Apparatus and method for collection of protocol adherence data

• US 10,395,009 B2
• Filed: 09/30/2015
• Issued: 08/27/2019
• Est. Priority Date: 03/22/2010
• Status: Active Grant

• Current Assignee: AI Cure Technologies LLC
• Original Assignee: AI Cure Technologies LLC
• Inventors: Hanina, Adam, Kessler, Gordon
• Primary Examiner(s): Morgan, Robert W
• Assistant Examiner(s): Winston, III, Edward B
• Application Number:
  US14/871,843
• Publication Number:
  US 20160019373A1
• Time in Patent Office: 1,427 Days
• CPC Class Codes: G06Q 10/10 Office automation; Time management
• CPC Class Codes: G16H 10/20 for electronic clinical trials or questionnaires
• 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 40/67 for remote operation

Abstract

A data capture and storage apparatus for use in confirming administration of medication in a clinical trial or other medication administration scenario is provided. The apparatus includes a data capture device for capturing one or more types of data related to administration of a medication, a storage device for storing the captured data and a processor for processing the stored captured data. The processor further includes an analysis element for performing a local analysis of the stored captured data. The processor is further adapted to identify a particular medication prescription regimen in accordance with the clinical trial or medication administration scenario, determine one or more procedures for administering such prescription regimen, identify one or more activity sequences associated with such procedures, capture activity sequences of actual administration of such prescription regimen compare the captured activity sequences to the identified activity sequences to determine differences therebetween, and providing a notice if differences are determined.

Claims

1. A medication adherence monitoring system, comprising:

a first storage device operable to store (i) one or more sets of video instructions and user prompts for encouraging proper performance of one or more predetermined movement sequences to be performed by a patient and (ii) additional video data comprising one or more videos of the one or more predetermined movement sequences, the one or more predetermined movement sequences being indicative of proper medication administration;

a display operable to display to the patient, one or more of the one or more sets of video instructions and user prompts for encouraging proper performance of the one or more predetermined movement sequences;

a video data capture device operable to capture at least video data of the patient performing one or more of the one or more predetermined movement sequences in response to the one or more of the one or more video instructions and user prompts;

a second storage device for storing the captured video data; and

a first processor operable to

output, to the display, a first type of alert that notifies the patient it is time to administer medication,

receive a patient medication administration initiation response following the output of the first type of alert,

output to the display, responsive to receiving the patient medication administration initiation response, the one or more of the one or more sets of video instructions and user prompts for encouraging proper performance of the one or more predetermined movement sequences,

receive the captured video data from the second storage device,

automatically compare the stored captured video data to the additional video data comprising the one or more videos of the one or more predetermined movement sequences,

determine, from the comparison, whether the patient has properly performed the predetermined movement sequences,

responsive to determining, from the comparison, that the patient has not properly performed the predetermined movement sequences, output, to the display, interactive feedback to the patient and an additional one or more of the one or more sets of video instructions and user prompts to further encourage proper performance of the one or more predetermined movement sequences.

2. The system of claim 1, further comprising a transmission system for transmitting the captured video data to a storage and analysis location that includes the first and second storage devices, and the first processor and that is remote from the video data capture device.

3. The system of claim 1, wherein the first processor is operable to, in response to the comparison of the stored captured video data to the additional video data, determine whether an immediate first response to the patient would be proper, and

subsequent to determining that an immediate first response to the patient would be proper, output to the display a second type of alert.

4. The system of claim 3, further comprising:

a storage and analysis location that includes a second processor and that is remote from the video data capture device; and

a transmission system for transmitting the captured video data to the storage and analysis location, wherein the second processor is operable to recognize and analyze medication administration including medication ingestion by the patient from the captured video data, and wherein the second processor is operable to, in response to analyzing the received video data, determine whether a second supplemental response to a patient would be proper.

5. The system of claim 4, wherein the second processor is operable to transmit, by the transmission system, the second supplemental response from the storage and analysis location to the display.

6. The system of claim 1, further comprising:

a transmission system operable to transmit the captured video data to a storage and analysis location that is remote from the video capture device; and

a receipt system operable to receive medication adherence response information from the storage and analysis location.

7. The system of claim 1, wherein the one or more predetermined movement sequences comprises an activity associated with administration of a prescription protocol.

8. A medication adherence monitoring system for use in confirming administration of medication in a clinical trial, comprising:

a first storage device operable to store one or more sets of video instructions and user prompts for encouraging proper performance of one or more predetermined movement sequences to be performed by a participant, the one or more predetermined movement sequences being indicative of proper performance of a predefined participant clinical trial protocol for medication administration;

a display operable to display to the participant one or more of the one or more sets of video instructions and user prompts for encouraging proper performance of the one or more predetermined movement sequences;

a video data capture device operable to capture at least video information of the participant performing one or more of the one or more predetermined movement sequences following the one or more of the one or more displayed video instructions and user prompts;

a second storage device for storing the captured video information;

a first processor operable to

output, to the display, a first type of alert that notifies the participant it is time to administer medication,

receive a participant medication administration initiation response following the output of the first type of alert,

output to the display, responsive to receiving the participant medication administration initiation response, the one or more of the one or more sets of video instructions and user prompts for encouraging proper performance of the one or more predetermined movement sequences,

receive the stored captured video information from the second storage device,

automatically analyze the stored captured video information to determine whether the participant has properly performed the predetermined movement sequences,

confirm, from the automatic analysis, whether the participant properly performed the predetermined movement sequences,

responsive to determining, from the comparison, that the participant has not properly performed the predetermined movement sequences, output, to the display, interactive feedback to the participant and an additional one or more of the one or more sets of video instructions and user prompts to further encourage proper performance of the one or more predetermined movement sequences.

9. The system of claim 8, wherein the predefined participant clinical trial protocol is provided by a clinical trial manager.

10. The system of claim 8, comprising a medical database stored on the first or second storage device, wherein the predefined participant clinical trial protocol are stored in the medical database.

11. The system of claim 8, further comprising:

a second processor at a storage and analysis location that is remote from the video data capture device;

a transmission system operable to transmit at least a portion of the captured video information to the remote storage and analysis location; and

a receipt system operable to receive medication adherence report information from the remote storage and analysis location, wherein

the second processor is adapted to perform a statistical analysis of the captured video information.

12. The system of claim 8, wherein the first processor is further adapted to:

retrieve medical history information of the participant;

determine whether a to be administered medication in the clinical trial is safe for the participant; and

output a warning, when the first processor determines that the to be administered medication is not safe for the participant or that the to be administered medication is not recognized.

13. The system of claim 12, wherein the first processor is operable to output additional instructions to a medication administrator when the first processor determines that the to be administered medication is not safe for the participant.

14. The system of claim 12, wherein the warning comprises additional instructions to a patient receiving the medication according to the predefined participant clinical trial protocol.

15. The system of claim 8, wherein the medication adherence monitoring system is operable to provide live contact with a clinical trial manager through audio and/or video communication.

16. A system for confirming administration of medication, the system comprising:

an authentication apparatus for authenticating a medication manager;

a database comprising prescription administration information for the medication; and

a medication adherence monitoring apparatus, the medication adherence monitoring apparatus comprising

a first storage device operable to store (i) one or more sets of video instructions and user prompts for encouraging proper performance of one or more predefined movement sequences to be performed by a patient and (ii) additional video data comprising one or more videos of the one or more predetermined movement sequences, the one or more predefined movement sequences being indicative of proper medication administration;

a display operable to display to the patient one or more of the one or more sets of video instructions and user prompts for encouraging proper performance of the one or more predefined movement sequences;

a video data capture device operable to capture at least video data of the patient performing one or more of the one or more predefined movement sequences following the one or more of the one or more displayed video instructions and user prompts;

a second storage device for storing the captured video data; and

a first processor operable to

output, to the display, a first type of alert that notifies the patient it is time to administer medication,

receive a patient medication administration initiation response following the output of the first type of alert,

output, to the display, responsive to receiving the patient medication administration response, the one or more of the one or more sets of video instructions and user prompts for encouraging proper performance of the one or more predetermined movement sequences,

receive the stored captured video data from the second storage device,

automatically compare the stored captured video data to the additional video data comprising the one or more videos of the one or more predefined movement sequences,

determine, from the comparison, whether the patient has properly performed the predefined movement sequences,

responsive to determining, from the comparison, that the patient has not properly performed the predefined movement sequences, output, to the display, an immediate notice to the patient that medication administration is not recognized and an additional one or more of the one or more sets of video instructions and user prompts to further encourage proper performance of the one or more predetermined movement sequences.

17. The system of claim 16, wherein the additional one or more sets of video instructions comprise real time interactive feedback to aid the patient in properly administering the medication during a current medication administration.