Thursday, October 08, 2015

Shared baselines as a guide to protocols

There have been some interesting and important discussions flying across the web in recent days on the issue of protocols in helping to reduce variation and reduce the incidence of harm to patients.  My mistake in the debate was assuming that medical leaders would be reasonable about how protocols should and should not be used.

A doctor friend, highly committed to patient safety, notes:

My point about the protocols is that I have been chastised for not following them in situations where it was blatantly obvious that they did not apply. ("The protocol is there for a reason.")

The chastisement comes not from hospital administrators, but from clinician leaders in the doctor's own department:

We just got another email scolding us for not following the "colorectal pathway" sufficiently. One of the provisions of that pathway, for example, is strict limitation of iv fluids, sometimes difficult to "comply" when patients are severely dehydrated from their bowel preps, particularly the elderly.

The initial goals were to decrease opiate use and decrease PACU LOS, both worthy goals, but we're all annoyed at being beaten over the head with them and getting our hands slapped if we deviate, even with good reason.

It's ironic that on the one hand we are extolling the virtues of gene-based individualized therapies, but on the other hand we are trying to pigeonhole every patient into a standardized protocol. 

This is disappointing in so many ways, but especially because the solution is in the hands of the profession.  Brent James discussed the sensible application of protocols to clinical process improvement, as employed in the Intermountain Health system, several years ago:

The concept of “shared baselines” came to rule:

1 -- Select a high priority clinical process;
2 -- Create evidence-based best practice guidelines;
3 -- Build the guidelines into the flow of clinical work;
4 -- Use the guidelines as a shared baseline, with doctors free to vary them based on individual patient needs;
5 -- Meanwhile, learn from and (over time) eliminate variation arising from the professionals, while retain variation arising from patients.

Note that this approach demands [my emphasis] that doctors modify shared protocols on the basis of patient needs.  The aim is not to step between doctors and their patients.  This is very different from the free form of patient care that exists generally in medicine.  Notes Brent, “We pay for our personal autonomy with the lives of our patients.  This is indefensible.”  The approach used at Intermountain values variation based on the patient, not the physician.

I guess my friend's experience is one example of the Law of Unintended Consequences.  I think the rigid approach being employed in that doctor's hospital and elsewhere is the result of little or no training in clinical process improvement in medical schools and in graduate medical education. We have often been told by residents, during our Telluride patient safety workshops, that they get more exposure to matters of clinical process improvement and high reliability systems in four days than in their seven previous years of medical training.

Brent expressed hope back in 2011:

Brent is optimistic because he has seen this philosophy of learning how to improve patient care extend to more and more doctors and hospitals around the country.  He views it as providing the answer to the rising cost of care, and he is excited about the potential.  He concludes that this is a “glorious time” to be in medicine because it is the “first time in 100 years” that doctors have a chance to institute fundamental change in the practice of medicine.

Thus far, such change only exists in certain islands of excellence, and it clearly takes energy and thoughtfulness to sustain it even in those places.


Anonymous said...

I do chart audits, review outliers from our ORYX auditor (attempting to find documentation to throw out the record), and brief senior hospital executives on these findings as part of my nursing role.

If physicians documented WHY they are deviating from the clinical pathway, then EVERYONE wins. It doesn't matter whether it's continued IV fluids, extension of antibiotics beyond the 24 hours post-op, or reasons for exemption of expected anticoagulation measures. If everyone just communicated (instead of assuming), then everyone involved with this patient's care would have a shared mental model and easily justify these deviations.

Paul Levy said...

Yes, yes, yes. Exactly right!

I've heard of anaesthesiologists who, during operations, felt responsible to vary some parameters because of observations they are making about a patient's status. They do it quietly and effectively, and at the end of the case, the surgeon would get angry because they violated the clinical pathway. A simple comment from one to the other during the case would avoid the conflict and enable the two as a team to decide on whether a variation was the right thing to do.

Carole said...

Mr. Levy
Can't say I would disagree with that surgeon for getting angry, has every right to. There's always the what it's, and when those happen puts surgeons reputation and career in jeopardy, and the patients life at risk.
Actually the whole team, right?
No offense but I'd throw that one person to the wolves.

Paul Levy said...

I think not. It is a team, and the person controlling the airway and blood pressure has a very important job to do. Your approach just breaks down the potential for essential cooperation.

Stefani said...

In my experience, protocols are excellent guides to reduce variation. But when medical judgment demands veering from the protocol, there has to be documentation describing the rationale otherwise the quality/performance improvement reviewers are without benefit of his thinking. This may be why this physician's colleagues are 'scolding' him since it affects the outcomes of his entire department.

Paul Levy said...

Hence the need for communication. We are in accord.

Why it should be so hard to build that into the culture is something we spend a lot of time with when we train residents!

Kevin Wang said...

Standardized Clinical Assessment and Management plans (SCAMPS) which ironically were developed at the Brigham and Boston Children's provide an excellent clinician-designed approach to protocols that accommodate patient differences and acts as a living document to account for new evidence and technology. By physicians explaining any deviation the document continues to evolve while promoting standardization where appropriate.

Bruce Ramshaw said...

This is a very important discussion. Guidelines and protocols should be a starting point, not the goal. What is best value for one patient might actually harm a different patient. The true definition of standardization is not uniformity, but optimal variety (Textbook- Introduction to Standards and Standardization). Using principles of complex systems science and tools, like predictive analytics, the optimal variety of processes for various patient subpopulations can be defined (better and better over time). I have a short video talking about this on the General Surgery News website:

Paul Levy said...

Thanks, Kevin and Bruce.

David States said...

We need to move from blaming the doc to supporting the doc. Most EMRs are really EBSs (Electronic Billing Systems) with medical communications thrown in almost as an afterthought. Count the number of lines of code or CPU cycles. The physician GUI remains a form based web interface to which few resources are devoted in either development or implementation. The vast majority of the resources go to billing and compliance, not enhancing clinical care or provider productivity.

Protocol deviations are by definition nonstandard aspects of care. Documenting protocol variations forces the physician into less used and less familiar aspects of the EMR, and the task is often substantially more time consuming than generating a standard note using familiar aspects of the EMR.

Analogy is often made between the airline industry and medicine. We provide pilots with black boxes so that they do not have to devote effort to documentation at critical moments. Anesthesia has been described as 99% boredom and 1% terror. When a protocol deviation occurs, would you prefer that the anesthesiologist focus on clinical care or documentation? We are in effect asking a pilot who has encountered a strong crosswind during landing to in the course of landing open the Flight Data Recording System, find the page describing landings, search for where cross winds are described, click on East or West, stop to recall whether the approach was from the North or South, scroll down to select the wind strength, scroll down to select the visibility, click checkboxes for rain, icing conditions, ... And meanwhile safely land the airplane. The anesthesiologist can spend some time after the case to add a note, but that is not what you are asking for, and they might not recall every detail.

IBM Watson won Jeopardy in 2011. Computers are now 4 times as fast and AI algorithms have improved significantly. Devoting IBM Watson level resources to individual physicians and nurses is quite feasible, and it only needs to enhance provider productivity modestly to more than pay for itself.

1) Deploy clinical NLP with restricted search spaces to improve accuracy. When Siri or Cortana or Google Now responds to your inquiry, they don't know whether you are asking about the stock market, weather, map navigation or the phase of the moon. SiriMed can focus on the case at hand. The smaller the hypothesis space that needs to be searched, the lower the chance of a random erroneous match and the greater the accuracy.

2) Deploy conversational NLP error correcting and ambiguity resolution. When SiriMed is not completely sure that she understands what you said, let her rephrase and ask for clarification. After all, even humans need to ask each other questions.

3) Build protocols into the EMR and help providers stay on track. Talk to the doc when protocols seem to be colliding and automatically document it (e.g. older patient, weight down from previous, may be dehydrated as a result of bowel prep protocol, do we need to deviate from the IV fluids protocol?). Let SiriMed document the context of the deviation without disrupting the physician or nurses cognitive workflow.

4) Institute physician impact statements for EMR changes and features. All the extras add up. ED physicians now spend more time on documentation than any other task.

5) Do cost benefit analysis on EMR changes and features. If you present it with convincing evidence that it will enhance patient care, your docs and nurses will embrace it enthusiastically. Not so much if it was just arbitrarily inflicted on them by someone who has never actually cared for a patient.

Bottom line, physician and nursing morale is at a low point because substantial documentation tasks have been added to their workloads without systematic evidence of benefit. Don't force our most valuable personnel to deal with antiquated and obsolete user interfaces while being blamed for less than perfect performance. If we want better performance, we need to better support front line providers.

Dave said...

Paul, please explain why it is ironic that the Brigham and Children's developed SCAMPS.

Paul Levy said...

I imagine he was referring to the fact that it was Dr. Samuels from the Brigham who seemed to object to this approach to quality and safety improvement.

Kim Oates said...

Of course protocols are valuable and of course they should be able to be modified depending on individual patient need.
I tell my students: "The fact that you put a protocol into gear does not mean that you put your brain into neutral"

Carole said...

I'm curious is a surgeon always entirely responsible for choosing his or her team?
Until now I only looked at the trust issues from a patients point of view, never the surgeon and his or her teams. After this conversation from what I've learned and now understand, I honestly have more compassion and respect for surgeons and their teams than Ive ever had before. The extraordinary amount of pressure they must have needing to trust one another, is unfathomable, and I never considered that.
How overwhelming must it be for a surgeon and others on his or her team when just one takes it upon themselves to deviate from protocols and not communicate with the team and a patient is harmed or loses their life. I get and understand it's a team, but I can't help but to feel bad when one persons mistake affects them all. I'm sure everyone will disagree with me, but I believe the one person should be held accountable and not the whole team or hospital, unless there's an attempt to hide or cover up the truth, of course that's a criminal act of fraud, the ultimate act of betrayal to us patients, and unforgivable at least for me and my family it is.

William Palmer MD said...

Reposted from the Health Care Blog:

Good discussion. Thanks. I wonder if we know enough to have very many solid protocols. The science is changing so fast it seems. Look at the variation in protocols themselves. Also, I wish folks would begin thinking about getting the correct diagnosis a little more. I want a few patients to have acute intermittent porphyria and not appendicitis and a few to have Mediterranean Fever instead of migratory arthritis, etc. I hope artificial intelligence can move along faster and help us here.

Jason_Lockette_MD_MBA said...

From THCB:

We wouldn’t need protocols if we would consistently practice evidence-based medicine. How often do our colleagues treat routine otitis externa with PO antibiotics? How often do we prescribe antibiotics for viral sinusitis/bronchitis? How many people are addicted to narcotics despite the fact that there is no good evidence to support their use in chronic, non-cancer pain? How many unnecessary CT scans are done daily in our ER’s? How many people have died because we failed to recognize the early signs of sepsis? We fail to police ourselves but then we complain when the dreaded protocols are forced on us.

PhilipAGreen said...

From THCB:

Perhaps part of the resistance to protocols in medicine is not just the loss of autonomy but the addition of multiple extra steps for even the simplest processes. Physicians are drowning in their computer screens already. Often a new protocol introduces multiple extra checklists, red flags, and automatic triggers in the EHR that must be addressed before meds can be ordered or fluids given.

Add in the fact that now many protocols are triggered automatically by EHRs and often enroll the wrong patients. Every single one of those patients the physician now has to spend time documenting why the protocol did not apply. That is time lost from patient care.

I think protocols clearly can improve patient safety and should be done. But there should be equal emphasis at studying how they will impact the efficiency of an entire department, not just the individual patient they are applied to. If protocols are designed that make patient care safer and at the same time improve the efficiency of an entire department, I think you will find physicians would be more than willing to implement them.

Rob Lamberts said...

From THCB:

We always need to realize (as I am sure you do) that for each patient n=1. We are not doing science or statistics; we are USING science and statistics to make sure we are doing the best care we can. Guidelines and protocols are condemned too quickly by physicians, no doubt. We are afraid to find out where we are deviating from the norm, when we should be grateful to know that reality. All physicians have inside their own head protocols as to what “normal” looks like for certain kinds of patients. This is called good care. On the other hand, assuming that deviating from normal is always indicative of bad care is also a problem. Docs need to know when they are outliers. We need to know when we are outside of the norm, but only for information. Being punitive in this case is not valuable in an environment where docs feel targeted (and where they are the key factor in controlling cost). In general, we docs should always hold ourselves to higher standard than that which any protocol puts us under. That is the definition of being a good doctor.