Tuesday, May 5, 2015

Safety and efficacy of nontoxigenic C. difficile spores in preventing recurrent CDI

Lead Author: Dr. Dale Gerding
We have written and spoken often on the efficacy of fecal transplants in treating recurrent C. difficile infections. Wouldn't it be great if there was a way to prevent recurrent CDI in the first place? What if "good" C. difficile strains that lack toxin production genes could be used to out compete bad strains and prevent recurrent CDI?

There is a new study just published in JAMA that evaluates the safety and efficacy of a nontoxigenic C. difficile strain M3 (VP20621; NTCD-M3) in preventing recurrent CDI in those patients initially treated with metronidazole and/or oral vancomycin. In the four-arms of the phase 2, double-blind placebo-controlled trial they compared patients given oral liquid formulation of NTCD-M3, 10^4 spores/day for 7 days (n = 43), 10^7 spores/day for 7 days (n = 44), or 10^7 spores/day for 14 days (n = 42), or placebo for 14 days (n = 44).

Recurrent CDI occurred in 13/43 (30%) of placebo patients and only 14/125 (11%) of patients treated with NTCD-M3 patients (odds ratio [OR], 0.28; 95% CI, 0.11-0.69; P = .006). Fecal colonization with the NTCD-M3 strain was reported in 69% of treated patients and was associated with lower recurrence: 2/86 (2%) recurrence if colonized vs. 12/39 (31%) recurrence in treated but uncolonized patients (OR, 0.01; 95% CI, 0.00-0.05). Side effects such as abdominal pain, diarrhea and serious side effects were actually higher in the placebo groups. If this smaller study's findings are confirmed in larger trials, we may just have a new treatment for the prevention of recurrent CDI. Very cool.

Check out the video interview with lead author Dr. Dale Gerding, another related video and the JAMA Associate Editor's podcast covering this article and other important studies.

Sunday, May 3, 2015

The new healthcare epidemiologist

The April issue of Infection Control and Hospital Epidemiology has a white paper on skills and competencies for the healthcare epidemiologist. True to form, the paper reflects the rather timid approach that SHEA never seems able to shake. As a disclaimer, I should state that I sit on the Board of Trustees of SHEA, and I’m not saying anything in this post that I haven’t shared previously.

While the paper mentions that the healthcare epidemiologist should have an understanding of quality improvement and safety, and is a valuable partner to the Chief Quality Officer (CQO), what it should state is that the healthcare epidemiologist is uniquely qualified to be the CQO. Infection prevention was the first QI program ever to emerge and remains better developed than QI and patient safety. Many healthcare epidemiologists have advanced degrees in public health or epidemiology, and the skill set is directly transferable to QI and safety. Increasingly hospitals are developing CQO positions, but very few of these positions are held by healthcare epidemiologists. In some cases, CQOs may not have a true appreciation for the value of the healthcare epidemiologist, and some of us fear that healthcare epidemiologists as we know them may ultimately be replaced by less trained individuals. Interestingly, Dick Wenzel published a book on quality improvement in 1992, but unfortunately, SHEA chose to remain confined to infectious adverse outcomes rather than expanding into the quality realm.

So my recommendations are these:
  1. SHEA should move aggressively and quickly into the quality and safety space.
  2. To broaden the skillset of the healthcare epidemiologist, SHEA needs to sponsor education on leadership, implementation science, human factors engineering, Six Sigma, Lean, and other quality improvement and patient safety topics.
  3. As much as I hate to talk about certification given the absolute mess the American Board of Internal Medicine has made of our certification processes, I continue to believe that healthcare epidemiology will never be seen as a valid entity until there is certification. Once certification occurs, then it becomes possible to build the requirement for a healthcare epidemiologist into payer’s conditions of participation, hospital accreditation, and hospital quality rankings. We need to make the healthcare epidemiologist indispensable. 
  4. SHEA’s journal, Infection Control and Hospital Epidemiology, should specifically solicit papers focused on noninfectious adverse outcomes, quality improvement and patient safety. 
In a nutshell, SHEA should define the role of the healthcare epidemiologist more broadly, which in the long run will help its members more easily achieve leadership positions in hospitals and have a seat at the table when important decisions are made.

Graphic: Stratabridge 

Thursday, April 30, 2015

ECCMID 2015 - "Best Of" Infection Control Literature (Part 1)

Every year it seems that one of us at the University of Iowa is roped into giving one of these "Best of Infection Control" talks at an annual conference. This year it seems that almost all of us have been asked and for some inexplicable reason, we all said yes! I was the lucky one to kick off the 2015 season with this talk I gave last week at ECCMID in Copenhagen. I covered S. aureus, MRSA, VRE, VRSA, surgical site infections and hand hygiene. I look forward to Mike's talk at SHEA. Loren Herwaldt's talk at ICPIC and Dan's talk at IDWeek. On Iowa.

Saturday, April 18, 2015

Value: The physician perspective

This week I was asked to give a very brief talk on value from the physician perspective as part of a panel discussion at the University of Iowa Carver College of Medicine's Annual Quality Improvement and Patient Safety Symposium. My remarks are below.

As we have heard today, value is defined as quality per unit cost. And I've been asked to address value from a physician perspective. Importantly, value and population health go hand in hand. Clinically, I work as an infectious disease physician, and when I think about value, it seems apparent to me that for several reasons, ID doctors are more oriented to population health and to value than any other clinical specialty than I can think of.

First, the drugs we use, antibiotics, are the only class of drugs that affect not only the patients we treat but other patients in the population, because we humans share our bugs, and antibiotic usage is correlated with the development of antibiotic resistance. Many of our diseases have public health implications, and we frequently make decisions to control transmission of infection to others in the population. Some of us work as hospital epidemiologists and antibiotic stewards, where we closely look at population health within the healthcare setting.

Clearly, RVU volume-based compensation has had a terrible impact on our field. It’s difficult to evaluate patients with complicated, undiagnosed conditions quickly enough to generate enough RVUs. Many ID doctors have been unable to generate their salaries and have left the field. And the number of young physicians entering ID is at a record low. But we do add value, in ways that I mentioned and in other ways, and I’m hopeful that in a value-based compensation model, a more level playing field will treat us a little better.

In my previous job as the chief of the infectious diseases division at another academic medical center, I inherited a dispirited faculty and a nearly million dollar debt (if you’re not in ID, I need to tell you that a million dollars is a whole lot of consults). I worked hard to increase our clinical volume, and over 5 years, despite reducing the number of faculty members through attrition, our clinical productivity grew four-fold, and our debt was eliminated. This was done by working in partnership with our faculty, outlining common goals and working towards a shared vision. All of us in the ID division were working hard, and had no complaints that we were being paid at the AAMC 25th percentile. And this is where value comes back into the picture. Not value the noun (quality per unit cost), but value the verb—to be made to feel that what you do every day as a physician is important work.

Consultants were brought in to develop a new volume-based compensation plan. It took years to develop the complicated formulas, and it was touted as the best thing since sliced bread. One of the leaders went to departments and announced that in the new comp plan, “the sky’s the limit. Your salary can be whatever you want it to be.” Nearly every ID doctor was projected to have a new salary at the AAMC 75th percentile based on their prior RVU productivity. But the new comp plan gave no credit for other important duties, such as teaching, mentoring, the quality of the clinical work provided, or scholarly publications. The comp plan was enacted, and over the next year, what do you think happened to clinical productivity? It plummeted, because almost every doctor in the ID division made an independent decision that they would rather see fewer patients and make less money. Now this should have come as a surprise to no one. The comp plan was based on the faulty assumption that all physicians are motivated by money. We are all homo economicus!...Except we aren't. ID is the lowest paid specialty in the world of adult medicine—if money were your driver, you probably wouldn't have chosen the job that pays the least. You see, in the new comp plan, the ID doctors no longer felt valued; caring for patients was reduced to nothing more than a series of transactions.

In his book Drive, Daniel Pink tells us that highly educated people, such as physicians, are motivated by 3 things. And interestingly, those 3 things don’t include money. In fact, he believes money is a poor motivator, because in order to maintain it’s effect on motivation, it has to be constantly increased as the effect of any given amount tends to extinguish. What gives us a high level of drive are: 
  • Mastery:  This is the willingness that all of us have demonstrated to spend 1-2 decades trying to understand the incredibly complicated structure, function, and pathology of the human body, and the even more complicated human spirit.
  • Autonomy:  As experts in our respective fields, we tend to have a reasonably good understanding of how to do what we do, and we’d like that to be recognized. At my old place, another group of consultants were retained to convince all of the 700 faculty that each of us should have the exact same clinic schedule. They decided that all new patients would be given a 40 minute slot. Now I worried how I could do an evaluation of fever of unknown origin in 40 minutes, especially when in my clinic the nurses typically needed the first 20 minutes of the visit to do their assessment. But a hand surgeon pointed out that his physical exam typically involves a single finger, and what in the world would he do to fill a 40-minute slot? Autonomy recognizes the expertise we bring to the table.
  • Sense of purpose:  When we leave the hospital at the end of the day, we simply want to feel that we have made a difference.
Mastery, autonomy, and sense of purpose: these are the forces that motivate us, and when they are encouraged to exist and allowed to flourish, we feel valued.

So the moral of my story is this: value is a two-way street. Each of us physicians on the pointed edge of the patient encounter must work hard to maximize quality and minimize cost to bring about truly high value health care. We physicians own value, the noun. And to those of you who have the difficult job of administering healthcare, or herding us cats, you must make us physicians feel valued. Value, the verb, is yours.

Sunday, April 12, 2015

Punished for precision (or, too much information (TMI) from the micro lab!)

We recently had a patient's blood culture turn positive for a Gram-positive, catalase-positive, facultative diphtheroid. In the “pre-MALDI” era, we’d have called this isolate a “diphtheroid”. Taking into account other aspects of the case, the NHSN definition would have categorized this as a contaminant (diphtheroids being on the “common commensal” list maintained by NHSN). By virtue of the wonders of mass spectrometry, we are now able to identify the organism to species-level as Actinomyces neuii, an organism previously categorized as CDC group 1-like coryneform bacteria (also on the “common commensal” list). 

Actinomyces neuii isn’t anywhere on the NHSN organism lists. However, Actinomyces species (as a group) can be found on the “all organisms” list but NOT on the “common commensal” list. The NHSN rules tell us we have to categorize any organism on the “all organisms” list that isn’t also on the “common commensals” list as a pathogen, meaning this positive blood culture now helps define a central-line associated bloodstream infection (CLABSI).

And that’s the story of how a contaminated blood culture became a CLABSI. We’ve had other similar cases since we introduced MALDI-TOF. Before the CLABSI rate became worth millions of dollars to a hospital’s bottom line and reputation, this might have been easy to navigate. Now, though, it’s a much bigger deal. 

These and other issues regarding the impact of microbiological advances on infection prevention will be discussed at SHEA 2015 (ever heard of it?). Register now!

Friday, April 10, 2015

SHEA 2015: *New* Post-Acute and Long-Term Care Track

This is a special guest post by Dr. Silvia Munoz-Price, Enterprise Epidemiologist at Froedtert & Medical College of Wisconsin Institute for Health and Society and the Department of Medicine. She is co-directing the new SHEA Certificate Track in Post-Acute and Long-Term Care at the 2015 SHEA Meeting in Orlando.

In healthcare, we are in the process of transforming our approach from caring of an isolated individual to caring for the population as a whole. Similarly, we are slowly migrating from paying attention to single hospital encounters to focusing on the continuum of care of individuals. These facts are important in the fields of Infection Control and Hospital Epidemiology, as in order to control the spread of highly resistant pathogens we need to internalize that our hospital systems are interconnected through patient transfers. This is particularly evident in the interactions between acute care hospitals, long term care acute care hospitals (LTACHs), and nursing homes within regions. A few years ago, this interrelatedness was elegantly described by Won and colleagues in the midst of a regional outbreak of KPC Klebsiella pneumoniae in the Chicago area (Won et al CID 53: 532-540, figure below). Furthermore, controlling the spreadwithin the LTACH changed the whole transmission dynamic in the region (Munoz-Price Infect Control Hosp Epidemiol. 2010 Apr;31(4):341-7).

Research dealing with Infection Control practices in post-acute care settings is progressing, as recently described in this blog here, here and here. Given our interdependence, it is fundamental that providers in post-acute care --who deal directly with these infection control issues-- are knowledgeable and up to date. This year, SHEA’s Spring meeting will have a 2-day post-acute care track specifically designed to provide a general infection control overview to infection control personnel in post-acute care and LTACHs. The co-Director of this track, Dr. Nimalie Stone, is the Medical Epidemiologist for Long-term Care in the Division of Healthcare Quality Promotion (DHQP) at CDC. Additionally, we will have top notch speakers such as David Nace, Lona Mody, Curtis Donskey, among others. Upon completion, attendees will receive a certificate from SHEA.

A full description of the track can be found here. Participation and engagement of our post-acute care/LTACH colleagues is fundamental to succeed in our fight against hospital acquired infections.

We hope to meet you in Orlando!

Discounted registration ends April 17th (save $100), so register now!

Wednesday, April 8, 2015

Screening, Decolonization and Environmental Decontamination for MRSA in Nursing Homes Doesn't Work

Just in the past couple of weeks, we've written about pneumonia prevention bundles, MDRO prevention bundles, and spread of S. aureus - all in nursing homes.  It's like no one cares about acute care facilities any more! (humor) There is now more great data for those charged with managing infection control in nursing homes.

Cristina Bellini and colleagues from Lausanne University Hospital in Switzerland just published the results of cluster-randomized trial of an MRSA prevention bundle in 104 nursing homes (53 intervention, 51 control) in the April ICHE. All residents in intervention and control nursing homes (NH), who gave consent, were screened for MRSA carriage at study entry and 12 months thereafter on a single day in each NH. Newly admitted or readmitted residents were screened when admitted to the NH. Screening included nasal, groin and ulcer swabs along with urine cultures if residents had an indwelling catheter. In the intervention NHs MRSA colonized residents underwent decolonization along with environmental decontamination.

The primary decolonization bundle included 5 days of nasal mupirocin, 5 days of CHG oral rinse twice per day, 5 days of CHG showers including CHG shampoo on day 1 and 5. Environmental disinfection included daily clothing changes for 5 days, new linens on day 1 and day 5, and daily bed/table/phone/remote/wheelchair/walker disinfection with 70% alcohol. A lot of steps.

Unfortunately, the MRSA decolonization and decontamination bundle was not successful. The baseline prevalence of MRSA was 8.9% in both groups. The rate declined in intervention units to 5.8% in the intervention unit and 6.6% on the control units after 12 months (p=0.66) Full stratified results are in Table 3 below, and as you can see, no matter how they analyzed the intervention, the MRSA bundle intervention did not reduce MRSA prevalence compared to controls. This was despite the fact that the participation rate was 87%.

A limitation of this study was that they only measured prevalence and not individual level acquisition of MRSA. It is possible that by measuring prevalence they missed detecting benefits of the intervention related to reduced patient-to-patient transmission of MRSA. In any case, as I said last week about the study in CID, congratulations to the authors and journal (this time ICHE) for publishing this important negative study.