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Wednesday, March 19, 2014

Principles of Critical Care Medicine for Non-Intensive Care Specialists: Harvard Medical Education at its best


I just got back from Boston where I visited friends and went to a really good and useful Harvard Medical school continuing medical education course. Harvard is one of the few institutions that I have found to have consistently good classes for practicing physicians, with a few exceptions. This Spring I wanted to get myself to Boston and so I went to the online list of Harvard CME courses, which is more exciting than a candy store. In the time block that I had available they offered two delicious options. One was a week long course on everything anyone ever wanted to know about internal medicine which would have earned me over 60 hours of credit while crushing my soul with 10 hour days of densely packed information mainly intended to help practicing physicians pass their board exams. The other was the course that I chose which delivered almost 20 hours over 2 1/2 days, leaving me time to walk along the waterfront and eat a little lobster and even frolic with my friends.

The course, the 2nd Annual Principles of Critical Care Medicine for Non-Intensive Care Specialists was designed with the knowledge that much of the intensive care delivered in the United States is by physicians who don't do intensive care medicine as their main thing, and haven't received fellowship training in it. Many of us have become pretty good at it, but we sure can benefit from hearing what highly intelligent and rigorously educated intensivists have to say. Three intensive care and pulmonary medicine specialists from Harvard's Beth Israel-Deaconess, Drs. J. Woodrow Weiss, Jeremy Richards and Peter Clardy, along with guest speakers, shared information that was geared to what I really needed to learn. They gave us "evidence based" recommendations, but more importantly they told us how things worked in their hospital's intensive care unit, what they had done to improve patient care and outcomes and what that actually looked like. They focused on some of the most deadly diseases, sepsis and acute respiratory distress syndrome, and about some relatively dismal long term outcome information for the patients who are saved from their dread diseases in intensive care units, often to be faced with long term physical and mental disability. They taught us to manage ventilators more skillfully and to actually engage our brains by remembering how human physiology is reflected in some of the data which is presented to us so copiously in critically ill patients. They taught us how we might prevent delirium in patients who frequently become confused and have a very hard time coming out of it. We were gently encouraged to give blood products only to patients who could really benefit from them, which is still a bit of a moving target.

In skills workshops which were wound into the lecture and small group problem solving sessions we had a chance to use ultrasound to practice procedures and image the hearts of a few live volunteers. We were taught the standard bedside echocardiographic views and used "phantoms" to practice placing central venous catheters and sampling fluid in the abdomen and chest.  Having attended many specific ultrasound training workshops I was a little disappointed in the cursory nature of these workshops, but the course was short and there truly was not enough time to cover everything that people should learn. The fact that bedside ultrasound was a part of the course means that the organizers not only feel that it is part of what should be done in intensive care units, but also that it is at the core of what anyone who practices intensive care medicine should be able to do, even (or maybe especially) at small community hospitals. This is a good message.

The course was small enough that it was possible to talk to all of the speakers and ask individual questions. The folks who attended were an interesting mix: we were primarily physicians who managed patients in hospitals where there were no intensivists, but we were also emergency physicians and advanced nurse practitioners and physician's assistants. It is unusual to run into many of these people at conferences because they are often too busy to attend, and we are a small minority of physicians in the US.

There was a feeling in the course of trying to make sure every recommendation was based on some kind of reputable research. Since only a minority of interesting questions have been addressed adequately by reputable researchers, this approach was impractical, and as the course wore on we more often treated to experience, deduction, good sense and critical questioning. There was a nice mix of research results and practical recommendations.

The course was held in the World Trade Center on the water in South Boston, where not too long ago only warehouses and fishing boats lived. It is near a beautiful museum of contemporary art, is served by $3 ferries to all sorts of destinations on the Boston Harbor, and has easy walking access to excellent restaurants. There is a very long foot path called the Harbor Walk which makes it easy to get exercise at the edge of the water. The Seaport Hotel where conference attendees stayed was large, well appointed, expensive but not ridiculously so. The World Trade Center was also hosting the Boston Flower and Garden Show, so parking would have been terrible, but renting a car was superfluous so it didn't matter. The show was really interesting, if you like that sort of thing, and it was possible to walk in from the conference without paying the $20 entrance fee, which was probably not intentional, but did not appear to be forbidden.

What I learned is readily usable. I look forward to treating my next intensive care patients to what is presently the cutting edge at one of America's best hospitals and sharing some really great ideas with my doctor colleagues.

Friday, March 7, 2014

Tranexamic acid--why you may be less likely to bleed to death in Britain than in the US if you get injured

The other day at an interdisciplinary rounds meeting at the hospital, one of our nurses who is also an emergency medical technician mentioned that in Britain injured patients receive tranexamic acid before arriving at the hospital because it reduces death from bleeding. "What's that?" I said. I kind of barely remembered hearing this medication's name associated with the treatment of a rare disease, but not treatment of trauma. So I was guessing that this was some drug that was invented long ago which had been found to be quite effective in other countries, but has not been really optimally used in the US because it is generic and therefore unlikely to make drug companies money.

Bingo.

Here's the story, as far as I can determine.

Tranexamic acid is a relatively simple cyclic molecule that blocks the fibrinolytic process, that is the natural breakdown of blood clots in the body. In the setting of any injury, especially severe ones, fibrinolysis is intensified, leading to a condition of excess bleeding in trauma victims. This is hardly ideal, and tranexamic acid can help reverse this. It also appears to have an effect on reducing inflammation, which may be even more significant. There have been a couple of major studies in the last 3 years showing significantly better outcomes in patients who have traumatic injury and who are treated with tranexamic acid intravenously soon after injury. The most recent study, published in the Archives of Surgery, looked at 896 patients injured in the military from registries in the UK and the US and identified the subset treated with tranexamic acid. Although this group was generally more severely injured, the mortality rate was significantly lower, 6.5% lower, than the group that had not received the drug. In very seriously injured patients, those who received massive transfusion of blood products, the difference in survival was nearly 14%. It is not often that we see an effect this powerful, especially in a group like this who are healthy and will likely have long and productive lives after being saved. An earlier study, published in 2011 in the Lancet entitled CRASH-2 showed similar results in civilian trauma victims, with a double blind prospective design.

The Cochrane Collaboration, a group of researchers who review randomized controlled trials concluded that tranexamic acid was safe and effective in reducing mortality in trauma patients without increasing adverse events.

So maybe it's actually very expensive, then. I called our hospital pharmacy to ask about that. Apparently a gram of it costs about $44. The usual protocol for trauma is 1 gram intravenously right away and then another gram over the next 8 hours. So $88 times 100 equals $8800 to save 6.5 lives (using the data from the military study), $1353 per life saved. That's pretty cheap. And since it probably reduces the severity of illness in the rest of the patients treated, it may end up reducing overall treatment costs.

Presently the only FDA (Food and Drug Administration) approved indication for this drug in the US is an oral formulation to be used for women with heavy periods and intravenously for prevention of dental bleeding in hemophiliacs. It is also used, off label, to reduce transfusion requirements in total joint surgeries (that's why we have it in our pharmacy), also in some places for prostate surgery, general surgery, gastrointestinal hemorrhage, bleeding around pregnancy and delivery and bleeding within the eye. It reduces the frequency of attacks of swelling in a condition called hereditary angioedema, which is rare, and was why I had even heard of it in the past. It has been available over the counter for years in Europe, marketed for heavy menstrual bleeding. The injectable formulation is also on the World Health Organization's list of 350 essential medicines which are considered safe and effective and necessary worldwide.

So what are its side effects? It may increase the risk of blood clots in the legs and lungs, but studies have shown this to be far less of an issue than one might guess, and it looks like the lives saved far outweigh this risk.  The CRASH-2 study showed that there might be a slight risk of increasing mortality if it was given to trauma patients more than 3 hours after their injury.

Why is it not FDA approved for reduction of bleeding in trauma and other similar situations for which there is ample evidence of safety and efficacy? The FDA approves drugs and devices when approval is requested, and usually the drug or device manufacturers who stand to make money from an FDA approved indication are the ones to make the request. I suspect there has been no request for approval for these other indications. Just because it is not FDA approved to reduce bleeding in trauma and surgery doesn't mean it can't be used, but physicians have a certain hesitance to use unfamiliar drugs "off label."

So the story of tranexamic acid is another excellent example of how simpler, cheaper and sometimes more effective treatments are not being widely used in the US, even though our patients may receive exorbitantly expensive medications and treatments of dubious or minimal benefit. This is because we allow powerful pharmaceutical companies to inform our practice. Sometimes this actually works, when companies produce groundbreaking innovations and encourage us to adopt them. It is unlikely, though, to help us find creative uses for inexpensive drugs that have been around a long time. This dynamic may mean that 6 or so people of the 100 who are probably just now being involved in accidents with bleeding will die when they would not have if use of this drug part of our routine practice.

Wednesday, March 5, 2014

Critical Access Hospitals--the 96 hour rule and other ridiculous and self defeating requirements in Medicare's payment for small hospitals

My home hospital is small. In a town of just over 20,000 people, this hospital has 25 beds and is designated "critical access" by Medicare because it is felt to be necessary to the health care of the community. Critical access is a designation which was introduced in 1997 when modernization of Medicare payment systems threatened to close a large proportion of hospitals in small communities which were unable to benefit from economies of scale. A small hospital needs to remain capable of providing services to small but significant floods of patients when everyone gets sick at once, and maintain skills and staff to care for a variety of different diseases. This can make such a hospital less financially efficient (though various other factors can partly offset this) and the critical access program spares my hospital some of the Medicare belt tightening that would make admitting Medicare insured patients prohibitively unprofitable.

Most larger hospitals are now paid for their Medicare insured patients according to the Prospective Payment System, in which a fixed amount of money is paid to the hospital according to what disease the patient has. This means that if a patient presents with pneumonia the hospital will get maybe $8,000 for all of the expenses involved in treating the patient, excluding doctor fees which are billed separately. If the patient does very well and only stays in the hospital 2 days, the hospital does very well and if the patient languishes and requires more resources, the hospital loses money. It is designed, ideally, to work out so the hospital survives, covers its costs and makes a profit. This encourages hospitals to make patients well as soon as possible by making sure that they don't profit from taking poor care of patients. It's generally a good system. Small hospitals, though, are very sensitive to individual patient disasters, and if a patient or two uses more resources than the Prospective Payment covers, the hospital can fail. For this reason critical access hospitals are paid "fee for service". Medicare pays 101% of its allowable fee for each service a patient uses in the hospital. Overall, this can end up costing Medicare more per patient, but it does keep small hospitals afloat.

In order to be critical access, a hospital must have 25 or fewer beds, though it can also have separate units for rehabilitation or psychiatric services, at 10 beds each. It must be 35 miles by primary road or 15 miles by secondary road from another hospital, or 15 miles in mountainous terrain. Up until 2006, it was also possible for the states to designate a hospital as a "necessary provider." Hospitals so designated remain critical access, though this loophole is no longer available. The 2014 budget will address this definition again, proposing to remove critical access status from hospitals within 10 miles of another hospital.

Because critical access hospitals don't have the usual built in incentives of the prospective payment system to limit the length of hospital stays, theoretically they can just make more money by keeping patients longer. Thus the 96 hour rule. Originally it was stipulated that critical access hospitals couldn't keep patients longer than 4 days. Since this was patently ridiculous, the law was changed to allow hospitals to average no more than 96 hours, which was a wee bit better.

So why do we even want to have little hospitals? They don't have very many medical specialists, they don't have dialysis units or cancer centers or cardiac cath labs. Sometimes they can't do MRI scans or nuclear stress tests, and the littlest ones can't even do surgeries. When you put all critical access hospitals (there are about 1300 in the US) in a big pot and average their results they have a higher mortality for many diagnoses than the bigger hospitals. Some of these hospitals are probably not good. But so are many larger hospitals. Communities often depend on the existence of hospitals. Businesses don't want to locate themselves far from a hospital. When a local hospital closes, the chronically ill and the poor who have trouble with transportation are prohibitively far from health care. Small hospitals support the work of primary care doctors with labs and radiology suites and emergency services. Communities without a hospital often have only very few and basic outpatient providers. Small hospitals often provide more appropriate care for patients because everyone knows everyone else, so we remember what happened last time, what worked, what didn't. The nurses know who drinks on the sly or is abused by their husband. The specialists and the hospital physicians know each other well and also know and share patients which makes care more personal and makes patients feel more secure. Communication is excellent and things get done right away. For those patients who have problems that are beyond the scope of a small facility, the emergency department can stabilize and transport. In our hospital we have a heliport on the roof and our patients can be up and out and at the major referral center that is 90 miles away in next to no time. The very old and very sick who want comfort rather than life prolonging procedures can get that right near home, with physicians who know them and often know their family and friends, and share their concerns.

So I guess I am a fan of good little hospitals. But I am not necessarily a fan of the critical access system. Our hospital is occasionally so full we need to turn away patients, but we have more actual physical room and could definitely squeeze in a few more patients if we weren't limited to 25 beds. Also the fee for service system really does not encourage us to develop innovations that make patients get better faster. I think we do a great job at my local hospital of reducing over-testing and over-treatment, but there is no financial incentive to do so since we make more money if we do more. We would be better at creative thriftiness if it actually saved us money. Our creativity is stifled by the need to be little and by being paid fee for service.

Lately we are being encouraged to take the "96 hour rule" more seriously. We need to certify when we admit a patient that they will only require 96 hours in the hospital. If we think they are likely to be in our hospital longer than that, we theoretically need to transfer them to the larger hospital 90 miles away. Seriously? And if we think they will only need 96 hours but we are wrong, theoretically we should then transfer them. So our dear sweet 96 year old who is admitted with diarrhea and turns out to have a small bowel obstruction and then develops pneumonia would need to take an ambulance ride or a $40,000 helicopter ride on day 4 just as we have her really nicely stabilized. The alcoholic with pancreatitis who never gets better in 4 days but is perfectly appropriate for our level of care would go straight from the emergency room to the tertiary care facility. The overworked doctors at those hospitals are so definitely not going to love that, as they deal with their own sick patients. I've been on both sides of this situation, as the doctor transferring a patient and as the one receiving the patient. If a patient is being transferred solely because it is difficult to design an appropriate discharge, it is more difficult to do that from a hospital 90 miles away from their home. It is also extremely likely that subtleties of the history will be lost and that procedures and tests and mistakes will be repeated. Transfer to a different hospital is necessary if the patient's recovery is stalled because of lack of expertise or technology, but if it is only to save the payer (Medicare) money, I expect it will do the opposite.

What to do? I'm thinking that the whole critical access system needs to be reconsidered. Managing all small community hospitals the same way doesn't make sense. Clearly little hospitals need support in order to survive, but giving them arbitrary rules and paying them fee for service is hardly the way to make them function better and certainly doesn't encourage creative innovation.