engineering the prevention of hospital acquired venous...

Christopher M. Masek, BSIE CSSBBVA Nebraska Western Iowa HealthcareSystem

Midwest Mountain Veterans EngineeringResource Center (VERC)

Engineering the Prevention of HospitalAcquired Venous Thromboembolism

Define Evaluate Design Implement Results Sustain Spread

Book Club

The Wisdom of Crowds. Surowiecki,J. New York: Anchor Books, 2005.

The Survivors Club. Sherwood, B.Grand Central Publishing 2010.

2

Objectives

What is Venous Thromboembolism(VTE)?

Lean Healthcare Implementation

Human Factors

Define Evaluate Design Implement Results Sustain Spread3

About the Presenter

BSIE University of Nebraska – Lincoln Dana Corporation Lucent/Avaya/Connectivity Solutions Mfg Goodyear Tire and Rubber Co./ Veyance

Inc. Veterans Affairs Nebraska Western Iowa

Healthcare System Midwest Mountain Veterans Engineering

Resource Center (VERC)


AcknowledgementsVTE Team

Ann Polich, MD

Gale Etherton, MD

Jon Knezevich, PharmD

Peter A. Woodbridge, MD, MBA

Melissa Eggink

Pam Florea

Susan Hallbeck, PhD

Justin RousekDefine Evaluate Design Implement Results Sustain Spread

5

Veterans Affairs Nebraska WesternIowa Healthcare System

From 104 counties in Nebraska, westernIowa, portions of Kansas and Missouri

Total Veteran population: 167,000

FY08 Vested Users: 47,000

FY08 Outpatient Visits: 408,000

FY08 Inpatient Admits: 5,000



Omaha, NE

In patient Care, Outpatient Care, ResidentialMental Health Programs, Research

Grand Island, NE

Outpatient Care, Community Living Center(nursing home), Residential Substance Abuse

Lincoln, NE

Large Community Based Outpatient Clinic(CBOC) providing Outpatient Care



Community Based Outpatient Clinics(CBOCs)

North Platte, NE

Norfolk, NE

Holdrege, NE

Bellevue, NE

Shenandoah, IA


Why is this important?

~44,000-98,000 Americans die eachyear from medical errors (IOM)

9Define Evaluate Design Implement Results Sustain Spread

Why?

“Medicine used to be simple, ineffectiveand relatively safe.

Now it is complex, effective anddangerous.”

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Sir Cyril Chantler, former DeanGuy’s, King and St. Thomas’s Medicaland Dental School, Lancet 1999


Why?

“We are carrying the 19th century clinicaloffice into the 21st century world. It’s

time to retire it.”

Donald Berwick, MD

Institute for Healthcare Improvement

12Define Evaluate Design Implement Results Sustain Spread

VTE Background

#1 preventable hospital acquired death isdue to VTE

8 times more likely to acquire VTE whenhospitalized

VTE is a preventable problem which is notapproached uniformly across all patients


What is VTE

Pulmonary embolism resulting fromdeep vein thrombosis (DVT) —collectively referred to as VTE — is themost common preventable cause ofhospital death. (Heit et al 2002,Tapson et al 2005,

Clagett et al 1995)


What is VTE in plainlanguage

A blood clot that forms in the leg

The blood clot breaks free and movesthrough the bloodstream

The clot travels to the lung and blocks oneor more arteries in the lung

Needs prompt treatment

It is life threatening

Can be prevented


16

Repenning QI Model *

* Repenning, N. and J. Sterman (2001). Nobody Ever Gets Credit for Fixing Defects that Didn't Happen:Creating and Sustaining Process Improvement, California Management Review, 43, 4: 64-88

ProcessReliability

Errosion inReliability

Investment inReliability


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The “Work Harder” Loop

ProcessReliability

Errosion inReliability


ActualPerformance

PerformanceGap

DesiredPerformance

Time Spent onImprovement

+

+

-

+

Time SpentWorking

+

Pressure todo work

+

+

Work Harder

delay


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The “Work Smarter” LoopProcess

ReliabilityErrosion inReliability


ActualPerformance

PerformanceGap

DesiredPerformance

Time Spent onImprovement

+

+

-

+

Time SpentWorking

+

Pressure todo work

+

+

Work Harder

Pressure toImprove

Capability+

+

Work Smarter

delay


Improvement Project

100 day Rapid Process ImprovementWorkshop (RPIW)

Lean Kaizen Event

Team focused

Highly scripted

Formal Charter

Education and Application of Lean tools


Charter-Problem Statement

Currently patients are not assessed at admission or dailyfor VTE uniformly.

There is a section on the current Computer PhysicianOrder Entry (CPOE) system that is skipped over.

The occurrence of VTE/DVT is relatively low, but when itdoes occur, it can cause additional complications to thepatient.

This problem most affects patient length of stay, mortality.

A possible consequence of changes to this process mayincrease drug use/cost, increased staffing, adverse effectsfrom anticoagulants.


Charter – Goal Statementand Scope

Goal

100% DVT VTE assessment onmedicine wards

Scope

Admitted Medicine patient, excludeSurgery patients


Improvement Project-Mapping

What is the current state?


Improvement Project-Voiceof the Customer (VOC)

Use SWOTModel to formatyour questions

Strengths

Weaknesses

Opportunities

Threats

Why do VOC?

Collection ofData

Engages nonteam membersin the process

Promotes Buy-Inof the efforts


Improvement Project-Voiceof the Customer (VOC)

Analysis of VOC

Themes willemerge

Problems willsurface

VTE Prophylaxis Problems No Scorecard - objective

assessment (a way to know ifwe are doing it right)

No explanation as to noprophylaxis

Uncertain status Risk bleeding Orders continuity , done

(written), implemented Pumps / TED hose Sense of Autonomy Under utilization of CPRS CPRS non-mandatory

training CPRS representative not part

of rounding team No standardization


Positive Deviants

Who gets itright?

Follow upquestion andanswer with PDindividuals.


Data Collection

Chart ReviewData

Characteristic HavingCharacteristic

Documentation of risk assessment 0/26

Mechanical 11/26

Pharmacological 19/26

Nothing 1/26

Creatintine > 1.5 8/25

BMI >35 7/26


Why do all of this?

Defining theProblem

Quantifiableinformation

Does not haveto be statisticallysound

Everyone cansee the wholepicture

Ensureimprovementefforts arefocused on thecorrect areas


Kapowies and Brainstorming

Stars are barriers

Flowers are opportunities

Brainstorm ideas to overcome the barriers


Affinity Diagram

Generation ofideas

Group intoThemes


Impact / Effort matrix


Design and Try

Rapid cycle changePDSA

Plan

Do

Study

Act

Test hypothesis

Adapt, Adopt,Abandon


Examples of PDSA Cycles

FAQ on drugs used for DVT treatment.

Develop tool for QM Nurse to reportback data.

Graph in ward to display VTEperformance.

Education of new residents on usingtools.


Aha Moments!

Documentation of assessment mustbe a forced function.

Documentation of assessment mustbe automatically recorded.

The assessment must beuncomplicated.


A different approachIntention to treat instead of risk stratification

Why? Universal risk to patients entering the hospital

Literature suggests physician under utilizationof chemo prophylaxis

Literature suggests mechanical devices areminimally effective

Patient population

Risk stratification is complex

You will be treated unless…


Intention to treat method

Based oncontraindications

Give the physiciana reason not toprovide chemoprophylaxis

Suggestappropriatepharmacologicalagent to treatwith.

Reduce thenumber ofdecisions


Classic Risk Stratification –High Risk

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Patient Admitted

High Risk

-Major Orthopedic Surgery

-Spinal Cord Injury or Trauma

Abdominal/Pelvic Cancer Undergoing Surgery

-Lower Extremity Athroplasty

-Hip or Pelvic or Severe Lower Extremity Fracture

Education about benefits of early ambulation

Intermediate Risk

(Most common category)

-Not Ambulating independently outside of room at least twice daily

-Active infectious or Inflammatory Process

-Active Malignancy

-Major Non Orthopedic Surgery

-History of Venous Thromboembolism (VTE)

-Prior Immoblization (>72hrs) pre op

-Obesity (>30 BMI)

-Stroke

-Inflammatory Bowel Disease (IBD)

-Central Venous Access

-Hormonal Replacement or Oral Contraceptive

-Nephrotic Syndrome

-Burns

-Patient Age>50 yrs

-Hypercoaguable State

-Cellulitis

-Varicose Veins

-Paresis


Patient at Low Risk

(this is the least common category)

-Minor Procedure & age < 40 yrs with no additional RiskFactors

-Ambulatory Patient with expected LOS < 24 hrs orminor surgery


= Questions to Answer



=

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VTE Prophylaxis:HIGH RISK Cont.

Contraindications to VTE Prophylaxis for Patients at HighRisk

Absolute

-Acute Hemorrhage from wounds ordrains or lesions

-Intracranial hemorrhage within the prior24 hrs

-Heparin induced Thrombocytopenia(HIT)

-Severe trauma to head or spinal cord orextremities

-Neuraxial anesthesia/spinal blockwithin12 hours of initiation or

discontinuation of anticoagulation

-Patient on Warfarin or Heparin orEnoxaparin for other indications

Relative

-GI or GU hemorrhage within the past 6months

-Coagulopathy (INR>1.5)

-Intracranial Lesion/Neoplasm

-Severe Thrombocytopenia (Plt < 50k)

-Neuraxial Anesthesia/Spinal Block

-Intracranial Hemorrhage within the past 6months

No Contraindications to Prophylaxis




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VTE Prophylaxis:HIGH RISK Cont.

ABSOLUTE CONTRAINDICATION

NonpharmacologicalTreatment

-Sequential CompressionDevices (SCDs)

-Antiembolic Stockings(TEDs)

RELATIVE CONTRAINDICATION

Pharmacologic Benefit Outweighs Risk

-Enoxaparin 40 mg SQ daily


(CrCl < 30 mL/min but not onhemodialysis)

-Enoxaparin 30 mg SQ Q 12 hrs

(Total Knee Arthroplasty)

-Fondaparinux 2.5 mg SQ daily

(CrCl < 30 mL/min)

-Warfarin

-Heparin 5000 units SQ Q 8 hrs

AND

Nonpharmacologic Treatment

-Sequential Compression Devices (SCDs)

-Antiembolic Stockings (TEDS)

Pharmacologic Risk Outweighs Benefit



NO CONTRAINDICATIONS

Pharmacologic Treatment (MUST USE)





(Total Knee Arthoplasty)


(CrCl < 30 mL/min)

-Warfarin


AND

Nonpharmacological Treatment





Classic Risk Stratification –Intermediate Risk

39

Patient Admitted

High Risk







Intermediate Risk




-Active Malignancy




-Obesity (>30 BMI)

-Stroke




-Nephrotic Syndrome

-Burns

-Patient Age>50 yrs


-Cellulitis

-Varicose Veins

-Paresis


Patient at Low Risk







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VTE Prophylaxis:INTERMEDIATE RISK Cont.

Contraindications to VTE Prophylaxis for Patients atIntermediate Risk

Absolute

-Acute Hemorrhage from wounds ordrains or lesions

-Intracranial hemorrhage within the prior24 hrs

-Heparin induced Thrombocytopenia(HIT)

-Severe trauma to head or spinal cord orextremities

-Neuraxial anesthesia/spinal blockwithin12 hours of initiation or

discontinuation of anticoagulation

-Patient on Warfarin or Heparin orEnoxaparin for other indications

Relative

-GI or GU hemorrhage within the past 6months

-Coagulopathy (INR>1.5)

-Intracranial Lesion/Neoplasm

-Severe Thrombocytopenia (Plt < 50k)

-Neuraxial Anesthesia/Spinal Block

-Intracranial Hemorrhage within the past 6months

No Contraindications to Prophylaxis



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VTE Prophylaxis:INTERMEDIATE RISK Cont.

ABSOLUTE CONTRAINDICATION

NonpharmacologicalTreatment

-Sequential CompressionDevices (SCDs)

-Antiembolic Stockings(TEDs)

RELATIVE CONTRAINDICATION

Pharmacologic Benefits Outweigh Risk





(Total Knee Arthroplasty)


(CrCl < 30 mL/min)

-Warfarin


OPTIONAL

Nonpharmacologic Treatment



Pharmacologic Risk Outweighs Benefit



NO CONTRAINDICATIONS

Pharmacologic Treatment (MUST USE)








(if underweight or age > 75)

OPTIONAL

Nonpharmacological Treatment




Classic Risk Stratification –Low Risk

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Patient Admitted

High Risk







Intermediate Risk




-Active Malignancy




-Obesity (>30 BMI)

-Stroke




-Nephrotic Syndrome

-Burns

-Patient Age>50 yrs


-Cellulitis

-Varicose Veins

-Paresis


Patient at Low Risk






Classic Risk Stratification –Low Risk

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VTE Prophylaxis:LOW RISK Cont.

OOB AD LIB


Intention to treat

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Patient Admitted

Assess the Patient for the following conditions that would be CI forpharmacologic VTE therapy

-Uncontrolled hypertension (i.e. hypertensive crisis)

-Active, uncontrollable bleeding

-Spinal Tap within 12 hours or epidural catheter placement

-Comfort care patient

-Severe head trauma

-Previous history of HIT or hypersensitivity to UFH or LMWH

-Patient is < 40 yrs of age and hospital length of stay is predicted to beless than 48 hours

-Other (blank box to fill in)

Conditions Present

Select the non-pharmacologicalmeasures that you would like the

patient to receive while hospitalized

(multiple selections available)

- SCDS

-TED Hose

-Ambulation

None of theconditions present

Does the patient:

-Weigh less than 50 kg

OR

-Have a CrCl < 30mL/min

NO

Select a pharmacological agent that you would like the patientto receive for DVT prophylaxis :

(Ambulation is not sufficient by itself)

-Fondaparinux (Arixtra) 2.5 mg SQ daily

(Half-life: 17 - 21 hrs)

-Enoxaparin (Lovenox) 40 mg SQ dailiy

(Half-life: 6 – 8 hrs)

-Unfractionated Heparin (UFH) 5,000 units SQ Q 8 hrs

(Not preferred with malignancy)

AND/OR

Select the non-pharmacological measures that you would likethe patient to receive while hospitalized in addition to the

pharmacological agent already prescribed :

(Multiple sections available)

-SCDS

-TED Hose

-Ambulation

YES

Select a pharmacologicalagent that you would like thepatient to receive for DVT prophylaxis:

(Ambulation is not sufficient by itself)

-Enoxaparin (Lovenox) 30 mg SQ daily

-Unfractionated Heparin (UFH) 5,000 units SQ Q 12 hrs

AND/OR

Select the non-pharmacological measures that you wouldlike the patient to receive while hospitalized in addition to

the pharmacological agent already prescribed :

(Multiple sections available)

-SCDS

-TED Hose

-Ambulation



Human factors - Usability

Improve performance

Safer system

More efficient system

Test system with various scenarios

Test the system in a sandbox to preventunintended harm to patients

Evaluate design for desired outcomes

Can we make it even better?


Usability Study

Test “Intention to Treat” methodagainst “Risk stratification”

Do we get the right answers?

Is one faster than the other?

Are some physicians better than others?


Test knowledge - “Intent to treat”method, “Risk stratification” method

Use 6 differentscenarios

10 randomizedruns

Use online toolto collect data

Evaluatedecision of 1,2,3year residentswhile in clinic


Online Tool - LimeSurvey

Open source

Ability to branchlogic – the nextquestion isdetermined bypreviousanswers

Modified tocollect timestamp of eachselection

Ability to importexportmethod/logic


Do we get the right answer?

Scenario

Correct Outcome

Intention to TreatMethod

RiskStratificationMethod

A 95% 68%

B 93% 78%

C 90% 66%

D 85% 66%

E 83% 71%

F 56% 29%


Is it faster?

64%

100%

Intention to Treat Risk Stratification

Perc

en

t

Method

Average Time to Complete


Correct Answers byResident Year

0%

10%

20%

30%

40%

50%

60%

70%

80%

90%

Year 1 Year 2 Year 3

Intention to Treat

Risk Stratification


Going forward

Integration into EMR

Forcing functions

Lead you to the right answer

Automated data collection

Reporting


References

Heit JA, O’Fallon WM, Petterson TM, et al. Relative impact of risk factors for deep vein thrombosis and pulmonaryembolism, Arch Intern Med, 2002;162:1245-1248.

Tapson VF, Hyers TM, Waldo AL, et al. Antithrombotic therapy practices in US hospitals in an era of practice guidelines,Arch Intern Med, 2005;165:1458-1464.

Clagett GP, Anderson FA, Heit JA, et al. Prevention of venous thromboembolism, Chest, 1995;108:312-334.

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Questions?

[email protected]

www.chrismasek.net

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