Do protocols and pathways improve care? The example of sepsis bundles
As I’ve written before, I have to confess I’ve never been a huge fan of pathways and protocols. They often struck me as rigid and insensitive to the the nuances of differences between patients. There also are times when they are just absurd, times when physicians, and especially mid-level providers, implement them when analysis of the clinical situation clearly shows them to be inappropriate. I suppose part of me feels rigid protocols and pathways diminish the art of medicine, especially for physicians like me who have been practicing for decades. But more and more evidence is emerging that these things help patient care by ensuring nothing falls through the cracks. I find myself noticing as I enter protocol-driven orders that they can remind me of how to proceed. In the electronic medical record I can always uncheck a pre-filled order box if it is inappropriate for a particular patient.
Now we have more data about the topic. The clinical situation that has been extensively studied with protocols is sepsis, which is a series of life-threatening systemic events that can be provoked by various things, but most commonly a serious infection. A key reason for sepsis being highly appropriate for protocols and pathways is that outcome, odds of survival, is highly influenced by early recognition and treatment. Moreover, the immediate treatment is simple, relatively safe, and available in any hospital. This is why virtually all hospitals now have what are called “sepsis bundles.” These are measures taken for suspected sepsis early in the course, before the diagnosis is confirmed. Because it’s common, researchers have looked at how implementing sepsis bundles has affected outcomes. Bear in mind these comparisons are generally not randomized trials because the ethics of that would be questionable. Historical controls, what happened before implementing the bundle, are often used. This approach carries the possibility of a Hawthorne Effect: the phenomenon that can happen when people know they are being observed and change their behavior.
Of the many investigations reporting an improvement in sepsis outcomes, this one and this one are representative. The latter is part of the Surviving Sepsis program, and initiative of the Society of Critical Care Medicine. The bottom line is that such bundles of strongly recommended actions improve outcomes. Sepsis is a bit of an unusual case, though, because in sepsis early and immediate action is important, something not the case in many other conditions in which we have time to ponder things. New York state offers an interesting test cast of bundle effectiveness since it has a state law that mandates them. The above studies were in adults. There have been several recent studies of sepsis bundles in children, such as here and here, and they also show benefit. New York provided the comparison, before and after the implementation of the mandate (“Rory’s Regulations).
I still believe slavish, unthinking adherence to pathways and protocols is bad because they can get in the way of clear thinking. And we don’t need protocols for everything. Yet with more and more acute care being delivered by mid-level, non-physician providers, people who do not have extensive training in the pathophysiology of disease, these things provide a safety net of care. I’ve become cautiously reconciled to them, especially things like sepsis and stroke, in which early and prompt action matters a great deal.