Peer-Driven Intervention for Sleep Apnea

COMPARATORS:

1. Intervention group: In order to address the proposed aims, we will recruit recently
diagnosed patients with obstructive sleep apnea (OSA) who have not been initiated on
CPAP therapy and randomly assign them to the PDI-IVR system to promote adherence to CPAP
therapy (intervention group) or be provided with educational brochures regarding OSA and
CPAP therapy (usual care [control] group). In the PDI-IVR intervention group, trained
and experienced peers (peer-buddy) with sleep apnea will be paired with the newly
diagnosed patients over a 6-month period. As in our preliminary study, the peer-buddy
will be matched with the subjects with regards to age, gender, race, ethnicity,
socioeconomic, and educational backgrounds. During this time the trained peers will
share experiences on coping strategies with CPAP device and equipment (promote self
efficacy), share their positive experiences (motivational effects and outcome
expectancies), share their knowledge of perceived vulnerabilities due to untreated sleep
apnea (promote risk perception), share methods for improving efficacy of CPAP equipment
and interface (patient education) and prepare their subjects for upcoming physician or
respiratory therapist appointments (patient activation). The interaction will occur
during supervised "in-person" sessions (two sessions at day 1 and day 7) and also
telephone-based conversations through the IVR system (once a week for one month followed
by telephone calls on a fortnightly basis). Additionally, they will help the patient
navigate the delivery system and effect better care coordination through the IVR system
at patient-initiated request.

2. Usual care description: All participants will receive usual care following initiation of
CPAP therapy. Usual care of the newly diagnosed patient with OSA consists of attending a
CPAP initiation and education class which is conducted either at the patient's home or
in the offices of a home care (DME) company by a dedicated respiratory therapist.
Patients are educated about the basics of the care and operation of the device, mask and
related equipment. Following this CPAP initiation and education class, they receive
instructions to either mail-in the CPAP adherence monitoring card ("Smart card") by mail
to the therapist about 4 weeks following the initial visit. The adherence information is
evaluated and posted in electronic medical records. Patients with OSA will be seen in
the sleep clinic at 1 and 3 months following initiation of CPAP therapy and will have
the option to call any of their care providers. In order to balance the number of
contacts and educational sessions between the two comparison groups, educational
brochures (from the AASM) and videos on DVD (from Industry stakeholders) will be mailed
to participants. We did not incorporate an attention-control arm requiring in-person
contacts as the comparator because the overarching goal of this proposal is to make this
study relevant to the real-world conditions of a well measured usual care arm to make
the study findings generalizable and better inform patients' decision-making. Such
external validity was felt to be of greater value than comparing two conditions that
currently do not exist in current practice.

Peer-buddy system: Selection and Training of Peer-buddies: Fifty peer-buddies will be
recruited from the four sleep clinics who are adherent to CPAP therapy. Peer buddies will be
consented and compensated for their role in the research study ($350 for 6 month
participation per subject). Each buddy may be paired with up to 12 subjects over the length
of the study.

Training: PI and research staff will educate the peer buddy and provide them with guidelines
for their interactions with the research participants. They will be instructed to share their
experiences and not to provide medical advice. The sharing of coping strategies will fall
under the following categories:

(i) Promote self efficacy: Strategies to deal with CPAP device and equipment (such as
pressure ramp feature, humidifier settings, mask and strap application; and cleaning of
device and related equipment). (ii) Promote outcome expectancies: Share their positive
experiences with regards to effects of CPAP on energy level or vigilance, sense of
well-being, hypertension control and other medical benefits that they possibly derived from
CPAP therapy. (iii) Risk perception: Share their knowledge of perceived vulnerabilities due
to untreated sleep apnea. Share methods for improving efficacy of CPAP equipment and
interface (patient education). (iv) Patient activation: Share experiences of how to prepare
for upcoming physician or respiratory therapist appointments, such as what questions to ask
the healthcare provider, what to take with them (e.g., CPAP adherence card or malfunctioning
device, humidifier, or mask, and what to expect at a given provider visit. At the end of the
training, a mock interaction between the peer-buddy and PI (playing the role of the patient
with OSA) will be undertaken before "certifying" or "graduating" the peer-buddy as competent.

Potential for inter-personal conflicts and management plan: The peer-buddy and research
participant will be informed that they can withdraw from participation if there is a
potential conflict or difficult situation (they feel threatened, face verbal abuse from
subject, individual is too demanding, frequent calls or late night calls). The peer-buddy and
subject starting CPAP will provide the research coordinator with an availability sheet as to
when they are available to take phone calls and/or appear in person. Each peer-buddy will be
paired up with one research participant, and may choose to take on up to 3 patients at a time
and take on a new assignment at the end of the 6-month participation period. Peer-buddy and
participant will be matched by age, gender, race, ethnicity, and socioeconomic status. The
peer-buddies will be instructed not to offer medical advice. If a medical need or problem
were to arise, the peer-buddies will be instructed to provide the research participant with
the phone number to call the PI (via call operator) who will assess their medical needs and
situation.

Fidelity assessments: Twenty percent of the telephonic communications between the peer-buddy
and patient will be randomly recorded by IVR system for fidelity assessments by the
behavioral therapist (Haynes, Co-investigator). Similarly, 20% of in-person visits will be
assessed by the behavioral therapist. Such fidelity assessments will be used to increase
fidelity (efficacy) during study.

In-person interactions: In-person interaction will occur on 2 occasions (30-minutes each)
within the first 10 days of CPAP initiation. The research coordinator will be present during
this interaction but will not be facilitating or running the interaction. A clean CPAP device
and related supplies for the patient will need to be present during these interactions for
demonstration purposes.

Telephonic IVR interactions: Once a week for the first month followed by 4 phone
conversations over the subsequent 2 month period (8 scheduled telephonic interactions) and as
needed in the subsequent 3 months. There will be no more than 10 such "as-needed" phone calls
in the latter 3-months between participant and peer-buddy. Therefore, over the 6-months,
there will not be in excess of 18 phone calls per subject assigned to peer-buddy. Each phone
conversation will last a maximum of 30 minutes. The PDI-IVR system will be programmed to
recognize the peer-buddy's phones (cell or home) and be programmed to link this with the
patient's phones (cell or home) and thereby protect the privacy of both participants. The
dyad of the peer-buddy and participant will introduce themselves on a first name basis and
will not be required to provide other personal information. However, the study does not
preclude them from sharing such information or developing long-lasting friendships. For each
dyad, the research coordinator may monitor a few calls (with the participants' knowledge and
random IVR-based recording) in order to monitor the content and level of participation
between the dyad; however, the coordinators will not direct the participation in any way.
Peer-buddies will share their experiences that would promote self-efficacy, outcome
expectations, risk perception and patient activation. During in-person interactions, greater
emphasis on promotion of self-efficacy will be placed, considering the physicality of the
medical device (CPAP) therapy, masks, hoses, humidifiers, and filters. During phone
interactions, greater emphasis on promotion of outcome expectancies, risk perception, and
patient activation will be undertaken. The research coordinators may provide feedback to the
peer-buddy regarding their performance and remind them to cover topics that were not covered
in order to ensure fidelity. Either the patient or the peer-buddy (on behalf of the patient)
can initiate calls to other members of the inter-disciplinary team, including obtaining CPAP
adherence data through the IVR that was derived from the industry server (figure 2). Call
backs from any of the providers (physician, RT, RN, DME representative, or sleep tech) will
be connected back to the initiator of the call (Patient or peer-buddy). IVR-initiated queries
regarding CPAP device - for adherence, leak, and efficacy [residual obstructive events] data
- will be faxed to the sleep physician's office (or designee [RN or RT]) by the IVR with a
note for patient call back. Content of interactions will pertain to OSA and CPAP therapy and
related supplies (mask, hose, filters and humidifier). Content will include aspects
pertaining to mask fitting, using ramp function on CPAP unit, using the CPAP humidification
system, etc. Conversations regarding erectile dysfunction or a similar sensitive matter will
be discouraged. Both peer-buddy and subject would have provided voluntary consent for sharing
their experiences with CPAP therapy and sleep apnea. A checklist of content areas will be
provided to the peer-buddy to ensure that such topical areas were discussed by the
peer-subject pair. We will refrain from writing a script for the peer-buddy as we believe
that would detract from the sense of bond or trust within the dyad.

Inclusion Criteria for Subject:

- Obstructive Sleep Apnea

- 18-85 years of age

- Availability of cell or other reliable phone line

Inclusion Criteria for Peer Buddy:

- Adherent to CPAP therapy ( greater than 4 hours per night of CPAP use)

- Willing to meet with subject on 2 occasions in-person

- Has a cell or other reliable telephone line and able to converse with subject on 8
occasions over the first 3 months and be available subsequently for a 3 month period
on an as-needed basis

- Willing to undergo 2 training and orientation sessions with the Principal Investigator
and research staff followed by a mock patient interaction session.

Exclusion Criteria for Subject:

- Central sleep apnea

- Participation in another intervention-based research study

- Patient's primary care provider refuses patient participation for medical instability

Exclusion Criteria for Peer Buddy:

- Central sleep apnea

- Participation in another intervention-based research study

- Patient's primary care provider refuses patient participation for medical instability

- Patients suffering from major depression or other major psychiatric illness

- Shift-worker or frequent out of town traveler

- Unwilling to participate in orientation and training session or unable to "graduate"
from the mock patient interaction session with study staff