Kendall Hall: Thank you so much for joining us. Could you start out by describing your current role and summarize how you engage with ESRD [end-stage renal disease] caregivers?

José A. Morfín: My name is José Morfín, and I’m at the UC Davis (UCD) School of Medicine, Department of Medicine and Nephrology in Sacramento. I am a Health Sciences Clinical Professor. At UCD, we have a robust kidney care program, and I’ve been working with at-home patients for about 15 years. We work with several dialysis providers. UC Davis doesn’t have its own dialysis outpatient program, so we work with external nonprofit and for-profit programs—DaVita, Fresenius, DCI [Dialysis Clinic, Inc.], Satellite Healthcare. So we have a vast array of settings in which we see our home patients. I am also the medical director at two of the programs, one in Sacramento and one in Folsom.

KH: So you are working with the dialysis companies and have your patients who are receiving dialysis through their centers moved into their homes?

JAM: Exactly; they all have an in-center program, which is what most conventional programs are, and we have home programs that operate in parallel with a whole different set of teams and nursing staff based on their programs.

KH: When you're working with these organizations, what is your role within the in-center program?

JAM: They provide the staffing and the infrastructure for the training and for the continual enrollment in the program for home dialysis. They also have different contracts with different companies in terms of the equipment. Whereas the nephrologist or the nephrology team are the prescribers, we prescribe the therapy and we oversee the care of that patient.

KH: In terms of patient safety, how would you describe your role in terms of making sure that patients are not being harmed by this care?

JAM: We have policies and procedures and training programs, and a lot of the intense safety considerations are initiated at training. When we're talking about home dialysis, we’re talking about two different modalities: peritoneal dialysis (PD) and hemodialysis (HD) at home. One (HD) requires a fistula or a catheter to provide access to the blood vessels. The other requires a PD catheter where you have fluid that is used in the abdomen for dialysis. What those two modalities have in common are policies and procedures for safety that assure that the patients have gone through different steps to demonstrate confidence in being able to deliver their therapy on their own and reduce their risk of events such as infection. Our nursing staff or training staff work closely with them through our training program and then we sign off that they can deliver their therapies at home themselves. We have frequent contact with these patients. Our staff is 24/7 for any troubleshooting issues that may occur, and we have a face-to-face monthly with the clinical team to review treatment logs. There's a lot of technology that has facilitated some of these safeguards over the last few years with Bluetooth availability and being able to use different platforms to register data for patients.

KH: Do you think it might be overwhelming for patients when they think about all that could happen during dialysis? It sounds like that's one of the issues creating hesitance for moving to in-home dialysis, particularly for HD.  

JAM: Correct. I always think of PD like getting your high school diploma and then HD is like getting your bachelor’s degree. Even though peritoneal is a daily therapy and it's done for 8 to 10 hours a day, it's very simplistic in that you’re not dealing with extracorporeal circuits, like with HD. With extracorporeal circuits, you are having to do more, even though it's shorter treatments oftentimes. There are some patients who could do it at night while they sleep. Now that's like getting a PhD degree when you're actually sleeping with needles in the arm. I think that what they both have in common (without getting into the weeds of the therapy) are the safeguards in place to assure patient safety for every patient and family. Safety is important because that's how we are able to get patients to feel confident in their ability to perform dialysis at home. This disease is crippling for many patients. I would say, that like most chronic diseases, oftentimes patients are paralyzed at the idea of doing this at home and would much rather go somewhere with all the “experts,” with the training staff or the nurse because they know best, they know me, and I trust them. That’s the conventional wisdom. So what we try to do is NOT to promote in-home treatment by saying how terrible our in-center units are, that's not really the message you want to send, but we really want to encourage talking about alternatives. That starts with discussions about safety, safeguards, and benefits. The major benefit is that we know that home dialysis delivers more patient-controlled, patient-centered care. I think it's going to have better outcomes. The Advancing American Kidney Health Initiative that was implemented by executive order in July of 2019 put a lot of things in motion and put more resources and more attention on being able to shift dialysis to the home. The spirit of this is not anything new; I've been working to promote home dialysis for 15 years, for others much longer. I think that with the nod of the federal government there is more shape to the effort and it’s making us think pragmatically. We’re scaling this where we can make this more attainable for patients, but I think it does start and end with safety and ensuring that patients have the confidence that they can perform this at home and be safe.

KH: At this time, what percentage of patients who are eligible are currently using in-home dialysis, either PD or HD?

JAM: Everybody in the center is “eligible,” but when you’re talking about delivering home dialysis, when it is all on the patient and their family, it just comes down to whether or not they have support and do they have the motivation? In addition, do they have access to the training? Some markets don't have the workforce to be able to train that many patients in a month, particularly as often you have to train one patient at a time. This is why we feel that we can move the needle with more exposure, more education, more outreach to patients, but also in providing more infrastructure and support for training.

KH: You mentioned earlier that the patient’s safety concern is one of the barriers to uptake, that they're worried about themselves or their family members taking this on. Focusing on the patient safety aspect, what are some of the risks for patients?

JAM: I think the risk, if you think about dialysis, is that it requires fluid exposure. So, your body has to be exposed to ultra-clean fluid that then relies on the diffusion of toxins from the patient, as kidney disease is a disease of retention. Patients develop toxic metabolites from their dietary intake, and electrolytes like potassium go up. Your acid load goes up, and then sodium and water build up, so then we have to remove fluid. This is fundamentally what dialysis does, and to do that you need an access, whether you’re doing PD or HD. I think infection control is a really high priority because infection can really derail treatment. Patients can get peritonitis, they can get an infection of their fascia, from dialysis catheters. In the first part of training, we really focus on how you take care of your access and exit sites. How do you take care of your fistula, what are the preparatory mechanisms, what is abnormal, or what are signs of an infection? Like in PD, what does the fluid look like if it gets infected? We really spend a lot of time showing patients examples of cloudy bags, for example. I think that infection control is absolutely paramount to be successful at home.

The second patient safety issue relates to removing fluid—volume control and blood pressure. We really want to make sure that patients understand how to do this safely. They are given a rubric of how they can adjust their removal of fluid based on their weight. Based on their self-assessment skills, they get a blood pressure reading, they get a heart rate reading, and they have a scale and they can make minor adjustments to their fluid removal. In PD, you can do a little every day so you are a bit closer to your “dry weight”; that is, your weight without any extra fluid. In HD, there is a little bit more of a gap since you’re maybe doing this five to six days a week, depending on the prescription. This is an area where we can take advantage of therapies being done a little differently at home. In-center treatments are only three days a week so you have more aggressive fluid removal than if you are doing it every day, which is really the major reason why patients may have an episode of low blood pressure during dialysis. We really work with patients on the hemodynamics piece of it, how to gauge your body and adjusting the treatment on a day-to-day basis, whether it’s suggesting the amount of fluid used for peritoneal or simply adjusting how much fluid is programmed into the machine to remove in hemodialysis. We also focus on how patients feel after a session of dialysis—if they're cramping, if they're feeling a little bit dehydrated, or they're noticing lower blood pressure. That's where we use our flow sheets, either manually or electronically, to document how they're doing on treatment and if anything has come up. We use it as a way to alert our staff to look at a particular treatment and close the loop and give feedback if there’s an incident.

I think those patient safety concerns are fundamental for both PD and HD. Obviously there are nuances in setting up the machine and troubleshooting the machines and cyclers, but I think, fundamentally, that those are really the front and center safety items in terms of how patients are assuring that they're actually following the training program and safety protocols.

KH: It sounds like, between in-home and in-facility dialysis, the concerns are similar. How do you mitigate the risk of infection with infection control practices, like when you're assessing patients for in-home dialysis? Are you looking at their home to see if they have what they need?  If they comply with proper hand hygiene, etc.?

JAM: You'll see different practices from different programs: all still ensure safety and quality. Some do the home visit before they start the program, some may do the home visit right as the patient is about to go home. Home visits and sterile technique check-ins occur at least annually and the very next time the patient is doing dialysis, if an infection occurs. If there has been an infection, they will use that visit to go back and work out what happened, as the patient is now at an increased risk for another infection or hospitalization. When you go back and say, “well, what happened here,” it acts as another safeguard and allows us to identify areas for additional training. When a PD patient gets peritonitis, nearly every time you can trace back and figure out what happened. Usually it’s a break-in technique. That is where we have a mediation and try to figure out how to best mitigate that recurrence. These infections are troublesome not only for the patient, hopefully they don't lead to a hospitalization, but it really makes their therapy that much more complicated. That one episode of peritonitis predisposes them to more episodes of peritonitis, particularly if you're not able to identify the cause and come up with an intervention. Maybe the patient has been on dialysis a long time but they’re now more advanced in age and are losing dexterity or having some cognitive gaps. Maybe they used to have a care partner but don’t anymore. That is some of the troubleshooting and evaluation we do to try to figure out what could have happened in the technique. It takes a lot of work, but it's work that is mandatory if we’re going to have a successful program and successful patients. We have to have this level of surveillance and interventions when complications are occurring. Home dialysis programs have quality benchmarks, such as peritonitis rate, hospitalizations, morbidity/mortality to further engage and enhance the level of care delivered.

KH: Can we go back to what you are monitoring? You had mentioned with the volume control and blood pressure, that you know that the patient is keeping a record. Is there any real-time monitoring during the dialysis procedure?

JAM: That’s been a big hot topic in our area for a long time, that and whether people want home monitoring. There are some examples, but it's not the standard. What has happened, as I referenced before, is that the advent of Bluetooth technology has lessened the burden on the patient. After each treatment session, an app will record the treatment, patients can provide comments on the treatment, and nurses and staff are able to download this data for review and for monthly visits. It provides an easier approach for data tabulation and recording that the clinical team can then get immediate access to. But the team is also not up at 2 or 3 in the morning watching every patient on the cycler at night. There's a little bit of that privacy piece—it’s keeping the patient close, but not too close. So we don't have anything real-time. We do have some other safeguards in place, though. When we talk about nocturnal HD, for example, we do require a partner in the building. If the patient's dialyzing with needles in the arm, there's also extra mesh and taping required to anchor the needle close to the skin. There is then a monitor in place where if it senses moisture, it will beep like hell and wake the patient up. In other words, we can still safely do even more complex dialysis procedures without real-time monitoring. I think there has been a lot of experience not only in this country, but also in Canada, over the past three decades of being successful in doing these therapies at home without the need for real-time monitoring. There are really good publications on safety and the risk of an outcome. For example, you're more likely to bleed out in an in-center dialysis unit than you are to bleed out from a home unit.¹ I think that probably is giving us a little bit of reassurance that real-time monitoring might be nice to have but isn’t necessary for good safety outcomes. But, of course, we always have to look at what's next and how we can further improve.

KH: Going back to the patient and the care partner education, that sounds like a pretty important part in all of this. What are the most effective ways of providing that training?

JAM: Yeah, so when we're looking at the patients, regardless of whether they're doing PD or they are doing HD, we ask that they have a care partner. We really like the patient to take on the majority of the care responsibilities, but know that the caregiver may need to take on more depending on the circumstances, particularly the ability of the patient. We’ve found that the more the patients do on their own, especially when it comes to some more involved therapies, it really allows for more sustainability than relying on just a care partner. We have them come in, and we typically have an introduction of the therapy and to infection control and protecting your access. We do that in-center because it’s especially important. The patients and their partners spend a fair amount of time on understanding the reasons to protect your access, how to protect the access, how to clean the access, how to maintain good hygiene, how to identify signs of infection, etc. Then, as you get into the therapy training, we get into why we are doing what we’re doing with the salt water and hemodynamics, and then how to adjust the therapy, the limitations of the therapy (for example, what’s the max amount of fluid that can be pulled off), and understanding some of the alarms they may get and how to troubleshoot that. A lot of face-to-face and a lot of contact. Patients will stay in the program as long as they need to. I’ve had patients that stay in the program even out to 10 weeks. In the training program, they add things every week and reinforce what’s already been taught. Then before they go home, especially when we’re talking about more involved therapies with a little bit more complexity, like the hemodialysis, we will review codes and different troubleshooting scenarios. The staff does this to reassure patients that they know how to troubleshoot different scenarios, even if it is simulated. During the first month after they go home, there's a lot of contact between our staff and the patients and their families to give them confidence that they're going to be fine and that they’re on the right track. It’s a lot of face-to-face contact.

There is also a lot of interest in using simulations that some of the platforms have developed to try to simplify the process and perhaps reduce the burden for the patient. When they forget, or are unsure, of a step or two, the machine can provide a visual model that actually shows the patient how to do the process and they just follow the steps. If a patient has forgotten what an alarm means, the tablet tells them right away rather than the patient having to flip through a book and search for an answer. There's an appetite to strengthen the technology and the connectivity piece to help reduce some of the troubleshooting that patients may experience, particularly after that first 90-day honeymoon period. They're excited, they’ve learned something, maybe they're feeling better if they’ve switched from in-center. But then once the glow wears off, then it becomes work. I think anything we can do to help alleviate some of that burden through technology is going to be very helpful in retaining our programs.

KH: That's great! I think that you’ve answered just about all of our questions. In closing, what is the future of home dialysis? More uptake, more people choosing to do home hemodialysis, and, if so, how do we support that trend? How does a clinical community do that?

JAM:  Kidney disease isn't going away, and I think when we are looking at treatment options, we have to know that there is more than just in-center dialysis and transplantation available—particularly because many of our patients may not even be transplant candidates due to other pre-existing conditions. We also need to think about home programs and the things that a home program provides. I think there's a lot of education that not only needs to be done for the patients and their families, but also in the medical community. A lot of folks think that home dialysis is PD only. For both therapies you need to have an activated patient who wants to do this, so it behooves us not only to educate, but also to promote home programs and reassure patients that they are safe and that there are safeguards in place. Additionally, we can speak from a position of strength that home dialysis is your best way to be able to have autonomy, control, freedom, and perhaps even travel. These therapies are mobile, and the technology will hopefully continue to get smaller and more comfortable for travel.

The more we can speak to the benefits and the more we’re able to provide resources similar to the in-center programs, such as patient care technicians to assist patients, the more supported patients will be. That may even include having assisted dialysis. Creating more time for support of our more elderly patients who we know are much more fragile, so perhaps doing therapy that's much gentler but can create more autonomy and independence at home. I think that there’s a lot of promise and hope that the Executive Order implementing a new payment model that encourages clinicians discussing and supporting home dialysis with patients will turn the tide, but I think the devil’s in the details. The more we can put on the table informing policymakers and our medical community about our programs, the better, so we can be able to promote this and to do the outreach.

KH: That is a great place to end. Is there anything that I haven't asked you or that you'd like to mention in addition to what we've covered?

JAM: I just want to thank you for taking time and for taking interest in this program. I think it's a very opportune time to have these conversations given the climate we are in.