Method and Apparatus for Verification of Clinical Trial Adherence

• US 20120310671A1
• Filed: 07/26/2012
• Published: 12/06/2012
• Est. Priority Date: 12/23/2009
• Status: Active Grant

• Current Assignee: AI Cure Technologies LLC
• Original Assignee: AI Cure Technologies LLC
• Inventors: Hanina, Adam, Kessler, Gordon
• Granted Patent: US 8,731,961 B2
• Time in Patent Office: Days
• US Class Current: 705/3
• CPC Class Codes: G06Q 10/10 Office automation; Time management
• CPC Class Codes: G06T 7/0012 Biomedical image inspection
• CPC Class Codes: G06V 20/48 Matching video sequences
• CPC Class Codes: G06V 40/20 Movements or behaviour, e.g. gesture recognition recognition of facial expressions G06V40/16
• 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 20/60 relating to nutrition control, e.g. diets

Abstract

A system and method of confirming administration of medication in a clinical trial is provided. The method comprises the steps of receiving information identifying a particular medication prescription regimen in accordance with the clinical trial, determining one or more procedures for administering such prescription regimen and identifying one or more activity sequences associated with such procedures. Activity sequences of actual administration of such prescription regimen are captured and then compared to the identified activity sequences to determine differences therebetween. A notice is provided if differences are determined.

Claims

1. A method of confirming administration of medication in a clinical trial, comprising the steps of:

identifying a particular medication prescription regimen in accordance with the clinical trial;

determining one or more procedures for administering such prescription regimen including ingestion of the medication in accordance with the clinical trial;

identifying one or more video activity sequences associated with such procedures;

capturing video activity sequences of actual administration including ingestion of such prescription regimen by a video capture device;

storing the captured video activity sequences to a non-transitory computer readable storage medium;

comparing the stored video activity sequences to the identified video activity sequences by a computer processor to determine differences therebetween; and

providing a notice if differences are determined, thereby automatically determining by the computer processor that confirmation of proper medication administration including ingestion has failed.

2. The method of claim 1, wherein the prescription regimen is provided by a clinical trial manager.

3. The method of claim 1, wherein the prescription regimen and procedures for administering the prescription are retrieved from a medical database.

4. The method of claim 1, further comprising the step of performing a statistical analysis of differences determined in the comparing step.

5. The method of claim 1, further comprising the steps of:

retrieving medical history information of a patient to receive the administered medication subject to the clinical trial; and

confirming that the administered medication is safe for the patient.

6. The method of claim 1, further comprising the steps of:

before capturing the one or more video activity sequences of administration of the prescription regimen including ingestion of the medication, determining the identity of a particular medication to be used in such administration; and

issuing a warning if it is determined by the computer processor that the determined identity is not the medication associated with the upcoming prescription regimen.

7. The method of claim 1, further comprising the steps of:

capturing video activity sequences of actual administration of the prescription regimen including ingestion of the medication during multiple instances of administration;

comparing by the computer processor the captured video activity sequences to the identified video activity sequences to determine differences therebetween, thereby automatically determining by the computer processor that confirmation of proper medication administration has failed; and

providing an analysis of adherence to a particular prescription regimen in accordance with the multiple instances of administration.

8. The method of claim 7, further comprising the step of providing additional instructions to a medication administrator in accordance with the provided analysis.

9. The method of claim 1, wherein the notice comprises contact to a clinical trial manager.

10. The method of claim 1, wherein the notice comprises additional instructions to a patient receiving the medication according to the one or more procedures of the clinical trial.

11. A system for confirming administration of medication in a clinical trial, comprising:

an authentication apparatus for authenticating a clinical trial manager;

an input device for receiving information identifying a particular medication prescription regimen from the authenticated clinical trial manager;

a database comprising prescription administration information for the medication subject to the clinical trial,

a storage device for storing prescription administration selected from the database and being associated with the identified medication prescription subject to the clinical trial, a set of instructions in accordance with which the prescription regimen is to be administered including ingestion of the medication, and one or more activity sequences associated with such instructions;

a video capture device for capturing video activity sequences of actual administration of such prescription regimen including ingestion of the medication over a plurality of administrations of the prescription regimen;

a processor for comparing the captured video activity sequences to the identified video activity sequences including ingestion of the medication to determine differences therebetween, thereby automatically determining by the processor that confirmation of proper medication administration has failed; and

an output device for providing an immediate notice if differences are determined in the comparing step by the processor that may place a patient receiving the prescription regimen in danger; and

for providing a notice if differences are determined in the comparing step that may improve future administration of the prescription regimen in the clinical trial.

12. The system of claim 11, wherein the information stored on the storage device may be modified by the authenticated clinical trial manager.

13. The system of claim 11, wherein the video capture device is further adapted to capture images of a particular medication to allow identification thereof.

14. A method of confirming administration of medication in a clinical trial, comprising the steps of:

authenticating a prescribing clinical trial manager;

receiving information identifying a particular medication prescription regimen from the authenticated clinical trial manager;

determining one or more procedures for administering such prescription regimen including ingestion of the medication from one or more databases including prescription regimen information in accordance with prescription information provided by the authenticated clinical trial manager;

modifying the procedures, if necessary, by the authenticated clinical trial manager;

providing a set of instructions including ingestion of the medication in accordance with which the prescription regimen is to be administered;

identifying one or more visual indicia for determining confirmation of prescription administration including ingestion of the medication associated with such instructions;

capturing appropriate visual indicia of actual administration including ingestion of such prescription regimen over a plurality of administrations of the prescription regimen by a video capture device;

storing the captured visual indicia to a non-transitory computer readable storage medium;

comparing by a computer processor the captured indicia for determining confirmation of prescription administration including medication ingestion to the identified indicia for determining confirmation of prescription administration including medication ingestion to determine differences therebetween;

providing an immediate notice if differences are determined in the comparing step by the computer processor that may place a patient receiving the prescription regimen in danger; and

providing a notice if differences are determined in the comparing step by the computer processor that may improve future administration of the prescription regimen in the clinical trial.

15. The method of claim 14, wherein the indicia for determining confirmation of prescription administration comprises one or more video activity sequences.

16. The method of claim 15, wherein the indicia for determining confirmation of prescription administration comprises an additional alternative method.

17. The method of claim 14, further comprising the steps of:

capturing visual indicia of activity of a patient before medication administration by the video capture device; and

providing a reminder to the patient at least in part in accordance with the captured visual indicia before medication administration.

18. The method of claim 14, further comprising the step of capturing visual indicia of activity of a patient by the video capture device before medication administration, wherein the captured visual indicia before medication administration comprises evidence of patient consent.

19. The method of claim 14, further comprising the steps of:

capturing visual indicia of activity of a patient by the video capture device after medication administration;

providing notification to a medical service provider of the activity; and

modifying at least one aspect of a prescription regimen in accordance with the captured visual indicia after medication administration.

20. The method of claim 19, wherein the captured visual indicia after medication administration comprises an adverse reaction to the medication.

21. The method of claim 14, further comprising the step of determining payments to a patient in a clinical trial based upon their level of compliance to the prescribed regimen in the clinical trial.