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_at_aol.com
• 215-654-1190

2
The Big Picture

• Competition and the US Economic Revolution 70s
  and 80s
• 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 gt 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

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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

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Other Motivations for Clinical Policy Development

• Turf Protection
• Reaction to Policies Developed by Others
• Fiscal Constraint / Limitation of Reimbursement

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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

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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

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Abuse of Standards Guidelines Especially by
Non-clinicians

• Payers To Pay or Not to Pay
• Administrators Hiring Controlling Physician
  Behavior
• Economic profiling
• Economic credentialing

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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

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Potential Pitfalls

• Geographic Bias
• Advocacy Bias
• Oversimplification
• Resistance to Change

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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,

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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

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History of ACEPs 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

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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

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Clinical Policies in Emergency Medicine Initial
US Topic Selection

• High Risk
• High Frequency
• High Cost
• "Presenting Complaint" Based
• Critical Clinical Questions

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Inherent Problems in Emergency Medicine

• Wide-ranging, undifferentiated population
• Wide variation of presentations
• Clinical judgement must be supported
• Outcome data limited

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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)

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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)

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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

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Do Clinical Guidelines Make a Difference?

• Anesthesiology
• Emergency Medicine
• Adoption of New Therapies
• Malpractice Liability/Payment/Charting Systems

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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

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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

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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

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Impact on Clinical Practice

• QA/QI/PI
• Computerized records
• Law defense and prosecution/legislation
• Members
• Lectures/educational programs/residencies
• Access
• JCAHO emphasis

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Technological Solutions

• Incorporation into "intelligent"
  computerized dictation systems
• Computer-aided access

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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

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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

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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?

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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