Apparatus and Methods for Monitoring and Modifying Anticoagulation Therapy of Remotely Located Patients

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.

1 . A method of monitoring 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 apparatus is configured to receive and analyze information regarding patient compliance with the patient-administered medication and coagulation test regimens, and wherein the apparatus is configured to modify the patient-administered medication and coagulation test regimens, the method comprising the following steps performed by a portable apparatus:
 receiving 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;   assessing severity of the received patient data;   prompting the patient to perform a patient-administered coagulation test if the received patient data are assessed to be above a threshold severity level;   receiving coagulation test results from the patient-administered test; and   communicating the received coagulation test results from the patient-administered test to a healthcare provider via a communications network.   
     
     
         2 . The method according to  claim 1  further comprising the steps of:
 assessing severity of the received coagulation test results from the patient-administered coagulation test; 
 modifying 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 
 communicating the modified patient-administered medication regimen to the patient. 
 
     
     
         3 . The method according to  claim 2  further comprising the step of communicating the modified patient-administered medication regimen to a healthcare provider via a communications network. 
     
     
         4 . The method according to  claim 2  further comprising the step of communicating the modified patient-administered medication regimen to a remotely located data processing system via a communications network. 
     
     
         5 . The method according to  claim 1  further comprising the step of receiving from the patient information about patient compliance with the patient-administered medication and coagulation test regimens during a preceding time period. 
     
     
         6 . The method according to  claim 1  further comprising the step of automatically communicating the received patient data to a healthcare provider via a communications network if patient data are assessed to be above a threshold severity level. 
     
     
         7 . The method according to  claim 6  wherein the step of automatically communicating the received patient data to a healthcare provider comprises paging the healthcare provider. 
     
     
         8 . The method according to  claim 4  further comprising the step of communicating information regarding medication dosage to the patient in response to determining that the patient did not comply with the medication regimen in the preceding time period. 
     
     
         9 . The method according to  claim 1  wherein the received patient data comprises at least one of information about hemorrhagic symptoms experienced by the patient and information about non-hemorrhagic symptoms experienced by the patient. 
     
     
         10 . An apparatus 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, 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 a 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;   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.   
     
     
         11 . The apparatus according to  claim 10  further comprising:
 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. 
 
     
     
         12 . The apparatus according to  claim 11  further comprising computer code executable by the processor that communicates the modified patient-administered medication regimen to a healthcare provider via a communications network. 
     
     
         13 . The apparatus according to  claim 11  further comprising computer code executable by the processor that communicates the modified patient-administered medication regimen to a remotely located data processing system via a communications network. 
     
     
         14 . The apparatus according to  claim 10  further comprising computer code executable by the processor that receives and stores information from a patient about patient compliance with the patient-administered medication and coagulation test regimens during a preceding time period. 
     
     
         15 . The apparatus according to  claim 10  further comprising computer code executable by the processor that automatically communicates the received patient data to a healthcare provider via a communications network if patient data are assessed to be above a threshold severity level. 
     
     
         16 . The apparatus according to  claim 15  wherein the computer code that automatically communicates the received patient data to a healthcare provider comprises computer code that sends a paging signal to a healthcare provider. 
     
     
         17 . The apparatus according to  claim 13  further comprising computer code executable by the processor that communicates information regarding medication dosage to the patient in response to determining that the patient did not comply with the medication regimen in the preceding time period. 
     
     
         18 . The apparatus according to  claim 10  wherein the received patient data comprises at least one of information about hemorrhagic symptoms experienced by the patient and information about non-hemorrhagic symptoms experienced by the patient. 
     
     
         19 . 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 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 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. 
   
     
     
         20 . The system according to  claim 19  wherein the 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. 
 
     
     
         21 . The system according to  claim 19  further comprising computer code that communicates treatment information from the remotely located data processing system to the patient apparatus. 
     
     
         22 . The system according to  claim 21  wherein the computer code that communicates treatment information from the remotely located data processing system to the patient apparatus comprises computer code that transmits treatment information via wireless, satellite, telephone, e-mail, AVM or facsimile transmission. 
     
     
         23 . The system according to  claim 22  wherein the computer code that communicates treatment information from the remotely located data processing system to the patient apparatus comprises computer code that modifies the medication algorithm within the patient apparatus. 
     
     
         24 . The system according to  claim 19  wherein the computer code that obtains patient data from the 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. 
 
     
     
         25 . The system according to  claim 19  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. 
 
     
     
         26 . The system according to  claim 19  wherein the computer code that displays identified patient medical conditions comprises computer code that displays selected ones of the identified patient medical conditions. 
     
     
         27 . The system according to  claim 19  wherein the 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. 
     
     
         28 . The system according to  claim 19  wherein the patient apparatus further comprise 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. 
     
     
         29 . A method of monitoring disease therapy of a patient, wherein the disease is selected from the group consisting of asthma, cancer chemotherapy, depression, high blood pressure, seizure disorders, and thrombosis, wherein the disease therapy includes a patient-administered medication regimen and a patient-administered regimen for a test that monitors efficacy of the medication regimen, wherein the apparatus is configured to receive and analyze information regarding patient compliance with the patient-administered medication and test regimens, and wherein the apparatus is configured to modify the patient-administered medication and test regimens, the method comprising the following steps performed by the apparatus:
 receiving 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;   assessing severity of the received patient data;   prompting the patient to perform a patient-administered test if the received patient data are assessed to be above a threshold severity level;   receiving test results from the patient-administered test; and   communicating the received test results from the patient-administered test to a healthcare provider via a communications network.   
     
     
         30 . The method according to  claim 29  further comprising the steps of:
 assessing severity of the received test results from the patient-administered test; 
 modifying the patient-administered medication regimen if the received test results from the patient-administered test are assessed to be above a threshold severity level; and 
 communicating the modified patient-administered medication regimen to the patient. 
 
     
     
         31 . The method according to  claim 30  further comprising the step of communicating the modified patient-administered medication regimen to a healthcare provider via a communications network. 
     
     
         32 . The method according to  claim 30  further comprising the step of communicating the modified patient-administered medication regimen to a remotely located data processing system via a communications network. 
     
     
         33 . The method according to  claim 29  further comprising the step of receiving from the patient information about patient compliance with the patient-administered medication and test regimens during a preceding time period. 
     
     
         34 . The method according to  claim 29  further comprising the step of automatically communicating the received patient data to a healthcare provider via a communications network if patient data are assessed to be above a threshold severity level. 
     
     
         35 . The method according to  claim 32  further comprising the step of communicating information regarding medication dosage to the patient in response to determining that the patient did not comply with the medication regimen in the preceding time period. 
     
     
         36 . The method according to  claim 29  wherein the received patient data further comprises at least one of information about a supra-therapeutic symptom experienced by the patient and information about a sub-therapeutic symptom experienced by the patient. 
     
     
         37 . An apparatus that monitors disease therapy of a patient, wherein the disease is selected from the group consisting of asthma, cancer chemotherapy, depression, high blood pressure, seizure disorders, and thrombosis, wherein the disease therapy includes a patient-administered medication regimen and a patient-administered regimen for a test that monitors efficacy of the medication regimen, the 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 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 test results from the patient-administered test; and   computer code executable by the processor that communicates the received test results from the patient-administered test to a healthcare provider via a communications network.   
     
     
         38 . The apparatus according to  claim 37  further comprising:
 computer code executable by the processor that assesses severity of the received test results from the patient-administered test; 
 computer code executable by the processor that modifies the patient-administered medication regimen if the received test results from the patient-administered 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. 
 
     
     
         39 . The apparatus according to  claim 38  further comprising computer code executable by the processor that communicates the modified patient-administered medication regimen to a healthcare provider via a communications network. 
     
     
         40 . The apparatus according to  claim 38  further comprising computer code executable by the processor that communicates the modified patient-administered medication regimen to a remotely located data processing system via a communications network. 
     
     
         41 . The apparatus according to  claim 37  further comprising computer code executable by the processor that receives and stores information provided by the patient about patient compliance with the patient-administered medication and test regimens during a preceding time period. 
     
     
         42 . The apparatus according to  claim 37  further comprising computer code executable by the processor that automatically communicates the received patient data to a healthcare provider via a communications network if patient data are assessed to be above a threshold severity level. 
     
     
         43 . The apparatus according to  claim 40  further comprising computer code executable by the processor that communicates information regarding medication dosage to the patient in response to determining that the patient did not comply with the medication regimen in the preceding time period.