Episode 47: An Update on Transitional Care Units
A recent study funded by Fresenius Medical Care digs into the impacts transitional care units (TCU) have had on patient outcomes. The goal of TCU is to empower patients to manage their own care and make the best therapy decision for themselves, and since the year 2020, Fresenius Kidney Care had opened over one-hundred TCU across the nation to help people recently diagnosed with kidney disease or kidney failure learn about kidney disease and the treatment options available to them, including home dialysis and transplantation. In this episode of Field Notes, Dr. Michael Kraus, Associate Chief Medical Officer of Fresenius Kidney Care, Dr. Dinesh Chatoth, Associate Chief Medical Officer of Fresenius Kidney Care, and Derek Blankenship, Senior Director of Epidemiology and Biostatistics at Fresenius Medical Care, talk about the results of this study and how TCU is an excellent way to provide predialysis care to patients, one of the most important components in a patient's kidney care journey. Read the full study here: https://onlinelibrary.wiley.com/doi/10.1111/hdi.13068.
Dr. Michael Kraus: Welcome, everyone, to this episode of Field Notes. I'm Dr. Michael Kraus, Associate Chief Medical Officer at Fresenius Kidney Care, and your host for this discussion today. Here we interview the experts, physicians, and caregivers who bring experience, compassion, and insight to the work we do every day.
In the year 2020, Fresenius Kidney Care started expanding transitional care units, or TCU. Since then, we've opened up over 100 TCU across the nation to help people recently diagnosed with kidney disease or kidney failure learn about kidney disease, medical care, and the treatment options available to them, including home dialysis and transplantation.
The goal of TCU is to empower patients to manage their own care and make the best therapy decisions for themselves. Pre-dialysis care and education is one of the most important components in a patient's kidney care journey, but sometimes not available to all patients. TCU were designed to meet the needs of all patients as an adjunct to those with prior education and as a primer for those who started their journey unaware of kidney disease.
We need to explore the impact that TCU have played in increasing home dialysis utilization, but also, and perhaps more importantly, what other impacts have they had on patient outcomes? Fresenius Medical Care recently funded a study to figure out just that. Fortunately, we have two of the authors of the study with us today. Joining me is Dr. Dinesh Chatoth, Associate Chief Medical Officer at Fresenius Kidney Care, and Derek Blankenship, Senior Director and Global Biostatistics Lead at Fresenius Medical Care.
Dinesh, Derek, welcome to Field Notes.
Dr. Dinesh Chatoth: Thanks, Mike. Happy to be here.
Derek Blankenship: It's great to be here, and thank you for having me, Dr. Kraus.
Dr. Michael Kraus: Dinesh, let's just start with the basics. What is a transitional care unit, and why do we use them, and why are they important?
Dr. Dinesh Chatoth: Mike, a transitional care unit is an innovative model that's been designed to allow patients who are new to dialysis, especially those who choose in center hemodialysis to experience more of a soft landing…these hemodialysis patients are admitted to a dedicated space in a dialysis facility to be medically as well as emotionally stabilized and educated on all treatment options while they get the treatment.
Now, a TCU experience is typically for about four weeks, and then we use a dedicated team, which afterwards the patient then makes an informed decision about what modality they want to choose. And I do want to point out that more than half of patients starting dialysis today in the U.S. have unplanned starts and are really unprepared to decide about dialysis options. And so, in my opinion, TCU is a perfect setup to educate these patients while providing dialysis treatment so that they're empowered to care for themselves on the modality of their choice.
Dr. Michael Kraus: Excellent. Derek, tell us about your role here at Fresenius Medical Care and tell us what you do exactly.
Derek Blankenship: My graduate education is in biostatistics and epidemiology. Usually when I tell people I'm a biostatistician, that pretty much ends the conversation, so, I really appreciate you asking more. For 20 years, I have designed and conducted numerous statistical analyses on a wide variety of clinical projects. For the past 10 to 12 years, including my last three with Fresenius, the largest bucket of projects I work on are program evaluations such as the TCU Project, which we'll discuss.
Basically, with these types of studies, as with all real world evidence projects, I work in collaboration with many subject matter experts. We develop an analysis plan to answer specific clinical questions and then collect process and statistically analyze patient, medical, and other data to address the research questions using the most rigorous statistical methods we can.
Dr. Michael Kraus: Derek, you were the lead author on the study I mentioned in the introduction. Tell me more about that. What is the basis for the study and the initial hypothesis?
Derek Blankenship: As you mentioned in the introduction, like you said, TCU are a relatively large program within Fresenius. At the time of the study, October 2019 through September 2020, there were 724 patients from 48 TCU that we looked at. TCU is one of many Fresenius initiatives with the relentless goal of continuing to improve patient care. Given the importance of these initiatives to our patients, it's critical to conduct rigorous and unbiased assessments of our initiatives to learn if and how a program is achieving its goals so that ultimately, we can decide to continue with the program as is, enhance it, or move on in another direction.
Specifically for the TCU analysis: The hypothesis was that TCU increase the rates of home modality usage and that this, as well as other education and training within the TCU, will also improve other patient outcomes. To get further into the study, we followed patients for up to 14 months to assess their chosen modality: in center hemodialysis, home hemodialysis, or peritoneal dialysis.
Other outcomes assessed included all-cause mortality, hospitalizations, status on the transplant waiting list, and for non PD patients, their vascular access type. Indeed, in our study we did verify that TCU do have an increased rate of modality usage. During the 14 month follw-up time, 26% of the TCU patients were on either home hemo or peritoneal dialysis as compared to 10% of the control group.
Dr. Michael Kraus: So, Dinesh, we put a program into place and then we study it to see if we can improve on it. Why is the study clinically relevant to you and does it help in planning for the future for patient care and empowerment?
Dr. Dinesh Chatoth: The study is actually very relevant clinically and today, in our experience, about 30% of new hemodialysis patients are referred to a TCU. And this is because physicians tend to screen patients for a TCU based on the likelihood of choosing a home dialysis modality. So our biases come in the way while referring patients to a TCU. The study clearly shows that patients who choose in center hemodialysis after being in a TCU have significant clinical benefits.
So based on the study, we should refer all in center hemodialysis patients to a TCU, irrespective of whether they're eventually going to choose in center or home dialysis. In fact, patients with a failed transplant or likely to drop off PD should also be considered candidates for a TCU. And then I would say that when a patient feels well physically and emotionally and then have time to be educated and therefore make an informed decision, they feel empowered, just like you said. And being empowered promotes better patient engagement, improves their participation in self-care, and also improves their communication with physicians, and I believe leads to better outcomes, as the study showed very clearly. So overall, I think this study is fantastic and really adds a lot to who would be a perfect candidate for a transitional care unit.
Dr. Michael Kraus: Transitions are such an important point in our patient's life journey. Can you speak to it and speak to the importance of helping patients through those transitions?
Dr. Dinesh Chatoth: Patients, when they come to us, as I mentioned earlier, a lot of them have fears, anxiety, may have preconceived ideas about dialysis, and are very minimally educated because some of them have unplanned starts. So, transitions are very stressful for patients, irrespective of whether the new to dialysis or transition between modalities. So having the patient be educated, be emotionally ready to receive that education, and interact with an interdisciplinary team… Remember, Mike, I mean, as you know, the team members are not just the transitional care unit staff. We also have home dialysis nurses, our kidney care advocates, patient advocates, financial counselors, social workers, dietitians. So, it goes on and on. So really, we've got a big team that actually touches our patients and makes sure that they have a smooth onboarding. And so, I believe, to your point, these transitions are periods where patients are most stressed, at least due to significant cost of care and poor outcomes. And so, the better we can manage these patients through a structured program like a TCU, the better it's going to be for these patients.
Dr. Michael Kraus: Exactly. And Derek, as we look at the study to make sure this works, we compared TCU patients to non-TCU patients. How can we be certain that we're comparing apples to apples and comparing healthy people to sick people? What did you do to make sure that we're really looking at similar groups?
Derek Blankenship: Good question. And one we spent a lot of time discussing and working on. In this study, we matched each of the 724 TCU patients to up to four controls using a method called propensity score matching. So, TCU patients and their controls, patients who did not initiate care within the TCU, were balanced on numerous demographic factors such as age, race, sex, geography, as well as clinical factors such as their cause of end stage kidney disease, comorbidity history, and lab values. So before even looking at any of the outcomes, we verify that there are no clinically relevant or statistically significant differences between the TCU patients and their controls and are comfortable with those comparisons.
Dr. Michael Kraus: And in general, these patients looked like our typical dialysis patients. We're not just looking at young people, we're not looking at one population. It covers them all, doesn't it?
Dr. Dinesh Chatoth: Absolutely. As Derek pointed out, it was extremely well matched cohort. So I feel like it sort of was a good representation of what we see typically in a dialysis population, Mike.
Dr. Michael Kraus: Derek, other than increasing home dialysis utilization, what outcomes did you find in the study that were quite important?
Derek Blankenship: We did find other positive and statistically significant results. Specifically, we found that TCU patients were more likely to be referred or waitlisted to the transplant waiting list. That was 57% versus 42% in the match controls and hemodialysis patients from a TCU were also more likely to have an arterial venous graft or fistula, 70% versus 63% in the match controls. Although not statistically significant, but at least directionally positive, we also saw that TCU patients were 17% less likely to pass away and 8% less likely to have a hospitalization at any point in time during the follw-up time period.
Dr. Michael Kraus: The follow-up was 14 months, right? I mean, this wasn't they went to TCU and then you looked at them a couple of days later.
Derek Blankenship: Correct, yes, yes.
Dr. Michael Kraus: So the overall benefits you saw were improved use of home therapies, improved use of a permanent access, improved referral to a transplant center. And we'll have to get a larger group to look at and follow morbidity and mortality even further. Is that a fair statement?
Derek Blankenship: It is, right, yeah. And you nailed it on the head. Just because we didn't see, quote, a statistically significant difference in hospitalization and mortality. That's often a sample size issue and one that an increased number of patients would be able to detect.
Dr. Michael Kraus: Dinesh, should we be looking and talking about TCU in different terms, not just focusing on home therapies? And it seems that they position into a patient's journey much like a rehab hospital ward or subspecialty nursing and care. Are those fair statements?
Dr. Dinesh Chatoth: They are, Mike, and we should be talking about TCU differently than just being a strategy to grow home dialysis. I think, in fact, the study confirms that TCU are a great option for patients who choose to go in center. And I agree that TCU functions more like a rehab hospital with specialized care and education being provided to the very vulnerable new dialysis start patient population. So overall, I think, yes, we should think about TCU as a broader strategy for all patients who are new to dialysis, if they need help making a decision to be emotionally ready and stabilized.
Dr. Michael Kraus: How important are the physicians in helping direct patients to a transitional care unit?
Dr. Dinesh Chatoth: I think physicians are absolutely critical in this because our patients trust their physicians to make the right decisions, choices and help them, guide them through the initial days on dialysis. And so giving the physicians an opportunity to actually nudge the patient along and giving them the option to actually be in a TCU is critical for success. So as a physician, I would just present this as a great strategy for all patients coming in so they can just settle down and get treated better, be medically stabilized, emotionally adjusted, and then be educated. So even if I have to drive past a dialysis clinic to get to a TCU, there's clear benefits of going to a TCU so I can make the right decisions, for me, in terms of options in dialysis choices.
Dr. Michael Kraus: I know you've spoken to a lot of physicians and been around the country talking about these issues. Is there a specific anecdote or experience you can share with us?
Dr. Dinesh Chatoth: Yeah, I recently spoke to a medical director, and he was telling me about a middle aged African American male patient who actually came to the hospital with headaches, nausea, vomiting, and was diagnosed with advanced kidney failure and hypertension. And the patient had no previous knowledge of any kidney disease. The patient was devastated by the diagnosis of kidney failure and had to be initiated on dialysis in the hospital. And this is like many other patients out there, are getting started on dialysis. And the physician was able to advise the patient to go to a transitional care unit for four weeks. And what was impressive was the patient completed that four week experience and apparently chose home hemodialysis, which is rare for a new patient to start. So, the physician actually told me about the story because of the outcome, which is a patient doing home hemodialysis after going for four weeks to a TCU and more importantly, the patient was able to continue work, take care of his family, while doing the dialysis treatments at home, which is what we all want to see in our patients. He has a new fistula placed and now he's been referred for a transplant program. So, this is the perfect sort of outcome for a patient who's just heard the devastating news that he now needs dialysis in order to function. And so, I think this is a great anecdote. And more stories like this are there and we hear about it all the time.
Dr. Michael Kraus: That's fantastic. Derek, I'm going to give you the last word on this. Is there anything else you care to share with us?
Derek Blankenship: I'd like to close with kind of two comments. One, you know, I alluded to it throughout the discussion, but I'm really proud of not just the programs Fresenius has to improve patient care, but more specifically the process we go through to assess them as well. The study designs and analysis, especially retrospective and observational, will always have their limitations. However, we hold each analysis to a very high standard, that being that they are technically sound, rigorous, and especially unbiased.
And secondly, I want to say thank you to everyone who worked on this initiative and analysis as well. You know, I get the opportunity to talk with both of you and take credit for all their hard work. But as you know, these projects require collaborations among many subject matter experts such as yourselves from the clinical side, as well as other analysis and data experts from Len Usvyat’s Clinical Advanced Analytics team, including Rachel Lasky. Thank you to them, thank you to our patients, and thank you to all the caregivers Dr. Chatoth mentioned that provide care within the TCU. And thank you both for your time.
Dr. Michael Kraus: Thanks, Derek. That’s a great way to end it. And I'm really glad to see all the progress we've made thus far to TCU programs. The study is an important testament to the impact of TCU and to our honesty, integrity and making sure we're doing the best for patient outcomes and lives. The goal is always to improve patient outcomes and patient experience and TCU have done an excellent job of that so far. I'm certain we will continue to work at improving the process, studying the results, and making sure we implement good habits. Be sure to read the study published in the Hemodialysis International called “Assessing the impact of transitional care units on dialysis patient outcomes: A multicenter propensity score-matched analysis” We’ll put the link in the show notes for you. Dinesh, Derek, thanks for being here today.
Dr. Dinesh Chatoth: Thanks, Mike.
Derek Blankenship: Thank you for the opportunity, Dr. Kraus.
Dr. Michael Kraus: And to our audience, thank you for joining us today. If you're new to the Field Notes podcast, you can download past episodes of the Apple Store, Google Play, or wherever you download your favorite podcasts. Please remember to subscribe so you can 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.
Take care, everyone, and let's begin a better tomorrow.