VIReC Clinical Informatics Seminar- 14 -Department of Veterans Affairs

VCI-051512

**Department of Veterans Affairs**

**VIReC Clinical Informatics Seminar**

**Telemonitoring and Sleep Apnea: Effect on CPAP Adherence**

**Carl J. Stepnowsky, Jr., Ph.D**

**May 15, 2012**

Moderator:  Welcome, everyone.  This session is part of the VA information resource center’s ongoing clinical informatics cyberseminar series.  

The series’ aims are to provide information about research and quality improvement applications in clinical informatics and also information about approaches for evaluating clinical informatics applications.  We want to thank cyber for providing technical and emotional support for this series. 

As I’ve indicated questions will be monitored during the talk and the Q&A portion, go to webinar.  And I will present them to the speaker at the end of the session.  We would just ask that you write in complete sentences if possible since we are—your audience is on mute and it helps a lot for the presenter to understand what is exactly what your question is. 

After our talk a brief evaluation questionnaire will appear when you close the go to webinar window.  We would appreciate if you would take a few minutes to complete the questionnaire.  Please let us know if there is a specific topic area or a suggested speaker that you would like us to consider for future sessions. 

At this time I would like to introduce our speaker.  Dr. Carl Stepnowsky is an assistant adjunct professor in the department of medicine at the University of California at San Diego, and a research health scientist at the Health San Diego Health Care System. 

Trained as a clinical psychologist with an emphasis in behavioral medicine, his current research efforts are focused on merging behavioral sleep medicine and health information technology.  His program and research focuses on how to best organize and deliver patient-centered collaborative care to those diagnosed with chronic illness, sleep apnea in particular.  It is our pleasure to introduce Dr. Stepnowsky. 

Carl Stepnowsky:  Hi.  Thank you for having me.  Today I’ll be talking about telemonitoring and sleep apnea and its affect on CPAP adherence.  

What I’ll do today is give a background first on sleep apnea and CPAP therapy for those who are maybe less familiar with this particular chronic disease and its treatment, then give an overview of some other telehealth kind of studies that have been done in this area, and then take a deeper dive into the presentation of two of our CPAP telemonitoring studies that we’ve done.  

So in terms of background to sleep apnea, sleep apnea is characterized by repetitive cessations of breath during sleep.  It’s comprised of apneas and hypopneas.

Apneas are complete cessations of breath for greater than ten seconds and hypopneas are partial reduction in air flow or breath, which are accompanied by either an oxygen desaturation or an arousal from sleep.  What we do is we get a count of both the apneas and hypopneas to get a measure of apnea to deep severity.  We call that the apnea/hypopnea index.  

And what that is is a count of the total number of apneas and hypopneas divided by the hours of sleep.  Between zero and five is considered normal.  Five to fifteen events per hour is considered mild.  Fifteen to thirty is considered moderate.  Greater than thirty events is considered serious or severe, just to put it into perspective, when someone has an [HI six] event, either having one event for every minute of sleep. 

Sleep apnea is associated with serious cardiovascular and psychosocial co-morbidities and associated with increased rates of mortality.  Sleep apnea is the primary sleep diagnosis with about eighty percent involved sleep diagnoses in sleep apnea. 

Prevalent chronic disease it’s prevalent in two percent of women, four percent of men who are middle aged working adults.  And it has higher prevalence rates in older adults and higher prevalence rates in veterans.  Veterans are at particular risk.  The primary risk factors for sleep apnea are the male being older. So this often times characterizes are veteran population. 

What is CPAP? I have a set up a picture of it in on the slide that you see.  CPAP stands for continuous positive airway pressure therapy.  It is comprised of a flow generator which typically sits on a nightstand next to the bed, a hose that attaches to a mask.  

The mask can come in different kinds of styles.  One is called the nasal mask which just goes over the nose.  It can be full-faced masks which go over the nose and the mouth, or nasal pillows which is the kind that you see in the picture or it’s just cushions that attach to the nostrils. 

The CPAP machine blows positive airway pressure and acts as a pneumatic splint to keep the airway open at night while someone is sleeping so it can either reduce or abolish any apneas or hypopneas.  Apneas and hypopneas I should have mentioned have their effect because what typically happens the body needs to awake itself up in order to keep breathing, so apneas and hypopneas can cause sleep fragmentation, which can then lead to excessive daytime sleepiness. 

Apneas and hypopneas can also lead to cardiovascular consequences so they use up the oxygen desaturation.  CPAPs prescribed for use whenever someone is asleep including naps.  There are some good dose response studies out there that suggest the more that CPAP is used the better the effect.  It’s considered a gold standard therapy and is considered first line for the treatment of sleep apnea.  

CPAP comes in several different kinds that can be fixed pressure settings where it’s just a single pressure across the entire night.  It could bi-level where there is separate inspiratory and expiratory pressure settings, or it could be auto adjusting where some CPAPs have the ability to measure airflow and how well someone is breathing.  And to the extent that the flow is limited the pressure can slowly adjust up to help take care of the apneas and hypopneas.  

Sleep apnea historically has been under diagnosed and there are some estimates that eighty percent or so of people haven’t been diagnosed.  Since that time there has been large emphasis on making the diagnosis.  

Any factors including increased awareness, increased capacity, lab capacity, the start of home sleep testing has resulted in increased numbers of OSA patients being diagnosed.  I have often said that there is an evolving emphasis on treatment initialization and follow-up. 

There has been such a large emphasis on just case identification and getting people diagnosed that we were dishing out CPAPs left and right and not doing a very good job of getting people started on it.  A couple years back Medicare had put out a ninety-day rule which has had a large influence on bringing treatment initialization and follow-up to the forefront.  

Essentially a certain amount of compliance needs to be shown in order for CPAP to be reimbursed.  So this has had a large effect and motivated especially the MEs to take a more proactive approach in encouraging and fostering treatment adherence.  

In terms of CPAP adherence rates this really is considered a complex treatment regimen to wear something over the face that involves breathing at night when we are vulnerable is difficult for a lot of people, so CPAP adherence rates and generally being considered sort of suboptimal.  In looking at the general CPAP adherence literature there is over 200 studies now that have data on CPAP adherence.  

This is my gross generalization of CPAP adherence rate.  About to seventy-five to eighty percent of those diagnosed, completely diagnosed sleep apnea patients will initially give CPAP a try.  Of those who give CPAP a try about fifty percent will continue to use one year later.  And of those that continue to use it at one year the average use is somewhere in the ballpark of three to four hours per night.

What this means if you put it in raw numbers and take a hundred newly diagnosed sleep apnea patients, eighty will give CPAP a try.  Forty will continue to use it at one year.  Of those forty maybe twenty will continue to use at recommended levels.  If we see out of an initial group of a hundred about twenty percent are using it to the extent prescribed after one year.  

So there is significant room for improvement in terms of getting people to an acceptable level.  I already mentioned CPAPs prescribed for use all night every night.  And so when people are only using it for half the night what I like to say is that they are engaging in what essentially amounts to a partial use pattern.  

Now sometimes people may be self -titrating the amount of use that they can so that maybe they really are deriving a benefit at that level.  Those response studies are relatively clear that the more use the better the outcomes, the better the symptom reduction.  

In terms of CPAP experience patterns consistent and inconsistent users can be distinguished within even the first week of use in these studies or that there is other evidence that use patterns are established relatively early in the treatment initialization process.  So for example adherence in week one is associated with adherence at six months, at one month is associated with are adherence at three months, and adherence at three months was associated with adherence at twenty-two months.  So I would like to say there is a window of opportunity early into in initialization process that should be taken advantage of, but perhaps isn’t being taken advantage of as much as it could be.

To emphasize that point we took a look at the nightly data from one of our usual care groups.  We took a look and plotted the mean adherence on each of the first fourteen nights and plotted that data.  It shows the patients started off with about 300 minutes of use over the first couple of nights.  Then you can see a drop off to closer to about 180 minutes about after two weeks of time, so about a forty percent drop in those two weeks.  

I should mention the CPAP has an internal computer that can measure the amount of time that CPAP is worn at the prescribed pressure.  You have a nice objective measure of CPAP adherence.  CPAP collects that data on a smartcard which then can be manually downloaded via software and that data looked at.  Oftentimes the first clinical contact isn’t for a month or two out and this window of opportunity is oftentimes missed.    

I wanted to show this slide early in the talk because I wanted to show the nightly data of the research which has been of ours.  It was in one of our intervention models.  This plot shows that the nightly experience across 365 nights, so one year’s worth of data, the plot’s adherence as the number of hours of use with the red dot being valid data and the black dot showing missing data. 

So you can see at about night 160 we had a block of missing data.  The blue line is the trend line.  And the black arrows show where there was some kind of patient/provider contact, whether that was by telephone or in person.  

One of the things that this graph shows that this patient has an overall upward trend in the amount of use.  And if you take a look at the bottom and zero hours of CPAP use you can see that in the beginning the first ninety to the 120 days there were a fair amount of zero nights.  When you look later on in the last quarter or so from 270 on you can see that there was just a handful of missed nights.  So this person had not only increasing average, but also a significant reduction in the number of zero nights.  

The other reason why I wanted to show this graph with one year’s worth of data was to highlight the variability of these.  This is a plot of someone who ended up being “experienced,” but the key point about viewing this type of data it’s very easy to simply use one summary statistic to summarize the data.  

In fact there’s a story here and it’s important that this kind of data has not boiled down to just a couple of summary statistics, but rather to use the origins of the data and what the story is for each of our patients.  When we do a download at thirty days, sixty days or ninety days and we look retrospectively we can oftentimes lose some of this data because it has happened in the past.  With new technologies we can get the studies on a, get this data on a net basis.  That’s what we’ll be talking about later.  

In terms of the feedback use pattern summary so adherence use patterns seem to be established relatively early in a treatment initialization process probably within the first couple of weeks.  These patterns can be highly variable.  They tell a story.  

This variability is important to monitor over time because inform us when to intervene, but only when we track it prospectively.  Technologically we can do this now.  And I will the next slide well I’ll show you how we do this.  The key issue is that our current system is not really well set up to take advantage of the data that we can potentially get.  

So this provides some background on interventional studies and other kinds of telehealth, telemedicine studies that are done in this area.  I just want to provide this general classification that I like to use to classify CPAP adherence interventional studies. 

It’s not meant to be exclusive and there may be other ways to categorize these studies, but in general we can identify whether there’s an educational component to a study or it’s the provision of pamphlets, group education, some sort of information about in people education about sleep apnea or treatments. 

Clinical support this is important in the provision of additional telephone or clinic visits, but with the specific focus on therapeutic change or advice, pressure setting changes, humidification changes, the use of expiratory pressure in [leaf] for example, so this kind of clinical support.  

Behavioral change interventions are where the specific target is looking at how do we change someone’s behavior?  How do we get them to use CPAP more for example, whether it’s motivational enhancement by [Mark Lahoya], cognitive behavioral therapy, self-management, et cetera, there’s a number of different kinds of behavioral change strategies using trying to help people use CPAP more. 

And then I would say another group is called the health information technology. So there’s the telemedicine tool, telephone-linked care, et cetera. What I’d like to state though is that health information technology is more of a tool to help foster or do one of the three other categories, whether it’s to provide more education, provide more clinical support or foster behavioral change. 

Let’s take a closer look at three studies that have used some sort of telemedicine tool of the CPAP here.  This one is a health buddy appliance, and many of us in the VA are probably quite familiar with the health study, a relatively simple device that asks questions of patients, nice large buttons, relatively easy for most users to use, but it oftentimes is based on a complexity of branching questions that can concern a range of topics.  

So for this study there were questions about symptom management, the kinds of symptoms the patients were having, the behaviors the person was engaging in, knowledge about sleep apnea and CPAP.  And it also asks about self-recorded amounts of apnea.  

In this study a patient recorded low use for three consecutive days when alert was sent to a provider who could then act on that data.  The intervention period for this study was one month or thirty days and was focused on new—they found no difference in adherence between intervention and control groups, 4.2 versus 4.3 hours per night.  

And the authors suggest that one potential barrier to effective use of this intervention that they thought that there was a time delay between the patient and provider and they can contact by phone after an alert was sent to the system.  Unfortunately they didn’t keep track of the number of alerts by patient or the number of contacts.

Another study was video teleconferencing study and by Dr. Smith and colleagues.  And what they did rather than looking at new users was they took a sample of non-adherent patients over the prior three months so these are people who had already had tried CPAP, but didn’t use it to the extent prescribed.  What they did is they randomized people to either video teleconferencing, which was accomplished with a video phone that you can see in the picture on the slide, and for a controlled group which was a vitamin placebo group where there was still contact and still contact between the patient and provider, but it wasn’t about sleep apnea or sleep [inaudible].  

It turns out the video teleconferencing group had higher adherence, and this study wasn’t recorded in terms of hours per night, but it was recorded in terms of a threshold which was considered to be greater than four hours per night of CPAP use on greater than reported nine out of fourteen nights.  And video conferencing group had higher adherence, ninety percent versus forty-four percent.

Another study looked at interactive voice response or what is considered telephone-linked care.  This is a full-scale study.  It incorporated a behavioral change component, motivational enhancement.  And it was a randomized control trial of TLC versus attention control, over a hundred people per group. 

There were weekly phone calls provided in the first month.  There were phones calls each week and then monthly phone calls after the first month.  So the twelve-month study was an assessment at six months and at the six month time point it was 2.4 hours per night and the intervention group versus 1.5 hours a night in the control group.  Of concern in this study was the magnitude of use which was a bit lower than other core studies.   

Looking to the work that we’ve done, what we’ve done is used, what we use at our CPAP telemonitoring system, and the two studies I’ll describe we used the [0.5] Resmed and used their AutoSet Spirit auto adjusting device.  We attached a wireless module to the back of it so you can see what it looks like. 

You can’t hide the fact that there’s a little antenna and something being sent out so the patients were aware.  The data was transmitted via pager or cell network the next day and was considered a store and forward manner.  So this isn’t real-time monitoring.  It happened the data gets collected at night and then the next day sometimes usually after either 1 p.m. the data, the wireless device we get pinged and the data sent.  Some other similar systems it’s important to point out on the market, for example EncoreAnywhere by Philips Respironics, and there’s some similarity of cross systems in terms of being able to get the data from the CPAP device.  

Just to take a little deeper dive and show how this was used, and we will provide this overview and then this overview and then this same system was used in the two studies that we’ll be talking about.  And this is just to give a feel of what the provider had access to. 

And it’s important to point out that this web-based system was only accessible to the provider.  There was no patient access to this system.  There were four tabs.  One is demographics where we could enter any background data that we wanted to, prescription which is where we allowed the setting of a particular threshold that we wanted to monitor, monitoring which is a calendar format for the reporting of data and the setting of the time period, and then the compliance calendar.  

I should go back to demographics.  I didn’t mean to imply that we did put any background information that we wanted to.  This was completely D identified.  At the time four or five years ago the VA was clamping down on what could be done.  And so everything that I’m going to talk about today we did in a D identified way, so we provided—we only used a coded subject number on this aspect. 

This is an example of the prescription.  So we could enter whether it’s APAP or CPAP.  And then you can see there are three things that we monitored.  One is the apnea/hypopnea index.  And we could set a threshold.  We set it at ten so we can get an alert of when it was above or below the AHI of ten.  

Leak we set to 0.14 so we could get an alert when there was high or low leak.  And then threshold we set to four hours, again so we could see the difference.  

The calendar, a little example of what the calendar looked like and it was color coded just to aid visual inspection of the data.  Each box was coded in the following way.  In the upper left corner was specific to adherence.  So if it was above four hours it was color coded green.  And if it was less than four hours it was color coded red. 

The lower right hand of the box was for either leak or residual AHI.  And so if it was yellow it meant that one of those parameters was in the abnormal range or the out of range value.  And if it was green it meant that both AHI and leak were within the defined threshold. 

I should point out I didn’t do a copy of the exception reporting, but one way to manage large numbers of patients, and in our research protocols we’d have upwards of thirty patients at any one time in our interventional protocol.  There’s another screen for exception reporting where you could look at all of the people you’re currently following and just look at their first seven days for example, so by the glance you would know who was within or outside of the thresholds that you’ve set, and thereby call and when.  

We specified the interventional algorithm in this way.  Over the course of three months—there’s probably more details here than you need to know, but what we wanted to do was to have a set protocol so that in week number one, which is up here, we looked at usage and efficacy data daily.

And so this is the green/green pathway.  If the parameters were green for the patient using it more than four hours and AHIZ [cohort] was in normal range, no intervention was done and then we would go to step three, which was week number two. 

Here we would start to taper off the monitoring.  So then we would just look at things every other day.  If it continued green/green then we would just do it on a weekly basis.  And if it continued green/green then it’s really the [inaudible] basis from there forward. 

Now if there were problems we had an intervention matrix that we would follow for those who had some sort of problem.  So you can see if someone had red, so they had low adherence what we would do is either call the patient or have them come in, and then figure out what the problem might be considered [calm physician] things that were done, then implement those things, if the problem was high leak or high AHI, again to set the problem to figure out what could be done if it was high leak following the interventional matrix, was high AHI.  And we would have to consider potentially pressure setting [tools]. 

So that was the algorithm that we followed.  So study number one was very focused just on CPAP telemonitoring and then acting on that data.  So we examined the effect of CPAP telemonitoring on improving CPAP adherence.  The provider had access to the website I just showed you to adherence and efficacy data.  They could act proactively.  There was no specific intervention on the patient side, so this essentially amounted to a clinical support study using telemedicine. 

Randomized trial comparing two groups, the usual clinical care versus what we term enhanced clinical care, twenty patients per group, enhanced clinical care received tailored feedback from clinical staff based on the wireless data collection.  And participants were followed for two months. 

Just to reiterate, adherence is the amount of time that treatment was worn at the prescribed pressure.  It’s an objective measure of treatment adherence.  Efficacy was the CPAP unit’s measurement of the apnea/hypopnea index while the device was being worn. 

So while this is a similar metric to what might be measured at baseline from a sleep study, whether it’s in lab or home sleep testing, it’s also a bit different from—I did a subsequent analysis because these we were relying on the AHI as measured by the CPAP units because most of the analysis to say how accurate it may be.  And we’ve done this—apneas measured by the CPAP device are very accurate. 

The hypopnea measurement by the CPAP units were less precise.  And the reason why was because all the CPAP unit can do is measure airflow.  It can measure that reduction in airflow, but it doesn’t have oximetry data or the EEG arousal data. 

So it tended to overestimate the number of hypopneas.  And we found it was on average pushed about overestimating hypopnea’s index by about a factor of two.  

The leak was the measure of the amount of air leaks, so to the extent that leak is high, so that means air is escaping somewhere between the mask and the skin.  So to the extent that leak is high pressure getting to the airway is lower.  And that can potentially make therapy less efficacious. 

In terms of our design we always try to think about how does the use of this tool fit into the clinical care process.  And so what you see here is we just have the clinical care process here.  And then we define what we consider to be usual and typical clinical care where there might be a one-week phone call, a one-month clinic visit where there’s a data download, then a two-month clinic visit data download. 

Importantly what happened on the usual clinical care side was a data download at the one-month visit.  For the enhanced clinical care group identical in terms of what got done in terms of introduction to CPAP and CPAP setup, one-week phone call.  And then this was at a minimum of one-week phone call or one-month clinic visit data download, two-month clinic visit data download. 

So really the only difference between the two groups was this 30-day period where the provider had access to the daily data from the CPAP machine.  When you think about this design it’s really see—it’s really—it can be really difficult to find an effect as we’re kind of stacking the odds against it.  The data was going to be downloaded at the one-month time point anyway.  It’s just whether or not we had, having access to it and acting on it within those first thirty days mattered. 

And this was in contrast to placebo kinds of studies, especially early on with CPAP where the design was placebo/ CPAP versus active CPAP.  So it was essentially no intervention versus intervention.  And here it’s just everyone gets the intervention.  It’s just whether or not they’re going to use it more. 

In terms of the differences I think I pretty much have summarized this slide.  The key difference was whether or not actively acting on our data in the thirty-day period had an effect.  Sample characteristics the average age was close to sixty.  Body mass index was about thirty-three.  The apnea/hypopnea index was on average severe.  The average CPAP pressure was about ten.  The Epworth was about thirteen or sort of a measure of sleepiness, so the entire group.  

In terms of differences between the two groups they did differ on adherence.  And I’ll show the slide, the graph next where the enhanced clinical care group averaged about 4.1 hours per night versus 2.8 in the usual clinical care group.  

What I also wanted to point out was that the percentage of night of CPAP use, any kind of CPAP use was higher.  It didn’t reach statistical significance, but there was a trend or a difference where the enhanced compare group used it on any level on almost eighty percent of the nights versus sixty percent to the nights in usual care group. 

Likewise another way to kind of categorize the data to [trend a jem nates] with at least greater than four hours.  And about fifty-two percent of the nights enhanced [come] prepared group uses more hours were greater versus thirty-seven percent of the nights or the clinical and usual clinical care group. 

So this was the primary outcome of the study.  So the enhanced clinical compare group uses on average about 4.1 hours per night versus the usual care group by 2.8 hours per night.  

And it’s important to point out too that with that extra intervention it appears that we got a little more control over the peak of it being less than 0.4 of the usual care group average of about 0.5. These trends for both greater CPAP adherence level in the enhanced clinical care group and lower mass to peak levels as in the compare group, outpatients had accessible leak levels and AHI levels, so it’s important to say that both appeared to be well treated.  

One thing to always keep in mind is this data leak AHI and the appearance that’s during the time that the person is using it.  So we never quite know what’s going on those other hours during the night when the patient is using it. 

Overall the enhanced clinical care patients were satisfied with their care.  They were very—said they were very likely to continue to use CPAP.  They also were very—we were very interested in finding out were they concerned about being monitored at home.  Like you saw in the picture there was a [wall] antenna so that they were aware that they were monitored.  

Some people had questions about what exactly was being monitored.  Could it pick up audio?  Could it pick up video?  And we assured them it was specific to the CPAP and only the data that the CPAP was transmitting. 

In project two what we decided to do was to intervene on the patient side as well.  So this was a combination study where we included the CPAP telemonitoring on the provider side just described before, but then we developed an interactive website for patients.  One of the things we noticed was lots of the same kind of questions, and we had lots of questions about what is CPAP?  What is CPAP?  How do I use this?

And so the idea behind this was that we wanted to take this data, feed the data not back just to providers, but to patients too.  What we found in the first study is the patients were asking how am I doing?  How much am I using?  What does the data show?  

And so we wanted to take that data so patients could monitor it as well.  And we also wanted to create this online resource for participants to essentially offload some of the more common questions in this. 

So what this was was a RCT comparing two groups, usual care versus, and this time we called it patient-centered collaborative care or PC3 because we wanted to emphasize the collaboration between patient and provider, 120 patients per group recruited from a local sleep clinic and supplemented by word of mouth referrals.  In this one we did include criteria for AHI above ten.  We wanted to get people and go higher mile. 

This is the same slide as before, just with a different intervention meaning again focusing on this first thirty days.  That’s really where the difference was in this study, along with the intervention on the patient side.  We’ll get into more detail on that in a second.  

First I want to provide a little background on providing good chronic illness care.  Back in 2001 [vita sent] published a report across from the quality chasm.  And it really focused on what do patients with chronic illnesses do?  

And these are just some of the points that were made in the continuous healing relationship, the regular assessments of how they are doing and the effective clinical management, and the information and ongoing support for self-management. They need a shared care plan and active sustained follow-up. 

And so we kind of wanted to use this as kind of the background for how we designed the [inaudible] and re-intervention.  So we wanted for example with regular assessments of how they are doing they could track themselves and see and more collaboratively to understand the data that they were seeing.  Effective clinical management oftentimes especially when downloaded, excuse me, are happening thirty, sixty, ninety days out.  AHI could be fifteen or twenty and our pressure settings are not being changed.  So that’s very difficult to ask someone to use a therapy that’s not really helping to manage outcome. 

What I did is we looked at the kind of care model for—and I really like this model for this reason because what we’re really focusing on are how do we design productive interaction between a prepared proactive practice team.  So prepared and proactive not only do you have the data on a regular basis, but then acting on that data and doing the right thing at the right time, but you can’t do that without an informed activated patient.  

So somehow you have to say to the patients here’s what you need to know.  Here’s what sleep apnea is.  Here are the symptoms.  Here are your symptoms.  Let’s talk and let’s figure out how to track problems specific to you and then include them in that process. 

The up above here we didn’t include all of these resources.  This is a very large overarching framework that gets up toward health systems and community resources and policies.  

What we essentially did is took a little bit from our self-management intervention that we had done and did a little bit on the clinical information side and system design.  So we really are just kind of tapping part of what we are tapping into. 

Same slide as before, just to emphasize the fact that using the same system, just a model of our CPAP wireless telemonitoring, so data comes from the home, goes up to a server where a provider can review it.  A patient can review it as well.  And then there’s the collaboration happens whether it’s by telephone, in person or by computer. 

So now let’s take a deeper dive and look at the patient side.  What did we create here on the patient side as a resource?  We call this my CPAP website.  It’s an interactive website designed to offload a lot of those tasks that tended to be repetitive to the provider, answering questions about what is sleep apnea, what are the symptoms, answering questions about how does CPAP work, what’s pressure, what humidification, et cetera. 

We included a reference manual where we developed a flash-based, took the dry reference manual that is included with all CPAP machines and made it interactive and flash-based so it actually looked interesting and people could learn how to clean the mask, how to take apart their masks and how to put them back together, how to take off their humidification or humidifier, clean it and how to put it back together.  Then we had an interactive component where my charts data, and I’ll show you some screen shots, so what we did is we worked with manufacturers to get access to the CPAP adherence efficacy data on the backend and populate our website with that data and then display it to the patient.  We also created a troubleshooting guide to help patients kind of work through some of the problems on their especially some of the more common [inaudible].  

This was the login screen.  Again this was completely D identified.  There was no specific patient identifiable information included on this website.  I think that that was what we had to do at the time.  I think what this represents is kind of the minimal of what could have been done and on the conclusion side I’ll offer some ideas on how this could fit. 

So they have a unique user and password so they would get to their dashboard.  We also did our research assessments through here.  And so if they were due for that they could click right here and go to an assessment that they might need to do for the research survey part of it, and then there was a dashboard that shows what else they could do. 

The learning center was comprised of seven lessons specific to sleep apnea.  These were little thirty to forty second, sometimes two minute long videos.  They were multimedia so they included graphics, moving things, voice and sometimes text for the most important points that we were trying to make.  So we were trying to get learning at multiple levels. 

Some of the topics are what is obstructive sleep apnea?  Why is sleep apnea not just snoring?  How do you know you have it, feel like?  And on the CPAP side what CPAP looks and feels like, how to use it, adjusting to it, how CPAP benefits you. 

In terms of the graphs we provided the same data that was to the provider, adherence level, residual AHI and the leak.  And then we provided it in a way where we tried to show what the threshold was and then what the person’s value was.  We tried to and if they were doing a good job tried to include some positive reinforcement, an important aspect of this.  And then we included some points of [French] open the slide interpreting the data, the same with the apnea index and the same with the average leak.

This was our troubleshooting guide.  What we wanted to do—this still required work.  There’s a lot of effort that went into this.  What we wanted to do was have them essentially do three clicks of a button or make, be posed with three questions and then get to solutions that they could try. 

So they would click here if they’re having trouble, problems using CPAP.  And then they would say are you having problems with your body or with the mask, and then or with the machine?  If it was the machine I would say it’s more on the CPAP side or the mask side.  And then they would go down like.  Solutions would be offered and then they could try those solutions. 

Here was the manual.  This was a flash-based CPAP machine reference guide.  They also include masks so then if they had questions on what kind of mask they had and CPAP they had they could find out more information. 

So based on there were no differences between both groups, they were of similar age, body mass index, apnea/hypopnea index and Epworth sleepiness scale, at the two-month time point those in the intervention group used it about 4.1 hours per night.  These [inaudible] used it about 3.2 hours per night.  This was a significant difference with a D index of about four. 

At the four-month time point the results held.  Oftentimes we see the intervention was only going on for the two-month time point.  Then it was two months without intervention, so oftentimes we see kind of a regression, but we saw that intervention held in level. 

I wanted to show this data.  This was the plot of the nightly data of the first ninety days for the usual care versus the PC3 group.  And just as we found with the other earlier slide, our usual care group we see an all-in offer reduction in use over those first ten days or first two weeks.  Here it only dropped about an hour per night from over four to about three or just over three. 

And what we see with the intervention group is that there was also a falling off, but it leveled out above four.  And then you see that this difference that was kind of established early on tended to hold across the rest of the night.  So again it looks like there’s this window of opportunity within those first two weeks that can be important. 

When we look at the outcome measures though we don’t necessarily see a difference in different kinds of outcomes, whether it’s sleepiness, sleep apnea, a specific quality of life, measures of depression or satisfaction.  We can see a difference between groups at two months or at twelve months. 

What we’re really testing here is whether or not one hour of extra use has a difference and at least in this study it doesn’t appear to. In the past oddly enough it – the depressions go and tend to pick up on the differences here again. 

We have a study three which is in progress.  This one we did a four-group design so now we’re starting to really try to tease out the differences.  We’ve done a — we did a group in-person self-management education in the past, but what we wanted to do looking forward was can we do this on an individualized basis.

The groups work really well or they can be challenging in terms of getting people together in a timely sort of way.  The research works is we’re able to get a cohort and follow those eight people for several weeks at a time.  On a clinic basis that can be really difficult to do, so I thought we’d transition the self-management program from group to individualized.

And here we’re testing whether or not there is a difference between CPAP telemonitoring or individualized self-management, combining them in group three and then comparing those three groups to usual care.  And so we’re in the process of analyzing that data. 

Turn to the conclusions, telemonitoring has provided the basis for several of our studies.  And we’ve been doing this for years.  It allows—the advantages are that it allows for timely objective data.  So many times clinically what happens, especially with a phone call is how are you doing and you are relying on subjective data.  We also saw some of the other telemedicine tools are relying on the use of subjective data, how much are you using this?  The data is pretty clear that patients tend to overestimate subjective use.  

CPAP telemonitoring can provide the basis of [inaudible] interaction between activated patients and a prepared provider.  And I think is what’s so critical, especially early in the process. 

Specifically in the PC3 intervention as potential health improved CPAP adherence in the clinical settings I think providing that support to patients we have to remember sleep apnea is a chronic disease that has gone typically over years of time.  Oftentimes we’re not providing adequate education for people to understand what it is, how it’s treated and what they should be looking for. 

So I think the PC3 intervention started to offload some of this information to the patient so that we can bring them up to speed and do what I like to say is talk the talk so that they can use the same lingo and the same language as the provider so they can work collaboratively together, both troubleshoot problems and identify benefits or identify those improvements.  The one-hour and the difference from the PC3 group held at both two and four-month time points. 

CPAP adherence intervention based on health information technology type of potential to be cost effective relative to more labor intensive intervention, some of the other clinical support studies I didn’t review have had clinical contacts that approached ten, fifteen hours.  These kind that we’re talking about we’re probably talking two to four hours of total contact time in that two-month intervention period.  

What we’re doing is we’re saying if you have the right data, you have objective data that can be acted on then we can be more focused in terms of those clinical interactions.  Now obviously there’s a cost to the treatment so that has to be factored into any cost analysis, but one thing that also gets overlooked is the cost to the patients for a clinic visit. 

So if we’re relying on a smart data card and patients have to travel in, even in this suburban environment in San Diego we looked at the average roundtrip was fifty miles for our patients here, not including having to deal with traffic and the time to get here and back.  Other areas, New Mexico, Connecticut there are going to be two, three, four, five hours to get to the local VA. 

So these kinds of tools have real potential to improve the clinical management.  And maybe it’s those as part of a stepped care plan, especially when we’re starting to look back.  The VA here manages upwards of 12,000 diagnosed sleep apnea patients, so identifying those who are at higher risk or maybe who have stopped using essentially these kinds of tools to get people restarted.   

I also want to point out that patient engagement with health IT tools is variable. For the second study we had presented we took all comers.  So if someone didn’t have a home computer we provided it.  If they didn’t have Internet we provided it.  If they had no computer experience we helped get them trained enough so that they could use the computer. 

I think the level of computer experience varies tremendously and familiarity with it.  Also are the incentives or rewards.  We didn’t offer anything other than here’s some extra information for you.  There may be other ways to get people to use the tools more, other incentives, rewards, a sense of community.

And that leads to the next point which is that future studies would do well to include forums and other kinds of peer support, as well as electronic communication of the provider.  The things we couldn’t provide was anything where there was use of an e-mail, anything potentially identifiable.  So we did not include forums where we could take groups of people and allow them interact or have any kind of online kinds of discussions between patient and provider. 

And back to the group self-management program, one of the things we learned in that group self-management program is based on chronic, the self-management program out of Stanford is that peer support it can be tremendously powerful.  And we saw that in the groups where sometimes the peers would listen to each other more than they would the person running the group. 

And that’s nature.  That’s human nature.  That’s why we unpack sorts of things that can be so powerful, especially within the VA environment. 

And then to conclude on the final point, to reemphasize the fact that these sorts of help IT interventions are really tools and we need to be looking at what is the clinical issue, what is the clinical process, how does the tool aid in that process?  The tool isn’t the intervention in and of itself.  It’s how does it aid the clinical issue or process. 

And I will stop there and acknowledge my project team and colleagues here at UCSD and outside of USCD as well as my clinic sources.  Thank you. 

Moderator:  Carl, thank you very much.  This is JoAnne.  We do have a couple of questions coming into Q&A so while other folks are thinking about their questions I will start with the first one.  Is that okay with you?

Carl Stepnowsky:  Yep, sure is. 

Moderator:  Okay.  So the first question is, are patients followed by sleep specialists or PCPs?

Carl Stepnowsky:  Our studies they’re followed by sleep specialists.  So in order to keep control what we actually did is we had hired respiratory therapists on staff and also had a pulmonologist who oversaw—he was a co-investigator on the projects.  And so most of the clinical contact was before done by the respiratory therapists and then more complex issues could be referred to the pulmonologist. 

Moderator:  Thank you.  The next is more of a comment I believe and not a question, but I’m going to read it anyway.  I’m not sure you can say that these tools improve patient management as the outcome data do not show significant difference.  We need to wait before we spend money on this. 

Carl Stepnowsky:  And that’s a great point.  I think that’s one of the issues which is what’s the ultimate goal.  What we also, and I need to go back and take a look at the percentage differences in terms of dropouts.  And so one thing that we are doing is reducing the number of dropouts.  So yes this needs to be looked at on a population basis and whether it’s an hour or an hour and half, is it worse than the use of these tools?  That’s a great point. 

Moderator:  Okay.  The next one is do we know the threshold of use that results in positive clinical outcomes?  Based on what the person remembers they did now reduce for night did not result in clinical differences.

Carl Stepnowsky:  Yes.  And another point to make on this topic is that our usual care group is, I don’t know the right way to say it, but oftentimes it sounds good or better than maybe what happens on a regular basis.  In the research protocol we’re able to kind of make sure that most people are keeping with the protocol, so we do the one-month phone call.  We do the one-month data download and if the patients are followed. 

I should point out that we did a retrospective chart review of CPAP adherence over a two-year period of 1,000 patients.  And of these 1,000 patients this they had data downloaded, so we know they had a clinic visit.  We don’t know how many people were diagnosed with sleep apnea who were prescribed sleep apnea who didn’t have a clinic visit, but of those that we saw forty-three percent used it between zero and two hours per night.  Another seventeen percent – another twenty percent had used it between two and four hours per night. 

That means from this representative sample of CPAP data download sixty-three percent were using it sub-optimally.  Thirty-seven percent were using it over four hours per night.  So if we take a look at the numbers when we look at what’s going on in research versus clinical, we’re really improving what’s going on.  

Moderator:  Thank you.  I’m going to read this next question because there may be a word or two missing, but I’m just going to read it as it is.  Can you provide that level of usual care in (UPC) described for all of your patients:  one week call and two follow-ups in the first two months?

Carl Stepnowsky:  Well was that a question?

Moderator:  The second part was a question with a question mark, so I don’t know if I can refer anything from that.  

Carl Stepnowsky:  Yeah.  I don’t know if I got that in that previous response, but yeah whether—how representative, I think a great study and one that I’ve been thinking about doing for years is what typically gets done.  Can we go back to a chart review?

And for all diagnosed CPAP users over the last one year what exactly is their clinical contact?  How many people have been seen?  How many people have had data downloads?  How many people have had that acted upon?  I think that’s really the reference for our research. 

And that would tell us how—whether or not the usual care groups that are being used not only in my research studies, but my [inaudible] other published in usual care groups whether they are representative of what’s going on out there. 

Moderator:  Okay.  Thank you.  I have a question of my own actually.  In regards to the patient’s use of the website, mycpap, what was the correlation if any regarding the patients’ access to the tools for education or help versus their increase in use of CPAP?

Carl Stepnowsky:  Yeah.  That’s a great question.  We haven’t looked at that yet because we’re still putting that data together.  We would hope that we would see a relationship between that, although we’re still analyzing that data.  

Moderator:  Okay.  Thank you.  Those are all the questions we have at this time.  We still have a couple of minutes so I would encourage those who are still on the line to complete our survey.  And for those of you who are still thinking of your questions please feel free to send them to the VIReC help desk and we will forward them to Dr. Stepnowsky.  

On behalf of VIReC I would like to thank Dr. Stepnowsky for taking the time to develop and present this text, extremely interesting, and also to let you know that our next session is scheduled for June 19th.  Our speaker is Dr. Barth Wilsey and the topic is the prescription opioid documentation and surveillance system.  

Again we would like to thank everyone for your participation and attendance today.  And, Dr. Stepnowsky, thank you so much.  

Carl Stepnowsky:  Great.  Thank you.  

Moderator:  Goodbye, everyone. 

Carl Stepnowsky:  Bye-bye.

**[End of Recording]**

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