Impact of Automated Education and Follow-up Mechanisms on Patient Engagement

Background

Obstructive sleep apnea (OSA) is a prevalent condition which based on polysomnographic
criteria affects 24% of men and 9% of women in the middle-aged population. Due to its high
prevalence, its association with cardiovascular disease, and impact on neurocognitive
function such as daytime vigilance, it carries a high healthcare burden in a given
population. A recent assessment estimated that the yearly economic cost of OSA to Australia
(population around 23 million) to be $21 billion. Thus, it is important for us to consider
effective treatment not just for the individual, but cost effective management of the
population.

Continuous positive airway pressure (CPAP) therapy remains the gold standard treatment given
its ability to provide near-complete physiologic effectiveness regardless of OSA phenotype.
This therapy improves daytime vigilance and is currently the only therapy with substantial
evidence suggesting improvement in cardiovascular risk. The primary and well-known challenge
with CPAP is the incomplete adherence of patients to this therapy (long-term CPAP compliance
defined by percentage of days with at least 4 hours usage is typically reported to be around
50%.) Advances in CPAP technology (such as with autoCPAP) have not been shown to enhance
use. Rather successfully improving CPAP use is likely through emphasizing patient education
regarding the risks associated with OSA, potential benefits of therapy, teaching techniques
to acclimate to CPAP, and providing a system of accountability through a follow-up process.

The impact of providing a system of accountability with further education/troubleshooting
was reflected in a study showing improved CPAP adherence when usage was tracked daily
(through a remote wireless process) followed by a telephone encounter if a problem with CPAP
use was revealed. Compared to a control group (usual clinical follow-up), average CPAP use
per night was higher (321 minutes versus 207 minutes; p<0.0001) 3 months after initiation of
therapy.

The challenge with replicating this telemedicine workflow in a real-world setting is the
labor-intensive nature of tracking patients on a daily basis and logistics of dispensing and
retrieving wireless modems. Furthermore, patient education is very time-consuming, and the
ability to provide comprehensive education without built-in efficiencies could potentially
affect the financial health of the provider. With the changing landscape of healthcare
reimbursement which emphasizes achieving positive clinical outcomes, discovering more
automated and self-directed methods of educating and follow-up is needed.

Web-Based Education

Emmi Solutions produces Web-based, simple to understand, healthcare related educational
programs. These programs are interactive sessions that last about 15 minutes, educating
patients on the risk of certain medical conditions or assists in preparing patients for
procedures. Emmi has also produced OSA related programs:

1. OSA program - this program educates patients on symptoms of OSA, provides animated
videos depicting airway narrowing during OSA events, discusses health related risks of
OSA such as cardiovascular disease and impact on daytime vigilance, preliminarily
discusses CPAP as potential therapy, and discusses the testing process with ambulatory
or in-lab polysomnography

2. CPAP program - this program educates patients on how to properly use CPAP and wear the
mask, discusses potential benefits of CPAP use including impact on health risks and
daytime vigilance, provides methods of acclimating to CPAP, encourages patients to give
a dedicated trial of CPAP even if initially having trouble, and instructs on how to
care for their device and need to replace equipment.

Links to each of these programs are emailed to the patient and date of birth needs to be
verified before the program will start. The programs ask the patient for feedback at regular
intervals and provide opportunities throughout to make notes or write down questions that
can be later printed. These programs are already approved for clinical use within Kaiser
Permanente which has a contract with the vendor.

Interactive Voice Response Interactive Voice Response (IVR) is a protocol in which automated
messages are delivered to patients to provide feedback regarding their CPAP use, intended to
improve therapy adherence. While IVR refers to voice calls via telephone, we use this term
to also include messages that are delivered by text messaging and email. The basic protocol
involves the use of CPAP devices that wirelessly send usage data to a cloud platform.
Automated algorithms will assess the usage data and send messages to the patient when there
is suboptimal usage or excessive leak, or to provide encouragement for successful use (See
Figure 1 for programmed thresholds that will trigger a message).

Specifically, the investigators will use CPAP devices with built-in modems (AirSense 10;
ResMed Corporation) which will send usage data via cellular network (Verizon or Sprint
depending on signal availability) to cloud based platform (AirView; ResMed Corporation).
This data will be transferred to a second cloud-based platform (U-Sleep; Umbian), and it is
this second platform that will automatically analyze the usage data and send the automated
messages back to the patients. With each message, there will be a reminder to contact the
sleep center for questions or problems regarding CPAP usage. Patients also have the ability
to login to the U-Sleep platform at any time to track their own therapy information.

Study Proposal

The investigators plan to investigate the impact of adjunct Web education and automated
follow-up on CPAP use and other measurements of patient engagement. The Kaiser Permanente
Fontana Sleep Disorders Center (Fontana, California) is an integrated sleep center that
functions as a closed-loop system which balances diagnostic testing with a wide array of
different follow-up programs. The primary diagnostic pathway within our center for suspected
OSA is with home sleep testing that begins with classroom education and includes setup of
home sleep testing device. Subsequent clinical visits are individual appointments, and
patients undergo a 1 week autoCPAP trial if OSA is present. If appropriate, patients are
subsequently ordered a CPAP for long-term use, and a 3 month follow-up visit is scheduled.

Our study enrolls patients into one of four pathways: 1) One-fourth of our patients will
follow our usual workflow that functions as our primary control group (Traditional Pathway);
2) One-fourth will follow the usual workflow with the addition of Emmi OSA education prior
to the initial OSA class and Emmi CPAP education in those undergoing an autoCPAP trial
(Telemedicine Education Pathway); 3) One-fourth will follow usual workflow with the addition
of IVR follow-up (Telemedicine IVR Pathway); 4) One fourth will follow usual workflow with
addition of both Emmi programs and IVR follow-up (Telemedicine Both Pathway)

The specific aims of this pilot study are as follows:

1. Assess impact of Telemedicine mechanisms on CPAP use 3 months after initiating therapy
in comparison to Traditional pathway patients.

2. Assess impact of Telemedicine mechanisms on functional outcomes and parameters of
healthcare utilization at 3 months after initiation of therapy in comparison to
Traditional pathway patients.

Methods

Study Design This performance improvement initiative is structured as a randomized
controlled trial designed to assess impact of automated educational and follow-up mechanisms
on measure of patient engagement in patients with OSA. Consecutive patients triaged to home
sleep testing for suspected OSA are scheduled to attend an OSA class (the investigators
schedule 5 classes of 13 patients per week). Classes will be variably assigned to follow one
of the 4 Pathways (1 Traditional and 3 Telemedicine) thus result in pseudo-randomization
effect (classes rather than individual patients are randomized) - See Figure 2. The
investigators plan to analyze outcomes between the four pathways after 1000 consecutive
patients (anticipated about 250 in each pathway) have attended OSA class and completed their
3 month CPAP follow-up.

Traditional Pathway Patients will attend a 1 hour OSA Class (class size 13) where OSA
education is provided and home sleep testing (Nox T3, Carefusion) is set up. These patients
return the next day for individual appointments where study is scored and test results are
discussed with patient. If study is consistent with OSA based on Apnea Hypopnea Index
(AHI4%) at least 5/hour, patients undergo a 1 week autoCPAP trial. During this week,
wireless remote monitoring (AirView; ResMed) is performed and troubleshooting is provided
via telephone encounter if problems with CPAP use are identified. The autoCPAP is returned
during an individual visit, and CPAP is ordered for long-term use based on trial results and
patient feedback. Patients are scheduled a 3 month follow-up appointment but are also
instructed to call their sleep center case manager (or visit the walk-in clinic) prior to
that visit if there are problems with CPAP use.

Telemedicine Education Pathway Patients follow our usual workflow as outlined in the
Traditional Pathway. In addition, patients are emailed a link to view the Emmi OSA program
within 2 weeks prior to their initial OSA class. If the patient tests positive for OSA and
agrees to an autoCPAP trial, the patient is emailed a link to view the Emmi CPAP program.
These patients are also scheduled for a 3 month follow-up visit to check CPAP usage.

Telemedicine IVR Pathway Patients follow our usual workflow as outlined in the Traditional
Pathway. Additionally, if CPAP is ordered for long-term therapy, the patient is enrolled
into an IVR protocol (U-Sleep) that automatically analyzes the patient's CPAP use. If
specific provider-defined thresholds are met (Figure 1), the platform will automatically
deliver feedback messages to the patient (via patient's choice of phone call, text
messaging, or email) with the intention of encouraging better CPAP use. Patients are
instructed to contact the sleep center for any issues with their therapy. This platform also
includes a method for patients to track their own usage online. Automated messaging
mechanism will be active for 3 months after CPAP is ordered, after which the messaging will
stop. These patients are also scheduled for a 3 month follow-up visit.

Telemedicine Both Pathway Patients follow our usual workflow as outlined in the Traditional
Pathway. In addition, patients are provided both Emmi education programs and IVR follow-up
as previously outlined. These patients are also scheduled for a 3 month follow-up.

Measured Variables Age, gender, body mass index, polysomnography respiratory parameters, ESS
(Epworth Sleepiness Scale), Functional Outcomes of Sleep Questionnaire - 10 Questions
(FOSQ-10) will be assessed at baseline. CPAP use, Epworth sleepiness Scale, and FOSQ-10 will
be assessed at 3 month follow-up. These measured variables are already part of our standard
clinical assessment. The investigators will also evaluate measures of patient engagement and
cost-effectiveness of care by collecting information regarding adherence and number of
provider encounters.

Inclusion Criteria:

- Clinical suspicion of obstructive sleep apnea (OSA)

- Appropriate for home sleep testing

- No prior use of CPAP or other therapies for OSA

Exclusion Criteria:

- Commercial drivers

- Complex sleep disorders (e.g. CSA)

- No DME (durable medical equipment) insurance coverage

- Declines CPAP therapy