Identification and CDS for

Supratheraputic INR Results

Barbara Antuna, MD

Susan Besheer

Mary Moore

MMI 406 Fall 2009

Lineup Background

Problem statement

CDS goals

Stakeholders

System information

Workflows

CDS Model

Implementation

Evaluation

Outcomes

Background Warfarin (Coumadin)Disease states utilizing

antithrombotic therapy:

• Venous and pulmonary thromboembolism

• Atrial fibrillation

• Ischemic stroke

• Prosthetic heart valves

• Coronary artery disease

• Heart failure

• Post operative lower extremity surgery

• Antiphospholipid syndrome

• Protein s deficiency

Background –prevalance of

Warfarin use

• 4.0% of injured patients in 2006 in

National Trauma Databank were

using Warfarin (2.3% in 2002)

• >65 years, rate of Warfarin use

increased from 7.3% in 2002 to

12.8% in 2006

• http://www.reuters.com/article/healthNews/iDUSTRE59E5LZ20091015

Background - Warfarin: major

adverse effect - BleedingAnnual bleeding rates

Fatal: 0-4.8%

Major: 2.4-8.1%

Minor: about 15%

Fitzmaurice D, Blann A, Lip G. BMJ. 2002 Oct; 325(7368):

828-831.

Background - PROTIME/INR

A measure of the efficacy of Warfarin

• prothrombin time – a

measure of extrinsic

pathway of coagulation,

ordered in the EMR as PT

• INR (international

normalized ratio) – the

results of the coagulation

test (results have been

standardized)

Background - Treatment options for high INR

• Withhold warfarin

• Vitamin K - in quantity overrides the

mechanism of warfarin in the liver

• Fresh Frozen Plasma – contains the

coagulation factors

• Prothrombin Complex Concentrate

(PCC) – contains clotting factors II, VII,

IX and X. An emerging addition to FFP

but costly

Background - Management of

Supratheraputic INR valuesTable 2 Management of supratherapeutic INR values

*

INR Patient situation Action

3.1–5.0

No bleeding or need for rapid reversal (i.e., no need for surgery)

Omit next few warfarin doses and/or restart at lower dose when INR approaches desired range. If the INR is only minimally above range, no dosage reduction may be required.

5.1–9.0 No bleeding or need for rapid reversal

Omit next 1–2 doses, monitor INR more frequently, and restart at lower dose when INR approaches target range or omit dose and give 1–2.5 mg vitamin K1 orally (use this if patient has risk factor for bleeding).

No bleeding but reversal needed for surgery or dental extraction within 24 hours

Vitamin K1 2–4 mg orally (expected reversal within 24 hours); give additional1–2 mg if INR remains high at 24 hours.

9.1–20.0 No bleeding

Stop warfarin; give vitamin K1 3–5 mg orally; follow INR closely; repeat vitamin K1 if needed. Reassess need and dose of warfarin when INR approaches desirable range.

Rapid reversal required (>20.0)

Serious bleeding or major warfarin overdose

Stop warfarin; give vitamin K1 10 mg by slow IV infusion. May repeat vitamin K1 every 12 hours and give fresh plasma transfusion or prothrombin complex concentrate as needed. When appropriate, heparin can be given until the patient becomes responsive to warfarin.

Life-threatening bleeding

Replace with prothrombin complex concentrate and give 10 mg of vitamin K1 by infusion. May repeat if needed.

*From reference 1.

Proc (Bayl Univ Med Cent). 2001 July; 14(3): 305–306. Copyright © 2001, Baylor University Medical Center

Problem and plan

Patients need a treatment plan for

high INR at the point of care

Incorporate CDS at the lab alert

for high INR

CDS Goals

Clinical Objectives: Improve treatment of and

appropriately utilize resources for patients with

high INR

Desired Action: Provide clinical decision support

(CDS) at the point of care/point of lab alert

Desired Outcome: 100% compliance in

documentation of treatment plan for all high INR

results

Stakeholders

• Pharmacy Director

• Quality Committee Director

• Chief Nursing Officer (CNO)

• Chief Medical Officer (CMO)

• Risk Management Office

• Safety Committee Chairman

• Chief Information Officer (CIO)

• Lab/Blood Bank Director

• Utilization Review

• Patients

Available Information Systems• Hospital

– CPOE

– Laboratory Information Management

System

• Physician Practice

– Laboratory Information Management

System

– CPOE

• Laboratory

– Information Management Systems

LIMS source: http://limsource.com/home.html

Hospital Information Systems / Intranet

Internet Interface

Health Access Layer

Privacy Security Rules Based CDS Engine

Confidentiality Audit Trail Validation

Health Access Layer

Order Results

Patient Consent

Terminology CDS Rules

Access / Audit Logs

Clinical Guideline Documentation

Patient Encounters

Healthcare Providers

HL 7

Architecture

Data Sources

Internal /

External

Data Sources

CMS, 2008. Medicaid Information Technology Architecture, http://www.mmisconference.org/mmispresentations08/Tuesday/HL7%20MITA%20Project_The%20MITA%20IA/HL7%20MITA%20Project%20and%20the%20MITA%20IA.pd

System

Information

`

`

`

Pharmacy Information Systems

Laboratory

Information Systems

Physician CPOE

On Rounds

Physician CPOE Abnormal

Lab Requires Action/

Documentation

Physician CPOE at

bedside

`

Physician Practice

CDS

System Information

Architecture

Proposed Process

Internet

Interface CPOE

1

4

3

6

2

5

1. Physician lab order

2. Lab retrieves order: results

transmitted to ProAccess DB

3. If INR is HIGH evaluated by

CDS rules engine, transmits to

ProAccess DB

4. MD receives CDS results alert

/ info displayed

5. MD confirms message /

documents action

6. CDS engine evaluates results,

transmitting to ProAccess DB

ProAccess

Database

CDS Rules

Engine

Walk-in

ClinicsMD Practices

Hospitals

HospitalsLaboratory

1

Attention: INR

>therapeutic range;

document

intervention

Workflow

CPOEPT order

For pt on

Warfarin

Labs

resulted

Low or

Normal INR

HIGH INR

CDS for

LOW INR

CDS for

HIGH INR

Repeat INR

If felt to be

Lab error

CLINICAL

GUIDELINE

INR 3.1-5Bleeding?

Rapid Rev

Hold coumadin

Restart lower

No FFP/PCC

INR 1-2 d

INR

5-9Bleeding?

Rapid Rev

Hold coumadin

Restart lower

No FFP/PCC

Vit K if bleed risk

INR 1 d

INR

9.1-20

Bleeding?

Rapid Rev

Hold coumadin

Restart lower

No FFP/PCC

Vit K 2.5-5mg PO

INR 12-24 hr

Hold coumadin

FFP/PCC

Vit K 10 mg IV, MR

INR to follow FFP

INR > 20

Bleeding?

Rapid Rev

Hold coumadin

FFP/PCC as need

Vit K 10mg IV

INR 6-12 hr

YES YES

NO

YES

YES

NO NO

YES YES

YES

NONO

YES

NO

Logical Flow of the Clinical Guideline

Clinical Guideline Flow in Electronic Format

INR RESULT Document if

Pt BLEEDING

IF

NO

IF

YES

3.1-5 Y/N Order set for

INR 3.1-5

Bleeding

Order set

5-9 Y/N Order set for

INR 5-9

Bleeding

Order set

9.1-20 Y/N Order set for

INR 9.1-20

Bleeding

Order set

>20 Y/N Order set for

INR > 20

Bleeding

Order Set

Order set

For INR

3.1-5

For INR

5-9

For INR

9.1-20

For INR

>20

Order set

BLEEDING

Hold

coumadin

Hold

coumadin

Hold

coumadin

Hold

coumadin

Hold

coumadin

New

Dose

order

New

Dose

order

New

Dose

order

Bleed risk?

Go to Vit K

order

Vit K

order

FFP/PCC

Order

Vit K order

FFP/PCC

Order

Vit K order

Repeat

INR

2 d

Repeat

INR

24 hr

Repeat

INR

12-24 hr

Repeat

INR

6-12 hr

Repeat

INR

After

FFP/PCC

Order sets for INR values/BLEEDING

The linkage between signs and symptoms to patient

data develops a correct diagnosis or proper

treatment regime. The recognition of this linkage is

dependent upon what patient data is selected as

input into a CDS

Tasks Issues Current Method Future Method

Decision Making 1. Origin of the decision 1. Reliance on physician 1. Clinical decision support

2. Documentation and memory and education and informed patient options

composition of the 2. Manual entry of decision 2. Evidence-based structured

decision and paper records of electronic clinical decision-

degrees of completion support

Implementation 1. Varied degrees of 1.Varing educational levels 1. Standardized orders that

of decision productivity and of facts, data and skills guides and critiques the ordering

performance decisions

2. Organizational 2. Accountability for 2. Clinical system support to

system-wide mistakes improve ordering practices

performance

CDS Model

CDS Model : Interventions

• Standardized decision making:

– Develop specific CDS intervention and order

sets

• Improve Care:

– Develop clinician documentation, protocols and

clinical pathways

– Educate providers in the process concerning

admin of meds/blood products

• Improve Compliance:

– Monitor physician overrides to CDSS

– Develop tracking audit tools to monitor

performance

CDS Model : Data Elements

• Gender, Age, Race

• Medical Record Number

• ICD-9-CM Diagnosis Code: Stroke, A-fib, coronary artery

disease, knee/hip surgery, embolism, heart valve

replacement, heart failure, antiphospholipid syndrome,

coronary artery stents, protein s deficiency

• Labs: INR, PTT, Hematicrit, hemoglobin, fecal blood

• Drug-drug, drug-food interactions

• Dose of drug warfarin

• Allergies

• Provider

CDS Model: Standards

• Active diagnosis: SNOMED CT or ICD-9

• Patient characteristics (age, gender, race, ethnicity, etc.): HL7 Table 0112, 0001, 0296, 0005, 0189

• Fecal blood: LOINC

• Labs: LOINC

• Allergies: UNII and RxNOrm

IMPLEMENTATION

• Obtaining consensus on the management of

supratherapeutic INR by utilizing evidence-based

medicine/guideline

• This consensus is what drives the formulas and rules for the

CDSS considered by some as cookbook medicine

• Inconsistent feedback from stakeholders give their opinion

on appropriate management and treatment therapy as

patient cases are put through the decision support system

• Continued need for change in the decision support tool as

continued adjustments are made in order to obtain the

greatest level of success

Garcia, D., Witt, D. et al. (2008) The Annals of Pharmacotherapy, Delivery of

Optimized Anticoagulatn Therapy: Consensus Statement for the Anticoagulation

Forum. 42(7):979-988.

Challenges

Implementation: PlanPlan – Do – Study – Act

PlanMost relevant data elements are

chosen by our involved

stakeholders

DoConsensus is reached on the management by

utilizing evidence-based medicine/guideline

This consensus is what drives the formulas and

rules for the CDSS which is standardized and

adjusted accordingly to achieve the greatest

possible agreement with the stakeholdersStudyLastly validation is obtained on decision support

system on the advice of our providers and

stakeholders

All possible inputs in the CDSS must by

analysed and responses are developed for each

one which are in turn stakeholders provide

responses that are inputted into the system

This feedback loop will align with published

guidelines but also must be continually updated

for operational management

Act:Continued auditing produces trends

which can provide guidelines development

Consistent trends in turn may

become accepted practice

Austin, T., Shanghua, S. et al. (2009) Clinical Benefits of an Embedded Decision Support System in Anticoagulant Control. World Academy of Science,

Engineering and Technology 53 retrieved from http://www.waset.org/journals/waset/v53/v53-174.pdf

Evaluation

• Increase % of appropriate use of: – Vitamin K

– Fresh Frozen Plasma

– Prothrombin Complex Concentrate (PCC)

• Increase % of patients receiving improved appropriate work-ups and treatment plans

• Decrease cost of service

Performance Measures

Outcome Measures

• Improve the appropriate use of Vitamin K, FFP and

PPC for the treatment of supratherapeutic INR levels

• Improve documentation of treatment results and follow-

up of high INR

Questions?