Mobile Health Monitoring Solution for Heart Failure Patients

It is estimated that 400,000 to 700,000 new cases of heart failure (HF) are diagnosed each
year and the number of deaths in the United States from this chronic condition has more than
doubled since 1979 - averaging 275,000 annually. HF accounts for over 1.1 million annual
hospital discharges, 3.4 million physician office visits, 668,000 emergency department
visits, and 293,000 outpatient visits per year. The economic impact is equally staggering:
the total estimated annual cost of heart failure exceeds $40 billion. This figure is expected
to reach $97 billion by 2030. While initial hospitalizations consume a vast amount of health
care resources, readmissions are also a significant problem. The overall readmission rate
(all cause) in the United States is 19.6%. Studies have shown the 30-day readmission rate for
HF to be 24%. The important clinical implication is that patients are particularly vulnerable
in the early post-discharge period (30-90 days from hospital to home) and require heightened
surveillance, especially if the hospital admission has been prolonged or if the patient has
had prior admissions for worsening HF. Despite advances in pharmacologic and monitoring
device therapy, the inability to effectively manage and influence patient behavior and the
inability of patients to identify signs and symptoms of decompensated HF are major hurdles to
improving outcomes and avoiding subsequent readmissions. Less than 10% of HF patients are
eligible for implantable monitoring devices due to a variety of reasons. Non-invasive cardiac
telemetry units only monitor a patient's echocardiograph (ECG). HF patients present with
numerous other physiologic parameters which largely go unmonitored and changes in status
undetected after discharge from hospital to home. A worsening status in any one of these
indicators may predict worsening condition or decompensation. This gap leaves a tremendous
percentage (the majority, in fact) of the HF population at risk for repeat medical crisis and
re-hospitalizations.

Managing the HF patient population requires highly skilled clinicians, stringent monitoring
and care coordination, and advanced technology integration. The investigators propose a
patient-centered non-invasive remote monitoring care system for HF. This model leverages
three distinct technology platforms. This unique care plan brings together physiologic data
capture with symptomatic and behavioral patient information into a dynamic patient engagement
and education mobile platform that analyzes, predicts and notifies clinicians when a
patient's baseline health is changing before it leads to a negative health consequence and
subsequent hospital re-admission or ER visit.

1. A small cutaneous Mobile Patient Monitoring patch (SEEQ®) from Medtronic that
continuously collects ECG data, plus heart rate, heart rate variability, respiratory
rate, and atrial fibrillation status. These added physiologic parameters provide
clinicians more precise insight into a patient's condition and clearly differentiates
the monitoring technology from standard approaches. The Medtronic patch is applied like
a band-aid to the patient's chest prior to hospital discharge. As it collects data, the
information is wirelessly transmitted via Bluetooth to a patient care platform from
which providers can access information in live-time for 30 days post discharge.
Medtronic's patch does not require leads like other commercially available systems, and
does not need to be removed during bathing and other normal activities. Thus this
product increases patient compliance and enhances satisfaction. An increase in patient
compliance will ensure a more complete and accurate picture of the patient's health.
Captured data is used to 1) provide clinicians with physiological data for patients who
are at risk of near-term decompensated HF, and 2) allow clinicians to deliver live-time
treatment intervention and guidance from anywhere at any time, preventing health
problems from escalating into health crises.

Another key differentiator in this care model is the patient's use of a tablet-based
tele-health mobile software application that includes the patient's discharge plan, a
daily medication management list, reminders, and CHAT features for live, interactive
communication with the care team. The software assesses the patient's psychosocial
status and enables clinicians to coach and guide patients to change negative health
behaviors and adhere to their care plan.

2. Medtronic's Cardiocom system deploys a proprietary cellular-based patient interface tool
(Commander Flex), a blood pressure cuff that interfaces directly with the Commander Flex
and a Bluetooth enabled medical-grade scale that also interfaces directly with the
Commander Flex. The patient is required to take the blood pressure and weight
measurements at prescribed intervals over the evaluation period (30 days) as well as
answer a variety of behavioral and symptomatic questions that operate on a proprietary
tree-based questioning algorithm.

3. Docview® mHealth solution encourages self-management and empowers patients to become
stakeholders in their health. The application collects real-time data with regular
"check-ins" to analyze state of wellness, and enables patients to connect live with
their care team - no matter where they are. The entire process takes less than one
minute to complete and the answers provide the care team an actionable
risk-stratification snapshot. Automating the process allows larger patient populations
to be monitored, yet drastically reduces provider-patient involvement, as only at-risk
patients need to be notified (10-15% estimated). In a traditional setting, the
monitoring team typically calls every patient and could maintain a caseload of only
20-25 patients (average call time 20-25 min). All patients have to be contacted by phone
just to determine if a risk exists. The proposed tele-health solution uses real-time
data analysis and predictive modeling to proactively notify a provider that a patient's
baseline health is changing prior to a negative health issue, and quickly delivers an
intervention to the patient based on clinical decisions and statistically validated
treatment algorithms.

This unique care plan brings together physiologic data capture with symptomatic and
behavioral patient information into a dynamic patient engagement and education mobile
platform that analyzes, predicts and notifies clinicians when a patient's baseline health is
changing before it leads to a negative health consequence and subsequent hospital
re-admission or ER visit.

Inclusion Criteria:

1. Admitted patients to Morristown Medical Center located on Gagnon 1 Heart Failure (HF)
dedicated unit with an anticipated Discharge DRG of HF

2. Subjects with acute decompensated HF

3. Subject > 55 years of age

4. Subject meets the indications for the use of the external patch

5. Subject is able and willing to provide informed consent

Exclusion Criteria:

1. Subjects with an implantable cardiac device or scheduled to receive a cardiac device
within 30 days of enrollment

2. Skilled Nursing Facility (SNF) bound patients who are unwilling/unable to receive care
at CareOne Madison

3. Subject with a scheduled readmission within 30 days of discharge

4. Subjects weighing > 500 lbs

5. Subjects with potentially life-threatening arrhythmias, or who require
inpatient/hospital monitoring

6. Subject who is expected to receive a heart transplant or a ventricular assist device
within 6 months of enrollment

7. Subject with known allergies or hypersensitivities to adhesives or hydrogels

8. Subject who cannot tolerate placement of external patch monitor on chest in the
proposed location (electrocardiogram lead II orientation)

9. Subject who will not comply with project protocol requirements (i.e. Docview/Cardiocom
engagement). This includes completing required data collection, and attending required
follow up visits

10. Prior enrollment in this study

11. Subjects who are pregnant

12. Subjects who are non-English speaking.