Dr. Michael Kraus: Welcome, everyone, to this episode of Field Notes. I'm Dr. Michael Kraus, the Associate Chief Medical Officer at Fresenius Kidney Care and your host for this discussion today. Here we interview the experts, researchers, physicians, and caregivers who bring experience, compassion, and insight into the work we do every day. 

Our goal is providers to give our patients the absolute best care possible. And that means we continuously work to improve and measure the quality of the care we provide. We believe that as we grow peritoneal dialysis, the care and treatment we provide patients should result in lower morbidity and the best outcomes. But to understand how to improve, we need to answer this question How do we measure the quality of peritoneal dialysis?

Luckily for us, we have an expert in quality here with us today: Michelle Carver, the Vice President of Clinical Services Initiatives at Fresenius Kidney Care. Michelle, welcome to Field Notes.

Michelle Carver: Hello, Dr. Kraus, and thanks so much for the invitation.

Dr. Michael Kraus: Michelle, to start things off today, tell us a little bit about your background and why you are an expert in this area.

Michelle Carver: Well, I'm a nurse. I have over 20 plus years in dialysis experience, specifically with home modalities, both peritoneal and home hemodialysis modalities. And I also currently am in a role that focuses very heavily on how we can better train and support a much larger home dialysis population in the future.

Dr. Michael Kraus: And with that emphasis on a much larger home dialysis population, I know that there's a lot of thought today in the country and even the world in the growth of home dialysis, particularly peritoneal dialysis. Why is it important to focus on quality at the same time that we're focusing on growth?

Michelle Carver: Quality really is the basis of success for us. We both know that home dialysis, including peritoneal dialysis, is not an easy thing for patients to take on. And so, for them, to be able to successfully and over a long span of time be successful at home, we have to ensure that we're delivering high quality care. Because to continue to do this, it takes patients feeling the benefits of peritoneal and home hemodialysis.

Dr. Michael Kraus: So, we can't grow without quality. We can train a lot, but we can't grow. What are the metrics or how do we know that we're providing a care that improves that quality of life the patient feels?

Michelle Carver: There's a lot of metrics that we need to take into account. First and foremost is we measure Kt/V in our patient population. And I always say that's kind of the bar we establish for monitoring adequacy of dialysis. But there's a lot of other things that go into evaluating whether or not that Kt/V is enough for our patients to reduce complications and improve clinical outcomes.

Dr. Michael Kraus: So, it's not about adequate dialysis per se. It's about optimal dialysis, making our patients feel better.

Michelle Carver: Exactly. If it was just about adequacy, we could drive that single number, and we can watch it every month and adjust our prescriptions based on that one number. But we all know every patient is different and every patient needs a different prescription for them to feel better and to have improved quality outcomes and also have great quality of life.

Dr. Michael Kraus: And I've heard you in the past, and we certainly spoke about optimal dialysis. How does that differ from adequate dialysis?

Michelle Carver: Adequate dialysis? Again, I often speak to when we measure Kt/V and we look at our targets, that's really the floor. That's the minimum of what we want to deliver for our patients. We have to evaluate the whole treatment over time. And not every treatment's going to be identical. So, if we're only delivering the floor, there's a very likely chance that we're under under-dialyzing our patients at some point.

So, we also want our patients to have improved clinical outcomes, improved survival, reduced hospitalized patients… and to do that, we have to deliver a prescription that far exceeds the basic adequate dialysis.

Dr. Michael Kraus: So, adequacy is a part of quality, but it is not always quality. What are the key components of measurable items that we can follow in FKC, or as the government or a payer in peritoneal dialysis? What kind of things are good quality metrics in your mind?

Michelle Carver: It's many other labs, things like phosphorus control, volume management, a patient's blood pressure. Also, there's just anecdotal information that we get from patients—their energy levels, their appetite, all of those things tell us a story around are we delivering optimal dialysis or are we just barely meeting our minimal clearance requirements?

Dr. Michael Kraus: So, I think I want to come back to particularly volume and maybe some other key components of optimal dialysis. Let's focus a little bit back on adequacy and Kt/V, adequacy being the definition from the government on urea clearance or Kt/V. I know there's a lot of discussion and always has been since that came out in the late eighties on whether Kt/V is a good indicator quality. And a lot of our leaders, key opinion leaders, say it's not and we should abandon it. What do you think of that?

Michelle Carver: I think the first thing is to, for those of us that have been in home dialysis a while, we all remember that the minimum Kt/V target for KDOQI used to be much higher and that was actually lowered to what we measure today, which is 1.7. I think if we didn't have Kt/V, what would our basis be to measure that we're clearing enough solute for our patients?

It is one piece of the puzzle. It isn't the whole puzzle. But I do think it gives us great insights into overall “how is the prescription working for the patients?” If I didn't have that measure, it would be difficult for me to establish a base treatment therapy for patients. I think it's a guide. I also think it helps us trend our patients as they lose residual renal function.

That number helps us be proactive with prescription changes with the physician that the patient might need so that we don't inadvertently under-dialyze a patient. We have to remember we're only also, in most cases, measuring PD adequacy once a quarter. We know a lot can change. So that number to me is very helpful in the overall picture of our patient success.

Dr. Michael Kraus: So, it's useful in quality because it is a reliable, easily measurable, reportable number that we can track. But you did mention that it's reduced in years, and I think that goes back to the ADEMEX trial from about 2002 where the Kt/V goals went down to 1.7. And I personally think that that study tells us why we don't want to go below 1.7.

What are your thoughts on that number? And if that does give us an idea that we shouldn't be lower than that?

Michelle Carver: Well, I agree with you. I think we wouldn't want to go below that number, most certainly. And in many cases, we want to target a much higher Kt/V than 1.7. But if you recall, that study was of CAPD patients and smaller, so I can't remember, I think those patients were somewhere around 69 kilos and the primary outcome of mortality was similar, but if you really look into the study, the lower Kt/V group had an increased morbidity. So, I think that study tells us a lot about the fact that the majority of patients actually would do much better on peritoneal dialysis if we targeted at a higher Kt/V.

Dr. Michael Kraus: So that 1.7 was okay to stay alive, but it was associated with more hospitalizations from fluid overload, more drop of therapy. So, it was not exactly equivalent, but it was okay with mortality. So that's why I agree. As we look at that optimal dialysis, certainly we don't want to go below that number. Let's move back to salt and water, because the low Kt/V also gives us a marker for salt and water clearance, I would suspect as well. How do we measure volume or how do you, in quality, think about volume in peritoneal dialysis?

Michelle Carver: Volume management is one of the most important things we can do for our patient population. Clearance, removing toxins. Absolutely, we have to do that well. But volume management is what's going to keep our patients out of the hospital. We know that peritoneal dialysis patients have a much more likely chance of being hospitalized for volume overload. And so, we really have to focus on the whole assessment of the patient.

It's not just about dry weight and our ultra-filtration, but it's about our patients’ blood pressure and it's also about the trends over time. So, measuring patient's urine output, we know that in most of our patients, over time, they will lose some residual renal function. If we're not consistently measuring that, it gets harder and harder to achieve the volume removal because we need to replace whatever they're losing at the same time. Otherwise, it is challenging for peritoneal dialysis patients to achieve their target ultra-filtration with every treatment.

Dr. Michael Kraus: And what markers of volume are you most interested in?

Michelle Carver: Teaching our patients a good volume assessment at home so that they can notify us when their volume status is changing. So, edema, or patients carrying more fluid in their ankles, in their face, you know, in their fingers. So, teaching patients to assess their edema. 

Blood pressure, blood pressure control is key to our patients. And it shouldn't be just “I see my patients are trending up in their blood pressure, so we add another blood pressure medication.” No, we should be saying “an increase in blood pressure likely means an adjustment in their target weight first.” So also evaluating appropriate estimated dry weight and doing that on a routine basis. I recommend at least monthly in our patient population. 

And then the other big thing is teaching our patients to measure their urine volume because as it changes, we need to know that. They don't have to bring in their whole urine volume, but just have them measure it, write down the total, and then when they come in to see you either face to face or through a telehealth, you can trend their urine volume over time and determine if it's time to approach the physician about a prescription adjustment.

Dr. Michael Kraus: And recently with the Fresenius Kidney Care has been rolling out this PD loss model or the artificial intelligence to help us determine who's at risk to drop for the next three months or six months. How can quality teams use that?

Michelle Carver: It helps us identify the patients that are at the highest risk of dropping from the therapy. Over time, patients are going to likely need significant prescription adjustments to be successful on peritoneal dialysis. So just trying to focus on outlier management, that risk tool can help identify the patients that are in greatest need of evaluation with the interdisciplinary team.

And sometimes, it's not always about a prescription adjustment. Sometimes, it's about diet and fluid counseling. Maybe the dietitian needs to spend a little more time with patients so that they can manage their volume status through watching what they drink a little closer or reducing their sodium intake. So that really is an interdisciplinary tool to say, okay, what can we do as a team to try to intervene and be proactive before a patient gets into trouble?

Dr. Michael Kraus: And if you see a higher percentage of people at risk on quality tools, is that alert for anything?

Michelle Carver: I do think it's an alert. I think it's an opportunity for our clinics to evaluate their clinical practices. If I have a very large percentage of our patients that are showing up, high risk or even very high risk, I would ask myself “what kind of quality improvement processes do we need to put into place to ensure that our patients are actually receiving optimal dialysis care in our clinical setting?”

That may be timely prescription adjustments. We both know that sometimes prescription adjustments aren't made as quickly as we would hope. We say, oh, we are seeing trends that indicate that we might need to increase the prescription, but we wait month after month before we actually complete that. At that point, sometimes the patients have had either complications or they don't feel well enough to continue to do their own treatments at home.

So, I think the biggest thing is evaluating your clinical practices as a whole and being much more proactive and timely about treatment adjustments that are needed.

Dr. Michael Kraus: So, this has been very helpful. It seems to me you think about optimal dialysis and providing that value to the patient, but you look at quality slightly differently. There's two levels, right? There's quality is you measure it from FKC so that there's consistency of good care throughout the programs and then there's quality at the bedside, which is the patient-nurse-doctor relationship for each individual patient. And both are exceedingly important, I would suspect.

Michelle Carver: They are. We have an obligation to ensure that every single dialysis patient receives optimal dialysis treatment and care. By monitoring quality from an organizational perspective, it helps us identify what processes do we need to change or implement to ensure that our broad patient population benefits in improved clinical care delivery. Then at the patient level, it's all about making our patients feel as good as possible so that they can continue to self-manage.

We want them to stay on therapy as long as possible, and the only way to do that is to ensure that they have high quality care and that they feel the benefits and want to continue to do that successfully at home.

Dr. Michael Kraus: It's so important to explore these details and to improve the quality of care for our patients. Measuring the quality of peritoneal dialysis allows us to improve the care of our patients and to help them achieve that optimal dialysis. Michelle, this has been a great conversation. Thank you for being here today.

Michelle Carver: Thank you.

Dr. Michael Kraus: And to our audience, thank you for joining us. If you're new to the Field Notes podcast, you can download past episodes on Apple Store or Google Play or even right here at FMCNA.com. And while you're there, please subscribe to receive the very latest updates as they happen. Until next time. I'm Dr. Michael Kraus, and you've been listening to Field Notes by Fresenius Medical Care North America.

Take care, everyone.