"CPAP Adherence" Sairam Parthasarathy (09/22/2021)

October 04, 2021

ID6955

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00:09So good afternoon everyone.
00:11So welcome to sleep seminar.
00:13So it's my first. I'd like to start
00:15with a couple of reminders that that
00:18these seminar sessions are available
00:20for CME credit and that in order to
00:23receive credit you do need to text
00:25the unique ID to the Yale cloud.
00:27See any account that information
00:29will show up in the chat.
00:31If you do have questions.
00:32During the talk,
00:33please use the chat feature so that way
00:36we can get to those questions at the end.
00:39Otherwise at the end we can ask you to
00:41unmute yourselves if you prefer to ask
00:43your own questions and then finally do,
00:45please keep your microphone
00:46muted throughout the talk.
00:48So now it is my great pleasure to
00:51introduce today's speaker Dr Siren,
00:53Pastor Athy.
00:54Dr.
00:54Parthasarathy is professor of
00:56medicine at University of Arizona,
00:58chief of the Division of Pulmonary
01:00Allergy Critical Care and Sleep Medicine.
01:03Director of the University of
01:04Arizona Health Sciences Center
01:06for Sleep and Circadian Sciences.
01:08Medical director for the Center of
01:10Sleep Disorders Banner University
01:11Medical Center in Tucson and program
01:14director for the Sleep Fellowship program.
01:16He received his medical degree from
01:18Madras Medical College in India
01:20and following anesthesia training.
01:21Did his postdoctoral training,
01:23including a pulmonary critical care
01:26fellowship in Chicago at Loyola.
01:28He was director of the Sleep Disorder
01:30Center at Loyola before moving to
01:31University of Arizona, where he spent.
01:33Much of his career.
01:35He has received numerous awards
01:37and served on multiple editorial
01:39boards including the Blue Journal,
01:41the Journal of Clinical Seat Medicine,
01:42and Sleep.
01:43His work is really far ranging and
01:45his CV includes over 100 come somewhat
01:48diverse and peer reviewed publications
01:50with many additional book chapters,
01:52abstracts and invited presentations.
01:54He has been a strong force in
01:58education in both ATS and ASM.
02:00His current research interests include
02:02sleep intervention during acute lung injury,
02:05positive airway pressure therapy for sleep,
02:06disordered breathing,
02:07and heart failure.
02:08Adherence to CPAP therapy in
02:10patients with sleep,
02:11disordered breathing and
02:12sleep deprivation in urine.
02:14Models we are so pleased to have
02:16doctor Pothys Rocky joined us
02:19today to discuss CPAP adherence,
02:21treatment, treatment,
02:22adherence in patients with sleep apnea,
02:24welcome doctor practice,
02:25wealthy.
02:26Thank you, thanks Janet.
02:28Thanks for the kind of invitation and
02:31thanks to all I see a lot of familiar
02:33faces and hello to everyone at Yale and
02:36it's an honor to be amongst you and.
02:40I will be talking about
02:41see Pepper Durance today.
02:42I understand you have a hard stop.
02:44So uh, I will try to stay within
02:48my time limit so that there's
02:50time for some questions.
02:51So I do have a disclosure.
02:55I am a consultant for Jazz Pharmaceuticals
02:59and I believe this is information for
03:02your folks who are interested in CME.
03:07Uhm, I you know these are some
03:10of my funding sources, UM?
03:12I wanted to start off with
03:16this philosophical slide.
03:17Uhm, uhm, and this is Everett Koop,
03:20who as you know the surgeon General
03:23who wrote his article and smoking,
03:26which was revealing as to how
03:29smoking can actually cause harm so.
03:32Uh, my mentor actually worked with him
03:34on that particular project of the report.
03:36The Surgeon General's report on how smoking
03:39can be harmful because prior to that,
03:41it wasn't.
03:42So he's as a high stature in
03:45medicine and public health in the
03:47United States and he famously said,
03:50you know,
03:51drugs don't work in patients who
03:53don't take them.
03:54So I guess you can say,
03:56supplant that with C PAP.
03:58And so that's essentially my.
04:02One and only slide,
04:03so I will just finish the talk very quickly
04:07so that I can entertain some questions.
04:10Now it's just kidding,
04:12so I think it's very important
04:14to recognize that CPAP adherence
04:19not only informs how we can
04:25help patients symptomatology and
04:28prevent downstream consequences,
04:29but also.
04:32CPAP here and seems to be playing a big
04:35role in how we creating scientific evidence,
04:38so that's kind of unique to this
04:41particular area of study.
04:42It's just not downstream
04:45implementation signs,
04:46but it seems to also be affecting
04:48the scientific body of evidence
04:50that we are developing that can
04:52actually show that treatment of
04:53sleep apnea can improve outcomes.
04:55So the objectives for a talk today
04:58are two sort of from a health
05:01services research standpoint.
05:02Talk about some of the health care policies,
05:04UM, in this area,
05:05which I can tie into see Pepper,
05:07durin's talk about the determinants
05:10of adherence.
05:11Do a technology assessment and why
05:13we should be very familiar with
05:14technology and how that plays a role.
05:16And again, talk about healthcare delivery,
05:19how the implementation and delivery
05:21of healthcare can actually affect
05:23outcomes which are relevant to
05:25see Pepper Durance and downstream
05:27consequences as well as talk a
05:30little bit about future research.
05:32So you know what?
05:34What is the state of affairs?
05:36I mean,
05:36it's cheaper and it's really an issue,
05:38so this slide sort of gives you
05:41a geographic representation.
05:43This is essentially Geo.
05:44Linked data of over 170,000 people
05:47were part of a vendors database where
05:51you know the the C PAP Adrian stated
05:54goes and then we look at that data.
05:56The red dots are people
05:58are non adhering by CMS
05:59criteria and the blue dots are those who are.
06:02Adherent by Seamus Katrina, and as you know,
06:04this seems pretty resigned.
06:05A little bar or lower bar
06:07than what we would want.
06:08Which is, you know,
06:09greater than four hours of use and
06:11five nights a week rather than all
06:12nights a week or greater number of
06:14duration of views on a nightly basis.
06:16And in this particular study,
06:18we found that 53% of people in the
06:20real world by informatics study
06:22were non adherence to CPAP therapy.
06:25There are other data in this area
06:28to actually which are looking
06:29at a large big data research.
06:31It showed that.
06:33Adherence is probably closer up to 70%.
06:36One of the concerns we have with that
06:39methodology is is that it removed
06:41patients from the denominator.
06:43If they had zero adherence.
06:46In other words,
06:47if they see PAP machine registered zero,
06:49they did not count them in the
06:50denominator and therefore they
06:52didn't get counted in the denominator
06:53nor the numerator,
06:54and that may artificially increase
06:56the proportion of people or ignorant.
06:58I still think,
06:59and I've been asked a lot of
07:00questions about this number,
07:02but I still think.
07:03As long as you are methodologically sound,
07:06if you take all comers and then
07:08from an intention to treat aspect
07:10we have patients in clinic who
07:12have never used their CPAP,
07:13where they register zero.
07:14So those people were given a
07:16machine and they didn't use it,
07:18so they are non adherence regard and
07:20not you can't just take the people
07:22who use it for a few minutes for them
07:24to be counted in the denominator.
07:26And so when you look at,
07:28you know a healthcare policy, you know.
07:29And there's the national
07:30carrier determination,
07:31local carrier determination.
07:32And these are the number of beneficiaries.
07:35And the problem is,
07:36a lot of these policies are odds
07:39with each other.
07:40But the majority of the courage
07:41of determinate at local levels.
07:42So what is true in Arizona may
07:44not be true in your neck of the
07:47woods and vice versa because they
07:49operationalized differently,
07:50which creates geographic variation
07:52in health care delivery,
07:53which in of itself is a problem
07:56because it creates.
07:57Health disparities and as you all know,
08:00there is this 90 day rule or 12
08:02week rule or three month rule.
08:04How you wanna call it?
08:06But I guess 90 day rule is the
08:09common terminology and and and
08:11and the problem with this is that
08:13even though at that time when this
08:16then CD came out they expanded
08:18coverage to include home sleep
08:20studies and remove their two hour
08:23rule for the diagnostic aspect.
08:26Still stood by the fact that you cannot
08:28complete diagnose someone with sleep apnea.
08:29You do need to do this study,
08:30which we agree with.
08:32However,
08:33the 90 day coverage is is that
08:35as you are now,
08:36people don't are not here in my semen
08:38standards the machine benefits or
08:40loss of the CPI benefits loss and
08:42people start getting bills,
08:43even if they're part of a Medicaid
08:46program which causes health
08:48disparities or accentuates health
08:50disparities in this population.
08:52And of course they did say courage is it
08:56is allowed if the centers accredited.
08:58And the physician and or the
09:01physician are certified,
09:02and so I've been alluding to this
09:05health disparity aspect and then
09:07why it's important to sleep field
09:09is we've been facing a lot of.
09:14Headband lately with the Phillips
09:16device recall and previously, you know,
09:19meta analysis in JAMA as well as a
09:22couple of large multicenter trials,
09:24multi continent trials that were negative
09:27and we will be talking about that.
09:29But one of the movements is, as you know,
09:32in health care policy making is
09:34good with value based purchasing,
09:36but one of the problems with
09:38value based purchasing.
09:38So what is value based purchasing?
09:40So let's say if you're in the ICU.
09:43If you have a higher clabsi rate,
09:44you'll get dinged.
09:45You know if you have higher hospital
09:47read re admissions of patients
09:49with COPD and heart failure,
09:50you get dinged and you end up in a penalty
09:53box where they deduct you know .5% or 1%,
09:57or 1.5% if you are in the lowest quartile
09:59of that performance characteristic.
10:02But we know there's something
10:04called addition next,
10:05which is the disproportionate share
10:07of health disparity populations.
10:09So if your hospitals in New Haven is
10:12taking care of people more people who
10:14are in the lower social economic strata,
10:17you're going to have worse outcomes
10:19because there may be access to care issues.
10:22There may be ability to inability to pay
10:24out of pocket expenses and get medications,
10:27or there may be health literacy issues.
10:29And what will happen is these
10:31hospitals and these providers
10:33will get penalized even more,
10:34which means that those providers
10:36may migrate to more affluent
10:38territory areas and zip codes,
10:40in which case the health disparity in the
10:42lower social economic stratum ZIP codes.
10:44Will be actually worsened and and
10:49so this was actually a very telling
10:52article that talked about how you
10:54cannot tie metrics to UM reimbursement.
10:58Because if you did that,
11:02you can actually worsen health disparities.
11:04It may be an unintended consequence
11:06and that actually changed.
11:08For once,
11:09Medicare health policy and actually
11:11not using CPAP audience,
11:12for example as a valley based metric.
11:15Uhm for Valley based purchasing,
11:17so that's actually a good thing,
11:18so anyone who advocates for CPAP
11:21durans for value based care you
11:23have to be careful because you're
11:25going down a slippery slope fast,
11:27slippery, slope of accentuating
11:29health disparities for the poor.
11:32So we we had done a survey before.
11:34You know,
11:35looking at some of those provider
11:38based variables which turned 30
11:40patients where we took hard outcome
11:44of discontinuation of therapy.
11:46You know,
11:46we can always quibble about what is a
11:48meaningful difference in C PAP urine.
11:49Is it 30 minutes which is derived
11:52through consensus and propagated by the
11:54American Academy of Sleep Medicine?
11:56Or is it something bigger?
11:57So in this particular study,
11:59we just went with discontinuation
12:00of therapy because that's a pretty
12:02hard endpoint, right?
12:03I mean, if someone stops using pet therapy,
12:06you can say, oh, that's a meaningful change.
12:08It's either using it or not using it.
12:10It's not about 20 minutes or 30 minutes
12:12or extra hour or so on and so forth,
12:14and we use validated.
12:16Questionnaires to look at these variables
12:18of patient education risk perception,
12:20and that also confounders as well
12:23as patient satisfaction because
12:24that ties into healthcare delivery.
12:26And we found that centers that were
12:29accredited or physicians that were certified.
12:31If both of them are the case,
12:33there was actually a lower proportion of
12:36people had stopped using CPAP like 5%.
12:39If one of them.
12:41Where certified or accredited it's 7%,
12:44but if neither of them were certified in
12:47ways of accreditation or certification,
12:50you can see that the proportion of people
12:52who stopped using it is to actually 21%.
12:54So it's almost like a dose
12:56effect that you know.
12:57If you have care delivery given by
13:00people or certified and accredited,
13:02your risk of CPAP discontinuation is lower,
13:06so there's a nice dose effect
13:08between both being satisfied,
13:09being having the least amount
13:11of discontinuation rates.
13:12Uh, with none having the highest amount
13:15of discontinuation rate as a proportion.
13:18And one of the important you know
13:20aspects here is when we dive deeper
13:22and I'll go into sort of the multiple
13:25logistic regression model is is that
13:27you know the accreditation status
13:30was associated with the grade or
13:32odds or odds ratio of over 1.86
13:34of people discontinuing.
13:35And I just want to show you in
13:38step two there's nasal congestion
13:40and medication for this condition,
13:42which correspondingly either worsened
13:45the discontinuation of therapy.
13:48Are introduced the discontinuation
13:51of therapy,
13:53as evidenced by odds ratio of 1.57 and .28,
13:56suggesting that the nasal congestion
13:58factors or treatment for that is,
14:01uh,
14:01you know important determinant
14:03of Adrian's to see PAP therapy.
14:05So I'm going to skip this next slide
14:09to share that you know there's this
14:12outcome about satisfaction with
14:14physicians satisfaction with the center.
14:15It seems like a soft non biomedical outcome,
14:19but.
14:19Actually,
14:20value based care tomorrow is not going
14:24to go towards hopefully Tootsie Pop
14:26at your end because there would be a problem,
14:29but patient satisfaction is going to be a
14:32major driver in how valid is care morphs.
14:35In the future.
14:36It's not the volume,
14:38but it's the quality of care and one
14:39of the quality indicators you know.
14:41Besides,
14:42some of these other endpoints
14:43that you can suggest are the
14:46ultimate client satisfaction rate.
14:47And just like if you were to go buy a car,
14:49you know.
14:50The customer satisfaction is key,
14:52and similarly your patient satisfaction
14:54is going to be key and it's going to
14:56become a major driver in all of healthcare.
14:58That's why I wanted to point that
15:00out and few variables here that
15:02came out was that the time delay,
15:05the greater the time delay that lower
15:08the satisfaction and so access to care
15:10is an issue and discontinuation of therapy.
15:13So this is outcomes based satisfaction
15:15sometimes you may do the best job
15:17and taking care of your patients,
15:19but at the end result.
15:21If the outcome is not good,
15:22it's an undesirable outcome.
15:24The patients are going to say
15:27that they are dissatisfied.
15:28So I talked about the nasal
15:31congestion factor already
15:33and I think we tried to subscribe
15:35for towards this in our center.
15:37It just sort of came out of this
15:40health professions education for the
15:42national academies back in 2003,
15:44which is delivering patient centered care.
15:48And I just put you know,
15:50two domain areas such as how do you surveil
15:53for the surveillance for sleep apnea?
15:55And how do you promote CPAP adherence?
15:57But you need 5.
16:00Areas where a center needs and you
16:01know the staff need to have core
16:03competencies and which is being able
16:05to provide patient centered care,
16:07have an interdisciplinary team.
16:09Practice evidence based medicine and
16:12focus on quality improvements and
16:14have a huge amount of informatics.
16:17And of course during the pandemic.
16:18Times were big on informatics.
16:19A lot of telemedicine,
16:21telehealth happening in from a
16:23quality improvement standpoint.
16:24We actually see metrics of what our CPD runs.
16:26Dashboard looks like on a on
16:30a quarterly basis period.
16:32For example, a variable.
16:33I mean,
16:34I'm a measure that we have for
16:36our center as a metric,
16:38and of course we try to practice
16:40as best as we can.
16:42Evidence based medicine,
16:43although sometimes the evidence is still
16:45not available and we truly function
16:47doesn't transcend interdisciplinary
16:48team and I'll and I'll talk about
16:50what I mean by transdisciplinary
16:52as opposed to interdisciplinary.
16:54In just a bit.
16:55And but the key thing in all of
16:58this is patient centered care.
17:00And I know that one of the big gorillas in
17:03the room is this Phillips device recall.
17:06And this is where we truly are
17:10practicing patient centered care.
17:12And I'm going to speak about that and just,
17:14you know,
17:14just here,
17:15verbally and I don't have a
17:17slide because I I know there's a
17:20lot of nebulous details there,
17:22but we take a, you know,
17:23such variables in their camp,
17:24you know, as the patient using C PAP.
17:27Or they have a history of cancer,
17:30do a derived symptomatic benefit
17:33from the device,
17:34and if they had stopped therapy,
17:35did they become symptomatic?
17:37How bad are there other
17:40comorbidities outside of cancer risk?
17:42As well as whether they see
17:43particulate material,
17:44whether they are using ozone cleaner or not,
17:48and we actually do combined.
17:52Patient centered medical decision
17:54making with the patient or the
17:56caregiver and then we make a decision
17:59as to whether they choose with us
18:01with our advise whether they want to
18:03continue to use the therapy or not.
18:05Because we really don't have
18:07signs and evidence to guide some
18:09of our recommendations to them,
18:11so I know that question is going to
18:14come up so we do couch it in that manner.
18:17We do say that it sort of happened
18:19and so caution,
18:20and there's human cancer risk is.
18:22Improving and the particle
18:25a material causing problems,
18:27or at least as being reported in terms
18:29of particles that can be visualized.
18:30It's about points or eight person,
18:32and so we have a discussion and we
18:35find that 70% of our patients choose
18:37to continue the therapy device.
18:39And of course even in those people we try
18:42to get them in alternative new device.
18:46If it's more than five years.
18:48But even if less than five years as
18:51Janet was mentioning, we have had some.
18:53Luck getting some device for some people,
18:55and some people buy devices out of pocket.
18:57And so again, patient centered
18:59care in that manner combined.
19:01Medical decision making should be are not
19:04store and that is what we are practicing.
19:07So there is this topic about specialists.
19:10You know there are 47 million
19:11people with sleep apnea.
19:12Can specialist really take care of them?
19:14And that's a source of conversation
19:17as to how that can actually influence
19:19care in patients with sleep apnea,
19:22and especially see pepper durance.
19:25But this is study one of our
19:27fellows did along time ago.
19:29I'm showing that non specialists
19:32were more likely to give
19:34sedative nautic agent to as yet.
19:37Undiagnosed patient with obstructive
19:39sleep apnea that actually was
19:41associated with increased risk for
19:43motor vehicle accidents or near misses
19:45in those patients who received such
19:48non sitting sitting hypnotics where
19:50their LabCorp sleep was misconstrued.
19:53It's insomnia and instead of looking for
19:56sleep apnea, they're prescribed that.
19:57Now this is back in 2005 things probably,
19:59I mean, are much better now.
20:02However,
20:02this whole question about who should be
20:04taking care of patients with sleep apnea is,
20:07you know.
20:08Relevant and dumb,
20:10and it wasn't any of the other
20:12characteristics that made a difference
20:13in terms of years since graduation.
20:15Their perception about sedative,
20:17nautics and risks associated with them,
20:20or whether it's sleep was included
20:21in their medical school curriculum
20:23and whether they are knowledgeable
20:25about contraindications.
20:26None of them were significant
20:28between the groups of patients
20:29are either prescribed sedative
20:31or not prescribed sedative.
20:32And remember these are all people with
20:34undiagnosed obstructive sleep apnea.
20:35We're getting this additive, you know.
20:37Hypnotic and so why is that relevant?
20:41Because there's this talk, you know,
20:43and there's this really nice paper
20:45that was published out from Australia.
20:47Buy chocolates are and colleagues
20:49Nick Antiage.
20:51Uhm,
20:51you know.
20:52A finding that in a randomized control
20:54trial and primary care physicians
20:57were taking care of these patients.
20:59I was a specialist that they see
21:02PAP at Urance was non inferior
21:06in patients randomized to.
21:09Primary care in our end.
21:12Yeah,
21:12trained in the area of Sleep Medicine,
21:13but one of the concerns I had with
21:17this is that these RNS had about an
21:19average of 10 years of experience
21:21working in the field of sleep apnea.
21:24So if you have a RN that works
21:26for 10 years and sleep apnea feel
21:29you know you can argue that that
21:31person is actually a specialist,
21:32you know is on the job training
21:34as opposed to someone who did a
21:36fellowship and calls themselves that.
21:38And so when we did a meta analysis.
21:41Come come on, this particular issue.
21:44We found that by doing a you know
21:48systematic review that the CPAP
21:51adherence was indeed better in people
21:53in the published literature and
21:55sleep specialists were taking care
21:56of them rather than primary care.
21:58So I totally subscribe to a combined
22:01model of specialist working hand in
22:03hand with primary care physicians
22:05and there would be test shifting
22:08and collaborative interdisciplinary
22:09care being provided totally for it.
22:12But with the complexity that's
22:13evolving in the area of sleep
22:15apnea such as the Philips device,
22:17recall these risks associated
22:18associated with that as well as I
22:21work being done at Yale in terms of
22:23looking at loop gain and arousal
22:25threshold and different approaches
22:26to managing patients with sleep
22:29apnea ranging from hypoglossal nerve
22:32stimulation to medications targeting
22:35the controller respiratory control.
22:39Are you really getting into it?
22:41Pretty complex area where there needs to be.
22:43Perhaps the easier cases handled our
22:45primary care and the more complex
22:47cases handled by a specialist,
22:49so it's going to be something that
22:53more research needs to be done on.
22:55So as segue to determinants of adherence
22:59here and and this is sort of the slide
23:03with that where you have domains
23:05of therapy based patient based and
23:07health care delivery based variables and.
23:10You know,
23:11under patient there's the psychological.
23:14There's a physical and the social and
23:16actually hadn't updated my slide in awhile.
23:18But after Andres paper get published,
23:21I added the lower arousal threshold
23:24as a physical factor that's
23:26contributing to see patterns.
23:28And some of these are reversible,
23:31some of them are obviously or not,
23:33and some of them can be targeted,
23:34and so the areas that are highlighted
23:37in red become our targets.
23:39If you want to really improve,
23:41see Pepper Durance.
23:42In patients with sleep apnea,
23:44these are the determinants
23:46that we should be targeting.
23:48And so just to.
23:52Give a refresher and all many of you
23:54know all this data by the back of your
23:57palm and you know auto PAP therapy,
24:01at least the last cocaine review which
24:03is again dated suggested that it may
24:06actually help a subgroup of patients.
24:08Although bilevel,
24:09PAP and patient titrated CPAP
24:11or humidification had no effect,
24:12but CBT emerged and educational support,
24:17behavioral support psychological
24:19support has been shown.
24:22Uhm,
24:22to have a pretty high signal but
24:25there were concerns that the amount
24:28of data there was smaller and so the
24:31confidence intervals were large.
24:33And of course it's a date, admit,
24:34analysis and and and and so.
24:38A segue into some other physician variables,
24:41again,
24:41that can affect the puppet you're insane.
24:43This is a study that we did a
24:45gosh back in 2005 where we found
24:48out that time out of C.
24:50Pap's were given only four percent
24:52of the times. 96% of the time.
24:53So whether CPAP Bipap and you know,
24:55you can argue that it's going
24:56to be pretty topsy turvy now,
24:58so a lot has changed and at that
25:00time 30% of physicians said
25:01that they never prosper auto,
25:02CPAP devices and many were
25:04not aware of all the
25:06contraindications for auto CPAP.
25:08Dumb and dumb. In other words,
25:11their knowledge base and dumb and
25:13patient physicians with who actually
25:15had a greater volume of patients with
25:17sleep apnea practice were more likely
25:19to prescribe odyssey type devices.
25:21And so, and at that time back in 2005,
25:24half them, half the physicians did not
25:27request or insist on adherence monitoring,
25:29because at that time you need to actually
25:32ask for CPAP unions device to be attached
25:34to a machine like a modem or something.
25:39Which was attached to
25:40the back of the machine.
25:42So if you probably I'm not even
25:44seeing what it looks like,
25:46but you can just see that you know
25:49in this span of about 16 years the
25:52field of Sleep Medicine has rapidly
25:54changed where it's universal adherence,
25:56monitoring and and so it's quite
25:59different as to how we manage.
26:02You know, patients with sleep apnea.
26:05So this is again a cornerstone in this area.
26:09Self supported, reported.
26:10See patterns or Smiths significantly,
26:13and the C PAP usage people always
26:15or estimate how much they're using.
26:17And so therefore self reported
26:19stupider insufficient,
26:20and that's why we need to monitor
26:23people or 100% for their C Pap when I
26:26have resident physicians and medical
26:28students rotate with us and sleep clinic,
26:31I do end up by asking them, you know,
26:33with what clinic did where you at before
26:36you're rotating in Sleep Medicine.
26:38And I'll say, oh, you know,
26:40I wasn't in Thomaston clinic,
26:41or I was in the primary clinic.
26:43And I asked them,
26:45did you find out whether this person
26:48who was on a cholesterol lowering
26:50medication or and hypertensive
26:52or who's taking insulin for their
26:56diabetes and inhalers for their COPD?
27:00Did you monitor their adherence and I
27:04would say 99% of the time the answer is no.
27:07And then the question is do you?
27:09Did you withhold therapy in any one of them?
27:12A diabetic.
27:13Is not taking insulin to withhold their
27:16insulin because they're non adherence?
27:19And again, universally, dancers.
27:22Wow. No, we would never do that.
27:25So when I submit to you is is that.
27:29Sleep Medicine is the only field
27:32where we withdraw CPAP benefits.
27:34UM,
27:35if patients are nonadherent and it's
27:37just as you know, not just for CMS,
27:41Medicare,
27:41Medicaid,
27:42but it also is taken up by other
27:44third party insurance.
27:46So I know the American Thoracic society,
27:48you know,
27:49part of a some of you are part of that task.
27:52Force policy document is being written
27:55that hopefully will go and change this,
27:57but I was on a call with seems innovation.
27:59Center as a KOL,
28:01I'm talking to them about what ails
28:04the sleeper in area and come along
28:08with people from AHRQ and Corey and.
28:14QMP Corey were aghast that
28:17such a policy existed.
28:19It's only see Ms Innovation
28:20Center and also the CAG Group,
28:22which is the advisory group
28:24that determines what is covered
28:25by Medicare and Medicaid.
28:27And of course,
28:28all insurances follow Medicare Medicaid
28:29as to what is coverage,
28:31so the coverage determinations
28:32being made is done by device cagri,
28:35and so they were on the call as well.
28:37And they seem to know the policy, they said.
28:39It's not even set by the Department
28:41of Health and Human Services.
28:43It's actually a congressional law.
28:44That was passed in 2001 that has been
28:47not implemented for the longest time,
28:49but in the year 2016 or so it
28:52became implemented, and so you know,
28:54there are lots of laws that are
28:56not implemented as you know,
28:57but they dusted it out from 2001
28:59and decided to implement it.
29:01So this 90 day rule actually has
29:04its theology to this archaic
29:08lauders possible Congress.
29:10So the only way to go and change it is
29:12actually go to Congress and change the law.
29:15It's not American Medicaid,
29:16so they said the more data that you
29:19folks can generate that shows the
29:21puppeteer and is harming these people
29:23and making them not use the device,
29:27sends that data and but also lobby
29:29so that you can actually go and
29:31change the policy in the land.
29:33Then there's no other chronic medical
29:35condition in the United States of America.
29:38Where treatment is withheld
29:39of people are non Indian.
29:41The only only condition is obstructive
29:44sleep apnea and it's based on CPAP
29:47nonadherence and so that's why you
29:50know we're talking about it here and
29:53so let's telemonitoring you know we
29:55just did a sea change in the way
29:57we practice medicine and I know
29:59at one point in time you all were
30:01practicing our person telemedicine VR.
30:03Right now I would say about 85, fifteen 85%.
30:08In person and 15% Tele medicine.
30:12Although that number keeps fluctuating
30:14of course,
30:15as we continue to go up on the
30:18foot surge and and this was done by
30:21Carl Stepnowski at UCSD and found
30:23that at that time that it was only
30:25as effective as usual care.
30:27But there's a question as to whether
30:29there's a underpowered study,
30:30which is 45 participants,
30:32and so one of the questions that keeps
30:35getting asked is where is the evidence?
30:37Why?
30:37Why?
30:38Why should we treat our circle sleep apnea?
30:41You know,
30:41it's just before I started making tacos.
30:43Just talking with Janet about
30:45you know we're having some basic
30:48discussions with patients when
30:49we're doing the Phillips recall.
30:51Like why are we treating you again?
30:53Oh yeah, I know,
30:54we're treating you because
30:55if you stop using it,
30:56you're sleepy or you have comorbidities.
30:58We're having that discussion now,
31:01but when you go to somehow in the
31:04HRQ released, you know, as you know,
31:06a document which said that why should
31:08we treat people with sleep apnea?
31:10Because there's no evidence in
31:11the field of sports that well,
31:13here's data.
31:14Uhm, you know this is the HYPOCRIT trial.
31:17This is the Spanish multi collaborative
31:19group which actually showed that
31:21you have reductions in 24 hour
31:24blood pressure with the mean,
31:26and that's solid blood pressure and you
31:28know when you compare that with blood
31:30pressure of meta analysis that have
31:32been done using inhabitants of these,
31:34you know data very, very, you know,
31:38compareable and so patient level strategies.
31:41Have resulted in a drop in blood
31:43pressure of 3.9 millimeters mercury,
31:45and that's very comparable to what
31:47was seen in this multicenter trial.
31:49Yes, it is true that this is for
31:51people with resistant hypertension
31:52and obstructive sleep apnea,
31:54so it's not all comers,
31:56but you can see that you know that C.
31:59Pap is beneficial in improving
32:01blood pressure, and as you know,
32:03with every millimeters of mercury I
32:04don't need to tell this group that
32:06you reduce their mean blood pressure.
32:08You introduce a lifetime risk
32:10for cardiovascular events.
32:11Including you know,
32:12heart attacks and strokes, so, uh,
32:13this these are real numbers and their
32:16compara bulto and hypertensive medications.
32:19And so when we hear about,
32:21you know where's the data?
32:22You know at least we have
32:24data in hypertension.
32:25Now Pastor air pressure therapy.
32:27You know in the form of anonymous passers,
32:30therapy or bilevel PAP therapy.
32:31In the home there's strong data,
32:34again, not from the US,
32:36from Europe and the UK.
32:40In a multicenter study by clean
32:42and all and Murphy and colleagues
32:45showing that when you apply an IPV
32:48or an Ivy in patients with COPD,
32:50you can reduce mortality.
32:54You can improve survival and so
32:57so data showing that posterior
32:59pressure therapy in these people.
33:02That Pastor impression therapy
33:04can make it then.
33:06On survival,
33:06but somehow in the US we haven't
33:09done a large multicenter trial
33:11in patients with CMPD,
33:13and so that's really a question
33:15as to what the strategic.
33:17Our plan is and what does the
33:20strategic plan support so many
33:22investigators in this area?
33:23You know, Jerry Kraner and Nick L.
33:26You know, I, you know I myself.
33:28We made a lot of attempts at doing.
33:31Gosh,
33:31twenty $30 million grants to actually
33:33address probably one of the top five
33:35reasons for death in the United
33:36States of America, which is COPD.
33:38And we saw can't get that trial done
33:41in EU S because why is that important?
33:43It's important because.
33:46Research, however,
33:47that level of evidence is done
33:49outside of the US.
33:50Don't change healthcare policy.
33:51This is should.
33:52Making the US you need a study done
33:54in the US to change healthcare
33:56US health care policy and it is.
33:59We are remiss and not doing multi
34:01center trials and not just COPDN IV.
34:04But not doing a large multicenter
34:06trial on sleep.
34:08Happy.
34:08And how we can improve
34:09outcomes because you know,
34:10you know this is a meta analysis showing
34:13that you know with the published literature,
34:15not just those two studies,
34:17you can reduce mortality.
34:18The hazard ratio mortality is lower,
34:21but why are we set back?
34:22Why can't we do this multicenter trial?
34:24Well,
34:24we actually have the odds piled up against.
34:26As you know,
34:27this is one of the hits that
34:29we took. You know, one of gosh,
34:31four heads that we've taken
34:32in the past five years.
34:34You know, starting with the SAFE study,
34:36the Soviet chef study,
34:38and other JAMA Meta analysis,
34:40and now the AHRQ report.
34:42And then the Phillips recall,
34:45and so in this particular study,
34:46this study is, she know,
34:47did not show improvement
34:49and survival similar to the
34:51RIKHOTSO trial and other trials.
34:53But when you do an analysis,
34:55secondary analysis,
34:56or even our priority stated analysis,
35:00where we look at the only people
35:02who are adherents and you can
35:03see that you can actually help.
35:05Show that there is a need,
35:06a signal and the signal is
35:07actually stronger for strokes,
35:09and I know that you know,
35:10uh, klar,
35:11yaggi and Don Bravata have
35:13published in stroke as well,
35:15showing that the signal is actually
35:17stronger in as being able to use
35:20plaster pressure therapy and sleep
35:22apnea to make a dent there and
35:24reduce the risk for having a stroke.
35:27Our repeat stroke after Tia A but,
35:30but of course,
35:31if you don't put that as a primary end point,
35:34you know all these secondary in points.
35:36It goes a wash even if you had
35:38stated that adjusted analysis,
35:40our priority,
35:41and of course that's why
35:42they put sleepiness score,
35:44which showed significant
35:45improvement in these people.
35:46Unlike the study done by Kushida
35:49effective CPAP on sleepiness,
35:51which was again a negative study,
35:53whereas in the same study it
35:55showed that sleepiness doesn't need
35:56improve and but of course it's.
35:59You know if you go use the FDA,
36:01you know rubrics.
36:02If it's not your primary
36:04endpoint or if it's not.
36:06If you don't hit your primary
36:07end point is a positive.
36:08Every other endpoint is out the door.
36:11You know,
36:11by evidence based medicine and by FDA rules,
36:14and so this is nobody
36:16speaks about this as much.
36:17Because yes,
36:18it was a native trial for criminal outcomes,
36:20but sleepiness did improve.
36:23And hospital anxiety depression scale
36:26improved as of 36 in EQ5D as quality
36:30of life indicators also improved.
36:32But what was very concerning
36:34is that in the SAVE trial she
36:37knows multi continent study.
36:38That adherence was in about
36:422.8 hours or so for the entire
36:44group in their treatment arm.
36:472.8 hours. Let's go back to you
36:49know whatever it SI Group said.
36:51If you don't use drugs.
36:53I'm going to help,
36:54and so if you don't use a C PAP
36:57in intention to treat analysis,
36:58we're going to draw a blank.
37:00So C pap insurance not only is
37:02important for patient centered care,
37:03but it's also affecting our ability
37:06to develop the scientific body
37:09of literature for us to address.
37:11And get third party payers to pay
37:13for it or be able to give this
37:15device to people and so that's
37:17where they you know that's why
37:19I see Papa John's assumes even
37:21more important than you know we.
37:23We talked about the service
37:24of trial and you know
37:26there are issues of the Soviets have trial
37:29which you know skip over here and to go
37:33to the meta analysis where there was,
37:36you know compare PAP therapy versus control
37:39or preventing cardiovascular events.
37:40Of course this came.
37:42You know well before the AHRQ
37:43report and they essentially drew
37:45the conclusion that there is no,
37:47you know, benefit to PAP therapy,
37:50but in the four trials where more than
37:53four hours of adherence were achieved,
37:55there was, you know, relative risk reduction,
37:5842% reduction in relative risk,
38:01and so, again,
38:02we cannot cherry pick those studies,
38:05but some other problems with this meta
38:07analysis was a heterogeneity of intervention.
38:11There's a heterogeneity.
38:12Of population, if you look at pick ATS,
38:14the event rates were low,
38:16which the authors themselves
38:17admitted to and then there was
38:19undue influence on one of one study.
38:21Essentially 73% of the three
38:24or 56 events were in.
38:28You know studies.
38:29You know there were contributed
38:31by the same study.
38:32So, uh,
38:33when you do a meta analysis,
38:35you have to look for a new influence,
38:36and so unfortunately there was undue
38:39influence of one study in the outcome of
38:42this meta analysis and and that is an issue.
38:45So what is being done about it?
38:47You know this is a last Cochrane review
38:50showing that you can do educational
38:53supportive behavioral interventions.
38:54You know all three different categories.
38:56Or the intervention.
38:57Could you know submit?
38:58All of these three inside of them can
39:01indeed improve adherence in these people,
39:04and but when you,
39:06when you look at how many there
39:09are in clinicaltrials.gov that are
39:11focused on improving, see paper.
39:12Durance is only 6.
39:14Yes, we live in an era of medications,
39:17addressing loop gain, arousal threshold.
39:19Yeah, have a glass of nerve stimulation.
39:23No, I don't know uh neck collars,
39:25you know,
39:26no sprays that are going to
39:28be addressing sleep happening,
39:29but right now when you have a bad
39:31patient diagnosed with sleep apnea,
39:32your choices are three which is C pap,
39:35you know?
39:37Hypoglossal nerve stimulation story,
39:38not in that order,
39:39but dental device and I haven't
39:40lost in isolation.
39:41So that is where we are in so right now,
39:45until all of that data comes to
39:47the forefront, you know.
39:49This is still something that is an
39:51issue that needs to be addressed,
39:54and so this whole concept of adherence,
39:56you know in certain fields it's
39:59not transposable to other fields.
40:01You know this is actually a work
40:02done by Lynn Gerald in our group.
40:04Here you know she did a large
40:07trial in children in Tucson,
40:09AZ and try to see what was the
40:11relationship between asthma control on
40:13the Y axis and adherence to the X axes,
40:16and she found there's no relationship.
40:18You know, the more adherent they are.
40:19Yes, well control in a questionnaire.
40:21Symptomatology was similar.
40:22Uhm,
40:23that's probably because you know
40:25the more severe asthmatics are gonna
40:27be taking more of the medications
40:29and vice versa,
40:30and it may even itself out.
40:33But in sleep, you know this is in a really
40:35nice paper and work done by Terry Beaver.
40:38But of course, I'm citing a review article
40:40showing that there is a dose effect you know,
40:42between you know in within C PAP use,
40:45and there's a some of them flatten out.
40:47Some of them seem to be going up, and so.
40:50And they don't show a flattening of
40:53that curve, suggesting that there
40:55is indeed a continuous dose effect.
40:57So more is indeed better in
41:00the field of C PAP therapy.
41:03And so apologies for that and so
41:06there is data showing that, UM.
41:11Cognitive behavioral therapy
41:12has a pretty strong,
41:14powerful effect as in the study,
41:17but the problem is is that you know there are
41:21small studies and they're not well powered,
41:23so more needs to be done along those lines.
41:26So I'm going to flashback to the
41:28first slide I showed you in terms
41:30of C pepper and some problem.
41:31It's actually much higher than what's
41:33the estimated by certain studies,
41:35and if you look at randomized control trials,
41:38the proportion is actually worse.
41:40In the real world studies,
41:41actually,
41:42if you take the acts and look at them,
41:44the audience in the treatment
41:46arm is actually worse than 47%.
41:50Here 53% are non Indian,
41:5347% are different and it's actually
41:54worse in in in clinical trials if
41:56you do it as a meta analysis and
41:59that's been published by folks in
42:01EMT who want to push for why you
42:02know people should be getting,
42:04you know up every surgeries or
42:06hypoglossal nerve stimulation.
42:08But then you take the ZIP code.
42:11To which the CPAP devices are Geo
42:13link and you plug in their median
42:15income of the ZIP code you see a huge
42:17health disparity and you know you
42:19see that as you go up on the median
42:22income quartile from one to four.
42:24A lot of people have shown this data,
42:26you know Jesse Baker,
42:28and has shown this in New Zealand.
42:31Pepper and company are showing
42:33that in the home PAP study UM and
42:36and so this is not novel.
42:38What we had done.
42:39But it was database which was nationally
42:42representative and we're able to actually
42:45see the socioeconomic data and show
42:48step changes in adherence across this.
42:50And this is very relevant because
42:51we live in a time where there's
42:53more recognition of how this
42:55Paris during the code pandemic,
42:56how it disproportionately effects
42:59communities in the lower SES and therefore.
43:02You know we need to do more,
43:04and so that's the reason why we went
43:06with a patient centered approach
43:07and doing behavioral support,
43:09which is focused on promoting stuff,
43:12efficacy,
43:13promoting outcome expectancies and risk
43:16perception and also activating the patient.
43:19Being able to actually make them
43:22take charge of their health care,
43:24combine them with the patient
43:26who's naive to the PAP therapy and
43:30user interactive voice response.
43:32Because I can tell you that
43:34the lowest paid employee
43:35in our sleep centers are always at the
43:37tip of the spear, they are incoming.
43:41All kinds of calls that are coming to them.
43:42So what we have adopted
43:44in this is I interact.
43:46Voice response approach that it actually
43:49distribute those calls to the respective
43:51person based on an algorithm through
43:53what the patient says that they want.
43:56So it'll go to resperate happens.
43:57It's a question about our ASP.
43:58It'll go to a nurse if it's about nasal
44:01congestion, it'll go to a support person.
44:04NYC where so and so we did this
44:06research differently, right?
44:07A lot of times we listen to a talk.
44:09We get a spark in our brain and say, oh,
44:12you know what I'm going to actually go study
44:13that that's not how the study was done.
44:15This is peak worries methodology, which
44:17is essentially research done differently.
44:19Where we actually said, OK,
44:21what is the burning issue in
44:22the sleep apnea field?
44:23Let's get all of these stakeholders,
44:25purchasers, payers principle investigators,
44:27the ASM American Sleep Apnea
44:29Association is a patient public
44:32advocacy organization providers,
44:33various kinds of providers.
44:35And patients and we brought them
44:37together and said, you know,
44:39how would you design this study?
44:41What are the outcomes that are important?
44:42How would you rank these outcomes
44:44and guess what?
44:45They ranked as number one.
44:46They ranked as global patient
44:48satisfaction of care dollars number one.
44:49And there was concordance amongst the
44:52various stakeholders that they agreed
44:54that this would actually be a top
44:56priority because patients are smart.
44:58They know when they got good care and
45:00when they didn't get good care and so
45:02we can come up with weird metrics.
45:04But global patient satisfaction.
45:06Emerged as our metric.
45:08And and then we got this what
45:09we call non binding input.
45:11You know if you're bidding for a home,
45:13you know you're on the hook.
45:16You know if they say you need
45:17to fix that shingle,
45:18you need to fix the shingle,
45:19otherwise you can't sell the home,
45:20whereas that's binding.
45:21Whereas here this is non binding input
45:24so we got seems Innovation Center.
45:26We got United Healthcare medical directors,
45:30you know of Aetna and everybody on
45:34as you know pairs to get their input.
45:38And they could give input without having
45:39to buy the product at the end of the day,
45:41they don't have to buy the product
45:42and so and again we got input from
45:44then and the conduct of the study.
45:46How we can actually do better recruitment
45:48as well as how we could do a better job
45:51with dissemination and implementation.
45:53And you know this is a study that
45:55was powered for about 260 people that
45:58were randomized to these two arms and
46:00there was an attention control arm
46:02besides the PD IVR which called Pure
46:05driven intervention with interactive
46:06voice response as compared to.
46:09Attention control,
46:10and when we randomize them,
46:12we found that global patient satisfaction
46:15was better in the PDI VR arm.
46:18You know we can have a discussion as
46:20to how significant that is or not.
46:22And this is the table that goes with that.
46:25But the C5 adherence data was actually,
46:28you know, better. Again,
46:29in terms of minutes you spend night or
46:31partial nights used greater than four hours.
46:33And again, lot of you know 50 minutes mean
46:36you know it's 50 minutes mean anything.
46:39And so that's why we looked
46:41at number needed to treat.
46:42In other words, what we looked at.
46:44The outcome was how many people
46:45did you need to treat with a peer
46:48driven intervention to prevent one
46:50person from losing CPAP benefits?
46:52In other words,
46:53but one person that did not meet
46:56the Medicare CMS 4 hour rule and
46:58therefore would have lost their
46:59CPAP benefit as a result of that.
47:02So we found that at the NT was nine.
47:05So if you actually ran,
47:06you know treated nine people with its PDI VR.
47:10You prevent one person from outright
47:12losing the C PAP therapy device,
47:14and so we thought that that
47:16was significant and and.
47:18And also we looked at measures
47:21of care coordination.
47:23And health care services and delivery and
47:25found that it was superior in this group,
47:28so I'm going to just touch
47:30upon technology assessments.
47:31UM, and I know I'm short of time, but.
47:36Uh,
47:36you know,
47:37know your device auto CPAP therapy
47:39devices or perform very differently.
47:42You know we have issues with the
47:44device recalls right now,
47:45but their performance is also very
47:46differently.
47:47Is a bench studies that we've done
47:48in the past during that,
47:50given the same set of conditions with
47:53a Starling resistor and resistor on
47:55a bench model with artificial lung,
47:58and that these devices perform
48:00differently and that air leak
48:02is a big issue with how they
48:04function or not function and.
48:06We showed that in both the bench
48:08model as well as when we did a
48:11human study and looking at idea
48:12in an Indian patients not with
48:14this level of sophistication that
48:16you know Andre is injected with
48:19your arousal thresholds and such.
48:21And we found that you know air
48:23leak was higher in the group.
48:25There was non adhering to supposed
48:27to adhere and so you know having
48:29a good mask fit is important and
48:32addressing that is important
48:34and I know I'm preaching to.
48:36Group that knows this.
48:39You know,
48:40by the back of their hand,
48:41so you know there are data out there,
48:43even though it analysts were
48:45not supportive that he did.
48:46Humidifiers reduce our effects provided
48:48urine's as well as nasal pillows.
48:50But there are so you know,
48:52single studies that are out there.
48:53Although they didn't make up up to
48:56a measurable level in meta analysis
48:59and this is work done my route,
49:01you know Buddy Roger,
49:02who who was you know who's in Harvard Nam,
49:04but you know was that you know
49:07to sign in at the uofa before.
49:10Where he showed that you know,
49:11early CPAP use predicted subsequent years.
49:13Why is that important?
49:14Because identifying those early
49:16CPAP non ideers that's when you can
49:18bring in your limited resources like
49:20appear to intervention into play or
49:22any other intervention that you have
49:24into play so that you can actually
49:26change the trajectory of non adherence
49:28as opposed to giving everybody that
49:30resource which is finite and limited.
49:32You'd be able to see how they do in
49:34the first seven days of adherence and
49:36bring that particular intervention into
49:38play and that's why that predictor of CPAP.
49:40Non adherence or adherence
49:42becomes relevant and important.
49:45I'm going to skip some slides here.
49:48Uh. And sorry,
49:50I just wanna make sure I come,
49:54you know, give some time but end
49:56with these couple of slides.
49:58What is was disappointing when we
50:00looked at ZIP code based median income
50:02quartile based non adherence is that
50:04when we looked at you know and this
50:06is about 170,000 people going back
50:08about 17 years and when we looked at
50:11them we found that when you put them
50:13in quartiles the people are the lowest
50:16income quartile which is the blue symbol.
50:19Uhm,
50:20continue to lag behind the others
50:21and you can see that between the
50:233rd and the 4th income quartile
50:25there is a steep drop off.
50:26It's almost like a hemoglobin
50:28dissociation curve or something,
50:30and the shoulder and,
50:31and I think that's about the time
50:34that out of pocket pay and expenses
50:36to be able to buy a mask that works
50:40for them becomes a factor for them.
50:41And people are picking and choosing
50:43us whether they're going to pay
50:44copay on their blood pressure,
50:45medications, heart failure,
50:47medications, and diabetes medications.
50:49Our father CPAP device,
50:52which has been withheld from them
50:55for nonadherence and So what is
50:57was doubly disappointing that the
50:59Affordable Care Act and Medicaid
51:01expansion in the year 2014 had made
51:04no dense in health disparities.
51:06So this is still an area that requires
51:09study and interventions to address that,
51:12and when we you know in this particular
51:14graph and you zoom in when you look at
51:17these quartiles and you do a Kaplan
51:19Meier for when they start becoming.
51:21At your end or non idea and you can
51:22see that they curve start display
51:24it on 90 days and then they start to
51:27display even more 120 days in focus
51:28groups with RDM we find that they
51:30give almost a 30 day grace period even
51:33though that there's the 90 day rule
51:34they give a call at the 90th day or so.
51:37Did they get to it and then they give
51:40multiple calls saying hey we're gonna
51:41report you to collection agency or
51:43they send them a bill in the mail
51:46or they you know I'm keep badgering
51:48them and so you can see that's when.
51:51It actually plays even more,
51:53and so when we look at a
51:55difference in difference analysis,
51:56we find that those two time points
51:5890 and 120
51:59days is where that health
52:01disparity becomes more apparent,
52:03and so I can't think of something
52:06more telling we came upon across
52:09this innocentis manner that this
52:11is ties to a man made rules,
52:13so it's hard enough to use an
52:16external device that requires
52:17behavioral change and use it nine
52:20play as opposed to an implanted.
52:21Device that needs to be turned on.
52:23UM, that requires behavioral change.
52:27Uhm, on top of that we have these
52:29man made rules that exist only
52:31for the sleep apnea condition.
52:33So I think we need to do a lot in
52:36this area to actually address there's
52:39some issue which is affecting the
52:42signs and affecting patient care,
52:44and we repeatedly keep doing the
52:47same studies without actually
52:49having strong robust CPAP adherence
52:52and proven CPAP adherence.
52:55Promotion interventions in the
52:57intention to treat or intervention
52:59arm as long as we keep doing that,
53:01we're not going to generate the data.
53:04Uh, to show you know what we
53:06would like to show up,
53:08so I'll stop there and I I don't.
53:11I'm sorry I didn't get
53:13much time for questions,
53:14but I appreciate your attention,
53:17so Janet handing it back to you.
53:21Thank you so much and that
53:22was absolutely outstanding.
53:23I mean, you really need just
53:25such a case for why it's so
53:26important to treat sleep apnea.
53:28Why it really needs to be approached from a
53:31patient centered and team based approach,
53:34and I think that's really key.
53:36You know, with a new man,
53:38you made a very good case for what you
53:39know with health disparities and where
53:40I think we're seeing that more and more,
53:42you know, at one point prior to the pandemic,
53:45I think some of our DNS as well as
53:48we at Yale had we're trying to think
53:50about and start a compassionate.
53:51CPAP program to just try to get these
53:54patients you know at that 90 day,
53:55you know because there are some
53:57people who really obviously can't
53:59afford you know those copays,
54:00and with the pandemic it seems that a
54:02lot of those programs have shut down
54:05and have it really started back up.
54:07What's been your experience with
54:08those kinds of programs?
54:11Our experience has been the same.
54:12There's a lot of concern
54:14about infection control.
54:15It existed even before.
54:17Must be honest,
54:18we use a lot of refurbished CPAP.
54:20There are local support groups,
54:22non profit centers that was actually
54:25refurbishing CPAP in issuing them.
54:29They actually couple of them shut
54:32down under threat of a lawsuit for
54:34spread of infection and this was
54:36even before the COVID pandemic.
54:38And of course the physicality
54:39of being able to meet people and
54:41support them as being a major issue.
54:43As you know and so we've had that
54:46same sort of sobering effect
54:48and dampening effect on such
54:50separate programs and mechanisms.
54:53Right, it's difficult.
54:54I'm gonna start reading some questions
54:56that are coming in from the chat one.
54:58We just move up from Clara Yagi,
55:00a wonderful talk.
55:01How about instead of a C PAP for all
55:04approach where half donate here and
55:06become disenfranchised from care?
55:08Seems that we like to be heading to.
55:10It seems we need to be heading
55:12to more of a precision medicine
55:14approach up front with multiple
55:16modalities targeted to an individual
55:18patient preference and Physiology.
55:19Your thoughts?
55:20I'm 100% in support of that.
55:23Uhm, I I just, uh, you know,
55:26as both the researcher and as a clinician,
55:28I want guidance.
55:30And I want also help with
55:33operationalizing the guidance right?
55:36I mean, we got 40 minutes for new patient,
55:3820 minutes for return. Patient.
55:39Sorry I'm sort of bashing
55:41our bean counters here.
55:42Which hey, you know,
55:42hopefully they're not on the talk.
55:44They don't get on these talks
55:45because they're counting the beans,
55:47and so all I'm saying is just that
55:51I am totally in agreement with that.
55:53Approach, I just need guidance
55:55that I can actually easily
55:57implement in my clinical practice.
56:00That's the ask.
56:01Thank you, Karen Johnson has a question.
56:04You know the unmap expert panel
56:05had a lot of discussion over
56:07what Medicare should be asked to
56:09cover for not appear in patients
56:10as well as weather follow up.
56:12Visits are needed to keep the device.
56:14If a patient is adherent,
56:15what specific ask would you have
56:17for CMS or Congress in terms of
56:19how to cover devices and supplies?
56:23I really think they need to cash,
56:25so there are two separate things.
56:27One is device and suppliers right?
56:29And so the they need to make
56:31this 90 day rule go away.
56:34I honestly that's what I think
56:35and I think it should be based on
56:38whether someone has intent to use it.
56:40If someone has an intent to use
56:42they should be allowed to use it.
56:43And it's not like withholding
56:44insulin from a diabetic was emo.
56:46Globin A1C is 9.
56:47I mean, that's ridiculous,
56:49and so that's one supplies.
56:53Uhm, you know I actually, I got called
56:55by the office of Inspector General.
56:57You know while ago because the red
56:59one of our papers on resupply rates,
57:00which I didn't share today,
57:02and because they wanted an opinion,
57:03I thought I was in trouble,
57:04but they said no no.
57:07Like no, no,
57:07we want your opinion because we're trying to,
57:09you know, audits EMS.
57:10I mean DHS as to how they are doing
57:13the supplies and I think they
57:14also talked to petrol and couple
57:17other people and so you know,
57:18as they initially of course
57:19it was a little taken aback.
57:21But you know where the supplies.
57:23I really think we need to do a
57:25better job giving supplies up front.
57:27You know what they have is a
57:30prescriptive oh every three months.
57:32But we all know that in the first
57:3490 days they probably need more.
57:36They need exposure to.
57:37More devices and then they can paper it
57:39out and so when we looked at a hearing,
57:41people and an Indian people we
57:42could see the refund rate threshold
57:44which was something like .75
57:47masks and accessories in a one
57:50year period and that's the that's
57:53what enduring people are using.
57:55But in the first three months
57:57they want four machine,
57:59four mass so that it can find
58:01the message works for them.
58:02So I think you know they're going with
58:04a cookie cutter approach rather than
58:06a tailored approach, and I think.
58:07We need to go with a tailored approach
58:09where they get 5 masks in the first 90 days.
58:12I don't know maximum and then you
58:14can taper down to you know one mask
58:16every six months rather than one mask
58:18every three months during the entire life.
58:21I think that sounds fabulous.
58:22I think. I think you're
58:23definitely onto something there.
58:25I think we have time for one more question.
58:26Andres in check.
58:28Also, thanks for a wonderful talk.
58:30He said. What utility did you
58:32find in having summary adherence
58:35data for your sleep center?
58:36Did it lead to changes in
58:38practice or new interventions?
58:41First of all, it meets our SGM
58:43requirement for someone to do
58:45a quality improvement project.
58:46It's a low hanging fruit.
58:48I'm just sharing that with you,
58:49so they're not struggling so that then
58:50they can focus on their research project.
58:52And as you know, with these software,
58:54you can actually do an output
58:55of an Excel file.
58:57That's all I ask him to do.
58:58Hey, go click the output button
58:59generated and tell me how many
59:01people right here in an Indian.
59:02Now you tell me you create a white
59:04paper on your Qi because you already
59:06done that in literally 5 minutes.
59:08You've done your QR project.
59:10I want you write a white paper.
59:11And what you gonna do to
59:12help improve adherence?
59:13And that's where I get all my
59:15ideas to do sleep over there,
59:16see studies and sorry the second
59:18part of the question was what,
59:20again,
59:21whether this led to changes in
59:23practice or new interventions.
59:25Yeah, it did.
59:26And that's where we get our ideas.
59:28It led to changes in practice.
59:31For example, one of them decided
59:33to do it selectively on people who
59:35recently hospital discharge and
59:37and he hasn't written a paper, but.
59:41You know, showing how the people are
59:43adherents with their device after hospital
59:45discharge you know these are people.
59:47Comma, dislike CPU,
59:48basically hyperinflation syndrome or
59:50failure or less likely to get re-admitted.
59:53Then we were able to actually show
59:54that to our 30 hospital healthcare
59:56system spanning five States and
59:58we actually have a working group
01:00:00about how we can actually promote
01:00:02have therapy be at an Ivy or C PAP
01:00:05for patients with comorbid CPD to
01:00:08help reduce re hospitalization.
01:00:10And of course we've tried.
01:00:11Getting funding from NIH DoD Bakery and
01:00:14you know, that's not just me, you know,
01:00:17Jerry Trainer and they kill myself.
01:00:19We've tried it so many times and failed,
01:00:22but now we want to try and do
01:00:24maybe something in the realm of
01:00:26implementation science, but that's what.
01:00:27Led to that idea.
01:00:29So these Qi projects,
01:00:30by being able to do that.
01:00:31Looking at the dashboard is a is a good
01:00:34way for us to improve our outcomes.
01:00:37I mean, thank you. I think we are.
01:00:39We are at time right now,
01:00:40but this has really been
01:00:41just such an informative and
01:00:43and just interesting talks.
01:00:44So thank you so much for your time,
01:00:46really appreciate it.
01:00:47Thank you so much.
01:00:48Thanks for hiring me.
01:00:49I'm good to see all of
01:00:51those friendly faces there.
01:00:52Yeah bye bye bye bye now.
01:00:54Thank you bye.