Telemedicine and Parkinson disease: Improving Care and Clinical Research


Uploaded by GoogleTechTalks on 25.03.2010

Transcript:
>>
WILLIAMS: I'm Patrick Williams. I'm hosting this particular Tech talk and it's kind of
serendipitous. I've been helping externally with an integration with Google health. And
Ray and Kevin were introduced to the project because of a Parkinson project that they're
looking at and they want to come here and share some information about how Google can
help with telecommunication and telemedicine and specifically around the Parkinson disease
and some of the research that they're doing. So, without further delay...
>> DORSEY: Good morning, my name is Ray Dorsey. Kevin Biglan and I are both neurologists at
the University of Rochester and are very pleased to be here to share ideas with you. We thank
Patrick Williams very much for the kind invitation to speak with you today. We want to talk to
you about Parkinson's disease and how its simple web-based technologies can improve
care and the clinical research related to Parkinson's disease. And using Parkinson's
disease is just an example of a chronic condition and that how this model can be applied to
other conditions as well. So this morning, we'd like to talk to you first about Parkinson's
disease as a chronic condition whose burden is growing both in the United States and globally.
Second, how telemedicine, using simple web-based video conferencing, can extend the reach of
care. Third, how telemedicine can also improve the conduct of research, and then discuss
with you some next steps and future directions. So first, a Parkinson's disease is a chronic
condition that is readily treatable. It's defined clinically by observation by the presence
of having two symptoms; an asymmetric rest tremor, slowness in movement, rigidity or
difficulty of walking. But we still don't know what the cause is as of 2010. About 10
percent of the cases we think are due to genetic mutations. The balance that they cause, we
think, are due to environmental exposures and the pathological hallmark is loss of nerve
cells in the brain that produce a chemical called, dopamine. The treatment is quite effective,
especially early in the course of the disease and was developed about 50 years ago, and
it consists of replacing that dopamine that is lost in the brain. Surgery is another treatment
that's been more recently developed as an option for--in some individuals. Parkinson's
disease, unlike other chronic conditions, often defines an individual. People have a
tremor, they have difficulty walking. And so, they're rarely identified as abnormal
or that something is wrong them. And that affects them, it affects their caregivers,
it affects their social interactions with everyone, and it's a difficult burden to bear
for individuals. People bear this burden for a very long time. People live for, on average,
about 14 years of their life and maybe a fifth of their life with Parkinson's disease and
40% of these individuals will require nursing home care at some point in time. So, this
is what Parkinson's disease looks like. >> Watching golf on T.V.
>> All right, the Master starts today. Do you watch that?
>> DORSEY: This is just a video clip showing a--some of the hallmarks. One is you can see
that his right hand has a little bit of tremor. >> Keep your arms out there for me. Just go
back and forth like this one and be as fast as you can.
>> DORSEY: You can see there's some slowness in movement especially with his right hand
compared to his left, and again, the tremor. >> Open and close your hands for me. Open
and close. >> DORSEY: You can see that his face doesn't--has
much less expression than normal. >> Take your right hand and touch your fingers
with [INDISTINCT] as fast as you can. Just these two. There you go. And the left hand,
[INDISTINCT] as fast as you can. Now, put your arms across your shoulders and stand
straight up for me. Perfect. >> DORSEY: Can you see that when he walks,
his right arm barely moves. >> Turn around.
>> DORSEY: He takes short strides, he's got a stooped posture, and he's got a tremor.
So these are all the clinical hallmarks of Parkinson disease. The challenge is that due
to aging demographics both in the United States and globally, the burden of a Parkinson's
disease is going to grow substantially. So between 2005 and 2030, doing some work that
we did, countries that are going to experience the 0% to 50% growth in number of individuals
with Parkinson's disease or some countries in Western Europe and Japan, the number of
individuals who are going to--with Parkinson's disease is going to go between 50% to 100%
by 2030, including the United States, Russia. A number of people with Parkinson's disease
will increase by 80% in the United States and there will be more than a doubling of
a number of individuals with Parkinson's disease in many of the developing economies of the
world, including China and India. Looked at a different way, in 2005, we estimated the
world's most populous countries conservatively there's about 4 million individuals with Parkinson
disease. By 2030, this number will more than double to over 8 million individuals and more
than half of these individuals with Parkinson disease and the world's most populous countries
will be Chinese. So this is not a United States problem. This is a national problem. This
is a global problem. The challenge is even greater because in the vast majority of these
countries, individuals with Parkinson disease have never sought treatment for their condition
and have never see a treatment; and this is despite the fact that treat--Parkinson's disease
is readily treatable with medications that decrease the risk of death and that these
medications are quite affordable and inexpensive. So what can we do? We know that improved access
to specialists who care for Parkinson's disease or for any chronic condition improves care
and outcomes, so that if you have increased access to specialists, you get higher quality
of patient care and that leads to improved outcomes and quality of life. This is true
for heart disease, where you have more appropriate medication use and increase survival. For
asthma, we have a greater adherence to medical guidelines and improved quality of life, and
for diabetes we have better process measures and fewer complications. The same holds true
for Parkinson's disease. A research that we did among the 350 individuals across the United
States with Parkinson's disease found out that individuals who see a Parkinson's disease
specialist are three times more likely to be satisfied with their care than individuals
who see a general neurologist. And this increase satisfaction was across every domain of care
of Parkinson's disease measurement including information received about Parkinson disease
and time spent with the physician, the information about complementary medic--the complementary
therapist for Parkinson disease. The challenge is that even in the United States, access
to specialist is very limited. So, this is a-- we live in Rochester, New York near Syracuse
and this area is the Finger Lakes region; this is about 150 miles in diameter. And in
this area there are over 30 nursing homes and there are only six neurologists and not
a single Parkinson's disease specialist. So even in the United States, you know, if you're
on Gilroy or if you're in, you know, Riverside and you have Parkinson's disease, you're ability
to access care is greatly limited. So how can we extend the reach of care and we think
you can do this--with just simple web-based video conferencing. So three years ago, a
nursing home in New Hartford, New York, population 20,000, has 250 residents. Their administrator
estimated that 20% of their residents had some form of Parkinson's disease and said,
"W have no Parkinson's disease specialist. We have no neurologists who are seeing these
patients. We're just seeing a general internist who's coming and seeing these patients. Can
you, in Rochester, provide care to our residents in New Hartford?" So, we said, "Yes". And
what we used to do that was very simple technology. There's a laptop computer with a broadband
connection, a webcam, a microphone, some software from Polycom, encrypted software for security
purposes, and that was it. The total cost of the entire set-up, beyond laptop computer,
and broadband connection was $200, and they had a very similar set-up on their end.
>> I'll just add that it's a laptop that we're not currently using. This is an outdated laptop
and the driver is [INDISTINCT]. >> DORSEY: So this is in contrast to other
telemedicine applications which are, you know, are extremely costly, capital-intensive; this
is not. So this is the first individual that Dr. Kevin Biglan saw about three years ago.
He's an individual who's actually used to get his care at Rochester, New York, but since
going to the nursing home, he was no longer able to access care. And we were called by
the nursing home because this individual is having behavior disturbances. He's trying
to climb out of the window at the nursing home. He was having trouble thinking. He was--his
score on their standard cognitive measure was 21 out of 30. He was on a medication for
tremors that makes thinking worse, and he was on a drug called Aricept, which is used
to improve cognition. So he's on a medicine that worsens his cognition and a medicine
to help his cognition. Kevin saw him, and after a series of about two or three visits,
he changed his medications, his behavioral disturbances went away, his cognitive--he
took all--both the medications for one in worsening cognition and one in helping cognition.
His score in the cognitive exam went to 30 out of 30, his behavioral problems resolved
and he became the one of the most popular residents in the nursing home. So, based on
this pilot experience, we as researchers, we said, "Let's conduct a randomized controlled
clinical trial to see whether improving access via simple web-based video conferencing can
make a difference in the lives of people with Parkinson disease. So we took four residents
who have Parkinson disease in this nursing home and assigned them to receive three visits
with us via, again, simple web-based video conferencing over six months. And then we
take 10 individuals who reside in the community, those individuals who, you know, go to the
grocery store, live independently, they have Parkinson disease, and we randomized them.
Half were randomized to receive the usual care for six months, whatever care they have
been receiving and half were randomized to receive visits with us via telemedicine for
six months. Primary outcome that we looked at was feasibility, and we found that 29 of
the 30 telemedicine visits were completed as scheduled. The one that wasn't was delayed
for two weeks because the patient was sick. We found out that our assessments that we
do, a standard exam that we do for Parkinson's disease was valid and reliable when conducted
over a web-based video conferencing compared to in person, so that there were--the quality
of the examination with the two minor exceptions, was--are just as good done remotely as in
person. And we looked at other secondary outcome measures. So, what does a telemedicine visit
look like? I'm going to show you, first, a clip of an individual who resides in the nursing
home at the beginning of the study and then we saw him three more times, then we'll show
you what he looked like at the end of the study and you can see if you can see any differences.
Good and the other hand? So this is me, in Rochester, New York and this is him in New
Hartford, New York. I'm just in a little conference room and he's in a conference room there. And your left hand?
And your left hand. And then the left foot. DORSEY: So, he can't get out of the wheelchair.
Good that's not too bad, good, good. This is six months later after we've adjusted his
medicines. Do the right hand again, please. >> Right hand?
>> DORSEY: Pretty good. How about the left side? Good. And the left hand? Good. And the
left foot? So you can see his slowness of movement has improved. Good. Pretty good.
>> Here we go. >> DORSEY: Okay. Yeah, it's enough.
>> I got him >> All right, good that's it.
>> DORSEY: So, after many times--in beginning he couldn't get at the wheel chair by himself,
he couldn't walk. And in the visit, just three months later--six months later after three
visits, he can get out of the wheel chair, he can take a few steps by himself, you know,
he can go to the bathroom, for example, by himself. He's clearly not normal, but that
clearly improved just over six months. So, what does the data show? Well, the data showed
that increasing access to specialty care improved quality of life and patient satisfaction.
So this is a scale of called the Parkinson's disease questionnaire 39. This is a standard
scale for measuring quality of life of individuals. It's just a survey instrument that's used
in a wide-range of clinical trials for Parkinson's disease. Those individuals who received telemedicine
had improvement in their quality of life. Those who received their usual care had significant
worsening. And we measure the patient satisfaction. Those who received telemedicine had significant
improvement in patient satisfaction compared to those who did usual care. Of no difference
in quality of life, if a drug did this, it would be considered the second most powerful
drug used for Parkinson's disease and this is greater change in quality of life than
even seen for surgery. Granted, this is a very small study. And then that motor function,
individuals with Parkinson disease saw no progression of their disease over the six
months, whereas those who had usual care had significant worsening of their disease over
six months. So, we were impressed; we were satisfied, but what really got us was the
feedback we received from patients. And this is one individual who we said we're going
to do a six-month study, and at the end of six months we weren't sure what was going
to happen because we didn't know if we were going to receive funding to continue the study.
>> Do you have any questions? >> After the [INDISTINCT] and this program
has started, I am no longer connected to you. >> Would you like--would you like to stay
connected? >> Yes. I would very much.
>> Well, the [INDISTINCT] home has been very generous in working with us to continue this
for another year at least. >> Okay.
>> Is that good? >> That's wonderful.
>> It brought her to tears. >> It has made such a difference.
>> Can you tell me a little bit what made it valuable for you?
>> Oh, gosh. I truly feel, personally, that I've got the type of attention that I needed
was not accessible to me because the area where I live, because of my Parkinson's condition.
>> DORSEY: So she basically said [INDISTINCT] as the value of proposition that we're providing.
We're able to provide care to individuals with Parkinson's disease anywhere that they
live. So no longer is a person's access to care determined by where they live, but now
that they can be free to live where they'd like to live and still receive the care that
they need. Unless you think it's anything that I had to do with it, this is a patient
of Dr. Biglan's and the feedback that she gave him. These are both individuals who reside
in the community with Parkinson disease. >> Okay, now, I'm getting very disappointed
that this is our last time that I will see you probably. I don't know if there's a [INDISTINCT].
You've been such a difference in my life. I mean [INDISTINCT] in the next few years.
This is done. It's phenomenal. >> And now, I think we've got to get particulars
about it, but I think our plan is to continue doing telemedicine for another year. So...
>> So it's sort of hold on that thought and see what happens?
>> Yeah, I guess. >> Oh, this is a gift. Oh, my God. God has
[INDISTINCT]. I can't believe this. Oh, wow. >> DORSEY: So, most of our patients don't
do that to us. So based on that feedback, we've been doing this now for three years
with these individuals; they all continue to do exceptionally well, and we're looking
to expand the model. So, this is, again, Rochester, New York--no, Toronto. And this area--yeah,
we live here in Rochester, New York with a Parkinson disease specialist. In this area,
there are 57 nursing homes; 5 neurologists, and no Parkinson disease specialist outside
of Rochester. So if you have, you know, a Parkinson disease or Alzheimer's disease or
any chronic condition, your care is just from a generalist, whoever comes into the nursing
home. And so we can do better. Can we provide care to the individuals in these different
nursing homes who have Parkinson disease? As we were planning to do later this month
actually is start a larger scale trial, just like we did with the first nursing home but
in a--with 50 patients in 5 different nursing homes. This is, you know, we're Parkinson
disease specialist, but this same model can be applied to any, virtually any chronic condition.
So here in 2010, there are 140 million Americans with at least one chronic condition. By 2030,
this will increase to half the U.S. population to have at least one chronic condition. 80
percent of these individuals live at home, and these individuals account for 75 percent
of healthcare expenditures in the United States. So how can we provide care to these individuals
regardless of where they live? And there's one thing, if you live, you know, in Mountain
View, you can go to Stanford. Even that can be difficult for individuals who have limited
mobility. Is there a way we can provide patient-centered care to individuals regardless of their location?
And what we want to do next is to provide the same model that we're providing into nursing
homes but provide that care directly into individual's homes. So providing a virtual
house call; and this virtual house call can be done with widely available--just simple
web-based video conferencing. I mean, most people in here probably use Skype. So, you
could practically use just Skype with some encryption to provide the care with--to households
that have computers and broadband access. But the real thing, the real value could be
greatly enhanced through our applications of Google. So you could merge the virtual
house call and use Google voice and video chat and incorporate that with the Google
health record. You could video tape the encounters that you have with patients and store that
as part of their electronic and health record. That information can then be used to monitor
the disease progression for the physician to see if the individuals are doing well or
responding well to medications, to educate the patient about how the disease has been
changing, and for the patient to give you information that you wouldn't otherwise be
able to capture. You can use Google to create virtual disease specific communities, virtual
support groups to educate or to provide support to individuals with Parkinson's disease. It's
a relatively common neurological disease, but the vast majority of individuals feel
isolated because they don't have friends or colleagues or peers who had the same condition
that they have or going this through the same thing. And the same could be true as that
of the caregivers. And, you know, Google's obviously making some efforts into increasing
broadband access, and this could be another way to expand virtual house calls. Another
way, virtual house calls could be conducted via simple plug-in computer, which you just
plug-in to the walls the size of your fist and that marvelous developed thing that you
can link the TV and camera to reach additional households that don't have computers, for
example. And, again, they apply the same Google applications to enhance the experience beyond
what is currently available. A television; right now our televisions are used to distribute
entertainment, but health and medicine could actually be a much more valuable application
for a television than entertainment. And that, you know, Google TV could be used to provide
it. Finally, you could provide truly mobile medical care through applications from web-enabled
phones, in a Nexus One phone, you know, it's--I was just I'm looking with Patrick today, you
know, it's more powerful than a stethoscope and can be a very powerful medical tool for
emprac--increasing access to care. We think that the--that the model with telemedicine
can actually be better than current model of care. So most of the time, telemedicine
is viewed as some substitute for care for individuals who otherwise can't access them--access
it. But there are many ways in which telemedicine can be much greater than--much better than
the current model of care. So with current model of care is that you drive to Stanford
to see your neurology of Parkinson disease and you have a doctor to patient relationship;
and that's a very nice relationship. If you do virtual house calls, you can still have
that patient to doctor relationship. You can actually have a relationship between the patient,
the caregiver and the doctor. A classic story is mom has Parkinson's disease, she lives
in Mountain View and she goes to see her doctor. But her daughter who's increasingly becoming
involved in her care lives Iowa. Now, the current models that the person has to travel
from Iowa to Mountain View to go see a patient--to go see her mother, to go see the physician.
Now, it can be that these people be in different geographic locations and receive care. Many
patients with Parkinson disease could see one doctor, doctor to improve educational
session, or many doctors could see one patient. If you have Parkinson's disease and you're
having depression, you could see a neurologist and a psychiatrist, for example. The current
model of care is synchronous. The patient, the doctor must meet at the--exactly at the
same point for care to be provided. With virtual house calls, you could have synchronous visits,
or you could have asynchronous visits in which patients can provide data, "You know, doctor,
sometimes my arms moves like this," could video tape it, video clip it and send it to
the physician for the physician to interpret at his or her convenience. Similarly, the
physician could provide information to the patient that the patient could access or take
part in at his or her convenience. Currently, the patient or the--I mean, the physician,
the patient must be in the same place at the same time. Right now, you can free both the
patient and the doctor. Kevin and I are taking a red-eye back to Rochester, New York today
or tonight, principally, because we both have patients tomorrow to see in clinic. If we
could do web-based video conferencing, we won't have to take the red-eye. Three months
ago, I was able to see patients via telemedicine in our office in Rochester, and I was home
with my sick child. And I was--I was going to do everything from home except that I actually
had to find a babysitter to watch my kid for two hours so could drive to work to go see
the patients via my web-based video conferencing set up at work. If I did it at home, I wouldn't
have to go into work. I wouldn't have to find a babysitter for my son. I just could have
done it from home. Cost or substantial travel cost. If you think about the time and--that
you spend when you go to the physician--to see a physician for 15, 20 or 30 minutes,
you should probably spent four times that amount of time, at least, just to go see the
physician. Many of our patients travel over a hundred miles to come see us. They spend
more on transportation. They spend more on just transportation, gas, car and tolls than
they do on the visit themselves. Medicare pays a $70 for--see a patient and follow-up.
If someone's driving 100 miles round trip, 100 miles each way, that's--IRS would pay
you $100. They spend more for travel than they do for the actual visit. There's enormous
loss of labor productivity from both the patient who is maybe working or often from the caregiver.
These are extremely resource intense environments. Hospitals and physician clinics are very expensive
places to receive care. Virtual house calls, no travel cost, minimal loss of productivity,
low capital investment, $200, probably less; minimal overhead. Delivering care in people's
home is not a pipe dream, it's feasible. Right now, the number of individual's households
with high-speed internet access is at least 75 million. Just last week, the Federal Communications
Commission release its strategy to bring high-speed internet access to seven million U.S. homes
that lack it while making existing broadband connections that serve 100 million households
at least 10 times as fast. I'm now going to turn over at how telemedicine can not only
improve care but improve our cognitive research to Dr. Kevin Biglan.
>> BIGLAN: Good morning. Thanks again for inviting us. We really welcome the opportunity
to talk to you all about the work we've been doing in Parkinson's disease and using remote
technologies for both for clinical care and for the conduct of clinical research. And
so, I'm going to focus now on our vision for using remote technologies in clinical trials
and other clinical research endeavors. So, developing drugs is an extraordinarily expensive
proposition, and in this proposition has increased dramatically over time. And so, the average
cost for bringing a drug from pre-clinical trials to clinical development and FDA approval
is about $802 million, half of that cost arises from the time required to conduct the research.
The majority of that time is devoted to recruiting subjects or recruiting appropriate individuals
to participate in the clinical research, the clinical trials of specific drugs. In addition,
we have to enroll about 20% more people in clinical trials than we think we need to,
to answer the scientific question at hand, largely, because we anticipated that about
20% of individuals would drop out of studies. And so, there's a large inefficiency there
in that. If we can somehow enhance the time for recruiting individuals, maintaining individuals
in studies, then certainly we could reduce these costs dramatically. And to give you
an idea, about 5% of all health care expenditures where $60 billion is spent on clinical research
for new drugs. So, we--we are very passionate about the idea that we think that remote assessments
can really be valuable in this context. We think it would be dramatically reduce costs.
One of the other driving forces of a health--of cost for clinical trials is that the individuals
who are in studies have to be seen relatively frequently, sometimes as often as every four
weeks, sometimes more frequently than that in order to really assess safety of the study
and to do clinical assessments on those individuals. Clinical--remote assessments would allow us
to really only do those in person assessments that are critical for the safety and conduct
of the trial. Most of the other assessments could potentially be done remotely. And that
would be a huge cost savings because in terms of, you know--so we have to--you know, in
order to conduct this research, we have to pay those investigators who were doing the
in person assessments a certain amount of money, we often have to pay for travel for
individual subjects enrolled in studies; and you can imagine the cost there. The biggest--bigger
issue as I alluded to previously is that we would save time on recruiting individuals
and subjects into studies. We often account six months, year, sometimes two years to enroll
all the individuals in a study. A lot of people's reluctance to be involved in clinical research
has to do with time commitment. And so to the extent that we can redu--say that, you
know, "Look, we only need you to come in twice. All the other visits could be done remotely
in your home". We think we would enhance recruitment that way. Maybe a little bit more technical
is the issue of currently most studies, particularly in diseases like Parkinson's disease where
you really need to recruit large numbers of subjects to be able to answer the questions
that you want to answer, we have to have multiple centers both nationally often internationally
to enroll that number of subjects into our trials. So, you have a number of different
individuals, different locations throughout America, throughout the world who are evaluating
these individuals. And there's a lot of variability that's merely associated with that investigator
evaluating that subject. And you have to account for that variability in terms of your ability
to detect meaningful treatment effects. So if you could use a single individual to rate
all these indivi--rate all these subjects on your most important to clinical measures
that are going to be most useful for evaluating whether the treatment works or not, we think
it'll reduce the variability considerably. We know it'd reduce the variability considerably
and now that we're reducing number of participants you need to enroll in trial and therefore
reduce costs. Recruitment, I'm going to harp on this a lot. Well, you know, clinical trials
for participants are burden some. There's the travel burden. You're really limited to
individuals who are geographically close to the site in question that's conducting the
research. Individual with Parkinson's disease had marked mobility issues as you saw, and
so they really need--we need to facilitate that as much possible to the extent that we
can reduce the burden on individual participants, we think we can enhance recruitment. And also
more importantly potentially, allow these individuals to stay in the study--studies,
and then maybe we wouldn't have to recruit that additional 20% of individuals above and
beyond what we need to answer our scientific questions. I think I touched on this already
is the geographic scope. You know, you have to be geographically close to a--currently
to a site that's conducting the research to do it. That really excludes individuals who
are, you know, living very rural environments. We have a colleague who now lives in--who
works in the University of Utah in Salt Lake City. You know, he's catchment area in terms
of the individuals that he sees is probably five different states, all in the rocky mountain
area. We don't travel through that area, it's very challenging. Most of these individuals
are lucky if they can see a Parkinson's specialist once a year, if at all. And certainly they're
not going to be able to participate in clinical research trials where individuals have to
come in on a frequent basis to be evaluated. More importantly, potentially, is the ability
to expand the population pool to individuals who otherwise would not participate in research
at all. And so, these are individuals with--who are mobile, but also individuals living in
nursing homes. A lot of the unmet therapeutic needs, particularly in Parkinson's disease
relate to conditions like dementia, cognitive impairment, and psychosis, hallucinations.
The majority of those individuals with those problems actually reside in nursing homes
and are not participating in clinical research and clinical trials. So our ability to develop
drugs that address those really unmet therapeutic needs is limited. And we think--and we've
shown that certainly you can evaluate people in nursing homes with this technology and
that you can get the net that--it is almost as good or if not as good as in-person assessments.
And so we can really open up therapeutic research trials to a whole cohort of individuals who
would otherwise not be able to participate. Finally, we think, you know, remote assessments
may potentially be an improvement on the--our current model. Similar to our clinical care
where we think that evaluating people in their homes is more, maybe, better than actually
the in person assessments that we currently conduct. If you think about it, we currently
conduct an in person assessment, it's a snapshot in time with that individual; they're in an
unusual environment; they've maybe travel an hour to get there, which has an impact
on how they're functioning or how their symptoms are. And then we have to get a subjective
sense for how they're doing at that time point based on how they think they're doing, which
is often more a reflection of how they're doing right at that time and not a good reflection
of how they're doing over time. So, as Ray stated, you know, the ability to have asynchronous
evaluations where you record clinical information at different time points when they're occurring,
and then evaluate them at a later time point, maybe more meaningful in the sense that you're
seeing people in their home environments, you're seeing them at times you would otherwise
not be able to see them. Similarly, we can do the same thing in clinical research. You
know one of the important aspects of conducting therapeutic research in Parkinson's disease
and other chronic conditions is the ability to monitor safety very closely. Currently,
we rely--we put the burden on the participants to let us know if they have any safety concerns
or side effects that are potentially related to the experimental treatment in question.
And that's a big burden to put on an individual, particularly with a chronic condition. Oftentimes,
we don't find that about these things until months later when they come see us at--as
part of their research visit. And so the ability to really detect these safety concerns in
the individual's home, in real time, with as little participant burden as possible is
a very valuable proposition for clinic trials. In Parkinson's disease, we often ask individuals
to keep written logs at how they're functioning and to--in order to address the idea of--in
order to address whether or not the treatments are having any impact on a day to day basis
on their function. Very common for individuals to be sitting in the waiting room on the day
of their visit, filling out their written logs as should have been done throughout the
time period. And so, these, you know, it's amazing actually that we've seen treatment
effects on these subjective diaries that actually have led to FDA approved medications for Parkinson's
disease, but certainly, the implication there is that the treatment effects may actually
be greater than what we're seeing. And the ability to--with little participant burden,
evaluate these--some of these clinical outcomes in real time is very valuable. Finally, the
ability to take that data as soon as it occurs and uploaded directly into our analog database
allows us to monitor safety on an ongoing basis very easily and we think the quality
of data therefore would better. Again, about recruitment, there's been a lot of work on
trying to understand what are burdens of participation. In general, in Parkinson's disease, less than
5% of individuals with Parkinson's disease could participate in clinical research, similarly
true in other chronic neurodegenerative conditions most people do not participate in clinical
research. And the question obviously is what are the burdens on individuals that prevent
them from participating? And so, [INDISTINCT] did a study--a survey study largely where
he asked individuals with Alzheimer's disease, what is the--what are the things that prevent
you from participating in research? And the number one thing that was most important was
the travel burden associated with frequent visits. And they found that if you really
were--did home visits for individuals that you could enhance recruitment dramatically.
The other things were associated with risk, associated with the drug, and the chance of
receiving placebo. But above and beyond that, home visits--travel burden was the most important.
And so for very little cost, they could enhance recruitment into trials by just by participating
in home visits. And we think, "Why go out to the individual's home when you can assess
them remotely in their home at probably potentially for a much lower cost?" So now I want to talk
about a collaboration of this--I'll talk about study that I'm involved with that's funded
by the Michael J. Fox Foundation and specifically about a collaboration with Marvell and their
plug-in computer in order to enhance our ability to detect safe--important safety outcomes
in this trial. So, Isradipine is an antihypertensive drug; that means it lowers blood pressure.
That's its assault, that's its main goal. It is what we call a calcium channel blocker
type of drug. And it has shown a promise in Parkinson's disease. So it has showed promise
in Parkinson's disease, animal models that it may prevent or prevent Parkinson's disease
in those models. And then more importantly actually in a number of large epidemiologic
studies in individuals who are otherwise healthy, they looked at individuals over time in these
primarily European healthcare databases, where they really have almost complete capture of
all individuals within a community. And they looked and said, "Well, if you're taking certain
types of medications, what was your risk for Parkinson's disease 10 years down the line?"
And they found that calcium channel blockers, and specifically the type of calcium channel
blockers that is Isradipine represents, really lowered your risk for developing Parkinson's
disease; and other blood pressure medications had no such effect. So, there's a lot of good
evidence, you know, from previous data that suggests that Isradipine maybe a useful drug
to study the drug in Parkinson's disease; that it may prevent or slow the progression
of disease. So we talked about Isradipine lowers blood pressure, so it actually has
the potential for having a significant serious side effects. In addition, individuals with
Parkinson's disease are at very high risk for low blood pressure. In general, they tend
to be hypotensive; they tend to have low blood pressure; they tend to have difficulty regulating
their blood pressure. And so, one of the major concern in giving people with Parkinson's
disease who are prone to low blood pressure to begin with often have baseline low blood
pressure is--can we worsen that and cause serious complications. So our study is a phase
two; it's a safety and tolerability study trying to identify a dosage of Isradipine
that is both tolerated and shows preliminary evidence of efficacy in individual with Parkinson's
disease; it's a one-year study. And we thought that--so the current model is that individuals
as they slowly increase the dose of the drug are required to take their blood pressure
twice a day. The blood pressure--actually I'm going to move on to the next slide. The
blood pressure monitor--wrong one. What's that?
>> [INDISTINCT] >> BIGLAN: I got it. The blood pressure monitor
here is a digital monitor; it has some memory capabilities to be able to store the blood
pressure recordings. And so it does store those blood pressure recordings. In addition--in
that--those blood pressure monitors are brought in about every two weeks or so to the research
site, it's uploaded to the database about every two weeks. In addition, we need to know
at the time of the in person research visit, whether a person is tolerating the drug so
that we can increase to the next dosage; to the higher dosage. And so what--the way that
we've approached that is a very inefficient way, we've asked individuals to actually keep
a written log of their blood pressure recordings. So you think about it; we're asking them to
take their blood pressure twice a day. We're then asking them to--also in addition to taking
it, keep a written log of that blood pressure recording, and then every two weeks they bring
that information in. And so we're really missing valuable time in terms of addressing any potential
complications of drug. We're putting again the burden on participants to record their
blood pressure and also to notify us if there's--they think there's a problem associated with their
blood pressure recordings. And so, this is actually a relatively significant burden for
these individuals with Parkinson's disease with reduced mobility, with reduced ability
to write; writing is often impaired in Parkinson's disease. And so our solution was to utilize
the Marvell plug-in computer to upload the data on a regular basis, ideally on a daily
basis. So that as investigators, we get that we can look at the database and look at it
in real time and make determinations about the safety of the drug in real time. And we've
also taken--we've reduced participant burden because individuals no longer need to record
a written log. That data is available to investigators, they can go on to. Currently we're uploading
it to Google health. They can go on to Google health, pull up that individual's health record,
with permission from the individual, of course, and evaluate what the blood pressure's been
doing at the time making determination whether it's okay to increase their medication. Still
at this point it requires that individuals take their plug-in computer and plug-in it
into their wireless router or what have you, or and--so that the information's uploaded
to the Internet. But certainly, the technology exists to make this a completely remote process
so that individuals would take their blood pressure and be done. They plug-in the--they
plug-in computer into the wall, they take their blood pressure, the data is automatically
transferred to a Google health or similar repository and you could imagine that you
could set settings on it so that an investigator might get a text message or what have you
that if the blood pressure is out of range or too low, so they can act on that immediately.
So we think this model really suggests that remote assessments may reduce burden on participants,
improve safety outcomes for individuals participating in clinical trials, and ideally save money.
In addition, we see the idea of doing assessments in the home as a means for evaluating how
people look clinically, what their examination shows maybe other assessments of how they're
functioning and genetic studies. So, 23andMe, as many of you are probably aware, is an initiative
to evaluate genome or genetic data on individuals. And individuals basically signed up, I think
they pay about $400 and they get a number of a--they get ancestral information which
I think is their--a driving force for a lot of individuals. But they'll also get specific
genes, specific data that's related to disease risk. And so they'll learn about their genetic
risk for a variety of diseases including Parkinson's disease as well as male pattern baldness,
but a variety of other things. And we think that that's interesting cohort to look at.
In addition, through 23andMe, they developed a Parkinson's diseases initiative. They're
specifically interested in looking at individuals with Parkinson's disease. So they've made
it very cost minimal too for individuals with Parkinson's disease to get their genetic data.
So I think they request $25 if you have Parkinson's disease. The question becomes, you're asking
a community of individuals without med--whether they have Parkinson's disease or not. Many
of these individuals probably have not been seen by a Parkinson's disease specialist or
maybe not even by a neurologist. And you're getting information about their genetics and
you're assuming that they have Parkinson's disease or some related condition. And the
reality is the data quality is quite low because you really don't know what they have. We could
see that video--remote assessment is a very--the web-based video conferencing, potentially
using the plug as a mediator of--for evaluating the video data is a--would be a useful, easy
way to; one, identify what their clinical examination shows in a very rigorous manner
in turn whether or not they have Parkinson's disease or some other related Parkinson's-like
disorder or some other related neuralgic condition. It's very common for individuals with tremors
to be diagnosed with Parkinson's disease and not have it. And in addition, it allows you
to follow clinically over time what happens to these individuals very easily and in a
cost-effective manner. So, we get genetic data. It'd be interesting to know that a specific
genetic genes associated with Parkinson's disease, or maybe in genes associated with
other conditions unrelated to Parkinson's disease have an influence on how people behave
over time in terms of their physical examination and maybe other features. In addition, the
cohort of individuals who are otherwise healthy and signed up for this service, a proportion
of them are going to actually have genes that put them at risk for Parkinson's disease.
So, these are individuals who are at risk, unbeknownst to them oftentimes, at risk for
Parkinson's disease based on their genetic profile. And it gives us an opportunity to
evaluate those individuals who are not yet sick, follow them again in a very cost effective,
low burden type of way, and determine what are the features that first unfold, what are
the features of disease that are most important in this pre-symptomatic period prior to the
onset of symptoms and prior to diagnosis, and allows us to potentially develop therapies
that would slow the--would delay the onset or prevent the disease onset in these populations.
So, I think that these genetic studies and coupled with remote assessments is a very
powerful means for evaluating a variety of questions in Parkinson's disease and potentially
developing therapies that may prevent or delay the onset of disease. I'm just going to click,
okay? So, finally, I want to say that another issue is using remote technologies to get
a better understanding of really day to day function and day to day disease manifestations.
So we've talked about the fact that people with Parkinson's disease may have some variability
in their function throughout the day. They have involuntary movements. It's often very
difficult to know what people mean when they have these types of problems without actually
visualizing it. And there may be automated technologies using devices like the Google
phone or other simple devices that include accelerometery so you could detect movement,
position, you can potentially identify mobility, how often are people active during the day.
We know that exercise and activity is very important for improving function and delaying
progression in Parkinson's disease. Falls are important morbidity in Parkinson's disease.
Falls is associated--are associated with fractures, nursing home placement and death in Parkinson's
population. So, monitoring falls is a very--and people are very poor at reporting how often
they fall or when they fall. So, the ability to automatically detect falls in this cohort
would be very useful both from a research perspective, but you could imagine from a
care perspective, if you can get notified or somebody can get notified whenever an individual
with Parkinson's disease falls, it's the, I think as Ray mentioned, it's the 21st century
help-me-I'm-falling-and-I-can't-get-up. Medication response, daytime activity, people with Parkinson's
and particularly people with Parkinson in disorders are prone to sleep apnea. In using
infrared technology, we can potentially monitor carbon dioxide levels in individuals and develop
interventions to address elevations in carbon dioxide associated with sleep apnea. And importantly,
using the UV detectors that can be available on these phones we can--and other devices,
we can monitor sunlight exposure. Recent data suggest that sunlight exposure is associated
with the conversion to Vitamin D. Vitamin D appears to be important for preventing cognitive
impairment and dementia. And so, there's reasons to think that it'd be important to monitor--you
guys don't have this problem in Northwood, California, but in Rochester, New York, everyone
has Vitamin D deficiency. So, we just want to finish up talking about what we see as
next steps and future directions for our research and where we think the collaborations may
exists. So we think that we can use Google application's capabilities and resources to
expand the telemedicine model primarily for care. As Ray talked about virtual house calls,
we are all aware of Google Chat and Google Video as an alternative means for performing
virtual visits in individual's homes. Our understanding that that can be encrypted in
a manner that can be utilized, utilizing the plug-in computer to allow people to--with
a camera and a TV to perform virtual house calls in that manner. For research purposes,
both using video conferencing and things like monitoring blood pressure, monitoring mobility,
monitoring medication response in real time. And we'd like to assess the feasibility and
value of new Google--the new technologies and services, such as the Marvell plug computer.
I think I've already talked about this Google Health for delivering care and performing
research. And ultimately, we'd like to expand the geographic scope. Most of our research
had been conducted in the western New York and up state New York region. We'd certainly
like to expand it to other states. And from a research perspective, we'd like to expand
it to multi-center of trials. The study I told you about is a multi-center study, but
the research we're doing is really done at the University of Rochester. At this point,
we have visions of expanding that to a multi-center trials and showing that we can conduct the
same assessments that are conducted in person remotely just as well, and that would really
have a huge impact on drug development and drug development costs, and participant recruitment
and retention. Ray is taking a faculty position at Johns Hopkins, and that really opens up
an opportunity for us to explore this technology in Maryland and probably internationally.
So this is our vision for the expansion and timeline for our expansion. So, first, we
plan on providing care to individuals directly in their homes; and that's something we plan
on doing actually, probably, next week. So we want to test the feasibility of performing
virtual house calls and ultimately expanding it to see whether or not virtual house calls
are an improvement over traditional care of both in terms of costs and the quality of
information that we receive. Next, we'd like to expand to incorporate remote assessments
into research studies. We talked about 23andMe as we see as being a very meaningful use of
this type of technology and into existing and future clinical trials. And finally, we
would like to apply the model to other chronic conditions, for example, Alzheimer's disease,
which is, you know, a chronic condition associated with aging, which is increasing in prevalence
dramatically as the population ages, and expand the geographic scope of both at this--within
North America and also internationally. And ultimately, as the one-patient that Ray showed
you so elegantly put, our vision is really is to provide patient centered care to individuals
with Parkinson's disease no matter where they live. And now, we want to thank you for your
time and we're happy to take any questions at this point. Scott?
>> SCOTT: I have one [INDISTINCT] here. The care that you gave to the nursing homes was
largely dependent on someone in the nursing home setting up the conferencing, right?
>> BIGLAN: Yes >> SCOTT: So, there's still a difficulty of
configuration for these people giving the remote care. Would you say that's true?
>> BIGLAN: Well, we don't know. >> SCOTT: Can you repeat the question? So...
>> BIGLAN: Oh, so the question was that in our nursing home experience, and in fact,
in our community experience, the day we've modeled around having these telehealth centers.
So, we have a telehealth center that is local to the individuals that are participating
in this--in it, but is--so, it's convenient for them, but they still have to leave their
home to come to the center. It's in the nursing homes, so the nursing home individuals actually
are right there and that's actually been tremendous convenience for them. But, we've had individuals
there for--to do--and have done things. One, they work the camera on their ends; so if
we asked to see something specifically, they'd move the camera to that specific location.
In addition, we have a nurse that we've trained to do some Parkinson's disease evaluations.
And so, the question is when you move to this type of technology or this type of service
into the home, you're really--it's, you know, on--somebody, I forget the term somebody used
for this once, but it's, you know, unassisted telemedicine visits. There's nobody there
necessarily; there may be a caregiver, but there's nobody there with training or expertise
to perform these. And so, we're certainly interested in assessing whether that is actually
a feasible possibility. We think it is feasible. We think we can get enough information in
order to make marked improvements in the quality of care and in patient's function and quality
of life. Did you want a comment on...? >>DORSEY: The technology is exactly the same
technology that grandma is using to speak to her grandson. So, why can't grandma speak
to her doctor? >> I think [INDISTINCT] very exciting. What
have been some of the challenges [INDISTINCT] people adopting this method? I know there
are sort of lack of in-person. There's a certain, you know, impersonal feeling about having
computer separating two people, so has there been a major drawbacks you see on that? And...
>> BIGLAN: So the question is what are the, I guess, the barriers to people adopting this
model on a larger scale. And one of the things you've raised is the whether there's an, you
know, you don't form that traditional physician-patient relationship and it's a little bit impersonal
through the computer. And so, we did conduct focus groups to try to address that very specific
question in the people that have participated in the studies, thus far, and we've actually
found that's not to be a concern, if there's at all. In fact, in general, the relationship
that people--the people feel that their relationship with us via telemedicine is better than with
the other doctors they've seen for their Parkinson's disease. There's been no concerns at all about
the interpersonal issue. I would say--and I'm going to segue to Ray on this--the major
barrier to adoption is largely been in terms of reimbursement for telemedicine services,
and I'm going to let Ray speak to that issue. >> DORSEY: Sure. So you really don't physically
touch the patient, you touch them in a different way. I think you should touch them in a more
meaningful way. The current way that we deliver care is really centered around the doctor's
convenience. You come into a waiting room, a holding cell, you're waiting for the doctor
if he's ready to come see you, and he comes out and sees you. This way, we're actually
coming to you. We're coming directly into your homes to provide care to you in the most
meaningful way possible in those patient-centered ways that we know of and at 2010. Reimbursement
is a challenge. Medicare currently covers telemedicine visits in certain settings. It
doesn't cover it in non-rural areas such as New Hartford, New York, population 20,000
for whatever reason. We think it's just a matter of time before payers will change.
I think there's other alternative economic models by which that this can work as well.
>> To your experience, as the developers, what was the first initiative to pick up the
plug computer and who, you know, developed the tool itself? Was it you? Was it easy for
you? You know, I wanted to have this kind of...
>> DORSEY: So how did is this program being initiated and what were the...
>> With you; with Google, yes. >> BIGLAN: You're specifically asking for
the plug? >> Yes.
>> BIGLAN: Well, actually, Marvell came to us. We were involved in--you know, they asked
they were interested in whether or not this could be a useful technology in clinical trials.
And they said who's doing clinical trial work. And they got Carl [INDISTINCT] name and ultimately
he referred you to us because we were doing some of this remote assessment work already.
And so, we met with Scott Smith and said, "Yeah, we think this is valuable. We're doing
a clinical trial in Parkinson's disease where we need to monitor blood pressure. This seems
like this will be a very useful test case to--and a simple way of improving the way
that we're currently doing things, both in terms of efficiency and reducing participant
burden and improving safety". With that in mind, I think Scott configured the device
to make it compatible with the blood pressure monitorings that we're already using in that
study. And so, that's--we didn't do any of the technology aspect ourselves in that regard.
>> If two people go just [INDISTINCT] will be physical for like, you know, doctors and
physicians like you to develop, you know, take this tool and develop or you will need
any support from us? >> BIGLAN: I would say that we would probably
need support in terms of the technological adaptation. So, say, you know, one of our
goals is to be able to increase access to web-based video or video conferencing technologies
so that we can do visual evaluations of individuals. So I think it's--in the short term at least,
it's going to be a very--we're not going to be able to get around doing some type of visual
synchronous evaluation, particularly in the context of clinical trial work. They're just
regulatory issues around that. In term of FDA approval processes there are certain outcomes
that need to be assessed in order for our drug to come to development. So, we, you know,
we think the plug computer potentially is a means for improving access beyond those
individuals with computers and beyond those individuals with broadband access potentially
using other, you know, the 3G network satellite, et cetera.
>> I just have a question about kind of the overall situation of the telemedicine. I'm
entrusted to know--I mean, I think it's great that you guys are using it like this. Obviously,
we have other technologies that could support the evolution of telemedicine, and this is
the first time that I've heard of it being used. So, is it rare? Is it something that's
growing? >> BIGLAN: So, you're question is the overall
penetration of telemedicine. Do you want to talk?
>> DORSEY: Sure. So telemedicine has being done everyday. It's been done right now. It's
been widely used in psychiatry and other fields for many years and many decades. So, for example,
telemedicine is used to provide care to individuals who--in the imprisons, prisoners. You know,
where it's very difficult to get in. It's used in the VA system to provide care to veterans
wherever it is. It's used to manage acute emergencies, so stroke. You can get a physician-to-physician
consultations. It's used in radiology, you know, where you can now separate the acquisition
of a picture image from its interpretation. It's used in dermatology. It's in used in
a wide variety of ways. You can get a second opinion from a doctor right now, if you wanted
to, on a runny nose. I think what we're trying to do is change the model a little bit and
then apply to chronic conditions such that you can develop a longer term of relationship
with patients overtime and free that individual--I mean, free the physician--from any geographic
restrictions where that individual lives. There's no reason that in 2010, an individual
has to decide where they want to retire based on their medical conditions and their proximity
to physicians. And there's no reason that the individual, you know, in Bangkok can't
get the treatment for his Parkinson's disease because there aren't Parkinson's disease specialists
in Bangkok. And those types of things just no longer need to happen in 2010; and the
technology is already there. You guys can easily create the technologies to enable this.
What's needed is, you know, partnerships, creativity, and will. And we need partners.
We need creative people, and we have some will that we'd be happy to pass on.
>> Can you say though that, obviously, the advances in technology maybe much easier?
I mean I don't think 10 years ago you could have had that type of analysis right in looking
at someone through video. >> DORSEY: And in the technology, the big
thing is, you know, is cost. This is no longer a cost issue. You know, you have--you have
mobile telemedicine vans, your mobile telemedicine units, you have cameras that, you know, $5,000,
$ 10,000, $ 100,000 of dollars. There's robot's out there that can make rounds for you for
$ 300,000. You know, our solution is not that capital intensive at all. It's low cost.
It's $ 200. It's less than, you know, a couple months of a cell phone bill. You know, it's
readily available technology. What was really needed is partnerships, creativity, and will
to make it happen. >> I have two questions. One, with this telemedicine,
it sounds like--are you saying that your [INDISTINCT] doctor as well has increased or you're enable
to do research and you're able to do sort of get more [INDISITNCT] in terms of your
time, so perhaps this means more patients get treatment? Is that sort of the correct
thing to say? >> DORSEY: So, does the productivity of physicians
increase with telemedicine? And, you know, patients likes time with doctors. And that's
always going to be a scarce thing. And you know, you can't make it right now that the
time is relatively similar. We spend about half an hour with follow-up visits. If you
come see us in clinic, we spend about half an hour on time. Our no-show rate is much
less for telemedicine visits that it is for regular visits. Our ability to conduct visits
will be increased because we can now do it, you know, from our home, from our desk. Right
now, for clinic, we--literally, both Kevin and I have to drive from our office to go
to clinic to go see our patients. When we see telemedicine, we don't move. We just turn
on our computer and do it. With telemedicine, you can extend your reach. You can reach more
than one individual at one time. You can reach caregivers. You can reach many patients at
once. So I think that many to one concept is another way to improve the entire model
of delivering care. So, there's lots of creative ways and we're just touching on them by which,
you know, telemedicine can improve the current conduct of care, 24-hour access means hundreds
of things. And we're restricted right now to our clinic, being open from 9:00 to 5:00,
from Monday to Friday. If I want to see a patient for, like, at 6 o'clock right now,
I can't do it. The clinic isn't open. And that's nonsense, right? That's when patients
want to be seen. Saturday morning, I can't do it. I won't see patients after I go to
bed on the west coast or if my kids go to sleep, I can't do it. Hundreds of different
ways that it can be done, and better. >> BIGLAN: A very short answer. If--you certainly
can expand access to care [INDISTINCT] and improved productivity. I know in our--in our,
you know, in our specific situation, the ability of how to see patients via telemedicine in
our office that we generally work in and not have to go somewhere else to see patients,
has a dramatic effect on our productivity. >> Yes. So, well, assuming that this is a
cost-effective of way of doing things and there should be some natural sponsors for
this. So we've seen the insurance companies should be a sponsor for this. The government
should be a sponsor for it. Organizations of doctors should be a sponsor for it. Who
are the existing sponsors of this? >> DORSEY: So, right now, our research is
being sponsored by the nursing home. So, the nursing home has a financial interest in,
you know, in filling beds. Retirement communities have an interest in, you know, providing great
care to their residents. Even interested in, you know, not having their patient have to
got to the hospital. Two different insurers have expressed interest in this model with
us: Excel, the local Blue Cross Blue Shield insurer in our area has committed to funds
to provide virtual house call--virtual house calls to individuals. We just had a conversation
last week with the United Health Care. They said they'd fly a Colorado license; they'd
have me doing telemedicine last week. So the payers are coming around to it. We have--we're
researchers, so we write grants, and we write lots of grants. And foundations will probably
be the next adaptors. And I think there's an increasing interest from federal government
in Department of Agriculture role of medicine to see this model expand. But again, it's
just, you know, partnerships, creativity, and will that are necessary to make it done.
You know, Kevin and I can't do it ourselves. We don't have all the capabilities and resources
that are necessary to do it. >> Do you have any license problems in dealing
across the boarders? >> DORSEY: So we coordinated in the United
States that telemedicine is restricted by UFB license in the state in which the patient
resides. It used to be a major barrier. Now, it's primarily a cost barrier. There are third
party providers who can get licenses for you in all different states. So, I'm currently
licensed in New York and in California. You're in license in New York and Pennsylvania, I
think, and Maryland. So you can, you know, readily expand licensure. And then overseas
and these are some other issues that we need to look into, but people where, you know,
coming in frequently to just to react [INDISTINCT] like Stanford spending thousands of dollars
in transportation cost to come to see their physician, they get a bill for $300 and then
to disappear and never be seen by that physician again, you know. And now, you can send them
home with a webcam and I'll say, "Well, see you in three months." And that will save you
thousands of dollars, and you can give us a little contribution of that.