Validation of the Michigan Risk Score for use in Brazil - A Multicenter Study
We are delighted to conduct this multi-center study in Brazil with the partnership of Prof. Dr. Vineet Chopra,from the University of Michigan, who was responsible for the development of the Michigan Risk Score (MRS). The MRS aims to estimate and predict risk of Peripherally Inserted Central Catheter (PICC)-related thrombosis. Although the score was developed and internally validated, it has not yet been externally validated. In fact, in Brazil - no tool to estimate the risk of PICC thrombosis currently exists. Therefore, in this study, we propose to externally validate the MRS and evaluate its applicability to the population in Brazil.
We will conduct this study in 23 institutions in Brazil, with representation from all of the 5 major regions of the country (Figure). All participating center have agreed to developing a dedicated team to this project, members of whom will be responsible for data collection. All researchers will use a standard protocol for data collection and will be trained by the coordinating center prior to starting the study. In order to ensure ongoing collaboration of this group to continue to study more vascular access questions. All of the principal investigators (PI) are registered in a PICC-BRAZILIAN RESEARCH GROUP
This group will not only collaborate for this project, but can now engage in other projects moving forward. The researcher responsible for this project in Brazil is Prof. Eneida Rejane Rabelo da Silva, RN, ScD
(CV: http://buscatextual.cnpq.br/buscatextual/visualizacv.do?id=K4701295A6) with her research group from the Hospital de Clínicas de Porto Alegre and the Universidade Federal do Rio Grande do Sul. We estimate that we will be able to accrue a sample size of 24,150 patients (including 5% of losses) in order to validate the MRS score. We propose to collect these data for analysis over an 18-month window.
I hear it everywhere I go.
"I wish I could have known that patient would have had a DVT..." "If only I could have done something different before ordering or placing the PICC..." "I had this feeling they were high risk, but I wasn't sure and it seemed like a reasonable choice..."
All of these are aphorisms of the sinking feeling when you get the call: the ultrasound is positive, and the patient has a PICC-DVT.
We know there are evidence-based ways to prevent this:
But even if you follow all of the above recommendations - some patients will still have a PICC-related DVT.
Is there a way to know?
I'm referring specifically to a crystal ball here - a way to be able to predict who will have a DVT and who won't, if you follow best practice.
That is what the Michigan Risk Score (MRS) does....
We looked at over 20,000 patients and separated those that had a PICC DVT from those that did not. Then - we went back in time to before the PICC was placed. What was it about those that had a DVT that different substantially enough from those that did not? Was there a signal?
We certainly found one - and published this for others to see/use. Here are the risk factors:
1. Presence of another CVC when the PICC was placed.
2. WBC count > 12, 000 at the time of PICC insertion
3. Number of PICC lumens
4. History of Venous Thromboembolism
5. Active cancer
Selecting each of these displays a final score and risk class (I-IV, IV being highest) that can then be used to determine whether the PICC is the best choice for the patient. This is particularly true for those with cancer or patients who have had prior VTE - since avoidance can be the best treatment in this subset as shown in the picture below.
There are a number of resources that can make this easier for you to apply on a day-to-day basis - before the PICC is ordered or placed (see below for links).
The MRS is now being validated through the leadership of a number of brilliant investigators and committed hospitals in Brazil. The project will likely take 18-24 months but will provide invaluable information about how the MRS performs and whether it can be improved. It's through tools like this - the proverbial crystal ball - that our patients will be best served.
See more information about the MRS and find a handy calculator here.
The Michigan Appropriateness Guide for Intravenous Catheters (MAGIC) is an evidence-based series of recommendations that provide guidance on how best to use, manage and care for vascular access devices. MAGIC is now being used in hundreds of hospitals across the nation, and many hospitals overseas.
But the question remains: does MAGIC work to improve patient safety?
Until recently, we all wanted to believe that it did. And belief was all we had...
But thanks to work by an inspirational physician and her team in a Michigan Hospital - now we know.
Dr. Lakshmi Swaminathan and her Vascular Access team led a real world "validation" study of MAGIC. Validation is a scientific process where a method or idea is removed from it's origin (or derivation) and makers and placed into a brand new environment to see if it "works" as designed. Often used for statistical models for prediction, validation serves to affirm that the method or research described does what is intended - while providing valuable insights about what worked and what didn't and why.
In an article published in this months British Medical Journal - Quality and Safety (BMJQS), Dr. Swaminathan and her team report findings following an interrupted time series implementation of MAGIC in their hospital. To ensure findings were rigorous, they compared their results to ten other hospitals involved in the Michigan Hospital Medicine Safety collaborative - members of which are all focused on PICC use and outcomes. Thus, this study answers a specific and important question: among hospitals all working to improve safety and use of PICCs, does adding MAGIC make a difference compared to baseline?
The results: absolute rates of inappropriate PICC use dropped 26% more than other sites. Even after adjusting (or taking into account) patient complexity, hospital characteristics and other improvements - MAGIC improved PICC appropriateness by 13.8%. Importantly, PICC complications also decreased at a substantial rate (34%) compared to other hospitals (26%).
In short - MAGIC worked to improve PICC use and patient safety, and does so in ways more than other quality improvement work might suggest.
But (as with all real world research) there are some important caveats. First, although the authors used a robust study method, this was not a randomized trial. Thus, unmeasured factors might explain the difference across the study hospital vs. other control sites. Second, multiple components of MAGIC (an electronic tool, algorithm, educational roll out and nurse-based checklist, etc.) were used; which component was the most critical (or was the "active ingredient") is not known. And finally, although the reduction in complications was great and outpaced that of other hospitals - it wasn't good enough to achieve statistical significance for CLABSI and DVT. A larger study with more patients is needed to better understand this aspect.
So what does this study add? A few key things: first, we know from this work that implementation of MAGIC leads to improved PICC appropriateness and outcomes at a hospital other than where it was created. This is good news, as other hospitals (particularly community hospitals where this work was performed) that use MAGIC are likely to see similar benefits. Second, we know that MAGIC reduces complications from PICCs more than hospitals using other QI approaches: thus, hospitals struggling with occlusion, CLABSI and DVT might particularly benefit from using MAGIC. And finally - this study tells us that a vascular access team driven initiative can have huge payoffs to a hospitals bottom line. The implementation study in this facility was driven largely by the vascular access team - and saved hundreds of thousands of dollars for this facility in terms of reduced complications and device appropriateness. That's the bottom line for many C-suite level leaders - and that helps answer why we need more vascular access teams in the country! If you're interested in learning more, check out our CLABSI and DVT Cost Calculator for a savings estimate!
But perhaps the best part of this work is that it lives beyond a paper in a journal. The team at this hospital continues to experience great reductions in inappropriate PICC use (including in ICU patients) and outcomes (all VTE in the hospital) as shown in the slideshow below! And the patients are simply better for it! That, perhaps, is the greatest reward of them all!
You'll find some key components of the MAGIC study in the links below, and you'll find a copy of the published article there as well. Please do share widely and post your comments and feedback. And remember - the easiest way to use MAGIC is through the app - which is available for free here!
Get your MAGIC On!
We all know that central line-associated bloodstream infections (CLABSI) are common, costly, morbid and lethal. While many interventions such as the checklist, bundle, and chlorhexidine-based products have been introduced to prevent CLABSI, the struggle continues for hospitals across the country. And for many – the battle is not being won.
One reason why CLABSIs are so hard to tackle is because the root causes of these infections are multifactorial. For example, not having the right team members or expertise to examine CLABSI cases represents a key gap in preventing future infections. Similarly, lack of support from leadership to implement change or trial new products can also be a barrier to infection prevention. In short – hospitals need a tool to diagnose their approach to CLABSI to understand what they can do better and where limited precious resources might be best directed.
Until recently, such a tool did not exist. However, we at the Patient Safety Enhancement Program at Michigan Medicine have developed a first-of-a-kind tool to help hospitals “diagnose” their CLABSI prevention efforts. Called the CLABSI Guide to Patient Safety (or, CLABSI GPS) this tool allows hospitals to understand what they are doing well – and what they are not. Developing following years of research, site visits and data analyses, we hope many members of the patient safety team – vascular access teams, infection preventionists, hospitalists, infectious disease physicians and various subspecialists – will use the team to help inform their CLABSI prevention efforts.
Tell us what you think about the CLABSI GPS by dropping us an email here. And thank you for working hard to keep your patients safe!
The recommendations found in the Michigan Appropriateness Guide for Intravenous Catheters, can now be found in an easy to use mobile application available on the iTunes App Store and on the Google Play Store.
The application is free and available for download by anyone with a mobile device running iOS / Android.
Based on user feedback, the Michigan Magic App will present the user with an easy to use set of recommendations on the appropriateness or inappropriateness of intravenous catheters as well as further information derived directly from the MAGIC publication.
Future iterations of the app will be expanded to include recommendations for patients as well as other types of providers so be sure to keep an eye out for updates!
For additional information on how to use the Michigan MAGIC app, please feel free to watch the short demonstration below narrated by Dr. Vineet Chopra.
"We have to keep moving forward" says a patient who helps shape research in vascular access
You might think that someone who spends nearly two months of every year in a University of Michigan hospital room would want to stay as far from the place as possible the rest of the time.
But not Georgiann Ziegler.
In fact, she says, it’s what she’s experienced as a “frequent flyer” at U-M over the last 12 years that keeps her coming back. Not just as a patient, but as a key member of several research and health care improvement teams.
“I’m a firm believer that what they [physicians] learn today from me could help somebody else, who won’t have to deal with what I’m dealing with,” she says “It may not help me today or tomorrow – but it definitely will help the next generation and maybe even me down the road.”
A patient behind the scenes
Georgiann has chronic pancreatitis, a disease that causes flare-ups of painful pancreas inflammation throughout the year.
She also has a port – a device implanted just under the skin of her chest that lets her U-M care team deliver pain medicine, nutrition and more without having to find new veins to put needles in every time she comes to the hospital.
Ports and their "cousins" called PICCs are known as vascular access devices because they provide a direct gateway to the bloodstream. They make life a little better for many patients every year – and for their caregivers.
But they also carry serious risks, since they can act as highways for germs to enter the body, or for dangerous blood clots to form. Georgiann experienced such a clot – called a DVT for deep vein thrombosis – herself.
U-M doctors who specialize in caring for hospitalized patients have studied the risks and benefits of devices such as PICCs and ports for years. They wanted to take that research to the next level, by making a guide to help doctors and nurses around the world understand which device to use, in which patients, and when, to get the best and safest result.
That’s where Georgiann came in.
Three years ago, the doctor who first suggested she get a port asked her to join the team that would write the guide. Vineet Chopra, M.D., M.Sc., was gathering experts in vascular access devices from U-M and around the world. But he wanted a patient’s perspective. And who better than Georgiann?
Even though she’s not a shy person, she remembers feeling in awe when she sat down at the table with the doctors, nurses and safety experts.
But then came a pivotal moment -- when the experts were debating a point about how to numb the skin of a patient who’s getting a new device. The only one in the room who knew just what that felt like was Georgiann. She helped them understand the issue from a patient’s perspective.
“As a patient or family member, we do not realize the work, time and dedication that goes into implementing the things out there that make us better,” she reflects. “Now that I’ve been able to sit in in on these efforts, I see it’s not just someone saying ‘I think we should do it this way.’ I have a greater appreciation for the things that are being done for me, and other patients, day by day in health research.”
The team of experts published their guide, called MAGIC for Michigan Appropriateness Guide for Intravenous Catheters, in 2015. Since that time, Georgiann has helped spread the word about them, bringing the patient’s perspective to gatherings of health care providers learning about the new guide.
“Having Georgiann as part of our MAGIC development team was invaluable,” says Chopra. “She provided an important perspective on selection of vascular access devices, including what types of information patients need, and how best to share decision-making with patients. Without her input, I am certain that the final product would not have had this important viewpoint for providers and stakeholders."
Above and beyond
But Georgiann’s role as the patient voice in improving care didn’t end with MAGIC. She now serves, with Chopra and a range of other patients and providers from around the country, on the steering committee of an effort called i-HOPE funded by a grant to the Society of Hospital Medicine.
Short for Improving Hospital Outcomes through Patient Engagement, it’s an effort funded by the federal Patient Centered Outcomes and Research Institute to better understand how patients, families, and others view the most important gaps in hospital care.
“Most patients and family members don’t have an understanding of how hard it is to get things implemented and to have it done right,” she says. “They don’t understand the behind-the-scenes work. As a patient it excites me to see that nobody’s giving up, especially when you have a condition like I have.”
Georgiann also serves on Michigan Medicine’s Patient, Family, Staff and Faculty Advisory Council, and in the U-M Medical School’s education program for medical students to learn from patients. She’s agreed to let her blood be used for laboratory research on pancreatitis, and allows student nurses to practice their port-related skills on her. She crochets blankets for hospitalized patients. And she even posed for a photo shoot to remind hospital laundry workers how much patients appreciate the clean sheets and gowns they deliver around the clock.
She’s also seen how care at U-M has changed over the years, because of new research on the best way to treat patients like her or prevent things like infections and DVTs.
That kind of research – aimed at improving health care delivery – may not get as much attention as the latest drugs for cancer or kidney disease, she says. But she hopes that funding for health care research stays strong.
“We can learn a lot from what’s already been done, but everything evolves and we have to keep moving forward, and figure out best practices that work,” she says. “I hope that the passion I saw around the MAGIC table continues – and that I can say to the researchers, ‘Thanks for doing this, because the things you find are helping me and other patients.’”
To learn how you can take part in research at U-M, as a healthy volunteer or in studies that need people with certain medical conditions, visit https://umhealthresearch.org/
As the CEO of the Infusion Nurses Society (INS), Mary Alexander is responsible for managing an international, nonprofit specialty nursing organization by assuring the consistent delivery of professional services to its more than 7,000 members. As the Editor of the Journal of Infusion Nursing, a scientific, research-based, peer-reviewed publication, Ms. Alexander writes bimonthly columns for the journal. She also handles editorial responsibilities for a bimonthly membership newsletter, INS Newsline. She is the Editor-in-Chief of the Core Curriculum for Infusion Nursing, 4th edition and Infusion Nursing: An Evidence-Based Approach. She is also responsible for the credentialing program of the Infusion Nurses Certification Corporation. We asked her to share her views and experiences with us this month.
VC: Tell us a bit about yourself and the Infusion Nurses Society?
MA: I began my career as a registered nurse at Massachusetts General Hospital (MGH) in Boston, MA, on a surgical floor, and after 3 years joined the IV team. In fact, MGH was the first to allow a nurse, Ada Plumer, one of the founders of INS, to be responsible for IV therapy administration. She eventually developed the first IV team. My clinical experience as an infusion nurse spans a variety of practice settings, including home care, alternative sites, and acute care settings.
In 1997 I was appointed as CEO of INS and INCC (Infusion Nurses Certification Corporation), where I serve as the editor of the Journal of Infusion Nursing (JIN), Core Curriculum for Infusion Nursing, and Infusion Nursing: An Evidenced-Based Approach. I’ve served the organization in a wide variety of roles at the local and national levels, including terms on the INS Board of Directors. My position has also taken me around the globe delivering infusion education programs to clinicians in Armenia, Brazil, China, Colombia, India, Japan, Mexico, and New Zealand, to name a few. I’ve maintained my certification in infusion nursing (CRNI®) since 1985, achieved the Certified Association Executive (CAE) designation in 2005, and was inducted as a Fellow in the American Academy of Nursing in 2008.
INS was established in 1973 and currently has over 7,000 members worldwide including 40 countries and territories and 3,500 CRNI®s. There is approximately a 50-50 split with INS members practicing in the hospital/acute care settings versus home care and alternative sites. Our mission is to set the standard of excellence in infusion nursing by developing and disseminating standards of practice, providing quality education, supporting research and certification, and advocating for the public, our patients. In order to meet our members’ needs and address nonmember queries, we provide numerous infusion-related resources—from face-to-face meetings, webinars, books, online offerings, position statements, JIN, and more, that can be found on the INS LEARNING Center.
VC: In 2016, INS released an updated version of the Infusion Therapy Standards of Practice with a subtle change to both its title and content. What’s new with this version?
MA: The 1st edition of the Infusion Nursing Standards of Practice was published in 1980. With the ever changing healthcare environment, advances in science, and increasingly more complex technology, INS is committed to revising the Standards every 5 years. This reference provides the framework to guide safe infusion practice to ensure the best patient outcomes.
While the title change for the 2016 Standards is subtle, there is a significant distinction. INS recognizes that not one discipline “owns” infusion therapy, but is the responsibility of all clinicians involved with infusion practice. Since infusion care goes beyond nursing, the title was changed to Infusion Therapy Standards of Practice. This change also aligns with today’s interprofessional approach to healthcare.
In this 7th edition, 4 new standards have been added (infusion team, vascular visualization, CVAD tip location, and nerve injuries) and other sections have been expanded to offer more guidance to clinicians. Explanations were added for clarity around the methodology for developing the Standards, including rating the strength of the body of evidence and determining practice criteria recommendations. Of note, the Standards Committee added rating V, “Committee Consensus”. It was applied when there was a lack of literature or very low levels of evidence with conflicting findings. Less than 2% of the practice criteria have this rating.
The 2016 Standards cites 350 more references than the 2011 Standards, a testament to the advancing science and research of infusion therapy. There was also a shift in the rankings of the strength of the evidence, with a 2% increase in Level I rankings (highest rating) and a 21% decrease in Level V (lowest rating) compared to the 2011 Standards. The distribution of rankings has changed thanks to the nature and robustness of the research.
VC: One big difference in the Standards is the recommendation regarding pH and route of therapy. Take us inside the conversations regarding this topic. Tell us more about this update and why it was made.
MA: Since 1998, the Standards has viewed pH as a critical factor in vascular access device (VAD) selection. It stated that infusates with a pH less than 5 or greater than 9 are not appropriate for short peripheral or midline catheters. The belief was that infusing those solutions peripherally would increase the incidence of phlebitis and infiltration, therefore implying that a CVAD should be selected in those situations. Recent evidence has shown that there are significant risks associated with CVADs, such as central line-associated bloodstream infection (CLABSI), deep vein thrombosis (DVT), and an increased utilization of unnecessary peripherally inserted central catheters (PICCs).
Committed to evidence-based practice and promulgating standards based on the strongest research available, the Standards Committee reviewed the evidence which was supporting the abandonment of using pH as the sole factor in device selection. As a result, the decision was made to revise the previous statement related to pH and device selection to reflect the current evidence.
VAD planning and selection requires critical thinking, and analysis and decisions should not rely on one factor only. In addition to the pH, the prescribed treatment, duration of therapy, vascular characteristics, and the patient’s age, comorbidities and history of infusion therapy should also be considered.
VC: Many people ask us whether the term infusion nurse and vascular access (VA) nurse are interchangeable? What do you think?
MA: There is confusion as to the definition of each role, in particular with patients, families, and caregivers, who may view them as one in the same. However, in my estimation, the terms infusion nurse and VA nurse, are not interchangeable.
A VA nurse is primarily focused on the pre-insertion assessment and the actual VAD insertion procedure. Post-insertion care and management may be limited based on the care setting. For instance, those in a radiology department may only be placing lines, not managing them after insertion.
The specialty practice of infusion nursing has a broader scope. In addition to preinsertion decision making, VAD insertion, and care and management, infusion nurses include additional aspects of care such as medication administration, fluid and electrolyte management, and nutritional and blood component therapy – the infusions going through the VAD. They address VAD complications and the relationships with the sciences of pharmacology, immunology, nutrition, to name a few. Preventing and managing complications from the therapies, along with those from the VAD, are fundamental elements of the specialty. Also, infusion nurses are employed in a wider variety of venues. Often VA nurses are performing procedures in a facility-based setting, while infusion nurses are practicing in all venues—acute care, home care, ambulatory care, and long-term care.
VC: We recently released the MAGIC document to guide vascular access device choice and care. How do you see this influencing infusion and vascular access practice? Did it influence the Standards?
MA: The conclusions from the MAGIC document offer constructive guidance for infusion and vascular access practice. It demonstrates that it’s not easy to apply a one-size-fits-all position when dealing with patient care issues. Patient assessment is key, an important aspect of infusion care that INS has long endorsed. The paper also provides a foundation to support practice, not just for the indication of PICC use, but the need to standardize care and maintenance practices based on evidence and research. With an array of different devices and equipment (e.g., visualization devices, ultrasound) to best meet our patients’ needs, clinicians must be vigilant in selecting devices best suited for the patient.
The MAGIC paper was cited as a reference in several Standards, VAD planning, site selection, VAD removal, infection, and CVAD malposition, to name a few.
VC: What are the three biggest challenges you see for infusion and vascular access nursing?
MA: First, a major issue is the lack of standardization in clinical practice. Many nurses get little to no infusion education in nursing school, and are expected to be skilled once they’re in practice. Lack of knowledge of the Standards, on-the-job training, and perpetuating traditions not supported by current evidence are factors that jeopardize the ability to prevent risk and provide safe infusion care. Providing curriculum in nursing (and medical) schools to better prepare graduates and increasing awareness of the Standards for application in clinical practice are steps to address this issue.
Second, despite the ubiquitous nature of the specialty, many clinicians don’t recognize the risks associated with infusion therapy. While complications may be local, such as a grade 1 phlebitis, others can be life-threatening. Infusion nurses need to be recognized as key members of the health care team and part of the discussion as it applies to strategic initiatives that impact patient outcomes. In particular, the C-suite needs to recognize the value infusion teams bring to an organization. The business case can be made to support infusion teams and their ability to impact an organization’s fiscal bottom line. Experienced, skilled infusion nurses impact costs—use fewer supplies, less labor, identify complications early and promptly implement treatments.
Third, establishing competencies and maintaining continued competence is a challenge. Clinicians need to stay abreast of the latest research and its impact on practice as well as the introduction of new technology that can enhance care delivery. Patients are living longer, more chronic diseases are being treated, and care is transitioning out of the hospital at a rapid pace. Clinicians must be prepared to competently and safely care for these patients. Standardized education and specialty certification will be vital in addressing these and related issues.
VC: We are a very research-oriented group. What are some of the major questions you see in the field that you think must be addressed by investigators such as us?
MA: Based on this “short” list of research questions, your team won’t be at a loss for potential projects!
How do we translate the research and/or accept the evidence-based principles, especially the Standards, into clinical practice? For example, while removal of a VAD is not based on dwell time and is performed when “clinically indicated”, uptake of this practice is still not widely accepted.
With the prevalence of short peripheral and midline catheter use, in lieu of CVADs to prevent CLABSIs, what’s the infection rate with these devices? With limited data on outcomes with midline catheters, what’s the incidence of venous thrombosis? Should we use of a higher level of aseptic technique (sterile gloves, draping) compared to standard practice? Outside of the hospital setting, what are the complication rates of both peripheral and central devices?
Is there a significant risk associated with ultrasound-guided peripheral catheter placement in deeper veins related to vein damage, infiltration and future vascular access?
More studies are needed on maintaining patency of long-term devices, not just the type of locking solution, but how often the device should be locked.
What’s the impact on patient outcomes and safety related to nurse/patient ratios?
The data, evidence, and research are the basis for our practice, validates what we do, and impacts patient care. Adding to the science of infusion therapy can only lead to best practices in infusion care—our patients deserve nothing less!
Its been a little over a year since we published MAGIC in Annals of Internal Medicine. Today, at the Annual Association for Vascular Access Annual Scientific Meeting, I shared just why and exactly how we developed this tool. I also provided some early insights into how it has started to influence practice. The journey, thus far has been amazing. Here are but a few highlights:
1. Many recommendations from MAGIC were widely incorporated in the latest Infusion Nursing Standards of Practice 2016;
2. MAGIC recommendations are being actively implemented in an ongoing project aimed at preventing CLABSI in over 500 US Hospitals;
3. Working with the AVATAR Group, discussion on creating MAGIC-Australia have begun. In this project, MAGIC recommendations will be adapted to the Australian context with respect to devices, operators, and practice standards;
4. In partnership with the Michigan Hospital Medicine Safety Consortium, we have started to move towards interventions that use MAGIC to improve PICC use and outcomes across 51 Michigan hospitals.
5. A recent market report from iData finds that use of midlines has increased in recent years - and credits MAGIC and the new INS Standards as being key forces in this change within the device market.
From a professional perspective, I cannot be happier. A tool is only as good as its user and I am delighted that MAGIC met with a warm reception today at AVA. I hope my talk today has inspired more people to take a closer look at MAGIC as a way to measure, evaluate and improve their performance. It has been heartwarming to see smaller hospitals with scarce resources turn to MAGIC to tackle CLABSI and VTE. I visited just one such hospital in Michigan that is making fantastic strides in midline and US peripheral IV catheter use in using MAGIC. It's inspiring to see the hard work of vascular access professionals in this way. I said it today and I will say it again: You are the secret....
This being said, I am wary of the future. Why? Because much more work needs to be done. Many changes need to be made. And these changes will not be easy.
If there is one thing that MAGIC makes perfectly clear, it's that choosing a vascular access device is not and should not be a reflexive process. We shouldn't knee-jerk to a PICC from a peripheral IV when faced with a patient with difficult IV access. Similarly, we shouldn't stick people two or three times blindly before we pull out the ultrasound machine to have a look. And yet, I know full well that this type of practice continues today...
There is a science to choosing devices that is based not just on indication on use and nature of infusion, but also on patient-, provider- and device-characteristics. Throughout our research - we have shown that these factors have to be carefully considered when selecting a vascular access device as they are most often associated with complications. And yet, I remain surprised at the overall lack of awareness of these issues - especially among my medical colleagues who order these devices. In fact, many aren't just blissfully unaware of catheters, they are also unaware of the risk of complications associated with these devices as we've shown here, here and here...
Why might this be the case? There are myriad reasons: lack of knowledge, awareness, ownership. But I want to discuss one more subtle one from our lexicon: use of the term "PICC nurse."
Think about it: what goes through your head when you hear PICC nurse? Do you think of a person empowered to help you make the right choice for what vascular device is best for a patient? Or do you think of someone who can place one device, and one device only? In fact, is it a verb or a noun?
In his best-selling book Blink, Malcolm Gladwell talks about how impressions and decisions about people and objects are made within milliseconds in our brains. He calls this the "unconscious adaptive," and the process - thin slicing. In my work and conversations with hundreds of providers to date, I am convinced that thin-slicing is a fundamental, dark part of the problem when it comes to vascular access. We are anchored to old ways of thinking about vascular teams and their roles.
We must move away from this euphemistic and naive approach and emphasize three linked components:
1. Vascular access professionals are consultants, not a procedure delivery service;
2. To attain #1, respect for the art and science of vascular access (and those that practice it) must rise;
3. In order to attain #2, vascular access specialists must work to define their value and role within the healthcare enterprise.
I heard someone at AVA say that, "we as a specialty should not be defined by the devices we place." And yet, vascular access specialists remain trapped in exactly this silo.
It is time for us to be the change we want to see.
No longer should the term PICC nurse or PICC team be used to characterize those involved in the placement of IV devices. Rather, vascular access consultant should be the new norm. Each of us in partnership with leading organizations such as AVA must take this charge so as to legitimize the specialty that we all know and love. MAGIC is one way to bring forward this legitimization -- a tool that harnesses evidence-based recommendations to inform and change practice. A tool that can measure, evaluate and benchmark your performance in ways that none other can.
So what's in a name? A lot. And I hope it changes with MAGIC.
If you were at the presentation and have thoughts about MAGIC, I would love to hear from you. Leave a comment below!
Mr. Carr has disclosed that he has served on speakers bureaus CareFusion in 2013 and Becton Dickinson in 2014 providing lectures on vascular access. He received a grant from CareFusion to attend a scientific meeting and a part-funded Scholarship from Becton Dickinson to support research activities.
VC: Tell me a bit about yourself and your background/calling to vascular access.
PC: I'm Irish which by default means I come from the most beautiful country in the world. However, I live in Perth, WA - the second most beautiful part of the world. If I want, I can cycle to work almost every day as the weather is super. I can even wear shorts in winter so what’s not to like!?
My professional interest in vascular access began in 2006 when I joined a European Working Time Directive initiative “IV Team”. A team of nurses and staff from the phlebotomy department provided peripheral intravenous cannulation to inpatients in Galway University Hospital; a teaching hospital in Ireland. While the service was disbanded due to the economic downturn, I had become motivated to research vascular access. My wife and I wanted a new adventure, a new challenge, to up skill clinically and academically so we departed the Emerald Isle taking a career leave from the Irish health service.
At that time the intention was to return and bring new knowledge/clinical methods back home. We have now been living “down under” for over 5 years and it looks like Australia is now our home and we appreciate the opportunity WA health have given us.
As a way of giving back to Australia, I am the current vice-president for the Australian Vascular Access Society and Scientific Chair for our 2nd Scientific Meeting. I am the Australian Global representative for World Congress on Vascular Access (WoCoVA) and lead the Western Australian Chapter of the AVATAR group. I won't be in these roles forever and the baton will be passed on in due course as change is a good thing (except for PIVCs!!).
VC: Tell me about your ongoing research work, interests and collaborators.
PC: I'm currently researching a clinical prediction model for first-time insertion success. This is focussed on appropriate insertion of peripheral cannulae on the first attempt in an anatomical location that will have greater dwell (and therefore reduce subsequent attempts ) by a clinician who is confident to do so.
It is part of my PhD and is co-supervised by a leading ultrasound expert and Emergency physician James Rippey. If clinicians/health care service providers are unable to succeed with traditional attempts then the appropriate use of ultrasound will be a superior method. For my research it is important to be with a clinical and academic expert in this area as James is.
I found the world leading researcher in vascular access in Prof Claire Rickard of Griffith University. Claire had the only vascular access research group that I could find in the world. There is nothing like working and learning from the best. Myself James, Prof Marie Cooke, Dr Niall Higgins and Gabor Mihala are a great team. I contribute to the AVATAR group with some of the most passionate scientific minds who focus on making positive vascular access experiences for patients and eliminating complications using scientific methods. In a word, AVATAR is an inspiration. I am so lucky to be involved with it. I am busy with a Cochrane systematic review title and would love for a few RCT’s on specialist teams for successful device insertion and prevention of failure. So if any of your readers have a clinical trial registration, protocol and RCT on this subject, please feel free to send it my way.
VC: You have always believed that insertion skills matter most? Why so?
PC: Well, insertion skill matters to the patient who receives the cannula, no? As clinicians we can be so focussed on trying not to miss and undertake repeated attempts without considering the feelings of the patient who is on the receiving end of the PIVC. Nothing beats genuine empathy. It is important for our colleagues to also understand that while insertion skill is critical, using the least appropriate device could result in a high failure rate on the first attempt or lead to a high post insertion failure. This requires us to be skilled in the assessment phase of the procedure and skilled in selecting the right devices suited to the patient.
I have seen and heard many comments such as “I can cannulate the small vein on your baby finger”. Well, find me a compos mentis adult who wants the PIVC in their pinky?
VC: So why has this issue not received more attention?
PC: Because PIVC is so frequently performed by a range of professionals, no one owns the insertion skill and this results in fragmentation in expertise. Some get protected proctoring by the worst possible mentors and very few get the best. It’s the classic bystander effect in clinical care, someone else will teach it, someone else will sort out the infection, the difficult patient and so on.
Inserting invasive devices into patient's anatomy is a unique relationship between provider and patient and we need to accept that we can always do better. People who we are privileged to look after are not getting good enough outcomes; at best 70-86% (note, not a 100%) first-time insertion success; is this acceptable in 2016? What about the other 30%.
Even with the use of ultrasound, you won't get a first pass success publication over 85%. This is what the scientific literature is telling us. Last week I gave a local presentation about PIVC evidence for an ultrasound PIVC workshop. When I told the audience the effectiveness of USG PIVC (based on randomised trials) was no better than traditional attempts it was like I stole the goose that laid the golden egg. But it's not a personal opinion but what the evidence is telling us! The latest systematic review (one of 5) on USG PIVC by Shannon Parker and colleagues from Canada sheds some perspectives on this.
The fact is after insertion 25%-50% (note, not 0%) can fail because of avoidable complications. I love the “getting to zero literature for CLASBI OR CRBSI” and applaud the clinical champions involved in this work but wonder why can't we get to down to 1 attempt? Behind each percent, each number, is our core business; human life; people in need of help. Imagine you are in a hospital bed, tired from chemo on your 5th PIVC insertion in 6 days (bear in mind you’ve had 8 attempts between the last two) and your thinking about your life, your kids, dog and you are finally getting some clarity before you hear the occlusion alarm on your infusion pump indicating another failure. This means another attempt and possibly more unsuccessful ones at that.
This is happening 24/7 around the world and it is going unnoticed as it is unrecognised or deemed to be of less importance amongst the array of competing healthcare issues. My hope is for our research to contribute to improving the insertion skills of clinicians today and in the future.
VC: So how do you propose to measure the skill of the inserter?
PC:We are working on a possible concept that we hope will attract funding (if you are a philanthropic reader, drop me a Tweet!). We (read as a generic term for Healthcare) poorly use data and poorly understand the relationship between data and vascular access regarding outcomes. One of those is the clinician's skill.
Let's say you had two medical/nursing inserters in the ED or Surgical ward, and on this occasion had to send 1 for mandatory PIVC training. Who would you send? (of course, some of your readers know this is a highly unlikely scenario… mandatory vascular access training that is) How would you pick the 1? The skill of the inserter is important, but they should want to be measured as a hospital mandate. Otherwise, we will continue with the keep trying until you get it approach; let's all have 2 attempts; call the anaesthetic to insert the PIVC or the local vein whisperer when all else fails.
Some clinicians reading this think they know how good they are, some might know how good they think they are, but what is their actual, factual data… if one of the aforementioned could say ”I put 50 PIVCs in this month; 44 traditional on the first needle puncture; 6 USG PIVCs on the first attempt. My outcomes are: 1 failed by accidental dislodgment, 29 remain insitu and 20 no longer needed and 0 infection/occlusion/thrombus. The category of patient was well spread between easy to difficult ones."
These data can help the manager allocate who they want to send for training. It's frustrating when people think they have data on the issue when they really don't. Because they have done the 2-4 hours mannequin venipuncture and cannulation training day and got someone to sign off on 20 insertions (if they got 20), they are ready for cannulation.
Do you think the patient should know what the success of the inserter is before he/she attempts one? Would you like your mother, father, brother sister, wife, husband, son, daughter to be the human simulator? We know (or at least I know) having observed 1,400 insertions in 2 large tertiary EDs with a variety of clinicians inserting that practice varies; training varies and success varies.
VC: Your research focuses a lot on the emergency department. Why did you choose this site as a venue for your study?
PC: It is the front door of the hospital and the first exposure that most patients (notwithstanding pre-hospital attempts) have with invasive devices. In Australia, we have a national target to get patient assessed, admitted, transferred or discharged within 4 hours. PIVC insertion is ever present in ED admitted patients.
My clinical background is also in ED and my experience in vascular access have contributed to the concepts my research seeks to evaluate. ED is where vessel health and preservation should commence. In my opinion (but biased by my studies!) insertion practice is no different on the ward when compared to ED. Clinical practice should be no different, it should be as per policy.
Insertion skill is the final act in a long process of critical clinical decision making; this can happen in seconds or much longer. Not to get too deep into cognitive psychology, but this is where Type 1 and 2 of thinking is evident. It could happen very quickly with some and be influenced by their Gestalt or others may take time with a procedure.
We are about to finish analysis on a data set that looks at which provider we could resource to certain veins based on their confidence. My clinical academic colleague James Rippey is fascinated by the influence of clinician gestalt on first-time insertion success. We have a paper in press in Emergency Medicine Australia.
Simply put, we hope to test an application of rules in future to resource the least experienced with the best veins so they amass consistent insertion success, increase their confidence and continue to develop successful procedural consistency and experience with patients with the fewest visible veins.
VC: How can one get better at inserting peripheral IVs? Is there a course or training you would recommend?
PC: It is a skill, an art and practice one can make permanent. You must know your product "intima"tely (pardon the pun) well. Your product target is a vein.
Jack LeDonne is a great friend and mentor, and he has a great saying “Feel is our fluoro” (this is the best advice he has told me). He’s right, though. The evidence to date is a visible palpable vessel is a strong predictor of insertion success. Don't set yourself up to fail; assessment is key. Once you can see and feel that vessel you approach it text book like (Aseptic-Sterile). You must be confident. Patient rapport and trust is important. Make them feel safe in your presence. Simple, really.
However, clinicians need to follow their outcomes. Imagine you’re the clinician who was at the pin of their collar so to speak, and got the PIVC in only for the device to fail by occlusion on the ward 6hrs later? Now the patient has the duty anaesthetist who has to make an extra attempt at an extra cost. These are modifiable and avoidable outcomes.
There are many courses one can take locally, online and many scientific meetings have pre-conference workshops. Seek out the local health care professionals whose paid role is to provide such training and mentorship. Ensure they actually perform clinical PIVC insertion themselves; I know may vascular access educators who insert vascular access devices in mannequins but not patients. That's a concern. Find the person who you think is the go-to person in your hospital, ask for mentorship/proctoring. Reflect on your performance.
VC: A lot of this comes back to having a dedicated group of providers to insert peripheral IVs? Is that your recommendation?
PC: You ask an excellent question Vineet. Yes it most certainly does, and in my opinion not just for PIVCs but for all peripheral and central vascular access devices. I have been grounded into defending my answers where possible with an evidence base. We just don't have the evidence for dedicated groups though; by evidence I mean many RCTs- followed by Systematic appraisal and meta–analysis of the data proving this is the case.
By dedicated groups, we don't know if nursing vascular access team exclusively are better than a mixed healthcare professional model (nurses, doctors, RTs, PA’s) versus the general inserters. We have a Cochrane review coming out soon, and there is not one published RCT that randomises the patient (or indeed a registered protocol for one at the time of typing this) that suggests a dedicated group of providers is superior when compared to the current combination of medical, nursing, technician provision. There is an obvious evidence gap.
Of course, there is evidence that local single centre initiatives prove teams are associated with good outcomes, but no causal data. This comes back to clinical confidence and procedural competency not defaulting to a technology. If you were to run against Usain Bolt in the morning who would win the 100m sprint? If you were to compare a vascular access team member with an HCP who focuses on less frequent insertion, who may you think will have better outcomes? We can’t all get the gold medal, but I’m willing to take a bet that we can have improved and sustained insertion success and a huge reduction in failure and waste with a process that uses a dedicated group of providers. Then patients will have a gold standard.
VC: What types of policies need to be enacted in Australia to ensure consistent practice on a local/regional/national scale?
PC: That is a tough one. As someone who has contributed to policy and guideline development, I respect the efforts that are made in writing them. However, based on current evidence I read daily, Australia needs an exclusive national vascular access device standard to include:
1. Better evidence-based assessment tools so we promote appropriate placement by appropriately trained professionals;
2. Device registries in hospitals and better use of technology to capture data and report all outcomes, not just infection related. For example, alerts on previous line history, whether it was difficult or not. Some great work is being done with renal patients in this area in Australia;
3. But the answer is in one word - consistent. Right now our first-time insertion success is “consistent” with 70-80% and post insertion failure is “consistent” 45%. Australia needs to continue to improve toward maintaining acceptable clinical outcomes for patients and aim for: “Consistent Practice” that reflects 100% first-time insertion success, 0% bloodstream infections, 0% complications through device failure.
In my opinion, the team approach to vascular access science is the biggest priority, and large metropolitan hospitals should have the professional entity that is “consistent” with practice approach. Otherwise, clinical decision-making will be underpinned by authority; let everyone have a go, rather than evidence.
Finally, with the development of our national society “AVAS”, we have ignited a flame for vascular access device practice and research to be promoted. That flame will continue to burn brightly next May in Perth with what we hope will be a cracking scientific meeting that will engage clinical practice with science, supported by the patient narrative. Toward better patient and hospital outcomes for Australia and afar.
VC: Prof. Antonio LaGreca is a surgeon at Catholic University in Rome. We recently held an Open Discussion regarding the MAGIC recommendations at WoCoVA. Our exchange led to a number of important points, many of which pertain not only to the contrarian point of view with respect to PICCs but also nuances regarding vascular access devices. I therefore invited him to consider submitting a blog for ImprovePICC.
Dr. LaGreca has indicated the following conflicts of interest with respect to this blog: "I am a member of the Italian Study Group on Vascular Access (GAVeCeLT). This a non-profit association aimed at deepening and spreading knowledge and practice on vascular access."
VC: Your views regarding the safety of PICCs differ from mine. Tell my why?
AG: I tried to underline that, from a conceptual point of view, PICCs are not something different from CICCs (centrally inserted central catheters) or FICCs (femoral inserted central catheters), as we like to classify central VADs. The difference lies in the approach, not in the vascular access device (VAD), and the approach makes a big difference. If we look back to the genesis of PICCs, they were born as second choice devices. When placed at the elbow, their clinical performance was so unsatisfying (early massive thrombophlebitis as high as 70% at 3 days, mechanical problems such as dislocation, rupture, occlusion, high failure rates at insertion) that they could not be considered a first line approach. After introducing the mid arm approach under ultrasound guidance, a revolution occurred: success rates improved, indications widened, and the ability to obtain a CENTRAL line without facing potentially life-threatening complications of a cervical or thoracic approach (e.g., pneumothorax, vessel injury, etc.) extended the range of operators that could feel (or try to feel) confident with the procedure.
VC: Interesting - how do you think this influenced the adoption of PICCs?
AG: The culture of patient safety in the field of vascular access has always grown with the introduction of new and enthusiastic operators involved in insertion and management of new devices. This was true for central venous catheters, and in todays era, we have to thank PICCs for this.
VC: So are there no problems, in your opinion, when it comes to PICCs?
AG: Well, PICCs have faced several technical and procedural problems in the recent past. Some of these problems have been overcome thanks to a huge cultural and technical effort by clinicians and companies.
Technical problems may be summarized as follows:
Procedural problems include correct indications and choice of device for each patient, wise proactive vascular planning, standardization of safe and effective insertion techniques.
In this context, numbers without wisdom can make the difference. If operators dealing with a new procedure increase, numbers may increase irrespective of actual needs and benefits, safe insertion and care procedures and cost-effectiveness. This may harm patients and health systems as well. I use to present a brief paradoxical example of what can happen if we consider the same issue from two different points of view: I call it "the rule of the numerator”…
In 2010, the vascular team of a small hospital inserts 100 PICCs, with a global complication rate of 10%. In 2013, the same team is able to insert 1000 PICCs with a global complications rate of 5%. The absolute percentage of complications looks much better in 2013, but if we look at the actual numbers of patients harmed - we had 10 complications in 2010 as compared to 50 in 2013. If the average complication costs 25,000 euros (as it happens for a single CR-BSI), we are facing a global cost of 1,250,000 Euros in 2013, as compared to 250,000 Euros in 2010. Is this balanced by an actual increase in patients outcomes and/or reduction in other expense sections such as procedural costs, operators’ workload etc.?
VC: I see - what about major problems like bloodstream infection?
AG: In the middle between technical and procedural problems, catheter related blood-stream infections are still a concern, related to numbers as well as correct indications, care protocols and use of supporting devices (dressings, sutureless devices, etc.). In this field we have good quality evidence and devices, but still need to better incorporate these data into practice. This is especially relevant in the case of PICCs given the wider adoption of these devices and the growing availability of dedicated operators and staff to maintain them.
VC: So how to move this forward so that everyone inserts and cares for PICCs safely, much like you do in in Rome?
AG: A huge cultural effort by clinicians and technological effort by companies could further improve results as follows:
These are all avoidable in my opinion, as follows: first we need to define and adopt an evidence-based, but comprehensive algorithm for choosing the right device in each patient. We are proposing our hospital algorithm throughout the country: it includes indications and contraindications, and provides a reasonable approach to the problem. Maybe an international approach, one that began with the MAGIC paper that can be further modified and integrated to the local context could work even better.
VC: What do you see as the major challenges in the field today?
AG: There are several important issues that need resolution:
VC: Your thoughts are very interesting. What final words of wisdom do you have for our readers?
AG: I told you in Lisbon that I see myself as a good clinician, not as a researcher: so tell me what do and I will do it the best I can. I haven’t got answers yet, but only some ideas. One of these is, if one of the major concerns is thrombosis, we need a big multicenter study with a very homogenous insertion protocol throughout the centers, including a strict indication for catheter-to-vein ratio. This is feasible and will give a definitive answer as concerns pathogenesis of catheter related thrombosis and related consequences on practice. Also, we need better cost-effectiveness studies and data regarding empiric outcomes. The field should work on a simple, but effective algorithm for indication and choice of vascular access devices to be spread all over the world of operators. I hope we can work together to provide answers and conduct these types of studies.
Blogs written and edited by Vineet Chopra unless otherwise stated in the header. Guest blogs are identified accordingly.