Methods and apparatus for authenticating informed consent

• US 6,171,112 B1
• Filed: 06/09/1999
• Issued: 01/09/2001
• Est. Priority Date: 09/18/1998
• Status: Expired due to Fees

• Current Assignee: Vital Link Financial Services LLC
• Original Assignee: Wyngate, Inc.
• Inventors: Clark, Robert L., Morgan, Glen A.
• Primary Examiner(s): Martin-Wallace, Valencia
• Assistant Examiner(s): ADAMS, CHANDA L
• Application Number:
  US09/328,685
• Time in Patent Office: 580 Days
• Field of Search: 434/219, 434/262, 434/354, 434/321, 434/322, 434/362, 434/350, 434/307.R, 705/2, 705/3
• US Class Current: 434/322
• CPC Class Codes: G09B 23/28 for medicine
• CPC Class Codes: G16H 40/20 for the management or administration of healthcare resources or facilities, e.g. managing hospital staff or surgery rooms

Abstract

A method and apparatus for recorded information conveyance and comprehension are provided that include a Virtual Interactive Teaching and Learning (VITAL) Center. The VITAL Center provides an interactive patient education and informed consent process that increases patient comprehension using presentations that offer a baseline education about medical and surgical procedures including the associated risks, benefits and alternatives. The patient'"'"'s comprehension of the material is confirmed throughout the presentation using summary questions focused on key information. The patient is able to record their own questions or concerns about the procedure while watching the presentation. After the presentation is finished, A healthcare professional reviews the patient questions upon completion of the presentation, and any information the patient did not understand is further explained at this time. After all questions and concerns are addressed and the patient has a comfortable understanding of the procedure, the patient signs an informed consent electronically. Using digital video capture, the VITAL Center simultaneously records the information presented, the patient viewing the interactive presentation, the patient-physician interaction, and the informed consent process. The entire recorded education session and informed consent is stored permanently on optical disk media.

Claims

1. A method for obtaining informed patient consent, comprising:

providing at least one interactive presentation on a medical procedure;

recording patient response to at least one summary question of the at least one interactive presentation;

recording at least one inquiry of the patient during the at least one interactive presentation;

recording visual images of the patient observing the at least one interactive presentation;

determining patient comprehension using the patient response; and

recording an informed consent including an electronic signature of the patient.

2. The method of claim 1, further comprising:

transmitting at least one recorded patient education session to a data system, wherein the at least one recorded patient education session includes the at least one interactive presentation, the at least one summary question, the recorded patient response, the recorded inquiry, the recorded visual images, the recorded personal marker, and the recorded electronic signature;

receiving the at least one recorded patient education session; and

archiving the at least one recorded patient education session, wherein archiving comprises storing the at least one patient education session on an optical disk storage media.

3. The method of claim 2, further comprising:

receiving at least one update to the at least one interactive presentation from the data system, wherein the at least one update includes information selected from a group comprising new procedures, pharmaceuticals, statistics, and modifications to the at least one interactive presentation; and

updating the at least one interactive presentation.

4. The method of claim 2, further comprising encrypting the at least one recorded patient education session for transmission, wherein transmitting and receiving are performed over a medium selected from a group comprising bidirectional networks, wireless networks, and the Internet.

5. The method of claim 1, further comprising:

receiving a transmission including the at least one interactive presentation from a data system; and

selecting the at least one interactive presentation to provide to the patient.

6. The method of claim 1, wherein the medical procedure is selected from a group comprising surgical procedures, non-surgical procedures, therapies, procedures involving chemicals and drugs, and testing.

7. The method of claim 1, wherein determining patient comprehension comprises:

determining at least one score for at least one portion of the at least one interactive presentation using the recorded patient responses;

determining a status of the at least one score using a specified threshold;

when the at least one score is below the specified threshold, performing at least one action selected from a group comprising repeating the at least one interactive presentation, repeating at least one portion of the at least one interactive presentation, presenting information to supplement the at least one interactive presentation, readministering the at least one summary question, administering at least one additional summary question, and terminating the at least one interactive presentation.

8. The method of claim 1, wherein providing at least one interactive presentation comprises providing a presentation including at least one format selected from a group comprising audio, visual, audiovisual, closed circuit, and digital imaging, wherein the at least one interactive presentation is provided to the patient using a device selected from a group comprising hand-held devices, portable devices, and remote devices.

9. The method of claim 1, further comprising recording at least one personal marker of the patient, the at least one personal marker comprising at least one biological marker selected from a group comprising pulse rates, breath rates, blood pressure, fingerprints, toe prints, footprints, corneal scans, and retinal scans.

10. The method of claim 1, further comprising correlating the at least one interactive presentation with at least one of the recorded visual images of the patient observing the at least one interactive presentation, the recorded patient responses, and the recorded at least one inquiry, wherein the correlation allows for simultaneous observation during presentation of a visual record of a patient education session.

11. A system for obtaining informed patient consent, comprising:

a processor-based remote audiovisual device for presenting at least one interactive presentation on a medical procedure, wherein the audiovisual device records at least one patient education session comprising recording visual images of a patient observing the at least one interactive presentation and recording an informed consent of the patient;

a means for providing the at least one interactive presentation to the audiovisual device;

a means for updating the at least one interactive presentation stored in the audiovisual device; and

a means for storing and archiving the at least one patient education session.

12. The system of claim 11, wherein the means for providing and the means for updating the at least one interactive presentation comprises a data system that transmits the at least one interactive presentation and at least one interactive presentation update to the remote device, wherein the at least one update is selected from a group comprising new procedures, pharmaceuticals, statistics, and modifications to the at least one interactive presentation.

13. The system of claim 11, further comprising:

a means for recording at least one personal marker of the patient;

a means for encrypting the at least one recorded patient education session;

a means for determining patient comprehension of the at least one interactive presentation;

a means for transmitting the at least one recorded patient education session to a data system; and

a means for correlating the at least one interactive presentation with the at least one recorded patient education session.

14. The system of claim 11, wherein the at least one recorded patient education session further comprises the at least one interactive presentation, at least one summary question, a patient response to the at least one summary question, at least one inquiry of the patient, at least one personal marker of the patient, and a recorded electronic signature.

15. A system for obtaining informed patient consent, comprising:

at least one portable device coupled to a network, wherein each portable device includes at least one processor configured to;

provide at least one interactive presentation on a medical procedure, wherein the at least one interactive presentation includes at least one summary question;

record visual images of the patient observing the at least one interactive presentation;

determine patient comprehension of the medical procedure using a recorded patient response to the at least one summary question;

record the informed patient consent; and

at least one data system coupled to the network, wherein each data system is capable of

receiving and archiving at least one recorded patient education session from the at least one portable device, the at least one recorded patient education session including the at least one interactive presentation, the recorded visual images, and the recorded informed patient consent; and

transmitting at least one update to the at least one interactive presentation, wherein the at least one update includes information selected from a group comprising new procedures, pharmaceuticals, statistics, and modifications to the at least one interactive presentation.

16. The system of claim 15, wherein each portable device is further configured to:

receive a transmission including the at least one interactive presentation from the at least one data system;

receive at least one update to the at least one interactive presentation from the at least one data system, wherein the at least one update includes information selected from a group comprising new procedures, pharmaceuticals, statistics, and modifications to the at least one interactive presentation; and

update the at least one interactive presentation.

17. The system of claim 15, wherein each portable device is further configured to:

record at least one personal marker of the patient comprising at least one biological marker selected from a group comprising pulse rates, breath rates, blood pressure, fingerprints, toe prints, footprints, corneal scans, and retinal scans;

encrypt the at least one recorded patient education session for transmission; and

transmit the at least one recorded patient education session to the at least one data system, wherein transmitting is performed over a medium selected from a group comprising bidirectional networks, wireless networks, and the Internet, wherein the at least one recorded patient education session includes the at least one interactive presentation, the at least one summary question, the recorded patient response, the recorded inquiry, the recorded visual images, a recorded personal marker of the patient, and the recorded electronic signature.

18. The system of claim 15, wherein each portable device is further configured to:

correlate the at least one interactive presentation with at least one of the recorded visual images of the patient observing the at least one interactive presentation, the recorded patient responses, the recorded at least one inquiry, and the recorded informed consent, wherein the correlation allows for simultaneous observation during presentation of a visual record of a patient education session; and

replay the at least one recorded patient education session.

19. The system of claim 15, wherein each portable device further includes:

at least one display comprising a touch-sensitive screen through which the patient may enter information; and

a visual image capture device that records the visual images, the visual image capture device selected from a group comprising a digital camera, a digital video camera, and a video camera.

20. The system of claim 15, wherein the at least one data system is further capable of:

transmitting the at least one interactive presentation to each portable device;

encrypting the at least one interactive presentation and the at least one update;

correlating the at least one interactive presentation with at least one of the recorded visual images of the patient observing the at least one interactive presentation, the recorded patient responses, and the recorded at least one inquiry, wherein the correlation allows for simultaneous observation during presentation of a visual record of a patient education session; and

storing the at least one patient education session using an optical disk system.

21. A remote device for obtaining informed patient consent, comprising at least one processor, at least one memory, at least one display, and at least one input device, wherein the remote device is capable of

providing at least one interactive presentation on a medical procedure;

recording patient response to at least one summary question of the at least one interactive presentation;

recording at least one inquiry of the patient during the at least one interactive presentation;

recording visual images of the patient observing the at least one interactive presentation;

determining patient comprehension using the patient response; and

recording an informed consent including an electronic signature of the patient.

22. The remote device of claim 21, wherein the remote device is further capable of:

receiving a transmission including the at least one interactive presentation from a data system;

receiving at least one update to the at least one interactive presentation from the data system, wherein the at least one update includes information selected from a group comprising new procedures, pharmaceuticals, statistics, and modifications to the at least one interactive presentation; and

updating the at least one interactive presentation.

23. The remote device of claim 21, wherein the remote device is further capable of:

recording at least one personal marker of the patient comprising at least one biological marker selected from a group comprising pulse rates, breath rates, blood pressure, fingerprints, toe prints, footprints, corneal scans, and retinal scans;

encrypting the at least one recorded patient education session for transmission; and

transmitting at least one recorded patient education session to a data system, wherein transmitting is performed over a medium selected from a group comprising bidirectional networks, wireless networks, and the Internet, wherein the at least one recorded patient education session includes the at least one interactive presentation, the at least one summary question, the recorded patient response, the recorded inquiry, the recorded visual images, a recorded personal marker of the patient, and the recorded electronic signature.

24. The remote device of claim 21, wherein determining patient comprehension comprises:

determining at least one score for at least one portion of the at least one interactive presentation using the recorded patient responses;

determining a status of the at least one score using a specified threshold;

when the at least one score is below the specified threshold, performing at least one action selected from a group comprising repeating the at least one interactive presentation, repeating at least one portion of the at least one interactive presentation, presenting information to supplement the at least one interactive presentation, readministering the at least one summary question, administering at least one additional summary question, and terminating the at least one interactive presentation.

25. The remote device of claim 21, further capable of correlating the at least one interactive presentation with at least one of the recorded visual images of the patient observing the at least one interactive presentation, the recorded patient responses, and the recorded at least one inquiry, wherein the correlation allows for simultaneous observation during presentation of a visual record of a patient education session.

26. The remote device of claim 21, wherein the at least one display comprises touch-sensitive screen through which the patient may enter information.

27. The remote device of claim 21, wherein the recording visual images is performed by a visual image capture device selected from a group comprising a digital camera, a digital video camera, and a video camera.

28. The remote device of claim 21, further capable of replaying at least one recorded patient education session, wherein the replay is correlated with the corresponding at least one interactive presentation, the recorded patient response, the recorded at least one inquiry, the recorded visual images, and the recorded informed consent.

29. A data system for obtaining informed patient consent, comprising at least one processor and at least one memory device, the data system capable of:

transmitting at least one interactive presentation to at least one remote device;

receiving and archiving at least one recorded patient education session from the at least one remote device, wherein the at least one recorded patient education session includes recorded visual images of a patient observing at least one interactive presentation and a recorded informed patient consent;

transmitting at least one interactive presentation update to the at least one remote device, the at least one interactive presentation update including information selected from a group comprising new procedures, pharmaceuticals, statistics, and modifications.

30. The data system of claim 29, wherein the at least one recorded patient education session further comprises the at least one interactive presentation, at least one summary question, a patient response to the at least one summary question, at least one inquiry of the patient, at least one biological marker of the patient, and a recorded electronic signature.

31. The data system of claim 29, wherein archiving comprises storing the at least one patient education session on an optical disk storage media.

32. The data system of claim 29, wherein the data system is further capable of transmitting at least one update to the at least one interactive presentation, wherein the at least one update is encrypted, wherein the at least one update includes information selected from a group comprising new procedures, pharmaceuticals, statistics, and modifications to the at least one interactive presentation.

33. The data system of claim 29, wherein the data system is further capable of correlating the at least one interactive presentation with at least one of the recorded visual images of the patient observing the at least one interactive presentation, the recorded patient responses, and the recorded at least one inquiry, wherein the correlation allows for simultaneous observation during presentation of a visual record of a patient education session.

34. A computer readable medium containing executable instructions which, when executed in a processing system, causes the system to obtain informed patient consent, the informed patient consent comprising:

providing at least one interactive presentation on a medical procedure;

recording patient response to at least one summary question of the at least one interactive presentation;

recording at least one inquiry of the patient during the at least one interactive presentation;

recording visual images of the patient observing the at least one interactive presentation;

determining patient comprehension using the patient response; and

recording an informed consent including an electronic signature of the patient.

35. The computer readable medium of claim 34, wherein the informed patient consent further comprises:

transmitting at least one recorded patient education session to a data system, wherein the at least one recorded patient education session includes the at least one interactive presentation, the at least one summary question, the recorded patient response, the recorded inquiry, the recorded visual images, the recorded personal marker, and the recorded electronic signature;

receiving the at least one recorded patient education session; and

archiving the at least one recorded patient education session, wherein archiving comprises storing the at least one patient education session on an optical disk storage media.

36. The computer readable medium of claim 35, wherein the informed patient consent further comprises encrypting the at least one recorded patient education session for transmission, wherein transmitting and receiving are performed over a medium selected from a group comprising bidirectional networks, wireless networks, and the Internet.

37. The computer readable medium of claim 34, wherein the informed patient consent further comprises:

receiving a transmission including the at least one interactive presentation from a data system; and

selecting the at least one interactive presentation to provide to the patient;

receiving at least one update to the at least one interactive presentation from the data system, wherein the at least one update includes information selected from a group comprising new procedures, pharmaceuticals, statistics, and modifications to the at least one interactive presentation; and

updating the at least one interactive presentation.

38. The computer readable medium of claim 34, wherein the informed patient consent further comprises:

recording at least one personal marker of the patient, the at least one personal marker comprising at least one biological marker selected from a group comprising pulse rates, breath rates, blood pressure, fingerprints, toe prints, footprints, corneal scans, and retinal scans; and

correlating the at least one interactive presentation with at least one of the recorded visual images of the patient observing the at least one interactive presentation, the recorded patient responses, and the recorded at least one inquiry, wherein the correlation allows for simultaneous observation during presentation of a visual record of a patient education session.

39. An electromagnetic medium containing executable instructions which, when executed in a processing system, causes the system to obtain informed patient consent, the informed patient consent comprising:

providing at least one interactive presentation on a medical procedure;

recording patient response to at least one summary question of the at least one interactive presentation;

recording at least one inquiry of the patient during the at least one interactive presentation;

recording visual images of the patient observing the at least one interactive presentation;

determining patient comprehension using the patient response; and

recording an informed consent including an electronic signature of the patient.

40. The electromagnetic medium of claim 39, wherein the informed patient consent further comprises:

transmitting at least one recorded patient education session to a data system, wherein the at least one recorded patient education session includes the at least one interactive presentation, the at least one summary question, the recorded patient response, the recorded inquiry, the recorded visual images, the recorded personal marker, and the recorded electronic signature;

receiving the at least one recorded patient education session; and

archiving the at least one recorded patient education session, wherein archiving comprises storing the at least one patient education session on an optical disk storage media.

41. The electromagnetic medium of claim 40, wherein the informed patient consent further comprises encrypting the at least one recorded patient education session for transmission, wherein transmitting and receiving are performed over a medium selected from a group comprising bidirectional networks, wireless networks, and the Internet.

42. The electromagnetic medium of claim 39, wherein the informed patient consent further comprises:

receiving a transmission including the at least one interactive presentation from a data system; and

selecting the at least one interactive presentation to provide to the patient;

receiving at least one update to the at least one interactive presentation from the data system, wherein the at least one update includes information selected from a group comprising new procedures, pharmaceuticals, statistics, and modifications to the at least one interactive presentation; and

updating the at least one interactive presentation.

43. The electromagnetic medium of claim 39, wherein the informed patient consent further comprises:

recording at least one personal marker of the patient, the at least one personal marker comprising at least one biological marker selected from a group comprising pulse rates, breath rates, blood pressure, fingerprints, toe prints, footprints, corneal scans, and retinal scans; and

correlating the at least one interactive presentation with at least one of the recorded visual images of the patient observing the at least one interactive presentation, the recorded patient responses, and the recorded at least one inquiry, wherein the correlation allows for simultaneous observation during presentation of a visual record of a patient education session.