Abstract:
A process that facilitates patient treatment management by allowing users to adhere to guidelines, best practices and medical procedures. For each individual patient the process software automatically recommends individualized treatment plans, medical tests that should be carried out, deviations or exceptions to recommended treatments and medical or clinical trials that the patient may be eligible to take part in. The process software will monitor and display in real time all patients being treated by a physician or at a hospital, surgery, clinic or other institution and display at what stage, test, specialty or procedure, or treatment each patient is currently located along a particular guideline, best practice or medical procedure and the cost included either at each stage or so far in the treatment path. The process software will also monitor and display for individual patient and in a consolidated manner financial, user and administrative information in real time.

Description:
CROSS REFERENCE TO RELATED APPLICATIONS 
       [0001]    This application claims priority from U.S. Provisional Patent Application Ser. No. 62/022,860 which was filed on Jul. 10, 2014, and U.S. Provisional Patent Application Ser. No. 62/055,383 which was filed on Sep. 25, 2014, the entire contents of which are expressly incorporated by reference herein. 
     
    
     BACKGROUND OF THE INVENTION 
       [0002]    The present invention relates to the field of medical treatments and, more specifically, to predicting treatment efficacy and determining optimal treatment for any illness, disease or abnormality. This invention also relates to interactive methods for delivering information to a healthcare provider which motivates him to take action and facilitates such action which will improve a healthcare consumer&#39;s compliance with desired best practice health care protocols. 
         [0003]    Healthcare providers spend significant amounts of time outside of seeing their patients to learn how to use new tools, and reviewing relevant cases to their practice in assessing, diagnosing, planning, and/or preparing for performing a treatment for their patients. However, once in the surgical or diagnostic suite, or other facility or location where the treatment is to be performed, the health care provider is largely left to relying on his or her own memory to effectively use the many tools at his or her disposal during the treatment. The health care provider may often encounter unexpected developments or complications during the treatment that may not have been anticipated prior to beginning the treatment. For example the treatment for breast cancer follows a complex pathway of actions with progress to the next treatment based on multiple factors and pre-determined trigger points. The latest treatment ‘flow diagram’ by National Comprehensive Cancer Network (NCCN) covers approximately one hundred and twenty nine pages and it is therefore difficult for attending physicians to monitor the treatment of a patient as they progress through the treatment because it is not at all easy to memorize and apply the guidelines in totality. There are electronic/web based versions of the NCCN guidelines in existence. However, these tend to be limited to online reference guides and do not automatically map the patient to the required treatment based on the latest clinical diagnosis, test results and previous treatments. 
         [0004]    Guidelines developed by government, medical and professional groups, NIH and other entities are designed to reduce unnecessary testing and workup, overtreatment with unproven interventions, under treatment in some cases. Such failures are estimated to cost our society upward of a trillion dollars in wasteful care and provide suboptimal and occasionally harmful treatments. Large amounts of medical research support the concept that guideline compliance creates better value by reducing waste and higher quality of care. 
         [0005]    Such guidelines are not readily available to the clinician at the “bedside” or available in a format that does not allow seamless integration into the daily delivery of healthcare. 
         [0006]    The delivery of interdisciplinary healthcare requires collaboration among different specialties and handoffs as patient transition from one modality of treatment to the next is frequently weak points where patients are lost to follow up without completing the prescribed treatment. 
         [0007]    Managers, program leaders and physician leadership cannot effectively monitor compliance with accepted guidelines in their organizations. Retrospective quality studies will simply show poor compliance without in time ability to intervene. 
         [0008]    The problem identified above has not been solved to-date in an effective and accurate manner. 
         [0009]    The limitations and the non-cost effectiveness of prior art are overcome by the instant invention as described below. 
       BRIEF SUMMARY OF THE INVENTION 
       [0010]    This invention at first creates a searchable, dynamic and rule based database. This database is at first created with the help of pathway of best practice guidelines made available by reliable organization, mainly government bodies, medical institutions, professional associations or not for profit organizations. The guidelines which are prescribed by the government and other entities are there usually in “PDF” format. 
         [0011]    The solution will be designed as a web application accessible by recent versions of the major browsers (IE, Chrome, Safari, Firefox, etc.). The application could be either hosted on a Cloud or tradition server by a third party specialist hosting supplier like Amazon, RackSpace or EasySpace or on any internally hosted Window Server. The Solution will be designed using a mature architecture implementing best patterns and practices to ensure a robust and scalable outcome. The solution will be based on SaaS (Software as a Service) architecture. This will allow a single installation of the application on a secure server while allowing different tenants (hospitals/etc.) to subscribe to the service and run autonomously of each other. Each tenant will be able to manage their own branding (how the application will look) and users (doctors) account permissions. Doctors will be able to create and manage a patient treatment case from beginning to end. 
         [0012]    All pathway steps, next steps, rules, clinical conditions and next treatment options are manually entered into a searchable, dynamic and rule based database. Interaction with the database created originates with the original diagnosis of the physician. The health care provider enters the specific diagnosis. For example the health care provider must enter predetermined fields encompassing critical medical information such as type of tumor, size, ER/PR positive, and other key information for example for breast cancer. 
         [0013]    Once the relevant information is entered by the health care provider, the instant invention displays a visual and/or text representations of the previous and next treatment steps or options as recommended by the guideline and for each patient and the location of the patient on the entire pathway or on a specific section of the pathway in a visual manner utilizing flow diagrams or other visual methods or charts. 
         [0014]    The health care provider utilizes the information provided to him by the instant invention and decides what step is to be followed for the treatment of the patient. The health care provider is at liberty to follow the suggestions made by the invention or ignore it on the basis of his/her personal knowledge, available resources and patient factors. The instant invention intelligently records the choices made by the health care provider in order to improve the database continuously. The instant invention may also link directly to third party databases which may help in automatically identifying patients suitable for certain clinical trials based on the diagnosis provided by the healthcare professional. 
         [0015]    It is the objective of the instant invention to create a process which can effectively and intelligently help health care providers to utilize the guidelines applicable to any treatment. It will also allow program leaders and/or managers to have an overview of the flow of multiple patients in their program and measure overall and individual provider&#39;s compliance with these guidelines. Guidelines and best practices recommend reasonable options to the provider. Our product allows for organizations and institutions to create or adopt certain guidelines as restrained by local availability of resources and identified needs. 
         [0016]    Our solution will also recommend clinical trials that are available to patients. Clinical trials available in a certain program or in the community would be entered in the database including eligibility criteria. 
         [0017]    These and other features, objects and advantages of the present invention will be readily apparent to persons of ordinary skill in the art upon reading the entirety of this disclosure, which includes the accompanying drawings and claims. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0018]      FIG. 1  shows an example of an initial diagnosis screen. 
           [0019]      FIG. 2  shows an example of a pathway location screen. 
           [0020]      FIG. 3  shows an example of a physician&#39;s consolidated patient view. 
           [0021]      FIG. 4  shows an example of detailed information for an individual patient&#39;s medical history. 
           [0022]      FIG. 5  shows an example of patients at points along the pathway. 
           [0023]      FIG. 6  shows an example of a view for tracking user and financial revenue information. 
           [0024]      FIG. 7  shows an example of all changes made to the system. 
           [0025]      FIG. 8  shows an example of consolidated information on test results. 
           [0026]      FIG. 9  shows an example of a secure and confidential database of patient demographics and identifying information. 
           [0027]      FIG. 10  shows an example of a module which allows a physician or nurse or other user to enter test results. 
           [0028]      FIG. 11  shows an example of an individual patient&#39;s progress along the relevant pathway. 
           [0029]      FIG. 12  shows another example of an individual patient&#39;s progress along the relevant pathway. 
           [0030]      FIG. 13  shows an example of a view of all tests that have taken place for each individual patient, the result of the test, the time and date of the test. 
           [0031]      FIG. 14  shows an example of a view of license tab. 
           [0032]      FIG. 15  shows an example of an owner&#39;s view of all users with access to the system. 
           [0033]      FIG. 16  shows an example of a view of the audit trail to track changes to each patient&#39;s record. 
           [0034]      FIG. 17  shows an example of user maintenance, access permissions and password details. 
           [0035]    The  FIGS. 18   a  and  18   b  shows an example of an interface to allow for editing the underlying database of guidelines or treatment best practices. 
           [0036]      FIG. 19  shows an example of a physician&#39;s view of each patient. 
           [0037]      FIG. 20  shows an example of a database editing interface. 
           [0038]      FIG. 21  shows an example of an individual patient details screen. 
           [0039]      FIG. 22  shows an example of a display of each visit by a patient. 
           [0040]      FIG. 23  shows an example of a view of messages sent to clients by owner or administrator. 
           [0041]      FIG. 24  shows an example of a display of patient&#39;s insurance details and lead physician attending each patient. 
           [0042]      FIG. 25  shows an example of a nurses tab. 
           [0043]      FIG. 26  shows an example of another consultants tab. 
           [0044]      FIG. 27  is a representation of the AMAL portal according to an embodiment of the invention. 
           [0045]      FIG. 28  is a representation of a treatment workflow according to an embodiment of the invention. 
       
    
    
     DETAILED DESCRIPTION OF THE INVENTION 
       [0046]    In the present disclosure, numerous specific details are provided, such as examples of module, components, and method, to provide a thorough understanding of embodiments of the invention. Persons of ordinary skill in the art will recognize, however, that the invention can be practiced without one or more of the specific details. In other instances, well-known details are not shown. 
         [0047]    The first step in the process is to create a dynamic, searchable and rule based database with the help of guidelines provided by the government organizations. The database is created by manually entering the information provided in the guideline. In the instant disclosure NCCN guidelines for the treatment of breast cancer has been taken as an example, though it must be understood that the invention is in no way restricted to the NCCN guideline. 
         [0048]    The NCCN guidelines for the treatment of breast cancer which are provided in a pdf form are entered into a database manually are entered into the database manually and a rule based mathematical formula is created to ensure that next treatment options are only recommended when prerequisite conditions have been met. Third party clinical trials database is also created or is linked to publicly available databases directly. The database so created is a searchable so that the relevant patient information can be matched and results can be generated in accordance with the instant invention. In the same manner third party clinical trial database is also created. 
         [0049]    The  FIG. 1  shows the diagnosis screen whereby specific details on patient condition, tumor size, status and stage are entered. The initial screen the user, typically a physician, will utilize upon primary consultation with a patient. The user mainly a health service provider inputs the medical history, test results and current diagnosis into the system. Underlying this module will be the relevant treatment pathway or guideline, which has been digitized and coded into a dynamic database, which ensures that the diagnosis input fields are able to identify the relevant position on the treatment pathway. A module that allows the user to input patient information, medical history, test results and create a diagnostic workup and treatment plan in addition to displaying an overview of the patient&#39;s progress along a treatment plan. 
         [0050]    The  FIG. 2  shows the pathway location screen whereby a patient is placed on the correct coordinates on the treatment pathway. This screen is the output from the detailed clinical diagnosis entered into the process software and allows for the system to overlay the patients current condition onto the correct treatment recommended as specified in a treatment guideline or best practice (for example such as the NCCN guidelines on great cancer treatment or other treatments). The eligibility criteria from relevant clinical trials are entered into the underlying database or linked directly to relevant open source third party clinical trial databases which ensure that should a diagnosis match the required pre requisite conditions for a relevant clinical trial the user may enter a patient automatically into such medical or clinical trials. This solution ensures that users (such as the supervising physician or other users) can ratify all next treatment step recommendations electronically. A user may choose not to follow the recommended step. However, the system will prompt the user to input justification for any deviation to the recommended treatment. All deviations from the recommended treatment will be recorded and consolidated to allow for further analysis to determine any reasons for deviation trends and whether improvements to the underlying guidelines are required and whether the pathway or treatment guideline owner needs to be informed of any deviations or anomalies. The process software will position the patient at the most relevant point on a treatment pathway based on the patient&#39;s current condition, medical history and test results. 
         [0051]    The  FIG. 3  shows a physician&#39;s consolidated patient view. The user can view a detailed record of the treatment history, test results, clinical trial eligibility and possible next treatment options for ratification by the physician for each patient. Maintain a record and create alerts for guideline deviation and noncompliance to treatment best practice or guidelines. This module ensures that the user is automatically informed of all test results and treatment results for each patient. Patients that have recently undergone a procedure or test by a third party specialist or nurse will appear in this section and the supervising physician will have the ability to accept or reject any results for each individual patient. The user has the ability to transfer a patient including all details on medical history and test results to another physician or medical institution, hospital or other organization. 
         [0052]    The  FIG. 4  shows detailed information for an individual patient&#39;s medical history. The user can view, in real time, detailed medical history information for each patient, previous test results and the next recommend treatment options along the treatment guideline or pathway. The user can scroll back to view the medical history and access individual diagnosis or test results for each individual patient. Test results may be entered directly into this screen by a user which will automatically identify and recommend the next treatment step by searching the underlying relevant treatment pathway or guideline, which has been digitized and coded into a dynamic database, which will identify the relevant next treatment step. 
         [0053]    The  FIG. 5  shows patients at points along the pathway. The process software allows users to view in real time an overview of the process, treatments, test results and other medical information in order to position patients at the correct point on the guidelines, pathway or best practice treatment stages. The ability to view all patients currently undertaking treatment at any point along the pathway can be overlaid upon the pathway is also there. The user will be able to zoom in or out to view the pathway in greater detail or for a high level perspective. Patient&#39;s position will be maintained at the correct point on the pathway at any zoom level. Scrolling over or clicking on a group of patients will open further screens with more detailed patient information and medical history. Patients or groups of patients that are following the treatment as per the guidelines appear in green, the patients or groups of patients that are deviating from the treatment guidelines will appear in red and should a group of patients at a particular node consist of both on track and off track with respect to treatment guidelines the highlight report will appear in amber. This solution allows users, institutions or entities to view in real time at what treatment stage any patient under their care is currently located. This also allows the identification of over and underutilization of resources needed to carry out medical tests, treatments or procedures and to allow for effective resource allocation and planning and the supervising physicians can manage the treatment progress of multiple patients by graphically demonstrating at what stage all patients under their care are currently positioned. 
         [0054]      FIG. 6  shows view for tracking user and financial revenue information. Owners of this product, overall users or administrator&#39;s dashboard view for tracking user and financial revenue and expenditure information. The users (such as administrators) will be able to view in real time detailed information on revenue, users and patients. Information can be displayed in a time specific manner on a monthly, quarterly or annual basis. A management module evaluates and displays financial information and treatment information on an individualized basis or in a consolidated manner for any group of patients, users, institutions or procedures. The management module shows the total number of clients (e.g. doctors, medical institutions, other), revenue generated, expenditure, total number of patients registered on the system and in ongoing care, most active users, and other management, user, patient and financial information. 
         [0055]      FIG. 7  shows all changes made to the system with the ability to search by date or by keyword. Here the user can search and filter the whole system with the help of keywords. 
         [0056]      FIG. 8  shows consolidated information on test results. Data input from  FIG. 4  and consequently  FIG. 10  will be automatically updated in this screen for each individual patient. Test results for an individual patient are displayed by date and displayed in a graphical manner to assist with interpretation of the data. A consolidated view of all test results can be displayed. Test results for an individual can be forwarded to other physicians or medical institutions. The cost of a specific medical test or treatment can be associated with each test type to provide the user with a visual representation of the cost per test and ongoing cost incurred for a given patient as they progress through the specific treatment path. 
         [0057]      FIG. 9  shows secure and confidential database of patient demographics and identifying information. Individual patient data once entered can be displayed in a consolidated manner whereby the user can select an individual patient row to edit patient information, remove a patient, transfer a patient to another institution or to delete or archive patient (removes the patient from the consolidated views but does not delete the data completely) information. Editing or changing patient information is password protected and all changes are tracked to ensure a proper audit trail is maintained. This module allows search and filter function. 
         [0058]      FIG. 10  shows a module which allows a physician or nurse or other user to enter test results. User will enter the date, time and information related to a specific test that has been carried out at the request of the supervising physician. Data entered on test results is automatically updated to the individual patient&#39;s medical history and triggers the next recommendation along the pathway based on the pre-determined criteria. The supervising physician is notified automatically of the test result that is input here and provided with the next most suitable treatment options. 
         [0059]      FIG. 11  shows an example of an individual patient&#39;s progress along the relevant pathway. 
         [0060]      FIG. 12  shows another example of an individual patient&#39;s progress along the relevant pathway. A user may view detailed information on the current status of the patient, the position on the treatment pathway, any test results, a record of the vital signs that may have been taken in the past, the original diagnosis and the physicians that are attending this patient. 
         [0061]      FIG. 13  shows a view of all tests that have taken place for each individual patient, the result of the test, the time and date of the test. The cost of each test can be associated with each treatment or test to provide a financial summary of the costs incurred so far each patient based on the treatment or test that has been carried out and the cost of carrying out such a test. 
         [0062]      FIG. 14  shows the view of license tab of the owners or this product or administrators view of the license types and pricing offered to clients of the product based on this invention. Product owners will be able to view or modify the price, and terms of use for each individual client. The product owners will be able to view all clients using the system, any special terms that have been agreed with the client, the costs of the service the client has agreed to pay and the expiry period of any agreement. Owners or administrators can edit the terms of use with the necessary access rights. Client contact information is recorded to allow for automatic reminders to be sent to users prior to the expiration of any user agreement and to automatically facilitate the renewal of service. 
         [0063]      FIG. 15  shows owner&#39;s view of all users with access to the system. Owners or administrators can suspend an institution or other organization or edit contact details with respect to maintenance of the user agreement (contact details etc.). 
         [0064]      FIG. 16  shows the view of the audit trail to track changes to each patient&#39;s record. All changes to a patient&#39;s record will be logged and details of the change recorded. This will also include name of the person changing any information, time, date and description of the change. This tab also has the search/filter function. 
         [0065]      FIG. 17  shows user maintenance, access permissions and password details. This displays users including different levels of access and rights. The ability to reset passwords for individual users is also provided along with Contact details for individual users. The ability to send mass emails to notify users of system related updates or changes along with the ability to set access rights to individual users in order to perform or restrict users from specific tasks is also there. For example users categorized as ‘admin’ would not be able to input test results. A search/filter function to allow for swift navigation is enabled. 
         [0066]    The  FIGS. 18   a  and  18   b  shows an interface to allow for editing the underlying database of guidelines or treatment best practices. This interface allows modification of guidelines or best practices based on the emergence of new information or studies, changes in the philosophy of care and availability of resources. Any changes to the underlying database are sent for ratification prior to a system wide upgrade. The user may view the proposed change to the database and may reject it or accept or propose changes. Utilizing existing user contact details any changes to the treatment guidelines or best practices in the database can be forwarded automatically to physicians. 
         [0067]      FIG. 19  shows a physician&#39;s view of each patient. The physician may view for each patient a detailed summery of vital signs, diagnosis test treats and any treatment that has taken place. Multiple diagnoses can be shown with the date that each diagnosis took place. 
         [0068]      FIG. 20  shows a database editing interface to allow access to multiple pathways that may be supported on the product. A searchable database of any guidelines and/or best practices many be edited, including but not limited to guidelines and best practices published by governments, medical institutions, associations or private entities and individuals e.g. NCCN guidelines for breast cancer care. 
         [0069]      FIG. 21  shows an individual patient details screen. A display of each patient and the institution at which treatment is taking place is there in this interface. A user may transfer a patient and all relevant patient history stored on the system to another institution. 
         [0070]      FIG. 22  shows a display of each visit by a patient. This interface allows the user to input any vital medical information such as blood pressure, heart rate and other measures for record keeping purpose. 
         [0071]      FIG. 23  shows Owner or administrator&#39;s view of messages sent to clients. By virtue of this function updates may be sent to multiple clients to inform about system updates, upgrade and changes. This interface also has records of all messages sent in the past. 
         [0072]      FIG. 24  shows a display of patient&#39;s insurance details and lead physician attending each patient. This interface allows hospitals, medical institutions and other organization to ensure that all patients under their care are correctly recorded with key medical staff, insurance details and other important information is recorded for billing and cost tracking and allocation purposes. A medical institution or other organization can monitor the patient under the care of each lead physician and any insurance or cost details under each physicians care. 
         [0073]      FIG. 25  shows a display that allows support staff to be allocated to particular patient which in turn permits the entry of relevant details to each patient&#39;s record. For example blood pressure or vital signs. Once a nurse or other support staff is allocated to a particular patient they will be automatically notified of any pending tasks or requests scheduled in the future with respect to this patient. Hospitals, medical institutions and other organizations can monitor resource allocation to patients to ensure that over or underutilization is minimized. A consolidated view with analytical data such as ratios of number of staff to patients can be produced in real time. 
         [0074]      FIG. 26  shows a display that allows specialist physicians to be allocated to particular patient which in turn permits the allocated staff member to input relevant diagnostic details to each patient&#39;s record. Once a physician is allocated to a particular patient they will be automatically notified electronically of any pending tasks or requests scheduled in the future with respect to the particular patient. Hospitals, medical institutions and other organizations can monitor resource allocation to patients to ensure that over or underutilization is minimized. A consolidated view with analytical data such as ratios of number of staff to patients can be produced in real time. This allows and provides for collaboration among different medical specialists and types of providers improving coordination of patient care. This interface can monitor resource allocation to patients to ensure that over or under utilization of specialists, equipment, employees and investment is minimized. The process software will ensure adherence to recognized guidelines and best practices to eliminate a reduction in inappropriate, ineffective or costly medical tests and procedures thereby providing targeted treatment plans for each patient and allowing healthcare providers to maximize the resources available for the benefit of a greater number of patients. 
         [0075]    This invention may be designed as a web application accessible by internet browsers or similar platforms. The application could be either hosted on a Cloud or tradition server by a third party specialist hosting supplier like Amazon, RackSpace or EasySpace or on any internally hosted Window Server. The instant invention will be based on SaaS (Software as a Service) architecture. This will allow a single installation of the application on a secure server while allowing different tenants (hospitals/etc.) to subscribe to the service and run autonomously of each other. Each tenant will be able to manage their own branding (how the application will look) and users (doctors) account permissions. Doctors will be able to create and manage a patient treatment case from beginning to end. 
         [0076]    This invention may be used in non-medical discipline when best practices are to be used or where complex guidelines are to be implemented. 
         [0077]    While specific embodiments of the present invention have been provided, it is to be understood that these embodiments are for illustration purposes and not limiting. Many additional embodiments will be apparent to persons of ordinary skill in the art reading this disclosure.