1. Decision Support at the Point of Care Robert A. Greenes, M.D., Ph.D. Harvard Medical School Brigham & Women’s Hospital Boston, MA, USA Representing & Managing Knowledge & Integrating it into the Care Process

2. 5/28/03Greenes2 We are at a turning point in clinical information systems  Old focus: EMR, retrieval, reporting, communication  New focus: Knowledge access & decision support

3. 5/28/03Greenes3

4. 5/28/03Greenes4 Seeds of change  New technologies for Dx & Rx  Medical literature doubling every 19 yr – Doubles every 22 months for AIDS care – 2 million facts needed to practice  Gene expression analyses doubling every 8 months volume months Medline reports gene analyses

5. 5/28/03Greenes5 Safety and quality concerns  To Err is Human (IOM 1999) – Adverse events in up to 3.7% of hospitalizations in US Up to 13.6% lead to death – Half preventable 22,000 – 49,000 people – Medical errors kill more people than MVAs (43,458), or breast cancer (42,297) – Costs to society of $17-29B 50% is health care

6. 5/28/03Greenes6 The treatment gap  Approximately 25% of U.S. population has an abnormal LDL requiring intervention – 10% qualify for drug intervention – Of those, only ¼ are presently being treated – Treatment gap for hyperlipidemia presently = 7.5% of US population)

7. Disparities: Variability in CABG where HRR = Hospital Referral Region

8. 5/28/03Greenes8 Demand for change Crossing the Quality Chasm: A New Health System for the 21st Century – Safe – Effective – Patient-centered – Timely – Efficient – Equitable Richardson, William C. Crossing the Quality Chasm, Institute of Medicine, 2001

9. 5/28/03Greenes9  More involved in care process  More knowledgeable  More activist  More technically savvy Consumer empowerment

11. Disclosure

12. Demand for CPOE

13. Amendment to California SB 1875 Introduced On February 15, 2002, California state Sen. Jackie Speier (D-San Francisco/San Mateo) introduced Senate Bill (SB) 801, which amends Section 1339.63 of the California Health and Safety Code, bolstering the requirements specified by SB 1875, “Facility Plan to Eliminate or Substantially Reduce Medication Errors.” SB 1875 required as a condition of licensure that all general acute care hospitals, surgical clinics, and special hospitals adopt a formal plan to eliminate or substantially reduce medication-related errors. Plans must be implemented on or before January 1, 2005. Amendment to California SB 1875 Introduced On February 15, 2002, California state Sen. Jackie Speier (D-San Francisco/San Mateo) introduced Senate Bill (SB) 801, which amends Section 1339.63 of the California Health and Safety Code, bolstering the requirements specified by SB 1875, “Facility Plan to Eliminate or Substantially Reduce Medication Errors.” SB 1875 required as a condition of licensure that all general acute care hospitals, surgical clinics, and special hospitals adopt a formal plan to eliminate or substantially reduce medication-related errors. Plans must be implemented on or before January 1, 2005.

14. 5/28/03Greenes14 Error reduction, safety, quality  Safety – Appropriate drug dose & form – Adjustments allergies, renal status, age, contraindications interactions  Quality – Best Rx for indication – Appropriate referrals  Cost-effectiveness, efficiency – Reduced redundant or inappropriate tests – Generic or lower-cost medications – Order sets & care pathways – Optimal workflow  Correct dispensation, administration  Monitoring for adverse events  Providing feedback, education

15. 5/28/03Greenes15 Experience exists  Demonstrated success of CPOE – Error checks, ADE reduction – Decreased cost  Alerts & reminders  Appropriateness criteria  Guidelines

16. BWH Order entry

17. Drug-drug interaction alert

18. Lab alerts

19. Order sets

20. 5/28/03Greenes20 Other functionality  Check for redundant tests  Interpretive reporting  Identify non-indicated imaging procedures  Adverse event monitoring rules  Charge display  Signout  Reference/handbook

21. 5/28/03Greenes21 Cost-effective  55% decrease in serious medication errors – Bates, JAMA 1998  Decreased redundant labs – Bates, Am J Med, 1997  More appropriate renal dosing  No reduction in inappropriate x-rays – Harpole, JAMIA, 1997  Minimal effect of charge display – Bates, Archives of Internal Medicine, 1995  More appropriate dosing, substitutions accepted – Teich, Archives of Internal Medicine, 2000  Decreased vancomycin use – Sojania, JAMIA, 1998

22. 5/28/03Greenes22 Guidelines  Much development of guidelines since 1970s  Recent efforts aimed at computer-based interpretation – Goal of delivering patient-specific recommendations at point of care – Guidelines as core technology for many decision support applications

23. 5/28/03Greenes23 Guidelines as a core technology  Protocol-based care  Chronic disease management  Consultations  Critical pathways, UR/monitoring  Referral management  Workflow/process optimization  “Infobuttons”  Education/training  …

24. 5/28/03Greenes24 All told, there is much to cheer about …  Public interest, demand  Growing number of activities  Successes – in error reduction – in cost-effectiveness Momentum is building!

25. 5/28/03Greenes25 So what’s broken?  Limited availability – Most successes are one-of-a-kind, often academic – Slow diffusion

26. Converting research to care Publication Bibliographic databases Submission Reviews, guidelines, textbook Negative results variable 0.3 year 6. 0 - 13.0 years 50% 46% 18% 35% 0.6 year 0.5 year 9.3 years Dickersin, 1987 Koren, 1989 Balas, 1995 Poynard, 1985 Kumar, 1992 Poyer, 1982 Antman, 1992 Negative results Lack of numbers Expertopinion Inconsistent indexing 17:14 Original research Acceptance Patient Care Balas EA, Boren SA. Managing clinical knowledge for health care improvement. Yrbk of Med Informatics 2000; 65-70 17 years to apply 14% of research knowledge to patient care! 17 years to apply 14% of research knowledge to patient care!

27. 5/28/03Greenes27 So what’s broken?  Limited availability – Most successes are one-of-a-kind, often academic – Slow diffusion  Incompatibility among approaches  Little sharing of experience or capabilities  Little ability to share – Knowledge embedded in systems – Difficulty to extract, generalize, and replicate – Vendor incompatibilities, lack of standards

28. 5/28/03Greenes28 Non-technical factors  Isolated implementations – Getting the message out – Failures as well as successes  Regulatory issues – e.g., HIPAA  Financial constraints or disincentives  Cultural issues – “Culture eats strategy for lunch” – Leadership and commitment level  Human factors – Ease of use – Time requirements

29. Cedars-Sinai Experience

30. 5/28/03Greenes30 Technical factors  Infrastructure limitations – Vendor capabilities, platform – Foundational systems: EMR, KBs – Design approach  Lack of local expertise  Inability to capitalize on external expertise

31. 5/28/03Greenes31 Standards & sharing  Major area of activity in past two years  Gaining momentum – National Health Information Infrastructure (NHII) – National Electronic Disease Surveillance System (NEDSS) – Legislative initiatives For quality and safety, support of NHII – Advocacy Connecting for Health (Markle Foundation) Leapfrog Group

32. 5/28/03Greenes32 Decision support has special requirements  Knowledge bases – Evidence-based, authoritative e.g., drugs, interactions, contraindications, alternative forms  Decision rules – Calculations, constraints e.g., limits, ranges, dose adjustments – Alerts and reminders – Guidelines  Regularly updated  Expressed in executable form

33. 5/28/03Greenes33 Executable KBs are expensive to develop & update  This argues for: 1. Standard representations for KBs 2. Shared content repositories 3. Tools For authoring and updating For adaptation, integration into host systems

34. 5/28/03Greenes34 Arden syntax was first approach to knowledge standardization  For Medical Logic Modules (MLMs) single step rules/reminders – data section defining all variables – logic section defining conditions – action if the condition is true  Intended as a standard – First proposed early 1990’s – adopted by ASTM and then HL7 in mid-late ’90’s

35. 5/28/03Greenes35 Guideline standardization: the GLIF* experience  Goal of creating a common representation for sharing executable clinical guidelines  InterMed project of Harvard, Columbia, Stanford  Supported by NLM, AHRQ, Army * GuideLine Interchange Format

36. Get age and occupation Health-care worker or Age>65? Yes No Give Flu shot Do Nothing Flu vaccine guideline Asympto- matic

37. 5/28/03Greenes37 Decision step, in GLIF {name = “High risk determination”; condition = Boolean_criterion 1 {type = Boolean; spec = “HCW OR age>65”;}; destination = (Action_Step 3); otherwise = (Conditional_Step 2);}

38. Guideline authoring

39. 5/28/03Greenes39 Standardization effort  Clinical Guidelines Special Interest Group formed in HL7 – Part of Clinical Decision Support Technical Committee – Arden Syntax SIG also under this TC – First meeting in Jan ’01 CDS TC CG SIG Arden Syntax SIG

40. 5/28/03Greenes40 Standards approach  Work in HL7 CDS TC focusing on common infrastructure components: – vMR: an object-oriented virtual medical record subset for decision support – GELLO: object-oriented query & expression language – for all decision rules – Vocabulary management tools – Taxonomy of services invoked by rules  Work in HL7 CG SIG – Process/workflow model Specific to guidelines

42. 5/28/03Greenes42 Knowledge content resources  Meds, interactions  Indications, allergies, contraindication, interactions  Templates for orders  Order sets  Rules – for order entry safety, quality, efficacy checking – for dose modification for age, renal disease, … – for monitoring for ADEs  Clinical guidelines & care pathways  Clinical trial protocols

43. 5/28/03Greenes43 Content dissemination  Government repositories – GenBank, Nat. Guideline Clearninghouse: guidelines.gov, ClinicalTrials.gov  Consortia, open source libraries – IMKI, OpenClinical, …  Professional specialty organizations – ADA, ACP, CAP, Medbiquitous, …  Commercial – First DataBank, Micromedex, …

46. 5/28/03Greenes46 Tools & infrastructure  For authoring, validation, dissemination, adaptation, execution  Most difficult problem  Must be done in conjunction with standards & content development  Should follow a lifecycle process

47. 5/28/03Greenes47 Conclusions - 1  Health care safety & quality now a priority  Examples of successful approaches demonstrate potential benefits  Yet impediments to widespread experimentation, dissemination, and adoption

48. 5/28/03Greenes48 Conclusions – 2  Concerted effort needed for integrating knowledge – Standards-based approaches – Sharing of knowledge, tools, and experiences – A joint activity of academic, vendor, health provider, payer, and public sectors