Remote Sleep Apnea Management

Obstructive sleep apnea (OSA) is estimated to be the third most common chronic disease in
Veterans and is associated with an increased risk of hypertension, heart attacks, strokes,
depression, and driving accidents. Current in-person management at a sleep center limits
Veterans' access to care, prolongs patient wait times, and requires Veterans living in remote
areas to travel long distances. This proposal will evaluate an innovative web-based clinical
pathway to diagnose and manage Veterans with OSA. In FY13, the investigative team received a
VHA Innovation Award to create the Remote Veteran Apnea Management Portal (REVAMP), a
personalized, interactive website that, when combined with other emerging telehealth
technologies, is designed to improve access to care, reduce patient wait times, and allow
Veterans to receive care without travelling to a sleep center. Veterans complete intake and
follow-up questionnaires on the REVAMP website and perform an unattended home sleep test
(HST) without in-person instructions. Sleep specialists review the findings with the patient
during an initial phone clinic. REVAMP auto-populates the Veteran's questionnaire responses
into templated progress notes that are exported to CPRS, the electronic medical record.
Veterans diagnosed with OSA are treated with automatically adjusting positive airway pressure
(APAP) units. These devices transmit data wirelessly to the website where treatment use and
its effectiveness can be monitored by both Veterans and practitioners, thereby promoting
patient self-management and productive patient-practitioner interactions.

The investigators' proposed prospective, randomized intervention will compare the clinical
and cost-effectiveness of REVAMP management of Veterans with OSA to in-person care. Aim 1
will determine if management with REVAMP is clinically non-inferior to in-person care in
terms of improvement in functional outcomes and APAP adherence. Non-inferiority of clinical
effectiveness following 3 months of APAP treatment will be expressed in terms of improvement
in the score of the Functional Outcomes of Sleep Questionnaire (FOSQ-10), the investigators'
primary outcome measure. Adherence to APAP will be objectively monitored by wireless
transmission of data from the participant's home unit. In Aim 2, patient preference, medical
service use and cost will be collected every 3 months for the entire observation period to
compare cost effectiveness of the two managements. Preference will be assessed by the SF-6D,6
and the EQ-5D.7, 8 Differences in the ratio of cost and quality-adjusted life years saved by
REVAMP compared to in-person management will test the hypothesis that REVAMP management will
have lower cost and equivalent outcomes. The results of Aims 1 and 2 will provide evidence to
support widespread dissemination of REVAMP. Formative evaluation in Aim 3 will use
qualitative (targeted phone interviews) and quantitative measures (attrition, work alliance,
and patient satisfaction) to inform clinicians, administrators and other stakeholders how to
implement this innovative chronic disease pathway.

Aim 1 (primary). To compare functional outcomes following 3 months of APAP treatment in
Veterans with OSA randomized to REVAMP versus in-person management. The primary outcome
measure in this modified intent-to-treat analysis (i.e., subjects initiated on APAP with at
least one FOSQ follow-up score) will be the change from baseline in the FOSQ-10 score.
Analysis will also compare the mean daily hours of APAP use in participants in the two groups
initiated on APAP treatment.

Hypothesis 1a: Mean change in FOSQ-10 score among participants randomized to REVAMP
management will be no more than one point less than that in participants receiving in-person
management.

Hypothesis 1b: Mean daily hours of APAP use among participants receiving REVAMP management
will be no more than 0.75 hour less than that in participants randomized to in-person
management.

Aim 2 (secondary): To compare the differences in cost and quality-adjusted life years (QALY)
between REVAMP management and in-person management. The perspective of the analysis will be
that of the VA and the intention to treat analysis set will include all randomized
participants.

Hypothesis 2a: Average total health-care delivery cost will be lower for participants
receiving REVAMP compared to in-person management.

Hypothesis 2b: The 90% lower limit of cost per QALY ratio comparing in-person versus REVAMP
manage-ment will be > $100,000 (i.e., the investigators will have 90% confidence that REVAMP
is good value for the cost).

Aim 3 (exploratory): To conduct a mixed methods formative evaluation that will guide REVAMP's
widespread implementation. Quantitative component: The investigators will track quantitative
outcome measures across both groups including attrition, participant- and practitioner-rated
therapeutic alliance (Working Alliance Inventory-Short Revised [WAI-SR]),9 and participant
treatment satisfaction (Client Satisfaction Questionnaire [CSQ-8]).10 The investigators will
compare the scores of the WAI-SR and CSQ-8 and attrition rates between treatment arms.
Qualitative component: The investigators will explore participant- and practitioner-level
perspectives, attitudes, and preferences regarding REVAMP versus in-person management, as
well as barriers and facilitators to participation in either clinical pathway through phone
interviews with participants from the two intervention groups, participants who withdraw from
either intervention, and staff who provide care through REVAMP.

Inclusion Criteria:

Veterans must meet the following inclusion criteria prior to enrollment:

- Referral to one of the participating sleep centers for evaluation of suspected OSA

- Access in the home to the internet, e-mail, and phone on all days

- Fluent in English as assessed on the initial phone contact

Exclusion Criteria:

Veterans will be excluded from the study for the following reasons:

- Unable or unwilling to provide informed consent and complete required questionnaires

- Previous diagnosis of:

- obstructive sleep apnea (OSA)

- central sleep apnea (50% of apneas on diagnostic testing are central apneas)

- Cheyne-Stokes breathing

- obesity hypoventilation syndrome

- narcolepsy

- Previous treatment with positive airway pressure, non-nasal surgery for OSA, or
current use of supplemental oxygen

- A clinically unstable medical condition in the previous 2 months as defined by a new
diagnosis, e.g.:

- pneumonia

- myocardial infarction

- congestive heart failure

- unstable angina

- thyroid disease

- depression or psychosis

- ventricular arrhythmias

- cirrhosis

- surgery

- recently diagnosed cancer

- Night shift workers in situations or occupations where they regularly experience jet
lag, or have irregular work schedules by history over the last 3 months

- Women who are pregnant or women who are sexually active and of child-bearing age who
are not using some form of contraceptive

- Unable to perform tests due to inability to communicate verbally, inability to read
and write, and visual, hearing or cognitive impairment