Systems and methods of treatment using intervention and tasking determination

• US 9,996,672 B2
• Filed: 09/22/2014
• Issued: 06/12/2018
• Est. Priority Date: 09/20/2013
• Status: Active Grant

• Current Assignee: Corcept Therapeutics Inc.
• Original Assignee: Corcept Therapeutics Inc.
• Inventors: Lo, Steven, Penake, David, Lyons, John, Tully, Kate, Waidner, Katherine
• Primary Examiner(s): Le, Linh Giang
• Application Number:
  US14/493,125
• Publication Number:
  US 20150088540A1
• Time in Patent Office: 1,359 Days
• CPC Class Codes: A61B 5/4833 Assessment of subject's compliance to treatment
• CPC Class Codes: A61B 5/4848 Monitoring or testing the effects of treatment, e.g. of medication
• CPC Class Codes: A61B 5/7405 using sound
• CPC Class Codes: A61B 5/742 using visual displays A61B5/339 takes precedence
• CPC Class Codes: A61B 5/746 Alarms related to a physiological condition, e.g. details of setting alarm thresholds or avoiding false alarms alarms per se G08B
• CPC Class Codes: A61B 5/7465 Arrangements for interactive communication between patient and care services, e.g. by using a telephone network telemetry of measured physiological signal A61B5/0002
• CPC Class Codes: G06Q 10/10 Office automation; Time management
• CPC Class Codes: G16H 10/60 for patient-specific data, e.g. for electronic patient records
• CPC Class Codes: G16H 20/10 relating to drugs or medications, e.g. for ensuring correct administration to patients
• CPC Class Codes: G16H 40/20 for the management or administration of healthcare resources or facilities, e.g. managing hospital staff or surgery rooms
• CPC Class Codes: G16H 50/20 for computer-aided diagnosis, e.g. based on medical expert systems
• CPC Class Codes: G16H 70/40 relating to drugs, e.g. their side effects or intended usage

Abstract

Devices, systems, and methods for use in managing patient treatments utilizing pharmaceutical or therapeutic compounds. Methods include accessing one or more fields of information relating to any of a patient, physician and drug treatment and relating the one or more fields, or combination thereof, to a particular attribute or outcome. By analyzing the one or more fields of data in relation to the attribute or outcome, the system determines suitability of an intervention(s) and tasks the intervention(s) to one or more entities to facilitate the desired attribute or outcome. In certain aspects, the system facilitates identification of complex relationships and trends between seemingly unrelated fields of information and outputs information for use in an intervention or various other purposes according to the attribute or outcome desired by the user.

Claims

1. A method of treatment of a Cushing'"'"'s syndrome patient using a drug protocol with a system having a relational database and a processor, the system being coupled to one or more electronic devices, wherein the drug protocol comprises administration of mifepristone to said Cushing'"'"'s syndrome patient, the method comprising:

accessing one or more fields of information from a plurality of differing information systems accessible by the system, wherein the plurality of fields of information includes any of a patient identifier, patient characteristic, treatment regimen information, drug dose information, drug refill history, symptom reporting, patient or physician communication, or any combination thereof;

identifying, with the system, patients or their physicians having need for an intervention for achieving a desired result, wherein said identifying need for an intervention comprises identifying, without requiring test results, patients not receiving a proper change in mifepristone dose, by;

A) identification by the system of the combination of high starting dose with multiple refills, no scheduled appointments, no upcoming laboratory draws, and patient is elderly;

or

B) identification by the system of a low starting dose with multiple refills, and no scheduled appointments;

wherein said desired result comprises proper change in the patient'"'"'s mifepristone dose level and one or more of improved patient compliance;

improved treatment efficacy;

improved patient outcome;

improved adherence to a treatment regimen;

improved adherence to a treatment regimen update; and

improved adherence to a regimen modification;

determining a plurality of tasks for addressing the intervention,

wherein said intervention comprises modifying a patient'"'"'s prescribed mifepristone dose, wherein said modification is selected from i) increasing said mifepristone dose when the system identifies that the physician has not increased the patient'"'"'s dose to a level that will likely generate a therapeutic effect and ii) limiting the mifepristone dosage to avoid unfavorable side effects; and

providing guidance relating to the treatment or determining whether follow-up blood work was planned, or both;

tasking the intervention by outputting an intervention alert or information communication to one or more different entities with the one or more electronic devices to facilitate the desired result; and

administering said modified mifepristone dose to the Cushing'"'"'s syndrome patient.

2. The method of claim 1, wherein the tasks of the plurality of tasks are determined by the system to be performed according to i) a particular sequence, ii) particular timing, or both i) and ii).

3. The method of claim 2, wherein tasking the intervention comprises tasking the tasks of the plurality of tasks to different entities according to the particular sequence, timing, or according to both the particular sequence and timing.

4. The method of claim 1, wherein tasking the intervention comprises coordinating performance of the tasks by receiving information or a confirmation, or both, regarding a first task of the plurality before tasking a second task of the plurality of tasks.

5. The method of claim 1, wherein the intervention corresponds to a change in treatment determined by the system based on information received by the system in one or more tasks of the plurality of tasks.

6. The method of claim 1, wherein said intervention further requires a pharmacist to contact a physician to discuss any adverse events before the pharmacist fills a prescription for said glucocorticoid receptor antagonist.

7. The method of claim 1, wherein tasking the intervention comprises identifying an individual, position, or computer device to perform the intervention.

8. The method of claim 1, wherein the desired result is associated with any of patient compliance, treatment efficacy, patient outcome, a regulatory process, a business process, an administrative process, or any combination thereof.

9. The method of claim 1, wherein the one or more computerized devices receiving the intervention alert output comprise a phone, a mobile personal device, a user interface terminal or any combination thereof.

10. The method of claim 1, wherein the alert output comprises an electronic communication, indicator or combination thereof.

11. The method of claim 1, wherein the intervention comprises an automated task performed by the one or more computerized devices.

12. The method of claim 1, wherein the intervention alert is output to one or more computerized devices associated with the patient or a patient advocate.

13. The method of claim 1, wherein the intervention alert is output to one or more computerized devices associated with a treating physician, medical facility, medical administrator, insurer, or any combination thereof.

14. The method of claim 1, wherein outputting the intervention alert comprises identifying an intended recipient of the intervention alert and assigning a task to the intended recipient.

15. The method of claim 14, wherein the intended recipient is a pharmacist and the assigned task comprises contacting the patient'"'"'s physician to i) assess the treatment regimen, ii) manage the treatment regimen, iii) update the treatment regimen, or combinations thereof.

16. The method of claim 14, wherein the intended recipient comprises a pharmaceutical manufacturer representative and the task comprises contacting the physician to discuss information relating to the drug protocol or treatment regimen.

17. The method of claim 14, wherein the intended recipient is a third-party associated with a program specific to the patient and the task comprises contacting the patient to discuss the treatment regimen, to manage the treatment regimen, or both.

18. The method of claim 14, wherein the intended recipient is an automated system and the task comprises generating a communication to the physician or patient relating to the treatment regimen.

19. A method of managing drug treatment of a Cushing'"'"'s syndrome patient using an information system having a processor and a relational database, wherein the drug treatment comprises administration of mifepristone to said Cushing'"'"'s syndrome patient, the method comprising:

Accessing, by said processor, a plurality of fields of information relating to said patient or treatment from a plurality of different information systems on which the plurality of fields of information are stored, wherein the plurality of fields of information comprises one or more of a patient identifier, patient characteristic, treatment regimen information, drug dose information, drug refill history, physician information, transaction date, symptom reporting, patient communication, and physician communication;

Relating, by the processor, the fields of information of the plurality using a relational database of the system and determining the need for an intervention based on the relationships of the fields of information of the plurality to facilitate a desired result,

Wherein identifying said need for an intervention comprises identifying, without requiring test results, patients not receiving a proper change in mifepristone dose, and is determined by;

A) identification by the system of the combination of high starting dose with multiple refills, no scheduled appointments, no upcoming laboratory draws, and patient is elderly;

or

B) identification by the system of a low starting dose with multiple refills, and no scheduled appointments;

wherein said desired result comprises proper change in the patient'"'"'s mifepristone dose level and one or more of improved patient compliance;

improved treatment efficacy;

improved patient outcome;

improved adherence to a treatment regimen;

improved adherence to a treatment regimen update; and

improved adherence to a regimen modification;

determining, by the processor, a plurality of tasks associated with the intervention with the system

wherein said intervention comprises modifying a patient'"'"'s prescribed mifepristone dose, wherein said modification is selected from i) increasing said mifepristone dose when the system identifies that the physician has not increased the patient'"'"'s dose to a level that will likely generate a therapeutic effect and ii) limiting the mifepristone dosage to avoid unfavorable side effects; and

providing guidance relating to the treatment or determining whether follow-up blood work was planned, or both;

performing, tasking, or both performing and tasking, by the processor, the plurality of tasks to multiple different entities according to a particular sequence and/or timing; and

administering said modified mifepristone dose to the Cushing'"'"'s syndrome patient.