Tuesday, 1 August 2017

Order Sets: A POKA-YOKE for Clinical Decisions by Dr. Ujjwal Rao, @DrUjjwalRao - Part 1/2

Poka (unintended mistake) Yoke (avoid) is the Japanese equivalent for “error proofing”.  
This Lean Manufacturing strategy is more relevant than ever in healthcare today. Why?

FIRST, DO NO HARM
The Supreme Court of India recently ordered one of the largest compensations so far in the country to a girl who lost her vision at birth in a case of medical negligence. The girl, who is now 18 years old, was born prematurely at a government hospital but was discharged from the hospital without a retinopathy test, a must for prematurely born babies. By the time the family discovered the lapse, the girl had lost her vision [1].

Fentanyl is a potent opioid medication used as part of anesthesia. A hospital pharmacist received an order for a ‘fentanyl drip 5,200 mcg per hour,’ which a nurse had just transcribed after accepting a telephone order. The pharmacist called the nurse to clarify the dose. The nurse confirmed that, although the dose was large, she had “read back” the order to the anesthesiologist several times to make sure she had heard the dose correctly. The pharmacist called the anesthesiologist himself, only to find that the intended order was for a fentanyl drip 50 to 100 mcg per hour [2].

The frequency of preventable medical errors resulting in patient injury and death is staggering. It is estimated that for every 100 hospitalisations, approximately 14 adverse events occur, translating to roughly 43 million avoidable patient injuries worldwide each year. In terms of quality of life for those inadvertently hurt: the loss of nearly 23 million years of healthy life [3]. And avoidable medical errors don’t just injure patients. Between 200,000 and 400,000 patients die every year in the United States as a result of preventable medical errors, [4] making avoidable hospital deaths the number three killer of American adults. 

These stunning figures clearly directly oppose the fundamental principle of medicine: First, Do No Harm.

THE MEDICAL INFORMATION EXPLOSION

Based on an extrapolation of a 2011 study [5] the stacking of CD-ROMs holding all of medical information available by 2020 would reach from earth to the moon and a half of the same distance beyond. And the rate of our medical knowledge growth is hard to fathom: by 2020, all that humanity understands about the body, health, and healthcare is projected to double every 73 days [6].

Just to keep up with the Primary Care literature would require a General Practitioner to read for 21 hours every single day [7]!

DIFFUSION OF KNOWLEDGE TAKES (A LONG) TIME

“Diffusion of medical knowledge” is the acceptance of new scientific discoveries into clinical practice. And such diffusion takes an extraordinarily long time... 

Back in the early 19th century, the idea of hand washing prior to examining pregnant women was considered revolutionary, and it was only after decades that hand washing to prevent puerperal fever was universally accepted in clinical practice. But you don’t have to look so far back. Take the case of β-blockers, a class of drugs whose beneficial effect in heart attack patients was established almost 30 years ago. Yet today, β-blockers are still widely under-prescribed [8]. 

The tragic reality is that even today, it takes an average of 17 years for only 14% of new scientific discoveries to find their way into daily clinical practice [9]. Thus our patients routinely wait to be prescribed drugs or undergo procedures or interventions proven effective decades earlier.

In the end, we have a disastrous collision of realities: all medical knowledge will soon be doubling every 73 days, while it will likely take decades for any new knowledge to routinely be incorporated into patient care.

GOOD CARE PAYS - POOR CARE COSTS

Healthcare is being reformed globally. In particular, the payment models are increasingly moving away from Fee-for-Service (FFS) to Pay-for-Performance (P4P). Full-fledged or partial P4P models are now increasingly being adopted by most of the developed nations, including the USA, UK, and Australia, among others. P4P models aim to encourage care providers (individuals and institutions) to provide better quality care by linking reimbursement (provider payments) to clinical and performance outcomes. The models also penalise medical errors, adverse outcomes, and excessive diagnostic and treatment costs. Thus in the P4P model, providers and healthcare systems risk significant financial penalties if they are unable to avoid adverse clinical outcomes and unnecessary tests and procedures.

To summarise, healthcare is now faced with a new dilemma: a significant burden of preventable medical errors, an explosion in the rate of medical information growth, and the historically slow adoption of new discoveries. Add to this an expanding regulatory environment demanding high-quality care plus the rapid rise of medical malpractice litigation and providers must ask themselves, “Is the practice of medicine no longer humanly possible?”

A SOLUTION TO THE MULTI-FACTORIAL

HEALTHCARE DILEMMA


So how do we reduce (and eventually eliminate) preventable medical errors? Providing current, credible, evidence-based information and guidance at all points of care is a cornerstone in the answer to this question. In the area of medication errors (a common form of preventable patient injury and death), a system analysis of a large sample of serious mistakes [10] identified 16 major types of causative system failures. All of the top eight were deemed preventable through the provision of better medical information.

Today, Clinical Decision Support Systems (CDSS) are being hailed as a major
weapon in the battle against preventable medical errors [11]. And at the heart of the most impactful CDSS lies evidence-based medicine (EBM). Advocated as a method to improve clinical outcomes [12], the incorporation of EBM into powerful CDSS has the potential to transform healthcare safety and quality, a true healthcare Poka-Yoke! As such, EBM is the foundation of evidence-based care, broadly defined as patient management through the conscientious and judicious use of current best evidence from clinical care research integrated with individual clinical expertise [13]. And to complete the picture, evidence-based care should also include patient preferences, input, and active participation. 

Clearly based on the foundations of the healthcare dilemma, in order to be safe, effective, and efficient, today’s physicians, nurses, pharmacists, therapists, patients, and other healthcare stakeholders must have real-time, mobile access to current, credible, evidence-based information. While many have been disappointed that Electronic Health Records (EHRs) have not on their own solved the dilemma, it is critical to appreciate that technology is the vehicle through which EBM and other information is delivered, not the primary source of information itself. In the absence of technology (in fact, long prior to the development of computers and the internet), current, credible, evidence-based information allowed the world’s leading healthcare providers to deliver high quality, evidence-based care.

Today’s technology represents a great leap forward in accessing high value care information at points across the globe, with the knowledge provided by EBM integrated into EHRs and available via “the cloud,” all as part of CDSS.

Evidence-based care is most impactful when current, credible, evidence-based knowledge is incorporated into the provider workflow; thus, the most advanced CDSS are “workflow-integrated.” More importantly, these systems are evidence-adaptive [12]; that is, the clinical knowledge within the CDSS continually reflects current EBM from the research literature plus sources of practice expertise. 


The full potential of a CDSS can be realised when it is seamlessly integrated into the clinical workflow and is evidence-adaptive [12].
Stay tuned for the Part TWO of the Blog from Dr. Ujjwal Rao.

Suggested Reading
Dr. Ujjwal was also asked in a recent interview with BioSpectrum India, to share more about the challenges, and most urgent needs in today’s healthcare systems. 

Some might argue that technology is the way forward but Dr. Ujjwal is of the view that technology is only the vehicle through which information and knowledge is delivered. High-quality and consistent care needs to be driven by both tech and evidence-based medicine. The full article can be read online here: 
http://www.biospectrumindia.com/interviews/71/9023/evidence-based-healthcare-is-the-need-of-the-hour.html

References
[1]: Vaidyanathan, A. “Supreme Court Orders Compensation of Rs. 1.8 Crore to
Chennai Girl in Medical Negligence Case.” NDTV, July-Aug. 2015. Web.
http://www.ndtv.com/india-news/supreme-court-orders-compensation-of-rs-1-8-crore-to-chennai-girl-in-medical-negligence-case-777238

[2]: Institute for Safe Medication Practices. “Safety Briefs: Single Digits.”
Medication Safety Alert! 9 (July 2004): 1.

[3]: Jha, Ashish K., et al. "The global burden of unsafe medical care: analytic
modelling of observational studies." BMJ quality & safety 22.10 (2013):
3809-815

[4]: James, John T. "A new, evidence-based estimate of patient harms associated with hospital care." Journal of patient safety 9.3 (2013): 122-128.

[5]: Hilbert, Martin, and Priscila López. "The world’s technological capacity to
store, communicate, and compute information." Science 332.6025 (2011):
60-65.

[6]: Densen, Peter. "Challenges and opportunities facing medical education."
Transactions of the American Clinical and Climatological Association 122
(2011): 48.

[7]: Alper, Brian S., et al. "How much effort is needed to keep up with the
literature relevant for primary care?." Journal of the Medical Library Association 92.4 (2004): 429.

[8]: Bradley, Elizabeth H., et al. "Quality improvement efforts and hospital
performance: rates of beta-blocker prescription after acute myocardial
infarction." Medical care 43.3 (2005): 282-292.

[9]: Balas, E. Andrew, and Suzanne A. Boren. "Managing clinical knowledge for
health care improvement." Yearbook of medical informatics 2000.2000 (2000):
65-70.

[10]: Leape, LucianL., et al. "Systems analysis of adverse drug events." Jama 274.1(1995): 35-43.

[11]: Bates, David W., et al. "Reducing the frequency of errors in medicine using information technology." Journal of the American Medical Informatics
Association 8.4 (2001): 299-308.

[12]: Sim, Ida, et al. "Clinical decision support systems for the practice of
evidence-based medicine." Journal of the American Medical Informatics
Association 8.6 (2001): 527-534.

Author
Dr. Ujjwal Rao
Dr. Ujjwal Rao is Senior Clinical Specialist in Integrated Decision Support Solutions, and is based in New Delhi, India. He provides strategic counsel to health providers on designing world-class clinical decision support systems with Elsevier’s comprehensive suite of current and evidence-based information solutions that can improve the quality and efficient delivery of healthcare.

An experienced emergency physician, executive, clinical informaticist and technology evangelist, Dr. Rao has a decade of experience serving in trust and corporate hospitals in various roles ranging from clinical administration, hospital operations to quality & accreditation. In his former positions, Dr. Rao led EHR implementations for large hospital groups and designed bespoke healthcare analytic solutions to raise profitability.

His passion to see transformation through technology led him to volunteer as a quality consultant with the United Nations. He also currently serves as an Assessor on the Panel of the Quality Council of India for the National Healthcare Accreditation Standards body, NABH.

Dr. Rao obtained his degree in Medicine and then specialized in Hospital and Health Systems Management, Medical Law and Ethics before completing his PhD in Quality and Medical Informatics.

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