Sunday, February 3, 2013

Our journey toward crossing the quality chasm - musings from the Intermountain ATP course

I spent all last week in Salt Lake City, Utah, at one of the worldwide recognized most prestigious academic activities in quality and patient safety - the Intermountain Advanced Training Program in Healthcare Delivery Improvement, which is taught by a veritable pantheon of healthcare quality improvement colossus leaded by Dr. Brent James.

This course is a 20 days course, taught over 4 weeks (one week each month for 4 months), and the attendees are the quality leaders in different institutions - all really smart and engaged individuals with a substantial amount of experience and knowledge in the field - several with 2 or 3 master degrees (MMM or MMA or MBA plus a MS or MPH). However, despite their knowledge and training, still something is missing. It is a fascinating experience to network with such a phenomenal group of professionals with a common goal - provide the best medical care in the world. 

This course helps to fill the gap - Dr. James has taken all the teachings from the gurus in quality, Dr. Deming and Dr. Shewhart and translated into healthcare. Essentially they teach how to understand that healthcare delivery is as well as in manufacturing, a series of processes which receive different inputs in order to have a final output or outcome, and its quality will depend whether it meets or not required specifications. Quality is defined by our own set of values, expectations, cultural beliefs, etc. and good quality is when the output meet specifications (which are defined expectations). The FOCUS-PDSA strategy allows to identify opportunities and implement quality improvement processes in small scales and translate subsequently toward a larger scale. It is very relevant to understand how the industry has improved and how certain industries achieve incredible safety records - e.g. aviation, car manufacturing, etc. - and how the application of Deming's philosophy has been instrumental in this incredible safety record. 

It is important to understand the history of healthcare delivery in America - how its philosophy has changed - after world war 2, there was an emphasis in ensuring access to healthcare to all the population; however after the costs started to rise and the insurance companies started to take control, the shift focused toward cost control and maximizing hospital reimbursement - this was sub-optimal as opportunities to care may have been missed by patients as insurance companies controlled the medical decision making not emphasizing at all in quality of care but just cost of healthcare delivery. However, quality of care was less than optimal and medical errors were the 6th cause of mortality in the US. This was highlighted in an publication by the Institute of Medicine called "To Err is Human" and subsequently by "Crossing the Quality Chasm". This has shifted equation of healthcare delivery toward "value" of care - which meant increasing the quality of healthcare delivery while minimizing unnecessary costs. This is the current philosophy that allows us to design the healthcare processes. 

It is important to stop practicing a highly variable "craft of Medicine" which allows for increase risk of errors and missed opportunities - it allows for an incredibly selfish and individualized practice of "what works for me". This can make a physician practice differently in a same patient/same scenario in different time periods. Patients are increasingly complex; medical knowledge is increasingly complex too - more than 10,000 different journals, it is impossible to know all the current evidence to support a safe medical practice. This is one of the reasons for having quality improvement systems in place - and to have all doctors get on board the ship of quality and safety and adopt the culture of quality as their main philosophy. 

But in order to ensure adequate quality delivery, we need to know whether we are meeting the specifications! Therefore, it is fundamental to have a clear understanding of our current performance - essentially, know well the data to be able to study and appraise it. Be able to graphically show where our performance gaps are is fundamental - using time series, pareto charts, Ishikawa (fish-bone) diagrams or other cause-effect diagrams, histograms, flow charts, etc. (Now a lot of things make more sense!). Metrics should drive performance when understood within an appropriate knowledge and understanding of our own institution philosophy, vision and mission. The graphs allows to identify outliers and areas of opportunity. Errors or mistakes are horrible words - should not be used; the purpose of quality improvement is not to punish or take action toward an individual - the context of all the theory is geared toward improving the system! Rather than using these words, it should be identified as "opportunities for improvement" or "outcomes outside of specification". All individuals within the system should be accountable, but the purpose of QI is to enhance the system in a consistent form. For example - you don't ask when climbing a regional jet whether your pilot is competent - you trust the system! The same should occur in hospitals - create systems that enhance patient safety and consistent quality delivery.

For quality improvement purposes, the most important aspect that Deming taught was to decrease variation - once variation is decreased, the area under the curve decreases - the population bell shape distribution narrows and its peak is more prominent - then it is easier to identify real outliers - the causes for real "signals" and be able to help improve. In a traditional bell shape, when arbitrary cut-offs are met, these outliers can mix with the rest of the population. So it is important to standardize processes to minimize variation. In healthcare, each patient will be different, so if we standardize our processes, the only variation will come from the patient who can receive an individualized care but the overall standards of care will be met. 

The leverage of all resources - technology: electronic health records, computerized-personal-order-entry systems (or CPOE), and non-technology: discharge processes, nurses/physician huddles, etc. - should be targeted toward minimizing variation and use all opportunities to meet top quality standards. 

Once a process is started - a work-flow diagram that illustrates the process and subsequent steps, can be modified with constant feedback from the end-users about its performance to improve it in a continuous way - what is also called continuous improvement.

A beauty if the QI philosophy is that once specifications are being met rather than "sleeping on the fame", a constant pursuit of further enhancement and refinement in the process should be maintained - this desire for continuous improvement is what creates safer and better environments - this philosophy is what helps the world to keep advancing and be a better place for the next generations. 

My responsibility will be to immediately apply all the currently acquired knowledge at my institution, as well as share this philosophy and knowledge with my peers, medical students and both Medicine and Pediatrics residents. This is important as the new generations must harbor the culture of quality and safety as their main philosophy. I'm excited as this will help to deliver a much better medical care and help to shape the Medicine of the future today. 

A safe medicine with highest quality standards allows us to practice our mantra....primum non nocere

Wednesday, January 2, 2013

Less is more - additional evidence against liberal blood transfusion (or in favor for parsimonious use of blood).

I went last year (yes, the year that just ended 2 days ago) to Mexico City to give a lecture at the International  Course of Internal Medicine sponsored by the Mexican College of Internal Medicine. My lecture was named "Blood is life: to transfuse or not" - and it was targeted toward presenting the evidence for parsimonious blood utilization. This invitation came as a result of my involvement with the preoperative anemia optimization program at the Cleveland Clinic.

At the Cleveland Clinic, a large effort was initiated about 6 years ago in order to decrease the number of transfusions, mainly red blood cells, and mostly in surgical patients. The efforts have yielded in an impressive decrease in blood utilization as well as in a more proactive behavior to optimize the patients' anemia before undergoing surgery. One of my main areas of interest is preoperative anemia optimization to minimize the risks of intra-operative or post-operative blood transfusion. We optimize the iron stores, or in special cases, use erithropoiesis stimulating agents (Jehovah's witnesses, hip and knee arthroplasties mainly).

The culture change has been slow but steady. Nowadays, nobody attempts to transfuse liberally in anybody with hemoglobin more than 7 g/dL; of course, each patients is evaluated individually and certainly you can transfuse at higher numbers in patients with other co-morbidities (for example, patients with severe chronic lung disease and active ischemic cardiomyopathy, or severe acute ischemic renal injury, etc.).

I have undergone a large review of literature which I presented in Mexico (the translated slide presentation can be seen here). The presentation raised controversy - some of my Mexican colleagues still transfuse based on "their experience" and not on the evidence; they are scared of using intravenous iron preparations; they still think an hemoglobin of 10 in a critically ill patient is an indication to transfuse. It was a big cultural shock to find out that it was in critical care patients where the evidence came from, supporting a parsimonious blood utilization. Some people advocate autologous blood donation (which we do not use here), as well as the use of perfluorocarbon blood substitutes (which as well we do not utilize here neither). A long road is to be traveled and a large educational effort is required to change long-standing practices; I was grateful by receiving the opportunity to help in the initiation of these efforts and will continue to share our experience and growing literature available.

In the past 2 weeks, two articles have come out to provide additional support to the parsimonious blood utilization - one published online in Archives of Internal Medicine which demonstrates and increased mortality in patients with acute myocardial infarction who were transfused - and the other published in tomorrow's NEJM - which fills out the missing part of the puzzle: whether pursuing a parsimonious blood utilization in active GI bleeding was a safe initiative.

The article in Archives, is a well designed metaanalysis which review 10 studies out of 729 finding interestingly a mortality risk ratio of 2.91 with a number needed to harm of 8 in patients hospitalized with myocardial infarction who were transfused. In addition, this risk was independent of the baseline hemoglobin level and to muddy the waters more, it was associated with increased risk of subsequent myocardial infarction. This is very interesting, as most guidelines recommend a higher threshold for transfusion (e.g 8 g/dL instead of 7 g/dL) in anemic patients with myocardial ischemia. I don't think clinicians should stop from transfusing patients that need blood; but I would advocate a more conservative approach looking into the causes of anemia - hematinic deficiencies (iron, vitamin B12, folate, etc.); bone marrow suppression or dysfunction; ongoing blood losses; etc. As the authors conclude a larger trial is needed and I concur; however, it is interesting to see the trend toward the worse outcomes, including reinfarction. 

The article in the NEJM, comes to provide very needed information in the actively bleeding population. We tend to transfuse as in an actively bleeding patient it is unclear whether the hemoglobin will stabilize or how low it can go. In my institution, we tend to monitor the hemoglobin every 4 to 6 hours in these patients - and hold for transfusion until the hemoglobin reaches 7 g/dL or less. This behavior is supported by this article, which certainly provides a sigh of relief to all who practice a parsimonious blood management. Of course, that in addition to this, clinicians should always optimize the hematinic deficiencies (iron stores, folate, vitamin B12, etc.), in order to maintain the substrate for an adequate hematopoietic response. I'm glad this article is out in print as certainly will provide a stronger support for all blood management programs, and minimize worse outcomes in our patients. 

Doctors and midlevel providers want the best for their patients. It is a matter of education and reaching a comfort level to pursue evidence based and common-sense based medicine. As always, we all strive for the best....primum non nocere.

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