pre-hospital STEMI diagnosis and management, EKG transmission, very early STEMI activation, bypass protocols and simulation are the process innovations that I find very stimulating.
What about the need for a national STEMI policy?

We are gradually moving toward that stage. For many people who are doing these procedures, it seems intuitive that we should have a clear policy in place that mandates that STEMI patients be taken to an institution providing specialized care rather than to the nearest facility, where they may not necessarily get the most appropriate and scientifically-based care.

It seems a lot of work is currently being done at the state level.

You are exactly right about this being primarily a state-wide or regional initiative. I think the storm is gathering. It should be just a matter of time before several agencies get their collaborative power behind these endeavors, including the American College of Cardiology, the American Heart Association, CMS and The Joint Commission. Yet the greatest thrust will come from the individual hospitals. Coronary artery disease and acute myocardial infarction still remain the number-one killers, affecting each and every one of us, whether directly or indirectly.

Can you share some of the highlights of LUMEN?

LUMEN is a one-stop rendezvous for the wide group of specialists who are involved in performing STEMI interventions. STEMI interventions are comprised of a very elaborate process that involves the EMS, the emergency department and the cardiac cath lab. In addition to the specialists involved in these three areas, the role of administration is even more paramount.

LUMEN offers a world-class faculty to address all these issues. Five principal investigators from the best regionalized STEMI systems of care will present their interventional experiences. There are dedicated sessions and workshops, including the ones on simulation, which will emphasize improving the processes of STEMI and patient safety, in order to deconstruct the chaos that occurs in a STEMI intervention. Workshops also focus directly on nursing care of the STEMI patient and address the complex administrative issues. There are sessions dedicated to hypothermia, to new intra-cardiac mapping techniques, to left ventricular assist devices. There will be debates on the two most critical questions in STEMI interventions — which type of stent to use and whether primary PCI should be done only at tertiary centers. LUMEN 2009 will also offer the first-ever STEMI EKG Certification Course, with lectures on the basic STEMI EKG and focus on numerous tips to augment the accuracy of EKG in diagnosing STEMI. There is also a presidential address by the President of the American College of Cardiology, Dr. Douglas Weaver. Keynote addresses are by Dr. Alice Jacobs, chairperson of the “Mission Lifeline” of the American Heart Association, as well as Dr. William O’Neill, a pioneer in STEMI interventions and primary PCI, and Dr. Martin Leon, Chairman Emeritus of the Cardiovascular Research Foundation and Professor of Medicine at Columbia University Medical Center, as well as director and founder of the annual Transcatheter Cardiovascular Therapeutics (TCT) meeting.

STEMI interventions involve a great deal of complex processes. The combination of process management and patient safety elicit some of the best value from in-situ simulation and demonstrate the glaring problem areas which occur when we are trying to work across the very diverse group involved with the EMS, ED and cath lab. At LUMEN, two dedicated two-hour sessions will demonstrate this entire process in video, from a patient presenting with a 911 call with a STEMI, to being transported and admitted with medical complications through the ED. The video demonstrates the very complex interactions which occur throughout, including live transfer of the patient to the cardiac cath lab. Once attendees visualize the process and its very complex interactions, it is fairly demonstrable how critical it is to improve the process.

I remain very aware and very appreciative of Dr. Hamman’s work. Having Dr. Hamman, a world-class expert, demonstrating In-situ simulation is crucial to the value of LUMEN in educating key people helping the STEMI intervention patient. n

More information is available about the February LUMEN 2009 meeting at www.lumenami.com.

Dr. Mehta’s work with the SINCERE database is discussed in an August 2007 interview available online at: http://www.cathlabdigest.com/ article/7659.

To learn more about the Textbook of STEMI Interventions, visit: www.stemiinterventions.com.

To learn more about Dr. Hamman’s work:

1. Hamman WR, Beaudin-Seiler BM, Beaubien JM, et al. Using In-situ Simulation® to identify and resolve latent environmental threats to patient safety: A case study involving emergency and cardiac catheterization departments. Submitted for publication.

2. Hamman WR, Beaudin-Seiler BM, Beaubien JM, et al. Using In-situ Simulation® to identify and resolve latent environmental threats to patient safety: A case study involving emergency and trauma departments. Submitted for publication.

3. Hamman WR. Will simulation fly in medicine as it has in aviation? Qual Saf Health Care 2004;13:397-399.

4. Hamman WR. The complexity of team training: What we have learned from aviation and its applications to medicine. Qual Saf Health Care 2004;13:i72-i79.

5. Hamman WR. The language of aviation simulation training: relevance for medical education. Accreditation Council for Graduate Medical Education (ACGME) Bulletin. December 2005: 5-7. Available online at http://www.acgme.org/acWebsite/bulletin/bulletin12_05.pdf. Accessed December 10, 2008.

6. Hamman WR. In-situ simulation®: Moving simulation to new levels of realism within healthcare organizations. Paper presented at: Safety Across High-Consequence Industries Conference; March 13-15, 2007; St. Louis, MO.

7. Riley W, Liang BA, Rutherford W, Hamman WR. Structure and Features of a Care Enhancement Model Implementing the Patient Safety and Quality Improvement Act. 2007 Advances in Patient Safety: New Directions and Alternative Approaches: Agency for Healthcare Research and Quality. Available online at http://www.ahrq.gov/downloads/ pub/advances2/vol1/Advances-Riley_59.pdf. Accessed December 10, 2008.˚˚˚

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