Good afternoon, everyone. I'd like to welcome you all to our session, Transitioning to Value-Based Stroke Care. I'm Dr. Sarah Cuccarullo and I'm here with Dr. Talia Fleming. And we're very excited to be sharing this information with you for the work we've been doing since 2015. I was asked to say, to just make a few announcements. There's a request for cell phones to be silenced. And note that all of these sessions will be audio recorded and you'll be able to access them so there's no need to record. There's a request that in order to claim CME credits that you please fill out the evaluation forms and the AAPMNR would love for you to visit the pavilion and all the booths that are available. And one last reminder is to pick up your physiatry t-shirt for Physiatry Day. So that's just to get started. But again, we're very happy to be here regarding transitioning, discussing Transitioning to Value-Based Stroke Care and the work that we've been doing. The disclosures that we have are listed here. The learning objectives that we're going to be talking about today are going to be comparing the medical and rehabilitation similarities between stroke and cardiac disease. We're going to be demonstrating how a value-based stroke recovery program modified by using a proven model in cardiac rehabilitation can improve function, mortality, hospital readmission rate and healthcare-related costs for stroke survivors. We're also going to be illustrating that stroke post-acute care deserves the same nationally supported healthcare delivery options that are effective for patients with other vascular diseases. So just to go through an outline of what we'll be talking about, we're going to be identifying the need for comprehensive post-stroke care including rehabilitation services. We're going to compare the similarities between stroke and cardiac disease. We're going to describe how the Stroke Recovery Program clinical research trials bridge the gap to show value in post-stroke care. And we're going to share with you the advocacy efforts that we've been involved with for value-based stroke care at the national level, improving access to comprehensive post-stroke care. So first we'll go over the need for comprehensive stroke care. In 2016, the American Heart Association and the American Stroke Association put out guidelines for adult stroke rehabilitation and recovery. And these findings found consistently in favor of the patients who meet the compliance issues related to being admitted to an inpatient rehab facility that they should go to an inpatient rehab facility and specifically because they will get better outcomes in preference to sending them to a skilled nursing facility or a nursing home. Studies that have compared outcomes in hospitalized stroke patients, should they instead go to a skilled nursing facility, they would have higher rehospitalization rates and substantially poor outcomes. Should they comply with inpatient rehab, they have higher rates of return to community living and greater functional recovery if they appropriately go to inpatient rehab facilities. In the Journal of Circulation there was an article put out that identified that once they finish their inpatient rehab stay or once they leave the acute care hospital, only about 30.7% of stroke survivors receive outpatient rehabilitation. And that's lower than would be expected if practice guidelines were followed for strokes who do need continued care because we know that their rehabilitation needs don't end once they leave the acute care hospital or they leave acute inpatient rehab. And they found that this was because of several barriers, but barriers that also included financial barriers. CMS has what's known as, many of you are probably very familiar with this, the CMS therapy threshold or therapy cap. Once a patient finishes their acute, either their acute care stay in the acute care hospital or if they go to inpatient rehab, there's a CMS therapy threshold or therapy cap that limits patient's access. The CMS funds about $2,230 for PT and speech services combined and about $2,000 for OT. And as many of you know, that gets used up very quickly with the neurorehab that the patients get on the outpatient side. But Medicare fully funds patients who require cardiac and pulmonary rehab outside of the Medicare therapy cap. They fund a full comprehensive cardiac or pulmonary rehab program, funding a 36 comprehensive session that involves multiple disciplines to help the patients recover. And this is again outside of the Medicare therapy cap or threshold. The candidates in cardiac rehab who comply with this include those with acute MI, stable angina, percutaneous transluminal coronary angioplasty or coronary stenting, CABGES, heart valve replacement, heart and lung transplant and congestive heart failure, which was recently added as a fully funded and compliant diagnostic category in 2014 due to data that was produced by cardiologists. In 2011 Mayo Clinic did a study on over 2,300 patients post stent placement or PCI, putting them through a comprehensive cardiac rehab program which included 36 sessions of cardiovascular interval training, rehab risk factor management, rehab psychology, nutritional consultations for education, and also smoking cessation. This resulted, the result of the study found that cardiac rehab after PCI was associated with a 45-47% reduction in 5-year all-cause mortality rate compared to the non-participant group. This information was groundbreaking as a result of the research and the data that was discovered. And pretty much, this is a YouTube video of the work done on cardiac rehab, basically stating that if someone came up with a pill that reduced mortality 45-47%, they would win the Nobel Prize. And because of this research, Medicare fully funds cardiac rehab. The goals of cardiac rehab include the following, maintaining or improving function in cardiovascular fitness, reducing risk of future cardiovascular events, improving modifiable risk factors, improving adherence to medication regimes, improving the quality of life, adopting life-long healthy behaviors, and decreasing overall mortality at 5 years post-participation. But what about our stroke patients? Instead of a heart attack, these patients are having a stroke or a brain attack. Instead of affecting their coronary arteries, the cerebral vasculature is affected. And ultimately, it's important to know and to realize as PM&R physicians that stroke is a cerebral vascular disease with neurologic consequences. So basically, right now CMS is only funding neurologic deficits that stroke patients suffer from. So they will fund with the CMS Medicare Therapy Cap-and-Threshold, they'll fund the NeuroRehab. So the deficits, as we all know, involve weakness, balance, coordination, and that is funded through the, you know, for traditional NeuroRehab. In our research, we have seen much greater benefits overall when the cardiovascular health is also treated. By addressing, so if you look off to the right, by addressing the cardiovascular risk factors and their cardiovascular health, utilizing a cardiac rehab program, we're finding that we're getting much better results in this patient population and they're doing much better overall. Patients with stroke often share many of the same risk factors as the cardiac rehab patients, hypertension, diabetes, hyperlipidemia, but have much more involved functional deficits as we all know, which would include dysphagia, aphasia, hemiplegia, cognitive deficits, and spasticity. But again, our patients recovering from stroke don't have access to this robust comprehensive cardiac rehab program and they must use the money within the Medicare Therapy Threshold. And this puts our patients at a major disadvantage, the stroke patients, during their stroke therapy and should they have a second event within that same year. So we developed a stroke recovery program to answer these unmet needs and presented a bold idea to change the way that stroke care is delivered using value-based care, which incorporates a modified cardiovascular interval training program for stroke patients. And now I'm going to have Dr. Fleming talk to you a little bit about the program and describe the program to you. »» Thank you. So as Dr. Cucurillo mentioned, we're both physiatrists and we saw the fact that patients with stroke have this underlying vascular disease. In addition, they're trying to overcome these neurologic deficits. And we said, once the patient's discharged from the inpatient rehab hospital, how is it that we develop a program which has more longitudinal care to care for them, not only for their stroke recovery, but is there a way that we could give them this modified cardiac rehab program to help change the underlying vasculature, to help them improve in outcomes not only for function, but also medical outcomes as well. So we took a look at how we would design this particular type of program. So we went from the idea to actual implementation. So the foundation of the Stroke Recovery Program starts with our outpatient follow-up visit with our stroke physiatrist. They come for a doctor's appointment and then the physiatrist manages their care. At that appointment, the physiatrist can order physical therapy, occupational therapy, or speech therapy, depending on the patient's needs. And they also prescribe this specific cardiovascular group, which met three times per week for a course of over between 12 to 16 weeks, for a total of 36 sessions. And that's similar to what cardiac rehab already has established. Also during those appointments, the physician is able to give specific education for nutrition. They also have a component where they address rehabilitation psychology and referral to a rehabilitation psychologist when needed. They can also refer to neuropsychologists, as well as driver's training. And at those physician visits, we also give education regarding nutrition, smoking cessation, the warning signs for stroke, and we also do a mood assessment, as well. So again, really comprehensive look at the patient. In terms of the exercise group, when we had this initial idea, we mentioned it to neurologists and cardiologists, and they said, you know, that's a great idea. I could see why you would want to do that. But how can patients with stroke, how can they exercise? They can barely walk. And so Dr. Kukurula and I looked at each other, and for us, it was a no-brainer. We said, but we're rehab. We do this all the time. We make modifications for our patients so that they can participate in a particular exercise or complete a certain activity. So that was what we did. We took a look at the most common challenges that patients have, such as weakness in their parietic side, changes with cognition or attention, trouble with safety awareness. We all know that post-stroke fatigue is very common, as well as underlying cardiovascular instability that they may have, in addition to any underlying comorbid conditions like pulmonary disease or an arthritic or orthopedic condition that may impact their ability to participate in the exercise group. We decided to use a particular machine, a recumbent cross-training bicycle, which allowed the patient to participate in exercise at a certain level of intensity. But this particular recumbent bike takes out the balance component that sometimes is a part of aerobic conditioning with either a treadmill or an elliptical or a different type of device. In addition, we were able to make modifications, including using a hand mitt for patients who had weakness in their arm. There was also a thigh cuff for people who had weakness in their thighs. And then there was also a special foot plate and Velcro straps to secure the lower extremity as they're doing the particular exercise. We developed interval training on the recumbent cross-trainer bicycle. And so the groups themselves were done in about a ratio of one to two patients per exercise physiologist. And they was administered in a group setting. So not only was the patient having interaction with our health care team, but they almost developed their own little support group as they're doing their exercise program, where they would encourage each other and share stories, share tips. So they really became a support for each other. Any patient who did the group had cardiac clearance prior to starting the group, because we wanted to make sure that they would be safe on the machines. And the program progressed from a low to a moderate intensity type of program. So this was more than just having the patient sit on the bike in the corner and just randomly move their arms and legs. It was a specific integral progression that they had. This also gave our staff a chance to provide fitness education for patients. So by the end of the 36 sessions, they had a certain level of confidence in what their body could tolerate in terms of exercise and exercise ability. So as we were thinking about this idea, we were implementing it in the real world clinical setting. Dr. Kukurulo and I took a step back and said, OK, let's start collecting data on this. What are our goals if we were to design a research trial around this? Number one, we wanted to see whether or not a program like this could reduce hospital readmissions, repeat stroke, as well as overall mortality. And then from a functional standpoint, we wanted to see if a program like this would help patients improve their function, as well as improve their cardiovascular conditioning. And the overall goal was we wanted to prove to Medicare and other insurance providers that patients with stroke really deserve this special carve-out, aside from their basic neural rehab. And we wanted them to have access to this extra level of care, similar to what cardiac patients have. So we designed our first clinical trial. It was a combination feasibility study, which also had a subgroup analysis. And we took a look at two particular groups. So both groups had an acute stroke. They went to our inpatient rehab hospital. And at discharge was where the groups diverged. So the standard of care group, or the control group, they were discharged to home. They followed up with their primary care doctor. They followed up with their neurologist. They may or may not have different levels of access to care in the community, in terms of their outpatient therapy. But that's typically how most stroke rehab is administered across the country, if you look generally. The participant group was a group that came back to JFK Johnson Rehab. They had this protected program for the first three to four months after their stroke, after they were discharged from the inpatient rehab hospital, where they had the physician visits. They had coordinated therapy services. And they also had this special cardiovascular group. »» So this following demographic table shows that we did the feasibility study on, if you look off to the second column in from the left, we did the feasibility study on 136 stroke recovery participants. And then we did a non-randomized match pair subgroup analysis of 76 match pairs. And if you look at the first column off from the left, you'll see that the stroke recovery participant match pair group was 76. That subgroup, that non-randomized subgroup analysis was set up very similar to the way that Mayo Clinic had set up cardiac rehab, which then moved CMS to basically support this program for cardiac patients. So we matched on multiple points, gender, race, type of stroke, age. We matched on their discharge impacts. And even though we did not match on comorbidity index, with the Cardiovascular Institute at Rutgers Robert Wood Johnson, we made sure that we did not see any major differences in the, we compared all the comorbidity indexes that you see here. And we did not see any significant differences in the matched groups in anything but smoking, which you can see that about five from the bottom on the right. We went to great lengths to make sure that both groups were very similar at baseline. So looking at some of the results of the initial review of our results, with regard to the feasibility study and with regard to their cardiac capacity or their exercise capacity, we looked at this program and we measured them in met minutes. The first thing that really stood out to us in putting these 136 patients through the program is that the program was safe. We were initially told when we went for grant funding that stroke patients can't exercise safely, there are fall risks, there's a lot of issues linked with the challenges of putting these stroke patients through interval cardiovascular conditioning. We found the program was safe. Every patient that came into the program, we worked with cardiologists and we got cardiac clearance on every patient that came into the program. What was really interesting is that every stroke patient saw a cardiologist, was cleared to come into the program. But we had four patients during this time that when we stressed them, when we did this low to moderate interval cardiovascular conditioning, they told us I feel chest tightness or I feel pain in my left arm. We sent them back to their cardiologist and four of them required stent placement. They had underlying coronary artery disease that was not appreciated even with a cardiac workup. So as we all know in this room that, you know, our stroke patients do suffer from cardiac disease as well, especially coronary artery disease. So the fact that it was safe was really a big plus for us and that the patients actually loved it. They felt empowered when we put them on the machines because with their good side they saw themselves progressing and doing better and better each time. We also, as Dr. Fleming said, that we did it in groups. We did group sessions. We had the benefit of it turning the group sessions turned into little mini group support sessions where we worked in their cardiac rehab with the neural rehab and they basically started bonding, having lunch together. The family members that came with them would share similar stories. It was really a very positive social situation that we were realizing was unfolding. We saw improvement in exercise duration. As I said, they felt empowered. They felt like they were doing more and more. When we looked at the met minutes, when we look at the baseline which you see here, the average baseline started at about 46 mets per minute. And then that went up by session 36 by the typical cardiac rehab, which again Medicare funds 36 sessions for our cardiac patients. By putting them through 36, they went up to a met minutes average of 95. When we convert that over to percentage, we saw 103% improvement in their exercise capacity. »» So as you can imagine, we're really excited. You know, we're taking you along on our journey. So we went from having this idea to implementing it directly in the clinic. Sometimes in research we have these ideas and we execute them in this sterile environment, but then it's difficult to translate it over into real life, what happened then. So this particular project is implemented in real life. We're starting to see the cardiovascular data, how it's improving. Then we took a look at the functional data. We decided to use the AMPACT, the Activity Measure for Post-Acute Care, for several different reasons. It's a measure that measures three different domains, has the ability to measure basic mobility, which is a measure of physical therapy skills, daily activity, which measures occupational therapy type skills, and applied cognitive, which measures speech therapy or cognitive and communication skills. The AMPACT is a measure of over 269 different functional activities. And the computerized version is able to be executed in a quick timeframe for our therapy staff to be able to answer questions based on the person's ability. The way the computer test works is that it asks a mid-level question, and then whether or not the person can or cannot do that function, it then shunts the remaining questions either up or down, so that after about six to seven questions per domain, you're able to come up with a quantitative number. That numeric measure of function can be tracked over time in different clinical settings. So as we know, in rehab there's different outcome measures that are more specific for either the acute care hospital setting, or for the outpatient setting, or for the skilled nursing level. But this particular measure can be tracked over time. And we wanted to see how our patients tracked for over a year. So that was an important reason why we chose this measure. And as well, this was measured, it was recognized by Medicare. So Medicare had already recognized this as a tool that was valid, that was reliable. So we moved forward with taking a look at the ANPAC specifically. So this is a graph of our basic mobility scores over time. You can see on the X-axis is time. So one data point was admission to the rehab hospital. The second time point is discharge from the rehab hospital. And then after that at 30-day intervals, 30-day, 60-day, 90-day and 120-day, we took measures of their functional outcome. On the Y-axis is the ANPAC score. So the higher the score, the better the function. We see the two different lines here. So for both lines, the top line represents the Stroke Recovery Program participants. That was the group that had that comprehensive program where they saw the physician, they had the cardiovascular group, they had the neurorehab. And then the bottom line is the control group. That's the group that was discharged to home. They had the standard of care. As we can see for both lines from admission to discharge, they look about the same, which makes sense. They were in the inpatient rehab hospital at that point. And then at that 30-day time point around when they were discharged from the hospital, that's when the lines diverge. Then we see that the Stroke Recovery Program participants were able to achieve a higher level of function compared to the non-participants. We found that this was statistically and clinically significant. So it was the difference between the Stroke Recovery Program participants who were able to have a level of comfort with their basic mobility in the community with a lower level of device, if they required a device at all, compared to the control group, which most of them still required a device and maybe even some assistance in the community. We took a look then at the daily activity scores. The same trend followed in the respect that from admission into discharge, both groups performed about the same. By that 120-day time point, and that was when that cardiovascular group ended, remember we needed about 36 sessions. So that took them about three months to get through. And the participant group, the one that had that particular program, were able to perform better compared to the non-participants. And this is a measure of their self-care scores. And then lastly, the applied cognitive scores where we see the same trend, again statistically and clinically significant, where the participant group was able to perform more independently compared to the non-participants. »» So this was really exciting to us because not only were we seeing their exercise capacity improve, but their functional capacity was improving because we were essentially training them as athletes. We were kind of putting them on, working with them day by day, going over that three to four month period. And they really took the program seriously and we continued to see these improvements. So then we wanted to look at how it impacted mortality. So regarding the mortality outcomes for the match pairs, when we compare the two groups, if you look at the pie graph off to the right on the top, that was the non-participant group. And in the group we examined, there were 10 deaths or about 15.2% deaths for one-year all-cause mortality. When we looked at the Stroke Recovery Participant Group, the group that we had put through the 36 training sessions including the Comprehensive Program, we only had one death, or about 1.3 percent death. So after fitting a Cox Proportional Hazard Model, the results of this model suggest that the non-participant group have a 9.09 times higher hazard of mortality than the Stroke Recovery Participants. So regarding the feasibility study, in 2011 the Journal of Stroke put out an article showing what the all-cause mortality for stroke patients was in the United States. And that stands at about 31%. And when we look at the all-cause mortality for our Stroke Recovery Participants in the feasibility study, in all of the individuals that have done the program, we saw that being 1.47%. So we went on to publish this in the American Journal of Physical Medicine and Rehabilitation. The paper was entitled Impact of a Stroke Recovery Program, Integrating Modified Cardiac Rehab on All-Cause Mortality, Cardiovascular Performance, and Functional Performance. And the conclusion was that stroke survivors receiving an SRP program or stroke recovery program integrating modified cardiac rehab may potentially benefit from reductions in all-cause mortality and improvements in cardiovascular performance and function. And for this paper, we were awarded the Excellence in Research Writing Award, which was awarded annually for the paper that was most impactful for the year for this journal. And after the paper came out and we continued our research, this got Medicare's attention. And Medicare asked for Dr. Fleming and I to come down and present this project to them. »» So as Dr. Cucurula mentioned, here we are in our journey. We're literally there in front of Medicare and their representatives at the CMMI. And they were surprisingly very, very supportive and really excited about the fact that we not only had this idea, but it made sense. And we could use a model that we already know works so well in cardiac rehab, just extend it to a new treatment group, a new group, which again may have some of the same physiology behind why their disorder is happening. So from that particular meeting, they gave us some homework. They said we love your idea, but we want you to take it a step further. Number one, can you prove that the stroke recovery program saves money? Number two, can you statistically validate your previous improvement in mortality or get more patients and let's see if this trend holds? And then number three, can you replicate this idea at other institutions nationally? So Dr. Cucurula and I, we packed our bags and said we'll take this challenge on. So the first one, can we prove that it saves money? This is one of the reasons why they were really interested in this. The cost for stroke care is expected to soar. We're anticipating over $240 billion will be invested in post-stroke care by the year 2030. And that was a conservative estimate and that was several years ago. If you take a look at both indirect and direct costs, those costs are actually even more than that right now. So we proposed what would happen, imagine a world where we change the healthcare delivery model so that patients who went from the acute care hospital, we know that they benefit from the inpatient rehab hospital. And then after that, instead of being discharged into the community, everyone was expected to have a specific stroke recovery program. Again, this protected program where they could have not only the neuro rehab and access to care, but also this extra cardiovascular component as well. So we redesigned our next particular study. We took a look at that same group that we had, the participants and the non-participants, that we had already shown improvements in cardiovascular function and improvements in general function. And we wanted to take a look at, okay, what metric can we use which will reflect the cost? What is the cost of care for this particular person? And we took a look at their readmissions to hospital. We know that readmissions cost X number of dollars. So let's take a look and see if there's a difference between the groups for that. So again, the groups were matched based on gender, race, type of stroke, and their functional scores and their medical complexity. Again, we had a matched group. So we wanted to compare apples to apples. We wanted to make sure that both groups looked the same at baseline. And then we would take a look at their trajectory and take a look at their cost or the cost that they had based on readmissions. So in taking on this challenge, which was very interesting because when we went and presented all of this, as many of you can imagine, what they had said to us is, all the clinical outcomes are great, but you really need to show us how it's going to save us money for all the things Dr. Fleming just discussed. So when we did compare the non-participant group to the stroke recovery participant group, we saw that the stroke recovery participant group, the people that did that comprehensive program had a 22% lower risk of all-cause readmission as compared to the matched non-participant group. So if we compare, and this slide kind of looks at all strokes, the 795,000 strokes that happen per year. If we compare all annual stroke admissions between conventional standard of care readmissions and the patients that participated in the stroke recovery program and their admissions, we can see that, as I said, about 795,000 strokes happen a year. And the column to the left kind of shows what the cost is to Medicare with about 55.6% readmissions. And each readmission is costing about $4,000. The average, from looking at the economic medical literature, an average cost of readmission is $14,400. And if we look at that, if we look at what it would cost Medicare, right now the average readmission rate is about, the cost to Medicare is about $9.67 billion annually for readmissions. When we look at what the Stroke Recovery Program did was reduce that 22%. So if we applied this to all stroke admissions and we reduced the readmission rate from 55.6%, which is the, again, annual all-cause readmission rate, we reduce that by 22%, that would bring the cost of readmissions annually down to about $8.55 billion, which would save Medicare, based solely on readmissions, not looking at improved function, not looking at long-term care, all these other issues that link with costs to Medicare, purely on readmissions. If every stroke did this program, it would be a cost savings of about $1.12 billion annually to Medicare. Now we know full well that not every stroke is going to be able to do this program. There are strokes at the more disabled categories and those that are minor that wouldn't participate. There's motivational factors. So we said let's just look at this slide, let's just look at the group that we did our research on, the group that came to inpatient rehab facilities. So about 22% of our patients, the patients nationally that have strokes will require an inpatient rehab facility stay. So looking at that, and looking at the, so reducing the number of actual patients down to just those that do inpatient rehab stays, and reducing that 22%, we found that looking just at that 22%, it would save Medicare an average cost of about $200 million annually by just looking at those people that went to inpatient rehab. Here's a slide on the cost comparison of what the program had cost us versus the conventional cost, you know, in efforts to, you know, look at what we can do as far as cost savings. Because what we realized after going for our first visit to Medicare, because we have since presented further results to them, that there's a good reason, they're cost conscious and there's a good reason for all the reasons that Dr. Fleming elaborated on before. So we went on to publish this paper in the American Journal of Physical Medicine and Rehab. It was called An Impact of a Modified Cardiac Rehabilitation Within a Stroke Recovery Program on All Cause Hospital Readmissions, with the conclusion being that acute care hospital readmissions were reduced by 22% in stroke survivors who participated in the stroke recovery program. So not only in terms of readmissions was the program beneficial, there's other cost savings that are embedded within implementing a program similar to this. In terms of long-term care costs, patients with stroke are the largest patient population receiving long-term care. And the number is increasing worldwide. Medicare's cost averages about $33,000 for patients discharged to a nursing home and only about $13,000 for those who cared for it at home, even if they require the assistance of a home health aide. And about one-fourth of Medicare beneficiaries discharged from the hospital to a skilled nursing facility were readmitted back to the hospital within 30 days. And that costed Medicare over $4.3 billion, and that was back in 2006. It's even more now. So in general, the improvement in the functional outcomes from patients within the stroke recovery program would reduce utilization of Medicare dollars through readmissions to nursing homes, clinical readmissions, and overall far less healthcare utilization of resources. So not only from the readmission standpoint, there's other benefits from having patients function better that are beyond just the clinical outcomes, but also financially as well. So the second question was, CMS asked us, can we statistically validate our previous improvement in mortality? So again, we took a look at our particular research. We collected more information for more patients. We had a larger sample size. And we showed that this demographic table showed, again, we wanted to compare apples and apples. We matched based on our matching criteria. And then Dr. Cucarillo will tell you the results. »» So by bringing this program to its full power and moving from the 136 group that we looked at before, and the 76 matched pairs, we moved it up to its full power and brought it to the 246 matched pairs. With doing that, when we looked at our one-year all-cause mortality, and you can see the green being the stroke recovery participant group, and the red being the non-participant group, we found that the estimated reduction in one-year all-cause mortality by staying connected to these patients, by putting them through the program, was reduced to 76.5%. So when we then looked at what Dr. Fleming reported on for the initial paper, when we looked at it for the entire group, we looked at their AMPAC scores, which followed these patients through the program. We see a very similar trend. We see for the basic mobility score, we see a difference of 10 points. And just to give you an example of what that means, the group with the dotted line again is the non-participant group at 52. Their average basic mobility score was 52. The group with the solid line above is at 62. So that basically differentiated a household ambulator versus a community ambulator for the people that went through those 36 sessions. Daily activity, again we saw a 9-point difference in the stroke recovery, the people that did the stroke recovery program, which again is the solid line. And the dotted line is the non-participants. We saw a 9-point difference in their self-care scores. With regard to applied cognitive and speech, we also saw a difference. Not as substantial, but as all of you in this room know that speech and cognition can take longer to continue to recover throughout the year. So we did see, we saw a difference here of about 7 points between the non-participants which are the dotted line and the stroke recovery participants. With regard to their exercise capacity and their cardiac status, when we put these patients through and we brought the paper to its full power, we found that the average improvement in exercise capacity was 78%. So we went on to publish this in the Journal of Stroke and Cerebrovascular Disease. The article is entitled, Stroke Recovery Program with Modified Cardiac Rehab, Improving Mortality Function and Cardiovascular Performance. And we found that our conclusion was that stroke survivors who participated in this comprehensive program which incorporated this Modified Interval Cardiovascular Conditioning Program had a four-fold reduction in one-year post-stroke mortality rate, as well as improved overall function and improved cardiovascular performance. »» All right. So we all know that healthcare is complex. That's an understatement. And we know that post-stroke care is also very complex. So for example, there's certain common themes that come up in the 30-day appointment, again, after an IRF discharge that are different than what come up at that 90-day or that 120-day appointment. So for example, at that 30-day appointment, oftentimes I'll have patients that say, Dr. Fleming, I have two envelopes, one from the acute care hospital, one from the IRF. They both have papers in it. I don't know what to do with it. Or I'll have patients that say, oh, yeah, you know, I stopped my Coumadin because they gave me a 30-day supply. They gave me a month's supply. I didn't know I had to keep taking it. And so, or another good one that happens is that the IRF discharged them home on a certain group of medications, but then by the time they went to their pharmacy, their pharmacy told them that it wasn't covered and that now they weren't sure what to do. Sometimes their primary care doctor was able to intervene, other times not. So there's a myriad of different things that can happen. Compared to that 90-day appointment, oftentimes many of the conversations are, ooh, Dr. Fleming, I thought I would have been better by now. I thought I would have been able to go back to work by now. My short-term disability is running out for my job. What do I do? You know, my spouse, the relationship with my significant other is now changing because they've had to help me toilet. They've had to care for me. They've had to change their life to take me back and forth to all these appointments. So we know that stroke care is going to be different for every person and that their journey is going to be different. And having these particular rehab physiatry appointments to manage, really, the whole outpatient world for them is very important and it's kind of life-changing for them. So as Dr. Cuccarullo and I are talking about this particular program, it's interesting that depending on the audience, their response or their comments back to us change. So for example, the patients say, thank God there's a program like this. We can't imagine a world where people are just discharged and they don't have someone like this to come back to. The family members and caregivers say, thank God that someone is there to help me manage this because these are all whole new words. I don't even know the words that you medical people are saying. Thank God there's someone I can go back to and ask these questions and guide. What is spasticity? What is neuropathic pain? Can you help diagnose my new post-stroke shoulder pain? When we talk to internal medicine doctors, their response is, thank God there is someone to help manage all these complex rehab needs because we don't have the time for it. We're managing their blood pressure, their blood sugar, their diabetes. We have 3.4 minutes to get whatever they need, renew their medications, and send them out the door. We don't even know what to do for spasticity. And when we talk to the neurologist, they say, thank God you guys are here because we want to be in the angiosweep pulling out the COTS. We want to do the TPA. We want to be doing that level of the assessment. And they recognize that many of these stroke algorithms, they're very hyper-focused on every single minute along the algorithm. It's door-to-needle time, door-to-cat scan time. Everything is micromanaged. And then the last part of their algorithm is discharge to rehab. We also know that when we speak to the cardiologists about this, they say, well, we've known this for a while. We've proved this years ago. That's how we got cardiac rehab funded. It's great that now rehab is stepping into the gap and gathering the data to prove these outcomes. What's interesting is that when we have these conversations with health care administrators, with CEOs, with CFOs of the hospital, their question is always, how is this going to save us money? Very similar to what Medicare had mentioned. In fact, when we presented some of our mortality data to Medicare, they said, that's great and all that you guys are saving lives, but actually the patients cost us less money when they die. So again, who's going to pay for this? That ends up being the underlying question. So we realized that having some of these conversations, more of these business-related conversations, which is different for us as physiatrists, we're trained to look at the clinical aspect of it. And we're not yet as astute as we need to be in looking at the business, at the health care economics of what this is going to mean, especially as health care is changing now. We're talking about value-based care, alternate payment models. How is it that we're going to show that we provide value? We know that what we do is important, but how do you show it? How do you use the language? How do you use the data-driven metrics to prove that to the medical directors, to the CEOs, to the CFOs, to the network, your value? So this particular value-based equation is a very basic level understanding that all of us can use, regardless of what setting you're in, to help to give some language to proving that value. So the equation is value equals quality over cost. And another way to measure quality, one of the other ways to measure quality, is to take a look at your actual outcomes. So again, if we take a look at outcomes and costs, we can equate that back to value. So what we did with our program for quality, again, we're improving cardiovascular capacity. Patients are moving around better. We're improving mobility, self-care, and cognitive function. By more than one functional level, patients are moving better. Patients are functioning better, as well as lower mortality rates. Three examples of improving quality. And then we're also reducing costs. So when you reduce hospital readmissions by 22%, that alone gets their attention. And then you're also reducing the health care burden by improving overall patient function. So as we took a look at this, not only from the organization or the network standpoint, and again, if you get into population health, now you start to get the interest of those health care administrators who are saying, wait a minute, as opposed to discharging the patient and maybe they leave our network, or maybe they flounder around, or they're getting readmitted to the hospital, what if we actually invested in a program like this that took better care of them, that have the patient engagement so they're interacting with the health care network more, and it's saving costs? Now that's a definitive value. That's data-driven value that we can all take home to our respective organizations and really put into practice. So again, increasing that quality and decreasing that cost helps to create particular value. And again, our overall goal is quality of care, of course. But as we think about this more strategically, especially as rehab, this is a space that we can step into. And regardless of whether you do stroke or spinal cord injury or musculoskeletal medicine, if we take this basic equation and start to create the language and start to actually prove it, this is something definitive that we can take back to our organizations and again prove some of that value that physiatry adds. »» So we'd like to talk to you a little bit about our ongoing advocacy efforts and the next steps we have planned. So as you've already heard, the homework that was given to us by Medicare, we answered question 1 and 2. But then they asked us, can we replicate the Stroke Recovery Program results at other institutions nationally? Is this something that's going to be able to be replicated at other programs, much like cardiac rehab is replicated? So they also talked to us a little bit about, it would be smarter for you as a representative of the stroke patients to potentially have strokes added to the existing full comprehensive cardiac rehab program. That would allow us to implement it more effectively now, rather than you starting a whole new set of policies that would be specifically for stroke. So keeping that in mind, as a research project, we wanted to look at that because we don't want to wait 10 to 20 years for strokes to benefit from this. So the question was, can you replicate the stroke recovery results at other institutions nationally? So we are currently embarking on a randomized control clinical trial at multiple centers nationally, which will be implementing cardiac rehab for stroke patients. So basically replicating, very similar to this program, but putting them as an additional diagnostic category in cardiac rehab. So we can prove to Medicare that the diagnosis of stroke should be added to the approved CMS diagnostic groups. So as we discussed before, these are the approved diagnostic group categories that existed before 2014. And cardiology did a lot of background research. They proved that all of these diagnostic categories would benefit from a full comprehensive program. And it was in February of 2014 that stable chronic heart failure was added to the diagnostic approved list. And this was due to the data-driven approach showing that cardiac rehab will improve the lives of patients with chronic heart failure via the chronic heart failure action trials. So this research in 2014 was done actually a little bit before 2000. It was actually done in 2009. By this data being generated, chronic heart failure was added. And one of the challenges we had with talking with the cardiologists at the Cardiovascular Institute was they said, come on, you guys got to generate this data because the stroke patients deserve this program and we want to help you get there. So in working with them, this is why we've been on this mission since 2015 to make this happen. So just to review, we had the approvals by CMS and the funding for CMS to support a cardiac rehab program for cardiac patients up until 2014 was for general cardiac issues that we described plus the chronic heart failure. Then there was research done on peripheral vascular disease. And CMS coverage was approved in 2017 for peripheral vascular disease. Again all the same vascular system. So we're targeting for this course study or the cardiac rehab of stroke survivors, we're targeting for strokes with cerebral vascular disease to be added to this category, again in a modified way, much the way we've done throughout this research. And to collect the data, get data acquisition that will continue to move Medicare to adding strokes to this list of compliant diagnostic categories that would be funded. So JFK Johnson is partnering with Johns Hopkins, Mayo Clinic, Burke Rehab, and you can see Muliano Park up in the top right from Burke Rehab, Preeti Raghavan from Johns Hopkins who's the Director of Stroke there, and Carmen Terzic who's the Director of Cardiac Rehab at Mayo. We are working together to try to basically move this forward and have a multi-site center study that would again be able to address that third request made by Medicare so that we can gather the data and basically go back again to Medicare and prove that this will continue to benefit our stroke patients. »» So as you can tell, we're very passionate about this particular project. We've done a lot of work to take this from a place of concept to direct implementation in the clinic to collecting the data and actually doing the advocacy end. And I remember when we first had the idea of going to Medicare to show them our data, a lot of people said, well, you're doing what now? Wait a minute, you're really trying to change healthcare policy? And we said, yes, yes we are, yes we are. So we've been sharing our study and our information not only nationally but also internationally. We're invited to go to Japan at the ISPRM, the International Rehab Medicine Organization. And the topic was innovations of care in the rehabilitation of medically complex patients. So we know that more and more patients are being discharged from the acute care hospital, from the inpatient rehab hospital faster and faster. So it's up to us as rehab to help develop these outpatient programs that are going to be that safety net for them, that are going to help to allow them to continue on their rehabilitation journey. And no one's going to do it for us. And so if we don't do it, then they're going to be discharged and just out in the community. So I implore all of you to, again, go back to where your home institution is and start thinking about these things in a different way, because this is needed. This is where health care is going, and it's an opportunity for physiatry to really step in that gap and really be seen as the leader, not just by us saying rehab helps people, but again, from a very data-driven approach. We've also presented this at multiple different conferences. We got invited to the American Heart Association to present there, to the set of cardiologists. They were very excited about it. We've presented this at the International Stroke Conference. In fact, this upcoming International Stroke Conference, they have a whole carve-out for us to talk about this, and particular models of post-stroke care. We've presented this at AAP, ACRM, AMRPA. So again, we're getting the message out more and more that types of programs like this are needed, and we have a model that we know works. So not only do we think it works at JFK Johnson, the next level is, why can't we roll this out across the country and have this be our new standard of care post-stroke? So again, the overarching idea is that stroke survivors, they deserve better. No one's trying to game the system. No one's trying to get extra therapy that they don't really need. It's really up to us to step into that gap to help to not only manage, help patients manage from the clinical end, but also how do we help to change the mindset for healthcare? And again, the overall goal is that if we can have patients have access to this special carved-out program, they will live longer, live better, and be better for it. All right, so thank you for your attention. Thank you very much for being here. We know, you know, this is a journey. And we're really very grateful that you're here to hear about our journey. And one of the big things that we're focused on is not just gathering the data and just, you know, putting out papers. We really are trying to keep Medicare engaged in this for policy change. We really, that's the way the patients are going to benefit from it, is to get the policies changed to get our patients the funding they need to benefit from this program. And for our specialty, you know, stroke patients are the number one admissions into inpatient rehab facilities. So we are, we're the vehicle, like our specialty is the vehicle that I think we can get this done. And we really need people like yourselves that kind of seek out this type of information to help us move this at the national level for stroke patients. But we do greatly appreciate you being here and your interest in all the care you deliver to stroke patients at your facilities and at the national level. So we'd like to take any questions that you have. And I was asked to make sure that you guys, they're taping this session. So they're asking anyone with a question can come up to the microphone and we'd be happy to answer any questions. »» Hi. This is Shane Lee from Houston, Texas. First, a congratulation to all your important work and thank you very much to do the important work for our field. So as Dr. Kukuru mentioned, not all facilities can deliver cardiac rehab program for stroke patients. So for example, for stroke patients in a small town in Texas, they said, what if we request just 36 sessions of PT, OT and speech instead of cardiac rehab and can we get the same amount of outcome or improvement? In other words, the question would be, is this improvement because of a cardiac rehab program or because of additional 36 sessions? Thank you. »» So each patient's very different. They have different needs for their neural rehab. One thing we're clear in speaking to Medicare about and we're clear in the research we've done, that neural rehab needs to stay in place. And there is a dosing issue. Is it the 36 sessions? Is it, you know, if we continue to expand rehab, listen, that would be great. I would love to get the 36 sessions of neural rehab and the 36 sessions of cardiac rehab because we have found that this underlying cardiac disease is a major cause of the mortality of our patients. So I think ignoring that does the stroke patients a disservice. And I think we have to look at the, one thing our specialty does so well is look at the whole patient. We're not just, you know, if we take care of the hemiplegia, we work with them with hemiplegia, with the dysphagia, with the aphasia, that's great. But if they have a heart attack nine months into it, that's problematic. We want to get them holistically healthy. And their cardiac status is a major cause of death in stroke patients. So I don't disagree with you. I would love for both. I mean, maybe that's some research, that's something you can get spurred on is increasing the neural rehab. Because I don't know, I'm sure many people in this audience think about how it's very labor-intensive for our institutes doing rehab to have to constantly justify why you want to extend their outpatient therapies. And typically they have this Medicare therapy threshold and cap because they hope the doctors, the individuals, their family practice people, whoever is prescribing the therapies in the beginning, they're just a little overwhelmed and a little overworked. And when their sessions are over, they're over. And they don't really go back and do all the justification to try and extend them. And usually there's a gap between that extension of neural rehab. And one of the really cool things we're finding, we are starting every patient within 30 days plus or minus 15. We're taking advantage of the neuroplasticity of perfusing the brain with the cardiac rehab, doing that interval. We're seeing, we think that's part of, because if you look at the neurophysiology, exercise really induces neural regeneration. And there's a lot of neurophysiology behind that. But we think doing the neural rehab and the cardiac rehab is going to be tremendously beneficial to our patients. And I would love for them to say 36 or both. So that may be the next thing up on the docket. Yeah, I echo everything that Dr. Cucurula mentioned. And I just want to add, I love your question for so many different reasons, part of which because in this current health care climate, we're used to having to justify, we're used to having to say, OK, if this is the piece of the pie that's allowed, how do I make do with what's there? Our approach of using this very similar to what cardiac rehab already has established is that they get access to 36 sessions in addition to whatever their standard therapy is. So if they have an orthopedic condition, if they have a neurological condition, if they have a cardio, they have a pulmonary condition, they're able to get access to their basic therapy in addition to the 36 sessions. So if the cardiac patients are getting it, we're insisting that the neuro patients get that as well. So we don't really believe that you have to choose the either or. We want them to have access to both. Again, going back to that value equation, we want to change the paradigm from looking at, as opposed to a fee for service exchange, take a look at the overall patient and the overall outcome. How do we invest in them getting better, not only from a neuro rehab standpoint, but also from a vascular standpoint? And if you telescope out, if you look at it from a bird's eye view, that more comprehensive approach, if providing those 36 sessions prevents just one readmission, already there's a financial benefit. That's without looking at that one year, that's without looking at two years, five years, 10 year outcomes of all of the times that that patient will interface with the health care system. But because we changed that trajectory, we changed their path, we changed the degrees of their trajectory. Now it has an overall higher impact and higher, a better effect for their overall health outcomes. That's what we're arguing. So similar to what you had mentioned, there's definitely a role for neuro rehab. We are not at all suggesting that neuro rehab should be removed, but we're saying, how do we take a slightly different approach to health care, again, in this value-based care system that we are moving towards? How do we create these programs where everyone wins? Patient wins, caregivers win, clinicians win, health care system wins? We're trying to thread that needle and find that sweet spot. Hillary Stevens from California. I was involved years ago in writing the first post-stroke rehabilitation guidelines published by AHCPR, now AHRQ. It was published in 1995. So we looked at all the data and everything. All I can say is, hats off. This is monumental work and extremely difficult to do. And if the audience hasn't tried doing research, this is stellar work. Thank you so much. Oh, thank you. I was involved with research, randomized controlled trial of care management in outpatient Parkinson's disease. And self-management was a key element. Teach the patient how to teach the individual, they're really not patients, they're individuals with Parkinson's, or teach these individuals, they're human beings, they happen to have had a stroke, teach them self-management so they know how to take their medications, they remember it, et cetera. Do you think part of your outcome is that, in fact, these people did learn how to just better self-manage aspects of their health, question number one. Question number two, by coming in for these 36 sessions during an at-risk time of their health, they just had a recent stroke, do you think your teams picked up more on subtle medical symptoms that then could be acted on? So it wasn't just doing your exercise, but these other things, harder to measure, that was, in fact, also going on. Thank you. Do you follow the second question? Yes. And the first question, again, you wanted to, it's the educational piece. And changing their behavior, better self-management, et cetera. So the educational piece, one of the premises of cardiac rehab is that you just don't do the sessions for 36 sessions and stop. You are then transitioned into Phase 3. You transition into going to your fitness center, being taught what you need to do when you go there. And that's something we worked hard with this group to tell them, once you finish your 36 sessions here, you have to continue this cardiovascular interval training for the rest of your life to keep yourself healthy. And we, you know, there's a fitness center associated with our facility that we really encouraged them to do that. We also encouraged them with picture your plate with cardiac rehab, how to take care of their nutrition. Many of them had no idea that their diet made such a difference, that smoking made such a difference. Because now there's smoking sensation with cardiac rehab. Also alcohol, they didn't realize that excessive alcohol. So we did a lot of education, but that's part of the cardiac rehab program. And one of the things Dr. Fleming and I really worked with, especially after leaving the Medicare presentations, when they gave us that piece of advice is don't try to start building this thing from the ground up because it will be a very long time before. Try to work this into the existing system. By doing this multi-site center study we hope to gather the data and basically we've managed this program for this trial so that cardiac rehab programs nationwide will be able to implement. It's not going to be that every different facility has to think about really the big things they'll have to think about, which many of you in the audience probably have, having new steps in the cardiac rehab division. The new steps, the recumbent cross-training bikes, because from what you saw, the patients love them because with their good side they can do this interval cardiovascular conditioning. And it makes the difference. So the education is important and implementation is important. And maybe Dr. Fleming, you want to take the second question? »» Yes. So you bring up a good point in terms of the self-management and education. The reality is that what's happening now is the acute care hospital is checking the fact that they did risk factor education. The IRF is checking off the box risk factor education. And they're coming to outpatient and they're still confused. There's additional questions. There's additional things that happen in life. And so you're absolutely right. A program like this gives them time and space to ask those questions and then to make sure that they understand it. I ask open-ended questions to them. What type of diet is recommended after stroke? What is your physical activity? What are the recommendations? And have them say it back to me. That's different than checking a box saying that I gave them a sheet of paper that said these are the recommendations and the guidelines. And part of that is the benefit of cardiac rehab that's well known and well documented that having access to the cardiac rehab nurses and healthcare staff to guide you along that path. Many of us from medical school, we remember the multiple path system. You don't understand everything to the depth where you need to the first time. There's certain principles that you need to hear over and over and over again before it clicks to the level of integrating into your life. And we know for ourselves, lifestyle change is difficult. Behavior change is difficult. But as you mentioned, oftentimes after a life event is when someone is more open to make those changes. We definitely think that that time period is important for that reason. And we lean into that as opposed to leaning away from that. So that was the education point. The second question was the... Did you pick up medical symptoms? Yes. They would be active on sooner. Yes. So that early intervention for medical complications, again, is another well-known, very documented benefit of cardiac rehab. Dr. Cucurulo mentioned those patients that were on the exercise bike. They had cardiac clearance, but they were challenging their body to exercise almost like a mini stress test. And they had those cardiac symptoms, symptomatology. So we refer them back to their cardiologist. Their cardiologist did the next level cardiac workup, and they needed actual stents, cardiac stents. So that was another layer where they were able to intervene and then have a better health outcome. That's in addition to the physiatrist managing their spasticity, their neuropathic pain, the device needed to be modified, all those other things that can happen in the outpatient physiatry world. So again, it's really a comprehensive look at what patients will need, and it just provides a framework. It provides the infrastructure to us to do what we're already good at in taking care of patients from head to toe. So very good question. Thank you. »» Yeah. And just to that point, right now our stroke patients are going home. They're getting the neurorehab, which for some people unfortunately is only lasting about four weeks. And then they go home and many of them, their families as you well know will say they're still concerned about their balance, their functional deficits. And they'll encourage them to stay sedentary. The degree of sedentary behavior exhibited by stroke patients, because the families are really working out of fear. They're trying. They don't want the family member to fall and end up coming back to the hospital. That hurts stroke patients in such big ways. So we really do want to keep them in a program like this, because it will identify during this critical time, just as you said, any medical issues that come up that we can address. Because a 12-25% risk of having a stroke, once you have a stroke you have a 12-25% chance of having a second stroke in that same year is devastating. I mean, clinically I'm a consult attending. And it would kill me to have somebody come, you know, go to inpatient rehab, go to outpatient and then six months later, you know, you're hoping they're home doing great. They're back on the stroke unit with their second stroke. Because you ask them what they did when they went home. And my family really wanted me to lay low because they were worried about me. Now I have a second stroke, which is usually more devastating than the first. So we need to move in and we need to make this, you know, really get our stroke patients in a better place. And it's wonderful to hear that you had started this back in 1995. So that's good to hear. So congratulations to you. Issa, do you have a question? »» I was going to say, I think the presenters for the next session are here. So I just wanted to be sensitive to their time. We'll be down here if anyone else had additional questions. But thank you everyone for coming. Thank you. »» Thank you.

comprehensive post-stroke care

Stroke Recovery Program

SRP

stroke

cardiac disease

modified cardiac rehabilitation program

function

mortality

hospital readmission rates

healthcare-related costs

Medicare