System and method for managing a patient with chronic disease

[0001] 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.

[0002] 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.

[0003] 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.

[0004] 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.

[0005] 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.

[0006] The invention features systems and methods for consolidating and automating the necessary patient care activities performed by various medical staff members.

[0007] 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.

[0008] 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.

[0009] Further features and advantages of the instant disclosed methods and systems will become more apparent from the following Drawings, Definitions, Detailed Description and Claims.

[0014] 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.

[0015]

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'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'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'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.

[0016] 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.

[0017] 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'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's laboratory values and symptoms. Other side effects from using peginterferon may include depression, rash, fever, coughing and other flu-like symptoms.

[0018] 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.

[0019] 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' 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's medical history. The urgency of the information usually dictates how quickly patient 100 is contacted.

[0020] In addition to testing for laboratory values, provider 125 also monitors the patient'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.

[0021] 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'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.

[0022] FIG. 1 also depicts a case manager 130 who coordinates all aspects of the patient'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.

[0023] 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'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.

[0024] 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'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.

[0025] 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.

[0026] 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.

[0027] 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.

[0028] 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).

[0029] Sub-process 300 submits (306) the recommendations to the provider 125 and inquires (308) whether the provider approves of the recommendation. Upon the provider'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.

[0030] 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.

[0031] 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.

[0032] 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's various symptoms. The questions are specific to management of the disease and the patient'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.

[0033] Process 200 then forwards the questionnaire answers to sub-process 400, which analyzes and generates recommendations based on the patient's symptoms. FIG. 4 illustrates sub-process 400, which applies (402) a pre-established set of algorithms and rules to the patient'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.

[0034] 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.

[0035] 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'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.

[0036] 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.

[0037] 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'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.

[0038] 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.

[0039] 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.

[0040] 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.

[0041] In addition, process 200 may determine the adequacy of the patient'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.

[0042] 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's query, which is then relayed to the patient.

[0043] 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's care team is alerted immediately, and the care team resumes any direct patient care.

[0044] Equivalents

[0045] 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.

[0046] 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.