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

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We are at a turning point in clinical information systems

Old focus: EMR, retrieval, reporting, communication

New focus: Knowledge access & decision support

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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

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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

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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)

Disparities: Variability in CABG

where HRR = Hospital Referral Region

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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

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More involved in care process More knowledgeable More activist More technically savvy

Consumer empowerment

Disclosure

Demand for CPOE

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.

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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

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Experience exists

Demonstrated success of CPOE– Error checks, ADE reduction– Decreased cost

Alerts & reminders Appropriateness criteria Guidelines

BWH Order entry

Drug-drug interaction alert

Lab alerts

Order sets

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Other functionality

Check for redundant tests Interpretive reporting Identify non-indicated imaging procedures Adverse event monitoring rules Charge display Signout Reference/handbook

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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

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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

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Guidelines as a core technology

Protocol-based care Chronic disease management Consultations Critical pathways, UR/monitoring Referral management Workflow/process optimization “Infobuttons” Education/training …

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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!

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So what’s broken?

Limited availability– Most successes are one-of-a-kind, often

academic– Slow diffusion

Converting research to care

Publication

Bibliographic databases

Submission

Reviews, guidelines, textbook

Negative results

variable

0.3 year

6. 0 - 13.0 years50%

46%

18%

35%

0.6 year

0.5 year

9.3 years

Dickersin, 1987

Koren, 1989

Balas, 1995

Poynard, 1985

Kumar, 1992

Kumar, 1992

Poyer, 1982

Antman, 1992

Negative results

Lack of numbers

ExpertExpertopinionopinion

Inconsistentindexing

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!

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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

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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

Cedars-Sinai Experience

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Technical factors

Infrastructure limitations– Vendor capabilities, platform– Foundational systems: EMR, KBs– Design approach

Lack of local expertise Inability to capitalize on

external expertise

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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

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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

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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

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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

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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

Get age and occupation

Health-care workeror Age>65?

Yes

NoGive Flu shot

Do Nothing

Flu vaccine guideline

Asympto-matic

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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);}

Guideline authoring

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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 TCCDS TC

CG SIGCG SIG Arden Syntax SIGArden Syntax SIG

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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

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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

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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, …

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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

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Conclusions - 1

Health care safety & quality now a priority

Examples of successful approaches demonstrate potential benefits

Yet impediments to widespread experimentation, dissemination, and adoption

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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