Health care management (e.g., record management, ICDA billing)

Apparatus and methods for monitoring and modifying anticoagulation therapy of remotely located patients

6980958

Abstract

A patient apparatus is configured to receive and analyze information regarding patient compliance with anticoagulation medication and self-test coagulation regimens related to anticoagulation therapy. In addition, a patient apparatus is configured to receive data from a patient, including physiological data, pathophysiological data, biological data, psychological data, neuropsychological data, and/or behavioral data. Utilizing the received patient data, a patient apparatus can modify a warfarin regimen using an algorithm contained within the apparatus. The apparatus can communicate the modified warfarin regimen to the patient and to third parties, such as remotely located healthcare providers. In addition, the apparatus can prompt a patient when to perform a self-test and can prompt a patient to seek immediate medical attention, or to directly contact medical help, when so warranted.


Claims

1. A system that monitors anticoagulation therapy of a patient, wherein the anticoagulation therapy includes a patient-administered medication regimen selected from the group consisting of warfarin and vitamin K antagonists, heparin and glucosaminoglycans, and direct thrombin inhibitors, and a patient-administered regimen for a coagulation test that monitors efficacy of the medication regimen, wherein the coagulation test is selected from the group consisting of prothrombin time (PT) test, partial thromboplastin time (PTT) test, activated clotting time (ACT) test, heparin assays, ecarin clotting time (ECT) test, and thrombin clotting time test, wherein the system comprises:

a portable patient apparatus, comprising:

a processor;

a user interface in communication with the processor;

computer code executable by the processor that receives and stores data from a patient, wherein the patient data includes at least one of physiological data, pathophysiological data, biological data, psychological data, neuropsychological data, and behavioral data;

computer code executable by the processor that assesses severity of the received patient data;

computer code executable by the processor that prompts the patient via the user interface to perform a patient-administered coagulation test if the received patient data are assessed to be above a threshold severity level;

computer code executable by the processor that receives and stores coagulation test results from the patient-administered coagulation test; and

computer code executable by the processor that communicates the received coagulation test results from the patient-administered coagulation test to a healthcare provider via a communications network; and

a remotely located data processing system configured to communicate with and receive data from the portable patient apparatus, the remotely located data processing system comprising:

computer code that obtains patient data from the patient apparatus;

computer code that analyzes the obtained patient data from to identify medical conditions of a patient;

computer code that displays identified patient medical conditions for a patient in selectable, prioritized order according to medical severity via a remotely located client in communication with the central data processing system; and

computer code that displays treatment options for treating a selected medical condition for a patient.

2. The system according to claim 1 wherein the portable patient apparatus further comprises:

computer code executable by the processor that assesses severity of the received coagulation test results from the patient-administered coagulation test;

computer code executable by the processor that modifies the patient-administered medication regimen if the received coagulation test results from the patient-administered coagulation test are assessed to be above a threshold severity level; and

computer code executable by the processor that communicates the modified patient-administered medication regimen to the patient.

3. The system according to claim 1 further comprising computer code that communicates treatment information from the remotely located data processing system to the patient apparatus.

4. The system according to claim 3 wherein the computer code that communicates treatment information from the remotely located data processing system to the portable patient apparatus comprises computer code that transmits treatment information via wireless, satellite, telephone, e-mail, AVM or facsimile transmission.

5. The system according to claim 4 wherein the computer code that communicates treatment information from the remotely located data processing system to the portable patient apparatus comprises computer code that modifies the medication algorithm within the portable patient apparatus.

6. The system according to claim 1 wherein the computer code that obtains patient data from the portable patient apparatus further comprises:

computer code that analyzes data transmitted from the patient apparatus substantially simultaneously with the transmission thereof to the remotely located data processing system to identify emergency medical conditions requiring immediate medical attention; and

computer code that automatically communicates treatment information to the patient apparatus for an identified emergency medical condition.

7. The system according to claim 1 wherein the remotely located data processing system further comprises:

computer code that monitors patient usage of medication; and

computer code that orders medication for a patient from a supplier of medication.

8. The system according to claim 1 wherein the computer code that displays identified patient medical conditions comprises computer code that displays selected ones of the identified patient medical conditions.

9. The system according to claim 1 wherein the portable patient apparatus further comprises computer code that receives information via the user interface about patient compliance with the patient-administered medication regimen and the patient-administered coagulation test regimen during a preceding time period.

10. The system according to claim 1 wherein the portable patient apparatus further comprises computer code that communicates information regarding medication dosage to a patient via the user interface in response to determining that a patient did not comply with the patient-administered medication regimen in a preceding time period.


Description

FIELD OF THE INVENTION

The present invention relates generally to data processing apparatus and methods and, more particularly, to medical monitoring apparatus and systems.

BACKGROUND OF THE INVENTION

Chronic disease management conventionally involves routinely monitoring patients who suffer from chronic disease to identify disease-related health problems before they become medically severe. Routine monitoring is also required in patients undergoing various forms of rehabilitation or primary prevention such as programs designed to promote healthy diet and exercise behavior. Disease management and prevention may also involve monitoring exercise and diet patterns of patients, as well as adherence to and adjustments of prescribed medicine. The management of chronic disease also often involves continuous treatment of a disease process with one or more medicines. Many of these medications have a relatively narrow therapeutic window; that is, there is a narrow range of medication dosages that provide optimal therapeutic effect without producing undesirable and potentially dangerous side effects. Other, often behavioral, factors such as illness, or changes in sleep, vitamins, diet, exercise, stress, menstrual cycles, etc. can impact the efficacy, absorption, dissipation, bioavailability and hence optimal dosing requirements of medication. Additionally, due to comorbid or co-occurring diseases or intercurrent illness, there are risks related to potential medication interactions that can also affect the efficacy dosing requirements of one or more of the medications used in treatment. Ideally, the effects of medication should be continuously monitored in order to insure that the patient is deriving maximal therapeutic benefit without suffering the effects of overmedication or from potentially dangerous interactions.

Most patient assessment of the efficacy of self-administered treatment programs such as medication regimens, rehabilitative recovery or primary prevention occurs in the offices of healthcare professionals. Unfortunately this is both time-consuming and expensive, and can only partially deal with issues related to timeliness and compliance. To overcome the disadvantages of requiring patients to visit a physician's office for assessment of their disease or condition, various health care organizations have implemented programs where case managers (i.e., persons with some level of medical training) telephone patients periodically to obtain patient data and to coordinate care. Unfortunately, with often hundreds of patients per case manager, personal contact with individual patients on a daily or even regular basis may be difficult. In addition, personal contact with individual patients on a regular basis may be somewhat expensive. Accordingly, case managers using conventional management techniques may not be able to monitor, adjust or promote a patient's medication dosage or other treatment regimen as often as desirable or necessary.

Another approach used in chronic disease management involves automated voice messaging (AVM) services, wherein patients receive regular telephone calls providing various educational and motivational messages from case managers. Exemplary messages may include reminding a patient of a scheduled physician visit. Some AVM services involve one-way communication, wherein a recorded message is delivered to a patient, but no information is obtained from the patient. As a result, the medical condition of a patient may not be available unless the patient is examined in-person by a physician.

AVM services involving two-way communications may allow patients to respond to AVM telephone queries via a touch tone telephone. Information received from patients may be reviewed by a case manager (CM). The CM then may identify which patients require callbacks for gathering more detailed information, discussing problems, or providing further information. Unfortunately, AVM services involving two-way communications may require some level of human intervention to identify patients with medically severe conditions that require immediate medical attention, such as a change in warfarin or insulin dosage. Chronic disease management via AVM has another drawback in that delays may occur between the identification of a patient with a medically severe condition and actual treatment of the condition.

In order to assist the physician and CM in following a patient with chronic disease, home monitoring devices have been developed and marketed that can collect physiologic data and report this data back to the physician. Examples of such devices include home blood glucose monitors, home blood pressure monitors, home peek-flow monitors for asthma, and home coagulation time monitors for patients undergoing anticoagulation therapy. While these systems can collect physiologic data at home, they do not provide direct guidance to the patient on need changes in chronic medication dosing. They also do not provide a convenient way for physicians to use the data generated to cost-effectively manage patients.

In addition to case managers, AVMs, and home diagnostic devices, several systems have been devised that collect disease-related data at home and transmit them to a central location where the data can be analyzed by a physician or other healthcare professionals. Such systems include DIABCARE (Roche Diagnostics), THE BUDDY SYSTEM, HEALTH HERO, and LIFECHART. Some of these systems directly interface with home physiologic monitors (e.g., DIABCARE and LIFECHART) as described above. However, all of these systems simply collect data from remotely-located patients and present the data in summary form. They do not attempt to help the physician or health care provider prioritize patients in need of attention, recommend actions to ameliorate the patient's condition, or give information back to the patient about what he or she should do in the event the a change in the therapy regimen in indicated.

One system that has attempted to automate disease management for insulin therapy in diabetes mellitus is the DIACARE® System, described in U.S. Pat. No. 4,731,726. Unfortunately, the DIACARE® System is narrowly focused on treating diabetic patients using insulin, and lacks many of the important features of a system that would be necessary for delivering a wide variety of interventions in a number of medical diseases or conditions such as anticoagulation therapy.

Warfarin and other anticoagulant therapies are indicated for conditions involving the increased likelihood of fibrin clot (thrombosis). These thromboses may increase the likelihood of stroke, myocardial infarctions or other cardiovascular events. Anticoagulant therapies interfere with or decrease the ability of the body to form a fibrin clot (thrombosis). Since under-medication can result in a thrombosis, and overmedication can result in potentially disastrous hemorrhagic complications, all of these therapies need to be very closely monitored. Examples of these therapies and the types of tests used to monitor them are shown in Table 1 below:

TABLE 1
Anticoagulation Therapies & Tests
THERAPY TEST
Warfarin and other vitamin Prothrombin (PT)
K antagonists
Heparin and similar Partial Thromboplastin
glucosaminoglycans Time (PTT)
Activated Clotting Time
(ACT)
Specific heparin or low
low molecular weight
heparin assays
Direct thrombin inhibitors Ecarin clotting time (ECT)
(e.g., hirutin, Thrombin clotting time
melagatgran) PT or PTT


PT or other coagulation tests (listed in Table 1) and regular visits to the physician or clinic are needed to monitor anticoagulation therapy. Anticoagulation therapy is a highly individualized matter that should be monitored closely. Numerous factors, alone or in combination, including travel, changes in diet, environment, physical state and medication may influence response of a patient to anticoagulants. As such, anticoagulant dosage should be controlled by periodic determinations of prothrombin time (PT)/International Normalized Ratio (INR) or other suitable coagulation tests.

Coagulation tests and regular visits to the physician or clinic are typically required to effectively monitor anticoagulation therapy. Unfortunately, regular visits to a physician or clinic can be expensive and inconvenient. In addition, patients may be required to attend training prior to being allowed to self-administer medication and testing regimens. Such training may be too complex and/or cost-prohibitive for many patients.

SUMMARY OF THE INVENTION

In view of the above discussion, it is an object of the present invention to provide apparatus and methods that allow patients to remotely self-monitor disease therapy, such as anticoagulation or other therapies that can be optimized (i.e., deliver maximum therapeutic benefit in the most cost-effective way with minimal side effects and complications by close monitoring, and that can modify medication regimens without requiring a patient to visit a healthcare provider.

It is another object of the present invention to allow health care providers to quickly and easily monitor many patients and to automatically identify patients with medical conditions that are pertinent to ongoing therapies and to organize identified medical conditions by severity.

These and other objects of the present invention are provided by apparatus and methods that allow a patient to self-monitor disease therapy and other potentially important variables without requiring the patient to visit a healthcare provider. In this way, the effects of medication can be more frequently assessed. Both sub-therapeutic dosing (under-dosing of medication) and supra-therapeutic dosing (over-dosing of medication) can be detected and rapidly ameliorated. Both sub-therapeutic and supra-therapeutic dosing may be associated with acute morbidity and mortality. Sub-therapeutic dosing can allow the underlying disease process out of control, while supra-therapeutic dosing is often associated with intolerable side effects which in some cases can be dangerous or toxic. Furthermore, dosing requirements may change due to a variety of factors and cannot be assumed to remain constant.

According to one embodiment of the present invention, anticoagulation therapy is indicated for such diseases such as atrial fibrillation, deep venous thrombosis, and thrombosis secondary to prosthetic heart value replacement. Other medical diseases or conditions that can be managed using these methods include seizure disorders, attention deficit hyperactivity disorder, cancer therapies and palliative treatments, pain control, renal dysfunction, various forms of depression including manic depression, high blood pressure, asthma, physical rehabilitation following injury, surgery or stroke, cardiovascular conditioning in cardiac rehabilitation, primary prevention and wellness promotion in at-risk groups, can all be monitored and prescriptively controlled via a remote and preferably portable apparatus. Typically, disease therapy (also referred to as chronic disease management) includes a medication regimen (e.g., warfarin for anticoagulation therapy, lithium or DEPAKOTE® (Divalproex Sodium, Abbott Labs) medication for manic depression, DEPAKENE® (valproic acid, Abbott Labs) or TEGRETOL® (carbamazepine USP; Basel Pharmaceuticals) for seizure disorders, RITALIN® (methylphenidate hydrochloride USP; CIBA Pharmaceuticals) for attention deficit hyperactivity disorder, or G-CSF (granulocyte colony stimulating factor) or erythropoietin (a hormone manufactured primarily in the kidneys which stimulates red blood cell production) for cancer chemotherapy patients, L-dopa therapy in Parkinson's Disease, and test regimens for monitoring the efficacy or toxicity of the medication dosing regimen. In rehabilitation and wellness promotion the prescription may include exercises and assessment could involve measurement of physical conditioning, range of motion, strength, endurance, rigidity, fine motor control, tremors, and the like. These can be monitored remotely and algorithmically adjusted using prescribed software routines. Exemplary test regimens for diseases include prothrombin time (PT) test for anticoagulation, white blood cell count in cancer chemotherapy patients, potassium or bicarbonate in patients with renal failure, blood pressure in hypertension, heart rate recovering in physical conditioning, depression rating scores or neuropsychological test performance in depression, and pain rating scales in chronic pain, for example.

A patient apparatus (i.e., an apparatus utilized by a patient according to the present invention) is configured to receive and analyze information regarding patient compliance with medication and test regimens. A patient apparatus according to the present invention is also configured to receive information or data from a patient concerning supra-therapeutic and sub-therapeutic conditions, signs, symptoms or test results. This same patient apparatus may also be configured to obtain data from the patient on factors which could impact ongoing therapies, such as data concerning diet, exercise, sleep, stress, illness, vitamin and other medication usage. The type of data which the patient apparatus may receive from a patient could include, but would not be limited to, physiological, pathophysiological, biological, psychological, neuropsychological (cognitive performance), behavioral data and/or specific knowledge assessments. For example, a patient can provide information or data regarding mood status, reaction times, tasks measuring divided attention or concentration, or symptoms the patient may be experiencing, along with changes in diet, exercise, stress or other medications.

A patient apparatus according to the present invention can also actively promote compliance with the prescribed treatment regimens using alarm-based initiation of routines which prompt the patient to initiate self-assessment or self-treatment protocols. Software routines in the device or managed through the device and initiated via hardware alarms or communications from remotely connected devices, servers or services can engage the patient in creative ways and help maintain motivation, initiation and completion of self-care regimens.

Utilizing the received patient data, a patient apparatus can modify a medication regimen using an algorithm contained within the apparatus. The apparatus can communicate the modified medication regimen to the patient and to third parties, such as remotely located healthcare providers. The apparatus can prompt a patient when to perform various types of self-assessments and home self-testing to provide data, directed towards monitoring the efficacy of a medication. In addition, the apparatus can prompt a patient to seek medical attention when so warranted. A patient apparatus according to the present invention can also automatically communicate patient information to a healthcare provider (or other third party) if the patient apparatus determines that symptoms that a patient is experiencing are above a severity threshold level.

According to another embodiment of the present invention, a patient apparatus for monitoring and modifying disease therapy can communicate directly with a remotely located data processing system that is configured to analyze data transmitted from the patient apparatus substantially simultaneously with the transmission thereof to identify emergency medical conditions requiring immediate medical attention. In response to identifying an emergency medical condition, treatment information may be automatically communicated to the respective patient apparatus while communications are still established.

The present invention provides a generic tool for automating the management of therapies for many chronic diseases, medical conditions or primary preventative interventions. A patient apparatus according to the present invention is ideally suited for conditions in which medication or other self-administered treatments are systematically administered and whose effects should be closely monitored, in order to maximize therapeutic benefit and minimize the risks of overmedication or other over-treatment. However, it can also significantly improve the cost effectiveness of delivering and assessing educational, rehabilitative and primary prevention programs in the patient's home environment. This invention involves the establishment of a remote electronic link between patient and caregiver, wherein the patient provides various types of assessment data and receives individualized interventions. Most patient interventions provided by this system will can be algorithmically programmed to automatically recommend individualized medication or other treatment changes in real time, or following communication with a remote computer system which is configured by the healthcare provider for patients. Besides providing access to these automated adjustment parameters, the healthcare provider's electronic interface contains powerful tools for assessing patient progress, prioritizing problems and screening for emergency conditions. The present invention is well suited for self-care regimens involving medications with a narrow therapeutic window, and will be thoroughly and primarily described throughout this disclosure with respect to the control of patients undergoing anticoagulation therapy. However, the potential applications for this system are broader and can apply to the control of other medications and/or interventions used in the prevention or treatment of other diseases.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 schematically illustrates a system for monitoring, diagnosing and treating medical conditions of a plurality of remotely located patients according to an embodiment of the present invention.

FIG. 2 illustrates an exemplary portable patient monitor (PPM).

FIG. 3 schematically illustrates operations for monitoring, diagnosing and treating medical conditions of a plurality of remotely located patients according to the present invention.

FIG. 4 schematically illustrates operations for obtaining data from a remotely located patient monitoring device.

FIG. 5 schematically illustrates operations for analyzing data to identify medical conditions of a remotely located patient.

FIG. 6 schematically illustrates operations for identifying medical conditions according to aspects of the present invention.

FIG. 7 schematically illustrates operations for prioritizing identified medical conditions according to aspects of the present invention.

FIG. 8 illustrates an exemplary user interface for displaying medical conditions prioritized according to medical severity.

FIG. 9 illustrates an exemplary user interface for displaying patient-specific information.

FIGS. 10A-10C illustrate exemplary user interfaces for facilitating communications with a remotely located patient.

FIG. 11 illustrates an exemplary user interface for adjusting a medicine dosage algorithm stored within a patient's PPM.

FIG. 12 illustrates an exemplary user interface for seeking input from other medical experts.

FIG. 13 illustrates an exemplary user interface for facilitating and tracking patient appointments with clinic personnel or other health care providers.

FIG. 14 illustrates an exemplary user interface for removing an identified medical condition from an active list.

FIGS. 15-19 schematically illustrate operations for monitoring anticoagulation therapy via a patient apparatus according to one embodiment of the present invention.

DETAILED DESCRIPTION OF THE INVENTION

The present invention now is described more fully hereinafter with reference to the accompanying drawings, in which preferred embodiments of the invention are shown. This invention may, however, be embodied in many different forms and should not be construed as limited to the embodiments set forth herein; rather, these embodiments are provided so that this disclosure will be thorough and complete, and will fully convey the scope of the invention to those skilled in the art. The present invention will now be described more fully hereinafter with reference to the accompanying drawings, in which preferred embodiments of the invention are shown. Like numbers refer to like elements throughout.

As will be appreciated by one of skill in the art, the present invention may be embodied as a method, data processing system, or computer program product. Accordingly, the present invention may take the form of an entirely hardware embodiment, an entirely software embodiment or an embodiment combining software and hardware aspects. Furthermore, the present invention may take the form of a computer program product on a computer-readable storage medium having computer-readable program code means embodied in the medium. Any suitable computer medium may be utilized including hard disks, CD-ROMs, optical storage devices, or magnetic storage devices.

The present invention is described below with reference to flowchart illustrations of methods, apparatus (systems) and computer program products according to embodiments of the invention. It will be understood that each block of the flowchart illustrations, and combinations of blocks in the flowchart illustrations, can be implemented by computer program instructions. These computer program instructions may be loaded onto a general purpose computer, special purpose computer, or other programmable data processing apparatus to produce a machine, such that the instructions which execute on the computer or other programmable data processing apparatus create means for implementing the functions specified in the flowchart block or blocks.

These computer program instructions may also be stored in a computer-usable memory that can direct a computer or other programmable data processing apparatus to function in a particular manner, such that the instructions stored in the computer-usable memory produce an article of manufacture including instruction means which implement the function specified in the flowchart block or blocks. The computer program instructions may also be loaded onto a computer or other programmable data processing apparatus to cause a series of operational steps to be performed on the computer or other programmable apparatus to produce a computer implemented process such that the instructions which execute on the computer or other programmable apparatus provide steps for implementing the functions specified in the flowchart block or blocks.

Accordingly, blocks of the flowchart illustrations support combinations of means for performing the specified functions, combinations of steps for performing the specified functions and program instruction means for performing the specified functions. It will also be understood that each block of the flowchart illustrations, and combinations of blocks in the flowchart illustrations, can be implemented by special purpose hardware-based computer systems which perform the specified functions or steps, or combinations of special purpose hardware and computer instructions.

Computer program for implementing the present invention may be written in various object-oriented programming languages, such as Delphi and Java®. However, it is understood that other object oriented programming languages, such as C++ and Smalltalk, as well as conventional programming languages, such as FORTRAN or COBOL, could be utilized without departing from the spirit and intent of the present invention.

System Overview

Referring now to FIG. 1, a system 10 for monitoring, diagnosing, and treating medical conditions of remotely located patients with various chronic illnesses, according to the present invention, is schematically illustrated. A plurality of remote or preferably portable patient monitors (PPMs) 12 are configured to establish communications directly with a central data processing system referred to as a Physicians Access Center server (hereinafter "PAC server") 14 via communications links 13. It is noted that a majority of the functionality provided by a PPM as described herein for many disease applications can be achieved using remote data terminals or internet browsers, which are not necessarily portable, but which can provide personal healthcare advice via connection to a properly configured database server system that supports the features of a PPM described below.

A plurality of case manager clients (CMCs) 16 are configured to establish client-server communications with the PAC server 14 via a computer network 17, such as the Internet or an Intranet. The term "CMC" can be considered as a synonym for professional or paraprofessional healthcare providers. It is understood that a CMC or PAC server or other apparatus configured to execute program code embodied within computer usable media, operates as means for performing the various functions and carries out the methods of the various operations of the present invention. It is also understood that the present invention may be used with various client-server communications protocols, and is not limited to specific protocols such as TCP/IP protocol.

Each of these components will be described in detail below. The present invention will be described throughout this disclosure with respect to the control of warfarin therapy for patients undergoing anticoagulation therapy. However, it is to be understood that the present invention may be utilized with a wide variety of medical therapies including, but not limited to, antiseizure therapy, cancer chemotherapy, renal failure therapy, congestive heart failure therapy, asthma therapy, high blood pressure therapy, attention deficit disorder therapy, depression therapy, and therapies for other chronic diseases and conditions.

For example a PPM may collect and use patient data to adjust medication dosage for respiratory therapy and anticoagulation therapy based on predefined physician prescriptions. The term "prescription" may include physician-prescribed algorithms for calculating medicine dosages, dosages calculated from algorithms, and fixed and contingent self-monitoring schedules for patients. An exemplary physician-prescribed medication algorithm is described in Guidelines for the Diagnosis and Management of Asthma; Expert Panel Report Two; National Institutes of Health; Heart and Lung Institute; Publication No.: 97-4051, April 1997, which is incorporated herein by reference in its entirety. Another exemplary physician-prescribed medication algorithm is described in Long-term Patient Self-management of Oral Anticoagulation; Jack E. Ansell et al.; Arch Intern Med. 1995; Vol. 155; pp. 2185-2189; which is incorporated herein by reference in its entirety.

A PPM may incorporate physician-prescribed algorithms for calculating medicine dosages for various chronic illnesses. Alternatively, a PAC server may implement a medication dosage algorithm for anticoagulation therapy, based on values communicated to the PAC server by a PPM, and communicate results directly to the patient. PAC server implemented dosage algorithms may be a logical alternative to having medication dosage algorithms stored within PPMs when medication dosage changes are infrequent.

Remote or Portable Patient Monitors (PPM)

A PPM (12 in FIG. 1) serves as primary means for collecting data from a patient and as means for case managers to interface with a patient. Exemplary features of a PPM for use in accordance with the present invention are summarized below in Table 2.

TABLE 2
Small and portable so patient can carry around.
Data processing capabilities and built-in modem or attachable
external modem.
Collects data from blood, breath or bodily fluids or other functions.
Collects patient supplied data on health status, compliance
with a medical treatment or management regimen, and psychological data.
Allows two-way communication with PAC server.
Analyzes patient data collected and delivers pre-recorded or calculated
responses and/or medication dosage recommendations based on
physician instructions loaded in PPM.
Downloads patient data to PAC server at specified time intervals
or in real time.
Receives messages, updates to physician instructions and prescription
dosage parameters, dosage algorithms, fixed or contingent self-
monitoring schedules, words of encouragement or other feedback from
PAC server.


Patient data collected via a PPM may include physiologic or biologic data and behavioral data (e.g., assessments related to diet, exercise, stress, mental status or the presence of intercurrent illness). A PPM may also monitor patient medication intake (e.g., warfarin dosage). A PPM, depending on the chronic illness of the patient, may contain software specifically designed for a particular patient's illness. For example; a PPM for an anticoagulation therapy patient may contain physician-prescribed warfarin dosage algorithms. It is understood that other medications, well known by those of skill in the art, may be utilized in anticoagulation therapy in addition to, or in lieu of, warfarin.

A PPM designed for a patient can store various data along with other relevant self-monitoring patient data. Blood from a pricked finger may be read on a chemically treated strip via the PPM. Automated warfarin adjustment algorithms with physician-prescribed parameters can be stored within each patient's PPM for real-time analysis and adjustment of a patient's warfarin dosage. The PPM may be configured to make automatic adjustments to a patient's self-monitoring and treatment regimen based on patient-entered data as will be described below. A PPM may also contain a database to help patients evaluate the effects of new medications on their target disease or to provide other disease-specific information to patients.

With respect to medications, the term "regimen" is intended to be synonymous with a schedule for taking medication. However, it is understood that some medications are taken in different doses on different days (or other time periods). Thus, the term "regimen" also refers to dosage amounts of a medication taken according to a particular schedule. Thus, the term "modifying a medication regimen" may include changing a schedule for taking a medication and/or changing a dosage amount of a medication. With respect to tests for monitoring the efficacy of medication in disease therapy, the term "regimen" is intended to be synonymous with a schedule for taking a test. Thus, the term "modifying a test regimen" may include changing a schedule for administering a test.

Patients are responsible for recording data within their PPMs and transmitting the data to a PAC server on a regular basis. Preferably, transmission of data to a PAC server is highly automated and substantially "hands-off" for a patient. A patient preferably can plug a PPM into a standard telephone jack and, with the press of a button, establish communications with a PAC server. Each PPM may have the ability to prompt patients when data transmissions are required, and to initiate and complete data transmissions using an alarm-driven timer.

Preferably, each PPM contains a user interface for displaying text, graphics, prompts and various other information. A PPM user interface serves as the primary means of communication between the PAC server and the patient. A PPM may also be configured to notify patients of transmission schedules to the PAC server; to notify patients having emergency medical conditions to promptly seek medical attention; and to provide motivational feedback to patients based upon past performance (e.g., reward patients for keeping on schedule with data recordings and transmissions of data to a PAC server).

Referring now to FIG. 2, an exemplary PPM 20 is illustrated. The illustrated PPM 20 includes a display 22 and a keyboard 24. The PPM 20 also preferably includes the following which are not shown: internal, non-volatile data storage, internally stored medication monitoring software, and a data processor for performing various functions and for communicating with a PAC server. Internal software (program code) may query a patient for various information via display 22. Preferably, the PPM internal software is menu-driven for ease-of-use by patients. Preferably, the menus are written in various languages including a children's version incorporating game-like features.

Preferably, all data entered within a PPM 20 is stored with date and time information and can be alarm initiated (i.e., a patient or PPM can be prompted to perform a task or function). Preferably, the PPM internal software analyzes the entered data and continuously informs the patient of his/her prescribed medication dose. The PPM internal software can calculate adjustments for a patient's medication dosage according to a physician's prescription as applied to the data entered into the PPM by the patient.

The internal software of a PPM can be configurable by a case manager via a PAC server. A case manager can make adjustments to a patient's medication dose calculations, to a patient's dosage algorithm, and to a patient's fixed or contingent self-monitoring schedules. These adjustments can be made automatically within a PPM during routine data transfer to a PAC server. In addition to providing disease therapy management, a PPM can be used to remind patients to schedule appointments for important examinations.

Preferably, a PPM contains a database of medication interaction information and is configured to allow a patient to query the database for information related to the patient's use of multiple medications. A PPM may be configured to communicate with an external database containing medication interaction information, as well. For example, a patient may query a database located within a PAC server when communications are established between the PPM and the PAC server. A PPM may also be configured to allow a patient to establish communications with other external databases, such as those residing in various legacy systems.

Other features of a PPM which are not illustrated, but which may be included, are PCMCIA slots for connecting a PPM to various peripheral devices; RJ11 connections to land line telephone systems; and infrared ports for communications with peripheral devices. Additional PPM features for diabetes patients are disclosed in U.S. Pat. No. 4,731,726 which is incorporated herein by reference in its entirety.

PPMs, according to the present invention, are not limited to land line telephone communications with a PAC server. PPMs may communicate with a PAC server using various communications technologies, without limitation. For example, a PPM may incorporate wireless communications technology for communicating with a PAC server. A PPM may also incorporate direct satellite communications technology for communicating with a PAC server.

Physician Access Center Server

Data entered into a PPM (12 of FIG. 1) by a patient is transferred to a central data processing system 14 (referred to hereinafter as a PAC server) via a telephone and modem. It is understood that a PAC server 14 may be one or more data processing devices arranged in a network. Preferably, a direct communications connection is established between a PPM 12 and a PAC server 14. Alternatively, an indirect communications connection may be established between a PPM 12 and the PAC server 14 via the Internet or other network. A communications server is preferably utilized to handle inbound and outbound communications between a PPM 12 and the PAC server 14, as would be understood by those skilled in the art of client-server communications. The term PAC server, as used herein, includes databases for storing and manipulating patient data as well as other server functions including, but not limited to web servers, application servers, e-mail servers, fax servers, AVM servers, and the like. A particularly preferred PAC server utilizes an Intel based processor running Windows NT Server 4.0 as its operating system. Preferably, a PAC server 14 is configured to handle more than 250,000 patients with at least 500 concurrent client connections. However, a PAC server 14 may be implemented using other processors and via other computing devices, including, but not limited to, mainframe computing systems and mini-computers.

A PAC server 14 analyzes and stores data transmitted from each patient PPM 12. This data is made available to authorized case managers who can access the data via a CCM 16 in TCP communication with a PAC server 14 via the Internet. In particular, a PAC server 14 identifies and prioritizes patient medical problems using the data transmitted from the patient PPMs 12. This allows case managers to focus their attention first on patients with significant medical problems.

Preferably, a PAC server 14 performs real-time analysis on data as it is being transmitted from a PPM to identify medical emergency situations that require immediate attention. If such a medical emergency is identified, a patient can be immediately notified via communications from a PAC server 14 to a PPM 12, without the intervention of a case manager. Alternatively, a case manager can be notified and the patient contacted directly via phone, e-mail, fax, or other modes of communication.

A PAC server 14 performs various other functions including allowing case managers to change the treatment program for patients, such as medication dosage, when a patient downloads data to a PAC server 14. In addition, a PAC server may include a "tickler system" for reminding case managers to verify that communications with patients have occurred and for verifying that medical conditions requiring medical attention have been resolved. A PAC server may also be configured to track patient medication supply usage automatically (e.g., warfarin, lancets, and syringes) and this information may be used to provide just-in-time delivery of replacement medications and supplies to a patient. A PAC server may be configured to communicate with manufacturers and distributors of medical supplies utilized by patients. By monitoring patient usage of supplies, orders can be placed with manufacturers and distributors directly via a PAC server such that medical supplies can be delivered to patients.

A separate warehouse database may be added to a PAC server 14 to support complex analysis of patient data, and may also be used to review prescriptive changes made to a patient's medical regimens and medication dosages.

Case Manager Clients

As illustrated in FIG. 1, case managers access a PAC server 14 via a case manager client (CMC) 16 connected to the same network. The CMC 16 preferably communicates with a PAC server 14 using TCP/IP protocol over an Internet connection between the CMC and the PAC server. Data encryption may be utilized and other security methods may be implemented to transfer information between a PPM and PAC server and between a CMC and the PAC server or a PPM.

Exemplary devices which may serve as CMCs 16 for purposes of the present invention may include, but are not limited to, desktop computers and portable computing devices, such as personal digital assistants (PDAs). A CMC 16 preferably includes a central processing unit, a display, a pointing device, a keyboard, access to persistent data storage, and an Internet connection for connecting to the Internet 17. An Internet connection may be made via a modem connected to traditional phone lines, an ISDN link, a T1 link, a T3 link, via cable television, via an ethernet network, and the like. An Internet connection may be made via a third party, such as an "Internet Service Provider" ("ISP").

An Internet connection may be made either by a direct connection of a CMC to the Internet or indirectly via another device connected to the Internet. In the latter case, a CMC is typically connected to this device via a local or wide area network (LAN or WAN). Preferably, data transfer rates between a CMC and a PAC server are equal to, or greater than, fourteen thousand four hundred baud (14,400 baud). However, lower data transfer rates may be utilized.

Preferably, a CMC 16 has an Intel® 80486 processor (or equivalent) with at least eight megabytes (8 MB) of RAM, and at least five megabytes (5 MB) of persistent computer storage for caching. Even more preferable is an Intel® Pentium® processor (or equivalent). However, it is to be understood that various processors may be utilized to carry out the present invention without being limited to those enumerated herein. Although a color display is preferable, a black and white display or standard broadcast or cable television monitor may be used. A CMC 16, if an IBM®, or IBM-compatible personal computer, preferably utilizes either a WINDOWS®3.1, WINDOWS 95®, WINDOWS NT®, UNIX®, or OS/2® operating system. However, it is to be understood that a terminal not having computational capability, such as an IBM® 3270 terminal or a network computer (NC), or having limited computational capability, such as a network PC (Net PC) may be utilized in accordance with an embodiment of the present invention for accessing the Internet in a client capacity.

Herein, the term "Internet" shall incorporate the term "computer network" and "communications network" such as an "Intranet", and any references to accessing the Internet shall be understood to mean accessing a hardwired computer network as well. Herein, the terms "computer network" and "communications network" shall incorporate publicly accessible computer networks and private computer networks, and shall be understood to support modem dial-up connections.

A case manager accesses a PAC server 14 via a CMC 16 to review the medical conditions of multiple patients. Case managers preferably are able to review, via information downloaded from a PAC server 14, all patient activity and data for their assigned patients including data transmission history, symptom reports, prescription review, analysis and adjustment. A CMC 16 allows a case manager to review patient data in various formats, including a hierarchical, problem-oriented format wherein patients with medical conditions requiring immediate attention are presented foremost. A CMC 16 may also allow a case manager to add, edit, and delete certain patient data stored in a PAC server 14. A CMC 16 also can interface directly with each PPM 12 to provide a patient with information and to modify illness-specific software contained therein. For example, a warfarin or other anticoagulation dosage algorithm contained within the internal software of a particular patient's PPM can be modified remotely by a case manager via a CMC 16.

System Security

Access to a system for monitoring, diagnosing, and treating medical conditions of remotely located patients with various chronic illnesses, according to the present invention, may be controlled using logon security which provides case managers and other users with certain circumscribed privileges to examine and/or edit data. These rights can limit certain users ability to examine confidential clinical health data, and may also be employed to limit the ability to edit any clinical data or make changes to specific fields in a patient's medication dosages or dosage adjustment algorithm. Similar access control may be applied to the data, at various levels, which define patients' medical conditions and their associated priorities and pre-emptive relationships.

Flexible configuration and associated security may be an element of a system for monitoring, diagnosing, and treating medical conditions of remotely located patients, according to the present invention, that permeates many of the subsystems. Default values and classifications for many values may be provided at the system level. Default values may be modified in a hierarchical manner, and may be controlled in part by access rights of a user, to a permit uniqueness at various levels.

Operations

Referring now to FIG. 3, operations for monitoring, identifying, prioritizing and treating medical conditions of patients with chronic illnesses, according to the present invention, are schematically illustrated. Patient data are obtained by a PAC server from a PPM (Block 100). A PAC server analyzes the obtained data to identify patients with medical conditions requiring treatment or some type of medical attention (Block 200). A PAC server prioritizes the identified patient conditions according to medical severity (Block 300). A PAC server displays to a case manager (or other user), via a client in communication with the PAC server, a selectable list of patients with identified medical conditions arranged in priority order (Block 400). A PAC server provides to a case manager, via a client, options for treating each identified medical condition (Block 500). Physician-prescribed medication dosage algorithms may be implemented based on patient data obtained from a PPM (Block 600). Treatment information may be communicated directly to a patient or to a patient's PPM by a case manager via a client in communication with a central data processing system (Block 700). The operations set forth in FIG. 3 are described in detail below.

Obtaining Data from PPM

In a preferred embodiment, when a PAC server obtains patient data from a PPM (Block 100), operations schematically illustrated in FIG. 4 may be performed. Preferably, data transmitted to a PAC server is analyzed substantially simultaneously with transmission of the data for the purposes of identifying "emergency" medical conditions requiring immediate medical attention (Block 102). Preferably, this analysis is performed while communications are still established between a PAC server and a PPM transmitting the data. If emergency medical conditions are not identified (Block 104), data obtained from a PPM is stored within a PAC server database for later analysis and retrieval (Block 110).

If emergency medical conditions are identified (Block 104), instructions are downloaded to the PPM regarding what actions should be taken by the patient (Block 106). For example, the patient may be instructed to immediately take a specific medication or to immediately seek medical attention. If a medication dosage algorithm is stored in a PAC server, the PAC server may communicate a new medication dose to the PPM, or to the patient via telephone, AVM, e-mail, facsimile transmission, and the like. In addition, changes may also be made to medicine dosage algorithms stored within a PPM or within the PAC server, such that a patient's next dose of medicine is changed in response to the identified emergency medical condition. Furthermore, changes may also be made to a patient's fixed or contingent self-monitoring schedules. The next scheduled time for data transmission from the PPM to the PAC server may be set, based on an identified medical condition's severity, such that higher condition severities result in more frequently scheduled transmissions (Block 108). For example, PPMs for patients with asthma may be reprogrammed to transmit every 12 hours, while PPMs for patients with high blood pressure may be adjusted to transmit every 3 days, while patients with no identified conditions may transmit on a routine schedule such as every week. The data obtained from a PPM is then stored within a PAC server database for later analysis and retrieval (Block 110).

Analyzing Patient Data to Identify Patients with Medical Conditions Requiring Medical Attention or Treatment

Referring now to FIG. 5, preferred operations for analyzing patient data transmitted from a PPM to a PAC server to identify medical conditions requiring medical attention or treatment are schematically illustrated. Initially, operations for identifying medical conditions from transmitted data (Block 202) are performed. Exemplary operations represented by Block 202 are schematically illustrated in FIG. 6, and are discussed below.

Still referring to FIG. 5, if medical conditions requiring attention are not identified from data transmitted from a PPM (Block 250), a determination is made whether there are any unresolved medical conditions for the patient requiring attention or treatment (Block 252). If there are no unresolved medical conditions, case managers may provide patients with positive feedback to reinforce their self-monitoring practices and encourage continued compliance with the treatment regimen(s) (Block 254). Additionally, patients with chronic diseases must have regularly scheduled reviews and assessments, with the latter performed predominantly in the clinic. Periodic comprehensive reviews of the patients can be performed and may utilize all available inputs, including the most recent month's PPM data. These periodic assessments may be flexibly scheduled depending upon the disease and/or disease state of individual patients. These reviews provide a structured means by which the case manager may work to optimize care for patients who otherwise are not specifically identified as having medical conditions that require treatment, but who nonetheless can benefit by feedback and further optimization of medication doses, algorithmic methods for adjusting doses, self-monitoring schedule and by coordinating medical assessments and procedure conducted by other medical specialists.

If medical conditions are identified (Block 250) from transmitted data from a PPM, or if there are unresolved medical conditions for the patient (Block 252), a determination is made whether a medical condition requires additional patient input (Block 256). If patient input is required, the patient is notified by various methods, such as via telephone, e-mail, AVM, facsimile transmission, or via the patient's PPM (Block 258). Preferably, the present invention includes a "tickler" system for monitoring whether a patient provides required input within a specified time period (Block 260). If a patient does not provide required input within a specified time period, the present invention may prompt a case manager to re-notify a patient of required input (Block 258).

If input from a patient is not required (Block 256) or if patient input has been received (Block 260), a case manager is provided with various options for resolving one or more medical conditions. A case manager may be presented with an option to contact a patient (Block 262). If a case manager decides to contact a patient, the present invention facilitates communication via telephone, e-mail, AVM and facsimile transmission (Block 272). A case manager may be presented with an option to adjust a medicine dosage algorithm, a patient's dosage, or a patient's fixed or contingent self-monitoring schedule, either within a patient's PPM or the PAC server (Block 264). If a case manager decides to adjust a medicine dosage algorithm within a patient's PPM, the present invention facilitates this modification though a PAC server the next time communications are established between the PAC server and the patient's PPM (Block 274). A patient may be prompted to establish communications between his/her PPM and a PAC server to receive modifications made by a case manager. Alternatively, if a medicine dosage algorithm resides within a PAC server, a case manager can instruct the PAC server to adjust medicine dosage and transmit this information to the patient.

In addition, a case manager may be presented with an option to schedule a patient for a visit with a health care provider (Block 266) or with an option to seek expert medical input (Block 268). If these options are selected, the present invention facilitates scheduling a patient to visit a health care provider (Block 276) or obtaining input from a medical expert (Block 278). A case manager may decide that no action is required for a particular medical condition and may remove an identified medical condition from an active medical condition list for a particular patient after reviewing available data (Block 270).

Referring now to FIG. 6, exemplary operations performed by a PAC server for identifying medical conditions requiring medical attention or treatment are schematically illustrated. Preferably, these operations are performed by a PAC server immediately after transmission of data from a PPM to the PAC server. For any given chronic disease, there may be relationships between medical conditions that a patient may have. For example, a patient afflicted with thrombosis may exhibit two medical conditions having differing degrees of medical severity. One medical condition may have a high degree of medical severity requiring immediate attention. The other medical condition may have a much lower priority and may not require immediate medical attention. When multiple medical conditions are identified, two or more of these conditions for a given patient may represent problems of a similar type which differ only in severity (as defined by the system implementation). Conditions of lesser severity of the same type may be ignored (if identified) or may not be identified in the first place, if a condition of the same type at a higher priority has already been identified. It is presumed that identification and treatment of the most severe condition identified will obviate the needs to identify or treatment less severe conditions of the same type. Two methods are presented for achieving this aim below.

The present invention facilitates identifying and addressing medical conditions having the highest degree of medical severity first by organizing possible medical conditions for a given chronic disease into various classifications and by prioritizing medical conditions within each classification. Classification and prioritization within classes are illustrated below with respect to Table 3.

TABLE 3
MEDICAL
CLASS CONDITION PRIORITY SUB—PRIORITY
1 A 1 A
1 A 1 B
1 A 1 D
1 A 1 L
1 A 1 Q
1 B 2 A
1 B 2 D
1 B 2 F
1 B 2 M
1 B 2 Q
1 B 2 Z
1 C 3 A
1 C 3 B
1 C 3 S
1 C 3 U
2 D 1 A
2 D 1 B
2 D 1 C
2 D 1 F
2 E 2 A
2 E 2 C
2 E 2 F
2 F 3 A
2 F 3 D
2 F 3 F
2 F 3 Z
3 G 1 A
3 G 1 B
3 G 1 D
3 H 2 A
3 H 2 B
3 H 2 C
3 H 2 D


The column entitled Sub—Priority presents medical conditions within each unique combination of class and medical condition (already sorted by priority with a class) in a sorted order that is defined expressly for each combination. That is, sub—priority provides a means by which the conditions in the list can be further sorted to provide additional information related to urgency. For example, problems related to late data transmissions (all within one class and assigned to have one priority) may be displayed in the order of the most overdue first. Subpriorities for each medical condition will be uniquely defined for that condition. In this example, the column labeled sub—priority may be conceived of as representing a "priority score" that can be defined for each condition. Other embodiments may utilize different methods to achieve similar means, and the process of prioritization could also be extended to additional levels as needed (i.e., sub—sub-priorities). Use of a single sub—priority column will support this feature.

Using Table 3, a relationship table may be derived to determine which medical conditions have a higher degree of medical severity than other medical conditions. An exemplary relationship table is illustrated below as Table 4. Conditions may be overridden that are either 1) unrelated but of a lesser priority than those in the first column, or 2) closely related or being of the same "type" and therefore need not be identified and treated since treatment for the most severe form will obviate the need for treatment of less severe conditions of the same type.

TABLE 4
Overrides Medical
Medical Condition Condition
A D and H
B G
D H
E F and G


Referring back to FIG. 6, operations for identifying medical conditions (Block 202) based upon Table 3 and Table 4 above are schematically illustrated. Initially a test is performed for medical condition A (Block 204). If transmitted data from a PPM indicates that a patient has medical condition A (Block 206), then tests for medical conditions D and H (Block 208-Block 214) are not performed because medical conditions D and H have lower priority than medical condition A. If transmitted data from a PPM indicates that a patient does not have medical condition A (Block 206), a test for medical condition D is performed (Block 208). If transmitted data from a PPM indicates that a patient has medical condition D (Block 210), then tests for medical condition H (Block 212-Block 214) are not performed because medical condition H has lower priority than medical condition D. If transmitted data from a PPM indicates that a patient does not have medical condition D (Block 210), a test for medical condition H is performed (Block 214).

Whether or not transmitted data from a PPM indicates that a patient has medical condition H (Block 210) or if a patient has medical condition A (Block 206), a test for medical condition B is performed (Block 216). If transmitted data from a PPM indicates that a patient has medical condition B (Block 218), then tests for medical condition H (Block 220-Block 222) are not performed because medical condition H has lower priority than medical condition B. If transmitted data from a PPM indicates that a patient does not have medical condition B (Block 218), a test for medical condition H is performed (Block 220).

Whether or not transmitted data from a PPM indicates that a patient has medical condition H (Block 222) or if a patient has medical condition B (Block 218), a test for medical condition C is performed (Block 224). Whether or not transmitted data from a PPM indicates that a patient has medical condition C (Block 226), a test for medical condition E is performed (Block 228).

If transmitted data from a PPM indicates that a patient has medical condition E (Block 230), then tests for medical conditions F and G (Block 232-Block 238) are not performed because medical conditions F and G have lower priority than medical condition E. If transmitted data from a PPM indicates that a patient does not have medical condition E (Block 230), a test for medical condition F is performed (Block 232). If transmitted data from a PPM indicates that a patient has medical condition F (Block 234), then tests for medical condition G (Block 236-Block 238) are not performed because medical condition G has lower priority than medical condition F. If transmitted data from a PPM indicates that a patient does not have medical condition F (Block 234), a test for medical condition G is performed (Block 238). All medical conditions identified are then stored within a PAC server (Block 240).

It should be further noted that the definition and specification of these medical conditions and their associated priorities, and of the relationship between conditions where the treatment and identification of lower priority condition may be superceded by those of higher priority is configurable. The problem definitions may be configured in part to reflect individual patient differences by adjustment of the default physiologic or behavioral parameters which will trigger the identification of a given problems. Where default values for identification are utilized, patient parameters are inherited from the doctor, and these may in turn be inherited from other, higher levels within the system.

Prioritizing Identified Patient Medical Conditions

According to a preferred embodiment of the present invention, identified patient medical conditions are prioritized based on a hierarchy of medical severity. In general, three classes of medical conditions (Class I, II and III) may be utilized. However, it is to be understood that various numbers and types of classes of medical conditions may be utilized without departing from the spirit and intent of the present invention.

Class I medical conditions are those that require immediate attention based on physiologic or behavioral data collected by a PPM. Although identified by a PAC server, many of these conditions may also be identified by a PPM and may result in prompts to the patient to transmit to a PAC server up-to-date data and to follow this up with a telephone call to the case manager or physician. While late transmissions may not necessarily require immediate action, they may be placed in the Class I category for reasons of health safety.

Class II medical conditions may be significant medical conditions, but may not require immediate medical attention or action on the part of a case manager. Class II medical conditions, if not addressed, may develop into Class I medical conditions that do require immediate attention.

Class III medical conditions are defined as suboptimal conditions in which room for patient improvement may be indicated by physiologic and/or behavioral data collected from a patient's PPM. Many Class III medical conditions may relate to poor or inconsistent compliance with a self-monitoring regimen.

Referring now to FIG. 7, operations for prioritizing identified medical conditions according to aspects of the present invention are schematically illustrated. Identified medical conditions are sorted by patient, medical condition, classification, priority and sub-priorities (Block 302). Medical conditions of lesser severity for each patient within each medical condition classification are eliminated (Block 304).

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