U.S. patent application number 13/449916 was filed with the patent office on 2013-01-17 for medical montioring and coordinated care system.
This patent application is currently assigned to Ideal Life, Inc.. The applicant listed for this patent is Thomas C. Beckerman, Jason Goldberg. Invention is credited to Thomas C. Beckerman, Jason Goldberg.
Application Number | 20130018668 13/449916 |
Document ID | / |
Family ID | 45953586 |
Filed Date | 2013-01-17 |
United States Patent
Application |
20130018668 |
Kind Code |
A1 |
Goldberg; Jason ; et
al. |
January 17, 2013 |
Medical Montioring and Coordinated Care System
Abstract
Systems and methods are provided for monitoring members of a
group and providing coordinated care of the members. Monitoring
devices are provided to each of the members which may take periodic
health measurements of the member. The health measurement is
compared to intervention criteria, which when satisfied, cause one
or more interventions to be provided, such as a message sent to a
member, a message sent to a health care provider or other
interested individual, medical care provided to the member, or
other intervention. Monitoring devices may be provided on a
subscription basis. Group membership can be dynamic and based on a
member's current health measurements. Health measurement
information may be provided in reports.
Inventors: |
Goldberg; Jason; (Toronto,
CA) ; Beckerman; Thomas C.; (Toronto, CA) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Goldberg; Jason
Beckerman; Thomas C. |
Toronto
Toronto |
|
CA
CA |
|
|
Assignee: |
Ideal Life, Inc.
Toronto
CA
|
Family ID: |
45953586 |
Appl. No.: |
13/449916 |
Filed: |
April 18, 2012 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
11356739 |
Feb 16, 2006 |
8165893 |
|
|
13449916 |
|
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60653653 |
Feb 16, 2005 |
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Current U.S.
Class: |
705/2 |
Current CPC
Class: |
G16H 15/00 20180101;
G16H 40/67 20180101; G06Q 40/08 20130101 |
Class at
Publication: |
705/2 |
International
Class: |
G06Q 50/22 20120101
G06Q050/22 |
Claims
1. A method for managing health care made available to a group of
people, comprising: receiving initial physiologic measurement data
related to each of a plurality of people in the group; receiving
additional physiological measurement data related to each person in
a sub-group of the plurality of people whose related initial
physiological measurement data satisfies at least one first
criterion obtained using a portable device provided to each person
in the sub-group; for each person in the sub-group whose additional
physiological measurement data obtained by a portable device
satisfies at least one second criterion, contacting the respective
person or a representative of the respective person in connection
with the additional physiological measurement data satisfying the
at least one second criteria.
Description
PRIORITY CLAIM
[0001] This application is a continuation of U.S. non-provisional
application Ser. No. 11/356,739 titled MEDICAL MONITORING AND
COORDINATED CARE SYSTEM, filed Feb. 16, 2006, which claims the
benefit of U.S. provisional application No. 60/653,653 titled
MEDICAL MONITORING AND COORDINATED CARE SYSTEM, filed Feb. 16,
2005. This application also claims priority of provisional
application No. 60/653,653. Application Nos. 60/653,653 and
11/356,739 are incorporated herein by reference in their
entireties.
RELATED APPLICATIONS
[0002] This application is related to the following U.S. patent
applications, the disclosures of each of which is incorporated
herein by reference:
[0003] U.S. patent application Ser. No. 09/075,097, titled MEDICAL
MONITORING SYSTEM AND DEVICE, filed Oct. 11, 2001 (now U.S. Pat.
No. 6,840,904);
[0004] U.S. patent application Ser. No. 10/963,205, titled MEDICAL
MONITORING/CONSUMABLES TRACKING DEVICE, filed Oct. 11, 2004;
[0005] U.S. Provisional Patent Application Ser. No. 60/487,471,
titled MEDICAL MONITORING/CONSUMABLES TRACKING DEVICE, filed Jul.
15, 2003;
[0006] U.S. patent application Ser. No. 10/892,520, titled MEDICAL
MONITORING/CONSUMABLES TRACKING DEVICE, filed Jul. 15, 2004;
[0007] U.S. Provisional Patent Application Ser. No. 60/493,904,
titled PERSONAL HEALTH MANAGEMENT DEVICE, METHOD AND SYSTEM, filed
Aug. 7, 2003;
[0008] U.S. patent application Ser. No. 10/913,140, titled PERSONAL
HEALTH MANAGEMENT DEVICE, METHOD AND SYSTEM, filed Aug. 6,
2004;
[0009] U.S. Provisional Patent Application Ser. No. 60/562,876,
titled MEDICAL MONITORING SYSTEM, filed Apr. 16, 2004;
[0010] U.S. patent application Ser. No. 11/108,355, titled PERSONAL
HEALTH MONITORING AND/OR COMMUNICATION SYSTEM, filed Apr. 18, 2005;
and
[0011] U.S. patent application Ser. No. 10/868,676, titled MEDICAL
MONITORING SYSTEM AND DEVICE, filed Jun. 15, 2004.
BACKGROUND OF THE INVENTION
[0012] The present invention relates to managing health care to be
provided to members of a group, e.g., managed health care plans,
groups and organizations such as HMOs, group health insurance plans
(HIPs), medical groups, and to individuals who may wish to manage
health care. More particularly, the invention relates to
identifying and/or monitoring members of the group based on the
state of health of members, e.g., actual or possible high blood
pressure, actual or possible high blood cholesterol, actual or
possible diabetes, actual or possible severe obesity, etc., and
managing health care provided to such members based on
measurements, e.g., physiological measurements, made on the
members. The invention contemplates the use of devices to provide
at least some of the measurements which can operate out of a health
care provider's or professional's facility, e.g., such devices may
be portable and carried by members and/or used in members' homes or
places of business.
SUMMARY OF THE INVENTION
[0013] An embodiment of the present invention provides methods,
systems, software, user interfaces and devices for managing health
care to be provided to a group of members so as to identify and/or
monitor members actually or possibly in need of care, and seeking
to provide such care before more serious or more expensive care is
needed. In this embodiment, members are identified for monitoring
based on data such as medical history and/or initial measurements
related to one or more medical conditions such as high blood
pressure. Measurements are taken on such members and provided to a
database. The database processes the measurements and provides data
which indicates, or from which can be determined, a need for health
care. Members in such need are notified of the need. Such members
may be encouraged to obtain the health care and/or arrangements may
be made to provide such members with the health care.
[0014] Embodiments of the invention contemplate using devices
operated without the aid of health care or other professionals,
e.g., a portable device which a member carries, or a device which a
member uses at home or a place of business, operated by a member,
or automatically, etc. Measurements may also be taken in facilities
of health care providers. Measurement data and other information
may be electronically provided to the database via a network,
communications system, intranet, Internet, e.g., a cell phone
system, radio system, PSTS or POTs telephone systems, paging
systems, satellite systems, etc. Examples of such devices and
systems are disclosed in the referenced patent applications and/or
are known in the prior art.
[0015] Embodiments of the invention contemplate that such groups
provide for and/or arrange health care for members by health care
professionals such as doctors, where the group may be responsible
for paying the health care professions for the health care service
and the group charges or is paid on a per member basis. Such
arrangements are known in the prior art. Such an arrangement may,
for example, encourage groups to deliver the health care services
at an aggregated cost that is low compared to the aggregated
amounts paid to the groups. For example, fees to be paid to
professionals may be pre-agreed for given health care services, and
equal or substantially equal fees may be charged to all or some
members of the group.
[0016] The invention disclosed herein allows groups such as those
described herein to identify members who may be in need of health
care, and to detect at an early stage when such health care should
be provided so as to present the possibility that less expensive
health care can be provided early to avoid the need to provide more
extensive and correspondingly more expensive health care later. In
an embodiment of the invention, health care practitioners, e.g.,
practitioners other than medical doctors such as nurses, medical
assistants, paramedics, trained staff, may determine when to
intervene and encourage or arrange for health care to be provided
to monitored members by appropriate health care professionals.
[0017] As a business model, a service provider may provide all or
some of the hardware and software needed to perform the monitoring,
data acquisition, data storage, data processing, etc., to a group
on a per member subscription basis. According to this model, the
group factors into its charges to members the cost of the per
member subscription and/or the projected savings to the group from
identification and early intervention of members needing health
care services. This model may also provide for the group
underwriting the cost of devices used by members, so that the
service provider avoids the need for a high capital investment for
each group that the service provider serves. In this model, the
service provider provides, maintains and operates a database (and
associated communication protocols, data acquisition and access,
etc.) which is used to service a plurality of groups. In one
embodiment, the service provider may opt to provide the devices
free or at low cost, and amortize the cost of the devices over the
term of a contract with a group. This provides a steady income
stream after initial delivery of the devices, much as a razor
company or computer printer company charges a low price for a razor
or printer with the expectation that razors and ink will be
purchased from the company over the life of the razor or
printer.
[0018] Embodiments of the invention described below provide for
enrollment of members, identifying members to be monitored, data
acquisition from members by remote devices and/or from measurements
made in health care professionals' facilities, processing of data
to form groups of members with like medical conditions and/or
degrees of seriousness of a medical condition, and/or to identify
candidates for intervention, e.g., by means of automatically
generated alerts, and/or to notify such members and/or health care
professionals attending to such members, etc.
[0019] For example, embodiments of the invention may obtain and/or
monitor physiologic and other information, such as, but not limited
to, blood pressure, heart rate, body temperature, weight, EKG, EEG,
glucose level (blood sugar), respiratory capacity (PEAK flow),
substances and/or chemical presence or level (e.g., drugs,
proteins, hormones, compounds, chemicals and things which may be
found in a member's body, blood, body fluids, etc.), therapeutic
effect, efficacy, compliance, etc. Although the present invention
may be described by way of example in relation to certain types of
information and monitoring, the invention is generally applicable
to many types information and monitoring.
[0020] Monitoring devices may be portable and may be easily worn
(e.g., on a wrist, belt, etc.) or carried (e.g., in a pocket,
pocketbook, etc.). Transmission devices may be stationary, and may
be placed in any convenient location in a home, office, play or
exercise facility. Monitoring devices and an associated
transmission device may be located in a same building or sub-part
of a building (e.g., a house, a room in a building, an apartment in
a building, an office in building, etc.). In this respect, a
monitored member may move freely about the building and information
will be transmitted between monitoring devices and a transmission
device. A monitored member may locate a monitoring device 10, such
as a scale, in one room and the transmission device in another,
e.g., convenient to a communications port (telephone jack, internet
terminal, etc.).
[0021] The specific type of monitoring device is not critical, and
any suitable monitoring device, communication protocol, network may
be used. A member and/or a health care professional may be notified
or provided with information as described herein or in any suitable
manner, e.g., telephone, pager, fax, Internet, mail, etc.
[0022] As mentioned, in an embodiment of the invention the system
includes a database for storing member information and other
information, as well as at least an associated computer. The
computer may receive information from and provide information to
monitoring devices, and may also provide information to and receive
information from health care providers, family members, etc. As
mentioned, the computer may provide and/or receive such information
over a network, e.g., the Internet.
[0023] The computer may be involved with the health and medical
condition of individual members, health and medical conditions in
general, and/or drug tests, clinical evaluations, etc. Thus, the
computer can collect information from individual members, and
analyze and process such information in the nature of a
health-related database for a specific health issue or condition.
Information may be provided, e.g., for research, analysis or other
purposes stripped of personal patient information. Where a
monitoring device includes an input device, members may enter
demographic information and other information that may be included,
e.g., with other member information for, e.g., analysis and
research purposes.
[0024] Member information may also be used by the computer for
targeted messages, e.g., free text or other messages, health
related news, alerts, advertising, etc. For example, where a
monitoring device supplies blood pressure information, the
information may be used to identify a member as a candidate for a
hypertension drug, etc. Similarly, such a member may be supplied
with an alert of an environmental condition, such as extreme high
or low temperatures, or ozone content using member position or
geographical information. A monitoring device that supplies
respiratory information may identify the associated member as a
candidate for an alert of high ozone content, or high air pollution
levels, etc.
[0025] The computer may also provide an interface for use in
providing coordinated care for one or more or a group of
individuals being monitored with the monitoring device. The
interface preferably provides information to a care-coordinator in
a manner for the coordinator to act appropriately in a proactive
manner. This may be accomplished, for example, by generating alerts
for the coordinator based on physiologic measurements and/or action
items for the coordinator based on the alerts.
[0026] With respect to compliance, the user interface of a
monitoring device may be used to provide and receive
compliance-related information.
[0027] In one embodiment, a method for managing health care made
available to a group of people is provided in which initial
physiological measurement data related to each of a plurality of
people in the group is received. In general, the group of people
may be any group of people, such as members of a managed health
care organization, members of a fitness organization, members of an
institution, all citizens of a state or country, all members of a
family, or other group. The physiologic measurement data may be any
data indicating a physiologic, health or other condition or state
of an individual. Initial measurements may be received to provide a
baseline health condition of the person. Additional physiological
measurement data related to each person in a sub-group of the group
of people may be received. In general, the persons in the sub-group
have an initial physiological measurement that satisfies a
criterion, such as a first criterion, which may be value. A
computing device may be used to automatically determine that the
initial physiologic measurement satisfies the first criterion. For
example, a sub-group of a group of persons may be created for
individuals having a blood pressure measurement above or below a
certain initial criteria. The additional physiological measurement
data may be obtained using a portable device, such as a medical
monitoring device that is provided to each person in the sub-group.
The additional physiological measurement may relate to the
sub-group, such as in the example above, additional blood pressure
readings, or other physiological measurement. The additional
monitoring may be received according to a frequency or period as
necessary for the sub-group. Additional monitoring may be based on
a treatment regimen that is appropriate for the sub-group.
[0028] Each person in the sub-group may be contacted when an
additional physiological measurement data obtained by a portable
device satisfies a second criterion, which may be a value, such as
a higher or lower reading than the initial first criterion. A
computing device may be used to automatically determine that the
initial physiologic measurement satisfies the second criterion. The
additional physiological measurements, when compared to a first and
second criterion may provide an indication of a change in a
person's health, physical or physiological condition. The person,
or representative or other contact, may be contacted in connection
with the reading. The contacting may be via an electronically
delivered message, such as a text message sent to a portable
device, email, voicemail or other message, or a telephone call from
a health care manager or other individual associated with providing
managed health care. Prior to the contact, an individual, such as a
health care provider, care coordinator, health care professional,
such as a nurse, doctor, physician's assistant, or other interested
individual may review the additional physiologic measurement that
satisfies the second criterion, or other additional physiologic
measurement, e.g., to ensure that intervention is appropriate. In
general, the method may be provided by health care practitioners,
which may include doctors, but is typically provided by a nurse,
physician's assistant or other health care provider or
professional.
[0029] In another embodiment, a method for managing health care is
provided in which initial physiologic measurement data related to
each of a plurality of people may be received. Additional
physiological measurement data related to each person in a group of
the plurality people whose related or associated initial
physiological measurement data satisfies at least one first
criterion obtained using a portable device provided to each person
in the group may also be received. Each person in the group whose
additional physiological measurement data obtained by a portable
device satisfies at least one second criterion, may be contacted in
connection with the additional physiological measurement data
satisfying the at least one second criteria.
[0030] In another embodiment, a method for managing health care
made available to a group of people is provided in which initial
physiologic measurement data related to a potential health-related
concern from each of a plurality of people in the group may be
received. In general, health-related concerns can be for example
related to blood pressure, weight, respiratory flow volumes,
cholesterol, blood insulin levels, or other health condition.
Additional physiological measurement data related to the potential
health concern may be received from each person in a sub-group of
the plurality of people whose related initial physiological
measurement data satisfies at least one first criterion obtained
using a portable device provided to each person in the sub-group.
Each person, or representative or other contact, in the sub-group
whose additional physiological measurement data obtained by a
portable device satisfies at least one second criterion indicating
that the potential health-related concern is an actual
health-related concern, may be contacted in connection with the
additional physiological measurement data satisfying the at least
one second criteria and informing of the actual health-related
concern. The actual health-related concern may be an indication
that a person's physiological measurement has changed, for example,
to the extent that treatment or intervention is necessary.
[0031] In another embodiment, a method for managing health care
made available to a group of people is provided in which an initial
physiologic measurement data related to a potential health-related
concern from each of a plurality of people in the group may be
received. With the aid of a computing device, a person may be
identified for a sub-group of the plurality of people, each
identified person having related initial physiological measurement
data that satisfies at least one first criterion. Each person in
the sub-group may be provided a portable device capable of
providing additional physiological measurement data related to the
potential health concern. The additional physiological measurement
data from each person in the sub-group may be received and the
additional physiological measurement may be obtained using the
portable device provided to each person in the sub-group.
[0032] A plurality of second criteria may be established, each of
which indicates at a different level that the potential health
concern is an actual concern. For example, criteria may be
established at one or more thresholds which indicate that a
physiological measurement may be problematic or cause concern. In
one example, for a sub-group relating to blood pressure, one or
more criteria may be established in which, an intervention may be
taken, such as a somewhat elevated blood pressure level, a lower
than normal and potentially unsafe blood pressure level, or an
emergency or high blood pressure level. Different levels of
intervention may be associated with each of the plurality of second
criteria. For example, for a slightly elevated blood pressure
measurement, a message may be sent asking a person whether
medication was missed, for a lower than normal blood pressure
measurement, a call may be made to an individual to determine
whether something out of the ordinary had occurred, and for a
dangerously high blood pressure level, 911 or other emergency
service may be called, or other appropriate intervention. A
computing device may be used to determine whether received
additional physiological measurement data of a person in the
sub-group satisfies the second criteria. In the event that the
additional physiological measurement data satisfies the second
criteria, an associate intervention may be taken. As described
above, interventions can include, for example, at a first level,
informing the concerned person or representative and informing of
the actual health-related concern, at a second level of
intervention, informing the concerned person or representative of
an action indicated by the actual health-related concern. In some
embodiments the actual person may be contacted, or in other
situations, a care giver, emergency contact, relative or other
concerned individual may be contacted.
[0033] In another embodiment, a method for managing health care
made available to a group of people is provided in which initial
physiologic measurement data related to a potential health-related
concern from each of a plurality of people in the group is
received. Additional physiological measurement data is also
received that is related to each person in a sub-group of the
plurality of people whose related initial physiological measurement
data satisfies at least one first criterion obtained using a
portable device provided to each person in the sub-group. For each
person in the sub-group whose additional physiological measurement
data obtained by a portable device satisfies at least one second
criterion, a level of intervention associated with the satisfied at
least one second criterion may be performed. For example, in a
blood pressure sub-group that may be populated by individuals
having blood pressure above a certain criterion, those individuals
who have an additional or further blood pressure measurement that
exceeds a second criterion may have an intervention which can be,
for example, a reminder to take medication, a telephone call to the
person, a 911 call, or other intervention.
[0034] In another embodiment, a method for managing health care
made available to a group of people is provided in which initial
physiologic measurement data related to a potential health-related
concern from each of a plurality of people in the group may be
received. With the aid of a computing device, persons may be
identified for a sub-group, each person in a sub-group of the
plurality of people whose related initial physiological measurement
data satisfies at least one first criterion. Each person in the
sub-group may be provided a portable device capable of providing
additional physiological measurement data related to the potential
health concern. Additional physiological measurement data may be
received from each person in the sub-group that is obtained using
the portable device provided to each person in the sub-group. A
computing device may be used to identify each person in the
sub-group having received additional physiological measurement data
that satisfies at least one second criterion. For those persons
having such a physiological measurement, an intervention associated
with the at least one second criterion may be performed.
[0035] In another embodiment, a method for managing health care may
be provided in which initial physiological measurement data of
persons related to a health concern may be received. A monitoring
device may be provided to a person who has been prescribed a
regimen relating to the health concern, the monitoring device
providing physiologic measurement data related to the health
concern. One example of a prescribed regimen can be, for example,
periodic or on-time administration of a medication. Other
prescribed regimens can include, for example, appropriate diet,
exercise, medical treatments, sleep or other regimen. Data obtained
by the at least one monitoring device may be received and based on
the initial physiological measurement data and the physiological
measurement data received from the monitoring device, a
determination may be made to intervene to determine compliance with
or the effectiveness of the regimen.
[0036] In another embodiment, a method for managing health care is
provided in which at least one monitoring device is provided to a
person having a health concern possibly affected by the occurrence
of a condition external to the person, the monitoring device
providing physiologic measurement data related to the health
concern. One example of a condition external to a person is an
environmental condition, such as pollution, smog levels or a high
or low temperature which may have a deleterious effect on lung
capacity, blood pressure, or other health condition, or which may
cause a health concern, such as weight, diabetes, blood pressure,
or other concern, to be affected. Data obtained by the at least one
monitoring device may be received. In general the data relates to a
person's physiologic measurement data which may relate to the
health concern. Occurrence of the condition may be monitored, e.g.,
by monitoring weather or pollution information. A determination to
perform an intervention with the person related to the health
concern may be made based on the monitoring and the received
physiological data.
BRIEF DESCRIPTION OF THE DRAWINGS
[0037] The invention is illustrated in the figures of the
accompanying drawings which are meant to be exemplary and not
limiting, in which like references are intended to refer to like or
corresponding parts, and in which:
[0038] FIG. 1 is a block diagram of a system according to one
embodiment of the invention, and
[0039] FIGS. 2-12 are graphic user interface screens for authorized
persons to access information obtained with the monitoring devices
and to communicate with the monitoring devices according to one
embodiment of the invention.
DETAILED DESCRIPTION
[0040] Referring to FIG. 1, in one embodiment of the invention, a
medical monitoring system is provided that includes at least one
computer 30 communicatively coupled to one or more monitoring
devices 10, via a transmission device or hub 15, over a
communications network 20. Computer 30 is generally one or more
server or host computers with access to one or more databases 31
that provide the remote functionality described herein. In one
embodiment, computer 30 is not located locally with respect to
monitoring devices 10 and may thus be referred to as a remote
computer. In one embodiment, the monitoring system includes at
least one computer 30 communicatively coupled to a plurality of
different types of monitoring devices 10, through the transmission
device or hub 15 or otherwise.
[0041] A monitoring device 10 is generally a data acquisition
device for obtaining and/or monitoring subjects for physiologic or
other information. (The terms "subject," "member," "user,"
"individual" are used in a broad sense and may be used
interchangeably unless the context indicates otherwise.) The
monitoring device 10 preferably includes, e.g., incorporated into
the device, at least one sensor 12 for measuring or otherwise
sensing directly at least one physiologic parameter of a subject.
Various types of sensors may be included in the monitoring devices
10, including, but not limited to, sensors that are used for
determining glucose level, weight, blood pressure, body
temperature, heart rate, EKG, EEG, substance presence or levels,
therapeutic effect, efficacy, compliance, etc. The monitoring
devices 10 may therefore be multi-purpose devices, e.g., having a
plurality of sensors for measuring different types of physiologic
parameters, or different types of devices 10 for measuring
different types of physiological parameters, such as a weight scale
to obtain a user's weight, a blood pressure cuff to obtain a user's
blood pressure, a glucose monitor to obtain a user's blood glucose
level, etc., or any combinations thereof, such as a combined
glucose and blood pressure measurement device. In certain
embodiments, the monitoring device 10 is portable and designed to
be wearable by a subject or easily carried.
[0042] In one embodiment, the monitoring device 10 includes one or
more of the following: an electronic controller 23, an electronic
memory 21, a user interface 25 for a user to input information
therein, such as buttons or keypad, an output device, such as a
display device 11, e.g., a graphic, non-back-lighted monochrome
liquid crystal display, a communications unit 19, and a power
source (not shown), such as batteries. The device 10 preferably
includes a clock and/or a calendar or other means for associating a
time and/or date with a physiologic measurement. The memory 21
generally provides a means for storing information collected
therewith or received from the remote computer 30, such as a
plurality of measurements, statistical data derived from the
measurements, e.g., in chart form or otherwise, user information,
e.g., a user identification number, device information, e.g., a
serial number, and time and date information. Some or all of the
user information may be stored in the monitoring device 10 memory,
for example, for later review. The monitoring device 10 is
preferably powered by standard batteries or chargeable using a
power charger, and may include a battery meter on the display
device indicating the power remaining in the monitoring device
10.
[0043] In one embodiment of the invention, a medical monitoring
device 10 is provided, which includes an electronic controller 23,
a display device 11, an electronic memory 21, and one or more
sensors 12 for measuring at least one physiologic parameter of a
subject. The sensor may also detect consumable usage and/or test or
otherwise determine at least one physiological parameter of a
subject using the consumable. In this respect, the invention
beneficially allows an authorized party to determine compliance
based on actual usage of a consumable as opposed to indirect or
assumed usage based on reporting acts from a subject. For example,
actual usage may be assured with a device that determines both
usage and blood glucose from a blood glucose sensor.
[0044] The monitoring device 10 may also include a communication
unit, e.g., incorporated into the device, which communicates
information measured or otherwise obtained therewith or any other
information stored in the computer memory 21, such as responses to
messages, to a transmission device 15. In preferred embodiments,
the monitoring device 10 communicates with the transmission device
15 using suitable wireless technology, such as an RF carrier,
although other wireless, or wired, communications may be used. In
this instance, the device 10 includes therein an appropriate
transmitter and/or a receiver for communicating with the
transmission device 15.
[0045] The transmission device 15 generally acts as a hub or base
for one or a plurality of monitoring devices 10, e.g., a plurality
of different types of devices, which communicates information
received from the monitoring devices 10 to the server computer 30.
In this respect, the transmission device 15 generally includes a
communication unit 27 for communicating with the monitoring devices
10 and a communication unit 29 for communicating with the server
computer 30. For example, the transmission device 15 may include a
transmitter and/or a receiver for communicating wirelessly with one
or more monitoring devices 10 and a modem and/or a jack, connector,
or other port for connecting to the server computer 30 over a
network 20, such as a cellular telephone network, the public
telephone network, the Internet, or any other network. The
plurality of different types of monitoring devices 10 preferably
communicate with the transmission using a common protocol thereby
allowing a single transmission device 15 to be used as a hub for a
number of different types of devices 10.
[0046] In one embodiment, the transmission device 15 communicates
automatically with the monitoring devices 10 and/or with the server
computer 30 without any direct prompting from a user. For example,
with regard to a monitoring device 10 for monitoring a subject's
blood pressure, the monitoring device 10 may automatically signal
the transmission device 15 when a physiologic measurement has been
taken and may automatically communicate necessary information,
including the measurement, to the transmission device 15. The
monitoring device 10 may also signal the transmission device 15
prior to taking a measurement, e.g., when the device is turned on.
In this respect, the transmission device 15 may attempt to connect
with the server computer 30 while the measurement is being taken to
shorten any response time from the server computer 30. This aspect
of the invention beneficially enhances the user's experience with
regard to the real time responsiveness from the system. The
monitoring device 10 may also store information therein for later
communication, e.g., in the event the monitoring device is not able
to communicate with the transmission device 15, and attempt to
establish communication with the transmission device 15, as
discussed below. The transmission device 15 may then automatically
establish communications with the server computer 30 and
communicate the information received thereto. In this respect, the
transmission device 15 does not require a display, however, a
signal indicator may be provided, such as an LED or LEDs, which,
e.g., flashes to indicate communication is taking place and/or
indicate status of the communication. Where transmission device 15
includes a cell phone, which typically includes a display, such
display need not be part of the subject experience in the process
of communicating between a transmission device and a remote
computer or using the monitoring device or sensors.
[0047] The transmission device 15 is preferably a portable device,
which can be easily transported and can establish a communication
connection wherever it is located. In other embodiments of the
invention, transmission device 15 is fixed in one location, for
example, within a subject's home. As noted above, the transmission
device 15 may also be configured to operate with a plurality of
monitoring devices 10, as shown in FIG. 1, whether of different
types or otherwise. In this instance, the transmission device 15
may be configured to recognize or otherwise identify each of the
plurality of monitoring devices 10. This may be accomplished, for
instance, with a unique device identifier that is communicated to
the transmission device 15 with the physiologic or other
information. In other embodiments, more than one subject may use
the same monitoring device 10. In this instance, the monitoring
device 10 and/or the transmission device 15 may be configured to
associate a particular patient's or subject's information with the
appropriate person. This may be accomplished by prompting the user
of the device 10 to identify himself or herself, in which instance,
a unique subject identifier may be communicated to the transmission
device 15 with the physiologic information. As noted above, the
monitoring devices 10 may also include a clock for associating
measurements taken therewith a time and date. In this instance,
time and date information is communicated to the transmission
device 15 with the physiologic information. In general, a
monitoring device 10 may be provided to a person or an individual
or a group of individuals as part of a treatment regimen to monitor
a physiologic condition.
[0048] If communications with the transmission device 15 cannot be
established immediately, e.g., soon after the physiologic
measurement has been taken, the monitoring device 10 may attempt to
establish communications at a later time. In one embodiment, the
monitoring device 10 may attempt several times successively soon
after the failed attempt. If communications cannot still be
achieved, the monitoring device 10 may store the information and
try to send the information at a later time, e.g., in 5, 10, 15,
20, etc. minute intervals.
[0049] The transmission device 15 generally communicates the
information obtained from the monitoring devices 10 to a server
computer 30 via network 20. The network 20 may be any network or a
plurality of networks suitable for communicating information from
the transmission device 15 to a remote computer 30, such as a
cellular telephone network, or any other wireless network, the
public telephone system, the Internet, a local area network (LAN),
a wide area network (WAN), etc. The manner in which the
transmission device 15 communicates to the server computer 30 will
depend on the resources available. For example, when available, the
transmission device 15 may be coupled to communicate via a cell
phone, which provides for maximum flexibility with respect to
monitoring subjects away from a particular location, e.g., the
subject's residence. Similarly, when available, the transmission
device 15 may communicate via the public telephone network or over
the Internet. In one embodiment, the transmission device includes a
plurality of different types of communications units 29, such as a
modem, a USB port, a serial or parallel port, etc.
[0050] Communication of patient or subject information is
preferably secure and/or encrypted. For example, patient
information can be sent as a single UDP datagram and error checking
can be provided (e.g., checksums, encryption, etc.).
[0051] In one embodiment of the invention, at least once,
periodically, or each time the monitoring device 10 communicates
with the transmission unit 15 and the computer 30 via network 20,
date and time on the monitoring device 10 and/or the transmission
unit 15 is synchronized with the date and time of the computer
30.
[0052] In one embodiment, the server computer 30 includes therein
software, hardware, or a combination thereof, which establishes or
at least attempts to establish communication with the user of the
monitoring device 10 based on the information received therefrom.
The computer 30, for instance, may initiate communication with the
user based on physiologic measurements communicated thereto from
the monitoring device 10. For example, the server computer 30 may
compare incoming data with thresholds, e.g., established based on
general standards or for the particular user, and initiate
communication with the user when the incoming data exceeds the
criterion or other threshold. For instance, if the system
determines that the user's weight, blood glucose level, blood
pressure, etc., or any statistical derivation thereof, exceeds a
criteria, level or threshold for such measurements, the system may
attempt to initiate communication with the particular measure
accordingly. For example, if the user's blood pressure appears
elevated based on a threshold set for the particular user or for a
group of users, the computer 30 may initiate communication with the
user to query the user regarding activities and symptoms that may
be associated with the elevated reading. Thresholds may be
established for a number of other criteria for establishing
communication with the user of the device 10. For example, the time
between measurements or non-measurement for a period of time may
trigger communication.
[0053] In some embodiments, a plurality of interventions may be
associated with each of a plurality of criteria or threshold. For
example, in a blood pressure treatment regimen or a blood pressure
group, different blood pressure levels may be established as a
criterion, each of which may have an associate intervention. For
example, for a somewhat elevated blood pressure measurement, an
intervention may be a message sent to the monitoring device 10,
which may be a free text message, include a query about medication
consumption, or other message. For a slightly higher blood pressure
measurement, an intervention may be a telephone call to the
individual, a care giver, emergency contact, or other individual.
For a dangerously high blood pressure measurement, other emergency
intervention may be taken.
[0054] Various or a plurality of various types of communications
may be initiated, including messaging back to the medical device
10, e-mail messaging, facsimile messaging, voice messaging, etc. In
one embodiment, the computer 30 is communicatively coupled to a
public telephone network 16 that provides access to the user with
user telephonic equipment 77. Messages can include free text which
may relate specifically to a particular user, data obtained by the
monitoring device 10 or other received data. Free text may include,
for example, text that is written, generated, created or otherwise
provided by a care coordinator, medical provider, concerned
individual, or other person. The free text can include
user-specific data and the free text message may be created in
response to or relate to a user's physiologic measurement. The free
text message may also include portions of predefined or canned text
or other automatic messaging data.
[0055] In one embodiment of the invention, some or all of the
communications between the various devices of the monitoring system
are performed in real-time, when possible. For instance,
information from the monitoring devices 10 may be communicated
automatically to the transmission device 15 once physiologic or
other information is obtained with the device 10, which may
subsequently be communicated automatically to the server computer
30. The server computer 30 may monitor incoming information and
establish or attempt to establish communication with the user once
the information is received. In this respect, the monitoring system
is capable of real-time monitoring and real-time responses to the
monitoring data.
[0056] The type of messaging and the form of notification may vary
based on the type of data received. For example, the messaging may
be free text, words of encouragement for a user participating in a
weight management program, statistical information based on the
information received, prompts for additional information, prompts
or directions to contact a person monitoring a user or a health
care provider, etc.
[0057] In addition to automated messaging, e.g., automatic
messaging based on information received, the system may further
provide access to the information received and/or messaging
capability to authorized users, such as users of the monitoring
device 10, health care providers and professionals, partners,
caregivers, family members, and any other interested party. In this
instance, the server computer 30 may be communicatively coupled to
a user computer 33, such as a personal computer, personal data
assistant (PDA), cell phone, or any other communicatively enabled
device, capable of displaying at least one graphic user interface
for accessing the stored information, such as the interface screens
depicted in FIGS. 2-12.
[0058] In one embodiment, the devices of the present invention and
the information therefrom is used and/or compared with information
obtained in a manner that is other than with self-monitoring, e.g.,
by a professional at a physician's office, hospital, pharmacy,
laboratory, insurance agency, etc. In this respect, the monitoring
system of the present invention includes or is otherwise
communicatively coupled to a healthcare provider computer 13 that
is associated with a database 17. The database 17 generally
includes therein information regarding an individual being
monitored obtained by, e.g., a healthcare provider during an office
visit or in any other office setting. The database 17 may include
any type of information relevant to the healthcare provider based
on the particular type of service provided therefrom, such as
physiologic measurements, laboratory or other test results,
prescribed medications and dosage, refill information, etc. This
information may be compared and reconciled with information
obtained with the medical monitoring device, e.g., for accuracy or
to identify any anomalies in the data. One example, of such
reconciliation may occur when using an electronic prescribing tool
in a doctor's or other medical or healthcare provider's office to
electronically prescribe a patient's medication. Data entered in
the electronic prescription may be automatically populated in the
database 17 in the patient's medication record so that it may be
compared and reconciled with the information obtained with the
medical monitoring device 10. This way, the patient can be tracked
for further diagnoses and progress, e.g., by comparing additional
physiologic monitoring.
[0059] As discussed herein, a monitoring device or a plurality of
monitoring devices 10 and a transmission device 15 can be located
within a household to serve one or more users therein. The term
household is used herein in a broad sense to include any location
in which a monitoring device 10 and transmission device 15 may be
located, and can include a hospital, institution, or other
location. The households are connected to remote computer 30 via a
network 20, described herein, which includes for example, a
cellular telephone network, the public telephone system, the
Internet, etc., or any other network. The computer 30 generally
includes a processor, memory storage, and other common computer
components suitable to execute the systems and methods described
herein. The computer 30 will typically include or access a database
31 to store a monitored subject's information, as well as other
information. The database is preferably a relational database. The
database may generally include various types of information
regarding the particular user that are relevant to the physiologic
parameter being monitored, such as the user's contact information,
physician(s) and their contact information, emergency contacts,
medications, allergies, medical history, clinical evaluations,
family histories, hospitalizations, medical visits, physiologic
measurements, e.g., glucose, weight, blood pressure, etc.,
thresholds, goals, passwords or identification numbers, unique
device identifiers e.g., serial number, etc. Some or all of
information may also be maintained by a healthcare provider that
obtains the information in a manner other than through
self-monitoring, such as in database 17.
[0060] Computer 30 may communicate patient information or other
information to service providers 50 and one or more recipients via
network 40. Incidentally, one or more of the recipients may be a
healthcare provider that maintains the database 17. For example, a
physician may maintain a database of patients under his or her
care, and may also have access to the patient information obtained
with the monitoring device 10. The network 40 may be a cellular
telephone network, the public telephone system, the Internet, etc.,
or any other network. Service providers 50 may be a doctor,
hospital, medical provider, emergency medical services, or another
service provider who may provide a service to a subject user based
on patient or subject information, such as the information entered
into or measured with the monitoring device 10. A recipient may be
a family member, interested individual, or any other person who may
wish to receive the monitored subject's information.
[0061] As noted above, the computer 30, service provider 50 and
recipient may also communicate with the monitoring device 10 via
the network 40, computer 30, network 20, and transmission unit 15,
for example to supply information or questions in response to
received patient information. An "envelope" icon or other message
indicator, may appear on the monitoring device 10 display, or an
audible message indicator alert may sound when such information is
received from a service provider 50, a recipient or the computer
30. A message from the computer 30, service provider 50 and a
recipient may require an acknowledgement from the user, for
example, before a user can take a measurement or use the monitoring
device 10, the user will be required to read a message and respond
to it or otherwise acknowledge the message. The response or
acknowledgement entered into the monitoring device 10 is
communicated over the network 20 to the computer 30, service
provider 50 or a recipient.
[0062] When a user first obtains a monitoring device 10, the user,
in one embodiment, must register the monitoring device 10. For
example, a user may enter an access code into the monitoring device
10 to "unlock" the monitoring device 10 to allow it to register
with the system. Informed consent information, such as system terms
and conditions, may also be displayed to a user and acknowledgement
or acceptance required prior to initiating a monitoring device 10.
In a first communication between the monitoring device 10,
transmission unit 15 and computer 30, a connection may be
established through a toll free number to register the user with
the system and to download a local dial in number for future use.
The access code may be a unique access code that may be stored with
the device 10 to identify the particular device and/or the user, or
some other unique identified, such as a serial number, may be
stored with the device to identify the device, the user, or a
combination thereof. In one embodiment, registration is initiated
with the user taking the first measurement with the monitoring
device 10. The first measurement may be communicated to the
computer 30 with the registration information, or at some other
time, such as on a subsequent communication session with the
computer 30. In this respect, the subsequent communication will
include a plurality of physiologic measurements.
[0063] After a user has registered or otherwise logged into the
system using the monitoring device 10, a menu may be displayed on
the display listing the primary information associated with the
daily operations of the monitoring device 10, which depicts a
display for a blood pressure monitor. The first menu may include a
readings selection menu item for accessing physiologic information
obtained with the device 10, a messages selection menu item for
accessing messages communicated to the device 10, and an options
selection menu item for specifying device options. Device 10 may
also display button identifiers that identify the function of the
buttons of the device, e.g., a scroll identifier, a select
identified, etc. A user may select a menu item to go to a next
screen that is displayed in response to the selection.
[0064] Upon selection of the readings menu item, the device may
display a measurements screen that includes measurements obtained
with the device 10. Measurements may be shown on the monitoring
device 10 display in more than one way, such as numeric data or
graphical data, or a combination thereof. Measurements are
preferably shown in the order of the measurement, e.g., by time,
day, week, month, etc. The device preferably provides scroll
functionality to display readings for other days. The graphical
representations of the measurements may be determined locally,
e.g., on the monitoring device, or remotely, e.g., by the server
computer 30, in which instance, the server computer may communicate
coordinate data, as well as other graphical data, for displaying
the graphical image of the measured data on the display of the
monitoring device 10.
[0065] Upon selection of the messages menu item, an appropriate
messaging screen is displayed. The messaging screen may provide a
list of opened and unopened messages, which may be selected by the
user for viewing. Upon selection, the contents of the selected
messages are displayed. As noted above, messaging may vary. The
messaging may be a prompt for information, such as a compliance
query, which shows a message from, e.g., computer 30, a service
provider 50, or a recipient, inquiring whether the user has taken
medication. Similarly, the messages may inquire regarding use of
the device, which may serve as a gentle reminder for the user to
use the device 10 more often. Other free text messages relating to
received data may also be sent to the device 10.
[0066] The monitoring device 10 options can be changed by selecting
an option selection on the display menu, which may provide access
for changing configurable features, such as alerts, beeper, signal,
connection, or transmission features. Connection settings generally
permit a user to set connection preferences, such as dial up
number, dialing pattern, line access, etc. Alternatively, or in
addition, the transmission device 15 automatically determines the
type of connection being used. Transmission settings also allow a
user to set transmission, e.g., enable or disable, for example when
a user is in a hospital and transmission must be turned off.
[0067] To initiate a measurement, a user may select a start button
on the device. Selecting the start button can cause a graphical
representation that instructs the user of the proper placement
and/or use of the monitoring device 10 screen. With regard to a
blood pressure cuff, the correct placement of the monitoring device
10 is depicted to assist the user in obtaining a correct blood
pressure measurement.
[0068] When a user is ready to take the measurement, the user may
so indicate through an input to the monitoring device 10. When the
measurement is completed, the reading will generally be displayed
on the screen of monitoring device 10 and stored to memory at least
temporarily with the time and date the measurement was taken. If
there was an error in the measurement, an error message may be
displayed on the screen, and the user may be prompted to repeat the
measurement.
[0069] In at least one embodiment of the invention, the subject's
information is communicated from the monitoring device 10 to the
computer 30 via network 20 at about the time the measurement is
taken. The monitoring device 10 screen can include indications that
the user's information is being transmitted, such as a transmission
or connection icon. When the computer 30 has been reached,
confirmation that the information has been received by the computer
30 may also be indicated by the monitoring device, e.g., with a
display on the monitoring device 10 screen, or an audible signal.
If computer 30 cannot be reached, an indication of the failed
communication will be indicated on the monitoring device
screen.
[0070] The monitoring device may include a plurality of input
devices such as buttons and other devices that are used in
conjunction with the display to provide the monitoring device 10
user interface. The monitoring device 10 may include several device
drivers, such as a Timer Manager that maintains, e.g., a 10
millisecond, time base to provide system wide timing for the
polling of keys or buttons, updating the display and other general
purpose timing requirements, a Display Manager that provides a
transparent interface to the LCD display, a Keypad Manager that
debounces and posts keypad entries to the application software, an
Eeprom Manager that provides an interface for non-volatile data
storage, a communications Manager that provides access to/from the
communication (RF) system, or other device drivers.
[0071] The Timer Manager generally uses a timer to generate an
interrupt, e.g., every ten milliseconds. The timer manager
maintains a timer for each of the following: Keypad Poll Timer,
e.g., of 20 milliseconds, which when the time expires activates the
keypad manager so that it can poll, debounce, and post any keys
that have been pressed, a Beeper Timer, which allows a single-tone
beeper to be activated with a variable duration On/Off time, and
General Timers, which are used by the application to send callback
messages to itself at defined intervals.
[0072] The Display Manager performs initialization of the
monitoring device 10 display controller and accepts text strings
(Null terminated character arrays) from the application for display
on the monitoring device 10. The API calls may include:
[0073] InitDisplay( );
[0074] This initializes the display controller.
[0075] ClearDisplay( );
[0076] This clears the display of any data.
[0077] DisplayString(char *string, byte_t position, byte_t
mode)
[0078] This displays a text string at the starting at the desired
character position.
[0079] The modes are: Normal, Inverse, Underscore
[0080] The Keypad Manager may be invoked by the timer manager at a
rate of 20 milliseconds. The manager maintains a state machine to
debounce and process key presses. Multiples of the 20 millisecond
rate are used to move a key or button through the state machine.
The states of the state machine may include: New Key--Key initially
pressed, Waiting For Debounce--Key is held, Debounced--Key was held
for required time. When a key reaches the Debounced state, it is
posted to the application.
[0081] The monitoring device 10 memory can be, for example a
25LC640, 64K bit Serial Electrically Erasable PROM [EEPROM]. The
memory is accessed via a Serial Peripheral Interface (SPI)
compatible serial bus. The bus signals required may be a clock
input (SCK) plus separate data in (SI) and data out (SO) lines.
Access to the device may be controlled through a Chip Select (CS)
input. Data stored in the Memory can include, for example: system
database, multiple measurements, chart data, messages from system,
user identification, serial number, time data for the measurements,
etc.
[0082] The monitoring device 10 may include a built-in A/D
converter that is used to measure the battery voltage. The state of
the battery is displayed as an icon on the LCD. Three levels: High,
medium and low may be represented using these icons. A measurement
of the battery may be taken each time that the monitoring device 10
enters a main menu screen, or, for example at power up.
[0083] The transmission device 15 software may be a real time
system that is designed as a combination of an interrupt
communication system and a polled event handler. The communications
sub-system handles RS232 communications (cell phone and modem) as
well as radio frequency communications, Bluetooth or other
communication means, with the blood pressure meter or any other
device. The transmission device 15 carries out commands to connect
via a network, such as the Internet, cellular telephone, public
telephone, to computer 30, and acts as a conduit for communications
between the computer 30 and the monitoring device 10.
[0084] In one embodiment, the transmission device 15 generally has
a modem, such as CMX866 integrated modem chip. The CMX866 is a
multi-standard modem for use in telephone based information and
telemetry systems. Control of the transmission device 15 is via
commands, such as AT commands over a 9600 bps serial interface. The
on-chip .mu.Controller interprets these AT commands and controls an
internal DSP, which provides the modem and ancillary functions such
as Ring Detection, Call Progress Detection, Hook Switch control and
DTMF autodialing.
[0085] The transmission device 15 can also have a cellular
telephone interface, such as a RS232 serial interface. Hardware
flow control using RTS/CTS is implemented. The signal lines
available are: Transmit, Receive, RTS (Request to Send), CTS (Clear
to Send), and Ground.
[0086] The monitoring device 10 and the transmission device 15
(collectively a "client device") may communicate with the server
computer 30 in a variety of ways. In one embodiment, the client
device communicates with the computer using the protocol outlined
in Appendix A. The data may be communicated between the devices in
a variety of different ways. In one embodiment, the information is
communicated to the server 30 in a datagram or packet that includes
at least one actual measurement taken with the monitoring device
10, such as a blood pressure, weight, glucose measurement and the
date and time the measurement was taken. Additional information for
associating the measurements with a particular user may also
communicated to the server 30, whether in the same datagram or
otherwise, such as a unique user identification number, access
code, etc., as well as information for identifying the particular
type of device being used, such as the serial number, responses to
messages, request datagrams, acknowledgement datagrams, etc.
Request datagrams generally contain a query or request for action
from the receiving device, such as a request to logon, logoff,
accept physiologic measurements, download charts, messages, etc.,
from the monitoring device. Acknowledgement datagrams generally
contain information that acknowledges a request or completion of a
request. For example, an acknowledgement may be communicated from a
monitoring device 10 to the computer 30 indicating receipt of a
physiologic measurement, a message, etc. The acknowledgements may
be used, e.g., to track which information items where communicated
between devices, such as measurements, charts, messages, etc., to
prevent inadvertent multiple transmission of the same information.
The various types of requests and acknowledgements are outlined in
Appendix B. Various types of information may also be sent to the
monitoring device 10 from the computer 30, such as chart data,
e.g., coordinates as well as other information for plotting a
graphical representation of the measure data, messages (long and
short form), request datagrams, acknowledgement datagrams, etc.
[0087] As discussed above, computer 30 may include one or more
databases which store information of the type described herein,
e.g., patient data, health and medical condition data of individual
patients, health and medical condition data in general, and/or drug
tests, clinical evaluations, data, etc. Computer 30 and/or other
computers may access, analyze and process such data in connection
with a specific health issue or condition, etc. Information from
such a database and other databases may be provided, e.g., for
research, analysis or other purposes stripped of user information
that may be used to identify particular users, such as the user's
name, address, identification number, etc. Where a monitoring
device 10 includes an input device or another means for entering
information is provided, patients may enter demographic information
and other information that may be included, e.g., with other
patient information for, e.g., analysis and research purposes.
Patient information may also be used in connection with the
provision by a remote computer and appropriate databases of
targeted messages, e.g., health related news, alerts, advertising,
etc. For example, where a monitoring device supplies blood pressure
information, the data may be used to identify the patient
associated with the monitoring device as a candidate for a
hypertension drug, etc. Such a patient may be supplied with an
alert of extreme high or low temperatures, or ozone content, e.g.
based on a geographic position. A monitoring device that supplies
respiratory information may be identified, for example, as a
candidate for an alert of high ozone content, or high air pollution
levels, etc. The above or another database may be provided for
compliance information.
[0088] In this respect, the service provider 50 may provide a
website or any graphical interface for accessing information, which
will generally be referred to herein as a website, for access to
such information and/or for messaging particular monitored users.
The particular user's information is preferably made available
based on specific user entitlement. For instance, a monitored user
may be entitled only to information regarding the user's own
monitoring, such as the user's own physiologic measurements,
charts, messages, etc. Similarly, a physician, caregiver, family
member, or other interested party will have access only to
information particularly entitled to, such as the interested
party's own patient(s), family member, etc. In this respect, the
monitored user may be provided with an interface or some other
means for providing access to his or her information for interested
parties. Website users may also be provided with information
regarding monitored users without authorization provided the
information does not contain any personalized information. For
instance, the website users may be provided with statistical data
regarding other monitored users, such as average readings for other
users with similar conditions, compliance, outcomes, etc. In these
respects, website users may first be provided with a logon
interface screen prompting the user for a user name and a
password.
[0089] As noted, a variety of interested parties may be provided
access to information based on specific entitlement. For instance,
a healthcare provider may be provided access to information for the
provider's own patients. The term healthcare provider generally
includes any individual or entity that is interested in the
patient's physiologic measurements, such as a physician, nurse,
aid, personal trainer, etc. In this respect, after logging on, the
healthcare provider will be provided with a list of menu items,
e.g., collectively under a "My Ideal Life" heading, that provide
authorized access to specific types of information, such as
personal information regarding all of the provider's patients or
subgroups thereof, information regarding the provider's patient's
readings or subgroups thereof, e.g., reports, messages or action
items (interactions) for the particular provider, an online
calendar, etc., as shown in FIGS. 2-12.
[0090] The service provider 50, i.e., in this instance, the entity
supplying the functionality of the computer 30 and database 31, may
provide the interface to a healthcare provider for the provider to
manage the health of a group of individuals. Various types of
health problems may be managed in accordance with the present
invention, such as high or low blood pressure, glucose levels,
weight, etc. The individuals may be grouped based on a variety of
criteria, such as health related issues, common physicians, common
insurance, etc., or a combination thereof. For example,
physiological measurement data of a group of individuals may be
received and compared to an initial criterion established for a
sub-group. The members or persons in the sub-group may be
associated with a particular treatment regimen appropriate for
their health condition and be provided a monitoring device. Several
levels of physiological measurement criteria may be established
which correspond to an appropriate intervention for the criteria.
For example, in a diabetes sub-group having members that have a
particular glucose level that satisfies an initial criteria, one or
more criteria may be established for different glucose levels which
may have an appropriate intervention.
[0091] In this embodiment, the monitoring system of the present
invention is used to manage the health of a group of users
belonging to a coordinated care group. In this instance the service
provider 50 is preferably a separate and distinct entity from the
healthcare provider, insofar as the service provider provides the
backend functionality of the service provider system, collectively
the computer 30, database 31, and the software associated
therewith. In this respect, a group administrator may provide the
monitoring devices to its members and monitor the member's health
with the interface provided by the service provider. A secondary
observer, e.g., other than an actual physician, such as a nurse
practitioner, may monitor the members' health to help doctors
control the members' health more efficiently. In one embodiment,
the interface provides information and alerts as well as other
functions for the nurse practitioner to act as a care-coordinator
that facilitates coordination between the physician and the
patient.
[0092] As noted above, the healthcare provider may maintain the
group members' information in a database 17 associated with a
healthcare provider computer 13. At least some of the members'
information, such as the members' names, addresses, demographic
information, physiologic measurements, etc., may at least initially
be shared with the database 31 associated with the remote server
computer 30. This may be accomplished to define the coordinated
care group. Once the group has been defined, the group administer
may provide the monitoring devices to the members of the group,
which may then activate the monitoring devices 10 by registering
the devices 10 with the service provider 50 as discussed above.
[0093] In one embodiment of the invention, individual members of
the group are monitored in accordance with a patient monitoring
program or treatment regimen. The patient monitoring program
generally includes a protocol that serves as a schedule for
individual users to take additional physiologic measurements. The
protocol may be fixed for the duration of the monitoring period or
may vary. In one embodiment, at least one individual is monitored
in accordance with a multi phase monitoring program, which may
include a first phase for screening individuals for coordinated
care regarding a health related issue indicative of a physiologic
parameter being monitored, e.g., using an initial criterion as a
comparison against physiological measurements to determine whether
an individual is appropriate for a coordinated care sub-group
(Phase I), a second phase to achieve control of the health related
issue (Phase II), a third phase for screening individuals to
determine if the health related issue is being controlled (Phase
III), and a fourth phase for determining whether the health related
issue is being controlled over an extended period of time (Phase
IV).
[0094] The various phases may be timed accordingly. For instance,
the first phase may entail measurements for a period of 8 days or
any other time necessary to determine if the individual is a
candidate for coordinated care with regard to a health related
issue, such as high blood pressure level or other initial criteria
for a group in coordinated care. Qualification for coordinated care
may be based on a variety of criteria, which includes at least one
physiologic measurement exceeding an acceptable threshold. If the
individual is a candidate for coordinated care, the individual may
be monitored for a longer period of time, fixed or otherwise, or
until control of the individual's health related issue is achieved.
Control may generally be achieved with coordinated care based on
the physiologic measurements taken with the monitoring device 10.
That is, the care-coordinator may review the physiologic
measurements and/or any alerts derived therefrom and act
accordingly in a proactive manner to control the health issue. It
is understood that control may be achieved in a variety of ways,
such as by prescribing medications or changing dosage, scheduling
follow-up visits with a physician, attending to non-compliance
issues, etc. Once the time period for control has lapsed, e.g., 6
months, the third phase may be applied to determine if the health
related issue is indeed under control and, if so, the fourth phase
may be applied to ensure that the health related issue remains
under control. The various phases may generally be repeated as
necessary until the desired control is achieved. In one embodiment,
coordinated care with regard to high blood pressure may be achieved
with the program outlined in Appendix B.
[0095] Group membership may be dynamic and based on a member's
current health status. For example, if a member's physiologic
measurements falls below or is considered better than an acceptable
criteria or threshold, the member may be removed from the group. In
another example, if more than one physiologic measurement is
obtained from the member, one measurement may indicate a relative
improvement of a condition which no longer exceeds an intervention
or treatment criteria, but second measurement may worsen and exceed
another criteria for membership in a coordinated care group or
sub-group. In such case, the member may be moved from a first group
to a second group.
[0096] As noted above, the service provider 50 may provide a
website that includes one or more graphic user interfaces for
monitoring physiologic measurements for the members of the
coordinated care group. The service provider 50 may provide a first
interface screen or a dashboard that provides an overview with
regard to the status of the coordinated care group in relation to
the monitoring program, such as the interface screen shown in FIG.
2. Referring to FIG. 2, the first interface screen may include a
program summary that indicates, for instance, how many of the
members of the group have not registered their monitoring devices,
and how many members of the group are in each particular stage of
the program. The program stages are preferably selectable links
that when selected cause to be displayed an interface screen that
allows the care-coordinator to view information for the individuals
included in the particular program stages, such as the interface
screens shown in FIGS. 3 and 4.
[0097] The first interface screen may also include a patient
summary that indicates how many members of the group fall within
health related classifications, such as hypertensive, hypotensive,
hypotensive suspect, and normotensive, and may include an
interaction summary that indicates how many alerts and interactions
are outstanding for the particular care-coordinator. Each of the
classifications and the interactions preferably include selectable
links that cause an appropriate interface to be displayed for
viewing information regarding the individuals so classified and
outstanding interactions, respectively.
[0098] Referring to FIG. 4, a patient interface screen may be
provided that includes a list of the patients under the care of the
particular care-coordinator. The interface screen preferably
includes form elements, such as drop down lists, for the
coordinator to define a subset of the coordinated care group. The
subset of coordinated care group may be defined, for example, by
health related classifications and/or program phase. The list
preferably includes a color coordinated alert for each of the
listed patients. The color displayed is generally based on the
severity of the alert, which is generated based on physiologic
measurements. Each of the listed patients may also have a
selectable link associated therewith for displaying a patient
summary interface screen or screens that includes additional
information for the selected patient, as shown in FIGS. 5-12. The
patient summary interface screen preferably includes a menu of
selectable links for displaying additional information for the
selected user, such as links for alerts, readings, office BP,
medications, pharmacy, and reports.
[0099] Referring to FIG. 5, in one embodiment of the invention, an
alerts interface screen is displayed in response to the
care-coordinator selecting the alerts menu item. The alerts
interface screen generally provides a list of alerts for the
particular care-coordinator. The interface screen may include a
form element, such as a drop down list, for narrowing the alerts to
a sub-set of all the alerts for the user, such as by particular
patient, patient sub-groups, completed and not completed alerts,
etc., or for broadening the alerts displayed. The individual alert
items may include a form element, such as a check box, for the user
to acknowledge receipt of the alert.
[0100] Referring to FIG. 6, in one embodiment of the invention, an
interactions interface screen is displayed in response to the
care-coordinator selecting the interactions menu item. The
interactions interface screen generally provides a list of action
items for the particular care-coordinator to follow up on. The
action items may be triggered by the alerts or manually entered by
another system user, such as a member of the group, a physician, a
service provider, etc. The interactions interface screen may also
include a form element, such as a drop down list, to narrow or
expand the information displayed, and may include a selectable link
that displays an interface screen for the care-coordinator to enter
information regarding an existing interaction or create a new
interaction for a particular member of the group, such as with the
interface screens shown in FIGS. 7-8.
[0101] Referring to FIG. 9, in one embodiment of the invention, an
Office BP interface screen is displayed in response to the
care-coordinator selecting the Office BP menu item. The Office BP
interface screen generally provides a list of physiologic
measurements taken in an office setting. The interface screen may
also include form elements for a user to enter such data therein
and update the databases 17, 31 accordingly. In this respect, the
information obtained by the particular healthcare providers may be
entered directly into the service provider's system. Alternatively,
or in addition, the information may be entered into the healthcare
provider's system and later communicated to the service provider
automatically. The service provider may also reconcile common data
between the measurements taken or data entered with the monitoring
device 10, and measurements taken or data entered in an office
setting.
[0102] Referring to FIG. 10, in one embodiment of the invention, a
readings interface screen is displayed in response to the
care-coordinator selecting the readings menu item. The readings
interface screen generally provides the physiologic measurements
obtained using the monitoring device 10, which may be displayed in
a graphic format or tabular format, or a combination thereof.
[0103] Referring to FIG. 11, in one embodiment of the invention, a
medications interface screen is displayed in response to the
care-coordinator selecting the medications menu item. The
medications interface screen generally provides information
regarding medications individual group members are taking or have
taken. The information may similarly be entered manually directly
into the service provider's system with form elements included in
the interface screen, automatically from information maintained by
a healthcare provider, such as a physician, pharmacist, etc., or a
combination thereof. For example, an electronic prescribing tool
may be used in a doctor's or other medical or healthcare provider's
office to electronically prescribe a patient's medication. Data
entered in the electronic prescription may be automatically
populated in the database 17 in the patient's medication record and
it may be compared and reconciled with the information obtained
with the medical monitoring device 10. This way, the patient can be
tracked for further diagnoses and progress, e.g., by comparing
additional physiologic monitoring.
[0104] In one embodiment of the invention, a pharmacy interface
screen is displayed in response to the care-coordinator selecting
the pharmacy menu item. The pharmacy interface screen generally
provides information related to prescriptions filled with a
pharmacy. In this instance, the database 31 receives, preferably
automatically, information regarding the prescriptions filled by
the group member, such as the medication, the dosage, quantity,
refills remaining, etc., from the pharmacy supplier. This
information may be presented to the care-coordinator with the
information provided with the medications interface screen, which
is generally entered manually, allowing the care-coordinator to
reconcile the data, e.g., with respect to changes to the
prescription, and/or to determine compliance or more generally to
get a better idea of whether or not the prescriptions are being
filled or used properly. This information can then be reconciled
with any changes in physiological readings. For example, with the
information provided, the care-coordinator may determine whether
the member of group is benefiting from changes to the prescription
based on the readings obtained with the device 10. Similarly, the
care-coordinator may associate non-responsive readings to
non-compliance with changes to the member's prescription.
[0105] Referring to FIGS. 12a-g, in one embodiment of the
invention, a reports interface screen is displayed in response to
the care-coordinator selecting the reports menu item. The reports
interface screen generally provides a report regarding the
measurements obtained using the monitoring device 10 similar to the
readings interface screen. The report interface screen preferably
includes form elements for the coordinator to specify a date range
for the report and the system will thereafter generate a report for
the individual group member's health care provider. The report may
be formatted for communication directly to the healthcare provider.
For instance, the report may be formatted as a fax that includes a
cover page with the recipients information automatically
pre-populated in the form. Similarly, the report may be prepared as
an email message with the to, cc, and subject items pre-populated.
The data included in a report may also be stored in a raw format or
other format in a database for data mining purposes, medical study,
or other use.
[0106] The interface screens may also include form elements, such
as a text box, for the care-coordinator to associate particular
alerts and/or interactions with the data maintained by the
healthcare provider. This may be accomplished, for instance, by
specifying, with the form element, a unique identification number
used by the healthcare provider to identify the records of
particular group members. In one embodiment, the service provider
50 accesses the information maintained by the healthcare provider
and provides an interface screen or window for the caregiver to
view and preferably to search information maintained by the
healthcare provider for information that may be required for
inclusion into the care-coordinator's follow up notes that may be
entered with the online website. Alternatively, the unique
identifiers may automatically be associated with group members. In
this respect, information maintained by the healthcare provider may
automatically be accessible without the need for input by the
care-coordinator.
[0107] In one embodiment of the invention, this association is used
to provide the interface screens discussed above with a selectable
link that provides direct access to the group member's information
maintained by the health care provider. The selectable link may be
associated with the group member's information in general or with
particular items of information. For example, a link may be
included in the interface screen that receives the group member's
address or telephone number, or any other particular item of
information maintained by the health care provider. The information
may be displayed for use by the care-coordinator, e.g., in filling
out form elements in the interface screens, or automatically used
to populate the relevant form elements in the interface screens.
The selectable link may also be associated with particular form
elements. For example, when the care coordinator has to enter
information for alerts, interactions, and even with other interface
screens or pages, a selectable button, that may be shown as a blue
question mark, may be displayed that when selected accesses the
healthcare provider's local network and retrieves therefrom
information that may then automatically be input into the relevant
form elements of the website. This allows the care-coordinator to
access a healthcare provider's internal network online and
automatically fill in reference data into the website for later
reconciliation (automatic or manual).
[0108] The backend functionality of the service provider's system,
e.g., the computer 30, database 31, and the software associated
therewith, is accomplished by processing the information obtained
regarding the members of the coordinated care group, including
physiologic measurements obtained with the monitoring devices 10 as
well as information provided by healthcare providers, the
care-coordinator, etc. The information may be processed
continuously or in batch form. In one embodiment, the information
is processed in accordance with the processing schedule in Appendix
C.
[0109] In one aspect of the invention, a business model is provided
for providing coordinated care. The business model involves
activities of a plurality of parties, including the service
provider that maintains and provides access to information obtained
with monitoring devices, the healthcare provider that provides
health related services to a plurality of individuals, and the
plurality of individuals. The healthcare provider generally
identifies at least one or preferably a group of individual's for
coordinated care as described above. The service provider
thereafter provides the monitoring devices to the healthcare
provider for the group of individuals, either directly or through
an administrator. The service provider may also provide all or some
of the hardware and software needed to perform the monitoring, data
acquisition, data storage, data processing, etc., to a group on a
per member subscription basis. The monitoring devices may be
purchased individually, leased, or included in a service
subscription. Once a monitoring device is registered, the service
provider will collect the information obtained with the monitoring
device and make the information available to interested parties,
including a care-coordinator. Data management and the functionality
of the service provider's system as described above is generally
sold on a subscription basis, e.g., per person per month. For
example, an HMO may in this respect purchase monitoring devices for
managing the blood pressure of a group of its members. The service
provider will collect the data from registered monitoring devices
and provide the backend functionality for the system for a monthly
fee. The service may similarly be provided directly to the public.
For example, the service provider may sell the devices and provide
information regarding the information obtained, such as weight loss
data, on a subscription basis.
[0110] A health manager may charge its members the cost of the per
member subscription or device cost, and/or reduce membership or
subscription fees by a projected savings to the group from
identification and early intervention of members needing health
care services. This model may also provide for the group
underwriting the cost of devices used by members, so that the
service provider avoids the need for a high capital investment for
each group that the service provider serves. In this model, the
service provider provides, maintains and operates a database (and
associated communication protocols, data acquisition and access,
etc.) which is used to service a plurality of groups. In one
embodiment, the service provider may opt to provide the devices
free or at low cost, and amortize the cost of the devices over the
term of a contract with a group.
[0111] While the invention has been described and illustrated in
connection with preferred embodiments, many variations and
modifications as will be evident to those skilled in the art may be
made without departing from the spirit and scope of the invention,
and the invention is thus not limited to the precise details of
methodology or construction set forth above as such variations and
modifications are intended to be included within the scope of the
invention.
APPENDIX A
[0112] 1. Communications between a monitoring device and
transmitting device (collectively "client device") and server
computer.
[0113] A. Client device Internet connection [0114] I. Client
devices may communicate with servers using an Internet connection
using a PPP (Point-to-Point Protocol) connection to the selected
ISP (Internet Service Provider). [0115] II. The ISP will provide a
national/international, e.g., toll-free, number for initial data
access, and may also provide an extensive network of
nationwide/international dial-up POPs (points of presence). [0116]
III. The initial, e.g., toll-free number, as well as other
information, such as a username, and password, may be loaded into
all client devices for registration. [0117] IV. During
registration, a local POP access number (or one that is as close as
possible to the user's home address), username, and password may be
sent to the client device, for further dial-up communications,
unless it is remotely or locally reset.
[0118] B. Communication protocol [0119] I. Communications sessions
with the server computer may be initiated by the client device
requesting either registration or logon to the server [0120] II.
The client device may first resolve the name of the server using a
DNS (Domain Name System) protocol, and use the IP address of the
server for all further communications for the particular session
[0121] III. The client device and server may communicate using the
UDP (User Datagram Protocol) protocol, and a record may be sent as
a single UDP datagram [0122] IV. Since UDP is a connectionless
protocol with no guaranteed delivery, the server and the client
applications may both be responsible for handshaking and monitoring
communications timeouts [0123] V. A communication timeout may occur
if there is no valid response from either the server or the client
device for a period of, e.g., 20 seconds or if there is no valid
transmission sent or received by either the client device or the
server for a period of, e.g., 120 seconds. A valid response is a
response which acknowledges a previous transmission and whose
checksum is valid. [0124] VI. A communication timeout will
terminate the session on both the client and the server, requiring
the client device to initiate a new session before data can be
transferred. [0125] VII. At a high level the sequence for datagram
communications is as follows: [0126] a. Registration (a one time
session to obtain a soft serial number, a user identification,
etc.). [0127] b. Logon [0128] c. Send readings from client to
server [0129] d. Send charts from server to client [0130] e. Send
messages from server to client [0131] f. Send message responses
from client to server [0132] g. Determine if a triggering event has
occurred, if so initiate/conduct a messaging session [0133] h.
Logoff
[0134] C. Date and Time Synchronization [0135] I. The client device
clock will be set by the server at the start of every session,
i.e., registration or logon [0136] II. The server may synchronize
with a time server on the internet to ensure accuracy [0137] III.
The server computer may record, e.g., in the database, the home
time zone for each client device when it is registered with the
contact center, or more generally the service provider, based upon
the user's home address [0138] IV. The server may convert and
transmit all date and time information to the client device from
"universal time", e.g., Greenwich Mean Time, to the user's home
local time [0139] V. The server may convert and store all date and
time information received from the client device from the user's
home local time to "universal time"
[0140] D. Language Preference [0141] I. The client device and the
server may store the user's language preference [0142] II. The
default language may be US English [0143] III. When the client
device is first used or after a reset, the user may be asked to
enter/confirm their language selection [0144] IV. If the user
specifies another language, the server may store the language
preference and download the language preference to the client
device during registration
[0145] E. Registration [0146] I. Preferably, the client device may
only be used once it has been successfully registered. On power-up,
registration status is checked. If the device is unregistered, the
user must enter, e.g., a five or six digit access code. [0147] II.
The access code may be obtained by making a voice call to a contact
center that provides a unique serial number necessary to initially
register with the service. The contact center may link the access
code to the serial number of the device in the database. [0148]
III. The information collected by the contact center may include
the full home address of the individual device user, including the
postal code, so that a user's local time zone can be determined and
stored on the server. The language preference for the user's client
device should also be collected and stored by the contact center.
[0149] IV. Client devices may not have their unique serial number
in read only memory (ROM), instead the serial number may be
downloaded from the server during the initial registration session.
The serial number may be a unique integer, e.g., whose binary
representation fits within 32 binary bits and is 10 decimal digits
long, with a significant (non-zero) digit in the first position
(i.e. decimal numbers from 1,000,000,000 to 4,294,967,295) [0150]
V. To register the device, the customer may [0151] a. Make a voice
call to the Contact Center or provide the information via the
Contact Center web-site and obtain an access code [0152] b. Enter
the access code on the device [0153] c. Connect the device to
server, e.g., with the toll-free ISP access number [0154] d. The
device will send a Registration Request datagram to the server
[0155] e. Receive a Registration Datagram, with the serial number,
local access number, username, password, language, date and local
time, web address, ports and cellular phone configuration
information from the server [0156] f. Send a Registration
Acknowledgement record to the server [0157] g. If the Registration
Status field is not equal to 0, the client device will reset itself
to factory default settings and terminate the call, otherwise, the
server will store the status of the device as Registered
[0158] F. Logon and Logoff [0159] I. After successful registration,
the client device will be required to logon to the server to start
a communications session [0160] II. To logon, the client device may
[0161] a. Connect to sever, e.g., using a local ISP access number
[0162] b. Send a Logon Request record to the server [0163] c.
Receive a Logon Data record, with the local time, etc. [0164] d.
Send a Logon Acknowledgement record to the server [0165] III. The
client device may initiate a normal logoff once all data to be sent
from the device has been sent and acknowledged, and no data has
been received and validated from the server for, e.g., 15 seconds.
To logoff, the client device [0166] a. Sends a Logoff Request
record to the server computer [0167] b. Receives a Logoff
Acknowledgement record from the server computer
[0168] G. Uploading blood pressure monitoring (BPM) Readings [0169]
I. Once logged on the client device may start sending any readings
that have not yet been successfully uploaded to the server [0170]
II. One BPM Reading record may be sent in a single UDP datagram
from the client device for each reading taken [0171] III. Each
valid BPM Reading record sent to the server may be acknowledged by
the server with a BPM Reading Acknowledged record. [0172] IV. If
the BPM Reading record is already in the server database (i.e., the
serial number, systolic, diastolic, heart rate, and converted
bpm_reading_date all match an existing server database record) no
duplicate record will be recorded in the server database, but the
server may send a BPM Reading Acknowledgement record to the client
device. [0173] V. The client device may modify its database when a
BPM Reading Acknowledged record is received from the server to
indicate that record should not be uploaded to the server again
[0174] H. Downloading Charts [0175] I. The client device may send a
chart request datagram to start the chart downloading process. This
may be done anytime after a successful logon and readings
transmission. The server acknowledges with a chart datagram, which
includes the number of charts to be downloaded. The device then
accepts one chart page datagram for each chart and acknowledges
each one with a chart acknowledged datagram. The process ends when
the number of charts expected is received and acknowledged [0176]
II. By default the server may download all available (up to 10)
chart types unless the user has specified otherwise, e.g., on the
contact center's web site [0177] III. The server may generate a
unique Chart ID for each chart that may be stored on the client
device as well for unique identification [0178] IV. The chart types
may include [0179] a. Systolic [0180] b. Diastolic [0181] c.
Systolic & Diastolic [0182] d. Heart Rate [0183] V. The chart
frequencies may be [0184] a. Latest [0185] b. Daily [0186] c.
Weekly [0187] d. Monthly [0188] VI. To provide a graphical
representation, e.g., bars, on the client device, the server may
supply top left and bottom right absolute screen co-ordinates for
each bar. The areas defined by the two extreme co-ordinates for a
bar may be filled in black on the display. [0189] VII. The server
may also transmit the values of the chart labels, such as values
for Vertical Label 1 for the top label and Vertical Label 5 for the
bottom Label. Similarly, Horizontal Label 1 may be transmitted for
the left label and Horizontal Label 2 for the right label. [0190]
VIII. The server may also transmit the exact number of characters
to fill each cell, including blanks for positioning properly within
the cells.
[0191] I. Client Device Messages [0192] I. Users, Professionals,
Caregivers, and Partners may use a form on the service provider
web-site to enter and send messages to the client devices [0193]
II. Messages may be available for these users, in a short format,
long format, free text format, or other format. The short format
may have fields for From, Subject, 5 lines of text and two button
labels for user response, which will generally be displayed on a
single screen of the client device. The long format message will
have fields for From, Subject, and 5 lines of text for the first
screen on the device, and the second screen will show the Subject
and, e.g., six, multiple choice answers. For the long format
message the button labels may be standardized on the device to
permit moving to the next screen and selecting an answer. [0194]
III. Once the user starts to review messages, all messages may be
required to be reviewed/answered in order unless the escape button
is pressed to exit the sequence. [0195] IV. Messages may be flagged
as Alerts, and these may cause the device to beep when displayed to
the device user until they are answered. [0196] V. The
communications process for sending messages to the client device is
. . . . [0197] a. Client sends MessageRequest datagram [0198] b.
Server responds with Message datagram, which includes a field
Number of Messages (left to send) [0199] c. Client responds with
MessageAcknowledged datagram [0200] d. If message just acknowledged
was a long format message, the server will send a MessageChoices
datagram [0201] e. If a MessageChoices datagram was sent, the
client will respond with a MessageChoicesAcknowledged datagram.
[0202] f. Loop until all messages are received or a timeout occurs
to end the session. [0203] VI. As the user reviews new messages on
the device, the read receipt flag for that message is set in a
corresponding MessageResponse record. As the user answers questions
posed by the messages, the MessageResponse record stores the
response. If a message has its alert flag set, the message may pop
up on the device at specified intervals until the user creates an
answer. All messages require a user response, even if it is only to
indicate they have been read. Message responses may be sent in a
later session than the one in which the messages were received or
during the same session if so required. [0204] VII. The
communications process for sending message responses to the server
is: [0205] a. The client sends the next unsent MessageResponse
datagram to the server. [0206] b. The server sends a
MessageResponseAcknowledged datagram to the device. Once received,
the device may delete the original message and its response. [0207]
c. Loop until all MessageResponseAcknowledged datagrams have been
received or a timeout occurs to end the session.
APPENDIX B
[0207] [0208] 1. Screening Phases--patients screened for one week
[0209] a. Patients monitor themselves 2 times per day, for 8 days
(once in the morning between 6-10 AM and once in the evening
between 6-10 PM) [0210] b. Calculation may be based on minimum of
10 readings, and days 2-8 (day 1 should not be included in the
calculation of overall MEAN home BP) [0211] i. If miss a
measurement, or miss a day, it will not affect the calculation, all
numbers should be included regardless of time [0212] ii. If there
is a need to go back later to verify times, some readings can be
looked at twice for inclusion as all are time and date stamped
[0213] 2. After screening [0214] a. Patients under drug therapy
with office blood pressure ("BP") readings equal to or greater than
140/90 mmHg [0215] i. If the MEAN home BP is under 135/85 mmHg
(<130/80 mmHg for diabetics and kidney disease), patients
monitor themselves once every 2 months for 8 days (similar to first
week screening method) until the end of the program, and followed
up by the nurse once a month. In patients with the low normal range
blood pressure (SYS BP less than 120 mmHg), treatment may be
reduced or discontinued if there is concern about adverse affects
related to hypotension (dizzy or light headed; ex. Pre-syncope). If
drug therapy is reduced, patients may be enrolled in the full
monitoring program. [0216] ii. If the MEAN home BP is equal to or
greater than 135/85 mmHg (.gtoreq.130/80 mmHg for diabetics and
kidney disease): Hypertension is confirmed and the patient is
enrolled into the full monitoring program. [0217] b. Newly
Diagnosed Patients with office BP readings equal to or greater than
140/90 mmHg [0218] i. If the MEAN home BP is under 135/85 mmHg
(<130/80 mmHg for diabetics and kidney disease): The patient is
considered to have a normal BP and may be monitored for 8 days
(similar to first week screening method) once every 2 months until
end of the program, and followed up with by the Nurse practitioner
once a month [0219] ii. If the MEAN home BP is equal to or greater
than 135/85 mmHg: Hypertension is confirmed and the patient is
enrolled into the full monitoring program [0220] 3. Full Monitoring
Program: Patients confirmed with Hypertension may require an
appointment with their Primary Care Physician for treatment [0221]
a. Patients do not need to have their home BP monitored until after
they are seen by their physician [0222] b. After the appointment,
the Nurse practitioner should ensure that the details of the
Primary Care Physician's treatment plan are entered into the
service provider website and that the patient begins to monitor
themselves MON WED FRI once between 6-10 AM and once between 6-10
PM each day (it does not matter if a day is missed, or the wrong
day is measured for the purposes of the calculation of MEAN home
BP) [0223] c. Fixed Follow-up Plan [0224] i. First 4 weeks of
program, Nurse should contact patient once a week for "check-in"
(takes 2-4 weeks for drug to take effect) [0225] ii. Following the
first 4 weeks of the program, Nurse should contact the patient once
every 2 weeks [0226] iii. At the midway point of the program; a
reevaluation of the follow-up plan should take place to see if 2
weeks or 1 month will suffice for follow-up calls [0227] iv. If one
week's worth of readings is not taken, the Nurse practitioner
should call the patient [0228] v. Depending on compelling
indications, the nurse can follow up with the patient more
frequently if necessary [0229] d. Every interaction by nurse
practitioner with a patient or Primary Care Physician should
require data entry into the website. The Nurse practitioner will
have forms where she can enter all information gathered directly
into the system. This information should include: [0230] a. Latest
office BP reading taken (if any) [0231] b. Medication changes
(type, dosage, frequency) [0232] c. Clinically significant
symptoms/side effects that may affect management/treatment (this
should be a free text window) [0233] d. Hospital visits [0234] e.
Hospital admissions [0235] f. Emergency room visits [0236] g. Other
notes regarding program from patient perspective [0237] h. MEDIC
(office appointment schedule software) [0238] e. The Nurse
practitioner may monitor her schedule and readings through the
IDEAL LIFE website [0239] f. Monthly reports may be faxed to
respective Primary Care Physicians (if able to, including
medication changes) [0240] g. Nurse practitioner should ensure that
patients do not become alarmed about infrequent "out of range"
measurements and should ensure that patient "issues" are addressed
appropriately [0241] 4. If there are any "Out of Range"
measurements, the nurse practitioner should call or otherwise
contact the patient and make sure an appointment is made with their
Primary Care Physician immediately (if the Primary Care Physician
is unavailable, the patient should be seen by a specialist in the
CCC or in the emergency room): [0242] a. Reading over 180/110 mmHg
[0243] b. Reading under 100/60 mmHg [0244] c. Increase or decrease
of more than 40/20 mmHg
APPENDIX C
Batch Processing
[0245] Nightly jobs will be run at 2 AM Pacific time. Each job must
return its success or failure and notify the system administrator
via email. The job should also create a log of the interactions
created, in a text file, with file name "nightly job name and
date".txt (e.g. FirstReadingCheck 15-JAN-2005.txt).
[0246] A nightly job will be run called FirstReadingCheck, checking
each Our Partner Individual with a BP Manager . . . . [0247] 1. If
the patient does not yet have a registered BP Manager, then go to
the next patient [0248] 2. If the patient has a BP Manager with a
registration date< >null, and has readings, then go to the
next patient [0249] 3. If the registration date is more than 24
hours before the current time, then create an interaction [0250] a.
(interaction_typeID=1, interaction_purpose_ID=1024,
interaction.auto-generated=8, interaction.comments="First Phase 1
reading not yet received.")
[0251] A second nightly job will be run called Phase1 to set the
value of the Phase1 Values and the Hypertensive flag above,
checking each Our Partner Individual with a BP Manager . . . .
[0252] 1. If the Phase1 Values for a patient are not null, then go
to the next patient [0253] 2. When the first reading from Our
Partner Individual is received that has a reading date later than
Jan. 1 2004, set the Phase1 Start Date to the Reading Date. DO THIS
ONLY ONCE--IF THE FIELD CONTAINS A VALUE DO NOT CHANGE IT. [0254]
3. If the Phase 1 start date is null go to the next patient [0255]
4. Check to see if the last 2 days are without readings. If so,
create an interaction for the Nurse Practitioner. [0256] a.
(interaction_typeID=1, interaction_purpose_ID=1024,
interaction.auto-generated=1, interaction.comments="Two consecutive
days of Phase 1 readings not received.") [0257] 5. If the number of
days elapsed since Phase1 start date is <9 the go to next
patient [0258] 6. Count the readings for Phase1 days 2 through 8
(i.e. Phase1 start date +1 through Phase1 start date +7), and if
there are less than 10 readings, and not more than 2 days without
readings, add an interaction for the Nurse practitioner to call the
patient to restart taking readings, and reset the Phase1 Start Date
for this user to Phase1 Start Date +1 day. [0259] a.
(interaction_typeID=1, interaction_purpose_ID=1024,
interaction.auto-generated=1, "Not enough readings to complete
Phase 1 in last 7 days.") [0260] 7. Calculate the average systolic,
diastolic and heartrate for days 2 through 8 (i.e. Phase1 start
date +1 through Phase1 start date +7), and store the values in
Phase 1 Values above. [0261] 8. If the
MeanSystolic>=ThreshholdControlSystolic or
MeanDiastolic>=ThreshholdControlDiastolic then set the
Hypertensive flag=2 [0262] 9. If the Hypertensive flag=2, remove
the Individual from the Normotensive static group and add them to
the Hypertensive static group [0263] 10. If Classification
type=existing drug therapy AND
MeanSystolic<ThreshholdMedicationControl the set the
Hypertensive flag=3, remove the Individual from the Normotensive
static group and add the Individual to the "Hypotensive suspect"
static group [0264] 11. Add records for the Phase 1 Fixed Follow-Up
Plan below, depending on whether the patient is Hypertensive,
Hypotensive, Hypotensive suspect, or Normotensive.
[0265] A third nightly job will be run called Phase2Startup to
create the Fixed Followup Plan after the Nurse Practitioner enters
the Phase 2 start date, checking each Our Partner Individual with a
BP Manager . . . . [0266] 1. If the Phase1 Values for a patient are
null, then go to the next patient [0267] 2. If the Phase2 start
date is null then go to the next patient [0268] 3. If the Phase 3
start date is not null then go to the next patient [0269] 4. Add
records for the Phase 2 Fixed Follow-Up Plan below, depending on
whether the patient is Hypertensive or Hypotensive.
[0270] A fourth nightly job will be run called Phase2 to set the
value of the Phase2 Values, and to start Phase3, checking each Our
Partner Individual with a BP Manager . . . . [0271] 1. If the
Phase1 Values for a patient are null, then go to the next patient
[0272] 2. If the Phase2 start date is null, then go to the next
patient [0273] 3. If the Phase 3 start date is not null, go to the
next patient [0274] 4. If the current date is less than 183 days
after the patient's program start date or the Phase2 Values are not
null, then go to the next patient [0275] 5. Calculate the average
systolic, diastolic and heartrate for days 177 through 183 (i.e.
Phase2 start date +176 through Phase1 start date +182) and store
the values in Phase2 Values above. [0276] 6. Update the Phase3
start date with the datetime of the nightly job [0277] a.
(interaction_typeID=1, interaction_purpose_ID=1024,
interaction.auto-generated=2, interaction.comments="Start twice
daily monitoring for Phase 3.")
[0278] A fifth nightly job will be run called Phase3 to set the
value of the Phase3 Values checking each Our Partner Individual
with a BP Manager . . . . [0279] 1. If the Phase3 start date is
null, then go to the next patient [0280] 2. If the Phase 4 start
date is not null, then go to the next patient [0281] 3. Check to
see if the last 2 days are without readings. If so, create an
interaction for the Nurse Practitioner. [0282] a.
(interaction_typeID=1, interaction_purpose_ID=1024,
interaction.auto-generated=3, interaction.comments="Two consecutive
days of Phase 3 readings not received.") [0283] 4. If the number of
days elapsed since Phase3 start date is <9 the go to next
patient [0284] 5. Count the readings for Phase3 days 2 through 8
(i.e. Phase3 start date +1 through Phase3 start date +7), and if
there are less than 10 readings, and not more than 2 days without
readings, add an interaction for the Nurse practitioner to call the
patient to restart taking readings, and reset the Phase3 Start Date
for this user to Phase3 Start Date +1 day. [0285] a.
(interaction_typeID=1, interaction_purpose_ID=1024,
interaction.auto-generated=3, "Not enough readings to complete
Phase 3 in last 7 days.") [0286] 6. Calculate the average systolic,
diastolic and heartrate for days 2 through 8 (i.e. Phase3 start
date +1 through Phase3 start date +7), and store the values in
Phase 3 Values above. [0287] 7. Add records for the Phase 3 Fixed
Follow-Up Plan below, depending on whether the patient is
Hypertensive, Hypotensive or Normotensive.
[0288] A sixth nightly job will be run called WeeklyReadingsCheck
to determine if a patient has skipped a week of readings. If a
patient has no readings for the entire previous week (7 days), and
any of the Phase1 start date, Phase2 start date or Phase3 start
dates are not null, then create an interaction for the Nurse
Practitioner to call the patient (interaction_typeID=1,
interaction_purpose_ID=1024, interaction.auto-generated=9,
interaction.comments="One week of readings not received.").
Interactions
[0289] To track patient interactions the following will be included
. . . .
TABLE-US-00001 1. Interaction a. interactionID b.
interaction_typeID c. individualID d. professionalID e. Our
Partner_interactionID f. interaction_date datetime g. duration
datetime h. comments memo i. completed yes/no flag default = no (0)
j. auto-generated values = 1, 2, 3, 4, 8, 9, 99 or default = null
2. InteractionType a. Interaction_typeID i. Call to patient = 1 ii.
Call to PCP = 2 iii. Call to Hospitalist = 3 iv. Call to Specialist
= 4 v. Visit by professional to patient at home = 10 vi. Visit by
professional to patient in hospital = 11 vii. Visit by patient to
hospital = 12 viii. Visit by patient to hospital admission = 13 ix.
Visit by patient to emergency room = 14 x. Visit by patient to
lab/test facility = 15 xi. Fax report to PCP = 20 xii. Reminder =
30 xiii. Update records = 40 b. Description varchar(50) i. Values
as above 3. InteractionPurpose a. Interaction_purposeID unsigned
VERY long integer (64 bits) TBD i. Discuss BP Manager usage = 1 ii.
Discuss general follow-up = 2 iii. Discuss out of range reading = 4
iv. Discuss change medication = 8 v. Discuss education = 16 vi.
Discuss motivation = 32 vii. Schedule appointment with physician =
64 viii. Schedule appointment with hospitalist = 128 ix. Schedule
appointment with specialist = 256 x. Schedule appointment with
patient = 512 xi. Remind patient about monitoring = 1024 xii.
Record PCP office visit details = 2048 xiii. Record symptoms/side
effects = 4096 xiv. Record medication change = 8192 xv. Record diet
change = 16384 xvi. Record hospital visit = 32768 xvii. Record
hospital admission = 65536 xviii. Record emergency room visit =
131072 xix. Record patient hospital visit = 262144 xx. Record
patient hospital admission = 524288 xxi. Record patient emergency
room visit = 1048576 xxii. Record patient lab/test facility results
= 2097152 xxiii. Provide monthly PCP report = 4194304 xxiv. Reset
hypotensive suspect status = 8388608 xxv. Record patient history =
16777216 xxvi. Red Zone Alert threshold reading = 33554432 xxvii.
Purple Zone Alert threshold reading = 67108864 xxviii. Yellow Zone
Alert threshold reading = 134217728 xxix. Other = 268435436 b.
Description varchar(50) i. Values as above ANDED together if more
than one selected
Followup Plans
[0290] 1. Phase 1 Fixed Followup Plan (interactions created with
nightly job Phase1) [0291] a. For Normotensive patients
(Hypertensive flag=0) the following interactions will be created
AUTOMATICALLY . . . . [0292] a. Set Phase2 start date=date of
nightly job [0293] b. All interactions created below will have
interaction.auto-generated=2 [0294] c. Normotensive patient
monitoring reminders at Phase 2 date +60, +120, +180 days
(interaction_typeID=1, interaction_purpose_ID=1024,
comments="Remind normotensive patient to start 8 days of twice
daily monitoring") [0295] d. Fax report to PCP at program start
date +9, +60, +120, +180 days (interaction_typeID=20,
interaction_purpose_ID=4194304, comments="Fax patient report PCP")
[0296] b. For Hypertensive patients (Hypertensive flag=2) the
following interactions will be created AUTOMATICALLY . . . . [0297]
a. All interactions created below will have
interaction.auto-generated=1 [0298] b. Phone calls to Book PCP
appointment dated at datetime of nightly job [0299] i.
(interaction_typeID=2, interaction_purpose_ID=64, comments="Call
PCP to book patient appointment") [0300] ii. (interaction_typeID=1,
interaction_purpose_ID=512, comments="Call patient to book PCP
appointment") [0301] c. Update the details of the PCP visit (at
nightly job date +4 days) [0302] i. (interaction_typeID=40,
interaction_purpose_ID=2048, comments="Enter the details of
patient's PCP appointment and set the Phase 2 start date") [0303]
c. For Hypotensive suspect patients (Hypertensive flag=3) the
following interactions will be created AUTOMATICALLY . . . . [0304]
a. All interactions created below will have
interaction.auto-generated=1 [0305] b. Phone calls to Book PCP
appointment dated at datetime of nightly job [0306] i.
(interaction_typeID=2, interaction_purpose_ID=64, comments="Call
PCP to book patient appointment") [0307] ii. (interaction_typeID=1,
interaction_purpose_ID=512, comments="Call patient to book PCP
appointment") [0308] c. Update the details of the PCP visit and
reset Hypertensive flag Normotensive or Hypotensive after the PCP
visit (at nightly job date +4 days) [0309] i.
(interaction_typeID=40, interaction_purpose_ID=2048,
comments="Enter the details of patient's PCP appointment and set
the Phase 2 start date") [0310] ii. (interaction_typeID=40,
interaction_purpose_ID=8388608, comments="Enter the new patient
group status of either Normotensive or Hypotensive") [0311] 2.
Phase 2 Fixed Followup Plan (interactions created with nightly job
Phase2) [0312] a. All Phase 2 interactions created with this
Followup Plan will have interaction.auto-generated=2 [0313] b. For
Normotensive patients (Hypertensive flag=0) the following
interactions will be created AUTOMATICALLY (this will apply only
for former "Hypotensive suspects" that the nurse changed to
"Normotensive") . . . . [0314] a. All interactions created below
will have interaction.auto-generated=2 [0315] b. Normotensive
patient monitoring reminders at Phase 2 date +60, +120, +180 days
(interaction_typeID=1, interaction_purpose_ID=1024,
comments="Remind normotensive patient to start 8 days of twice
daily monitoring") [0316] c. Fax report to PCP at program start
date +9, +60, +90, +120, +150, +180 days (interaction_typeID=20,
interaction_purpose_ID=4194304, comments="Fax patient report PCP")
[0317] c. For Hypertensive and Hypotensive patients (Hypertensive
flag=1 or 2) the following interactions will be created
AUTOMATICALLY . . . . [0318] a. Recurring phone calls to patient
for followup at Phase2 start date +7, +14, +21, +28, +42, +56, +70,
+84, +98, +112, +126, +140, +154, +168, +182 days with multiple
purposes [0319] i. (interaction_typeID=1, interaction_purpose_ID=63
i.e. Purposes (1, 2, 4, 8, 16, AND 32), comments="Scheduled patient
followup call") [0320] b. Fax report to PCP at program start date
+30, +60, +120, +180 days [0321] i. (interaction_typeID=20,
interaction_purpose_ID=4194304, comments="Fax patient report PCP")
[0322] 3. End of Phase 3 Fixed Followup Plan (interactions created
with nightly job Phase3) [0323] a. All Phase 3 interactions created
with this Followup Plan will have interaction.auto-generated=3
[0324] b. Fax report to PCP [0325] a. (interaction_typeID=20,
interaction_purpose_ID=4194304, comments="Fax patient report PCP")
[0326] c. Phone calls to Book PCP appointment dated at datetime of
nightly job [0327] a. (interaction_typeID=2,
interaction_purpose_ID=64, comments="Call PCP to book patient
appointment") [0328] b. (interaction_typeID=1,
interaction_purpose_ID=512, comments="Call patient to book PCP
appointment") [0329] d. Update the details of the PCP visit (at
nightly job date +4 days) [0330] a. (interaction_typeID=40,
interaction_purpose_ID=2048, comments="Enter the details of
patient's PCP appointment") [0331] 4. Phase 4 Fixed Followup Plan
(interactions created with nightly job Phase4) [0332] a. All Phase
4 interactions created with this Followup Plan will have
interaction.auto-generated=4 [0333] b. Content TBD
Threshholds
[0334] Threshholds will be created automatically for each patient .
. . . [0335] 1. Red Zone for readings greater than 180 systolic or
110 diastolic [0336] 2. Purple Zone for readings less than 100
systolic or 60 diastolic [0337] 3. Yellow Zone for readings with an
absolute value change greater than or equal to 40 systolic or 20
diastolic
Alerts
[0338] Email alerts will be sent automatically to the Nurse
Practitioner for the following (we will also attach alerts to other
communication media) [0339] 1. Red Zone threshold readings [0340]
2. Purple Zone threshold readings [0341] 3. Yellow Zone threshold
readings
[0342] When an alert is generated it will also generate the
following interactions . . . . [0343] 1. All interactions created
below will have interaction.auto-generated=99 [0344] 2. Phone call
to the patient for threshold alert followup (one of the following
depending on alert type) . . . . [0345] a. (interaction_typeID=1,
interaction_purpose_ID=33554432, comments="Red Zone Alert
Followup--Systolic greater than 180 or diastolic greater than 110")
[0346] b. (interaction_typeID=1, interaction_purpose_ID=67108864,
comments="Purple Zone Alert Followup--Systolic less than 100 or
diastolic less than 60") [0347] c. (interaction_typeID=1,
interaction_purpose_ID=134217728, comments="Yellow Zone Alert
Followup--Systolic change greater than 40 or diastolic change
greater than 20") [0348] 3. Phone call to the PCP for threshold
alert followup (one of the following depending on alert type) . . .
. [0349] a. (interaction_typeID=2, interaction_purpose_ID=33554432,
comments="Red Zone Alert Followup--Systolic greater than 180 or
diastolic greater than 110--CALL PCP (IF IS PCP UNAVAILABLE ENSURE
PATIENT IS SEEN BY HOSPITALIST IN CCC OR ER)") [0350] b.
(interaction_typeID=2, interaction_purpose_ID=367108864,
comments="Purple Zone Alert Followup--Systolic less than 100 or
diastolic less than 60--CALL PCP (IF IS PCP UNAVAILABLE ENSURE
PATIENT IS SEEN BY HOSPITALIST IN CCC OR ER)") [0351] c.
(interaction_typeID=2, interaction_purpose_ID=134217728,
comments="Yellow Zone Alert Followup--Systolic change greater than
40 or diastolic change greater than 20--CALL PCP (IF IS PCP
UNAVAILABLE ENSURE PATIENT IS SEEN BY HOSPITALIST IN CCC OR ER)")
[0352] 4. Update the outcome(s) of the earlier alert . . . . [0353]
a. (interaction_typeID=40, interaction_purpose_ID=4192256 i.e.
Purposes (4096 through 2097152, ANDED), comments="Enter the
outcome(s) of the earlier alert--visit/admission/medication
etc.")
Web Pages
[0354] The Professional role web pages used by the Nurse
Practitioner will include the Project Dashboard, with a summary of
groups, patient type, alerts and interactions, with current counts.
Selecting a group will bring up a hyperlinked list of all patients
in the group. Hyperlinks will also lead to other sections that
include: Readings, Alerts, Interactions, Medications, Patient
Groups, Office BP and Reports.
[0355] The Readings page will offer the standard set of existing
charts.
[0356] The Alerts page will show all alerts for a patient,
completed/not completed/all (default=not completed). A hyperlinked
list of interactions will expand one interaction to show all detail
and permit editing. Completed alerts can be ticked and removed with
the Submit button.
[0357] The Interactions page will show all interactions for a
patient, completed/not completed/all (default=not completed). A
hyperlinked list of interactions will expand one interaction to
show all detail and permit editing. Completed interactions can be
ticked and removed with the Submit button. Also, the user will be
able to enter a new interaction on the same page separate page.
[0358] The Pharmacy page will show the pharmacy records for the
patient, uploaded monthly from Our Partner
[0359] The Medications page will show new medications entered
between pharmacy uploads for the patient, permit entry of a new
medications and reconciliation with pharmacy records.
(Reconciliation will also be automated)
[0360] The Office BP page will show a list of all Office BP
readings for a patient, and permit entry of new readings.
[0361] The Reports page will show the standard report to be faxed
to the PCP, and a print button will print the cover page and report
for faxing offline. (we will log with time and date stamps every
time the print button is clicked on, so that we can create a
monitoring mechanism for faxes to be sent; we will also create a
button for auto faxing--this feature will not require the nurse
practitioner to manually fax the printed report but the database
will automatically send out the fax from a the fax server).
[0362] The Contact Center role web pages used by the Nurse
Practitioner will be customized for Our Partner patient data, and
will provide the ability to enter or edit data for patients, and to
register or change registration of BP Managers. Claims:
* * * * *