System and method for remotely evaluating patient compliance status

• US 9,597,029 B2
• Filed: 06/19/2007
• Issued: 03/21/2017
• Est. Priority Date: 06/19/2007
• Status: Active Grant

• Current Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Original Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Inventors: Patangay, Abhilash, Cazares, Shelley Marie
• Primary Examiner(s): Thomson, William
• Assistant Examiner(s): Archer, Marie
• Application Number:
  US11/820,798
• Publication Number:
  US 20080319272A1
• Time in Patent Office: 3,563 Days
• Field of Search: None
• US Class Current: 1/1
• CPC Class Codes: A61B 5/0002 Remote monitoring of patients using telemetry, e.g. transmission of vital signals via a communication network A61B5/07 takes precedence; transmission systems for measured values G08C; transmission H04B; transmission of digital information H04L; wireless communication networks H04W
• CPC Class Codes: A61B 5/16 Devices for psychotechnics using teaching or educational appliances G09B1/00 - G09B7/00; Testing reaction times ; Devices for evaluating the psychological state
• CPC Class Codes: A61B 5/165 Evaluating the state of mind, e.g. depression, anxiety
• CPC Class Codes: A61B 5/4833 Assessment of subject's compliance to treatment
• CPC Class Codes: A61B 5/686 Permanently implanted devices, e.g. pacemakers, other stimulators, biochips A61B5/6861 takes precedence
• CPC Class Codes: A61B 5/74 Details of notification to user or communication with user or patient indicating measured values G01D7/00; user input means input or output arrangements for computers G06F3/00
• CPC Class Codes: A61N 1/372 Arrangements in connection with the implantation of stimulators
• CPC Class Codes: G16H 20/10 relating to drugs or medications, e.g. for ensuring correct administration to patients
• CPC Class Codes: G16H 20/60 relating to nutrition control, e.g. diets
• CPC Class Codes: G16H 40/67 for remote operation

Abstract

A system and method for remotely evaluating patient compliance status is presented. Compliance to a course of treatment is periodically checked through qualitative inquiry of a patient under remote management. Physiometry of the patient, that indicates emotional state, is remotely monitored contemporaneously with the qualitative state. Patient status is evaluated, including at least one of corroborating the compliance and identifying an emotional imbalance, based upon the indicated emotional state of the patient.

Claims

1. A system for remotely evaluating compliance of a patient to a prescribed course of treatment, comprising:

an implantable medical device (IMD) implanted in the patient, the IMD comprising one or more sensors;

a query module configured to check compliance to the course of treatment of a patient under remote management on a periodic and regular basis,

the query module comprising a communicator configured to provide an interactive user interface for performing a qualitative inquiry of patient compliance and emotional state,

the communicator further configured to receive responses to the qualitative inquiry;

wherein the one or more sensors are configured to remotely monitor health related physiometry of the patient contemporaneously with the qualitative inquiry;

a data storage device configured to store physiometry and the responses to the qualitative inquiry; and

an evaluation module configured to evaluate patient compliance based upon a comparison of the physiometry to baseline physiometric data and configured to assess contemporaneously received responses to the qualitative inquiry to determine an emotional state and to corroborate patient compliance with the determined emotional state,

wherein the evaluation module is further configured to identify emotional imbalance based upon the comparison of the physiometry to baseline physiometric data and the assessment of the contemporaneously received responses to the qualitative inquiry, and

wherein the evaluation module is further configured to output information regarding at least one of corroborating compliance, identifying an emotional imbalance, or a combination thereof, which is related to patient compliance toward the prescribed course of treatment.

2. A system according to claim 1, wherein the data storage device further comprises:

stored factors bearing on patient compliance selected from the group consisting of medication, dietary restrictions, lifestyle modifications; and

combinations thereof.

3. A system according to claim 1, wherein the evaluation module further comprises:

a relative scale for determining emotional stability along a continuum or discrete set of emotional levels.

4. A system according to claim 1, wherein the interactive user interface comprises one or more of:

a strictly formatted qualitative inquiry, comprising questions and answers;

an intermediately formatted qualitative inquiry, comprising one or more of visual analog scales, five factor wellness scales, comfort scales, pain scales, stress scales, and spiritual wellness scales;

a loosely formatted qualitative inquiry, comprising one or more of written wellness journals, spoken wellness journals, present-time day logs, and time-to-time day logs;

or a combination thereof.

5. A system according to claim 1, wherein the evaluation module performs the evaluation following one or more of each response to the qualitative inquiry, at an end of a section of the qualitative inquiry, and upon completion of the qualitative inquiry.

6. A system according to claim 1, wherein the evaluation module dynamically modifies at least one of a nature, ordering, and directness of the evaluation.

7. A system according to claim 6, wherein the dynamic modification is based upon a perceived departure from normative or expected values.

8. A system according to claim 7, wherein the evaluation module further comprises:

one or more of stored thresholds, trending, and baseline data to define the normative or expected values.

9. A system according to claim 1, wherein the physiometry is selected from the group consisting of temperature, heart rate, blood pressure, respiratory rate, skin resistance, pulmonary arterial pressure, heart rate variability, heart sounds, oxygen saturation, sympathetic drive, tidal volume, and combinations thereof.

10. A system according to claim 1, further comprising:

a post processing module to post process the evaluation on a patient specific, patient peer group, or general patient population basis.

11. A system according to claim 10, wherein the post processing comprises one or more of following up, alerting, analyzing, sharing, and storing the evaluation.

12. A system according to claim 1, further comprising:

a compliance checking device comprising at least one of a self-contained communicator-type device and a general purpose programmable device; and

a physiometry monitor comprising at least one of an internal sensor and an external sensor.

13. A method for remotely evaluating compliance of a patient to a prescribed course of treatment, comprising:

checking compliance to the course of treatment on a periodic and regular basis through qualitative inquiry of a patient under remote management, and receiving responses to the qualitative inquiry;

remotely monitoring health related physiometry of the patient contemporaneously with the qualitative inquiry using an implantable medical device (IMD) implanted in the patient;

evaluating patient compliance status based upon a comparison of the physiometry to baseline physiometric data and assessing contemporaneously received responses to the qualitative inquiry to determine an emotional state and to corroborate patient compliance with the determined emotional state;

determining whether emotional imbalance exists based upon the comparison of the physiometry to baseline physiometric data and to the assessment of the contemporaneously received responses to the qualitative inquiry; and

outputting information regarding at least one of corroborating compliance, identifying an emotional imbalance, or a combination thereof, which is related to patient compliance toward the prescribed course of treatment.

14. A method according to claim 13, further comprising:

setting factors bearing on patient compliance selected from the group consisting of medication, dietary restrictions, lifestyle modifications, and a combination thereof.

15. A method according to claim 13, further comprising:

determining emotional stability using a relative scale along a continuum or discrete set of emotional levels.

16. A method according to claim 13, further comprising one or more of:

formatting the qualitative inquiry in a strict format, comprising questions and answers;

formatting the qualitative inquiry in an intermediate format, comprising one or more of visual analog scales, five factor wellness scales, comfort scales, pain scales, stress scales, and spiritual wellness scales; and

formatting the qualitative inquiry in a loose format, comprising one or more of written wellness journals, spoken wellness journals, present-time day logs, and time-to-time day logs.

17. A method according to claim 13, further comprising one or more of:

performing the evaluation following each response to the qualitative inquiry;

performing the evaluation at an end of a section of the qualitative inquiry; and

performing the evaluation upon completion of the qualitative inquiry.

18. A method according to claim 13, further comprising:

dynamically modifying at least one of a nature, ordering, and directness of the evaluation.

19. A method according to claim 18, further comprising:

basing the dynamic modification upon a perceived departure from normative or expected values.

20. A method according to claim 19, further comprising:

defining the normative or expected values as one or more of thresholds, trending, and baseline data.

21. A method according to claim 13, wherein the physiometry is selected from the group consisting of temperature, heart rate, blood pressure, respiratory rate, skin resistance, pulmonary arterial pressure, heart rate variability, heart sounds, oxygen saturation, sympathetic drive, tidal volume, and combinations thereof.

22. A method according to claim 13, further comprising:

post processing the evaluation on a patient specific, patient peer group, or general patient population basis.

23. A method according to claim 22, wherein the post processing comprises one or more of following up, alerting, analyzing, sharing, and storing the evaluation.

24. A method according to claim 13, further comprising:

compliance checking the patient using at least one of a self-contained communicator-type device and a general purpose programmable device; and

physiometry monitoring using at least one of an internal sensor and an external sensor.

25. A non-transitory computer-readable storage medium storing instructions that, when executed by a computer, cause the computer to perform the method according to claim 13.

26. An apparatus for remotely evaluating compliance of a patient to a prescribed course of treatment, comprising:

means for checking compliance to the course of treatment on a periodic and regular basis through qualitative inquiry of a patient under remote management and receiving responses to the qualitative inquiry;

means for remotely monitoring health related physiometry of the patient contemporaneously with the qualitative inquiry using an implantable medical device (IMD) implanted in the patient; and

means for evaluating patient compliance, comprising means for determining an emotional state and corroborating compliance with the determined emotional state based upon a comparison of the physiometry to baseline physiometric data and an assessment of the contemporaneously received responses to the qualitative inquiry, wherein the means for evaluating further comprises at least one means for identifying an emotional imbalance based upon a comparison of the physiometry to baseline physiometric data and to the assessment of the contemporaneously received responses to the qualitative inquiry, and wherein the means for evaluating further comprises means to output information regarding at least one of corroborating compliance, identifying an emotional imbalance, or a combination thereof, which is related to patient compliance toward the prescribed course of treatment.