Toppling Barriers to CPAP Compliance

How Patient Education, New Technology Help OSA Patients Get Sleep

• By Janis Rizzuto
• Apr 01, 2010

• Discomfort with the constant air pressure
• Irritation from an ill-fi tting mask
• Confusion about equipment function
• Embarrassment in front of a bed partner
• Depression about having a sleep disorder

And the list goes on…

The barriers to patient compliance with continuous positive airway pressure (CPAP) therapy can be many and vary by patient. So toppling those barriers isn’t easy, but sleep experts say they can—and must—fall if obstructive sleep apnea (OSA) patients are to get restful sleep. Layer on this the challenging Medicare compliance requirements that drive reimbursement for CPAP equipment, and the mandate for compliance becomes crystal clear.

Still, there is a long way to go. Experts in the CPAP arena quote statistics showing alarming rates of noncompliance. Some say that about half of CPAP patients give up on therapy in the fi rst year. Worse, what “compliance” itself means can be an issue. Do providers subscribe to the Medicare defi nition that says a patient is “compliant” by using the equipment four hours per night, 70 percent of the time in a 30-day period? Or do providers aim for something beyond that, measured more by an improvement in the patient’s condition?

Despite the lack of consensus about the defi nition, respiratory therapists, equipment providers and manufacturers agree there are two general avenues to boost compliance—better patient education and appropriate use of advanced technology.

The Power of Patient Education

Educate early and often—that’s what every source says. “I’m a total believer in patient education,” says Tracy Nasca, a 20-year bilevel user and founder of Talk About Sleep, a patient resource organization. “At the same time, I am keenly aware of the fact that there is little profi t margin on the provider side so patient education may be lacking. Still, part of me is very excited about the Medicare regulation. Ninety days is a short window to get patients compliant, so that means providers need to step up and take patient education seriously.”

Providers’ fi rst opportunity to take education seriously comes during the initial equipment setup appointment. It’s critical, and experts note that there are some essential elements of a good setup. Time—at least an hour. Patience—to explain things thoroughly. Honestly—to communicate frankly about the therapy. And written materials—for muddled, sleep-deprived people to reference later. “It’s all in the teacher’s hands,” Nasca says. “They can relieve fear and anxiety and give hope, so that when patients are at home on therapy, they are going to have a positive mindset.”

When it comes to the time spent setting up a patient, Doug Bumstead, CRT, RRT, clinical manager at Respira Medical in Linthicum, Md., doesn’t really even look at the clock. “The patient has invested hours in having the sleep study, and they are about to invest the rest of their lives in CPAP therapy. We want to give them a good outcome so we give them whatever time is necessary to start the process.” The instruction on the equipment usually takes place in a common area of the home, so all parties are comfortable being together for a longer period of time. Bumstead says going into the patient’s bedroom can be awkward.

The conversation is as frank as possible, Bumstead says. “We don’t suggest that this is going to be a pleasant process,” he says. “We tell them it will take a few weeks to get used to the therapy and that it will happen gradually. We try to stress the guidelines right away, which are that they should aim to use the equipment at least fi ve nights a week, at least four hours a night. It’s important to give them a goal so they don’t start deciding for themselves how long to wear it.”

Nasca agrees that the realities of CPAP therapy shouldn’t be sugarcoated. “Often, patients are not told that there is going to be a diffi cult adjustment period,” she says. “If they were, it wouldn’t be so shocking and devastating when there are challenges. A therapist can say, ‘These are all of the challenges you might face, but I can help you through them. Call me, and we are going to work on them together.’ Sometimes the best apnea treatment is found through trial and error.”

Another rather blunt topic Nasca suggests therapists cover is the anatomical anomalies that cause apneas. “If all patients understand their specifi c anomalies that cause them to have apnea, they are going to have a better understanding of why CPAP therapy is going to work for them,” she says. “Therapists should discuss the surgical and dental options for those anomalies, which will often lead patients to decide they should be excited about CPAP therapy.”

Further, the risks associated with untreated apnea can be motivating as well. Experts suggest therapists make clear that evidence shows high blood pressure, heart disease, stroke and type 2 diabetes are tied in with sleep disorders. “Patients don’t realize the effects sleep apnea can have on their body and the risks they take when they don’t use the equipment properly,” says Kim Cosgrove, RRT, clinical coordinator for respiratory care at BayCare HomeCare in Largo, Fla. “We have patients who come back to us two or three years later, after having given up and turned in their equipment. Their blood pressure is higher or their type 2 diabetes is not controlled. At some point they realize that they have to go on therapy.”

Once all the equipment and disease education is complete, how can a provider ensure she’s been heard? She can’t, so that’s why Nasca advocates using written tools. “Sleep apnea patients are sleepy people who often have depression, memory loss and an inability to concentrate,” she says. “Rather than just give a lecture, providers should leave something in their hands like a troubleshooting guide, so patients have something they can refer back to. Using written materials is a good way to deal with sleepy, depressed, moody people.”

Manufacturers can be a great ally in this regard. Therapists can readily distribute patient support materials. “We have many clinical education tools including pamphlets, brochures and DVDs that can educate patients on the benefi ts of therapy, such as relief of excessive daytime sleepiness and re-engineering of sleep architecture for sound and refreshing sleep,” says Michael Farrell, senior vice president, Global Strategic Business Unit, Sleep, at ResMed in San Diego. “We also provide information showing the negative effects of untreated sleep apnea, including implications in high blood pressure, heart disease, stroke and type 2 diabetes, so that providers can talk about the downsides of noncompliance from a clinical perspective.”

At Respira, instructional material is loaded on the company Web site. “We have every manual for every piece of equipment we offer, and all the clinicians have access to the clinical library,” Bumstead says. “Patients can go online to learn about their equipment any time they want. Clinicians can go online while they are in the fi eld to access the operating manuals for various equipment.”

Developing Flawless Follow-Up

A high-quality setup sets the stage for compliance, but it is a provider’s follow-up that ultimately makes the difference. Says ResMed’s Farrell: “Communication, particularly in those critical fi rst seven and 14 days of therapy, has been shown to be highly correlated with long-term compliance.”

Indeed, follow-up is where compliance gets tricky. A provider has both a clinical and fi nancial incentive to ensure CPAP therapy is working. Clinical, because the provider wants to help the patient realize the benefi ts of treatment. And fi nancial, because the provider won’t get paid unless compliance standards are met. Since the standards went into effect in 2008, providers have been keenly focused on developing elaborate processes to ensure compliance.

For example, Respira uses an automated system from medSage Technologies to help with compliance, Bumstead says. The telephone system calls patients to remind them to send in datacards. To keep compliance in the forefront, it also calls patients at regular intervals, asking them to key in the average number of hours per night they use CPAP therapy, which clinicians then compare with monitoring reports from the equipment itself. Further, the system contacts patients with reminders to meet Medicare guidelines by making followup appointments with their physicians. In addition, medSage enables an automated system for reordering supplies, he adds.

At Respira, Tara Minisci is in charge of compliance. “Our numbers are pretty good,” she says. “Since we started the process with all the new guidelines, about 74 percent of our patients are fully complaint after their fi rst download.” The rest of the patients who may be having trouble get to know Minisci well. “We are not so much of a numbers company that we give up if they are not compliant at 90 days. They can talk to me. I’m a familiar face and a familiar voice, so that if we are going outside the 90 days where we cannot bill, the priority is to make sure they continue therapy so they can get the benefi ts. That is first and foremost.”

Provider accessibility is the key to encouraging compliance, experts agree. If a provider wants compliant patients, he’s going to have to welcome after-hours calls, Bumstead says. “We have a clinician available 24 hours a day for patients who have questions or concerns about their PAP device or their mask. There is always someone to talk to.”

BayCare HomeCare takes an “offi ce hours” approach, offering CPAP clinics in its sleep labs, Cosgrove says. “The Mease Countryside CPAP clinic is open to patients and even the general public from 10 a.m. to 4 p.m. on Tuesdays. It is staffed by a respiratory therapist. Patients can come in to have their machine checked, deliver download cards, get new accessories or have us complete an order to have the pressure changed,” she says. “We want to be available to the community as much as possible.” Cosgrove adds that around 20 to 25 people come in each week. The approach saves the company from making trips out to their homes and is often more convenient for the patients. Other BayCare facilities have CPAP clinics on different days at different times.

Encouraging Patient Responsibility

An adjunct to provider accessibility is patient responsibility. “It’s their life and their health, and they need to report the successes and the challenges,” Nasca says. “The doctor doesn’t have a crystal ball, and the respiratory therapist doesn’t have a crystal ball. Patients need to let them know about problems. Some can be easily solved. They shouldn’t wait until the bridge of their nose is cut because their mask isn’t fi tting well. They need to come forward.”

If education leads to involvement, that’s the best-case scenario, experts say.

“Patients who are more engaged in their therapy tend to do better in the long run,” says Simon Johnson, director of global product marketing, SeQual Technologies, San Diego. “The more involved the patient, the better the compliance.”

Nasca agrees. “Therapists need to develop in patients a spirit of participation,” she says. “They should be part of the team in their care management with the respiratory therapist and the sleep doctor. The patient has to take responsibility in the therapy. It’s so important to deliver the right tools immediately and to make sure the patient is involved. For example, the patient needs to be involved in the choice of masks, not just picking the mask, but learning the nuances of adjusting the mask.”

Engaged patients are learning a lot about sleep therapy online, and sources say they should be encouraged to do so. Maura Weis, senior marketing manager, sleep therapy, at Philips Home Healthcare Solutions in Monroeville, Pa., offers a list of her favorite Web sites in the sidebar “Patient Resources Online,” at the end of this article.

Weis adds that Philips Respironics is also exploring another avenue to engage patients—motivational enhancement therapy. “This means working with patients at an emotional level to get them to understand the importance of therapy inside the framework of their lives.” For example, clinicians ask a series of questions about behavior change to get the patients thinking about how and why to bring sleep therapy into their lives. “Patients have to be engaged with therapy. Clinicians have to get their buy-in. But with every patient, it’s different. It takes working with them to get them to see how important it is to change their behavior.” Philips Respironics offers a resource with continuing education credits that explains the details of motivational enhancement therapy.

The benefi ts of patient engagement extend far beyond developing compliance for the moment for billing purposes. “Providers need to take education seriously and do it right from the beginning,” Nasca says. “Ultimately, it’s going to be a timesaver and business-builder for them. I don’t understand the comment that they can’t afford to educate the patient, because a compliant patient is going to be a customer for life. The incentive for the home care provider is to make their own market. Once patients are compliant, they keep coming back for masks and tubing and more for their entire lives.”

The Trends in Technology

Perhaps the biggest boon to compliance is quantifi able data about equipment use generated by increasingly sophisticated monitoring devices. Manufacturers each have their own approach. “The good news is that with direct downloads, card downloads as well as wireless communication systems, there are multiple ways for HME providers and physicians to gather compliance data for their patients,” Farrell says.

“ResMed devices equipped with ResTraxx wireless communication technologies provide the ability for ‘no-touch’ or ‘no effort by the patient’ systems that make good clinical and good economic sense,” Farrell says. “Importantly, these systems provide the ability for two-way wireless communication from HME providers and physicians to patients. This communication technology allows providers and physicians to remote review hours of use, mask leak and Apnea-Hypopnea Index data. Then, they can make appropriate clinical decisions regarding whether to intervene by either calling patients [on the phone] or calling them into a CPAP clinic. Noncompliant patients are being discovered early in the process with these ‘no-touch’ technologies so that action can be taken, including education, mask changes, humidifi cation changes, as well as upgrades to AutoSet or VPAP Auto therapy technologies.

“The net result is that the patient gets better attention and optimal therapy without having to carry cards or devices to a computer or a doctor’s offi ce, the HME provider has a costeffective way of accessing patient data, the physician has ready access to clinical information, and the insurance company can be assured that the customer is using the device that they paid for,” Farrell says. “This is a positive feedback loop for all.”

Philips Respironics offers the Web-based platform of EncoreAnywhere, Weis says, which makes it simple to obtain timely, accurate patient information and instantly change prescriptions or communicate from a secure-access Web site. Updates to the device are automatic, and summary and daily detail reports of therapy data are arranged by time frame. Particularly important are the “Best 30” reports that show the best 30 consecutive days of greater than four-hour sessions. Weis says provider suggestions helped to develop this feature, which directly delivers the patient compliance data needed for reimbursement.

Providers can expect continued innovation in compliance monitoring, manufacturers say. “Our job as manufacturers is to partner with our HME and physician colleagues and help them design and execute the best system that fi ts their needs and allows them to intervene using ‘management by exception’ to maximize compliance rates and continue to change the lives of as many sleep apnea sufferers as possible,” Farrell says.

Pursuing Patient Comfort Features

In addition to improving their devices’ monitoring capabilities, equipment manufacturers are heavily engaged in advancing elements of the devices that make patients more inclined to use them. These improvements range from delivering more natural pressure, offering specifi c humidifi cation options, reducing noise, shrinking a unit’s overall size and developing a nonmedical look.

Weis notes that the Philips Respironics Flex Family of pressure relief technologies continues to evolve to meet patient and professional needs. With Flex technology, an advanced algorithm detects the onset of inspiration and expiration to deliver the right amount of pressure relief and emulate natural breathing. The newest enhancement, C-Flex+, is designed for advanced units when in fi xed CPAP mode. It provides relief at the beginning of exhalation and softens the pressure transition from inhalation to exhalation, Weis says. “It’s a key comfort enhancement for patients because it really mirrors their natural breathing,” she says. “So now it’s not just whether they use a fi xed or auto or bilevel device, but how they adjust the comfort setting, which can really enhance the therapy experience. That comfort setting is so powerful.”

ResMed has tackled the issue of noise and humidifi cation, according to Farrell. “The latest S9 Series of fl ow generators delivers the most comfortable device we have ever brought to market—50 percent to 70 percent quieter than previous devices in terms of conducted noise for the patient,” he says. “We also have Climate Control so that a patient can ‘set and forget’ a temperature and humidity comfort setting that provides control with sensors right at the end of the heated tubing—so the comfortable setting is maintained no matter what happens to the external environment.”

Focusing on Interfaces

Compliance happens—or doesn’t—based on the patient interface. It’s the proverbial place where the rubber meets the road, or the nose, in this case. Innovation continues to bring new interfaces to market, and HME companies have a variety of products to offer patients as options. Those options range from full-face masks to nasal masks to nasal pillows and are as diverse as the faces that use them.

BayCare HomeCare’s Cosgrove considers the mask the biggest barrier to compliance. “Patients have to be comfortable with the mask that they are fi t with. They have to be able to get to sleep with it on,” she says. Providers need to be flexible and allow patients to try various masks. BayCare patients can change masks one or more times within 30 days without charge. At Respira, Bumstead keeps about two dozen samples of different masks on hand in a sleep training clinic for patients to come in and try. “Patients may talk to fellow CPAP users about their masks and want to try this one and that one, but everyone’s face is different,” Cosgrove says. “What may work on one, may not on another.”

That’s why individual manufacturers are focused on developing patient choice when it comes to interfaces. For example, in February, ResMed debuted its Swift FX, a low-profi le nasal pillows system with silicone headgear that’s designed to be less obtrusive and more comfortable on the face, according to the manufacturer. And Circadiance Inc. is pioneering the SleepWeaver mask made out of cloth. “The No. 1 reason for noncompliance is dissatisfaction with and intolerance of hard CPAP masks,” says David Groll, CEO of Circadiance, Export, Pa. “We are taking the different approach in the design of mask, using cloth and the principles of a balloon, to infl ate the mask and conform it to the patient’s face, with a leak-free seal and no pressure points.” The SleepWeaver was fi rst introduced in 2007, and a third-generation version debuted in October, he says. Updated features include more ergonomic headgear, a smaller, less obtrusive mask, a better fi t and seal, and additional cloth colors. “The colors and size have to do with appeal when patients put it on,” he says. “The real improvements are in the fit and seal and the ergonomic headgear.”

The SleepWeaver is noted for its ability to reduce skin irritation, according to Groll. “The fact that we use the CPAP pressure itself to infl ate the mask and hold it on, and not mechanical pressure in the headgear, eliminates problems with pressure sores,” he says. Patient feedback has been gratifying, he says, as anecdotes of successful use and improved CPAP compliance are received regularly. Circadiance is in the process of turning those anecdotes into statistics. “Our goal is to demonstrate that we provide a much higher CPAP compliance rate,” he says. “We are commissioning studies and are working to generate data that we can publish through peer-reviewed journals that will support that.”

Adding Accessories to the CPAP Mix

Mask accessories are also coming to the fore, including SeQual Technologies’ Sleep Comfort Care Pad, introduced in November. “Comfort and usability are the No. 1 and No. 2 criteria in terms of compliance,” SeQual’s Johnson says. “The Comfort Care Pad is a very simple, inert product that almost looks like a gummy bear. It provides a barrier between the mask and the skin, acting like a shock absorber, cutting down on skin breakdown and reducing leaks.”

Johnson says the pad can be a buffer for new CPAP patients who are overwhelmed, sleep-deprived and just trying to get used to the therapy. “They don’t always remember what to do to fi t the mask properly. They over-tighten it and get discomfort on the bridge on the nose.” Or maybe they aren’t yet using the best mask for their face. “Picking a mask is like picking a pair of shoes. If the shoes are not the right style and size, they end up giving you a blister,” he says. “Patients have to pick the right mask for their disease state and facial structure.”

“The gel pad is a way to do triage in the early days of therapy,” Johnson says. “It is a comfort barrier that takes the risk out of fi tting the mask very quickly. It can also prevent mask leaks, which reduce the effectiveness of therapy.”

Offering another helpful accessory, Contour Products, Fort Lauderdale, Fla., manufacturers the CPAP Pillow. The pillow is designed to reduce discomfort from the mask pressing against a CPAP user’s face during sleep, according to Scott Davis, founder. The pillow uses a molded design with pressure-free zones to accommodate any respiratory mask so users stay comfortable, even in the side-sleeping position. Contour commissioned a study in conjunction with National Respiratory Care Week in 2009 that shows respiratory therapists largely agree that the pillow reduces mask leaks and mask pressure against the face, two major issues in compliance with CPAP therapy.

Ultimately, an effective CPAP technology application comes down to coordinating three elements, Weis concludes. “The devices now are not only more sophisticated and offer good medical management, but they provide different options for patients to determine what is most comfortable for them,” she says. “Second is the very personal aspect of therapy to determine the best technology for the patient when it comes to masks. A patient needs the ability to try masks on their individual physiology. And the third stage is how the device and the mask can work together to optimize the therapy experience.” She says a good clinician has a handle on the options with devices and masks, and then optimizes them together. “It’s a circular approach, always going back to the patient, measuring what’s working and what’s not, and how we can do it better.”

Indeed, in the CPAP market, there’s a lot riding on “doing it better”—increased compliance, reliable reimbursement and of course, healthier lives for patients.

This article originally appeared in the Respiratory & Sleep Management April 2010 issue of HME Business.