Abstract:
A system, method and apparatus for managing a patient affected with a disease. In one aspect, the invention is directed to an apparatus for managing a patient, the apparatus comprising a system that provides: A) a means for enrolling a patient into a system including storing general information about the patient into the system&#39;s database; B) a means for storing a schedule for the patient; C) a means for reminding the patient to execute the patient care activities; D) a means for retrieving patient information comprising responses to side effects questionnaires and laboratory results; E) a means for storing the patient information into the system; F) a means for analyzing the patient information and generating a recommendation; G) a means for submitting the recommendation to a provider for approval; and H) a means for receiving approval or a modified recommendation and sending the recommendation or modified recommendation to the patient.

Description:
CROSS-REFERENCE TO RELATED APPLICATION 
   The present application claims the benefit under 35 U.S.C. §119(e) of U.S. Provisional Patent Application Ser. No. 60/615,666, filed on Oct. 4, 2004, entitled “System for Automating Management of Chronic Hepatitis C Virus Patients,” which is incorporated herein by reference. 

   BACKGROUND OF THE INVENTION 
   Chronic diseases affect around 20% of the U.S. population, which amounts to nearly 90 million U.S. residents. Medical care for persons suffering from chronic diseases accounts for over 70% of total medical care expenditures. One growing chronic disease is Hepatitis C Virus (HCV) with an estimated 4 million cases in the U.S. These numbers are projected to triple in the next 10-20 years with a projected $10.7 billion dollars spent on direct medical expenditures in the United States. 
   The medical therapies for chronic diseases are cumbersome and typically involve the use of combined pharmacological therapy with associated adverse reactions, frequent dose adjustments and extensive care and monitoring of the patient. In addition to cost of the medications, chronic disease management requires long term, on-going and frequent time commitments primarily of professionally trained staff. 
   The relatively frequent and serious adverse drug reactions associated with HCV pharmacological therapy makes the management of this disease even more complex and expensive. HCV patients require frequent interventions and a high level of support. Consequently, treatment fails 25-50% of the time. An estimated 30 % of the treatment failure can be ascribed to non-compliance and lack of nursing and medical support. In fact, it has been estimated that the lifetime cost per patient with untreated chronic HCV is around $53,000 for outpatient and hospital care. While a course of potentially curative therapy is approximately $12,000. 
   Thus, an automated disease management program designed to facilitate chronic medical therapy is of paramount importance today. By decreasing cost and streamlining human resources, such a program eliminates many of the issues described above. 
   SUMMARY 
   The invention features systems and methods for consolidating and automating the necessary patient care activities performed by various medical staff members. 
   Certain aspects of the present disclosure are directed to systems and methods for managing a patient. In one exemplary embodiment, the automated system develops a schedule for the patient, wherein the schedule determines an execution date for patient care activities. Based on the schedule, the system reminds the patient or a third party to execute the patient care activities, which results in the generation of patient information. The system retrieves and stores the patient information into the system. After analyzing the patient information, the system generates a recommendation based on the patient information thus analyzed. The system sends the recommendation to the provider and the patient for review, approval or modification. The foregoing process may be iterated multiple times, for example, throughout the entire treatment of the patient. In some embodiments, system retrieves a modified recommendation from the provider, where the provider rejects the recommendation thus submitted. The system sends the modified recommendation to the patient. 
   In various embodiments, the recommendation is of critical status, which results in the notification being sent to the provider in real-time. In another embodiment, the disclosed systems and methods answer questions that patients may have about the management of the disease. To this end, the system receives a question on disease management from the patient and matches the question with a pre-determined answer. If no match is found, then the system contacts the provider with the question and retrieves the answer from the provider. The system responds to the patient with the pre-determined answer and the provider assisted answer. 
   Further features and advantages of the instant disclosed methods and systems will become more apparent from the following Drawings, Definitions, Detailed Description and Claims. 

   
     BRIEF DESCRIPTION OF THE DRAWINGS 
       FIG. 1  provides an overview of a traditional patient management team. 
       FIG. 2  is a flow diagram of a system for managing a patient with chronic disease. 
       FIG. 3  is a flow diagram of a process for analyzing symptoms and generating recommendations. 
       FIG. 4  is a flow diagram of a process for analyzing laboratory results and generating recommendations. 
   

   DEFINITIONS 
   For convenience, the meaning of certain terms and phrases employed in the detailed description and claims are provided below. Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art. 
   
     
       
             
             
           
         
             
                 
             
             
               TERM 
               DEFINITION 
             
             
                 
             
           
           
             
               critical status 
               Patient information that requires immediate attention by a provider. 
             
             
               dosage recommendation 
               The amount of medication prescribed to a patient. 
             
             
               entity 
               A person including, but not limited to, a patient, a provider or a 
             
             
                 
               third party. More than one entity may be involved in a process, in 
             
             
                 
               which case the entities, which may be of the same or different type 
             
             
                 
               are referred to as entity 1, entity 2, etc . . . 
             
             
               execution date 
               The scheduled date for executing or performing a patient care activity. 
             
             
                 
               Certain activities may have reoccurring execution dates, such 
             
             
                 
               as once every week. 
             
             
               intervention instruction 
               An adjusted treatment instruction that is aimed at ameliorating side 
             
             
                 
               effects, and detecting and preventing potential adverse outcomes 
             
             
                 
               from an administered therapy. 
             
             
               test 
               A test conducted by a laboratory or clinic on information obtained 
             
             
                 
               from a patient that indicates symptoms and side effects. 
             
             
               medical history information 
               A collection of information concerning the patient&#39;s past and current 
             
             
                 
               health. This includes, but is not limited to, a list of previous illnesses, 
             
             
                 
               present conditions, symptoms, medications and health risk 
             
             
                 
               factors. 
             
             
               modified recommendation 
               A recommendation which has been modified by a provider. 
             
             
               patient 
               A person who suffers from a disease, an injury or condition. 
             
             
               patient information 
               Medical information about the patient, including but not limited to, 
             
             
                 
               the patient&#39;s medical history, reaction (side effects) profile to certain 
             
             
                 
               drugs, reported symptoms and side effects, test results, dosage 
             
             
                 
               recommendations, and treatment instructions. 
             
             
               patient care activities 
               Actions taken by a patient or third party to treat a disease or a side 
             
             
                 
               effect. Examples include, but are not limited to undergoing tests, 
             
             
                 
               visiting a provider for a follow-up check, or answering a weekly 
             
             
                 
               questionnaire on side effects. 
             
             
               provider 
               A healthcare professional who provides healthcare services to a patient, 
             
             
                 
               including but not limited to a physician, a physician&#39;s assistant, 
             
             
                 
               and an advanced practiced registered nurse. 
             
             
               question on disease 
               A question being asked by a patient or a third party regarding the 
             
             
               management 
               disease, the symptoms, the side effects, the dosage recommendations, 
             
             
                 
               the treatment recommendations, the intervention instructions, 
             
             
                 
               and the administration of any patient care activity. 
             
             
               recommendation 
               An instruction to the patient about the execution of a patient care 
             
             
                 
               activity, such as providing the dosage amount for the drug, adjusting 
             
             
                 
               the dosage schedule, instructions on the administration of the 
             
             
                 
               treatment, providing an intervention for minimizing side effects, 
             
             
                 
               recommending more tests. 
             
             
               rule 
               A pre-determined set of algorithms for evaluating patient information. 
             
             
                 
               For example, a rule may represent the thought processes that a 
             
             
                 
               provider undergoes in evaluating and ameliorating side effects in a 
             
             
                 
               patient. 
             
             
               schedule 
               Dates for various patient care activities, such as routine follow-up 
             
             
                 
               visits, tests, injections of the drug therapy, and phone calls asking 
             
             
                 
               the patient to answer a questionnaire of side effects. 
             
             
               side effect 
               A reaction that is experienced by a patient and is associated with a 
             
             
                 
               particular drug or therapy, including but not limited to chest pains, 
             
             
                 
               depression, weight loss, diarrhea. 
             
             
               side effect questionnaire 
               A patient interview which reviews symptoms and side effects experienced 
             
             
                 
               by the patient. 
             
             
               symptom 
               Any sensation or change in bodily function that is experienced by a 
             
             
                 
               patient and is associated with a particular disease. 
             
             
               therapy 
               Any measure taken to treat a disease, including but not limited to 
             
             
                 
               the administration of drugs. 
             
             
                 
             
           
        
       
     
   
   DETAILED DESCRIPTION 
     FIG. 1  illustrates a traditional team for managing a patient  100  affected by a disease. The patient  100  receives a form of therapy to treat the disease and undergoes periodic tests in order to monitor her symptoms and side effects. 
   For example, a patient affected with the hepatitis C virus (HCV) receives weekly injections of the drug peginterferon and daily doses of oral anti-viral medications, such as ribavirin. She must have blood work done initially every two weeks in order to monitor her symptoms and side effects. The therapy may cause the patient to suffer from low white blood cell count (or leukopenia) and/or low immature white blood cell count (or neutropenia), both of which increase the patient&#39;s risk for infection. She also may suffer from low red blood cell count (or anemia), which results in weakness, shortness of breath, and various cardiac symptoms. Thrombocytopenia (or low platelet count) is another side effect of the therapy that increases the risk of bleeding. Thus, the severity and frequency of the side effects demand frequent monitoring of the patient&#39;s laboratory values and symptoms. Other side effects from using peginterferon may include depression, rash, fever, coughing and other flu-like symptoms. 
   Typically, patient  100  self-administers the therapy at home. In some instances, a third party member  110 , such as a family member or a home health nurse, administers the therapy. A nursing staff  115  from the clinic usually educates patient  100  and/or third party member  110 , about the proper administration of the therapy. Nursing staff  115  is also responsible for the education about the disease itself, the treatments and the potential side effects. Any need for continued or re-education is done by nursing staff  115  either in the clinic or over telephone. 
   In order to monitor her symptoms and side effects, patient  100  is required to have tests conducted at the clinic or laboratory  120 . The results from the test are sent to provider  125  for review. Provider  125  may be a physician, a physicians&#39; assistant and an advanced practice registered nurse. After provider  125  reviews the laboratory results, she or one of her staff members relays the results to patient  100  either via telephone, e-mail or in person. Provider  125  may contact patient  100  in order to adjust or discontinue the therapy based on the laboratory results and the patient&#39;s medical history. The urgency of the information usually dictates how quickly patient  100  is contacted. 
   In addition to testing for laboratory values, provider  125  also monitors the patient&#39;s various symptoms, or reactions to the therapy. Generally, provider  125  learns of these symptoms during routine follow-up visits or routine phone interviews with the patients. In the case of severe side effects, patient  100  may call nursing staff  115  or provider  125  before scheduling a follow-up visit. Based on these reported symptoms, provider  125  may adjust the dosage and/or discontinue the treatment. 
   Provider  125  may prescribe adjunct therapies to treat some of the symptoms as well. For example, in the example described above, a provider may prescribe erthropoietin to in order to treat for anemia in the patient; or she may prescribe filgrastim for treating leucopenia/neutropenia in the patient. In cases where adjunct therapies are prescribed, the patient&#39;s laboratory values are monitored more frequently than usual. Dosage adjustments for the adjunct therapies are based on the laboratory values, the side effects and the past medical history of the patient. 
     FIG. 1  also depicts a case manager  130  who coordinates all aspects of the patient&#39;s care. As such, the case manager  130  interacts with all members of the management team. As seen above, a need arises for an inexpensive and efficient system for managing patients with chronic diseases.  FIG. 2  is a flow diagram of process  200 , which automates the management steps. 
   As shown in  FIG. 2 , process  200  enrolls ( 202 ) a patient with a chronic disease into the system. During the enrollment process ( 202 ), information about the patient, as well as information about the provider, medical staff, laboratory facility and pharmacy are stored into the system&#39;s database. Patient information may include, but is not limited to medical history, contact information, family history, and allergic reactions. Likewise, laboratory information may include whether an electronic interface exists for the facility. An electronic interface enables a laboratory facility to send the results directly to the system. Where no electronic interface exists, a system for manually inputting the results must be established. In addition, contact information for each of the parties is established during enrollment ( 202 ). In particular, each provider is asked to specify her preferred method of external communication, e.g. pager, cellular phone, facsimile and short message service. This ensures that the system can effectively deliver an urgent message to the provider in the event of an emergency. 
   After enrolling ( 202 ) the patient, process  200  develops ( 204 ) a schedule for routine laboratory work, periodic patient contacts for side effect profile questionnaires, and regular injections and appointments. Throughout the patient&#39;s entire treatment course, process  200  repeatedly inquires ( 206 ,  208 ,  210 ) whether information is available for each of these schedule events, respectively. At any given point in time, a patient may respond affirmatively or negatively to all or some of the inquires. For example, she may have both laboratory results and a schedule side effects questionnaire simultaneously; or she may have only laboratory results, but no schedule side effects questionnaire. 
   In one embodiment, process  200  determines ( 208 ) whether any laboratory results, such as blood work or urine samples, are available for processing. If laboratory results are available, process  200  retrieves ( 212 ) and stores ( 214 ) the laboratory results into the system. 
   Process  200  determines ( 216 ) whether the laboratory results require an urgent alert to provider  125 . For example, in the case of critically abnormal lab values, process  200  immediately alerts ( 218 ) provider  125 , in real-time, with an urgent message. Using a decision tree capable of intelligently triaging each alert, process  200  alerts ( 218 ) the appropriate medical staff member with the urgent results. As described above, the system has asked each provider, in advance, to specify her preferred method of external communication. After alerting ( 218 ) the provider, process  200  allows provider  125  to take over the situation. 
   For non-urgent laboratory results, process  200  sends the laboratory results to subprocess  300 , which analyzes the laboratory results and generates recommendations based on the results. 
   As shown in  FIG. 3 , sub-process  300  applies ( 302 ) a pre-established set of algorithms and rules to the laboratory results, and calculates ( 304 ) recommendations, or dosage adjustments and intervention instructions, based on the laboratory results. The guidelines for these dose adjustments are established by the pharmaceutical companies and medical organizations that recommend the standards of care. Some examples include the National Institute of Health (NIH) and American Association for the Study of Liver Disease (AASLD). 
   Sub-process  300  submits ( 306 ) the recommendations to the provider  125  and inquires ( 308 ) whether the provider approves of the recommendation. Upon the provider&#39;s approval, the recommendations are sent ( 314 ) to the patient  100  and then submitted ( 310 ) back to process  200 . However, where the provider rejects the recommendation, subprocess  300  requests ( 312 ) that the provider modify the recommendations and then submits ( 314 ) the modified recommendations to the patient  100  and then sends ( 310 ) the recommendations back to process  200 . 
   Referring back to FIG.  2 ., process  200  stores ( 220 ) the recommendations and/or modified recommendations from sub-process  300  into the system. Process  200  then inquires ( 222 ) whether a side effect questionnaire is due for the patient. The side effect questionnaire describes the symptoms experienced by patient  100  while using the therapy. The frequency at which the side effect questionnaire is requested differs for each patient. For example, a patient using both the therapy and various adjunct therapies may require a weekly monitor, whereas a patient suffering from a mild form of the disease may require only a monthly monitor. 
   Where no side effect questionnaire is scheduled at that particular time, process  200  updates ( 224 ) the electronic medical record that is stored in the system with the new lab results, symptoms, dosage adjustments and intervention instructions. Throughout the entire treatment course, process  200  is repeated as often as deemed necessary by provider  125 . 
   However, if process  200  determines ( 222 ) that a side effect questionnaire is available for patient  100 , then process  200  contacts ( 226 ) the patient with questions from a side effects questionnaire. The side effects questionnaire contains specific questions directed at analyzing the patient&#39;s various symptoms. The questions are specific to management of the disease and the patient&#39;s co-morbidities. This side effects questionnaire is modeled after typical questions asked by providers during routine follow-up visits, thus each questionnaire may vary depending on the particular provider taking care of the patient. After patient  100  responds to questionnaire, process  200  retrieves ( 228 ) the questionnaire and stores ( 230 ) the information into the system. 
   Process  200  then forwards the questionnaire answers to sub-process  400 , which analyzes and generates recommendations based on the patient&#39;s symptoms.  FIG. 4  illustrates sub-process  400 , which applies ( 402 ) a pre-established set of algorithms and rules to the patient&#39;s various symptoms. Each known symptom of the therapy is assigned a particular pre-determined algorithm. For example, in the case of the drug peg interferon, which is used for the treatment of HCV, some common side effects include chest pains, depression and anemia. As detailed below, each of these symptoms is analyzed according to a particular set of algorithms. 
   Sub-process  400  applies ( 402 ) the appropriate algorithm by inquiring ( 404 ) into the specifics of the symptoms, i.e. parameter questions. For example, a patient may indicate that she is suffering from weight loss and/or anorexia (or the abnormal loss of appetite for food). As a result, sub-process  300  inquires ( 404 ) as to the amount of weight lost, e.g. greater than 10%, between 5% and 10%, or less than 5%. Based on these responses to these questions, sub-process  400  then calculates ( 406 ) the recommended dosage adjustments and intervention instructions for the patient. Sub-process  400  sends ( 408 ) the recommendations to patient  100 . 
   In another embodiment, a patient may experience chest pains. Here, sub-process  400  inquires ( 404 ) as to the severity of the pain on a scale from 1 to 10. A selection of a number from 1 to 4 indicates mild pain, whereas a selection of a number from 5 to 7 and 8 to 10 indicates, respectively, moderate and severe pain. Sub-process  300  also inquiries ( 404 ) about various coronary artery disease (CAD) factors, as well as the patient&#39;s age and gender. In addition, sub-process  400  may inquire ( 404 ) as to external reactions such as anemia, infections and fevers. Based on these responses to these questions, sub-process  400  determines ( 406 ) the recommended dosage adjustments and intervention instructions for the patient. Sub-process  400  then sends ( 408 ) the recommendations back to patient  100 . 
   Sub-process  400  may be applied to any number of symptoms, including but not limited to nausea, vomiting, diarrhea, depression, dyspnea/coughing, aggression, irritability, visual changes, and other flu-like symptoms. 
   After submission ( 408 ) of the recommendations to patient  100 , sub-process  400  sends ( 410 ) the recommendations to the provider  125  and inquires ( 412 ) whether the provider approves of the recommendation. Upon the provider&#39;s approval, sub-process  400  coordinates the modified recommendations with the recommendations based on the laboratory results, and submits ( 414 ) the coordinate recommendations back to process  200 . 
   Where the provider does not approve of the recommendation, sub-process  400  requests ( 416 ) that the provider modify the recommendations. The provider may contact ( 418 ) the patient  100  about these modifications by either calling patient  100  directly, or leaving a message for patient  100  on the system. Sub-process  400  reconciles the modified recommendations from sub-process  400  with the recommendations derived from sub-process  300 , and submits ( 414 ) the reconciled recommendations back to process  200 . 
   Referring back to  FIG. 2 , process  200  determines ( 232 ) whether the recommendations require an urgent alert to provider  125 . As described above, if process  200  detects an urgent message, it alerts ( 234 ) the appropriate medical staff member with the results. As described above, the system has asked each provider, in advance, to specify her preferred method of external communication. After alerting ( 234 ) the provider, process  200  stores ( 236 ) the recommendations into the system. Process  200  updates ( 224 ) the electronic medical record that is stored in the system with the new lab results, symptoms, dosage adjustments and intervention instructions. Throughout the entire treatment course, process  200  is repeated as often as deemed necessary by provider  125 . 
   Process  200  also determines ( 210 ) whether patient  100  has an upcoming follow-up visit, a laboratory appointment or a scheduled therapy injection. Process  200  sends ( 238 ) reminder notifications regarding each of these appointments to patients  100 . Reminder notifications may also be sent ( 238 ) to medical staff in order to remind them of pending items. In the preferred embodiment, the system notifies each patient in her preferred language, e.g. English, Spanish, Creole or Chinese. 
   In addition, process  200  may determine the adequacy of the patient&#39;s medical supply. The system contains information regarding the pharmacies used by the patient, provider and clinic. If a refill is deemed necessary, process  200  generates a refill request and sends the refill request directly to the pharmacy for further processing. In some embodiments, process  200  generates and submits laboratory and/or radiology requests to corresponding imaging and radiology departments as well. 
   At any point during process  200 , patient  100  may contact the system in order to listen to instructions, learn about lab results, report a new side effect (in advance of a scheduled profile questionnaire request), report a medication refill or record an ad lib message. In addition, patient  100  may obtain educational information regarding various aspects of the treatment, such as the disease, therapy, proper administration of the drugs, proven complimentary therapies, medications and medication side effects by contacting the system as well. A pre-determined set of answers addressing commonly asked questions is available to patient  100  through the system. Questions that cannot be handled by the system are forwarded to an appropriate medical staff member. The staff member may record on the system a response to the patient&#39;s query, which is then relayed to the patient. 
   In some embodiments, the system incorporates a round-the-clock system maintenance, redundancy and surveillance in order to quickly identify any malfunctions. In the case of a malfunction, the patient&#39;s care team is alerted immediately, and the care team resumes any direct patient care. 
   Equivalents 
   The methods and systems described herein are not limited to the specific formats set forth above. Elements of different implementations may be combined to form other implementations not specifically described above. Other implementations not specifically described herein, may be ascertain by those of skill in the art using no more than routine experimentation and are within the scope of the following claims. 
   Although the present invention has been described in the context of HCV treatment, various other chronic diseases, such as HIV and diabetes, may be treated by the system as well. For example, the system may monitor a cohort of patients using a study drug, which requires frequent checking of adverse drug reactions and patient status. In another example, the system monitors patients on chemotherapy and require close monitoring of her symptoms and laboratory values.