Welcome back. I hope you are well rested and have refilled your beverage of choice for our next session. We will begin with our 2020 abstract award winner, Lindsay Yoder, physician assistant with Indiana University Health. Born and raised in Indiana, she has worked as a physician assistant since 2011, graduating with her bachelor's in biology from Indiana University and a master's of physician assistant studies from Butler University. Last year, Ms. Yoder created the transitional liver clinic to see all hospitalized liver patients within 14 days of their discharge in the outpatient hepatology clinic. Today we are honored to have her present her analysis of patient outcomes related to this initiative. Next up we will hear about updates and cholestatic diseases by Andrea Gossard. Ms. Gossard is a certified nurse practitioner, a clinical associate in gastroenterology and hepatology, and an associate professor of medicine at Mayo Clinic in Rochester, Minnesota. She received her bachelor of science in nursing with a minor in psychology from the University of Wisconsin and her master's in science as a nurse practitioner from Winona State University. Her clinical and research interests include autoimmune liver and biliary tract disease, including primary sclerosin cholangitis, primary biliary cholangitis, and autoimmune hepatitis. She has authored or co-authored 48 peer-reviewed articles, five book chapters, and over 50 abstracts on liver disease. In addition to her clinical practice, Ms. Gossard is actively engaged in leadership of nurse practitioner and physician assistant practice within her department, the Midwest Regional Practice, and the Mayo Clinic Enterprise. Ms. Adrienne Anderson comes to us from the University of Maryland Medical Center, where she works as a clinical nurse manager in the hepatology division of gastroenterology, and will speak to us about how to get care to patients and improve healthcare outcomes. In her over 32 years of healthcare experience, she has collaborated on multiple IRB-approved research projects with a focus on the coordination of care and hepatitis C treatment, and earlier this year was nominated for Outstanding Nurse of the Year 2020 at the University of Maryland Medical Center. Her expansive nursing career includes experience in the OR with the GI and liver kidney pancreas transplant program to outpatient management of decompensated cirrhosis, and she is truly an expert in hepatology care coordination. Vicki Shaw, physician assistant, is currently working at Rush University in Chicago, Illinois, as solid organ transplant lead advanced practice provider. Ms. Gossard has 10 years of hepatology experience and has added a certificate in obesity medicine over two years. Along with an American Board of Obesity Medicine certified attending, she helps run an advanced practice provider-led weight intervention in liver disease clinic with great patient success. She's currently working on her doctorate in medical sciences. So thank you to our speakers, and thank you to our participants, and may you enjoy our second session. Good evening. Thank you to AASLD and those who put together the liver meeting for asking me to present our abstract to you today. My name is Lindsay Yoder, and I'm a PA with IU Health in Indiana, also a research associate of the Indiana University School of Medicine, and we're going to be talking about reducing 30-day hospital readmissions in patients with severe liver disease using TLC, or our transitional liver clinic. I have no financial disclosures. I went to Indiana University in Bloomington for my undergraduate degree, followed by obtaining my master's in physician assistant studies at Butler University in Indianapolis, and I continue to live and work in downtown Indianapolis. Specifically, my practice is at University Hospital within the IU Health system. This is the poster that was created from the abstract that we submitted. I know this text is quite small. This is online here at the liver meeting for you to go and see it and zoom in on it if you would like, but again, we're talking about a post-discharge transition clinic for patients with liver disease that reduced hospital readmissions. You know the issue, the problem with our decompensated liver patients where they are hospitalized for ascites or encephalopathy or a variceal bleed. They go home. Something happens where they are not seen or cared for quick enough. Their pain returns. Their ascites returns. There was no good plan. No one saw them quickly, and they have been readmitted before you even have a chance to realize what's happened. The complications of decompensated or advanced liver disease lead to these high rates of preventable early hospital readmissions in this patient population that we all enjoy taking care of. Again, we've talked about ascites, HE, variceal bleed, also acute kidney injury, electrolyte derangement, and all of this is underscored, we know, by socioeconomic factors and substance abuse in our liver patients. I'd like to point out that most of the literature regarding 30-day hospital readmissions for liver patients have been those who are cirrhotic. There is some data on those as well with alcoholic hepatitis. We've seen the gaps that lead to these preventable readmissions. Difficult to treat ascites, intractable brittle hepatic encephalopathy, poor handoff from inpatient to outpatient providers, lack of caregiver education or patient education or the capacity for patients to understand the instructions that have been given to them, lack of follow-up appointments, patients just disappearing after they leave. Difficulty with transportation and communication. We've all seen the Zyfaxan prescription that probably went in by the inpatient fellow that was on service for that week who then has left by the time the pharmacy tries to contact someone to complete a prior auth, so prior auth doesn't get done or the copay is quite high. That prescription never makes it into the hand of the patient after they've been discharged and then in the outpatient setting, they continue to suffer from hepatic encephalopathy and get readmitted. Identifying this critical time of transitional care between when a patient is discharged and quickly seeing them in the outpatient setting has been applied to other diseases such as congestive heart failure and COPD to try and target reducing readmissions, so much so that CMS actually created a set of CPT codes specific to this kind of transitional care management. Some of the requirements are to communicate with the patient within two days of discharge, and that can be a phone call, and then see them face-to-face within 14 days at a minimum. Specific things that are expected are medication reconciliation and management, education, referrals, and further follow-up. We recognized that most of us hepatology providers didn't have a capacity within one to two weeks to see patients of ours that were being discharged from the hospital, so we wanted to create a specific clinic where these patients could be absorbed and seen quickly to try and understand if that could make a difference in reducing readmission rates, which led us to create a transitional liver clinic. This was in our outpatient ambulatory clinic, a half-day clinic session. Patients were scheduled for 30-minute follow-ups. This clinic was staffed by me, a hepatology PA, with the support of my liver nurses making that 48-hour phone call after they'd been discharged. We saw the advantages to this to prevent overbooking on our normal regular clinic templates for these hospital follow-ups, and then as well as just preventing the inevitable delay of scheduling patients when you already have an overbooked clinic schedule and nowhere to absorb seeing a patient that quickly needs to be seen after they've gone home from the hospital. If a patient was admitted to our IU Health Academic Healthcare Center, which is either a university hospital or Methodist hospital, whether they were admitted to our service directly or they were admitted to another service and we were consulting, when they were getting ready for discharge, we would be alerted. We would determine if they needed to be seen within 7 days or 14 days, create a reminder for our liver nurse to call them within 48 hours after they were discharged. Are there medicines that were started on, that were picked up? Did they have any issues? Did a PA need done? Was the medication costly? In general, just how are you doing since you went home from the hospital? Follow up on any labs that the patient needed, and then importantly, letting them know if it didn't make it into their discharge paperwork. When they're coming back to see us in TLC, where are they going? Who are they seeing? Do they have a phone number to call us if they have any questions? I would like to point out that we did not see patients who were discharged in hospice care. Those patients are not eligible for TLC. As well as our pre and post liver transplant patients are sort of cared for by a separate set of hepatology providers with their own post discharge plans. Then we would see them in TLC and then create a follow up plan thereafter. If a patient had been hospitalized and never seen anyone in our practice before, I could absorb those patients for follow up in my own practice. If a partner of mine had already seen that patient in the outpatient setting prior to their hospitalization, then certainly they would still continue to follow up with their primary hepatologist and just see me for that one transitional appointment. The stars are next to the various types of interventions that we identified that we complete in this standard TLC workflow. And then this is just to give you an idea, the kind of bullet point plan of care that I try to hit with every patient that I see in TLC. There are 14 things listed there and some of them are straightforward and some of them are complex. Having the mindset in the TLC that these are specific post-hospital discharge follow-ups really allows me to focus my time and conversation with these patients to address their very specific post-hospital discharge needs. We talk about whether or not they're a liver transplant candidate. Reviewing labs. Do they have renal tolerance of diuretics that they were started on in the hospital? Are their electrolytes okay? Do they need to make dietary or fluid restriction changes? How are they up to date for liver cancer screening? Are they up to date for endoscopy for variceal screening? Can we prevent bleeding? Whatever their underlying liver disease is, is there education that they need regarding that? A big part of this with our alcoholic hepatitis patients is understanding how they got here. How can I help get them hooked up with local rehab resources that are covered by their insurance? Do they need an IOP? Do they need AA? Do they need a one-on-one counseling with a therapist? And then certainly the routine things that we do but can focus on, depending on what their reason for admission was, ascites management, encephalopathy management, anemia management if they've had variceal or GI bleeding. Can we help get them set up for blood transfusions in an outpatient setting and not just send them back to the ER for a transfusion? Do they need to see our dietician to really have more highly tailored specific planning for low-sodium diet, high-protein diet to prevent sarcopenia? Do they need referrals to physical therapy? Do they need home health care? Are there other specialists that they need to see such as nephrology or psychiatry? And then a really good thorough medical reconciliation. Every med, every dose. Do they need refills? Are there PAs? Are there cost considerations? Are there any interactions? Anything that's hepatotoxic? And then certainly making their follow-up plan and making sure they have a good way to contact us. Do they have our email? Do they have our phone number? Are they going to use a patient portal? But I think it's very important that a patient knows when they go home and inevitably have questions that they forgot to ask, how can they get a hold of us to make sure their issues are addressed and not resort to just going back to an emergency room? The big question is, creating this TLC, did it make any difference? So in 2019, when we look back, there were 606 patients that were eligible for us to include in our analysis. The TLC started in April 2019, and at first we only did the clinic piece. Starting in July 2019, that's when we added in that RN phone call that I have referenced. The five patients that are shown that came to clinic that are before that April time period were discharged right before April at the end of March, but then seen when the TLC started in April. So that's those five patients before April. As you can see, the show rate was not great, but it was improved once we started the nurses making that phone call. We looked at and compared demographic and clinical characteristics of the patients and categorized them as far as those patients that were seen in the transition liver clinic, which was 120 patients of the 606 versus those that were not seen. And then the big question was, did it make a difference in their 30 day hospital readmission rate? Those seen in TLC had 18% 30 day readmission rate. Those not seen in TLC had a 28% 30 day readmission rate, which was statistically significant. You can see the P value there of 0.02. Mortality of the patients seen in TLC was also less, but it was not statistically significant. So the big conclusion is a transition liver clinic significantly reduced 30 day hospital readmission rates for patients with decompensated liver disease. It's 2020. We've been doing this for over a year now. Looking back and looking forward, what have we learned and where are we going? I already mentioned we had a low show rate. Overall, only 27% of eligible patients were seen in the TLC. Some patients had no follow up plan made. Just call us if you need us. Some patients had an alternative follow up plan made. Either they refused to come back and see us. And we said, follow up with your local GI team. Some patients might have already had an upcoming outpatient follow up in near proximity with their primary hepatologist to their discharge date. So they weren't scheduled in the TLC. But the majority of patients either canceled or just did not show up for their appointments. This did improve with that 48 hour nursing phone call. Other things we learned again in Indianapolis at IU. We are a tertiary medical center and the only liver transplant center in the state. So we see patients from all over. I'm sure it's very similar for many of you at your centers. This distance from their home can lead to patients not having the resources, either monetarily or support, to come back and see us. In 2020, prompted by the COVID pandemic, we were able to do a lot more. We actually started offering virtual visits. And this has seemed to improve the show rate in our transition clinic. We've also started to address any transportation issues, if that's the main thing limiting them from coming back to see us when my nurse makes that 48 hour phone call. We let our social worker know so that if we can help out with a gas card or arranging a Medicaid cab for patients. We just don't want transportation to be the thing that limits them from getting the care that they need. We've also identified some patients we get notified of very late, like right before they're going home, that they need a discharge appointment. And then the appointment might not get made till the following day. And that patient has already left the hospital. So the earlier we can be notified about them needing an appointment in TLC, it increases the chance of that appointment making it into their discharge summary. And that patient leaves knowing when they're coming, where they're going, and increases the chance that they will actually make it to where they are scheduled. Oftentimes, patients are lost after discharge. Again, the substance abuse and socioeconomic barriers for some of our patients. We don't have an address on file. We don't have a phone number on file. The contact that's listed isn't the right one, etc. Something else that we have added since we started this TLC originally is a full-time inpatient hepatology PA on our consult service. So she is the continuity of care day in and day out. she is there as our staff hepatologists and our fellows rotate. She has the luxury of seeing patients every day while they are admitted and then getting to say hey you're going to come back and see me for your appointment in seven days or in 14 days because she now also has her own transition liver clinic to really be full circle continuity of care for these decompensated liver patients. As we are looking ahead we would like to do prospective studies to really establish the efficacy of this intervention and then deeper in analysis as far as which of the individual interventions that we're completing in TLC seem to be the most responsible for the benefits that we've seen. Not all of the patients that we see in TLC have cirrhosis. A great majority of them are alcoholic hepatitis, some of them are autoimmune hepatitis flares, some of them are acute viral hepatitis, tylenol overdose, drug-induced liver injury, things that have decompensation but not necessarily cirrhosis. So if we look at them separately who seems to get more benefit and are there particular interventions that are better suited for cirrhotics versus non-cirrhotics. Because we do a lot of education in TLC I'm interested also for us to look and see if we have any effect positively hopefully on patient reported outcomes and caregiver burden by empowering them through education to be able to take the best care of themselves at home that they can to try and reduce those preventable readmissions. Thank you very much for listening. My email is included here on this slide so if I can be a resource to you in any means or you have any questions or concerns please feel free to touch base with me by email. I certainly did not do this on my own. I have many colleagues to thank for their help in making this possible. My thanks go out to Dr. Eric Orman, Dr. Raju Balanchi, Dr. Archita Desai, Dr. Naga Chalasani, and my PA colleagues in hepatology Laura Corbido and Haley Hansen. Thank you so much and I hope you have a wonderful rest of your day. My name is Andrea Gossard and I'm a nurse practitioner at Mayo Clinic in Rochester, Minnesota. My clinical practice is focused on patients with cholestatic liver disease. Today I will be speaking with you about primary biliary cholangitis and primary sclerosing cholangitis in 2020. I have no disclosures to disclose. The educational objectives for today's talk is to review the current understanding of primary biliary cholangitis and primary sclerosing cholangitis. We will discuss key management recommendations in your care of these patients and identify current and emerging therapies for patients both with primary biliary cholangitis and primary sclerosing cholangitis. First we'll direct our attention to primary biliary cholangitis or PBC. PBC is thought to be a chronic progressive autoimmune condition that affects the bile ducts within the liver. We don't fully understand the etiology of primary biliary cholangitis but believe it to be associated with influences both from a genetic perspective and environmental perspective. This condition creates an immune response and ultimately bile duct damage that can lead to cirrhosis or permanent scarring of the liver. The typical PBC phenotype consists of people in the fourth or fifth decade of life, a female predominance of nine to one to male. The most typical serology presentation would be a positive anti-mitochondrial antibody. This is the case in 95% of patients with PBC. Perhaps a positive anti-nuclear antibody and anti-smooth muscle antibody may be present. Importantly, an MR cholangiogram, if performed, would reveal normal appearing bile ducts. However, histologically there's evidence of a lymphocytic infiltrate, inflammatory ductal lesions, and perhaps the classic florid duct lesions along with granulomas. One of the most important clinical distinguishing features is that we don't typically see inflammatory bowel disease in the setting of PBC, unlike the second condition we'll be talking about today. The question of whether or not primary biliary cholangitis is the cause of a patient's liver test abnormalities often leads to whether or not a liver biopsy should be performed. In general, if the patient meets many of the phenotypical descriptors noted on the prior slide, including an alkaline phosphatase of greater than one and a half times the upper limit of normal, a more mild elevation of the AST, and a positive antimitochondrial antibody, then a liver biopsy is unlikely to add additional diagnostic assistance. Overall, in such a setting, the positive predictive value for primary biliary cholangitis is greater than 98%. As such, performing a biopsy would not be helpful. Management of patients with primary biliary cholangitis include monitoring their liver enzymes and synthetic function. For patients that have had the condition for some time, or perhaps are newly diagnosed with evidence of more advanced fibrosis, surveillance should be performed for complications associated with advanced fibrosis, such as portal hypertension, including the development of esophageal varices, fluid retention, or GI bleeding, along with surveying for hepatocellular carcinoma. This is unlikely to occur in the setting of early-stage disease, but as the disease progresses, and particularly in the setting of cirrhosis, HCC remains a concern. Endoscopic surveillance is necessary to evaluate for esophageal varices in the setting of advanced In addition, patients with PBC are at an increased risk for metabolic bone disease, perhaps from the female predominance, along with the typical age range, but also the cholestatic nature of this liver condition. Fat-soluble vitamin deficiencies should be monitored for, along with zinc levels, to ensure that these are corrected, if noted. Treatment, FDA, I'm sorry, FDA-approved therapies to date include ursa deoxycholic acid, which was approved in the late 1990s. This is a therapy that is orally administered, typically in two to three doses per day. At 13 to 15 milligrams per day, it's recommended that you take a dose of ursa deoxycholic acid every day, typically in two to three doses per day, at 13 to 15 milligrams per kilogram of body weight. For most patients, if their biochemistries are going to improve, it's going to occur over the first several weeks of taking therapy, up to perhaps six to nine months. Importantly, there is currently a lack of consensus on the specific descriptor of biochemical response. As such, there are multiple criteria currently to define response across the globe. The Mayo Clinic response is defined as a reduction in alkaline phosphatase to less than two times the upper limit of normal in six months. Others may extend that duration to one year or two years, as identified on this graph. Spanish criteria includes a reduction of 40% from baseline. The Paris 1 criteria suggests a decrease to less than three times the upper limit of normal, along with an AST that decreases and the bilirubin being normal. Dutch criteria includes normalization of bilirubin or albumin. Toronto is again focused on the alkaline phosphatase, less than 1.67 times the upper limit of normal. And the Paris 2 criteria focuses on alkaline phosphatase reduction, along with AST and, again, normal bilirubin. In the event a patient has an inadequate response to ursa deoxycholic acid, there is a second FDA-approved therapy, approved in 2016, that can be offered to patients. This can be as adjunct to ursa deoxycholic acid or as monotherapy. FXR agonists work by improving choleresis and decreasing inflammation. Obeticholic acid needs to be prescribed based on the stage of disease. Importantly, patients with no or mild hepatic impairment, child's PEW score of A, can start at 5 milligrams once daily. This dose can be increased after three months to 10 milligrams per day, assuming the patient is tolerating the medicine okay. For more advanced-stage patients with moderate to severe hepatic impairment, so child PEW score of B or C, it is recommended that they start at 5 milligrams once weekly, with a potential to increase to 10 milligrams twice weekly, dependent on biochemical response and tolerability. Future therapies may include further research on bizifibrate, a paroxysosome proliferator-activated receptor A therapy. A relatively recent study, published in 2018 in the New England Journal of Medicine, evaluated this therapy over a 24-month period of time in a double-blind, placebo-controlled study. 100 patients were part of the study, half of whom received the dose of 400 milligrams per day. 31% achieved complete normalization of their biochemistries. Side effects included increased creatinine levels and myalgias. Another such therapy was evaluated and published in 2017, a 12-week placebo-controlled trial evaluating Seladelpar. 41 patients were assigned to placebo, or 50 milligrams or 200 milligrams of the therapy. This study was terminated early due to three patients who developed a presumed drug-induced liver injury. For the five patients who completed the entire 12 weeks of therapy, they normalized their alkaline phosphatase levels. Further study may be considered. Now we will turn to primary sclerosing cholangitis. Primary sclerosing cholangitis is a diagnosis that's often made after liver enzyme elevations are noted in the classic cholestatic profile and commonly in the setting of known inflammatory bowel disease. We don't have specific autoantibodies that are diagnostic for primary sclerosing cholangitis, unlike primary biliary cholangitis. However, MR-clangiogram and ER-clangiogram is oftentimes done and diagnostic, demonstrating evidence of a regular appearing bile ducts. A liver biopsy is usually not necessary. One of the challenges with liver biopsy is a tendency toward a patchy distribution of primary sclerosing cholangitis, making it somewhat difficult to retrieve tissue that is specifically, that's showing evidence specifically of PSC. So biopsies are at times non-diagnostic, so not particularly helpful. We don't fully understand what causes primary sclerosing cholangitis, but again, it's likely a combination of genetic and environmental factors. The estimated prevalence of primary sclerosing cholangitis is 6 per 100,000 people with the median age of 41 years. Unlike primary biliary cholangitis, primary sclerosing cholangitis can develop in young people, even to the age of preteen. This would be unusual in the setting of primary biliary cholangitis, which tends to afflict people in the fourth or fifth decade of life. Primary sclerosing cholangitis is more common in men, with perhaps 75% of patients being male. As I'd mentioned previously, there is a high association with inflammatory bowel disease. In my clinical practice, which is focused on these two conditions, of all of the patients we see with primary sclerosing cholangitis, perhaps 80% of them will have inflammatory bowel disease, most commonly chronic ulcerative colitis. PSC causes diffuse inflammation and fibrosis of the biliary tree, leading to strictures and ultimately cirrhosis. The natural history is quite variable, but importantly, these patients are at an increased risk for bile duct cancer. The lifetime risk of cholangiocarcinoma in the setting of PSC is perhaps 10%. Now, it's important to distinguish that PSC is not a Now, it's important to distinguish that PSC may present in three different sort of phenotypes. One would be the classic findings of PSC involving the large bile ducts. Perhaps 5% to 10% of patients with PSC develop what we call small duct PSC, involving the smallest bile ducts. And then there are those patients that have primary sclerosing cholangitis and an overlap syndrome with autoimmune hepatitis, which we will not discuss today. This is an ER cholangiogram, and to orient you, this allows you to see the scope that's curved at the bottom of the image, and then the wire going up into the biliary tree, the hilum, which branches into the right system and into the left system. And what you can see is the somewhat saccular appearance of the biliary tree. This is an area of dilation, presumably from a stricture that's downstream. ERCP may be performed for diagnostic and therapeutic purposes. This is an image of an MR cholangiogram. Of course, we can see the gallbladder illuminated as the large structure to the lower left, the common bile duct, the common hepatic duct, both of which appear somewhat dilated, but no evidence of strictures in those areas, along with the intrahepatic ducts, where you do see the stricturing and beading effect in the right side of the liver as well as the left side. And multiple smaller ducts show that same intermittent segmental stricturing that is classic and diagnostic for PSC. Management of primary sclerosing cholangitis involves important surveillance for various cancers. If the patient has inflammatory bowel disease, we would recommend, or it is recommended, that patients undergo colonoscopy with surveillance biopsies on an annual basis. If there's no clinical or endoscopic evidence of inflammatory bowel disease, screening should be performed for these patients every five years, simply because the risk is so high. Surveillance, of course, for advanced fibrosis, as is done for all liver diseases, along with complications such as portal hypertension, is necessary. Screening for cholangiocarcinoma is important on an annual basis, if not more often, dependent on the patient's specific clinical situation. And endoscopic screening for esophageal varices, as appropriate. If patients develop symptomatic bile duct strictures of the larger bile ducts, ERCP may be indicated. When this is performed, it can be conducted not only for diagnostic reasons, as mentioned previously, but also therapeutic reasons, including balloon dilation of strictures and the introduction of stints into the bile duct, if indicated. We prefer to not have patients chronically stinted, but rather remove them after perhaps 2 to 12 weeks, depending on the degree of stricture. If the narrowing is significant, repeat stinting may be performed, but eventually we work to have these patients be stint-free. Stints, while beneficial, can become occluded and lead to further symptoms of obstruction. The other benefit of ERCP, before I move to treatment, is that you can obtain diagnostic sampling of any strictures that are noted. Unfortunately for primary sclerosing cholangitis, there is no FDA-approved therapy. There have been many, many studies of ursodeoxycholic acid yielding unfortunate results. This is a therapy that has not, throughout the trials, provided evidence of benefits long-term for patients with PSC. In perhaps 25% of patients, it can improve their biochemistries when taken at the dose similar to what's used in PBC. For some of our patients, it can decrease the symptoms of pruritus, but as I'd mentioned, it has not demonstrated evidence that it's beneficial with respect to the natural history of the disease. Currently in the United States, there are multiple phase II studies and two phase III studies. We are evaluating vancomycin at doses from 125 milligrams four times daily, increased over time to up to 375 milligrams four times daily in patients for over an 18-month period of time. In addition, silofexor, we're evaluating at 100 milligrams daily, and this is a 96-week clinical trial. Both of these trials are available at Mayo Clinic if referral is appropriate for your patients. So, in summary, primary biliary cholangitis and primary sclerosant cholangitis are both considered chronic progressive cholestatic diseases with variable natural histories. PBC has two FDA-approved therapies to consider. PSC currently has two phase III clinical trials to consider. For these patients, active and ongoing management is necessary given the variability of the natural history, as such close monitoring is needed from hepatology healthcare providers. Thank you. Good day, everyone. My name is Adrienne Anderson, and I would like to welcome you to this segment of the Hepatology Associates course. First, I'd like to express what an honor and a privilege it is to be asked to present this year at AASLD's The Liver Meeting Digital Experience 2020. I am so excited to share, so let's get started. My topic this year is getting care to hepatology patients via telemedicine and improving outcomes during COVID-19. Just a few housekeeping things here. I have no financial disclosures to report. And by the end of this presentation, I plan to explain the role of the hepatology nurse coordinator and the multidisciplinary care approach. I plan to discuss the changes of the care coordination due to the pandemic, what telemedicine is, its benefits and barriers, and key takeaways. The role of the hepatology nurse coordinator. The care coordinator role goes by many names, and it varies by region and facility. So some of the names that you may notice are transition care manager, nurse navigator, patient care facilitator, and sometimes just plain nurse coordinator. Despite what we are called, we all have some of the same roles and goals in mind with care coordination for the patient. Some of those goals are listed to the right, and we plan to coordinate care for patients through various specialties to discuss health conditions, medications, and provide instructions to the patient. We consult with the healthcare team and other outside vendors to make sure the patient receives optimal care. By developing a comprehensive care plan to meet the patient's needs, and we manage each case individually to ensure care is provided safely, effectively, and with the utmost quality. The multidisciplinary care approach. So the multidisciplinary care approach looks a little something like this. You have key stakeholders that consist of the physician, the nurse practitioner, physicians assistants, registered nurse, pharmacists, social workers, dieticians, your medical secretaries, medical office assistants, and all of those compose the team. So it's very important to establish these relationships in-house and in the community to help ensure that patients can get the access to the care that they need. Changes to the care coordination role due to COVID-19. For us in the U.S., March 2020 came and some drastic and rapid changes had to take place in order for us to give the care that we needed to give and how patients receive that care. So there was ever-changing information which we had to stay abreast of in order to deliver the care and keep patients calm about their medications, appointments, procedures, and anything that caused them issues. There was a learning curve to the healthcare system as a whole, which really put a light on that system and made it easier for us to communicate which really put a light on that system all over the world and proved that there were varying degrees of readiness worldwide and preparedness within the system. Each department, while working together, did not always operate the same and some had been doing telemedicine for a while while others had not. What is telemedicine? Telemedicine is the practice of caring for patients at a distance using various electronic technologies to communicate when the provider and the patient cannot be in the same space at the same time. So within a few weeks, we had to figure out how to get ourselves and our patients on board with this new concept of care delivery. And we did that by using some of the concepts listed here. An example of the live video conference was Zoom, Skype, and Doximity. Some mobile health apps that we used were MyPortfolio or MyChart. The electronic transmission were through online faxes, sharing of content and data with other outside sources, and the reporting of patient monitoring, where we use spreadsheets and patient lists within our EMR system. So the benefits of telemedicine were many. It improved access to care. So we found that many patients had smartphones or laptops. It provided a holistic approach to care, which allowed the provider to be able to think outside the box and see what's really going on with the patient outside of its normal medical care. It reduces the burden of illness, which is also known as the cost of illness. So it seemed that even though the pandemic came, Medicare and other insurances pretty much got on board very quickly with the use of telemedicine, despite some stipulations and regulations. We found that it aids in early detection because people were at home and able to focus on themselves a lot more and really wanted to contact us to see what they could do to ensure that they received care. So while the benefits of telemedicine were there, we also noted the barriers as well. So for patients, many did not have laptops, or if they did, they may not have had internet connection at home. They found that there was an inability to use their smartphone or those who did not possess a smartphone at all. There was fear of technology and HIPAA rights being violated and patient privacy issues. So for the care coordinators, we found that there was an inability to print patient information while working remotely. Faxing lab results, office notes, et cetera, to outside places proved to be a burden. There were internet connectivity challenges, even while working remotely through your company's VPN. And early on, there were reimbursement issues with where the patient was, where the physician was, and how that affected the cost reimbursement for each individual case. Now we'll talk about some of the outcomes. So who was affected in hepatology? We found that our pre-transplant evaluations, which are usually held in person and consist of a very long day, with the patient seeing six to eight clinician visits, were hugely impacted by the pandemic. Those patients with routine hepatology care, such as your stable patients with some diseases, such as autoimmune hepatitis, Wilson's disease, and maybe hereditary hemochromatosis, while they all received routine care, it's usually stretched out a little bit. So while we still had to monitor for their labs and their appointments, some of those could be pushed out a little bit. Those most affected were your patients that need close monitoring, such as your hepatitis B and C patients, especially those on treatment, your cirrhotic patients, which need HCC surveillance every three to six months, your hepatocellular carcinoma patients, who were already known and may have also been undergoing treatment, and the liver transplants, who were expected because new ones were put on hold and those recently transplanted within the last 90 days and need close follow-up. And even sometimes your stable transplants who tend to get in trouble at times because they're still immune compromised. What did the healthcare team do? We all came together to see how we could best serve and keep patients healthy during the pandemic. We made short-term and long-term goals as discussed here. So some of our short-term goals were 90-day supply medications with refills, standing lab orders, checking in on patients more often. We postponed in-person appointments and procedures and created lists or spreadsheets to keep track of those patients. Long-term, from those spreadsheets, we rescheduled those patients from the COVID-19 list and put them in telemedicine visits. To this day, the telemedicine visits remain. We began to reschedule procedures when it was safe to do so, starting with urgent emergent cases. And as the state opened up more, we were able to do more elective cases. In-person appointments resumed if the patient desired, and we continue to check on patients very often. Now we are many months into the pandemic and we beg the question, what's next, right? Is telemedicine here to stay? I would venture to say yes. Can we continue to improve upon the processes? Absolutely. Medicine is ever-evolving and we should always be looking to improve. How much of this will be driven by insurance reimbursement versus patient care and needs? That's a great question, and only time will tell. But as long as reimbursement is available and can be done safely, I can't see why this would not continue. In closing, some key takeaways I would like for you to walk away with are that nurse coordinators are a vital component to providing excellent patient care to the hepatology community. We continue to research and find innovative ways to deliver the best care possible, and we advocate for evidence-based care and we advocate for evidence-based practice that telemedicine is helpful in the right setting. For our providers, we want you to understand that effective care from the coordinators have been proven to bring forth positive patient outcomes. We are here to bridge the gap between you and the patient. Close communication with and encouraging continued education for your nurse coordinator keeps the entire team informed as well as the patient. I want to say thank you again for allowing me to share my topic with you. And at this time, we can open for questions if you have any. Hi, and welcome to the lecture Getting the Weight Off, Obesity Management in NASH. I am Vicky Shaw, Physician Assistant at Rush University in Chicago, Illinois. I am the Solid Organ Transplant Lead APP. I have a Certificate in Advanced Education in Obesity Medicine from the Obesity Medical Association, and I'm currently pursuing my doctorate in the sciences. My disclosures include advisory board for AbbVie for Hepatitis C and focus grant funding from Gilead for Hepatitis C. The objectives today include assessment of a patient, nutrition, exercise, behavioral modification, weight loss medications, bariatric surgery, how all this applies to NASH patients, and eventually long-term follow-up. As we know, obesity used to be considered energy in and energy out. At this point, it is now considered a multi-factorial disease that includes genetics, immune response, and environmental factors. We can look at obesity causing two types of fat disease, which one is called sick fat disease and the other one is fat mass. Sick fat is issues with endocrine and immune response that results in diabetes, dyslipidemia, and other metabolic diseases. Fat mass is weight-bearing issues, like joint immobility, tissue compression with sleep apnea reflux. When we are about to assess a patient for considering obesity medicine, we do extensive history, which also includes a fat mass disease and sick mass disease processes, eating disorders, mental stress, sleep patterns, also economic status, cultural background, occupation, who's living at home, and current location. Physical exam, in addition to a regular general physical exam, would include body mass index, weight circumference, and net circumference measurements. When you are looking at the diagnostics, we want to differentiate BMI by class group 1, 2, and 3. These can also categorize with abdominal obesity by measuring the waist, and also percent body fat. Routine labs that we do regularly can play into part into obesity medicine, which includes the A1C lipid panel, but also uric acid, TSH, and vitamin D levels. Here is a list of individualized testing that you can consider for insulin resistance or PCOS, low testosterone. This is a slide for reference. Also, here's another list of diagnostic testing for individualized treatment when you suspect other issues, including cardiac testing, sleep studies. Making sure you rule out secondary causes of fat mass gain to include genetic disorders, behavioral conditions, and medical conditions. This is a list of medications that you can refer to that might increase body weight, which includes some diabetic medications, steroids, some psychiatric medications, and also beta blockers. When we collect nutrition history, we really want to spend time on details of timing, frequency, who's cooking the meals, how are they accessing meals, where are they eating the meals, and their behaviors. Is there any triggers, binge eating, emotional eating? When we're discussing with the patient, really the principles of healthy eating is limiting highly processed foods and energy-dense beverages, and we want to consume the healthy protein, fats, and vegetables. Picking complex carbs over simple sugars, and high fiber foods over low, and it's the quality of calories that matter, not reducing the quantity of calories. When you look at a restricted carbohydrate diet, a low carbohydrate diet is defined as 50 to 150 grams of carbs per day. This results in a greater weight loss when you compare it to a fat-restricted diet over the first six months, but afterwards, it's similar. This may help with reducing food cravings, and it does have a good metabolic effects on cholesterol, and insulin resistance, and these benefits can occur even without weight loss. The risk with this type of diet is carbohydrate cravings and supplementing with that. Also, if they're on a protein-restricted diet with severe kidney disease, that might be an issue. On a fat-restricted diet, only 10 to 30% of calories should be from fat, and after six months, it was similar to weight loss as compared to a low carbohydrate diet. It may reduce insulin levels and glucose levels, and decrease HDL and LDL. There's a hunger control issue with this type of diet, and so considering weight loss medications to help with that. When fat is restricted, we see an increase in carbohydrate intake, which can make increase of glucose, insulin, and triglycerides. We want to look at the Mediterranean diet. On the Leon diet heart study, after 46 months, patients who followed the Mediterranean diet had a 50 to 70% lower risk of recurrent heart disease. This is a plant food-based diet with fruits as dessert to include nuts, beans, whole-grain seeds, and using plant or fish-based foods for healthy fat choices. This can include moderate amounts of fish, poultry, and up to four eggs, small amounts of red meat, and moderate amount of wine, and we want to limit the amount of saturated fat. It is the most extensively studied diet to date and has reliable research to improving a person's quality of life and lowering disease risk. When we look at weight loss in the Journal of Clinical Endocrinology and Metabolism, they saw a correlation of increased serum insulin causing suppression of lipolysis in muscle and adipose tissue in addition to systemic levels. This is really important as we want to try to decrease serum insulin levels. When we look at picking an appropriate diet for a patient, we want to pick something that's safe and effective and that the patient can adhere to. We're looking at the personal food preferences, cultural background, cooking skills, but when it comes down to it, we want to decrease the stimulus of serum insulin, which is predominantly carbohydrates. If we can modify the diet to suppress appetite and then having calorie reduction and weight loss as a side effect. When you look at the ultimate response to weight loss with dietary modifications, adherence is the key. When you're assessing physical activity, you want to see what their current fitness level is, their endurance capacity, and if they're not currently doing physical activity, why do they stop, what was the reason why, and any kind of barriers. If they have limited mobility, you want to consider seated exercise programs, arm exercise, swimming, maybe walking, a referral to physical therapy for special equipment. Aerobic training is recommended, 150 minutes of moderate activity or 75 of intense activity, which has a modest amount of weight loss and prevent weight gain. If they're able to exercise over 300 minutes moderately or 150 minutes intensely per week, we're going to see a more robust weight loss and prevent weight regain. For anaerobic strength training, we want to really make sure that they're using appropriate weight lifting technique and using a variety of free weights, machines, and resistant bands and emphasizing on core exercises. Also pushing leisure time physical activity like recreational sports or time with the family, being outside and being more active. The last one is called NEAT or non-exercise activity thermogenesis, so using a standing desk at work or using public transportation, walking, using the stairs instead of the elevator would include NEAT. You can give a patient an exercise prescription that includes a frequency, intensity, time spent, and type of exercise, and also you want to make sure that they're enjoying their exercise. Behavioral modification is a very interesting concept because we want to address why are people eating like they do, so there are biological forces that resist weight loss and weaker forces that resist weight gain. We also want to look at how hungry are they before meals, a lack of satiety, if there's mental stress, what time, sometimes people eat because it's that time to eat or they're emotionally eating with stress or boredom. It can also be a reward type of eating or pleasure eating. If they were grown up as in the clean plate syndrome, maybe they have a lack of knowledge of what healthy foods are consistent and the senses that we attach with the sight of food or smell can make people want to have food when they're not hungry. I want to go over weight loss medications. We want to consider that if you're struggling with lifestyle modifications and their BMI is greater or equal to 30 or greater and equal to 27 with the presence of some kind of obesity complication, weight loss is variable but averages 5 to 10%. If you don't see clinical improvement, about 5% of weight loss after 12 to 16 weeks, then you need to consider a different medication or increasing the current one you are giving. You want to assess safety and efficacy every month for the first three months and then every three months. So fentramine was approved in 1959 as a schedule for stimulant. It's a norepinephrine-releasing agent. It's used for short-term, so please also look at your state policies on how long you can prescribe this medication. Average weight loss is 7.9 pounds. I do, for each slide, have side effects, when not to use it, and DDIs, so you can refer to this if you're considering prescribing. Orlistat was approved in 1990, and it's a pancreatic and gastric lipase inhibitor. Impairs digestion of dietary fat. You must take a multivitamin, and it can have 6.5 to 7.5 pounds of weight loss. Lorcasarin is another schedule for drug approved in 2012. It's a 5HT2C receptor agonist, and it improves the sense of fullness, and you can lose 5 to 10% of body weight. Lair glutide, approved in 2014, is a GLP-1 agonist, and it's injectable, but lower dose is given for type 2, for diabetes. The weight loss is 12.8 pounds weight loss, on average. Naltrexone bupropion was approved in 2014, and bupropion is a reuptake inhibitor of dopamine and norepinephrine. An opioid antagonist, we all know, is naltrexone. They're used separately for addiction or depression, smoking sensation, and we have a 4.8% weight loss. Phentramine and tapiramate combination, tapiramate is used by itself for seizures and migraine. This combination is considered a schedule 4 and approved in 2012. So you're combining the norepinephrine-releasing agent with a GABA receptor modulator, and you can have a 14.5 pound weight loss and a 18.9 pound weight loss at a higher dose. Metformin can be given off-label. Tapiramate can reduce appetite by improving insulin sensitivity, leptin sensitivity, reduce neuropeptide Y levels, and increase GLP-1 activity. Weight loss can fluctuate between 5.8 to all the way to about 14 kilograms of weight loss with a higher dose of 2,500 milligrams per day. So if you're considering bariatric surgery in a patient, you want to first assess a BMI, and if they're greater than 35 or equal to, and they must have an adverse health consequence from obesity. If the BMI is greater than or equal to 40, they can have a complication or not have a complication to be considered for obesity or bariatric surgery. I have a list of things that are requirements, including insurance, making sure they can have appropriate follow-up for post-operative care, so addressing those things first. This is a reference handout for you of different bariatric surgical procedures and expected weight loss and the pros and cons associated with each one. So when we related to NAPL and NASH, the first diet prescription you should give during your initial appointment, once you do your intake information, is recommending carbohydrate reduced 50 to 75 net carbs per day Mediterranean diet, so combining the two. This is 30% or less of their diet from carbs, 30 to 35 on protein, 40% from fat, really coming from plant or fish-based sources. Must be individualized, but we want to minimize carbohydrate exposure to decrease insulin exposure to allow lipolysis. We want to suppress the appetite, as discussed before, by change of the micronutrients rather than looking at calorie restrictions, so really pushing protein, vegetable, and healthy fat and understanding that good carbs are still carbohydrates. You can also recommend meal replacements, protein-forward snacks, low glycemic index foods, and you can use online dietary trackers for carbohydrates. At the first appointment, you want to discuss at least 80% is really diet-driven and 20% is exercise, and that's during the first appointment. So when you look at the Mediterranean diet in NAFLD, we saw a significant reduction in hepatic steatosis with the Mediterranean diet when compared to low-fat, high-carb with 39%, and also improvement of insulin sensitivity. The adherence correlated with improved insulin levels and insulin resistance. There was worse adherence in NASH than it is in NAFLD. When looking at exercise and diet in NASH, we saw a significant improvement if the weight loss was greater than 7% with improvement of steatosis, ballooning, and NAS. There was a trend towards improved steatosis when the weight loss was greater than 7%. You could also see in this study that there was a regression of fibrosis with the increased weight loss in patients with NASH. Specifically, if we looked at a layer of glutide, they saw a resolution of NASH in patients was much greater in layer of glutide versus placebo and a decrease of worsening of fibrosis. So long-term follow-up should include reviewing tracking apps of their calorie intake and activity and their percentage of micronutrients. We want to do a patient-focused language and identify barriers, always assessing for eating disorders or mental disorders, treat metabolic syndrome aggressively, statins are fine to prescribe, treat triglycerides, and refer as needed. For us, follow-up, we recommend frequent visits every four weeks. Best option is with the provider, especially if starting a new weight loss medication. There are options of other touch points. We have a weight intervention in liver disease clinic at Rush University with the ABOM certified hepatologist and three APPs are trained in obesity medicine that run this pathway to help patients with obesity management and liver disease. When it comes down to it, we have to understand that obesity is defined as a chronic relapsing disease process. And I want you to take away the understanding of a low carbohydrate Mediterranean diet, physical activity, behavioral modification, weight loss medications, and bariatric surgery are all available to help with a lifelong follow-up. And more importantly, is weight loss is the single most important intervention we can do and whose provider has mentioned that in the past, that they were overweight or more likely to achieve weight. In addition to helping with NAFLD and NASH, a 10% weight loss can help with hypertension, insulin resistant, hyperlipidemia, sleep apnea, mood, fat mass diseases also. So thank you for joining me today. If you have any questions, go ahead and type it in the chat box and I'll be able to answer any questions. Thank you. I'd also like to give a special thanks to Dr. Sajid Jannardhan at Rush University, our weight loss intervention.

hepatology

liver disease management

hospital readmissions

transitional liver clinic

cholestatic diseases

primary sclerosing cholangitis

primary biliary cholangitis

COVID-19 pandemic

obesity management

NASH

personalized care plans