INFORMATION DELIVERY SYSTEM Background
This application relates to the delivery of information from physicians or other
medical practitioners to patients, pursuant to the practitioner's obligation of obtaining
informed consent to treatment.
The doctrine of informed consent provides that a practitioner must disclose to a patient the practitioner's diagnosis of the patient's condition, the nature and purpose of any proposed treatment, the risks and consequences of that treatment, any reasonably feasible
treatment alternatives and the prognosis if the proposed treatment is not undertaken.
Historically, practitioners have directly imparted this information verbally to the patient.
Thus, the effectiveness of the information transfer was dependent on the practitioner's memory and communication skills. Also, this approach consumed a considerable amount of the practitioner's time and did not provide effective documentation of the information
transfer.
Accordingly, practitioners began using pre-packaged disclosure and consent forms
containing basic explanations of specific diagnostic and therapeutic procedures. Since such documentary disclosure devices were dependent on the patient's literacy, they evolved into video devices, such as video cassettes, which could be viewed either at a station in the
practitioner's office or at the patient's home, if the patient had a VCR. However,
documentation of the video cassette transfer was less satisfactory then with written
disclosure documents, since the consent form could only refer to the video cassette, whereas a documentary disclosure form could embody the consent, so that the patient's
signature on the consent was proof that the patient had at least seen the document.
However, all of these devices had a fundamental drawback in that they could not assure
the patient's comprehension of the information in the document or video tape.
With the dawn of the computer age, more interactive programs of patient education
became possible. One such program is the Patient Advise and Consent Encounter
("PACE"), developed by the American College of Obstetrics and Gynecology. The PACE
program is an interactive CD-ROM system, utilizing a separate CD-ROM program or module for each procedure or group of related procedures. The patient plays the
interactive program on a multimedia computer in the practitioner's office and responds to
its prompts and questions. The patient's progress is recorded on a floppy disk and a
summary printout is generated for the practitioner. The electronic record documents that the information was presented and also evidences the level of the patient's comprehension.
The program uses a separate CD-ROM for each information module to make it more
convenient for the practitioner to limit the patient's exposure to only those modules which
are prescribed. However, this program must be utilized in the practitioner's office, which may be an inhibiting and distracting venue. Furthermore, the program does not provide for
regular updates of the information modules.
Summary
This application discloses a system and method for controlling delivery of information from a medical practitioner to a patient, which avoids disadvantages of prior systems while affording additional advantages.
An aspect of the system and method is that it utilizes a virtual site on a computer
network for controlling, and recording the progress of, the patient's review of prescribed information.
Another aspect is the use of access control and access codes so that multiple
modules of information can be stored on a single storage medium while still limiting the patient's access to only prescribed modules.
In connection with the foregoing aspects, another aspect is the prevention of
viewing of the encrypted modules except via the virtual site.
Still another aspect is the provision of immediate feedback to the practitioner and
to the information module producers via the computer network.
Still another aspect is the use of the Internet without compromising patient confidentiality by obviating transmission of patient information. Yet another aspect is effective electronic documentation of patient review of and
comprehension of prescribed information.
A still further aspect is the accommodation of patient review of prescribed
information in privacy and at the patient's own pace.
Certain ones of these and other aspects may be realized by providing a computer system for controlling delivery of information from a medical practitioner to a patient,
comprising: a computer network, a portable storage medium storing modules of
information, a patient computer in communication with the network and programmed to
read the storage medium to display patient interface screens to guide the patient through review of modules of information stored on the medium in accordance with a prescription by the medical practitioner, and a system computer in communication with the network
and programmed to establish a virtual site accessible via the network from the patient
computer, the patient computer being programmed to access the virtual site via the
network, the system computer being programmed to record at the virtual site the progress of patient review of modules of information.
Other aspects may be realized by providing a system of the type set forth wherein
the modules of information are access contiOlled, access codes for selected modules being provided on another storage medium which is also received in the patient computer for
controlling access to the selected modules. Still other aspects maybe realized by controlling the access and decryption through
the virtual site.
Other aspects maybe realized by updating the information modules in accordance
with feedback from the patient and the practitioner.
Brief Description of the Drawings
For the purpose of facilitating an understanding of the subject matter sought to be
protected, there are illustrated in the accompanying drawings embodiments thereof, from
an inspection of which, when considered in connection with the following description, the
subject matter sought to be protected, its construction and operation, and many of its
advantages should be readily understood and appreciated.
FIG. 1 is a functional block diagrammatic view of an information prescription
system;
FIG. 2 is a functional flow chart of the operation of the system of FIG 1; FIGS. 3, 3A and 3B are a flow chart of software controlling operations of the
interaction between the patient computer and the Web site of the systems of FIG. 1; and FIGS. 4A - 4E are illustration of computer screen displays usable in the operation
of system of FIG 1.
Detailed Description
Referring to FIG. 1, there is illustrated an information prescription system 10. The
system includes a production/operations site 11 (which may represent more than one physical location), wherein the information content is generated and recorded on a storage
medium, such as a compact disk ("CD") 12. While each CD 12 could be of the writeable
type, it is preferably in the form of read-only memory, i.e., a CD-ROM. The information
is organized into modules, with each module relating to a particular subject, such as a
particular illness, condition, medication, treatment, or the like, and each module may include both text and images or videos organized so as to facilitate comprehension. The
modules of information are stored on the storage medium in an access controlled form, and
a number of such modules may be stored on a single CD 12 or other storage medium.
Access control may be provided by, e.g., encrypting the data on the CD, hidden directory (wherein the directory of CD contents is stored away from the CD), control through the Web site server or the like. Access may be authorized, e.g., by a hardware key, such as a
floppy disk containing authorization codes, or by entry of authorization codes on the Web
site server, such as by a nurse or other staff person.
The completed CDs are distributed to physicians, or other medical practitioners. Thus, the system 10 includes a medical practitioner ("MP") office 13 which includes a CD
library 14, including a number of the CDs 12 pertinent to the MP's practice. The MP
office 13 also includes a kiosk 15, which is a computer or other Internet access device
dedicated to patient use in viewing information modules stored on a CD 12. Typically, the MP office 13 will also include an MP computer 16 for use by the practitioner.
Both the kiosk 15 and the MP computer 16 are provided with suitable modems (not
shown) for providing connection, via an Internet service provider, to the Internet, indicated
at 17. The system 10 also includes a system virtual site, in the nature of a Web site 18
established by a system computer 18 a, which is also coupled to the Internet 17 and is in
direct communication with the production/operations site 11, which site is preferably also adapted to be coupled to the Internet 17. While a patient can view information modules at
the kiosk 15 at the MP office 13, the system also contemplates viewing the information
modules at a home computer 20 located at the patient's home. This is feasible as long as
the home computer 20 includes a CD-ROM drive 21 and a floppy drive 22 for accommodating a standard "floppy" disk 23, such as a 3%"-diskette. Thus, it will be
appreciated that all of the production/operations site 11, the MP office 13, the Web site 18
and the patient computer 20 are coupled to the Internet for Internet communication with
one another. In this regard, preferably the kiosk 15 is designed for automatic Internet
connection with the Web site 18, as will be explained more fully below.
Referring to FIG. 2, the operation of the system 10 will be explained in greater
detail. FIG. 2 depicts a flow chart 30 of the system operation, with particular emphasis on
the CD production aspect of the system. Fundamentally, CD production takes place at the
production/operations site 11. Data is collected at 31 from standard sources, such as online sources, medical texts, journals and the like, and organized into information modules, as explained above. Initially, each module is written or revised at an MP level at 32 and
the content is then edited, at 33, and submitted to a review panel for acceptance. If, at 34,
the module information content is not accepted, it is returned to 32 for further rewriting or
revision. If it is accepted, it is then rewritten for comprehension at the fourth-grade level, at 35, and then animation, graphics, photographs and other images are added, as necessary
and/or desirable, and a prototype is then mounted at 36. Then, at 37, the prototype content
is submitted to a focus group for review. If, at 38, the content is not accepted, it is
returned for rewrite and/or revision of graphics at 35 and 36. If it is accepted, a prototype
CD is created at 39 and tested at 40. If, at 41, the prototype is not accepted after testing, it
is returned to 39. If it is accepted, it is submitted for focus group review of the entire system at 42. If, at 43, the system is not accepted, it is returned to 39. If it is accepted, the
final CD is produced at 44, provided with an identifier such as an appropriate number and,
at 45, distributed to medical practitioners.
At the MP office 13, the MP who wishes certain infoπnation to be reviewed by a patient, such as for the purpose of obtaining informed consent to a treatment procedure,
writes a prescription for the desired information, such as by checking off appropriate modules from a list or prescription form. The prescription is then submitted to a nurse or
other assistant who issues the CD or CDs containing the prescribed information module or modules, and, in the case of a hardware key, may also add to an access control floppy disk
access codes for the prescribed information modules. Both the access controlled CD and
the floppy disk (if used) are then given to the patient to view the information, either at the kiosk 15 in the MP office 13 or at the home computer 20. In either case, the patient
accesses the Web site 18, as at 48, and views the prescribed information modules.
Preferably, each of the information modules is designed in the form of a tutorial and
includes questions designed to test the patient's comprehension of the material. Thus, after each section of an information module, one or more questions may be presented,
preferably in multiple-choice form, and the patient answers the questions with the use of a
keyboard, mouse or the like, as at 49. As will be explained more fully below, the Web site
18 automatically monitors the progress of the patient's review of the information modules
and checks at 50 to see if the infoπnation is being comprehended. If it is not, the patient is prompted to review the material at 48.
When the patient has completed review, of the material, then, at 51, a record of the
patient review process is analyzed at the Web site and then, at 52, an E-mail with the comprehension review analysis is forwarded to the prescribing MP. The MP can then, if
necessary, conduct supplemental or follow-up education of the patient and can also, at 53,
feed back to the system comments on the information module. At 54, on a weekly basis,
the patient comprehension review analysis and MP feedback with respect thereto is
analyzed and then reviewed at 55 and this review result is then utilized for revision of the
information module content at 32, as necessary. This review infonnation is also used, at
56, along with information from the standard data sources, for producing MP updates of new technology and practices for submission to the MP for current education of the MP.
Thus, a significant aspect of the present system is that it affords both patient and medical
practitioner feedback which may be used in evaluating, updating and revising information
modules.
The operation of the system 10 for interactive patient review of information
modules will now be explained with reference to FIGS. 3-3B and 4A-4E. FIGS. 3-3B
illustrate a flowchart of the program software 60 controlling the interactive patient review
of information modules,. FIG. 3 A illustrating that portion of the program executed at
either the kiosk 15 or the home computer 20, either of which may hereinafter be referred to as a "patient computer," while FIG. 3B illustrates that portion of the program executed at
the system computer 18 A using the Web site 18. FIGS . 4A-4E illustrate representative
computer screen displays.
Initially, at 61, the program accesses the Web site 18. Preferably, this will occur automatically at the kiosk 15 and, at the home computer 20, the patient would access the Web site 18 in the same manner that any other Internet Web site is accessed. After the
Web site is accessed, at 63, the site will begin to monitor the patient computer at 64. At
this point, the screen display of FIGS 4A-4B would appear, prompting the patient to select a particular information module by entering a user name code next to that module
designation. If the user has not been authorized to view that module, the user would be so
5 informed by an appropriate display message. If the user is authorized, the screen display
of FIG. 4C would appear, prompting the user to insert the CD (and, if used, the floppy disk) in the appropriate drives. Then, at 62 (FIG. 3A), the patient loads the access controlled CD 12 and the floppy disk 23 (if used), respectively, into the CD-ROM drive 21
and floppy drive 22 of the patient computer 15 or 20 (see FIG. 1). When the CD is
o inserted, the authorized and selected infoπnation module will begin to be displayed. The
first screen display of such a module is illustrated in FIG. 4D. It will be appreciated that
the module could include numerous such pages, including both text and images or videos. Interspersed tlirougliout the module screen displays or at the end thereof, will be displayed
patient-comprehension evaluation questions (not shown) which will prompt patient
5 responses to enable the system to evaluate the patient's comprehension of the material.
The last screen display of the module, illustrated in FIG. 4E, includes alternative NEXT
prompts, depending upon whether the patient does or does not have further questions. If the patient has no questions, selection of that prompt will return the user to the screen
display of FIG. 4 A. If there are questions, selection of that prompt will bring up an e-mail
o section (not shown) to pennit the patient to enter and e-mail the questions to the Web site server.
Meanwhile, at 65 (FIG. 3A), the patient computer will read the CD number and
access codes at 65 and then, at 66, will check to see if a patient entry has been made (via
keyboard or mouse click). If not, the program will return to 26 and continue checking for
a patient entry. If there is a patient entry, the program will next check at 67 to see if it is
an E-mail transmission. If so, the program will, at 68, transmit the E-mail message to the MP computer 16. If the entry is not an E-mail, the program then, at 69, checks to see if it
is an answer to a comprehension question. If so, the program, at 70, transmits the answer
to the Web site 18.
At the Web site, at 73 (FIG. 3B), the program checks to see if a transmission has been received from the patient computer. If not, it returns to 64 to continue monitoring. If
a transmission is received, the program then checks at 74 to see if it is a request to view an
information module. If not, it then checks at 75 to see if the entry is an answer to a
comprehension question. If not, it returns to 64. If the entry is an answer to a
comprehension question, the program then records it at 76 against the information module section being viewed.
Meanwhile, at the patient computer, if, at 69, the patient entry was not an answer to
a comprehension question, the program then checks, at 71, to see if it is a request to view
an infoπnation module section. If not, the program returns to 66. If it is a request to view, the program then, at 72, transmits this request, along with the CD number, the access
codes and a time stamp to the Web site, where it will cause a "YES" answer at 74. The
program will then, at 77, stop a timer, if it is already running, and record the elapsed time
for review of the previously- viewed information module section. The program then, at 78,
restarts the timer and, at 79, checks the transmit request against the CD number and access codes and then decides, at 80, whether the section sought to be viewed is on the CD and
has been approved for viewing. If not, the program, at 81, advises the patient computer
that access is denied. If there is a match, the program, at 82, transmits an access control key to the patient computer.
Meanwhile, at the patient computer (FIG. 3 A), after the transmit request has been
transmitted to the Web site at 72, the program checks at 83 to see if a response has been received. If not, it returns to 72. If so, it checks at 84 to see if the response is an access
control key. If not, it then, at 85, displays an access denied screen and returns to 66. If the
5 response is an access control key, the program, at 86, displays the selected module section
and then returns to 66.
Thus, it can be seen that the patient cannot view a prescribed information module
without accessing the Web site, and the Web site is actively involved in authorizing
decryption of the prescribed module or module section, and in monitoring the patient
o review process. Even though there is interaction between the patient computer and the
Web site, no patient information need be transmitted. The only information that is
transmitted to the Web site is the number of the CD loaded in the patient's computer and
the access codes on the floppy disk.. Only the MP knows what disk was given to what
patient. Because no patient information is transmitted to the system administrator, patient
5 privacy is fully protected
Significantly, the present system provides a complete electronic record of patient
review of the prescribed information modules, so that there is full documentation not only
of the fact that the infoπnation was transmitted to the patient, but also the level of the patient's comprehension. The pace of the patient review is completely under the patient's
o control, repetition is easily accomplished, and the CD may, if desired, be viewed at the patient's home in privacy and without the distractions and pressures which might exists in
the MP's office. Patient comprehension is enhanced by the fact that the patient receives
only the information modules which are prescribed by the physician as being necessary, so
the patient is not burdened with extraneous material. A summary of the patient review is
e-mailed or faxed to the practitioner, who can then determine if further patient education is
needed. The hybrid CD/Web site nature of the system affords the connectivity and
immediate feedback of the Internet, but allows the high resolution video and in-depth
multimedia content available with the CD format. Frequent and regular updates of information modules is a fundamental aspect of the system, and the automated nature of
the feedback involved permits inexpensive creation of databases of great utility to
insurance companies, health research groups and others seeking large-scale information on
real patient outcomes.
While, in FIGS. 3-3B, a specific interactive protocol has been described, it will be
appreciated that other interactive approaches could be used. Also, while the preferred
storage medium for the information modules is a CD, it will be appreciated that other
types of storage media could be utilized.
From the foregoing, it can be seen that there has been provided an improved system for delivering information from a medical practitioner to a patient, which affords
complete patient privacy, fosters patient comprehension, eliminates irrelevant information
transfer, provides automatic patient and MP feedback, and automatically documents
patient review and comprehension.
The matter set forth in the foregoing description and accompanying drawings is offered by way of illustration only and not as a limitation. While particular embodiments
have been shown and described, it will be obvious to those skilled in the art that changes
and modifications may be made without departing from the broader aspects of applicants'
contribution. The actual scope of the protection sought is intended to be defined in the following claims when viewed in their proper perspective based on the prior art.