Checklist-based flow and tracking system for patient care by medical providers

• US 20040044546A1
• Filed: 05/16/2003
• Published: 03/04/2004
• Est. Priority Date: 05/16/2002
• Status: Active Grant

• Current Assignee: Cerylion Incorporated
• Original Assignee: Alan J. Dworsky
• Inventors: Moore, Gordon T.
• Granted Patent: US 7,693,727 B2
• Time in Patent Office: Days
• US Class Current: 705/2
• CPC Class Codes: G06Q 10/10 Office automation; Time management
• CPC Class Codes: G06Q 40/08 Insurance
• CPC Class Codes: G16H 10/60 for patient-specific data, e.g. for electronic patient records
• CPC Class Codes: G16H 15/00 ICT specially adapted for medical reports, e.g. generation or transmission thereof
• CPC Class Codes: G16H 50/20 for computer-aided diagnosis, e.g. based on medical expert systems
• CPC Class Codes: G16H 70/20 relating to practices or guidelines
• CPC Class Codes: G16H 80/00 ICT specially adapted for facilitating communication between medical practitioners or patients, e.g. for collaborative diagnosis, therapy or health monitoring

Abstract

Interactive methods and systems for directing, integrating, documenting, and tracking steps taken by medical providers during the process of care for a patient'"'"'s given condition. Doctors'"'"' actions are directed by a prescriptive protocol - a checklist of discrete steps designed for efficient or optimal care of an individual patient'"'"'s specific condition. The step-by-step checklist is abstracted from decision tree guidelines for the optimal work up and treatment for the condition using probability-based methodology. The care protocols can be derived from widely available and non-proprietary guidelines and decision trees based on public medical research literature.

In one embodiment, the invention can be employed by a primary care clinician at the point of referral into the specialist sector, and at the specialist level when proposing a risky or expensive or otherwise problematic medical or surgical diagnostic or treatment intervention. At these two critical transaction points in care, the checklist functions like a lock, based on a hidden clinical decision algorithm (an explanation of which can be displayed upon request). The system asks the clinician for data and then generates the patient'"'"'s optimal checklist, displaying it as a point and click form keyed to the stage of care being undertaken by each doctor. As the clinician enters data into the checklist, a decision engine determines whether the checklist data satisfies predetermined criteria for authorization of the proposed action. The system can also document each transaction taken in the process of care to create an electronic record that can be made accessible to all clinicians involved in the process of care.

Claims

1. A method of converting evidence-based clinical decision support guidelines into a prescriptive patient-specific checklist of actions to satisfy process and outcome requirements for care of a specific diagnosis and episode of illness comprising:

deconstructing a guideline into its constituent symptom, physical exam finding, test, or treatment datum inputs;

subjecting each datum input to Bayesian test characteristic analysis using, when available, the sensitivity and specificity of each datum input with respect to a suspected medical condition, and the prior probability of the suspected medical condition, and calculating post-test probability of a positive or negative result for each datum input;

based upon the test characteristic analysis, creating plurality of protocols, each protocol associated with a prior probability of a patient'"'"'s diagnosis, each protocol representing the optimal number and sequence of datum inputs for the care of the clinical condition through to resolution; and

based on the protocols, extracting the datum input or combination of datum inputs at each decision step of the guideline, and constructing its medical representation, the totality of the medical representations constituting the checklist.

2. The method as claimed in claim 1, wherein the prior probability of a patient'"'"'s diagnosis is determined by a decision algorithm that estimates a patient'"'"'s prior probability of a diagnosis based upon at least one, or more, elements of patient data, information from the medical literature, and analysis of the accumulated experience of a plurality of patients represented in an episode data base.

3. The method as claimed in claim 1, wherein the prior probability of a patient'"'"'s diagnosis is determined by assigning the patient to a prior probability level.

4. The method as claimed in claim 1, wherein the estimate of prior probability generates a unique checklist workup protocol for the specified patient'"'"'s episode of illness care by specialists.

5. A method of managing a patient'"'"'s episode of specialist care through using a temporary, integrated medical episode record that is based upon an algorithmically constructed checklist that specifies and tracks decisions about care comprising:

at a referring user interface, selecting a medical specialty;

from a data base, based on the selected medical specialty, returning to the referring user interface a set of condition-specific queries for patient information, the patient information comprising at least one of symptoms, physical exam finding, tests, or treatment data;

at the user interface inputting patient information in response to the queries;

at the data base, receiving the patient information and, based on decision logic, determining the patient'"'"'s probability of a medical condition and comparing this probability to a threshold probability for authorizing or refusing referral to a specialist within the selected medical specialty.

6. The method of claim 5, further comprising:

at a specialist user interface, receiving patient information input through the referring user interface and selecting a procedure to be performed;

from a data base, based on the selected medical specialty, returning to the referring user interface a set of condition-specific queries for patient information, the patient information comprising at least one of symptoms, physical exam finding, tests, or treatment data

at the specialist user interface, inputting patient information in response to the queries;

at the data base, receiving the patient information and, based on decision logic, determining the patient'"'"'s probability of a medical condition and comparing this probability to a threshold probability for authorizing or refusing authorization for the proposed medical procedure.

7. The method of claim 6, further comprising:

at the data base, storing the referring and specialist patient data in a linked temporary transaction record that documents the patient'"'"'s care process and progress.

8. A method as claimed in claim 5 wherein the database is behind an insurer'"'"'s, a practice'"'"'s, or a hospital'"'"'s privacy and HIPAA privacy compliant fire wall.

9. The method as claimed in claim 5 wherein the database returns to the referring user interface a list of eligible specialists, one of which is selected at the user interface.

10. A method as claimed in claim 9 wherein the specialists in the list who have access to the database are highlighted in the list.

11. A method as claimed in claim 5 wherein a web-based GUI hypertext referral form from primary care to specialty doctors incorporating checklist protocols is created in a point and click format.

12. A method as claimed in claim 6 wherein a specialist may customize the decision logic to include procedures to be performed by a referring medical practitioner.

13. A method as claimed in claim 6 wherein patient insurance information is delivered to at least one of the referring and specialist user interfaces.

14. A method as claimed in claim 5 wherein the database receives information about the patient from another electronic information database.

15. A method as claimed in claim 5 further comprising automatically generating a referral note from the referring user to a specialist.

16. A method as claimed in claim 6 wherein the database provides evidence-based decision guidelines, relevant articles, and expert commentary to each of the user interfaces upon request.

17. A method as claimed in claim 5 wherein the database returns patient care recommendations through the referring user interface.

18. A method as claimed in claim 17 wherein the recommendations include procedures to be performed by a referring medical practitioner to assist the specialist.

19. A method as claimed in claim 17 wherein the recommendations include patient information about location and other special advice regarding the consultation

20. A method as claimed in claim 6 whereby the sequence of medical decisions and data are aggregated into a temporary electronic episode record linking the checklist data of all clinicians and documenting transactions and incremental progress.

21. A method as claimed in claim 6 wherein the database returns to the referring user interface patient information input at the specialist user interface concerning the care including tests and procedures and outcomes.

22. A method as claimed in claim 21 wherein the database identifies discrepancies between expected check list expected items and values and the information entered through at least one of the referring user interface and the specialist user interface.

23. A method as claimed in claim 6, further comprising extracting tracking information about the patient'"'"'s progress on the check list and communicating deviations from the check list protocol back to the referring user.

24. A method as claimed in claim 22 wherein discrepancies relating to at least one of timing, location, completion of check list items, and values of checklist items are published as a visual scorecard for primary care doctors and/or patients.

25. The method as claimed in claim 5, wherein the active episode record is stripped of patient identifying data and stored in a relational data base of check list elements of all patient, doctor and insurer users of the system and wherein the data base performs analysis of referring and/or specialist physicians'"'"' and insurer'"'"'s performance over plural doctors, plural patients and plural insurers.

26. A patient referral management data processing system, comprising:

a referring user interface by which a medical practitioner identifies a specialty to which he intends to refer a patient and inputs patient information; and

a referral data base process which, based on the selected specialty, returns to the referring user interface a set of condition-specific queries for patient information, the patient information comprising at least one of symptoms, physical exam findings, tests, or treatment data, and, based upon the patient information entered at the referring user interface, determines the patient'"'"'s probability of a medical condition and compares this probability to a threshold probability for authorizing or refusing authorization for a referral to a specialist within the selected medical specialty.

27. The system of claim 26, wherein the data base process receives patient information from the referring user interface and, based on deviation from the patient'"'"'s checklist protocol, notifies the referring user interface of the availability of backup explanation and further recommendations.

28. The system of claim 26, wherein the database process returns to the referring user interface an insurer'"'"'s approval and authorization to proceed from an insurance data base, based on concordance with the check list.

29. The system as claimed in claim 28 wherein an accounts payable data bank initiates payment by the insurer to the doctor for the referral process.

30. A procedure approval data processing system wherein the intended action is a specialist clinical procedure comprising:

a specialist user interface by which a specialist identifies an intended procedure for which he seeks approval and inputs patient information;

a procedure approval data base process which, based on the selected procedure, returns to the referring user interface a set of condition-specific queries for patient information, the patient information comprising at least one of symptoms, physical exam findings, tests, or treatment data, and, based upon the patient information entered at the specialist user interface, determines the patient'"'"'s probability of a medical condition and compares this probability to a threshold probability for authorizing or refusing authorization for the selected procedure.

31. The system of claim 30, wherein the procedure approval data base process receives patient information from the specialist user interface and, based on deviation from the patient'"'"'s checklist protocol, notifies the specialist user interface of the availability of backup explanation and further recommendations.

32. The system of claim 30, wherein the procedure approval database process returns to the specialist user interface an insurer'"'"'s approval and authorization to proceed from an insurance data base, based on concordance with the check list.

33. The system of claim 32, wherein an accounts payable data bank initiates payment by the insurer to the doctor for the approved procedure.

34. A method of managing an episode of medical care in a data processing system, comprising:

at a user interface, selecting a proposed medical action;

from a database, based upon the selected medical action, returning an interactive checklist of data points for the episode of care, the data points comprising representations of decision nodes of an evidence-based clinical decision support guideline associated with the proposed medical action;

at the user interface, inputting data into a data point of the checklist;

using the data input for the data point, calculating a probability of a medical condition associated with the proposed medical action based upon a prior probability of the condition, the sensitivity of the data point with respect to the condition, and the specificity of the data point with respect to the condition;

comparing the calculated probability of the medical condition to a pre-determined threshold probability of the condition that is associated with the proposed medical action; and

based upon the comparison, authorizing the proposed medical action, refusing authorization of the proposed medical action, or requesting additional data input into the checklist.

35. The method of claim 34, wherein the pre-determined threshold probability comprises an approval threshold, and the proposed medical action is authorized when the calculated probability exceeds the approval threshold.

36. The method of claim 34, wherein the pre-determined threshold probability comprises a rejection threshold, and the proposed medical action is refused authorization when the calculated probability is less than the rejection threshold.

37. The method of claim 34, wherein the calculated probability is compared to both an approval threshold and a rejection threshold, the proposed medical action being authorized when the calculated probability exceeds the approval threshold, and refused authorization when the calculated probability is less than the rejection threshold.

38. The method of claim 34, wherein the proposed medical action comprises a referral to a specialist physician.

39. The method of claim 34, wherein the proposed medical action comprises a medical test or examination.

40. The method of claim 34, wherein the proposed medical action comprises a medical or surgical diagnostic or treatment procedure.

41. The method of claim 40, wherein the proposed procedure comprises surgery.

42. The method of claim 34, wherein data input into data points on the checklist comprises at least one item of items of medical history, physical examination findings, medical tests, and medical procedures.

43. The method of claim 34, further comprising determining an initial prior probability of the medical condition for a patient based on at least one of presenting symptoms, physical examination findings, the patient'"'"'s personal medical history, information from medical literature, the frequency of the condition within a population of which the patient is a member, and an analysis of the accumulated experience of patients stored in a database accessible by the data processing system.

44. The method of claim 43, wherein determining an initial prior probability comprises assigning the patient to an initial prior probability level.

45. The method of claim 43, wherein the checklist returned is associated with a particular initial prior probability level.

46. The method of claim 45, wherein at least one of the number and sequence of data points on the checklist is determined based upon the initial prior probability associated with the checklist.

47. The method of claim 46, wherein the checklist is generated by calculating, for each decision node of the evidence-based clinical decision support guideline associated with the proposed medical action, the probability of the existence of a particular medical condition based upon the initial prior probability level, the sensitivity of the decision node with respect to the condition, and the specificity of the decision node with respect to the condition, and, based upon these calculations, determining an optimal sequence and number of data inputs to reach a pre-selected probability of the existence of the condition.

48. The method of claim 47, wherein from each evidence-based clinical decision support guideline, a plurality of checklists are generated, each checklist associated with a different initial prior probability level.

49. The method of claim 47, wherein the sequence and number of data inputs is optimized with reference to at least one of the cost, the risk, and the change in probability level associated with each data input.

50. The method of claim 34, wherein for each data point on the checklist, the prior probability of the condition is determined by the probability calculation for the preceding data point.

51. The method of claim 34, wherein the threshold probability of the condition is determined based upon an analysis of risks and benefits associated with the proposed medical action.

52. The method of claim 34, wherein the probability calculation and comparison steps are repeated for each data point on the checklist until the proposed medical action is authorized or refused authorization, or all data points on the checklist are exhausted.

53. The method of claim 34, wherein the user interface accesses the database remotely via a computer network.

54. The method of claim 53, wherein the network comprises the world wide web.

55. The method of claim 53, wherein the database is located behind a privacy firewall of a health insurance provider such as an insurance company, a government insurer, or a self-insured employer.

56. A medical care data management system comprising:

a user interface by which a physician proposes a medical action;

an interactive checklist of data points for the episode of care, the data points comprising representations of decision nodes of an evidence-based clinical decision support guideline associated with the proposed medical action, the checklist permitting the input of data into the data points via the user interface;

a database process which, based on the selected medical action, returns the checklist to the user interface, uses data input into a data point of the checklist to calculate the probability of a medical condition associated with the proposed medical condition, the probability calculation being based upon a prior probability of the condition, the sensitivity of the data point with respect to the condition, and the specificity of the data point with respect to the condition, compares the calculated probability of the medical condition to a pre-determined threshold probability, based upon the comparison, authorizes the proposed medical action, refuses authorization of the proposed medical action, or requests additional data input into the checklist.

57. The system of claim 56, wherein the pre-determined threshold probability comprises an approval threshold, and the proposed medical action is authorized when the calculated probability exceeds the approval threshold.

58. The system of claim 56, wherein the pre-determined threshold probability comprises a rejection threshold, and the proposed medical action is refused authorization when the calculated probability is less than the rejection threshold.

59. The system of claim 56, wherein the calculated probability is compared to both an approval threshold and a rejection threshold, the proposed medical action being authorized when the calculated probability exceeds the approval threshold, and refused authorization when the calculated probability is less than the rejection threshold.

60. The system of claim 56, wherein the proposed medical action comprises a referral to a specialist physician.

61. The system of claim 56, wherein the proposed medical action comprises a medical test or procedure.

62. The system of claim 61, wherein the procedure comprises a surgical test or procedure.

63. The system of claim 56, wherein the data input into data points comprises at least one item of items of medical history, physical examination findings, medical tests, and medical procedures.

64. The system of claim 56, wherein the database process further comprises a prior probability database process which determines an initial prior probability for the medical condition based upon at least one of presenting symptoms, physical examination findings, the patient'"'"'s personal medical history, information from medical literature, the frequency of the condition within a population of which the patient is a member, and an analysis of the accumulated experience of patients stored in a database, and wherein the database process uses the initial prior probability to calculate the probability of the condition for an initial data point on the checklist.

65. The system of claim 64, wherein for each subsequent data point on the checklist after the initial data point, the prior probability of the condition is determined by the probability calculation for the preceding data point.

66. The system of claim 64, wherein the database process further comprises a checklist database process which receives an initial prior probability for the medical condition from the prior probability database process, and returns a checklist associated with the initial prior probability.

67. The system of claim 66, wherein at least one of the number and sequence of data points on the checklist is determined based upon the initial prior probability associated with the checklist.

68. The system of claim 67, wherein the checklist is generated by calculating, for each decision node of the evidence-based clinical decision support guideline associated with the proposed medical action, the probability of the existence of a particular medical condition based upon the initial prior probability level, the sensitivity of the decision node with respect to the condition, and the specificity of the decision node with respect to the condition, and, based upon these calculations, determining an optimal sequence and number of data inputs to reach a pre-selected probability of the existence of the condition.

69. The system of claim 68, wherein from each evidence-based clinical decision support guideline, a plurality of checklists are generated, each checklist associated with a different initial prior probability.

70. The system of claim 68, wherein the sequence and number of data inputs is optimized with reference to at least one of the cost, the risk, and the change in probability of the condition associated with each data input.

71. The system of claim 56, wherein the database process further comprises a threshold probability database process which, based on the proposed medical action, returns a threshold probability value associated with the proposed medical action.

72. The system of claim 71, wherein the threshold probability value is determined based upon an analysis of risks and benefits associated with the proposed medical action.

73. A method of managing an episode of medical care in a data processing system, comprising:

at a referring user interface, selecting a medical specialty and inputting patient information;

at a database, receiving the selected medical specialty and the patient information, and determining an initial prior probability of a medical condition associated with the selected medical specialty;

from the database, based upon the initial prior probability, returning to the user interface an interactive checklist of data points for the episode of care, the data points comprising representations of decision nodes of an evidence-based clinical decision support guideline associated with the medical specialty;

at the user interface, inputting data into a data points of the checklist; and

at the database, using the data input into the data points of the checklist to determine whether a referral to a specialist physician is authorized.

74. The method of claim 73, further comprising:

at a specialist user interface, receiving patient information input through the referring user interface, inputting additional patient information, and selecting a medical or surgical diagnostic or treatment intervention; and

at the database, using the patient information input through the referring user interface and the specialist user interface, determining whether the selected medical procedure is authorized.

75. The method of claim 74, further comprising:

at the database, determining an initial prior probability of a medical condition associated with the selected medical procedure; and

from the database, based upon the initial prior probability, returning to the specialist user interface an interactive checklist of data points for the episode of care, the data points comprising representations of decision nodes of an evidence-based clinical decision support guideline associated with the selected medical procedure; and

at the specialist user interface, inputting data into the data points of the checklist, wherein the checklist data points are used with the patient information input through the referring user interface, the specialist user interface, and interfaces with other data sources laboratories and patients, for example.

76. The method of claim 75, further comprising:

at the database, storing the referring and specialist checklists and patient information in a temporary episode record.

77. The method of claim 76, wherein the referring user, patient, or other authorized user can access the temporary episode record to track the progress of patient care.

78. The method of claim 76, further comprising:

from the database, reporting information entered by the specialist back to the referring user.

79. The method of claim 78, wherein the information reported back to the referring user comprises discrepancies between information entered by the specialist physician and an expected treatment protocol.

80. The method of claim 73, wherein the database is located behind a privacy firewall of an insurer, and authorization for the referral and the medical procedure is provided by the insurer.

81. The method of claim 76,. wherein, upon completion of an episode of care, the temporary episode record is stripped of patient identifying data and stored in a database.

82. The method of claim 73, further comprising:

upon authorization of a referral, returning to the referring user interface a list of eligible specialist physicians.

83. The method of claim 82, further comprising:

at the referring user interface, selecting an eligible specialist physician; and

at the database, using checklist data to automatically generate a referral note from the referring user to the selected specialist.