• LecturehallThe Diabetic Foot Team in 2019
  • Lecture Transcript
  • TAPE STARTS – [00:00]


    Unknown Speaker: Alright, our last speaker of the day is Dr. Lee Rogers, which I'm sure most of you have had the opportunity to listen to his boring lectures. Lee is a good friend of mine. We have shared the platform on many occasions. He is involved with a division of Restorix. He is actually the Medical Director of Amputation Prevention Centers of America in White Plains, New York. He has been cited in many publications. He's been on television for many reasons, some of which we won't discuss. But at this point, we're going to ask Dr. Rogers to give us the final talk on the Diabetic Foot Team in 2019. Please welcome Dr. Lee Rogers.

    [APPLAUSE]

    Rogers: Well, thank you very much. I'm happy to be able to close out the day here, and I’m really impressed with the work that Rob Lee and his team have done in bringing and present -- we know the statistics, most of the people are from LA County or Orange County that are here. Only about 5% of the people that are attending this meeting are from out of California. But those of you that have been to this meeting before and have seen the growth over the past five years or so until now, probably would agree with me, looking at the exhibit hall and then the room how full it is. So it’s nice to see this happened here in LA. And for us to have a big meeting that's really leading the way.

    I'm going to talk about what your Diabetic Foot Team should consist of, and this comes from a lot of the work that I've done at Restorix. Restorix is a company that manages wound care and limb salvage centers. We have 235 centers in 35 states. And my role at that company is to help develop the policies and procedures, the clinical practice pathways and then also do quality assurance and performance improvement.

    [2:17]

    Those are all very boring buzzwords, but I put it together in a more concise and interesting way so that you can see how you can work with this, either in your practice or in a hospital-based wound care center or in an off-site wound care center. So these are my disclosures, the learning objectives, which are also published. We want to understand how the team approach impacts diabetic foot outcomes. We're going to know what skill sets are useful on a Diabetic Foot Team and then get exposure to the audit improvement system that involves a Diabetic Foot Team.

    So, the thing about the diabetic foot is that, when you talk to mostly payers, we're going in and we're working with big insurance companies or Medicare, and we're saying, “You know, the diabetic foot is a big problem for you. You spend a lot of money on it.” And most of the time, they say, it's usually their medical director and they say, “Well, you know, we spend some money on it, but it's not that big of a problem.” Because they're thinking about one thing, when they think of the diabetic foot. They're thinking about a diabetic foot ulcer, when in reality the diabetic foot is a syndrome and it includes everything from PAD, lower extremity abscess, gangrene, foot deformity, Charcot neuropathy, foot ulcers, CLI, amputations which are super expensive, and other soft tissue infections. And when you put all of these things together, when you give them a whole list of the ICD-10s and you ask them to look at these ICD-10s, usually they come back and they say, “Wow, we are really spending a lot of money on the diabetic foot.”

    [4:00]

    And we also know from some of our own research and that of both David Armstrong and Larry Lavery, looking at the total cost of diabetes, the lower extremity accounts for almost a third of the total cost of diabetes. So diabetes is the most expensive chronic disease. And in the most expensive chronic disease, a third of that cost is related to the diabetic foot. And that's where podiatrist and those of us who specialize in wound care really can play a prominent role in the health system, and helping to not only take care of these patients but help to reduce cost to the system.

    So we're going to talk about how to create excellence in diabetic foot care and their three essential steps; establishing a team, create standardized pathways, and then create a process for audit and improvement.

    So first, the Diabetic Foot Teams. People often say, “Well, why do I even need a team?” Well, here's a couple of quotes for some papers. One, Ryan Fitzgerald, who wrote a paper about the 7 Essential Skills for Targeted Limb Salvage. He wrote that the Acute Foot Team is an interdisciplinary team model whose core involves the ability to rapidly diagnose and provide effective treatment to patients with lower extremity complications.

    And then Nick Bevilacqua and David Armstrong and I wrote in our paper, the Toe and Flow paper, a team of dedicated specialists is required to prevent lower extremity amputation in people with diabetes because it would be exceedingly rare to find a single practitioner capable of managing all aspects of care for the diabetic foot. And this is unusual in that if you go into the Emergency Department and you have chest pain, you see the ER doc, but you really only need a cardiologist at that point. But if you go in with a diabetic foot attack, you do need a team of people that span a variety of skill sets in order to prevent your foot from being amputated.

    [6:08]

    And unless that team is already set up in advance, and we’ll show you some of the data about this, then your outcome is going to be worse when it's just being done on the fly. So looking at some of the research that's been done on teams, and in fact, when you compare the research that's been done on products versus the research that's been done just on diabetic foot teams, diabetic foot teams use advanced products. But you look at products, various skin substitutes or negative pressure devices, or all of that, the impact that a team makes is actually much greater impact on limb salvage than the impact that a product makes.

    And so, implementation of multidisciplinary teams reduced amputation in the Netherlands by 34% in the entire nation after they implemented mandatory teams. Amputation reduced by 72% in the US hospitals after implementing an amputation prevention team. And then studies from the UK, Finland, Italy, India, Australia all have had similar conclusions. Italy itself is probably one of the more advanced diabetic foot systems in the world, of any place I've been to. They have mandatory referral for any patient that has a diabetic foot problem to a diabetic foot team. And there are 22 of those teams around the country, Centers of Excellence essentially. And so it's really, from a system standpoint, one of the most advanced that we've seen. Whether or not they're using advanced products or techniques, the system is very advanced.

    So people often ask, “Who do I need on my team?” And I think that, that's the wrong question to ask. And instead, the question should be “What skills are needed on my team?” Because there are different types of people that can perform these different skills.

    [8:06]

    So you first ask what skills do I need, and then you plug in who is going to perform those skills later. And the reason for that is because -- for example, in vascular care, we've got typically vascular surgeons that provided most of the peripheral vascular care. But now we have interventional cardiologist and interventional radiologists that are doing very distal procedures and with good success rates. And so it may not be necessary that you have a vascular surgeon on the team. And instead, it's just necessary that you have somebody that's restoring perfusion and you can find somebody that can do that in your system, therefore creating a well-rounded team.

    So when we look at what skills are needed, we want to have an effective limb salvage team; the ability to perform hemodynamic and anatomic vascular assessment with revascularization, that could be endovascular or open bypass; the ability to perform a neurologic workup; the ability to perform site appropriate culture techniques; the ability to perform a wound assessment, and staging and grading of infection and ischemia; the ability to perform site-specific bedside and intraoperative I&D or debridement; the ability to initiate modified culture-specific and patient-appropriate antibiotics; and the ability to perform appropriate postoperative monitoring to reduce the risk of re-ulceration and infection.

    Now looking through this list, you can probably say well, I could think of a few different specialties that would fit into multiple categories here. So when we look at the standard treatment pathway for diabetic foot ulcers, taking care of infection and then making sure there's adequate perfusion and green ischemia here, treating the wound and healing the wound, possibly doing surgery, and then rehabilitation and prevention.

    [10:05]

    We can see that in each of these categories, there are diagnostics, interventions, possible surgery. Now you can see the types of specialists that might get involved here. So in infection, for diagnostics, maybe we're getting a radiologist involved; maybe ID; podiatrist is certainly necessary here; antibiotics; performing surgery, podiatrist or a surgeon. Ischemia; you can see here, there's diagnostics, endovascular open bypass. So all of these types of specialists might get involved. Wound care; we have offloading, debridement, local care. So you got these people here. Pulmonologist are sometimes involved with HBO treatment. Surgical treatments here. So you get a more complete picture of what the team might look like. And it doesn't always have to have a vascular surgeon, a plastic surgeon or a podiatrist, even though those have been described in other articles.

    The structure of the wound care team has also been written about a lot, and the traditional model is the wound care center model. And those of you that have worked in a wound care center before, probably are most familiar with this model. It's probably the most prolific model around the country and this is where an interdisciplinary team, they may not be really functioning as a team because they're not all present at the same time, but an interdisciplinary group of doctors are working on taking half-day-a-week panels and working together. So your ID doc may come in on a Monday morning and the vascular surgeon on a Monday afternoon and the podiatrist on Tuesday morning. And those are very common models that are present around the country. The problem with that model is that, while it is kind of a one-stop shop, it's not really patient-centric, because the patient has to come back multiple times to see different specialists.

    [12:03]

    And, also some of these specialists, like let's say an infectious disease specialist, if you have a patient that needs to see an ID doc today, they need to see an ID doc today, they don't need to see one next Thursday. And so some of these models there, the problem exists in that model, than you'll see in a later model I'll show you, which is a little different. So there's the VA model that's been written about, which is a podiatry centric clinic. That's done in the VA. There's also the military hospital model, which has been written about. What's more common in the UK and in Italy is an endocrinology-directed model. Really, endocrinologists are the only ones that are interested in the diabetic foot, only out of necessity really, and so they're leading the way.

    Again, I'll come back to Italy. In Italy, the people that are doing diabetic foot surgery are actually endocrinologists. They came to the United States and learned how to do some simple things. So some of us taught them how to do tendon lengthenings, Achilles tendon lengthenings, and snap tenotomies, and some debridements, and things like that, that you would say, well, these things might be very useful in general diabetic foot practice, and then you could train an endocrinologist how to do it. And in their system, they really don't have any liability, so they can kind of do whatever they want. And the orthopedic surgeons definitely don't want to do it. So the Italian endocrinologists were doing this.

    And I remember one time, when after this group came and worked with David Armstrong and I, and they sent pictures back next week from the clinic. “Oh, yeah, look at this TAL we did.” And then they kind of went silent for a while, maybe two or three months. And then I got a picture of a Charcot foot reconstruction with an iron rod. And they're like, “Look what we did in this case.” And they just read about it and looked at a few pictures. And so now they're really doing very, very complex surgeries. But they’re endocrinologists who never had any official training in their residency programs on surgery, but are doing it out of necessity because otherwise they would have patients with a lot of amputations.

    [14:13]

    There's the Georgetown University model which has been written by Chris Attinger and John Steinberg. And that's a model that contains plastic surgery. It's mostly plastics-led, but it's plastic surgery, podiatry and vascular; kind of as a three-legged stool. David Armstrong and I wrote about the Toe and Flow model we published in the Journal of Vascular Surgery, which is primarily podiatry and vascular surgery, although it really could exist with podiatry and interventional, or in some parts of the world where podiatrists are not present, as long as somebody's doing the foot surgery, the surgeon and the revascularization.

    And then probably the newest model, which is coming out of the cardiology world, is really the interventionalists-led CLI model where they're using office-based labs. There're actually several around LA, where they're using office-based labs to perform revascularizations, but they don't have the wound care components. So they're working with podiatrists in their office to refer patients in to have the wound care done.

    So the paper we wrote about the Toe and Flow model was -- we described the central components and structure of the amputation prevention team. And we divided this up just like you have trauma centers; level one, two and three. We have a basic, intermediate, and Center of Excellence level model, and described the skill sets and all the tools that might be needed for each of these models, and how to set that up. So, in this creation of excellence, I described now how to form the team. Now you have the team, but how is the team going to function within the center or in this hospital?

    [16:01]

    We want to make sure that we're taking the clinical practice guidelines. These are things that are written by societies, like SVS or Society for Vascular Surgery, or IDSA, or the American Diabetes Association. They're writing clinical practice guidelines. Now, clinical practice guidelines are great. They give you a guideline, but they can't be implemented in every locality, because maybe something is not available or the geographic practice is different. So in that case, you can take the clinical practice guideline and just plop it in your hospital. So that way, you create your own clinical practice pathway that's based on clinical practice guidelines. So these are based on evidence. And then this is based on the evidence-based document. Then underneath clinical practice pathway, you write policies and procedures of how things are going to function in your clinic or in your office. You have Quality Assurance to measure whether these policies and procedures are being done. And then if they're not being done, you have performance improvement. And that's the general pathway for creating excellence and monitoring the system.

    My email address is down here at the bottom. And if you want a copy of these, I have all of these in PDF, I can just email you the whole file. But we have the more current ones. We have the SVS or Society for Vascular Surgery in conjunction with the APMA created a guideline on management of the diabetic foot. Not to be outdone by the SVS, the American Heart Association and the American College of Cardiology created their own guideline on management of patients with lower extremity PAD. We have from the ADA, the American Diabetes Association, how to manage the diabetic foot as an inpatient. The NICE guidelines which come from the National Institute for Clinical Excellence in the UK, they have their diabetic foot guidelines.

    [18:11]

    The European Union of Wound Healing Societies has their guidelines. These are a little older now. But the one previous to this, the IDSA Guidelines for 2006, the more recent one is now 2012, they probably are working on an update to this but it is the most current one. The Infectious Diseases Society of America Guideline on the Treatment of Diabetic Foot Infections. And then, we have ones on the Charcot foot and diabetes.

    So, we have these clinical practice guidelines that we need to now turn into clinical practice pathways. So we take statements out of these and we're just going to use these few examples. And we'll stick with peripheral artery disease in the diabetic foot, for example. And we look at here, this is the SVS guidelines from 2016. So we'll look at these things and we'll take an evidence-based statement. Like this, Recommendation #3, in patients with diabetic foot ulcers ref peripheral artery disease, we recommend revascularization by either surgical bypass or endovascular therapy, grade 1B evidence. So then we want to put this into our clinical practice pathway.

    So when we create a perfusion pathway, a clinical practice pathway, we take these recommendations, and we have the clinical diagnosis part up here, laboratory diagnosis, we have other imaging, and then the treatment part, which is to restore in-line perfusion to the foot. This is either adequate or inadequate. If it's inadequate, we attempt a revascularization. If it's successful, move on to wound care; unsuccessful, wound hospice or possibly amputation. So this is what a general clinical practice pathway looks like.

    [20:09]

    And you're going to have several of these within the same disease entity. So this one's about perfusion, you're going to have one that's about infection, you have one about the general treatment of wounds, maybe one specifically on offloading that would be used. Then underneath that clinical practice pathway, you have policies and procedures that are going to be written, that make sure you're following the pathway.

    Again, we’ll stay on PAD. This is one about noninvasive vascular studies. These are all supported by the evidence, by what's coming out of these societies. And so you make statements like this. Generally, policies and procedures have a purpose. They can provide a little background information, so people understand why they're following the policy and procedure. And then they list the policy and then sometimes have additional information, like in this one, interpretation of some of these vascular tests.

    So here's the policy. The policy is -- this actually comes from our centers, so this is what we do. All new patients with a lower extremity wound will have a noninvasive vascular study, either an ABI, a TBI or skin perfusion pressure, to determine the ability to heal and if vascular intervention is needed. And again, the background on this is 50% of patients who have a diabetic foot ulcer have impaired perfusion. And so 50% of the people that are coming in your office already have impaired perfusion and you're not doing a vascular study to uncover that, and usually these are silent problems in somebody with diabetes and neuropathy, then you're going to miss a lot of these patients that require a revascularization. So that's why policies are written to make sure that we're following this and everybody's getting these studies.

    [22:04]

    So then also patients who fail a 30-day reevaluation have their perfusion reassessed. Perform noninvasive vascular studies on any patients with intermittent claudication or rest pain, that's fairly rare in people with diabetes and neuropathy. And then, perform the tests according to manufacturer’s recommendations. So now we have our policy that's going to be followed by the staff in the center, by the physicians, and everybody else.

    Well, how do you take this policy then and make sure that we're following it? Well, this is the quality assurance part. So now we look and we see that, this is an example, a skin perfusion pressure should be completed within seven days of a new ulcer. We put a target here, 90%. So 90% of the time we want to see that a study is done within seven days of presentation of a new ulcer. If the skin perfusion pressure is less than 50 mmHg and that’s significant for -- well I can tell you that above 50 mmHg indicates that perfusion is fine, less than 30 mmHg of skin perfusion is highly significant for failure of wound healing and amputation level, 30 to 50 is kind of a gray zone. So that's why we say, less than 50 mmHg, a consult should be obtained with a vascular specialist. We want to see that happen 90% of the time, because there’s always going to be 10% whether it's been documented in electronic medical record and the patient transfers out, or it's just not appropriate, and it's up to the physician to make this determination. There's always going to be some wiggle room in there, so it's not 100% ever. So we want to see this happen 90% of the time. Recommendations for intervention should be carried out within seven days. We want to see that happen 90% of the time. And so if it doesn't happen 90% of the time, then we move on to performance improvements.

    [23:58]

    So other quality assurance measures, these are sometimes called audit measures, that you might have in your facility or your office, you want to look at the overall healing percentage of wounds and then create a target. And these are targets that we use, but the target should be individualized to each facility. And it should be based on historical healing percentages. But let's say healing percentage of all wounds, you want to see 85% of all wounds healed in this program. Healing percent diabetic foot only, our target is 88% diabetic foot only. Median days to heal a wound, it's not mean, it’s not average, it’s median days, at the center if you created a graph; we want to see 55 days or less. High low amputation ratio; this was written by Jim Robblee about looking at the number of high amputation to the number of low amputations, the target is 0.5. Noninvasive vascular study on all new ulcers, 90% of that, I had that in the previous slide. Debridement interval on DFU visits, 70% of visits should have a debridement on DFU, because that's the standard of care. Total contact cast usage in DFU cases, 40% target.

    So when these things aren't being done, then we move on to performance improvement. And those performance improvement techniques can be things like staff retraining, education. Sometimes I have to go in to a center where we already identified ahead of time, what the problem is. The problem might be one or two providers, where the other providers have pretty good outcomes and one or two providers have outcomes that are below the standard. And then we have to offer to send the provider to a course. Maybe they're not using total contact cast at all, because they're either unfamiliar with how the cast is used, and sometimes even unfamiliar with how to bill for it, don't understand that they can get paid to do it, so they don't do it. So we send them to a course on how to do that.

    [26:05]

    And the worst case scenario is, obviously, some type of HR event that you might have to deal with staff or a physician if they're not following policies and procedures. But this is good documentation from an HR standpoint, if you need to document somebody who needs to be let go because they have bad outcomes and it's not good for patient care. It's great to have policies and procedures written because then if you ever get sued afterwards for wrongful termination, you're able to say, “We have policies and procedures in our clinic or in my office that say that these are going to be followed and these are the standard and everybody else follows these and the staff has signed these. Usually staff sign the policies and procedures, that they've read them and they understand the policies and procedures.” And that way it saves you from a liability incident if you have to fire somebody for not following policies and procedures.

    So I'll leave you with this quote from Hannibal, not Hannibal the cannibal, but Hannibal the Emperor who was trying to conquer Rome. At the time, Hannibal was trying to go from Central Europe in to Southern Europe, and he had the best military technology, which were a bunch of elephants. He was the Emperor and his generals said, “You're never going to get these elephants over the Alps to get in to Italy.” And he said, “We will either find a way or we’ll make one.” And that I think is how I feel a lot of times with the diabetic foot. There are so many obstacles, whether they’re system-based obstacles, patient-based obstacles, some provider-based obstacles; and you have to go into this with the mentality that you're either going to find a way or make one. And limb salvage really is about being a philosophy.

    So thank you very much.

    [APPLAUSE]

    TAPE ENDS [0:28:08]