System and method for managing alert notifications in an automated patient management system

• US 20060253301A1
• Filed: 05/03/2005
• Published: 11/09/2006
• Est. Priority Date: 05/03/2005
• Status: Active Grant

• Current Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Original Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Inventors: Kalgren, James R., Srivathsa, Muralidharan, Johnson, David C., Simms, Howard D., Hoyme, Kenneth P.
• Granted Patent: US 8,781,847 B2
• Time in Patent Office: Days
• US Class Current: 705/2
• CPC Class Codes: G06Q 10/00 Administration; Management
• CPC Class Codes: G16H 10/60 for patient-specific data, e.g. for electronic patient records
• CPC Class Codes: G16H 40/67 for remote operation

Abstract

A system and method for managing alert notifications in an automated patient management system is presented. One or more settings specifying patient data collection periodicity are defined. One or more patient data sources operating on a remotely managed patient and selected from at least one of a physiological sensor and a therapy delivery device are also defined. One or more triggers associated with a condition occurring in relation to at least one such patient data evaluateable subsequent to collection are defined. Finally, a notification scheme executable upon detection of at least one such trigger is determined to provide an external indicator of the condition occurrence.

Claims

1. A system for managing alert notifications in an automated patient management system, comprising:

one or more settings defined to specify patient data collection periodicity and one or more patient data sources operating on a remotely managed patient and selected from at least one of a physiological sensor and a therapy delivery device;

one or more triggers defined to be associated with a condition occurring in relation to at least one such patient data evaluateable subsequent to collection; and

a notifier to determine a notification scheme executable upon detection of at least one such trigger to provide an external indicator of the condition occurrence.

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

data collection options, comprising at least one of;

a schedule defined to be associated with at least one such patient data source to provide automated retrieval of the patient data;

a schedule defined to be associated with at least one such patient data source to provide prompted retrieval of the patient data by the remotely managed patient;

a frequency defined to be associated with at least one such patient data source to track or limit on-demand retrieval of the patient data;

a follow-up scheme defined to be associated with at least one such patient data source executable in an absence of expected patient data collection; and

a follow-up scheme defined to be associated with at least one of the remotely managed patient and a patient-managing clinician executable in an absence of expected patient data collection.

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

data evaluation options, comprising at least one of;

an evaluation frequency to be specified with at least one such trigger;

a flag to control enablement of at least one such trigger by permitting or restricting the enablement; and

an indicator to provide performing evaluation of the triggers in one or more of a data collection device and a server communicatively interfaced to the data collection device.

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

alert notification options, comprising at least one of;

a configurable parameter defined to be evaluated as at least one such condition;

a plurality of the conditions to be combined into one such trigger comprising one or more Boolean operations; and

alert levels to be assigned to alert notifications that are each triggered upon detection of the conditions having increasing degrees of severity.

5. A system according to claim 4, wherein the alert levels are assigned to a plurality of the alert notifications that are each triggered upon detection of one or more of the conditions having a common degree of severity.

6. A system according to claim 5, further comprising:

an escalation scheme defined to execute in relation to the alert levels upon the detection of one such condition having a common degree of severity.

7. A system according to claim 4, further comprising:

default setting groups of data evaluation options defined to be selected from the group comprising system-wide, sub-population specific, user-specified default settings for all patients, and a user-specified default settings for custom patient grouping.

8. A system according to claim 4, wherein a plurality of alert levels are associated with a plurality of the triggers, further comprising:

an immutable alert level to be assigned to one or more of the alert levels.

9. A system according to claim 1, wherein the notification scheme is executable only upon an initial detection of the at least one such trigger.

10. A system according to claim 1, wherein cumulative collection of the patient data from a plurality of the patient data sources is specified.

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

a monitor to monitor and analyze responses to an external indicator, and to modify the corresponding notification scheme based on behaviors identified in the responses.

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

a database to store the collected patient data, wherein the stored collected patient data is included as the at least one such patient data evaluateable subsequent to collection.

13. A system according to claim 1, wherein the patient data source comprises at least one of an implantable medical device, implantable diagnostic multi-sensor non-therapeutic device, external medical device, implantable sensor, and external sensor.

14. A system according to claim 1, wherein the condition is selected from the group comprising battery level low, including end of life and early replacement indicated;

excessive battery use, including whether rate of battery depletion is above an expected threshold;

tachycardia therapy disabled, including tachycardia mode monitor only, tachycardia mode off, and magnet mode therapy disable;

implanted lead conditions, including defibrillation lead conditions and pacing lead conditions;

pacing capture conditions, including loss of capture and safety margin too low;

pacing percentage above or below an expected range;

tachycardia therapy conditions, including tachycardia therapy delivered to convert arrhythmia, tachycardia therapy accelerated arrhythmia, and tachycardia therapy exhausted;

atrial conditions, including time in atrial fibrillation exceeding a threshold and time in Atrial flutter exceeding a threshold, and atrial therapy delivered;

activity level above or below a threshold;

heart rate variability below a threshold;

maximum heart rate above a threshold;

weight increase or decrease;

blood pressure, including systolic, diastolic, or mean arterial pressures, above or below a threshold;

blood sugar above or below a threshold;

apnea index above a threshold;

device failure, including implanted and external devices;

patient triggered event;

oxygen saturation below a threshold; and

implanted sensor information, including cardiac output below a threshold, pulmonary artery pressure above or below a threshold, and pulmonary edema level above a threshold.

15. A method for managing alert notifications in an automated patient management system, comprising:

defining one or more settings specifying patient data collection periodicity and one or more patient data sources operating on a remotely managed patient and selected from at least one of a physiological sensor and a therapy delivery device;

defining one or more triggers associated with a condition occurring in relation to at least one such patient data evaluateable subsequent to collection; and

determining a notification scheme executable upon detection of at least one such trigger to provide an external indicator of the condition occurrence.

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

defining data collection options, comprising at least one of;

defining a schedule associated with at least one such patient data source to provide automated retrieval of the patient data;

defining a schedule associated with at least one such patient data source to provide prompted retrieval of the patient data by the remotely managed patient;

defining a frequency associated with at least one such patient data source to track or limit on-demand retrieval of the patient data;

defining a follow-up scheme associated with at least one such patient data source executable in an absence of expected patient data collection; and

defining a follow-up scheme associated with at least one of the remotely managed patient and a patient-managing clinician executable in an absence of expected patient data collection.

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

defining data evaluation options, comprising at least one of;

specifying an evaluation frequency with at least one such trigger;

controlling enablement of at least one such trigger by permitting or restricting the enablement; and

performing evaluation of the triggers in one or more of a data collection device and a server communicatively interfaced to the data collection device.

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

defining alert notification options, comprising at least one of;

defining a configurable parameter to be evaluated as at least one such condition;

combining a plurality of the conditions into one such trigger comprising one or more Boolean operations; and

assigning alert levels to alert notifications that are each triggered upon detection of the conditions having increasing degrees of severity.

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

assigning the alert levels to a plurality of the alert notifications that are each triggered upon detection of one or more of the conditions having a common degree of severity.

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

defining an escalation scheme to execute in relation to the alert levels upon the detection of one such condition having a common degree of severity.

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

defining default setting groups of data evaluation options selected from the group comprising system-wide, sub-population specific, user-specified default settings for all patients, and a user-specified default settings for custom patient grouping.

22. A method according to claim 18, wherein a plurality of alert levels are associated with a plurality of the triggers, further comprising:

assigning an immutable alert level to one or more of the alert levels.

23. A method according to claim 15, wherein the notification scheme is executable only upon an initial detection of the at least one such trigger.

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

specifying cumulative collection of the patient data from a plurality of the patient data sources.

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

monitoring and analyzing responses to an external indicator; and

modifying the corresponding notification scheme based on behaviors identified in the responses.

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

storing the collected patient data; and

including the stored collected patient data as the at least one such patient data evaluateable subsequent to collection.

27. A method according to claim 15, wherein the patient data source comprises at least one of an implantable medical device, implantable diagnostic multi-sensor non-therapeutic device, external medical device, implantable sensor, and external sensor.

28. A method according to claim 15, wherein the condition is selected from the group comprising battery level low, including end of life and early replacement indicated;

excessive battery use, including whether rate of battery depletion is above an expected threshold;

tachycardia therapy disabled, including tachycardia mode monitor only, tachycardia mode off, and magnet mode therapy disable;

implanted lead conditions, including defibrillation lead conditions and pacing lead conditions;

pacing capture conditions, including loss of capture and safety margin too low;

pacing percentage above or below an expected range;

tachycardia therapy conditions, including tachycardia therapy delivered to convert arrhythmia, tachycardia therapy accelerated arrhythmia, and tachycardia therapy exhausted;

atrial conditions, including time in atrial fibrillation exceeding a threshold and time in Atrial flutter exceeding a threshold, and atrial therapy delivered;

activity level above or below a threshold;

heart rate variability below a threshold;

maximum heart rate above a threshold;

weight increase or decrease;

blood pressure, including systolic, diastolic, or mean arterial pressures, above or below a threshold;

blood sugar above or below a threshold;

apnea index above a threshold;

device failure, including implanted and external devices;

patient triggered event;

oxygen saturation below a threshold; and

implanted sensor information, including cardiac output below a threshold, pulmonary artery pressure above or below a threshold, and pulmonary edema level above a threshold.

29. A computer-readable storage medium holding code for performing the method according to claim 15.

30. An apparatus for managing alert notifications in an automated patient management system, comprising:

means for defining one or more settings specifying patient data collection periodicity and one or more patient data sources operating on a remotely managed patient and selected from at least one of a physiological sensor and a therapy delivery device;

means for defining one or more triggers associated with a condition occurring in relation to at least one such patient data evaluateable subsequent to collection; and

means for determining a notification scheme executable upon detection of at least one such trigger to provide an external indicator of the condition occurrence.