Living in the ACA World - Community Paramedicine and Other Darwinian Thoughts

The questions come on a daily basis – “Do I reposition my EMS business in the face of the Affordable Care Act (ACA) and if so, how?” One of my favorite truisms is ‘the practical function of conventional wisdom is to save one from original thought.’ The banks of the river of conventional wisdom are currently overflowing with the ‘opportunities’ and ‘solutions’ presented by community paramedicine as a response to the post-ACA world.

For the record, I am not a nay-sayer, or against community paramedicine initiatives, nor am I a troglodyte who denies that the world is changing and that by merely ignoring the outside world, survival is guaranteed. In fact, I am accused of being the complete opposite. I would, however, offer for careful consideration the following discussion and thoughts which are derived from work with clients in a variety of businesses engaged in transformative efforts (including health care and transportation) and hopefully can help identify landmines as well as describe a possible route of success in your post ACA adaptations. In spending a lifetime in studying and working with organizations I have come to adopt a very simple, yet very powerful (notice how almost everything that is truly powerful is simple?) model that contains the elements that are present in all successful and sustainable organizations and change efforts. This simple model holds that there are three elements, all critical and all interacting and depending on the other two.

 That is to say that any successful concept, ideal, initiative, program or organization, must have the physical structure (staffing, governance and appropriate relationships) within which reside systems that are uniquely designed and positioned to support and provide feedback (guidance) on the success of the Guiding Idea. Viewing your response through the prism of this model helps highlight the implications of applying the current conventional wisdom of community paramedicine as a go-to strategy

Systems

Most EMS providers have internal systems that are ill-equipped to deal with the needs of a community paramedicine delivery product. The current paradigm of EMS delivery is focused on acute / episodic care. Data systems are designed around procedures and protocols and quality measures are almost always about the application of these elements. Community paramedicine, on the other hand, is an element of a Population Health Management (PHM) strategy driven by incentives designed for a comprehensive approach to health management and not the episodic / acute needs of the EMS provider. The successful EMS Provider data system will transition and integrate in several significant ways, some of which are offered below:

• Clinical data transitions from procedure success to more biometric data or lab data, and possibly health risk assessment (HRA) data, that contributes (on a real-time basis) to the identification of risks and cost drivers within the PHM system and is used to monitor the program’s success.

 • Utilization data will focus on the utilization patterns and integrate with the PHM providers data on, for example, how are people accessing their healthcare and what were the obstacles to care?

 • Elements of ‘Adherence’ will replace the word ‘compliance. This refers to how well members and providers are adhering to evidence-based medicine guidelines. Are they filling their prescriptions consistently? Are they getting preventive or scheduled care? To what extent are predicted re-admissions not happening?

 • Operational data becomes participation data, productivity data, disability data and other information that helps to monitor and develop the programs as opposed to response times and system status levels.

 • Financial data is integrated with clinical and operational data to illustrate how this healthcare activity that you’re offering translates to dollars and opportunities for real hard dollar savings in the population involved.

 • Satisfaction data is necessary to monitor how sponsers, participants and key stakeholders view your efforts.

 The industry is heading in these directions with NEMSIS-3 and HL7 integration, however many, if not most, current data system elements ranging from data capture (i.e. ePCR) to analytics, are not designed around these guiding ideas nor is there any meaningful focus on potential integration with legacy systems - that will not be abandoned by their owners.

Structures 

Aside from the somewhat obvious need to alter staffing models to include levels and standards of care in a different proportion to what is most often found, the organizational structure of the post ACA-organization requires careful design consideration. Most current supervision structures rose out of a classic command-and-control model and models of control are primarily internally facing, monitoring unit availability, time on task and protocol adherence, etc. Successful community paramedicine efforts must develop an equally weighted focus on external factors as these initiatives are only an element of a comprehensive population health management effort.

While primarily in the public sector, both public and private sector delivery models must carefully evaluate and monitor the relationship and interaction between operations based, ‘positional’ authority (rank or seniority) and clinically based, ‘specialization’ authority. It is a tension that has been in EMS as long as EMS has existed, and it is apparent  that this dynamic will only be exacerbated in the new environment.

 The Guiding Idea 

Often organizations launch new initiatives almost in panic, believing that to not follow the new ‘conventional wisdom’ is to doom itself to extinction. I am reminded of the almost blind following of hospitals and medical groups into the capitated reimbursement environment of the late 1980’s, only to be amazed by research conducted by Health Leaders some 10 years later wherein 72% of CEO’s surveyed agreed with the statement that they didn’t "fully understand capitated reimbursement agreements," but felt that failure to enter into the market with them would doom them to uncompetitiveness.

In the airline industry, the early 80’s were manifest with efforts at horizontal and vertical integration in order to reduce the impact of economic cycles and capture more of the travel dollar. The peak of these efforts was the Allegis conglomerate formed by United Airlines, Hertz, Hilton and Weston that exploded in dramatic failure in 1987. The ultimate success of the airline industry business model came when the industry identified how to effectively manage its capacity and increase the available revenue per seat mile in the post 9/11 travel world. The driver of this success was the realization that the belly space of scheduled airline flights could be utilized for cargo with a big increase in marginal revenue. In fact, the entire dynamic pricing structure found in the airline industry today, is a function of the discovery that the airline industry is a cargo business with the top cabin being self-loading, and the belly contents requiring some help (my apologies to Southwest Airlines and their mantra of being a service industry that flies planes, but the rule always has an exception, right?).

The point is, that success in both of these approaches to the conventional wisdom came from rethinking the application of things that were already familiar - competencies that were already possessed. Elements of the business in which there was confidence and trust, not only in the company’s ability to deliver, but confidence on the part of the market that they could actually be delivered.  Likewise, it is prudent to assume that Community Paramedicine is A need in the current environment, it is not THE need.

 It is highly likely that successful PHM initiatives by EMS and medical transportation providers will come from existing relationships and competencies that providers have already established with their partner-client facilities or groups. The ability to display prior competencies in a particular, specific area of your clients’ needs, whether it be patient flow management, logistics, or comprehensive transportation management, will likely be the area where organizations will be successful in redefining their role in the new post-ACA environment.

In this environment, one thing is true: That which creates value will be paid for. Community paramedicine can be an important strategy for creating value in the management of health populations. However, merely redirecting your existing capacity of delivery will not deliver success. There is much consternation on compensation and reimbursement mechanisms associated with the post ACA world.  Your organization must integrate, measure and report in meaningful ways to even begin to discuss compensation. All of this means your future revenues are tied directly to decisions you make today regarding the ideas you have about where you are best positioned to create that value.  The effectiveness of that positioning will depend completely on the the extent to which you can structure and develop appropriate systems throughout your organization in support of your chosen value creating position.

The Disagreeable Absence of a Free Lunch

While doing a project for a large county on the west coast a few years ago, I was told my job was to solicit input from all the stakeholders and design an EMS and trauma system the incorporated everybody’s wants. “After all,” the elected officials said, “it’ll just go on the insurance bill, and everybody wins.” Despite my objections, I went forth and undertook the task, put the system together and readied myself for my presentation to the Board.

“Congratulations,” I muttered, “based on your theory of system design, you will be the proud owners of the world’s first $4,000 average ambulance charge and your starting ED bill will be around $13,000”

For more than two decades we have been involved in this internecine conflict between public and private providers, between tax and health care dollars and our whimsical belief that more always equates to better. Despite our virtuous screams about concerns of “patient care,” I dare say that our efforts are much more often about the flow of revenues and the creation/retention/distribution of jobs than about the real, verifiable impact of our decisions on the ultimate outcome on the patient or on the total community cost of what we are providing.

And I am as guilty as anyone. I was at the forefront of delivering those system designs and negotiating those contracts that created the mirage of a revenue generating feeding trough and only postponed the inevitable. Because, at the end of the day, there is no free lunch. The days of transferring all forms of cost to health care bills in the form of ambulance service charges are quickly coming to an end. At the leading edge of this exodus are two unavoidable realities: The collapse of the marginal collection rate curve and rising cost of healthcare.

The collapse of the marginal collection rate is complex to explain (if you are reading this you probably understand it anyway, but...) basically given that Medicare reimbursement is based on their ability to pay rather than on value, the rates are set at artificial (read low) levels. As the demographic aging wage sweeps through, there are less and less people paying the real cost of providing care, so their charges go up, because the percentage that will be realized from those charges continually go down – to the point you will receive exactly zero dollars for any new dollar you add to a charge.

And then there’s the dirty little secret that gets lost in the rhetoric of the overall health care debate: Costs are going to go up. You can put a cap on insurance rates and reimbursement - but costs will go up. Simple fact: People are living longer and there is more stuff we can, and will, do to, and for them. So costs will go up – which will create continued pressure on our current forms of reimbursement and compensation. Things that add value will be expanded and things that detract value will be killed. This represents one of the greatest un-recognized trends affecting EMS and public safety today: We are moving from emotionally based drivers to economically based drivers.

Historically, we have always been able to play the emotion card in public policy debates: “If it was your grandmother who needed help, you wouldn’t want this or that...”, “I know if it was my family member I wouldn’t want...etc.”

The unintended consequence of our time tested ability to pull at the emotional heartstrings of our communities to continually expand our services and enhance our service levels has led us to a false sense that the future will resemble the past. The fact is, that the growing reliance of health care dollars has created the environment where the change to economically driven decision drivers will obliterate these cries of concern.

The ability to clearly demonstrate the value added (from an economic perspective) of EMS is becoming more difficult every day as literature shows us the minimal impact that ALS has in the vast majority of patient outcomes, and the fact that where patient stabilization is most important, we invest the least.

So what can be done to manage in these shifting currents? Well, here’s a minimal approach to think about:

- Develop scenario plans of the impact of losing 15%, 30% and 60% of the revenue you receive from ambulance service or pass through fees. Create a picture of what your service delivery would look like if you had to manage to that level of revenue

- Develop value generating scenarios for each element of your value chain. If your organization has a billing service, can they monetize your accounts receivable and accelerate your cash flow? Can they provide revenue advances or revenue anticipation bonding for capital asset acquisition? To what extent are your vendors at risk for the quality of their supplies?

- Invest in technology that improves productivity and efficiency. Stop investments in innovation for innovation’s sake. Predictive modeling logic has developed tremendously and “intelligent asset utilization” should be a minimum requirement of new CAD investments or improvements. Utilize medical equipment that has a definitive positive impact on real outcomes, not arrival at ED statistics.

- Work with the quality initiatives of your primary facilities and/or groups. Extend their quality initiatives both on the pre- and post-hospital experiences. Quality always costs less.

- Integrate, integrate and when you are done, integrate some more. Integrate your data – CAD to ePCR to RMS to Hospital EMR to Outcome to whatever. Integrate your quality initiatives as stated above, integrate professional development, integrate call taking. Wherever you can do it...integrate.

It’s been a good ride – but it is now clearly prudent to prepare for the next chapter. Despite our proclivity to believe that somehow everything will work out, it is quickly becoming the time to put on our big people pants and recognize that for every action there is an equal reaction, that to be accountable is part of being an adult, and that there is a disagreeable absence of a free lunch anywhere in the real world.

One Paramedic or Two?... and the Crash of United 173

I’ve been in health care and EMS now for 32 years (it doesn’t seem possible) – and for 30 of those years there has been an argument about the efficacy of one-paramedic vs. two-paramedic systems. I’ve had the ability to witness this debacle from all four corners of the continent and even weighed in on the discussion in systems on foreign shores.

I’ve also had the blessing of being able to work in and with other industries and work environments which allows me, perhaps, to provide a little different perspective on many issues – including this one. One such detour occurred during my fellowship when I was with NASA in the development of the first Crew Resource Management (CRM) programs which are now mandatory training in the airline industry and techniques from which are making there way into the health care delivery field.

The genesis of this effort was the crash of United 173. This flight was a DC-8 that crashed short of the Portland airport because the Captain became fixated on a landing gear warning light and ignored the communications from his crew that they were having a “fuel exhaustion” problem – i.e. they were running out of gas. This lack of communication was a function of what is we now call Human Factors Engineering – which is really the study of how people interact in, and how relations effect the processes in the work environment.

Given this bias - I have come to believe that it is this issue – the issue of Human Factors – that serves as the critical question in the debate over staffing models, not only in para-medicine, but in health care delivery in general. Strange as it may seem – there is some data – which although taken from disparate environments, may – just may – when viewed in aggregate, may support my hallucination.

Bayley, et al (2008) conducted a study of one- versus, two-paramedic treatment scenarios in a simulated cardiac arrest. While intubation times for the 2-medic crews were substantially lower than in the single medic scenarios, based on errors of sequence, commission, and total errors combined in the resuscitation effort, the study concluded that:

“...two paramedic crews were more error-prone and did not perform most interventions more rapidly with the exception of intubation. These data do not support the proposition that two paramedic crews provide higher quality cardiac care than paramedic-EMT crews in a simulated ventricular fibrillation arrest.”

While this may seem counterintuitive, there are a couple of interesting studies that, in the context of our understanding of human dynamics and what we have learned from our complex study of the role of hierarchy through the development of CRM, may make this a little less counter intuitive and point us toward a new approach to the debate about paramedic staffing levels.

Marsch, et al (2004) and (2005) conducted studies regarding the effectiveness and efficiency of resuscitation efforts in intensive care units of a hospital. One study involved a simulated event where a full arrest is discovered by a single nurse, with two other nurses (i.e. peers) and a physician (superior non-peer) being available to assist, once being called upon to run the code. In the other study, the researchers constructed teams of peers (i.e. nurses and physicians acting together on separate teams). A full arrest was then simulated and the performance of the team was monitored and evaluated.

In both these scenarios of simulated witnessed cardiac arrest almost two thirds of teams composed of qualified health-care workers failed to provide basic life support and/or defibrillation within appropriate time frames.

When compared to a metric of hierarchical leadership/direction the “absence of leadership behavior and absence of explicit task distribution were associated with poor team performance.” In other words, it was not the level of accreditation that mattered; it was the effective construction and deployment of an effective team.

In the mixed peer scenario (nurses and physicians) the study found that “the early availability of a physician increased the number of countershocks administered and greater protocol compliance.” In other words, based upon the expectations of the work environment, the presence of the hierarchical superior resulted in more appropriate protocol administration.

The lessons here are several. First and foremost, more research is needed on my developing hypothesis that levels of clinical certification are not as important as effective team formation and goal orientation. Having said that, the cumulative effect of this research, I think, serves as a starting point to redefine how we evaluate the issue of staffing configurations in our EMS system designs.

As we learned from United 173, ultimately it is the expectations of those that comprise the work environment that set the standard for appropriateness. As all of us in the emergency services know, there is a certain flexibility required in our leadership style throughout a given day because of the widely fluctuating demands of our work environment.

If nothing else, I think this literature reinforces the need for all of us in the EMS community to focus on how our relationships impact the care we provide our patients – and by relationships I mean all relationships – between people and organizations.

Oh...one more thing. One other result of the Marsch study – when asked to recall and recite the actions and treatments of the simulated full arrest, delays and inactions were consistently not recalled. This supports a rather consistent body of literature that demonstrates that “..self reporting of effectiveness is unsuitable to reliably assess performance.” So how effective is your system in delivering care?.... and how do you know?

Evolving the Dream – Lessons in Leadership from a Cold War Warrior

Back in the day – I had the opportunity to do a fellowship that took me to the Ames Research Center of NASA. There, tucked in a small corner office, off of a typically bureaucratic hall was the cluttered office of an aging gentle man, who toiled in near obscurity, surrounded by small mementoes of his life – autographed pictures of he and President Johnson, personalized memorabilia from Neil Armstrong and Buzz Aldrin, and memorial tokens of the Gus Grissom – who was a personal friend, lost in the tragic fire aboard Apollo 1.

In short, this quiet, gentle man had been around. He had been there when NASA was where the elite of the elite strode down its halls and catapulted American pride and technological innovation to new highs.

I didn’t know this man directly, and my project didn’t put me in direct touch with him – but I was fascinated. Fascinated in what his perspective would be on how NASA went from a world class organization to what is perceived as a bungling bureaucracy. How did it happen and what lessons can be learned?

Over time I developed a relationship with this man and the lessons he taught me about leading in organizations are priceless:


1. “We were great when we didn’t know what we couldn’t accomplish. We got bad when we managed to our limits.”

He went on to explain that in the halcyon days of NASA, the common vision had no limits on what could be developed – on what could be done. There were no constraints on the thinking of the approach to problems and often what was found that the question at hand was really a 3rd tier issue that required the development of solutions to the 1st and 2nd tier first. It was in this “open sky” vision that NASA found most of its magic.

After the moon landing, NASA started ‘managing to the budget’ rather than to the vision. Constraints replaced energy as the guiding framework of the organization. “If you know how far you can go – then that’s as far as you will go” he told me. Of course, the magic is in defining the “can.”


2. “A common enemy helps...”

“You have to remember,” he said, “that originally NASA was created and evolved out of a fear that the Soviet Union would militarize space.” “Whether its fear or some other catalyst, there has to be a strong emotional driver shared throughout the organization.” “The worst thing that happened to the space program,” he said, “was when we lost our common enemy.”


3. “Leaps in vision need to get geometrically bigger...”

The final nail in NASA’s coffin was the inability to expand the vision beyond the moon. “In current technology, you have Moore’s Law,” he stated matter of factly. In computing you double processing power every two years. “I’ve come to believe that Moore’s Law is not so much a function of technology as a basic need in the human animal.” “As a people we have always naturally tended to do things better, faster, more efficiently – but in order to feel we have control we create systems – governments, bureaucracies, whatever – that provide obstacles to our natural tendency to grow.” “My experience,” he said, “is that organized collections of people – project teams, organizations, agencies – will wilt and die if they can’t keep setting the bar geometrically higher.”

“Once we reached the moon – it was almost incomprehensible to set the bar to Mars – very few understand the magnitude of the effort, and it seems like the same thing. We did a very poor job of evolving the dream.”


I’ve spent a lot of time studying people and organizations – I read a lot and done a fair amount of research. But the sad wisdom of an aging warrior provides a simple, but bountiful Rosetta stone for managing in our organizations.

I wish you well, old warrior, and thank you!

Crib Notes Cram on Health Care Reform

In our current world, political realities require a simple, 3-second sound bite solution for even the most complex problems. I consistently talk of the need for an 8th Grade solution to a graduate school problem if a solution is to be politically viable.

If it were not for the potential damage that it could do to our health, our lives, our economy and our way of life, the current discussion about health care reform has taken turns that would be laughable. Even though the emotional debate has reached a fevered pitch, the most basic elements are ignored, lost in the haze of social agendas and political power.

Here then are the fundamental issues that have been completely lost:

1. Insurance is not a payment scheme – It is a Risk Mitigation measure.

By definition, insurance is a means of indemnity against occurrence of an uncertain event. Insurance is designed to limit the losses incurred by a hazard that that is “uncertain”. It is that uncertainty that makes insurance work.

Imagine that your congressman came to you and said, “Every American is entitled to government funded life insurance.” Well, it’s pretty certain that the hazard here (death) is not uncertain. Every American will certainly, at some time, die. The only way to make that system work would be to ensure that the amount of money coming in (premiums and use of that money) exceeded the certain amount of money expended. That is not insurance, that is wealth re-distribution. The only reason life insurance works is that relatively low risk populations, make payments in advance to mitigate a hazard that they hopefully will never experience. Ergo, the benefits paid out will be less than the premiums received in. That is the very nature of insurance.

Since it is both economical, common-sensical, and appropriate that people receive health care, both in an effort to promote wellness and mitigate disease, health care does not meet the basic premise required of an insurable (variable risk) condition. So how do we introduce variable risk back into the equation? We recognize that the expenses related to our health are legitimate personal issues of responsibility up to some point.

If you buy a new car with a manufacturers warranty, the warranty becomes void if you fail to properly maintain your car – do your oil changes, appropriate tune-ups, etc. Yet, we have come to expect dollar one of our wellness or health care be paid by someone else – either our employer or our insurance company. We in essence can take our car to the dealer and demand he pay for our service whether we have met our responsibilities or not.

This issue can be resolved by making personal expenditures on health care, health insurance and wellness fully tax deductable (or as a direct tax credit) and transferring the responsibility for wellness back to the individual through these type of incentives.

No person in America should go broke because they are sick – everyone agrees. Then let’s return to a model of insurance that provides protection for the catastrophic uncertain events and not pretend that we have a workable full payment system.


2. The cost to the Government is not the total cost of the program.

In the effort to dumb down the discussion to a tolerable level, our politicians avoid and evade one basic fact. You can’t suspend the laws of economics.

Here’s the deal. Insurance companies make profits. They have to. If they don’t, investors don’t invest in the stock, don’t buy their bonds, and the insurance companies are unable to leverage the money they receive from premiums to pay claims. Again, that is the nature of insurance.

There are primarily two segments of the risk faced by insurance companies, premium setting and population risk.

Premiums are the engine of the insurance company’s revenues. They are set by actuarial determinations of risk (here we go with that concept of an uncertain event again). These determinations have a variety of factors that are utilized to set rates – included in these are past medical history and current medical condition.

Population risk is provided by a company’s exposure to a certain population. We don’t ask the rate payers of an insurance plan to accept the costs associated with certain populations – such as the risks posed by individuals in the military because the cost of this risk would be prohibitively expensive to the rate payers.

It sounds really good to state that “no one can be denied insurance because of pre-existing conditions or change in employment”, or whatever – but the practical result of limiting these variables in the setting of rates means that EVERYONES (that’s you and me) EXPENSES WILL GO UP. This is a totally hidden “tax” that is not even on the government’s books and will actually increase the cost of care – not reduce it.

If we are really interested in meaningful reform, the government can provide some form of risk limitation by providing subsidies for those at risk populations and providing a safety net for those who fall out. But defining levels of care and determining actuarial rules will only burden our, and future, generations with ever escalating costs.


3. Savings from Fraud, Abuse and Efficiencies – The Medicare Conundrum

I guess there will always be a segment of any population that will seek to exploit the system and utilize fraud to their economic gain. My experience though, is that more money, time and effort are spent on trying to ensure that byzantine rules for our Medicare reimbursement system are followed than are spent in outright fraud and abuse. The poorly constructed language of the re-imbursement rules and legislation create its own bureaucracy and all manner of interpretation and confusion.

This bureaucracy provides a gigantic obstacle to innovation and improvement our processes of delivery. Many clients I work with on a daily basis have avoided, or cannot fully implement, Electronic Health Records because of their concerns about how technology bills for services and feel it necessary to provide adequate checks and balances (human review) for the unreasonable level of scrutiny – and ultimate delay in payment, or bad public relations - they will receive if they are subject to a Medicare Audit.

More importantly, nobody is mentioning that Medicare is responsible for about $520 billion a year in cost shifting which directly results in increased costs to the system. Cost shifting occurs because Medicare reimbursement is not based on the actual cost of doing anything – it is based on the ability of the government to pay. Thus an aspirin, which may have a legitimate cost of two dollars, is re-imbursed by Medicare at 40-cents. As the population covered by Medicare increases, a smaller and smaller number of people are left to pay the difference between that 40-cents and the real cost of two-dollars. This means that practitioners must bill seven-dollars from those remaining, non-Medicare patients to recoup their legitimate costs of doing business.

It is ironic, at one level, and intolerable on another, that Medicare is responsible for such a large portion of the escalation in our health care costs yet no one is talking about this Medicare Effect. At the same time Medicare that is held out as an example of how the government can effectively run a health insurance program.

Oh – and by the way. The week after whatever reform is, or is not passed, we will get hit with the insolvency of the social security system. Despite the rhetoric – these are not the same issue and they are not the same balance sheet. The social security debacle will dwarf the impacts of this debate – so stand by.

How Emergency Medicine Resembles a French Fry

The Lord of the Fries

It is a critical axiom in solving problems that we 1). Make sure we are asking the right questions, and 2). Make sure we are measuring the right things.

My favorite learning moment in this regard is a business case study involving not the Cleveland Clinic, but Burger King Restaurants. In the 1980’s Burger King was getting their competitive clock cleaned by other fast food operators and one of the primary drivers of dis-satisfaction with their product was their french fries. So in good old fashioned quality improvement fashion, Burger King set out, through focus groups and surveys, to “measure” what traits constituted a “good” french fry. When all was said and done, they came up with a list of “attributes” that constituted a “quality” french fry, framed these in the form of a “specification” and sent out these requirements to potato farmers and french fry manufacturers (if there is such a thing). And it came to be, that all of the vendors could meet all of the specs – except for one.

This spec was a requirement that a “quality” french fry had to be of such a consistency that it could to be chewed something like 21 times before being swallowed. So they measured and they measured and only one vendor could provide a fry that met all the specifications (including the requisite number of mastications). Burger King happily verified the compliance of the product with the specifications and happily announced to the world that they had developed the perfect, high quality, french fry. With much fanfare it was rolled out all over the world – at which time one small problem was discovered.

Although it met all the measurements, and every minute specification was met – the french fries tasted like crap.

So it becomes critical that we understand our environments and our systems sufficiently to know what the right questions are, and what are the appropriate measures. As the re-defining of health care evolves, it is crucial that we all take a step back from the madness and make sure our view of the world allows us to focus on the right things and measure what is important.

I mention this because (for a variety of reasons) the delivery of health care has devolved to a segmented, task driven process. Each of us is responsible for our own little corner of the world (or of the patient) and as long as all of “our boxes” are checked, it is just assumed that we are doing what is right for the patient and delivering “quality care”. What this has resulted in is our increasingly defining a “successful outcome” for the patient only by how successful we are in passing the patient through our little spot on the assembly line of treating their medical event.

WHY we have a Problem

This was brought to mind as I watched an EMS professional being interviewed on TV in the wake of Michael Jackson’s death. He had been dutifully presented to a local news outlet to illustrate to the community the efficacy of the AutoPulse™ device which his service had recently purchased. Now in the interest of full disclosure – I own no stock in Zoll or any other manufacturer of medical devices or equipment. I have absolutely nothing against Zoll and I think the marketing people that I have met from Zoll are absolutely the nicest people in the world (with the exception of Lauren Angrest at Alvarado Hospital in San Diego – it’s true... look it up). So I’m not trying to pick on Zoll – it’s just a handy example of my point. So my apologies to begin with.

In any event, the television audience and I were informed by the uniformed EMS professional that since utilizing the AutoPulse™, the “save rate of their service had gone from 6% to over 68%”. Wow.... that’s impressive! It’s a better “save” rate than witnessed arrests in a hospital environment.... hmmm.

Well I guessed, and subsequent research confirmed, that our EMS professional was defining a “save” as a patient who, sometime during the EMS encounter, experienced a Return to Spontaneous Circulation (ROSC). Oh.. and did I mention the population on which this was based was 8 patients – but that’s another story.

Alright, I get it. This is a tremendously sucky environment (that’s a technical term only to be used by trained economists, so don’t try that at home) and we are all competing for scant resources so any chance to create some PR buzz is a good thing – right?

Well, I contend that that approach would be correct if we were all aligned and in agreement about what the goal of our health care system is. And clearly we are not aligned. Ideally, I think we could all agree that a system that focused on, and rewarded, health and a high quality of independent life, would be preferable to our current system. However, that’s just not the case. Our incentives (i.e. reimbursement) have created a system of tests and treatments rather than real health attainment. So given that, I think most knowledgeable people recognize that our goal should be to attain the best value for the patient, in obtaining a mutually agreed to outcome, across the entire spectrum of a medical event.

But it is highly unusual for any of us in healthcare to view the value of our actions across an entire medical event. Rather we gauge our value and our effectiveness only on the impact that we have in a given moment (or small segment of time). Historically, we have claimed that there are just too many other variables in the system for any one person or one treatment segment to be held accountable. But those arguments will no longer sustain the weight of scrutiny.

One thing is clear in the current debate about the reinvention of health care in the U.S. – regardless of what models are ultimately adopted – that which adds value will receive compensation – that which does not, will fall by the wayside.

The only way to effectively measure “value” is across the entire spectrum of a patient’s medical condition. In the absence of such a view, relatively expensive “short term” fixes, will always give way to less expensive “long term management” even if the expensive, up front costs are ultimately cheaper over the long run. As an example, let’s go back to the AutoPulse™ example.

These devices are available to the market for around $11 - $14,000. There have been 3 studies conducted with relevance to the efficacy. In one, the data supports that it enhances perfusion and hemo-dynamic stability in a porcine (pig) body. The largest randomized sample study on humans (Hallstrom, 2006) had a total of 1,071 enrollees. The primary end point for the study was survival to 4-hours and there was no difference between the AutoPulse™ population and manual CPR. On a much more meaningful dimension patients who received manual CPR had almost twice the chance of survival to discharge (9.9% vs. 5.8%). In the most meaningful measure, Cerebral Performance Category (a rating of brain function and performance) those who were patients discharged from the hospital after being treated with manual CPR far exceeded those treated with the AutoPulse™ (CPC Category 1 or 2 which maintains at minimum sufficient cerebral capacity to carry out independent activities of daily life - 7.5% for manual CPR and 3.1% for AutoPulse). In fact the Institutional Review Board, halted the research in March of 2005 because of the deleterious neurological outcomes associated with the AutoPulse™ device.

Also in 2006, Krep, et al. conducted a study of the AutoPulse efficacy. The design measures in this study, however, were ROSC and End-Tidal CO2 values. The sample size of this study was 46 (1/10^th the size of the Hallstrom study). It revealed that ROSC was achieved in 54.3% of patients and 21.8% of patients were discharged from ICU. Of these patients, however, 70% (7 of the 10 admitted to the ICU) were discharged with CPC Category 3 or higher meaning –

“Severe cerebral disability: conscious, dependent on others for daily support because of impaired brain function. Ranges from partially ambulatory state to severe dementia or paralysis”.

Six months after discharge, 5 of the 7 patients were still alive with no improvement in their neurological state, 3 patients had died and there was no information available for the remaining 2.

To put it another way, manual CPR yielded a human being capable of independent living in 7.5% of out-of-hospital arrests. The Load distributed device (AutoPulse™) yielded 3.1% in one study and 2.2% in the smaller study.

The point being – from the perspective of treating the patient in a manner consistent with quality across the entire spectrum of a medical event, here is a device that cannot yet be demonstrated as adding value. In fact, a case can be made that while successful in the mechanical perfusion of individuals, the ultimate outcomes are worse and vastly more expensive than if nothing had been applied at all.

So here we have the perfect of example of an answer in search of the right question. Clearly this device has the potential to enhance perfusion and ultimately improve etCO2 and perhaps even ROSC. And in a world where we measure success by our little corner of the world – that was all and good.

But we are entering a different world now, and those of us that ignore that reality do so at our own peril. Just as Burger King’s focus should have been on the ultimate taste of the french fry, our focus needs to be on the totality of the patient experience. Our world will shortly not tolerate nor reward treatments or expenditures that cannot prove a value - and our new world, value can only be viewed across the spectrum of an entire medical condition.

It’s way past time to start re-thinking the questions we ask and ensuring we are measuring what is important. More and more, we are forced to view our actions as a small part of a holistic scheme wherein we gauge our success not on our actions, but on the ultimate result from the perspective of the patient.

Epilogue

In a November, 2008 taste test, Burger King ranked Number 3 out of the top 5 fast food restaurants. I’m not quite sure what that means.

Blog Information Profile for drcrcarlson

Throwing Away Quality - Redefining Health Care

As the efforts at health care reform accelerate, a barrage of perspectives and concerns related to the “quality” of clinical care delivery will be ever escalating. As was brought up by a physician colleague of mine, this raises a really excellent question – what is “quality”.

An effort to raise this question in a meeting, or forum, or virtual bulletin board will result in a vigorous discussion, multiple variables, and at the end, invariably – some member of the discussion group will conclude that “it doesn’t matter because quality in medicine is, and always will be, highly subjective.”

There is much danger in dismissing efforts at defining quality as wholly “subjective”. As we focus more and more on our medical insurance and reimbursement schemes, the ultimate measure against which cost must be evaluated is quality. To dismiss quality as immeasurable – surrenders the importance of clinical delivery to the whims of the masters of the financial suite. As the old adage goes, medicine is much too important to be left to the accountants.

Rather, a more holistic view of quality would be most helpful. Such a holistic view of quality has existed in the business and marketing world for a couple of decades and has proven most useful.

The clinicians’ view of quality has traditionally related to clinical procedures, inputs and outcomes – infection rates, length of stay, minimalizaiton of repeat invasive procedures, etc. While useful to the management of our current health care systems, the fundemental problem with this historic approach is that it has very limited relevance to the consumer (i.e. patient).

While these measures are important to the “tactics” and the processes of delivering medical care, they do not (except in the most extreme cases) cast a shadow of relevance onto the awareness of the patient (or their families).

There are two important changes in perspective that are necessary to move to a more appropriate and relevant view of quality:

- Quality is measured from the patient’s perspective of “the job that needs to get done”.

- Quality has three components

a). Functional
b). Emotional
c). Social




The Job that Needs to Get Done

We have done a horrendous job of defining quality, even to the point of total lack of awareness, from the perspective of what the “job the patient (or patient’s family) needs to have done”. Our training and our conventional wisdom holds that “the job” is to provide clinical interventions, within appropriately understood protocols, to restore health (or at least slow deterioration). It is this world view on which almost all our current quality measures are based – and it is this world view that is preventing us from meeting the challenges of the current environment in an effective and meaningful way.

Appropriate clinical interventions and protocols may, or may not be the “job” that the patient environment “needs to have done” (although they are mostly likely a pretty good baseline). The “job” the patient may need will certainly vary and may include –

- “Be a participant in a meaningful and understood communication”
- “Help in understanding options for care and access to those options”
- “Pain Relief”
- “Access to appropriate specialties”
- “Reasonable response to requests for service”
- “Appropriate and safe therapy”

Or...other things that we will only know if we seek out the understanding of their true importance. The salient point is that to have a meaningful measurement of quality – that level of quality must derive...

a). From the perspective of the patient, and

b). With respect to the job the patient thinks needs to be done.


The elements of Quality

Clinical caregivers have gotten pretty good at the functional aspect of quality definition. These are the processes, variables, and tasks that can be quantified, measured, and analyzed on a fairly precise and consistent basis. However, it is the absence of the other two components of quality that render our discussions about quality clinical care delivery futile. These are the social and emotional dimensions.

It is important to understand that all of the aspects of Quality are inter-related and co-dependent. How the patient (or family) perceives the “job to be done” directly defines the measures of the functional, social and emotional aspects of the quality perception.

For example, if a family member of a patient is a physician, the social aspects of quality will drive a greater expectation of communication and attending physician access than will be found in other environments. One of the multiple and concurrent “jobs to be done” in the physician family member scenario might become ready access and perhaps greater degrees of concurrence with treatment plans (functional aspect expectations).

In another scenario, a patient may have expectations or needs with respect to wireless internet access to maintain her business (functional aspect). The “job to be done” which is defined as minimizing hospital stay and expediting the patient’s return to daily living activities now enjoys a greater importance in the quality equation.

Does this high degree of variability mean we can’t measure Quality?

Of course not! And herein lies the greatest opportunity to change the way we think, and thus the way we approach quality.

Our first thought about this multiple dimension view of quality leads us to believe that there are just too many variables within the human condition to move our quality efforts toward this patient centered approach. But this is only true if one views this challenge from our conventional perspective of centralized systems and centralized data driving our care delivery processes.

One of the tenants of lean manufacturing is that the first step to solving a complicated problem is to --- simplify the problem. Complexity is usually found around elements of a process chain where centralization occurs. This is because in any process centralization occurs where someone, at some time, had felt that either control or the need to fit two non-modular elements of the process together required the process to come to some choke point for review or approval action.

As a practical example for your consideration. My father suffered a significant stroke which left him aphasic and with no remaining gag reflex. Upon admission to the floor he received the standard admission process visits from housekeeping, labs, and nutrition. Each of these specialties had their standardized processes to meet the needs of their individual specialties, and all dutifully (and literally) checked the boxes after their visits – dutifully meeting the needs of the care delivery system.

Now, please imagine the absurdity of a dietetic technician going through her checklist with an aphasic and swallowless man. Food preferences were just not that high a priority at that moment in time for that patient. The ludicrousness of this is driven by the design of processes around system needs instead of the more proper focus on the “job that needs to be done” from the patient’s perspective.

Problems invariably become simpler (lose their complexity) when they are defined from the product, or the patient, or the part as opposed to the perspective of the system into which they are participating.

How much more effective would the admission (which is the introduction of the patient into your quality system) have been if it was set up around the needs and condition of the individual patient instead of the condition of the hospital sub-systems? What if the needs of the patient drove the contacts and the communication rather than the needs of well meaning caregivers to “check the box”?

An admission (and care process) that identifies specific patient information in not just the clinical (i.e. functional), but social and emotional realms would allow a quality process that defines (at least initially) the “job that needs to be done”. This data, which follows the patient, provides a framework for which metrics to utilize in quantifying these multiple quality dimensions. More importantly, it allows for the continual development and utilization of additional metrics and the contribution of the data to a whole new set of knowledge more relevant and meaningful to the care giving experience.

As noted above, this is quickly becoming a need beyond the issues of patient care and comfort. These issues of perception are becoming the balancing point for the most significant financial discussion in health care in 50 years. It is a critical dimension that cannot be surrendered to those whose interests (while legitimate) do not represent the complete, accurate or – taken in isolation – appropriate view of the delivery of health care in our country.

Let’s no longer throw our hands up in the air and deem quality as merely subjective noise. Let’s use this environment to re-think the way we view quality, and in so doing, redefine the way we approach our jobs, our patients, and our lives.