Wednesday, July 29, 2009

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 (1/10th 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.


Sunday, July 5, 2009

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.