Domain Expert Working Session

1. Domain Expert Working Session caEHR Analysis Team January 19-20, 2011

2. caBIG® Clinical Information Suite January 19-20, 2011

3. Announcements • Introductions • Next call is January 26th • Asking about Chicago for next Face-to-face • Lunch arrangements

4. Agenda Review

5. Agenda Review

6. caBIG® Clinical Information Suite Chemotherapy Management

7. caBIG® Clinical Information Suite Demo Pilot

8. Demo Pilot - Purpose • Demonstrate • Tolven as a reference • Use of Service Oriented Architecture (SOA) • Extract outcomes data in format usable by foreign system • Find an evidence-based regimen • Ability to create and send HL73 messages • Use of new standard terminologies such as Snomed-CT

9. Demo Pilot – Take away today • Thanks again to Dr. Schorer & Dr. Ellerton for assistance with data! • Wireframe design specifications

10. Demo Pilot - Diagnosis

11. Demo Pilot – Cancer Staging

12. Demo Pilot – Pathology Report

13. Demo Pilot – Performance Status • ECOG • Karnofsky • Lansky

14. Demo Pilot – Adverse Events • Adverse events as described in the U.S. Department of Health and Human Services’ May 28, 2009 Version 4.0 Common Terminology Criteria for Adverse Events (CTCAE)

15. Treatment Regimen • Select an evidence-based regimen for the patient

16. Demo Pilot – Lesion Assessment (RECIST)

17. Demo Pilot – Death Information

18. Patient List

19. Overview

20. Primary Diagnosis

21. Staging (pathologic)

22. Pathology Report

23. Find a Regimen

24. Performance Status

25. Demo Pilot – Adverse Events

26. Lunch!

27. caBIG® Clinical Information Suite Patient Trial Finder

28. caBIG® Clinical Information Suite Patient Trial Finder

29. Patient Trial Finder Review Use Cases & Descriptions : • Identify Scope of Analysis • Discuss Use Case Relationships • Confirm Descriptions and Conditions • Primary Event Flow • Search Clinical Trials- Review Descriptions. • Requirements • Review & Confirm/Adjust

30. This diagram shows all the use cases and actors touched on in our discussions and research. The actors here represent roles. The Protocol Repository Role is a system role and represents the local collection of trials for which a site has already gained approval to offer. The boundary (PatientTrialFinder) shows the scope of our topic by differentiating those use cases for which we believe our reference implementation should be supporting.

31. Diagram - Select Clinical Trial

32. Diagram- Select Clinical Trial «actor» ACT10.01: Information 1. Source PTF-UC01.07.04 Retrieve single trial detail 2. ACT02.01: Health 3. Care Provider PTF-UC01.07.01 Compare PTF-UC01.07.03 Retrieve trial and patient criteria «include» list of trial detail 4. «extend» Note: Numbering is just for identification and not meant to represent sequence. PTF-UC01.07.02 Organize results ACT03.01: Patient

33. 1. Retrieve Single Trial Detail • The title and/or unique identifier of the trial is known. Unique identifiers are attributed to trials in several schemes. • Clinical Trials.gov (e.g. NCT00032890) • National Cancer Institute ( e.g. NCI-02-C-0052, discontinued as registry in 2010) • Sponsor-assigned unique ID (e.g. Merck-023) • US NIH Grant/Contract Award Number (e.g. R01DA013131) • European Union Drug Regulatory Authorities Clinical Trial System • Universal Trial Number (WHO International Clinical Trials Registry Platform) The aim of the UTN is to facilitate the unambiguous identification of clinical trials. The UTN is not a registration number. • Pre-conditions: • A unique trial identifier can be specified • Post-conditions: • Trial details are provided «actor» ACT10.01: Information 1. Source PTF-UC01.07.04 Retrieve single trial detail ACT02.01: Health Care Provider

34. 2. Retrieve List of Trial Detail • The list of appropriate trials is formed by matching patient medical data with trial treatment and inclusion/exclusion specifications. As more medical data is collected, the list may be refined. • Pre-requisites: • A repository of clinical trials is available to search • Post-conditions: • A list (possibly empty) of clinical trials for which the patient may qualify is provided • The query used to create the list is available to inspect and/or save. 2. 3. PTF-UC01.07.01 Compare PTF-UC01.07.03 Retrieve trial and patient criteria «include» ACT02.01: Health list of trial detail Care Provider 4. «extend» PTF-UC01.07.02 Organize results

35. 3. Compare Trial and Patient Criteria • To match any trial with the given medical data of a patient, a consideration of the trial criteria has to be assessed for similarity to the patient medical profile • Pre-conditions: • A description of the trial inclusion/exclusion criteria is available • A description of the trial protocol is available • A medical history of the patient is available • Any current treatment plan for the patient is available • Post-conditions: • The trial is recommended or not. • If recommended, some rank ordering is assigned. «actor» ACT10.01: Information Source PTF-UC01.07.01 Compare 3. PTF-UC01.07.03 Retrieve trial and patient criteria «include» list of trial detail

36. 4. Organize Results • The list of appropriate clinical trials can be arranged by ordinality of one or more attribute value sets. Phase, size, (alphabetical) treatment, costs. • Pre-condition: • A collection of trials in some initial order • Post-condition: • A collection of trials presented in order by selected attribute 2. PTF-UC01.07.03 Retrieve list of trial detail 4. «extend» PTF-UC01.07.02 Organize results

37. Event Flow – Search Clinical Trials Consider trial Collect the personal and medical information for the patient. This needs include any current treatment plan the patient may be on, as that would bring into consideration clinical trials for cancer control (anti-nausea, pain management, observational, etc) [insufficient data] PTF-AM01.01 Collect patient information [sufficient data] no search Interpret patient data in terms translatable to trial descriptions PTF-AM01.02 Examine patient record Consider all the trials in collection and retrieve those matching the query attributes PTF-AM01.03 Retrieve matching trials The list of trial references are organized by goodness of fit or some other ordinal value. Indicate those trials that are already offered by the practice PTF-AM01.04 Organize matching trials Trial found

38. Requirement Review Consider trial FRQ-PTF-026 - The system will automatically initiate a query for clinical trials when the minimal required patient information is captured. [insufficient data] Minimal patient info has been established as: o Age and gender o Diagnosis o Staging PTF-AM01.01 INF-PTF-032 - The system shall require a minimal set of patient data to automatically trigger a clinical trial search Collect patient information [sufficient data] no search PTF-AM01.02 Examine patient record FRQ-PTF-030 - The system shall allow for manual search in addition to automatic search PTF-AM01.03 Retrieve matching trials FRQ-PTF-033 - The system shall provide for ad-hoc (manual) search where clinical trial attributes can be directly specified PTF-AM01.04 Organize matching INF-PTF-034 - The system shall provide the ability to inspect any query over clinical trial attributes automatically generated from patient data trials Trial found

39. Requirement Review –Part 2 Consider trial [insufficient data] PTF-AM01.01 Collect patient information [sufficient data] no search PTF-AM01.02 Examine patient record • The alert may be one of: • visual cue presented with patient data • email to designated health care provider FRQ-PTF-023 - The system shall generate an alert if a patient matches one or more a clinical studies. PTF-AM01.03 Retrieve matching trials PTF-AM01.04 Organize matching trials Trial found

40. Requirement Review- Part 3 FRQ-PTF-002 - The system shall indicate the total number of matching trials for any submitted query FRQ-PTF-003 - The system shall provide for the sorting of trials by distance from specified zip code FRQ-PTF-004 - The system shall provide for the sorting of trials by sponsor Consider trial [insufficient data] PTF-AM01.01 Collect patient An intervention can be drugs, devices, procedures, or vaccines used in a trial. FRQ-PTF-006 - The system shall provide for the sorting of trials by intervention information [sufficient data] no search FRQ-PTF-007 - The system may provide for the categorization of trials by financial assistance/financial commitment PTF-AM01.02 Examine patient record FRQ-PTF-007 - The system may provide for the categorization of trials by financial assistance/financial commitment PTF-AM01.03 Retrieve matching trials FRQ-PTF-010 - The system shall provide estimates of out-of-pocket costs for patient participation based on their insurance context PTF-AM01.04 Organize matching trials Trial found

41. Requirements Review – Part 3A Treatment setting refers to the intent of treatment e.g. curative, supportive, correlative (correlation?), pedigree, etc FRQ-PTF-012 - The system shall provide a list of offered trials sorted first by diagnosis, then by treatment setting Consider trial The business rules would account for - site resources required by trial protocol - regulatory effort to participation - coverage estimate given current patient population FRQ-PTF-017 - The system shall provide for business rules that can determine an estimate of cost to site for trial participation [insufficient data] PTF-AM01.01 Collect patient information [sufficient data] no search FRQ-PTF-019 - The system shall have the capability to aggregate trial descriptions from multiple sites PTF-AM01.02 Examine patient record FRQ-PTF-020 - The system shall have the capability to distinguish trials offered by the practice already from those that are not. The local trial repository is typically those trials for which the site has already gained approval to run PTF-AM01.03 Retrieve matching trials FRQ-PTF-029 - For every item in result set, system shall provide reference to entries additional entries in other repository sites that offer additional content PTF-AM01.04 Organize matching trials

42. Requirements Review – Part 3b We need to assemble list of important trial aspects to make this testable. Common complaints with existing search sites is that not enough information is returned to typically make a decision The specific content inventory: o inclusion criteria o exclusion criteria o consent forms o protocol synopsis o sites administered o investigators INF-PTF-022 - The system shall provide a detailed and succinct description of most useful trial aspects (decisionable content) Consider trial PTF-AM01.01 Collect patient information [sufficient data] no search PTF-AM01.02 Examine patient record INF-PTF-025 - The system shall provide the ability to capture and display at least two protocol/clinical trial identifiers associated with a patient's treatment regimen. (this is referring to different identifiers for the same trial. A functional requirement for ONC, but could be cast as informational requirement as part of clinical trial description that must be retrieved and/or queried on PTF-AM01.03 Retrieve matching trials PTF-AM01.04 Organize matching trials

43. caBIG® Clinical Information Suite Chemotherapy Management

44. Agenda

45. caBIG® Clinical Information Suite Patient care coordination

46. Patient Care Coordination • What is currently done or given to the patient? • Examples: • Diagnostic testing • Therapies outside of clinic • Patient moves and will continue chemo elsewhere • Overlap with Referral Management? • Overlap with Chemotherapy Management? • ‘Running’ Patient Treatment Summary? • Differences between evidence-based regimen and clinical trial? • Patient calendar or patient flow?

47. Patient Care Coordination CCHIT Proposed Treatment Summary Criteria (1) Patient name; (2) Patient record number; (3) Date of birth and age; (4) Patient phone and email; (5) Physician name and contact information; (6) Problem list; (7) Allergies; (8) Medication list; (9) Advance directives; (10) AJCC staging (11) Height, weight , BSA, AUC (if applicable); (12) Treatment intent (curative vs palliative); (13) Name of chemotherapy regimen (e.g. CHOP) (14) Specific chemotherapy names, doses (per m/2 etc) & schedule; (15) Number of treatment cycles received; (16) Start and stop dates of chemotherapy; (17) Reason for stopping therapy (18) Best response: Adjuvant – not applicable; complete, response, partial (19) Major toxicities (20) Radiation therapy plan or treatment received

48. Patient Care Coordination CCHIT Proposed Treatment Summary Criteria (21) Surgery Plan or treatment received (22) Follow up plan for visits (23) Areas for surveillance (recurrence, secondary cancers, infection, etc – may be manually entered); and (24) Preventive care recommendations

49. caBIG® Clinical Information Suite Chemotherapy Costs/Billing

50. Chemotherapy Billing • Major steps in billing process • Charge Capture – the services, tests, etc. are tallied • Validation (typically Coding and Document Review) – the services, etc. are cross-checked against another process to ensure nothing has been missed or over-counted • Posting (Claims Processing) - The verified charge capture for each patient is submitted to Practice Management system and claims are generated and submitted electronically.