Clinical Policies In Emergency Medicine: The United States Experience

1. Clinical Policies In Emergency Medicine:The United States Experience William C. Dalsey, MD, FACEP, MBA Department of Emergency Medicine Robert Wood Johnson University Hospital New Jersey sparkledmd@aol.com 215-654-1190

2. “The Big Picture” • Competition and the US Economic Revolution 70’s and 80’s • Deming and Juran, Tom Peters, Michael Hammer, and others • Manufacturing and Service Sectors

3. Characteristics Business System • Clear Specific and Measurable Goals • Education/Training • System/Process • Simplify/Inefficiency • Measurement/Computerization • Feedback • Error/Variation

4. State of the Healthcare Industry • Runaway Costs: HC > 14% GNP • Inefficiency: Variations Cost • Uncertain Quality/Outcomes: Tonsillectomy Incidence Varied with Proximity to Hospital

5. Medicine • Art (Masterpiece) vs. Science (Widget) • Computerization/Informatics

6. Quality of Care • Reports of Inappropriate Care • Example: RAND Utilization Study - 1981 • "One quarter to one third of ALL medical care may be unnecessary"

7. What Did “They” Want in Healthcare • Predictable Costs • Predictable and Measurable Outcomes • Application of the “Process” to Healthcare

8. "Clinical Policies" - Terminology • Clinical Practice Standards • Practice Guidelines • Protocols • Practice Recommendations • Practice Parameters • Practice Options • Critical Pathways • Key Clinical Pathways

9. USA Historical Perspective: "Standards" Present More Than 50 Years • Medical Literature • Specialty Society Publications: • American Academy of Pediatrics - 1938 • American College of Obstetrics & Gynecology - 1959 • American College of Physicians - 1980 • American Society of Anesthesiologists - 1986 • American College of Emergency Physicians - 1987 • Currently More Than 60 Specialty Societies or Physician Groups Involved

10. US Federal Government Interest and Activity • 1989 - US Agency for Health Care Policy and Research at Level of CDC and NIH • Initial charge: • Develop quality assurance standards • Develop performance measures • Develop medical review criteria • Develop, review, update practice guidelines via contracts • AHCPR Ceased Practice Guideline Production in 1996

11. Other American Groups Active In "Standards" Development • American Medical Association • Council Of Medical Specialty Societies • RAND Corporation • Institute of Medicine • Health Care Insurance Carriers • Private Corporations • State Governments

12. Currently more than 2600 guidelines are complete or in process in the US • Wide Variation in Scope and Nature • Size: Single page to massive tomes • Target Audience: Local specialists to all physicians • Science of development: Fair to abysmal

13. Why Develop Practice Guidelines? • So we know what is expected • Establish a base level of care to allow for improvement, better research and healthcare system design • Maintain and advance the level of patient care based on scientific evidence

14. Other Motivations for Clinical Policy Development • Turf Protection • Reaction to Policies Developed by Others • Fiscal Constraint / Limitation of Reimbursement

15. Desired Outcome Measures for Clinical Policies • Improved Quality of Care • Improved Consistency of Care • Better Resource Utilization • Improved Provider Satisfaction • Lower Health Care Expenditures • Decreased Liability

16. Potential Negative Results • Ignored by Practitioners • No Change in Quality of Care • No Change in Consistency of Care • No Impact or Increased Resource Utilization • Increased Provider "Hassle" Factor • No Impact or Increased Health Expenditures • Another Additional Indirect Cost • Increased Liability • Dissatisfied Patients

17. Abuse of Standards & Guidelines: Especially by Non-clinicians • Payers: To Pay or Not to Pay • Administrators: Hiring & Controlling Physician Behavior • Economic profiling • Economic credentialing

18. Clinical Policy Development: Desirable Attributes • Developed by or with physician organizations • Reliable methodologies used for creation • Product is based on current scientific information • Product is widely distributed

19. Potential Pitfalls • Geographic Bias • Advocacy Bias • Oversimplification • Resistance to Change

20. Who is Developing Practice Guidelines? • Academic Enterprise: Cochrane Group, Oxford, AHCPR • Organizations: AHA, AMA, Colleges, Consortium, Partnerships, • Payers: Government, Insurance Groups, Proprietary Management Groups • Advocates: Patient Groups, Interest Groups, …

21. Methodology of Clinical Policy Development: Consensus-Based • Informal • "Five guys/girls in a room" • Many early policies were of this type • Key Clinical Pathways / Care Maps • Formal • Defined approach for development, including literature review • Early ACEP policies of this type

22. History of ACEP’s Clinical Policy Development • We wanted Emergency Physicians to Determine Clinical Policies for Ourselves • Initially a Symptom Based Approach Largely Using Formalized Consensus • Evidence-Based and Critical Clinical Questions

23. Principles of Quality Clinical Policies • Evidence-Based Approach • Consensus with Disclosure • Defined Process for Development • Standardized Criteria for Assessing Literature • Levels of Strength of Recommendations • Identify Participants • Incorporation Societal/Ethical/Cost Issues

24. Clinical Policies in Emergency Medicine: Initial US Topic Selection: • High Risk • High Frequency • High Cost • "Presenting Complaint" Based • Critical Clinical Questions

25. Inherent Problems in Emergency Medicine • Wide-ranging, undifferentiated population • Wide variation of presentations • Clinical judgement must be supported • Outcome data limited

26. Current ACEP Clinical Policies: Complaint Based • Chest Pain (April 1990, February, 1995 Rev) • Pediatric Fever (March, 1993) • Abdominal Pain (April, 1994, October 2000 Rev) • Headache (June, 1996, January 2002 Rev) • Vaginal bleeding (March, 1997) • Seizure (May 1993 May, 1997 Rev) • Blunt Trauma (June 1993, March, 1998 Rev) • Altered mental status (February, 1999) • Extremity Trauma (May, 1999 [Rev]) • Toxic Ingestion (April 1995, June, 1999 Rev) • Ischemic Chest Pain (May, 2000)

27. ACEP Policies (Continued) • Penetrating Extremity Trauma (May 1994, May 1999) • Acute MI and Unstable Angina (May 2000) • Syncope (June 2001) • Community Acquired Pneumonia (July 2001) • Procedural Sedation and Analgesia (May 1998) • Pulmonary Embolus (In Process) • DVT (In Process) • Asymptomatic Hypertension (In Process) • Joint Statement on NeuroImaging in Emergency Patients Presenting with Seizure (July 1996)

28. ACEP Policy Statements • Rapid Sequence Intubation • Expiratory CO2 Monitoring • Verification Endotracheal Tube Placement • TPA and Stroke • Initial Management of Patients that Present to the ED with a Work-Related Injury or Illness

29. Do Clinical Guidelines Make a Difference? • Anesthesiology • Emergency Medicine • Adoption of New Therapies • Malpractice Liability/Payment/Charting Systems

30. Impact of Clinical Policies in Emergency Medicine • Paucity of research in this area • None in EM is patient outcome based • Evidence that initial chest pain policy did not drastically altered care (Lewis, 1995) • Sometimes used in quality review and improvement

31. Impact... • May hasten reasonable improvements in care (Wigder, 1996) • Working knowledge of clinical policies may be limited • Dissemination, alone, not adequate • Multi-pronged educational programs worked best

32. Implications for Our Practice • Awareness of Existence • Evaluation With Regard to Your Practice • Departmental Resources • Local Custom • Written Documentation of Any Intended Variances • Incorporation Into Daily Practice • Quick Forms for Patient Care Use or Review • QA Focused Review

33. Impact on Clinical Practice • QA/QI/PI • Computerized records • Law defense and prosecution/legislation • Members • Lectures/educational programs/residencies • Access • JCAHO emphasis

34. Technological Solutions • Incorporation into "intelligent" computerized dictation systems • Computer-aided access

35. Changes in Institutional Environment: Key Clinical Pathways • Viewed as a hospital-specific way to: • "Standardize" care • Decrease outliers • Cut costs • Motivation may be largely fiscal • Local, Interdisciplinary • Involves physicians, nurses, respiratory therapists, pathologists, radiologists, etc • Emergency medicine will sit on the front end • Many implementations are limited and superficial

36. Interaction With Other Specialties/Organizations • AHCPR, AAN, AAP, Spinal Cord Consortium, AHA, ACC, Brain Trauma Foundation, AAFP, AAP, AANS, AS of Neuroradiology, SCCM, ACR, ACChest Physicians, ALung Association/Thoracic Society, ACOG, ASIM, AMA, JCAHO, Hospital Association • Internationally Italy, England, Holland

37. Proposed JCAHO Standards on Clinical Guideline Use • Are clinical guidelines considered for use in designing or improving processes? • When guidelines are used, have leaders identified criteria to guide their selection and implementation? • Do the criteria anticipate variation? • Do mechanisms exist to manage and evaluate variation? • Is there a process to monitor and review the effectiveness of clinical practice guidelines and make appropriate changes?

38. Future Activity • Ongoing review and revision • Permission “Not To Act” • Encouragement of research into the effects of clinical policies on patient care

39. Conclusions: Clinical Policies • Expensive and labor intensive to develop and maintain • Actual impact on the quality of care is nearly impossible to determine • Probable indirect positive benefits of this effort: • Increased acceptance of concept of "standards" • Increased attention to our individual practices of medicine, especially over time • Decreased practice variation