How RPM technology can improve chronic disease management
In a new episode of Cadence Conversations, Cadence Chief Medical Officer Dr. Theodore Feldman sat down with Dr. Benjamin Scirica, Associate Professor at Harvard Medical School, Cardiovascular Medicine, for a wide-ranging discussion about the effectiveness of remote patient monitoring (RPM) platforms and the potential for clinical trials to improve the utilization of guideline directed medications.
Cadence Conversations is a podcast from Cadence featuring clinicians, healthcare executives, as well as tech entrepreneurs discussing their experiences driving innovation and progress. Previous episodes include Tim Hingtgen, CEO of Community Health Systems, discussing how CHS approaches digital innovation and new technology, Rob Jay, CEO of ScionHealth discussing the hospital system's partnership with Cadence, Dr. David Shulkin, 9th Secretary, U.S. Department of Veteran Affairs discussing the future of RPM, and Dr. Toby Cosgrove, former President and CEO of Cleveland Clinic and currently an Executive Advisor to a number of startups, discussing how to ensure effective partnerships between health systems and technology companies.
In addition to his work at Harvard Medical School, Dr. Scirica is a director of quality initiatives at Brigham and Women’s Hospital’s (BWH) Cardiovascular Division and a senior investigator at the Thrombolysis and Myocardial Infarction (TIMI) Study Group. He recently published a marquee study on RPM across more than 10,000 patients which found that remote monitoring helped to significantly reduce blood pressure and lipid levels.
On the podcast, Dr. Scirica spoke at length about the results of this study, which took place over a three-year period and relied on extensive data — including 400,000 blood pressure readings from patients and over 130,000 laboratory data — as well as its implications for the future adoption of RPM technology by clinicians to help treat their patients with chronic conditions.
"To unbreak the system, we are going to have to have clinics that work on many levels where there is a whole lot of work that's being done that the physician does not have day-to-day involvement on. Otherwise, we won't be able to provide care to the growing elderly and sicker population," he shared.
Dr. Scirica said he believes that RPM technology can serve as a "physician extender" and free up cardiologists' valuable in-person time to focus on caring for their sickest patients, or those in need of the most complex care. In this way, RPM should serve to ease some of cardiologists' administrative hurdles and busy schedules, while at the same time, ensuring more routine and better access to high quality care for patients.
"What I think is universality is there are not enough cardiologists out there," he shared. "In fact, what we really need to do is we need to see the more complex patients. … I'd rather see the new patient where there has to be more complex medical decisions where there will likely be many more downstream revenue procedures ... and by getting rid of some of those other return visits that can be done by physician extenders, you open up those and you have a better model."
Dr. Feldman and Scirica also discussed Cadence's recently published clinical data at the 2022 Heart Failure Society of America conference, which also showed positive results in using remote patient monitoring to treat heart failure patients.
As part of the results of that study, Cadence observed a 5.5x increase in the percentage of patients on all four pillars of GDMT compared to baseline, a 1.5x increase in the percentage of patients on mineralocorticoid receptor antagonists (MRA), a 3x increase in the percentage of patients on sodium glucose co transporter 2 inhibitors (SGLT2i), and a significant increase in the percentage of patients on >50% target dose of GDMT for each pillar other than beta blockers.
"Congratulations on those results to you and the team," Dr. Scirica shared.
"What you showed I think is how well a dedicated personnel when focused on a singular task can implement care. I think having the nurse practitioner be able to have that as their goal, continually contacting the patient, up-titrating the medications, making sure there are no side effects, getting them there, is the only way that it's going to happen."
If you are a clinician, this is an important and wide-ranging discussion about the use of technology to expand and improve access to care for chronic diseases.
Check out the full episode above and subscribe to Cadence Conversations wherever you get your podcasts.
Read the full transcript of the conversation below:
Episode Transcript
Introduction: Welcome to Cadence Conversations, where we're talking with prominent physicians, healthcare leaders, and tech entrepreneurs about their experiences driving innovation and progress. This week, Ted Feldman, Chief Medical Officer at Cadence, had an opportunity to sit down with Benjamin Scirica, Associate Professor at Harvard Medical School and Attending Cardiologist and Director of Innovation for the Cardiovascular Division at Brigham and Women's Hospital. Ted and Ben discussed some of the recent data released by both of their teams on the effectiveness of remote patient monitoring platforms. So let's get to this week's Cadence Conversation.
Ted Feldman (TF): Ben, thank you so much for joining us for this episode of Cadence Conversations. You wear a lot of hats these days. You're an associate professor at Harvard Medical School, an attending physician at Brigham and Women's Hospital and head of innovation within the cardiovascular division there. Can you just share with us a little bit with someone who's wearing as many hats as you are, how you're dividing your time and what's your real passion?
Ben Scirica (BS): Thanks, Ted. It's great to be with you today and talk about topics that we both are very passionate about. I'm a cardiologist. I do general cardiology as an outpatient and critical care cardiology as an inpatient and that takes about a third of my life. The other parts of my life have been filled in a couple different ways. The first, I've been an investigator at the TIMI Study Group for my entire career where I've led clinical trials. We have had the fortune of being able to do a lot of very successful clinical trials where we've identified new strategies or new medicines that help people have fewer heart attacks and die less with cardiovascular disease. But there has been, I'd say a frustratingly low rate of implementation of those.
About six or seven years ago, we started to think about how can we improve the utilization of guideline directed medications. We started looking at some chronic cardiovascular diseases like heart failure, like hypertension, like hypercholesterolemia, and tried to look at what are the different barriers, and there are many, that prevent patients from getting even on generic drugs at a rate that would seem appropriate for their underlying risk.
What gets me excited now is that we have so many new therapies and new options for patients with cardiometabolic or cardiovascular disease, but we still have so much to go in terms of getting people on the right medicines. It's been particularly challenging in populations that have traditionally been undertreated or underserved by medicine. And I think the evolution of how we as a society are going to deliver care is going to have to really focus on what's the problem. And I think one of the great problems is we know a lot but we're not giving patients and able to get patients the medicines that we know will help them.
The Future of Clinical Trials in the Remote Patient Monitoring (RPM) Space
TF: I couldn't agree more. I mean, certainly I'm dating myself here but was excited to be part of TIMI I and TIMI II, the GUSTO trials when in my interventional cardiology world, it did seem that the early TIMI trials really was able to change guideline-directed medical therapy because it was more focused on the hospital where we had a lot more control. Now obviously a lot of the therapies and some of the things we'll discuss today, as you referred, in chronic disease management are much more in the outpatient perspective.
How do you see these types of trials kind of playing out? The clinical trials have been so much focused on randomized, double-blind, placebo controlled, population-based multicenter trials, which we as clinical trialists really value and which our national societies really focus on the level one best evidence to be able to say this becomes the standard of care. But yet we're doing such a poor job in converting them into clinical practice. I mean, is there a role for randomized trials in this space?
BS: Now, I mean, I think should we do randomization? I think there still very much is a place for randomization, but I think it does have to be thought of perhaps more as AB comparisons rather than randomization. We know even with the guidelines with class I indications, and heart failure is a good example, class I indications where there are four or five therapies that are class I indications, there really is not any evidence of which one should I do first? How fast should I do it? Should I do two at a time or three in one or two and two, how fast should I do it? All of that stuff is just we're all doing our own thing out here. Patients are almost randomizing themselves when they come to a different doctor or a different clinic. I think in that sense there's the ability to do sort of much more rapid implementation of AB comparisons of sequences of guideline directed medicines, timing of the guideline-directed medicines, even simple stuff like how often do I need to get labs? I mean, that's all, again, people are making this up without data. I think to be able to have a platform where you can do these much more rapid iterative type of AB comparisons and then pick the winner and then go on to the next comparison is the real goal. And this has been going on in the technology world for decades.
I think as sort of a card-carrying clinical trialist, I certainly recognize the importance of the double-blind, randomized, controlled trials with a protocol that can only be changed with an amendment that has to be, I mean, just iron tight for FDA. I think we do not and should not hold that standard to the rapid implementation type of trials.
I think the other thing is that we just also have to be able to do this quickly. We can't say that we're going to set an experiment and wait two years and then get a result. I think we have to think about how to do it more quickly. That's going to require some, I think, recognition or at least acknowledgement between IRBs, journals, FDA, everybody involved, about what is research and what's implementation, and that gray area is very hard. Do you need to get informed consent or can this be part of a quality improvement program that doesn't need consent? Should I do it as cluster randomization or patient level randomization or institution versus institution? There are a lot of different methodologies to do this.
The other, I think, important part is that doing it against just standard of care, I don't think you need to do a randomization against standard of care. I think we know what standard of care is like. When we looked at our data, you look at the last three or four years and it's exactly the same. So there isn't some magical sort of temporal improvement that's happening. We've plateaued on many of these quality metrics. So that if you can show when I start a program now and in six months we're at a much better spot, I think that's good enough for me to say, "Let's do that." I think the big question, and I think we'll get into this, is how do you make these sustainable programs so that they can continue and that you really do add value to the environment?
How RPM Can Improve Chronic Cardiovascular Healthcare
TF: I appreciate those comments because that's really been a lot of our focus here at Cadence. I want to speak a little bit more about your innovation hat in particular. I saw a recent quote from you where you said that our current health system is "broken and for decades has failed to deliver effective chronic cardiovascular care." Can you talk about what specifically you think's broken and when it comes to cardiovascular health, what role you believe technology will help in addressing these shortcomings, particularly remote monitoring and the ability to interact with our chronic disease management patients now in a virtual world?
BS: So where I think we have problems are on a couple levels. First, I think we are very much a health system that is predominantly based in the 1950s type of model of Marcus Welby where things only happen when a patient and a provider are in the same geographic space. It actually still is very important, especially for acute events, to be able to do that and have an assessment and come up with an immediate plan that happens. But as all of us are becoming responsible for more and more types of care ... I mean, even if you're a specialist, there are so many more options in what you have to do, so many more considerations … It's getting harder and harder to be able to do that yourself and remember that.
The current technologies, I think EHR are not meant to be longitudinal care management programs. I mean I often joke, our EHR, the way that we are supposed to remember things, is we literally have an electronic sticky note where you type notes to yourself that you can then see in two weeks but it doesn't remind you to do something. It doesn't sort of help you. But it is a system that is set up for human error. Where I think that breaks down is when we're dealing with chronic diseases in cardiovascular disease, many of which are sort of the silent killers, whether it's high cholesterol, high blood pressure, dysglycemia and diabetes, and even some forms of heart failure where it's really easy for patients to let that slip.
For doctors, and it means that we have to be able to keep a much more constant contact with them, and expecting somebody to come into the office every three months just to get a blood pressure check or just to get their weight or get their symptoms is both unreasonable on the patient and impossible given the access issues for our limited number of providers to be able to perform.
So I think what it means is that a typical thing is that I see somebody on a yearly basis, their blood pressure's a little up, and their cholesterol may be a little bit up and we talk about, "Oh that's great. Why don't you eat a little bit better? Why don't you lose a little weight, do a little more exercise. And by the way, your blood pressure's elevated here, but that's often high. Can you send me four or five blood pressures from home?" They never do, and they're back in a month and we're having the exact same conversation and their blood pressure is still up. That's been another year of probably uncontrolled hypertension and untreated hyperlipidemia. They may have lost three or four pounds up front, but then they're back to the same place they were a year later.
I just think that is not the way we want to care for patients. Even when we know the diagnosis, we still see that there are huge percentages. I mean, a third to a half of patients who are indicated for guideline-directed medical therapy aren't getting them. That's why I said it's broken.
Positive Clinical Trial Results from a Recent Study of RPM in Over 10,000 Patients
TF: I totally agree. It's just I think folks like you and I are passionate about finding ways to use technology in virtual care to expand the top of the funnel, improve access and really improve the care around these chronic diseases, particularly in our area, hypertension, hyperlipidemia, metabolic syndrome, and diabetes. Which is a perfect segue into getting into some of the exciting work that you guys at Mass General Brigham have recently published.
During the COVID-19 pandemic, you led a team that developed a program for remote patient monitoring for improving blood pressure and lipid management through treatment algorithms, digital solutions, Wi-Fi enabled cuffs. How did your work begin, and what do you think the impact of that very important study will be to the way in which we manage hypertension and dyslipidemia into the future?
BS: We started the programs well before COVID. And we had a couple key components that we wanted to try to implement. First, it had to be remote. We just knew coming into the office was going to be a huge barrier. Secondly, we wanted to do fairly aggressive task shifting. We trained up non-licensed navigators, we call them, who really were the face of the program and spent most of the time with the patients. We created very strict medical clinical decision algorithms as well as patient flow algorithms. With that, it allowed us to have a pharmacist, advanced practice pharmacist, prescribe medications when they're following this protocol without a co-signature. And then that was overseen by a nurse practitioner and a physician. By doing that, it meant that we really could have everybody working at the top of their license and have a scale that you couldn't do even if you just had a nurse doing this by themselves.
And the other part of it is that we added some technology. The technology, the way we first approached it, is that we tried to keep the technology to the patient very minimal because we recognized that that could be a barrier or a digital barrier. On the backside, we used some software CRM and omnichannel communication software external to the EHR to be able to basically code up our algorithms and do better workforce management, queuing, and task management. What it meant is that again, you could have 20 or so navigators and a couple pharmacists working independently, asynchronously, and communicating with thousands of patients.
Now, when we hit COVID and we had the stay-at-home order that came in Massachusetts, our enrollment went up like 50% for the first months. I mean, because people wanted it, doctors wanted it, and we were able to maintain that momentum as we moved through and as we finished the 10,000 patients, and that's what we just published in JAMA Cardiology.
TF: Could you share some of those results, Ben? I mean, for those who haven't had the opportunity to see the results in JAMA Cardiology, though it was widely covered both in the medical and lay press, I think it's really becoming a landmark study for those of us in the field.
BS: For sure. So this was over about a three-year period we enrolled these patients. Almost 6,500 patients were managed for their lipids. Almost 6,500 patients were managed for their lipids and about 3,500 for their hypertension and almost 1,000 were managed for both. For these patients who are all in our system, in total I think we got 400,000 blood pressure readings from all the different patients. We ordered or interpreted over 130,000 laboratory data. This was all work that the primary provider didn't have to do. We really offered this as a Coumadin clinic for hypertension and for hyperlipidemia.
TF: People were referred to the clinic and then all of the management vis-à-vis hypertension and lipids would be left to the team assuming that the patient remained stable.
BS: That's exactly right. We got patients ways. We had referrals, which were most of our hypertension patients. Then we also did population health screening for lipids. So we looked for people with atherosclerotic cardiovascular disease, we looked for people with diabetes, we looked for people who had an LDL cholesterol of over 190 and who were not at their lipid goals. We outreached to them directly and said, "We have a program that might benefit you, and your provider is in agreement," and then we were able to enroll them. In lipids, that was about 85% of the patients were basically us going out to patients and having them join us.
We were able to overall, in all patients, get a reduction of about 10 mm Hg systolic and about six mm diastolic. In patients who actually made it through the program, they got a little higher blood pressure reductions of about 13 and seven mm diastolic. This is all from the home blood pressure. What was interesting is when we got patients based on their office blood pressure, that was much higher. So the drop from office to home was over 20 mm Hg when we got them under control.
In terms of the lipids, we saw overall a reduction of about 45 mg/dL. That was the most in those patients who had an LDL greater than 190. The average in those patients we had an LDL reduction of 92 mg/dL. In the patients with atherosclerotic cardiovascular disease, we achieved almost over a 50% reduction. This is predominantly using statins and ezetimibe. If we had to do prior authorizations for PCSK9 inhibitors, then we'd do it, but we were able to get a lot of patients to go on generic.
TF: I'd like to separate a little bit more detail, dig in on the hypertension side. Obviously the recent SPRINT trial dramatically changed guidelines from systolics of 150 down to 130, and in that trial suggested that people needed multiple drugs in order to get their blood pressure controlled. Was most of the improved control around up titrating existing meds or what percentage of people, ballpark, needed additional meds? If you looked at that controlled population, what does that look like in terms of medical therapy?
BS: Yeah, it was a combination of both. We ended up adding a fair amount of medications to people so that we ended up with I'd say probably 25% of people who ended up on three to four drugs at the end and maybe a third on two. Then there was just maybe 30% or so who ended up on one med.
Two important things about the blood pressure. Not only two, but we first had to deal with how would we deal with out-of-range blood pressures because we're getting these thousands of blood pressures a day. Not surprising, you'll start getting some that are 180, 200/110 and how do you manage those? So we had to set up an entire sort of alarm system.
Then secondly, there are certainly patients who can't be followed by an algorithm. They're more complicated, and so we developed what we called a hypertension plus program where those patients who we try the algorithm and it didn't work would be bumped up to one of our cardiovascular nurse practitioners who together would try to make some moves to either get them back on the algorithm or manage them with medicines that wouldn't be on the algorithm or refer them to one of our hypertension specialists directly, in which case they were then getting somebody who had clearly shown that they couldn't be managed by a skilled team. And then they would continue the workup for secondary hypertension and problems.
Cadence's Recent Data Showing Positive Results of RPM on Heart Failure Patients
TF: Great. I'd like to maybe take this chance to maybe switch into the CHF realm. I know we were both at the HFSA, the Heart Failure Society of America meetings this year, and we at Cadence had the opportunity to present some of our early data on RPM and HFrEF, heart failure with reduced ejection fraction about getting more folks on the four pillars of GDMT. And I'd love to share with you some of our results and then obviously get your comments about the significance and the implications moving forward.
We had a 5.5x increase in the percentage of patients on all four pillars of GDMT. Went from 7% to 39%. We had a 1.5x increase in the percentage of patients on mineralocorticoid receptor antagonists, drugs like spironolactone and eplerenone at follow up, so we went from 42% to 65%. We had a 3x increase in the percentage of patients on SGLT2 inhibitors, which are the sodium glucose cotransporter 2 inhibitors. We went from 18% to 53%. And we had a significant increase in the percentage of patients who had greater than a 50% target dose of GDMT for each pillar.
When you hear data like this, what is your reaction in terms of the implications for treatment now as well as into the future given the fact that we used an NP model in order to accomplish this?
BS: First, congratulations on those results to you and the team. I mean, the bar now is so high for heart failures, and it is daunting as a provider to think about how you're going to start them yourselves. What you showed I think is how well a dedicated personnel when focused on a singular task can implement care. I think having the nurse practitioner be able to have that as their goal is to continually contacting the patient, up titrating the medications, making sure there are no side effects, getting them there is the only way that it's going to happen.
I mean, there is as you heard at HFSA, and in some other places there's this now four and four, getting people on four drugs in four weeks. I mean, certainly aren't going to get that into my clinic by myself. I'm going to need help. I think this is a great example of how it can be done and I think what doctors often want is an easy button. I mean, they've made the diagnosis, they know what needs to be done, they'd like somebody else to implement it and they can then continue ... I mean, I think, and a lot of heart failure clinics are able to have nurse practitioners. A lot of general cardiologists or other doctors like electrophysiologists who treat these patients don't have that infrastructure to be able to do it.
Driving Adoption of RPM Technology in the Future
TF: But do you see as we move to the future practices incorporating more of mid-level providers and lower level providers under supervision of physicians and NP experts within the field? Is this sort of going to become the standard?
How are we going to overcome some of the pushback from providers, particularly cardiologists who say, "Wait. That's what I do."
BS: As in most things in life, time and money are probably the two things that it comes down to. I say that a little facetiously, but I think it then broadens out into two big questions. How is this paid for? What is the value that these types of disease management programs can provide? Is it fee-for-service or on sort of RPM billing or chronic care management so that by doing this a clinic and have a new revenue stream that supports itself and maybe even has a margin because it can actually take more patients now. Or in a value-based system is this, which we know is better care and will lead to fewer hospitalizations, going to improve the overall total medical costs and therefore help the system?
I think the problem right now is American medicine has a foot in both of those and each different state practice doctor is a little bit different.
But what I think is universality is there are not enough cardiologists out there and honestly every cardiologist out there has got a job that's going to be ... well there'll be work for all of us. In fact, what we really need to do is we need to see the more complex patients. I actually think that a patient coming in and spending 15 minutes or 20 minutes that I'm allotted and all I'm doing is doubling their metoprolol and even adding an SGLT2 inhibitor is not using my highest brain function. I'd rather see the new patient where there has to be more complex medical decision where there will likely be many more downstream revenue procedures ... And I think that's the way ... And by getting rid of some of those other return visits that can be done by physician extenders, you open up those and you have a better model.
Even just opening access ... I mean, my next available return patient visit is months and months apart. I have to double book people to bring them back just because there isn't enough access in most people's clinics. So getting back to where we started, I think to unbreak the system, we are going to have to have clinics that work on many levels where there is a whole lot of work that's being done that the physician does not have day-to-day involvement on. Otherwise, we won't be able to provide the care to the growing elderly and sicker population.
TF: As we get ready to wrap up. Looking ahead for the next five years and we've sort of covered this, but maybe an opportunity to kind of summarize for today, what gets you most excited as it relates to our remote patient programs? Where do you see this having its major impact in how we look and care for our patients?
BS: I think there are a couple important things. I think the first is that we now have more and more options to treat patients, and we know that we often have to treat them more intensely and earlier than in the past. By doing so, we will improve the care of what is an older and growing and more sick population as a whole.
I think much of that should be done at home or remotely and the technology is getting there. I think COVID certainly pushed us over a year what probably would've taken five to 10 years. But the technology is such that so much more can be done at home that it really does open up the possibility for both synchronous and asynchronous type of care that's being delivered.
I think for that to happen, there has to be continued evolution of the payment structures, whether it is for RPM billing and who actually needs to do it and what are the requirements, as well as sort of the value-based approach to be able to appropriately incorporate these types of non-traditional care so that they are supported and reimbursed within the healthcare system. I think to do that will allow systems to more rapidly change their overall care delivery structure, especially for ambulatory and chronic care.
TF: That's great, Ben. I can't thank you enough for joining me today and sharing all of your insights and experience with the Cadence community. Obviously we appreciate the work you're doing to further remote monitoring research and the impact it'll have on our patients, and we look forward to the opportunity to work together into the future.
Conclusion: Thanks again to Ben for taking time to talk with Ted this week. If you're interested in learning more about Cadence and how to get involved, visit cadence.care, and please get in touch with our team. To make sure you get updates on our future conversations, please subscribe to Cadence Conversations wherever you to listen to podcasts. At Cadence, we believe that everyone deserves to receive the best care possible, and we won't stop working until that vision becomes reality.
