What’s New in the Patient Safety World

April 2016

 

 

·         Dexmedetomidine and Delirium

·         Can Antibiotics Lead to Delirium?

·         HAI’s: Gaming the System?

·         Nudge: An Example for Hand Hygiene

 

 

 

Dexmedetomidine and Delirium

 

 

Pharmacologic interventions to prevent or treat delirium have been elusive. Antipsychotic drugs have sometimes been touted to be successful but the evidence has not been very convincing. A meta-analysis of antipsychotic treatment in patients with delirium (Kishi 2015) suggested that second generation antipsychotics have a benefit for the treatment of delirium with regard to efficacy and safety compared with haloperidol but emphasized that further study using larger samples is required. But another recent systematic review and meta-analysis found that current evidence does not support the use of antipsychotics for prevention or treatment of delirium (Neufeld 2016). Those authors found antipsychotic use was not associated with reduction in delirium incidence, change in delirium duration, severity, or hospital or ICU length of stay.

 

For several years now there has been interest in the use of dexmedetomidine, an α2-adrenoreceptor agonist, as a sedation agent in the ICU because it might be associated with less delirium. In our February 10, 2009 Patient Safety Tip of the Week “Sedation in the ICU: The Dexmedetomidine Study” we discussed the SEDCOM (Safety and Efficacy of Dexmedetomidine Compared With Midazolam) Study, which concluded that dexmedetomidine was as effective as midazolam at keeping patients in the desired sedation range and was associated with a reduced prevalence of delirium and reduced time to extubation (Riker 2009). However, we urged caution in interpreting the conclusions of that study because of several methodological and other concerns outlined in our column. We again discussed dexmedetomidine in our June 16, 2015 Patient Safety Tip of the Week “Updates on Delirium”.

 

Now another study has addressed the use of dexmedetomidine in intubated ICU patients with delirium (Reade 2016). The Dexmedetomidine to Lessen ICU Agitation (DahLIA) study was a double-blind, placebo-controlled, parallel-group randomized clinical trial in 15 ICU’s in Australia and New Zealand. Subjects were ICU patients who were deemed to be ready for extubation except that they had delirium. Dexmedetomidine increased ventilator-free hours at 7 days compared with placebo (median, 144.8 hours vs 127.5 hours, respectively). Among several secondary outcome measures they also found that dexmedetomidine reduced time to extubation (median, 21.9 hours vs 44.3 hours with placebo), and accelerated resolution of delirium (median, 23.3 hours vs 40.0 hours).

 

Again, this sounds encouraging, particularly since our pharmacologic armamentarium for managing delirium is so limited. Yet there are again some red flags that urge us to be cautious in recommending widespread use of dexmedetomidine. First of all, this study applies only to a very select group of patients – those who were already well enough to be being considered for extubation except for their delirium. The authors note that they screened 21,500 patients to recruit just the 74 patients randomized in the study! That small sample size (actually only 71 patients after 3 withdrawals for various reasons). Even more importantly, the study was terminated before its planned recruitment of 96 patients. Studies with early termination typically show more exaggerated effect sizes. Early termination was apparently done because the funding source ceased funding beyond the originally defined period. The authors note that the funding source had no role in the design of the study and had no access to study data during the study, and the authors performed sensitivity analyses suggesting the abbreviated sample size was unlikely to alter the primary conclusion. Nevertheless, such occurrences always raise our “hype radar” or “spin radar” (see our February 16, 2010 Patient Safety Tip of the Week “Spin/Hype…Knowing It When You See It”).

 

So while we are somewhat encouraged by the results of the DahLIA study, we’re not yet ready to jump on the dexmedetomidine bandwagon for more widespread use. Remember, this was a very narrow patient population and it would be premature to extrapolate the results to patients with delirium earlier in their ICU course (i.e. before they were deemed otherwise ready for extubation). The good news, though, is that the dexmedetomidine seemed to be well tolerated in this study and adverse events were rare. We therefore look forward to further studies on the use of dexmedetomidine for either prevention or treatment of delirium.

 

 

 

Some of our prior columns on delirium assessment and management:

·         October 21, 2008 “Preventing Delirium

·         October 14, 2008 “Managing Delirium

·         February 10, 2009 “Sedation in the ICU: The Dexmedetomidine Study

·         March 31, 2009 “Screening Patients for Risk of Delirium

·         June 23, 2009  More on Delirium in the ICU

·         January 26, 2010 “Preventing Postoperative Delirium

·         August 31, 2010 “Postoperative Delirium

·         September 2011 “Modified HELP Helps Outcomes in Elderly Undergoing Abdominal Surgery

·         December 2010 “The ABCDE Bundle

·         February 28, 2012AACN Practice Alert on Delirium in Critical Care

·         April 3, 2012 “New Risk for Postoperative Delirium: Obstructive Sleep Apnea

·         August 7, 2012 “Cognition, Post-Op Delirium, and Post-Op Outcomes

·         September 2013 “Disappointing Results in Delirium

·         October 29, 2013 “PAD: The Pain, Agitation, and Delirium Care Bundle

·         February 2014 “New Studies on Delirium

·         March 25, 2014 “Melatonin and Delirium

·         May 2014 “New Delirium Severity Score

·         August 2014 “A New Rapid Screen for Delirium in the Elderly

·         August 2014 “Delirium in Pediatrics

·         November 2014 “The 3D-CAM for Delirium

·         December 2014 “American Geriatrics Society Guideline on Postoperative Delirium in Older Adults

·         June 16, 2015 “Updates on Delirium

·         October 2015 “Predicting Delirium

·         April 2016 “Can Antibiotics Lead to Delirium?

 

 

 

References:

 

 

Kishi T, Hirota T, Matsunaga S, Iwata N. Antipsychotic medications for the treatment of delirium: a systematic review and meta-analysis of randomised controlled trials. J Neurol Neurosurg Psychiatry 2015; Published online first September 4, 2015

http://jnnp.bmj.com/content/early/2015/09/04/jnnp-2015-311049.abstract

 

 

Neufeld KJ, Yue J, Robinson TN, et al. Antipsychotic Medication for Prevention and Treatment of Delirium in Hospitalized Adults: A Systematic Review and Meta-Analysis.  Journal of the American Geriatrics Society 2016; published online 23 March 2016

http://onlinelibrary.wiley.com/doi/10.1111/jgs.14076/abstract

 

 

Riker RR, Shehabi Y, Bokesch PM, et al for the SEDCOM (Safety and Efficacy of Dexmedetomidine Compared With Midazolam) Study Group. Dexmedetomidine vs Midazolam for Sedation of Critically Ill Patients. A Randomized Trial. JAMA. 2009; 301(5):489-499. Published online February 2, 2009

http://jama.jamanetwork.com/article.aspx?articleid=183300

 

 

Reade MC, Eastwood GM, Bellomo R, et al. Effect of Dexmedetomidine Added to Standard Care on Ventilator-Free Time in Patients With Agitated Delirium: A Randomized Clinical Trial. JAMA  2016; Published online March 15, 2016

http://jama.jamanetwork.com/article.aspx?articleid=2503421

 

 

 

 

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Can Antibiotics Lead to Delirium?

 

 

When confronted with patients having delirium our first approach is to look for and remove any precipitating or contributing factors. One such factor we tend to forget about is the use of antibiotics. Given the high prevalence of delirium in the ICU and post-operative settings, it would not be surprising to find antibiotic use frequent in such patients.

 

A recent review of antibiotic-associated encephalopathy (Bhattacharyya 2016) is very timely and identifies 3 unique clinical phenotypes: encephalopathy commonly accompanied by seizures or myoclonus arising within days after antibiotic administration (caused by cephalosporins and penicillin); encephalopathy characterized by psychosis arising within days of antibiotic administration (caused by quinolones, macrolides, and procaine penicillin); and encephalopathy accompanied by cerebellar signs and MRI abnormalities emerging weeks after initiation of antibiotics (caused by metronidazole). Those clinical features of each phenotype can and should lead to recognition of the pathogenetic role being played by the antibiotic and lead to its discontinuation.

 

The phenotype characterized by myoclonus and/or seizures (Type 1 AAE) is often due to penicillin or cephalosporins and often occurs in the setting of renal insufficiency. It usually appears within days of antibiotic administration. Seizures associated with cephalosporin-associated encephalopathy were frequently nonconvulsive. EEG may show generalized slowing but often shows periodic discharges with triphasic morphology or epileptiform discharges. MRI is normal in these cases. The encephalopathy usually resolves within days of discontinuation of the offending antibiotic.

 

Type 2 AAE also typically begins within days of antibiotic initiation and is characterized by frequent occurrence of psychosis and resolution within days of discontinuation of the offending antibiotic. Seizures are rare in this type and the EEG is more likely to be normal (or show nonspecific findings). MRI is usually normal. This phenotype may occur with procaine penicillin, sulfonamides, fluoroquinolones, and macrolides.

 

The third type (Type 3 AAE) occurs with metronidazole begins weeks after initiation and is characterized by frequent occurrence of cerebellar dysfunction. Seizures are rare and EEG usually shows only nonspecific abnormalities but the MRI is typically abnormal, showing a typical pattern of T2 hyperintensities in the dentate nuclei of the cerebellum

with variable involvement of the brainstem, corpus callosum, or other regions.

 

The authors also note that isoniazid (INH) may cause an encephalopathy that does not fit nicely into one of the 3 above phenotypes. Onset is weeks to months after INH initiation. Psychosis is common but seizures are rare and EEG may just show nonspecific abnormalities.

 

The Bhattacharyya paper acknowledges the issue of strength of association with antibiotic use in each phenotype and also has a nice discussion on the possible pathophysiologies of each phenotype and the pharmacokinetic and patient-related factors that are important.

 

Overall this is an important contribution to the clinical management of the patient with delirium and a key reminder to evaluate all aspects of care.

 

 

Some of our prior columns on delirium assessment and management:

·         October 21, 2008 “Preventing Delirium

·         October 14, 2008 “Managing Delirium

·         February 10, 2009 “Sedation in the ICU: The Dexmedetomidine Study

·         March 31, 2009 “Screening Patients for Risk of Delirium

·         June 23, 2009  More on Delirium in the ICU

·         January 26, 2010 “Preventing Postoperative Delirium

·         August 31, 2010 “Postoperative Delirium

·         September 2011 “Modified HELP Helps Outcomes in Elderly Undergoing Abdominal Surgery

·         December 2010 “The ABCDE Bundle

·         February 28, 2012AACN Practice Alert on Delirium in Critical Care

·         April 3, 2012 “New Risk for Postoperative Delirium: Obstructive Sleep Apnea

·         August 7, 2012 “Cognition, Post-Op Delirium, and Post-Op Outcomes

·         September 2013 “Disappointing Results in Delirium

·         October 29, 2013 “PAD: The Pain, Agitation, and Delirium Care Bundle

·         February 2014 “New Studies on Delirium

·         March 25, 2014 “Melatonin and Delirium

·         May 2014 “New Delirium Severity Score

·         August 2014 “A New Rapid Screen for Delirium in the Elderly

·         August 2014 “Delirium in Pediatrics

·         November 2014 “The 3D-CAM for Delirium

·         December 2014 “American Geriatrics Society Guideline on Postoperative Delirium in Older Adults

·         June 16, 2015 “Updates on Delirium

·         October 2015 “Predicting Delirium

·         April 2016 “Dexmedetomidine and Delirium

 

 

 

References:

 

 

Bhattacharyya S, Darby RR, Raibagkar P, et al. Antibiotic-associated encephalopathy. Neurology 2016; published online before print February 17, 2016

http://www.neurology.org/content/early/2016/02/17/WNL.0000000000002455

 

 

 

 

 

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HAI’s: Gaming the System?

 

 

Our What's New in the Patient Safety World columns for February 2015 “17% Fewer HAC’s: Progress or Propaganda?” and January 2016 HAC’s Have Declined Since 2010discussed interim data sets from AHRQ which showed that there was a 17% reduction in hospital-acquired conditions (HAC’s) between 2010 and 2014. Over the 4-year period the biggest reductions in HAC’s percentage-wise were seen for CLABSI’s (-72%), CAUTI’s (-38%), and post-op venous thromboembolism (-43%).

 

AHRQ’s Chartbook on Patient Safety summarizes patient safety measures, including overall hospital-acquired conditions (HAC’s) and hospital-associated infections (HAI’s), highlighting the trends between 2010 and 2014 (AHRQ 2016). Similarly, CDC has reported substantial reductions in CLABSI’s, CAUTI’s, surgical site infections (SSI’s), hospital-onset C. difficile infections, and hospital-onset MRSA bacteremias over a roughly similar time frame (CDC 2016).

 

While we’ve had some degree of skepticism in interpretation of the data, overall we’ve felt comfortable that true progress is being made.

 

One of the many interventions cited as contributing to the apparent improvement in HAI and HAC rates is the financial penalty hospitals pay for poor performance in these rates (primarily for CMS/Medicare patients but also for some other insurers). We’ve always been concerned about how coding changes have obfuscated some quality parameters. For example, we’ve always been concerned about changes in sepsis coding may have artificially lowered mortality rates for both sepsis and pneumonia (see our

March 2016 What's New in the Patient Safety World column “Finally…A More Rationale Definition for Sepsis”). Now a study from the Stanford Graduate School of Business questions whether coding practices have similarly impacted quality reporting for the HAI’s reported to CMS as well (Bastani 2015).

 

Bastani and colleagues note that CMS does not directly monitor the occurrence of the various HAI’s. Rather it collects administrative (billing) data from hospitals and does chart reviews of a small sampling to assess validity. The Stanford researchers used more sophisticated techniques to assess how rampant “upcoding” might be. In particular, one form of upcoding would be assigning a designation present-on-admission (POA) to an infection when it was, in fact, a hospital-acquired infection. Upcoding would be financially beneficial to hospitals either by increasing reimbursement or avoiding penalties.

 

They compared rates of HAI’s in states that require strict reporting of HAI’s to those in states that have weaker reporting requirements. Overall, they found hospitals in the more weakly regulated states reported lower rates of HAIs and higher rates of POA infections. They estimate there are more than 10,000 upcoded infections annually, resulting in an added costs of $200 million to CMS.

 

Bastani and colleagues are careful to not impute a motive to such “upcoding” While such could be intentional in attempt to avoid the CMS penalties, they also note it might reflect lack of clinical knowledge by “coders” or lack of communication between clinicians and coders (talk about being tactful and politically correct!).

 

They conclude that their findings suggest, contrary to widely-held beliefs, increasing financial penalties alone may not reduce HAI incidence and may even exacerbate the problem. They make several policy recommendations based on their results, including a new measure for targeted HAI auditing and suggestions for effective adverse event reporting systems.

 

Interesting perspective.

 

 

 

References:

 

 

AHRQ (Agency for Healthcare Quality and Research). Chartbook on Patient Safety. March 2016

http://www.ahrq.gov/research/findings/nhqrdr/chartbooks/patientsafety/index.html?utm_source=GOVDEL&utm_medium=PSLS&utm_term=&utm_content=20&utm_campaign=AHRQ_PSCB_2016

 

 

CDC (Centers for Disease Control and Prevention). National and State Healthcare Associated Infections Progress Report. 2016

http://www.cdc.gov/HAI/pdfs/progress-report/hai-progress-report.pdf

 

 

Bastani H, Goh J, Bayati M. Evidence of Strategic Behavior in Medicare Claims Reporting. Stanford Graduate School of Business 2015; Working Paper No. 3396; July 13,,2015

http://www.gsb.stanford.edu/faculty-research/working-papers/evidence-strategic-behavior-medicare-claims-reporting

 

 

 

 

 

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Nudge: An Example for Hand Hygiene

 

 

Our July 7, 2009 Patient Safety Tip of the Week “Nudge: Small Changes, Big Impacts” reviewed the book “Nudge” by Richard Thaler and Cass Sunstein. Yes, that’s the one that leads in with the story about how painting a picture of a fly in a male urinal resulted in 80% decreased spillage! The theme obviously is that small changes which cost little or nothing (i.e. nudges) can result in big impacts. The book is full of examples of how nudges can help steer people to make better choices in their personal life (savings, investments, healthcare, etc.) or from a societal perspective (improve the environment, improve organ donations, etc.).

 

In that 2009 column and in our February 18, 2014 Patient Safety Tip of the Week “Nudged, But Who Nudged Who?” we gave examples of how such small changes or “nudges” may lead to desirable changes in behavior in healthcare.

 

Hand hygiene is one area in which nudges may be helpful and that applies not only to healthcare personnel but also to visitors. A new study looked at factors related to use of alcohol-based hand sanitizers by visitors to a hospital (Hobbs 2016). The key finding was that when the hand sanitizers were placed in the middle of the lobby (with limited landmarks or barriers) visitors were 5.28 times more likely to use them. But the other key finding was that group behavior is important as well. In the Hobbs study individuals in a group were 39% more likely to use alcohol-based hand sanitizers. We’ve often viewed the same scenario with healthcare workers. A team in a teaching hospital (attending, several residents and students, and maybe a nurse or two) is doing rounds. If the attending stops to do hand hygiene before interacting with the patient, the whole team does hand hygiene. If he/she does not do hand hygiene, no one does. That’s a “nudge” that has a powerful impact.

 

So that addresses healthcare workers and visitors. What about patients themselves? After publication of a study last month (Cao 2016) we may need a “nudge” for them, too. Cao and colleagues did cultures of the hands of patients being admitted to post-acute care facilities from acute care hospitals. They found that 24.1% had at least one multidrug-resistant organism (MDRO) on their hands. Of course, other body parts may be colonized with hospital-acquired organisms but the patients’ hands are most likely to have been in contact with environmental surfaces, health care workers’ hands, or even other patients. Clearly, further studies need to be done to see how to intervene and prevent spread of such organisms in patients being discharged. Adding hand hygiene to patients being admitted to long-term care facilities would make sense. But adding hand hygiene to the discharge checklist of patients being discharged from acute care hospitals may make more sense since even those going home may be spreading MDRO’s. So a little “nudge” may be needed at discharge. Maybe putting another alcohol-based hand sanitizer in the lobby facing the other way will get both patients and visitors to perform hand hygiene on the way out, too!

 

“Nudges” do have positive impacts and we need to learn how to better deploy them.

 

 

 

Some of our other columns on hand hygiene:

 

 

January 5, 2010           How’s Your Hand Hygiene?

December 28, 2010     HAI’s: Looking In All The Wrong Places

May 24, 2011              Hand Hygiene Resources

October 2011              Another Unintended Consequence of Hand Hygiene Device?

March 2012                 Smile…You’re on Candid Camera

August 2012               Anesthesiology and Surgical Infections

October 2013              HAI’s: Costs, WHO Hand Hygiene, etc.

November 18, 2014    Handwashing Fades at End of Shift, ?Smartwatch to the Rescue

January 20, 2015         He Didn’t Wash His Hands After What!

September 2015          APIC’s New Guide to Hand Hygiene Programs

November 2015          Hand Hygiene: Paradoxical Solution?

 

 

 

References:

 

 

Thaler RH, Sunstein CR. Nudge. Improving Decisions about Health, Wealth, and Happiness. New Haven: Yale University Press, 2008

http://www.amazon.com/Nudge-Improving-Decisions-Health-Happiness/dp/014311526X

 

 

Hobbs MA, Robinson S, Neyens DM, Steed C. Visitor characteristics and alcohol-based hand sanitizer dispenser locations at the hospital entrance: Effect on visitor use rates.

Am J Infection Contol 2016; 44(3): 258-262

http://www.ajicjournal.org/article/S0196-6553%2815%2901158-X/abstract

 

 

Cao J, Min L, Lansing B, Foxman B, Mody L. Multidrug-Resistant Organisms on Patients’ Hands. A Missed Opportunity. JAMA Intern Med 2016; Published online March 14, 2016

http://archinte.jamanetwork.com/article.aspx?articleid=2500025&resultClick=1

 

 

 

 

 

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