Note: Descriptions are shown in the official language in which they were submitted.
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CHRONIC PATIENT MANAGEMENT SYSTEM
Technical Field of the Invention
The present invention is in the field of patient management systems.
Specifically, the
present invention is in the field of medical information collecting,
monitoring, and reporting
systems for the care of patients with chronic conditions and illnesses.
Background of the Invention
Recent advances in medical technology have improved the prognosis of
chronically ill
patients. Many chronically ill patients today are able to receive transplanted
organs that
improve the quality of their lives. When a patient receives a transplanted
organ, it is very
important that all of his or her healthcare needs are considered. Most of the
problems
encountered by transplant patients occur after the patient has been discharged
from the
hospital, usually during the first six'to 12 months after transplantation.
Monitoring the patient
for rejection of the transplanted organ and control of the patient's
medications are important
aspects of the patient's care. Many of the medications that a patient must
take result in
undesired side effects that also must be controlled. For example, some anti-
rejection
medications cause an increased risk for some kinds of cancer.
The wide-range of problems that must be addressed pre- and post-transplant
require
the skills of healthcare professionals in many disciplines. A patient who has
a chronic illness
may start by seeing his or her primary care physician. The patient may be then
be referred to
one or more physicians who assist in a diagnosis of the patient's illness. For
example, a
patient with a heart condition may visit a cardiologist and a pulmonary
specialist. If the
patient requires surgery, he or she may then visit one.or more surgeons who
will complete an
evaluation of the patient and make recommendations. Following surgery, the
patient may
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return to the care of his primary care physician. Each healthcare professional
that the
individual visits records information and data about the patient in order to
assist the patient in
his or her healthcare needs. However, there is typically no way to consolidate
this
information to develop a comprehensive patient care record for use by all of
the healthcare
professionals involved in the patient's care.
Therefore, there is a need for a comprehensive and integrated patient
management
system for chronically ill patients, including transplant patients.
Summary of the Invention
The present invention is a comprehensive and integrated modular patient
management
system designed to manage chronically ill patients such as transplant
patients. The system
generates a longitudinal permanent patient record that may be used for daily
patient
management and for performing aggregate studies on a population. In a
preferred
embodiment of the present invention, transplant related information for
patients is collected,
monitored, and reported. The present invention, however, may be used for
tracking of
information related to any chronic illness or condition. The use of transplant
specific
information is not required. The data related to the patient that is collected
and tracked may
be used to develop a treatment plan for each patient and to evaluate the
effectiveness of the
treatment plan.
Information is tracked over a long period of time, preferably, throughout the
patient's
lifetime, so that a complete and comprehensive record for the patient is
created and
maintained. A modular design is used so that the system may be customized to
meet the
needs of a care provider and new features and functionality are easily added.
Most
importantly, modifications of source code are not required in order to tailor
and customize the
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system for a variety of purposes. Therefore, healthcare professionals involved
in different
disciplines may use the system to view data and track conditions that are
relevant to their area
of care. Furthermore, the same information can be viewed by different
physicians in different
disciplines.
An administrator component supports configuration and customization features
of the
system. Standard screens are provided and may be selected or deselected. In
addition,
screens may be configured and customized to meet the needs of individuals
providing patient
care as well as the facility through which patient caxe services are provided.
Screen
properties may be modified and fields may be added or deleted from screens as
needed. The
system may fiu-ther be configured to enable or disable specific types of
information (e.g.,
transplant information). Graphing capabilities may be manipulated by a user at
runtime.
Graphs may be generated from any screens added from the administrator. A user
may select
any laboratory item and related time period to be displayed. The ability to
configure and
customize screens allows viewing of patient data and all data related to the
patient in formats
that are best suited fog each healthcare professional.
An interface component supports various interface engines so that data from
various
sources may be imported and integrated into the system of the present
invention. The ability
to import and export data allows for the development of a more complete and
comprehensive
patient data record. For example, patient history from a variety of sources
may be imported to
the system. Insurance, demographic, and other information relevant to the
patient's care may
also be imported. Finally, information regarding medications and other data
useful in
developing and evaluating a treatment plan may be imported. _
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A pre-transplant component provides for tracking of patients who may be
eligible for
transplants. A complete patient history may be developed for use in
determining whether a
patient is a candidate for a transplant. Data from the patient's primary care
physician may be
evaluated in addition to data from other healthcare professionals the patient
has seen.
Government regulations control many pre-transplant activities for a patient.
The present
invention supports the pre-transplant activities through development of a pre-
transplant
checklist for each patient. The checklist has checklist data that identifies
the items for each
patient that must be completed prior to a transplant. Finally, insurance and
other information
relevant to the patient's care may be used in evaluating a patient's
eligibility for a transplant.
A post-transplant component allows physicians and other healthcaxe
professionals to
efficiently manage the care of patients who have received transplanted organs.
A variety of
forms support the collection and display of medical, demographic, insurance,
and other data.
Longitudinal data may be displayed on various forms so that the patient's
condition over time
may be evaluated. Extensive use of lookup tables provides for consistent data
across screens.
Unique algorithms for monitoring patient status axe used so that physicians
and healthcare
providers are able to obtain useful and meaningful information when providing
care to and
managing chronically ill patients.
The present invention will be described in greater detail hereinafter. The
present
invention is described in the form of preferred embodiments and is not to be
limited to those
preferred embodiments but instead shall be given the broadest scope of
protection affordable
under the law in view of the allowed claims.
Brief Description of the Drawings
Fig. 1 is a schematic drawing of a preferred embodiment of the present
invention;
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Fig. 2 is a schematic drawing of the primary components for a preferred
embodiment
of the present invention;
Figs. 3-& are sample screens for an administrator component for a preferred
embodiment of the present invention;
Fig. 7 is a schematic drawing of a pre-transplant component for a preferred
embodiment of the present invention;
Figs. 8-9 are sample screens for a pre-transplant referrals component for a
preferred
embodiment of the present invention;
Fig. 10 is a sample screen for a pre-transplant living donor component for a
preferred
embodiment of the present invention;
Fig. 11 is a sample screen for a pre-transplant insurance component for a
preferred
embodiment of the present invention;
Fig. 12 is a sample screen for a pre-transplant lab batteries component for a
preferred
embodiment of the present invention;
Figs. 13-16 are sample screens for a pre-transplant medical evaluations
component for
a preferred embodiment of the present invention;
Fig. 17 is a sample screen for a pre-transplant summary component for a
preferred
embodiment of the present invention;
Fig. 18 is a sample screen for a pre-transplant checklist component for a
preferred
embodiment of the present invention;
Fig. 19-27 are sample screens for a pre-transplant tissue typing component for
a
preferred embodiment of the present invention;
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Fig. 28 is a schematic drawing of a post-transplant component for a preferred
embodiment of the present invention;
Figs. 29-30- are sample screens for a post-transplant medications component
for a
preferred embodiment of the present invention;
Fig. 31-32 are sample screens for a post-transplant prednisone taper component
for a
preferred embodiment of the present invention;
Fig. 33 is a sample screen for a post-transplant blood pressure component for
a
preferred embodiment of the present invention;
Figs. 34-36 are sample screens for a post-transplant rejection episodes
component for
a preferred embodiment of the present invention;
Figs. 37-42 are sample screens for a post-transplant problem list component
for a
preferred embodiment of the present invention;
Figs. 43-44 are sample screens for post-transplant lab data analysis
components for a
preferred embodiment of the present invention; and
Figs. 45-46 are sample screens for a chart export component for a preferred
embodiment of the present invention.
Detailed Description of Preferred Embodiments)
Referring to Fig. l, a schematic drawing of a preferred embodiment of the
present
invention is shown. As shown in Fig. 1, the patient management system of the
present
invention is adapted to accept information and data from a plurality of
sources so that a
comprehensive and complete patient record may be developed for each
chronically ill patient.
Preferably, the information and data used by the patient management system is
designed fox
operation in accordance with a client workstation 20 and a server 14 so that
it may be
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accessed from remote locations. The server may be a PC based computer that is
equipped,
preferably, with an operating system such as Windows NT Server and a database
server such
as Microsoft's SQL Server. Preferably, communications with the server are in
accordance
with the TCP/IP protocol. One or more servers may be used to provide the
features and
functionality of the patient management system. Information and data may be
stored in one
or more databases located at the server. Patient data, clinical data, and
administrative data 22
may come from other healthcare information systems such as a medical center
mainframe 10
used by a hospital or other major medical center. Patient data, clinical data,
and
administrative data may also come from information systems used in physicians'
and other
healthcare professionals' offices.
As shown in Fig. 2, patient data, clinical data, and administrative data 22
imported to
the patient management system 14 may be transmitted through a Health Level 7
(HL7)-
Datagate that supports real-time information feeds from other systems. HL7 is
a standard in
the healthcare domain that supports the exchange of information between
information
systems that conform to the standard. HL7 allows disparate healthcare
applications to
exchange key sets of clinical and administrative data. Information may be also
be exported
from the patient management system 14 to a medical center mainframe 10 or
other healthcare
information system using the datagate 12.
Patient data and cliiucal data may also be entered or recorded into the
patient
management system 14 using a telephone 16 and interactive voice response (IVR)
system 18.
The management of chronically ill patients requires frequent tests and
procedures to
determine changes in the patients' conditions. Many of these tests and
procedures may be
performed at outpatient clinics, physicians' offices, or other healthcare
facilities. Clinical
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data 24 related to these tests and procedures may be entered or recorded in
the patient
management system 14 remotely through a telephone 16 and IVR system 18. The
patient
may call the IVR 18 and be prompted for patient data as well as clinical data
for the latest test
or procedure. For example, data related to a patient's blood pressure,
urinalysis, culture, etc.
may be entered or recorded. The convenience of using the telephone to enter
data increases
the likelihood that the healthcare professionals monitoring the patient's
condition will have
the most current data available.
Healthcare professionals may access all of the available information and data
for a
patient, including patient data, clinical data, and administrative data, using
a workstation 20
in communication with the patient management system server 14. Preferably, the
workstation
is equipped with an operating system such as Windows 95/98/NT, a network
interface card
(NIC), and a database interface such as Microsoft's ODBC. Preferably,
communications with
the server 14 are accomplished in accordance with TCP/IP. Because the
worlcstation 20 and
server 14 are adapted for TCP/IP communications, the patient management system
may be
accessed via the Internet. In addition to viewing and evaluating the available
data, the
healthcare professional may enter additional information and data through the
workstation.
Workstations for accessing the patient management system may be located at
physicians'
offices, hospitals, medical centers, and other healthcare facilities.
Therefore, all of the
healthcare professionals involved in a patient's care including a primary care
physician,
surgeon, nurse, and other clinicians may access the same data. The
customization features of
the present invention allow each clinician to develop views of the data that
are most
appropriate for his or her field of expertise.
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The patient management system of the present invention supports the
collection,
monitoring, and reporting of patient data, clinical data, and administrative
data 22. Patient
data may include identifying data for a patient (e.g., name, address, social
security number,
patient number), demographic data (e.g., age, sex, employment history, family
history, next of
kin, etc.), and complete medical history data (e.g., allergies, medications,
adverse events,
physicians, date of transplant, transplant physician, transplant coordinator,
number and type
of transplanted organs, etc.). Clinical data includes data related to the
patient's condition and
may include lab and test data, biopsy data, physical examination data, etc.
Administrative
data may include insurance data and other data as may be required to cover all
aspects of a
patient's care.
Fig. 2 is a schematic drawing of the primary components for a preferred
embodiment
of the present invention. As shown in Fig. 2, the primary components of the
present
invention are adapted for transmission of information and data to and from the
databases) of
the patient management system 3 8. The information and data in the patient
management
system databases support the development of a comprehensive and complete
patient record
for chronically ill patients.
The interface component 40 supports the transfer of imported and exported data
40.
As described above, patient data, clinical data, and administrative data from
other healthcare
information systems such as medical center mainframes or healthcare offices
may be
imported to the patient management system databases 38 using a HL7-Datagate or
other
system that supports HL7. The transmission of data may be bi-directional so
that information
and data may be exported from the patient management system databases 38 to
other
healthcare information systems.
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The administrator 36 preferably comprises a graphical user interface that
supports
configuration of the system for the specific needs of the user. The elements
of the system that
may be configured include the menu system, application name, and screens for
viewing data.
In addition, the use of transplant specific information is optional, as is the
use of standard
screens. In a preferred embodiment of the present invention as described
herein, transplant
specific is used. Preferably, a plurality of lookup tables 48 are used to
support the features
and functionality of the present invention. New lookup tables 48 are easily
integrated in to
the system because the administrator 36 automatically detects them. The
extensive use of
lookup tables rather than free text provides consistency in the use of
terminology across
screens. New lookup tables and new screen definitions may be developed without
any
modifications to source code. The ability to create new lookup table and
screen definitions
allows the patient management system to be customized by each healthcare
professional
involved in a patient's care.
Referring to Fig. 3, a sample screen for the graphical user interface of the
administrator component is shown. As shown in Fig. 3, the present invention
may be
configured to meet the needs of the facility in which it is operational. As
shown in Fig. 3, the
use of transplant specific information in accordance with a configured
application is optional.
A plurality of standard screens may be defined for each application configured
for use
by a hospital, medical center, etc. The administrator supports the selection
of standard
screens to include in a configured application and specific screen properties
for the screens
that comprise the~application. Referring to Fig. 4, screen properties for
screens that comprise
an application may be modified. Referring to Fig. 5, the standard screens to
be included in a
configured application may be selected through the administrator. Referring to
Fig. 6, for
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each configurable screen, the administrator provides a variety of options for
managing the
information appearing on the screen. For example, fields may be added or
deleted from a
screen, the display order for fields may be modified, and the field type and
field width may be
modified. In addition, various attributes may be associated with each field
appearing on a
customized screen. For example, a field may be defined to be required or
modifiable and a
user may specify whether the field's value is found in a lookup table.
Referring again to Fig. 2, the pre-transplant component 32 provides for
tracking of
patients who may become candidates for transplants. The pre-transplant
component supports
the entry and review of patient data 44. Initially, an individual who is
referred is considered a
referral of the chronic patient management system. An individual who meets
certain criteria
and is determined to be eligible to receive an organ is considered a candidate
of the chronic
patient management system. In a preferred embodiment of the present invention,
data for
referrals is not fully accessible within the patient management system while
data for
candidates (i.e., patients eligible to receive organs) is fully accessible
within the patient
management system. A complete patient history may be developed for use in
determining
whether a patient is eligible for a transplant. The complete patient history
may be developed
from patient data, clinical data, and administrative data related to the
patient. Data from the
patient's primary care physician may be evaluated in addition to data from
other healthcare
professionals the patient has seen. Insurance and other information relevant
to the patient's
care may be used in evaluating a patient's eligibility for a transplant.
The post-transplant component 42 supports the efficient management of medical
care
for patients who have received transplanted organs. The post-transplant
component 42 also
supports the management of medical care for patients who have chronic
illnesses. Preferably,
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it provides forms for the collection and display of patient, clinical,
administrative, medical,
demographic, insurance, and other data. The post-transplant component quickly
displays
longitudinal laboratory data on easy to interpret forms for individual
patients.
Referring to Fig. 7, a schematic drawing of a pre-transplant component for a
preferred
embodiment of the present invention is shown. The pre-transplant component
comprises a
plurality of components or processes for interacting with the patient
management system
database 38. The pre-transplant component supports the entry and review of
several hundred
parameters or data values and creates electronic charts. The data is organized
in a manner so
that a physician or healthcare professional can use the screens easily in a
clinical setting and
so that reporting on any parameter or data value may be completed easily. The
pre-transplant
component for a preferred embodiment of the present invention comprises a
referrals
component 50, a living donor component 54, a cadaveric donor component 58, an
insurance
component 62, a lab batteries component 66, a medical evaluations component
70, a
summary component 74, a checklist component 80, and a tissue typing component
90.
The referrals component 50 supports the entry and review of referral data 52
that
relates to a patient who may become a candidate for a transplant. Patients who
are
chronically ill are typically referred by their primary care physicians to
specialists who can
assist the patient with management of the illness. In some cases, replacement
of one or more
organs may be necessary to manage the patient's illness. The referrals
component 50 may be
used to start the process of creating a complete and comprehensive patient
record so that the
patient's chronic illness is managed appropriately. An individual who is
referred is
considered a referral. If a patient meets all criteria for receiving an organ,
the patient becomes
a candidate.
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Referring to Fig. 8, a sample screen for adding a new patient to the chronic
patient
management system is shown. Identifying information such as the patient's
name, medical
record number (MRN), and social security number (SSN) may be entered. If a
patient is a
possible candidate for a specific organ, information identifying the organ
type may be entered.
S Finally, insurance information may be entered.
Referring to Fig. 9, information regarding the referral may be provided.
Information
from the screen in which the new referral information was added may be carried
over to the
referral list screen. For the identif ed referral, information regarding the
referring physician
and his or her location and information regarding the patient's general
diagnosis may be
provided.
Referring again to Fig. 7, a living donor component S4 supports the entry and
review
of living donor data S6. Referring to Fig. 10, information or data regarding a
living donor for
a referral may be entered. Preferably, the living donor information is linked
to the referral
information so that the list of living donors for a patient may be located
easily. In addition to
1 S identifying and contact information for a living donor, demographic
information and
information regarding the donor's physical condition may be entered and
reviewed. Living
donors are typically individuals who may be able to provide a kidney to a
patient.
Referring again to Fig. 7, a cadaveric donor component S8 supports the entry
and
review of cadaveric donor data 60. Information may also be tracked for
cadaveric donors.
,0 Typically, the information is minimal and very confidential. Tissue typing
information may
be added for cadaveric donors to determine whether the donor is a good match
for a particular
patient. Cadaveric donor information may be linked to a patient.
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In a preferred embodiment of the present invention, after referral or donor
information
is added, the referral data may be accessed only for tissue typing tests and
for monthly
statistics via a monthly referral/activation report. Preferably, referrals are
not fully active in
the system until they have been "added." Once a patient meets all the
necessary criteria for
becoming eligible to receive an organ, the patient is considered a candidate
rather than a
referral. Preferably, patient data for referrals who do not become candidates
(because they do
meet the necessary criteria) is deleted from the patient management system
databases.
Preferably, living and cadaveric donor information may be fully accessible
once it has been
entered although not all options in the system may be available for donors.
Preferably, once
enough medical and demographic information has been entered for a patient, the
patient
information is added to the system such that it is fully accessible in
addition to being
accessible for tissue typing tests and for monthly statistics.
Referring to Fig. 7, an insurance component 62 supports the entry and review
of
insurance data 64. Referring to Fig. 11, insurance data for a patient may be
entered. The
insurance information may include information about the provider, the general
coverage
provided, the prescription coverage provided, and the transplant coverage
provided. In
addition, third party payer information may be entered. Current information
regarding the
patient's insurance is important in ensuring that, to the extent possible, the
patient's treatment
is subject to the patient's insurance policy.
?0 Referring again to Fig. 7, a lab batteries component 66 supports the entry
and review
of lab battery data 68. Referring to Fig. 12, lab battery data for a patient
may be entered or
recorded. The lab battery data screen is designed for rapid entry of
laboratory values. The
data may apply to a specific organ so that the most cormnon lab tests are
available based on
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organ type. Preferably, for each of the data fields shown, a user may enter
"P" for positive
and "N" for negative. Numeric data may also be entered. Preferably, the lab
battery data is
stored according to date. One patient may have a number of lab data records.
Referring again to Fig. 7, the medical evaluations component 70 of the pre-
transplant
component contains functions for transplant patients and living donors. The
medical
evaluation information, which may comprise lab data, test data, physical exam
data, and
problem list data 72, may be used to determine whether a particular donor is a
good match for
a patient. When determining whether a donor is a good match for a patient, a
physician
considers a number of factors regarding the donor's physical condition. The
physician would
like to know that if the donor's organ is transplanted, it is likely to be
accepted by the
recipient patient. Data from lab procedures and tests performed on the
transplant candidate
and donor may help the physician determine the likelihood of rejection.
Therefore, the
present invention is designed to malce the information used in making a
determination readily
available.
Referring to Fig. 13, the labs screen displays all laboratory results for a
candidate who
may be a recipient or a donor. Any result entered or recorded from a lab
battery screen as
shown in Fig. 12 may be displayed. Preferably, a single laboratory value may
be entered on
the screen. In addition, an expiration date may be assigned to the Iab. The
expiration date is
important in monitoring a patient's eligibility for an organ transplant or a
donor's potential in
~0 offering an organ. For example, a physician may order an AFP on a patient.
The result may
be elevated. The physician then determines that the patient cannot be
transplanted unless the
AFP is repeated in three months. When the initial AFP is entered or recorded
into the system,
an expiration date may be added to the test result. In monitoring the
patient's eligibility for a
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transplant, a report may be generated to determine if the patient has lab
results that are ready
to expire. If the report shows that certain lab results are ready to expire,
the patient may be
called for an appointment to have the lab repeated. In the example, the
patient may be called
to have the AFP repeated. If the results are elevated once again, the
expiration date may
indicate that the patient should be called again. If the results are as
expected, other factors
may be examined to determine whether the patient is eligible for~a transplant.
Preferably, the labs screen displays results by date, then lab. Optional
filters allow
viewing by month, expired labs, and individual labs. The flexibility in
viewing information
allows a user to select the most appropriate method of displaying the
information. Preferably,
new labs may be added. Labs may then be selected individually. Filters may be
available to
view by lab group (chem, heme, etc.). Preferably, an expired lab is displayed
in a different
color such as red to indicate clearly to the user that the lab has expired.
Referring to Fig. 14, the tests screen displays results by date, then test.
Tests may
include EKG, Stress MUGA, MRI, etc. An expiration date may be assigned to the
test. As
explained above, the expiration date is important in monitoring a patient's
eligibility for an
organ transplant or a donor's potential in offering an organ. Optional filters
allow viewing by
month, expired labs, and individual tests. Preferably, new tests may be added.
Tests may
then be selected individually. Filters may be available to view by test group
(radiology,
cardiology). Preferably, an expired lab is displayed in a different color such
as red to indicate
ZO clearly to the user that the lab has expired.
Referring to Fig. 15, physical exam data for a patient or a donor may be
entered or
recorded. A number of tabs may be provided =for collecting data relevant to
the physical
examination. Preferably, notes fields are provided on the physical exam
screens so that
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telephone conversations and other medical information that is not entered or
recorded
elsewhere may be stored or recorded for each patient.
Referring to Fig. 16, a problem list screen supports tracking of organ system
problems. An example of a problem to be tracked is a heart attack. A detailed
wizard may be
used to add information to the patient management system from a lookup table.
Information
related to key elements, organ system, symptoms, diagnostics, interventions,
and a current
plan may be entered or recorded.
Referring again to Fig. 7, a summary component 74 supports the entry and
review of
summary data 74. Referring to Fig. 17, a summary screen references data from
multiple areas
in the chronic patient management system. The summary screen provides a quick
view of all
information the physician needs to make a decision on whether or not to use a
given organ in
this patient. The information provided on the screen helps the physician
determine which
patients are qualified for receiving an organ and which donors are qualified
for providing an
organ.
L 5 Government regulations control many pre-transplant activities for a
patient. Federal
law requires tracking and monitoring of many aspects of a patient's condition
or the patient
cannot receive an organ. The present invention supports the pre-transplant
activities through
development of a pre-transplant checklist for each patient. Referring again to
Fig. 7, a
checklist component 80 supports the entry and review of checklist data 82.
Referring to Fig.
?0 18, a checklist screen and associated report generator displays checklist
data that identifies the
items for each patient that must be completed prior to a transplant. For
example, lab and test
results for certain procedures must be current before a patient may be
considered a candidate
for a transplant. The expiration dates associated with each lab or test result
allow a healthcare
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provider to track the patient's eligibility for a transplant. If lab or test
results will expire soon,
based on the associated expiration date, arrangements may be made to perform
the required
procedure. Specific reports may be accessed to further assess the patient's
eligibility.
Tissue typing is an important aspect in determining whether a patient and a
donor
match so that an organ may be transplanted from the donor to the patient. A
physician
considers a number of factors when evaluating matches between patients and
donors. An
important goal in matching is minimizing the likelihood of rejection of the
transplanted organ
by the recipient. The present invention supports several activities related to
tissue typing so
that the information needed by the physician is readily available. Referring
again to Fig. 7, a
tissue typing component 82 supports the entry and review of tissue typing data
84. Referring
to Fig. 19, HLA information may be evaluated by a physician in determining
whether a
patient and a donor match. Referring to Fig. 20, HLA information for a
candidate (recipient
or donor) may be entered or recorded.
The HLA provides general information regarding the compatibility between a
patient
and a possible donor. Another important factor to consider in determining
whether a
particular donor's organ may be used in a patient is the percent reactive
antibody or PRA.
The PRA provides an indication of the likelihood that a patient will reject a
transplanted
organ. A low PRA value indicates a low likelihood of rejection. A high PRA
value indicates
a high likelihood of rejection. To perform a PRA test, cells from a donor and
serum from a
?0 patient are combined and an antibody measurement is taken. If the number of
antibodies
present is high, then the PRA value is high. As potential donors for a patient
are identified,
the PRA test may be performed.
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Referring to Fig. 21, PRA data may be displayed for review. A physician may
review
the information to evaluate whether a patient and donor may be matched.
Referring to Fig.
22, PRA data may be entered or recorded. Associated antibody specificities
based on a
workgroup sheet may be used in evaluating the data. Referring to Fig. 23,
antibody
specificities may be added. Referring to Fig. 25, workgroups may be defined
for creating
antibody specificities. Preferably, samples may be added to the workgroup
under creation by
clicking on an entry appearing on the screen. Referring to Fig. 26, cross
match information
may be evaluated, also in accordance with workgroups. Workgroups may be
constructed and
modified as described for PRA. Also data may be entered in a form as described
for PRA.
Referring to Fig. 27, serum data may be entered or recorded for a candidate.
As described
above, serum data for a patient is used in determining PRA values. Therefore,
serum data
may be tracked so that PRA data may be developed.
Referring to Fig. 28, a schematic drawing of the primary components for the
post-
transplant component for a preferred embodiment of the present invention is
shown. The
post-transplant component comprises a plurality of components or processes for
interacting
with the patient management system database 3 8.
The medications component 100 supports the entry and viewing of patient
medications to assist a healthcare professional in regulating medications and
developing or
altering a treatment plan. Medication data may be presented to a user as shown
in Fig. 29.
)0 The information shown for each medication may include start date and end
date, class, drug,
dose, units, route, and frequency. The prescriptions are inserted into the
medications records
when the insert button is clicked. Other medication data may be added to
patient's
medications information using a select medication form as shown in Fig. 30.
Preferably,
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medications may be selected from a list so that a user is not required to type
the information.
After the needed medication name is highlighted and the other required
elements are
completed (start date, end date, dose, units, and frequency), selection of the
OK button adds
the prescription to the medication records. Additional information such as
prescriber, title,
and free-text comments may be provided.
Referring again to Fig. 28, the medications taper component 104 provide
special
functions related the regulation of a medication that may be prescribed to
many transplant
patients. For example, Prednisone is typically prescribed to many transplant
patients.
Prednisone is typically prescribed with an initial dose, which is then
gradually reduced or
tapered at a predetermined rate over a period of a year starting at the
initial dose. The doses
axe dependent on the patient's weight. The prednisone component 104 uses
dosage data 106
to construct a series of Prednisone prescriptions of 11 specific doses over
the prescribed time
period based on the weight of the patient and the starting date of the first
dose of the series.
Referring to Fig. 31, the user may start the computation of the Prednisone
prescription by
selecting the patient's weight from a list and selecting a compute button.
Preferably, the
recommended dosage is shown on the chart for each weight so that a user may
know what is
recommended. Referring to Fig. 32, the computed dosages for the entered weight
are shown.
A recommended dosage and start/end date pair is shown so that the dosage
administered to
the patient is appropriate. Although described in relation to Prednisone, the
medications taper
component may be used for any type of medication in which doses over time may
be
prescribed. This medication taper feature of the present invention facilitates
the care of
transplant patients by providing readily available dosage information based on
a patient's
weight.
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High blood pressure is a significant cause of organ failure. A kidney
transplant
typically does not correct the underlying disease causing high blood pressure,
which
uncontrolled can lead to early graft failure. Unregulated high blood pressure
in transplant
patients may result in serious consequences. Referring again to Fig. 28, the
blood pressure
component 108 produces a specialized graph that presents blood pressure and
anti-
hypertensive medication data 110 to assist a clinician in determining the
effectiveness of
blood pressure medication classes on the regulation of high blood pressure.
Referring to Fig.
33, an example of a chart that graphs the patient's blood pressure and the
administration of
anti-hypertension medications for the selected patient is shown. Preferably,
the time period to
be graphed may be specified as months after the transplant (months post tx) or
by date range.
Preferably, the units on the axis scale may also be selected by clicking on
the needed items.
The patient systolic, diastolic blood pressure, and MAP (Means Arterial
Pressure) may be
graphed on the top of the chart. Below the blood pressure lines the
administration of blood
pressure medications is displayed grouped by the class of anti-hypertensive
medication. The
class of medication depends on the method of action on blood pressure. The
blood pressure
information provided by this feature of the present invention is important in
assessing the
condition of a transplant patient. A clinician reviewing the blood pressure
information for a
patient may decide to alter the patient's current treatment plan or to order
additional tests.
The blood pressure presentation feature of the present invention facilitates
the care of
ZO transplant patients by providing readily available information regarding a
patient's condition
and its relationship to the medications the patient has been taking.
Rejection episodes of transplanted organs are conditions that must be
monitored
carefully. How effectively a rejection episode can be resolved is useful in
determining how
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much function was lost as a result of a rejection episode. Therefore, it is
very important to
record information about rejection episodes for later review and analysis.
Referring again to
Fig. 28, the rejection episode component 112 supports the entry and review of
event data,
biopsy data, and episode data 114 fox the effective management of rejection
episodes.
Referring to Fig. 34, an acute rejection form presents data about acute
rejection episodes.
Each rejection episode that a patient experiences may be assigned a number so
that it may be
tracked. Information regarding anti-lymphocyte therapy, steroid, and
conversions may be
shown for each rejection episode. For chronically ill patients who have not
received
transplants, acute episodes or flare-ups related to the patient's chronic
illness may be tracked
through the acute episodes component. By tracking acute episodes for a
chronically patient, it
is possible to monitor the frequency, severity, etc. of episodes. The ability
to monitor
episodes such as rejection episodes and acute episodes and view episode data
assists
healthcare professionals in developing treatment plans fox patients. The
treatment plan may
include adding or changing medications, ordering additional tests or
procedures, altering a
patient's diet, or any one of a number of activities that may improve the
patient's health
condition.
Selection of the biopsy button on the screen of Fig. 34 may result in the
display of the
specific biopsy information as shown in Fig. 35. As shov~m in Fig. 35, details
regarding each
biopsy may be shown. Another important aspect of monitoring rejection episodes
is tracking
of creatinine levels. Selection of the creatinine graph button of Fig. 34 may
result in the
display of a graph of creatinine levels from one month before and after a
selected rejection
episode as shown in Fig. 36. The specialized screen of Fig. 36 graphs a number
of creatinine
averages and individual values that are reflective of renal function.
Preferably, colored lines
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are used in the graph to indicate all of the creatinine values, the patient's
average creatinine
before and after the rejection episode, and the lowest (best) creatinine since
transplantation.
This creatinine graph feature of the present invention is very helpful in
assessing the patient's
condition and the need for any modifications to the patient's treatment plan.
Managing a large number of patients increases the difficulty in moW toring the
problems an individual patient may have. An organ system specific problem list
allows
documentation and monitoring of an unlimited number of problems for each
patient. With
the present invention, the user may easily document a problem by selecting
from a number of
organ system specific symptoms, interventions, and diagnostic tests. A current
treatment plan
may also be documented. The treatment plan may include details regarding the
patient's
medications, diet, tests or procedures, and other activities designed to
improve the health of
the patient. This problem list feature allows the caregiver to quickly focus
on the status of
specific problems that are of concern for each patient.
Referring again to Fig. 28, organ specific problems may be documented using a
problem lists component 116. Data regarding symptoms, interventions, tests,
and plans 118
may be tracked. A series of forms allows the user to document the specific
problem and
select associated symptoms, interventions, and diagnostic tests. Referring to
Fig. 37, a
problem list summary form shows all of the recorded problems for a selected
patient. For
each problem in the list, a date, TPT, status, presenting symptom, organ
system, problem
description, and pre-transplant/post-transplant indicator may be provided.
Preferably, the
information appearing in the problem list may be filtered by specifying a
particular status
(e.g., active or hot), specifying an organ system (e.g., cardiac, ophthalmic,
skin, etc.), or
specifying the display of symptoms without problems. The ability to record and
review
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problem data may be important in identifying rejection episodes in a patient
or determining or
altering a treatment plan. Preferably, new problems may be added to the
problem list by
completing a series of forms. Referring to Fig. 38, the user may first select
a problem by
identifying an organ system, selecting a problem associated with the organ
system, identifying
a date for the problem, identifying the status of the problem, and selecting
an indicator as to
whether the problem occurred pre- or post-transplant. Referring to Fig. 39,
the user may
identify the symptoms that occurred on a specific date. Referring to Fig. 40,
the user may
identify interventions that occurred on a specific date. Referring to Fig. 41,
the user may
identify the diagnostics that were performed on a specific date. Finally,
referring to Fig. 42,
the user may enter in a current plan section flee-text to be associated with
the current problem
definition. The current plan section allows the user to document any other
information
required. The details of previously entered or recorded problems may be
reviewed or
modified as necessazy so that a complete and comprehensive record may be
developed for the
patient.
I 5 Other useful tools for the management of the chronically ill patient are
the lab data
analysis components. RefeiTing again to Fig. 28, the lab data forms for organ
specific lab
data analysis 120 and general lab data analysis 126 present data in a similar
format. The
information provided may include organ specific lab data 122 and general lab
data 126. The
kidney lab data form of Fig. 43 is typical of the format. Referring to Fig.
43, lab data that is
organ specific or general may be view in tabular form by lab date, by time
post transplant, or
by time in comparison to a specified date. Referring to Fig. 44, a sample form
for adding new
data to organ specific or general lab data is shown.
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Referring again to Fig. 28, in addition to standard screen definitions, new
screen
definitions are easily developed using a dynamic charting system or "chart
expert." The
custom charts component 130 comprises a chart expert allows the user to
dynamically graph
user selected data 132 for any of number items from any lab data forms. The
type of chart,
the items graphed, the time period and the time interval may all be selected
at the time the
chart is displayed and printed. Referring to Fig. 45, a chart expert form for
a preferred
embodiment of the present invention is shown. Several items) may be specified
by clicking
the appropriate check box or radio button. These items include:
~ Chart Title
~ Items to be graphed (Select Data Series (Y Axis))
~ Chart Type (Line, Bar, 3D)
~ Data Range by Days Post-Transplant or Date Range
~ Axis Scale
~ Inserting a Legend
~ Filling in Missing Data
An example of a chart completed in accordance with the chart expert is shown
in Fig.
46.
The chronic patient management system of the present invention supports the
management of medical care for chronically ill patients. The integrated
interface,
administrator, pre-transplant, and post-transplant components of the patient
management
system are designed so that many important aspects of patient's chronic
illness may be
tracked and monitored. Sub-components within the pre- and post-transplant
components
support the entry and review of data that is particularly important in
managing care for
transplant patients. The patient data that is collected and reviewed allows
all of the healthcare
professionals involved in a patient's care to develop a treatment plan and
evaluate the
effectiveness of the treatment plan. A longitudinal permanent patient record
that is developed
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using the system may be used for daily patient management and for performing
aggregate
studies on a population. In a preferred embodiment of the present invention,
transplant
related information for patients is collected, monitored, and reported. The
present invention,
however, may be used for tracking of information related to any chronic
illness or condition.
The preferred embodiments herein disclosed are not intended to be exhaustive
or to
umlecessarily limit the scope of the invention. The preferred embodiments were
chosen and
described in order to explain the principles of the present invention so that
others skilled in
the art may practice the invention. Having shown and described preferred
embodiments of
the present invention, it will be within the ability of one of ordinary skill
in the art to make
alterations or modifications to the present invention, such as through the
substitution of
equivalent components and arrangements, or through the use of equivalent
process steps, so
as to be able to practice the present invention without departing from its
spirit as reflected in
the appended claims, the text and teaching of which are hereby incorporated by
reference
herein. It is the intention, therefore, to limit the invention only as
indicated by the scope of
the claims and equivalents thereof
26
