Clinical Policies In Emergency Clinical Policies In Emergency Medicine:Medicine:

The United States ExperienceThe United States Experience

William C. Dalsey, MD, FACEP, MBADepartment of Emergency Medicine

Robert Wood Johnson University HospitalNew Jersey

sparkledmd@aol.com215-654-1190

“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

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

State of the Healthcare Industry• Runaway Costs: HC > 14% GNP

• Inefficiency: Variations Cost

• Uncertain Quality/Outcomes: Tonsillectomy Incidence Varied with Proximity to Hospital

Medicine

• Art (Masterpiece) vs. Science (Widget)

• Computerization/Informatics

Quality of Care

• Reports of Inappropriate Care–Example: RAND Utilization Study -

1981• "One quarter to one third of ALL

medical care may be unnecessary"

What Did “They” Want in Healthcare

• Predictable Costs

• Predictable and Measurable Outcomes

• Application of the “Process” to Healthcare

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

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

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

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

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

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

Other Motivations for Clinical Policy Development

• Turf Protection

• Reaction to Policies Developed by Others

• Fiscal Constraint / Limitation of Reimbursement

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

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

Abuse of Standards & Guidelines: Especially by Non-clinicians

• Payers: To Pay or Not to Pay

• Administrators: Hiring & Controlling Physician Behavior–Economic profiling

–Economic credentialing

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

Potential Pitfalls

• Geographic Bias

• Advocacy Bias

• Oversimplification

• Resistance to Change

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, …

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

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

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

Clinical Policies in Emergency Medicine: Initial US Topic Selection:

• High Risk

• High Frequency

• High Cost

• "Presenting Complaint" Based

• Critical Clinical Questions

Inherent Problems in Emergency Medicine

• Wide-ranging, undifferentiated population

• Wide variation of presentations

• Clinical judgement must be supported

• Outcome data limited

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)

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)

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

Do Clinical Guidelines Make a Difference?

• Anesthesiology

• Emergency Medicine

• Adoption of New Therapies

• Malpractice Liability/Payment/Charting Systems

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

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

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

Impact on Clinical Practice

• QA/QI/PI• Computerized records• Law defense and prosecution/legislation• Members• Lectures/educational

programs/residencies• Access• JCAHO emphasis

Technological Solutions

• Incorporation into "intelligent" computerized dictation systems

• Computer-aided access

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

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

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?

Future Activity

• Ongoing review and revision

• Permission “Not To Act”

• Encouragement of research into the effects of clinical policies on patient care

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