Lean Six Sigma in Outpatient Medicine

Lean Six Sigma in Outpatient Medicine:

Achieving the Best Hypertension Outcomes in the US

Bob MatthewsMay 12, 2010

© MediSync 2010

Personal Introduction

• President/CEO, MediSync (www.medisync.com)• Executive Director, PriMed Physicians

– Greater Dayton, OH multi-specialty group• Executive Director, Health First Physicians

– Greater Cincinnati, OH primary care group

• Black Belt Trained in Six Sigma• Lead designer of multi-year approach to medical

group quality improvement• Quality Leader for four disease management Task

Forces

Challenges to USHealthcare Delivery System

1. Very low quality as measured by error rates and outcomes

• Errors of commission• Errors of omission

2. Very high costs• US compared to other 1st world economies

3. Value equation for US healthcare delivery is a national threat

Health Care Costs in US Markedly Exceed that of Other Countries and Increasing More Rapidly

Data: OECD Health Data 2005 and 2006.

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Average spending on healthper capita ($US PPP)

Total expenditures on healthas percent of GDP

EFFICIENCY

Source: Commonwealth Fund National Scorecard on U.S. Health System Performance, 2006

Mortality Amenable to Health CareDeaths per 100,000 population*

7681

88 84 89 8999 97

8897

109 106116 115 113

130 134128

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* Countries’ age-standardized death rates before age 75; including ischemic heart disease, diabetes, stroke, and bacterial infections.

Data: E. Nolte and C. M. McKee, London School of Hygiene and Tropical Medicine analysis of World Health Organization mortality files (Nolte and McKee 2008).Source: Commonwealth Fund National Scorecard on U.S. Health System Performance, 2008.

Quality In Hospitals vs.Medical Groups To Date

• Many hospitals have engaged in quality via Institute for Healthcare Improvement (IHI) programs and models

• A few systems are renovating to achieve significant quality changes

• Projects tend to be inpatient focused (many dollars, many opportunities)

• Minority of projects involve physicians significantly

• Exceptions (i.e. Inter-mountain Healthcare, Virginia Mason, Park Nicollet, etc.)

• Medical group quality at an earlier stage of development, behind hospitals

• Disease management and wellness prevention outcomes below international standards for many reasons

• A few groups piloting truly innovative quality programs with remarkable outcomes

• Physician culture in medical groups is a significant challenge

The Physician Venture Is In Trouble

• Significant and growing financial challenges

• Rising expectations for quality and cost effectiveness

• Economic sector that is behind in adoption of quality theory and practice, IT, operations improvement, etc.

Challenges to Physician Success

• The professional model for physicians evolved from a craftsman tradition…

– Physician ethos, training, work habits and methods have evolved little over decades…

– During the same timeframe, medicine has become vastly more complex

Healthcare Has Become Too Complex for the Old Paradigm of Physician Expertise

↑ Increases in the volume of scientific medical literature

↑ Increases in the number of drugs↑ Increases in the diagnostic options↑ Increases in the number of sub-specialties

and sub-subspecialties↑ Increases in the number and complexity of

evidenced based standards

Volume 348(26) 26 June 2003 pp 2635-2645

The Quality of Health Care Delivered To Adults In t he United States

McGlynn, Elizabeth A.: Asch, Steven M.: Adams, John: Jeesey, Joan: Hicks, Jennifer:DeCristofaro, Alison: Kerr, Eve A.

BACKGROUNDWe have little systematic information about the extent to which standard processes involved in healthcare—a key element of quality—are delivered in the United States.METHODSWe telephoned a random sample of adults living in 12 metropolitan areas in the United States and…received written consent to copy their medical records…to evaluate performance on 439 indicators of quality of care for 30 acute and chronic conditions as well as preventative care…RESULTSParticipants received 54.9 percent of recommended care. CONCLUSIONSThe deficits we have identified in adherence to recommended processes for basic care pose serious threats to the health of the American public. Strategies to reduce these deficits are warranted.

The Costs of Poor Quality

McGlynn et al’s Findings

Disease State Practices* % Best

Arial Fibrillation 25%Diabetes 45%Congestive Heart Failure 63%Hypertension 65%Coronary Artery Disease 68%Average 55%

* These are PROCESS not OUTCOME measures

When You Get To Outcomes:

• Average “% at goal” per JNC-7 for HTN is ~31% • Diabetics should have a BP of ≤129/79; Lipids

of 70 or 100; A1c of <7 -- <4% have all three.– Meeting D5 criteria is <2%

• <1:8 women properly screened for Osteo• 1:14 following the Evidence Standard for

Asthma• Etc.• Difference between outcome versus process

goals is critical

Primary Care Mission

1. Acute Care

2. Chronic Disease Management• Diabetes, Hypertension, COPD, Asthma, CAD,

Lipids, Depression, CHF, etc.

3. Wellness, Risk Assessments and Preventive Care (WRAP)

What Are The Design Specifications For A Medical Quality Solution?

• Wellness and preventive care at the evidenced based standard.• Diabetes, hypertension, lipids and other chronic

diseases treated to the evidenced based standard –both outcome and process standards.

• Cost effectiveness– All the care that is proven effective provided to

patients but only the care that is proven to be effective is provided to patients

– Waste is constantly reduced (Waste is currently estimated to be >30% of cost for healthcare…)

• Safety - Much lower error rate (meds errors, “missed”screenings, etc.) in both in- and outpatient care.

• Service - Patients able to access healthcare and enjoy service levels as in other economic sectors

How Are Medical Groups GoingAbout Quality Improvement?

• Most are not, yet.

• Of those who do approach medical quality, the majority do not have a QI methodology– Tendency to sit in conference rooms and “throw

solutions at the wall”

Sample Methods of Medical Groups Who Are Doing Medical QI

1. Print the evidence based standards (EBS) – or excerpts of the EBS – and publish to doctors

2. Install an EHR and create templates for certain types of care so as to remind physicians about the EBS or necessary care elements

3. Hire nurses or other ancillary staff to organize charts, remind doctors, contact patients, etc.

4. Using the methodology employed by pharma companies, do “quality detailing” to remind doctors about EBS

5. Install an EHR and generate lists of patients who are missing some element(s) of care or are not at goal and call them in for additional care

How Are Medical Groups GoingAbout Quality Improvement?

• Most are not, yet.

• Of those who do approach medical quality, the majority do not have a QI methodology– Tendency to sit in conference rooms and “throw

solutions at the wall”

• A small minority of medical groups have a defined QI methodology, a strategic plan including quality, dedicated resources, etc.

What Does the “Standard Approach”Get You

• Modest improvement

• Sometimes sustained, often not

• But, you “hit the wall”

Medical Quality Goal:Move One Variable (i.e. BP)G

roup

Mea

n P

erce

nt to

Goa

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Time in Months

1st 3rd2nd 5th4th 6th 8th7th 9th 10th11th12th13th14th15th16th

Advantages of a Thorough, Planned Quality Approach

• PriMed Physicians – Dayton, Ohio– Market turmoil in the 1990s resulting in lowest

compensation in the nation– Developing a “balanced scorecard” strategic plan that

emphases group size and medical quality– Lean Six Sigma training for management and doctors (>8

Black Belts)– Create a detailed, multi-year medical quality improvement

plan for medical quality– Prioritization of projects – operations and medical quality

• Demographic Profile: 180,000 patients, ~40,000 patients with HTN, 10,000 patients with diabetes

Starting Quality:Needed Early Wins

1. E&M Coding was first project – provided cash to fund more physician time and energy with patients

Examples of “Out of Control”Basic Business Processes

Distribution Of Level 4 Codes For Established Patie nts

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otal

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Family PracticeEstablished Patient Visits

9.72%

3.01%

68.25%

27.61%

0.75%0.38%

3.80%

22.38%

3.49%

60.61%

0.0%10.0%20.0%30.0%40.0%50.0%60.0%70.0%80.0%

99211 99212 99213 99214 99215

Trained MGMA

Starting Quality:Needed Early Wins

1. E&M Coding was first project – provided cash to fund more physician time and energy with patients

2. Systematized physician recruitment– Growth and group size was essential element to

strategy– Cost of growth highly determined by success rate of

new physicians staying with the practice

3. Began work on Medical Quality

PriMed’s Goals:

• WRAP provided at the EBS for 90% of all patients.

• 90% of all patients to EBS goals for the most common & costly chronic diseases:

– Hypertension – Lipids – Diabetes – Osteoporosis – Coronary Artery Disease – Asthma – Congestive Heart Failure – Depression– Etc.

Medical Quality

• Hypertension is most common chronic disease –PriMed now has ~40,000 patients diagnosed with HTN

• Costs to the system and to the patient for poorly controlled HTN are high:– Increased risk/rates for stroke, renal disease and

failure, heart disease, vascular damage– All of the above are expensive in medicine and

they are expensive in lost life functions

• Clear, evidence based standard for HTN – JNC-VII

First Medical Quality ProjectCreate HTN Process

1. Create an Ishikawa or “fish head” cause of error analysis

HTN %TO GOAL

STAFF (POLICIES/PROCEDURES)PROCESSES

INTERNAL ENVIRONMENT –SYSTEMS-OFFICE, EQUIPMENT, MATERIALS,SUPPLIES, HARDWARE/SOFTWARE,

ETC.

HEALTHCARE ENVIRONMENT(EXTERNAL) – INSUR. CO., GOV’T.

AGENCIES, SPEC., HOSPITAL, PHARM., ETC.PATIENTSPHYSICIANS

Compliance

KnowledgeB.P. Tech.

Knowledge

√ Knowledge of HTN

“Rou

nding”

off

Access. of Office for Pt.

Measurements ReportedWhat Defines Goal BP?

No ShowsPolicy/Comm. between Cardio., Spec.-Renal (Role Clarity) Phys., & PCP’s

√ Algorithm

On

char

t

Curre

nt ve

rsion

Compl

ianc

e

Under

stand

ing

Lack

of f

/u fo

r

“Opt

ing o

ut”“ C

ircle”

√(adjusti

ng meds.)

Where

to g

o w/ a

lgorithm

?

Following “visits” not “Pts.”Randomized not

Sequential

Home MonitorInaccuracy

Lack of

documentationPaying bills (invoice) Process

Late“Little Old Lady”

Resistance to SBP

Pt. provide full disclosure of meds.

Pt. Population (defining)

Process to f/u with Pt. √

Coverage – ICG Test

ICGmalfunction

supplies

Delay of dataresults (over a month)

refills √

Appt. scheduling

Algorithm

BP Cuff

size

calib

ratio

n

Efficiency of Office

Role Clarification – PCP, Cardio, Renal

Review of Meds.(med. list)

upda

ted

Algorithm

agreement

White Coat Synd.

√ Inter-phys. variation


Complianceknowledge

√ Time Buy in

Lack of

Reluctance to treat

Buy in

Too many m

eds.Side effects

No showsMoney

Dialysis of Pts.


Planning (med refill)

Socio. / Econ./ √Demographics / Ethnicity

√ Complianceknowledge

Motivation(lack of)

Definition of Pt.

White Coat Synd.

√ Cost

Missed w

ork

ICG

OV-copay

Med

s.

“Little Old Lady”

Full disclosure of meds.Employer (perception)

Pharmacy

Ambul. BP monitoringcoverage

Insurancepayment

coverage

formulary

chan ges

Media“hype” etc.re: drugs


1. Create a “fish head” cause of error analysis

2. Design a true process to address high priority issues identified in the Ishikawa

• Every patient with HTN address every visit

• Guidance for drug selection and dosing

• Constant feedback


1. Create a “fish head” cause of error analysis

2. Design a true process

3. Use statistics to evaluate the parts of the process that were counter-intuitive or highly controversial with physicians

Inside Expert’s DOE AnalysisUsefulness of ICG

Y-hat Model

BP@Goal Factor Name Low High Exper

Factor Name Coeff P(2 Tail) Tol Act

ive

Const 0.47645 0.0000 A StatusCoded -1 1 0C A StatusCoded -0.00136 0.7305 0.8938 X B AlgFollow edCoded -1 1 0C B AlgFollow edCoded -0.00487 0.1671 0.9781 X C ICG_RightCoded -1 1 0

C C ICG_RightCoded 0.47597 0.0000 0.8767 X

R2 0.8710 Multiple Response Prediction

Adj R2 0.8709Std Error 0.1742 99% Confidence Interval

F 6205.1690 Y-hat S-hat Lower Bound Upper BoundSig F 0.0000 BP@Goal 0.4765 0.1742 -0.046 0.999

FLOF 2.5130Sig FLOF 0.0398

Source SS df MSRegression 564.8 3 188.3

Error 83.7 2757 0.0Error Pure 83.4 2753 0.0Error LOF 0.3 4 0.1

Total 648.5 2760

Inside Expert’s DOE AnalysisUsefulness of ICG

PriMedY bar Marginal Means

SBP &DBP Combined at BP GoalDec 05

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Effect Levels

StatusCoded

AlgFollowedCoded

ICG_RightCoded

Outside Expert Six Sigma Findings

• 122,000 office visits from November 2004 through August 2008 (continued progress since)

• Initial Chi^2 Tests were performed to determine the key variables:– Whether or not the physician followed the algorithm– Whether there was a co-morbid condition– Whether the ICG test was used when the patient was not

at goal.

• Design of experiment to study the elements of the process

Design of Experiment

HTN RESULTS:

HTN vs Comorbid

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% A

t Goa

l

HTN Only

Comorbid

All

Reasons for Success

• We are not smarter and we haven’t graduated from better medical schools…

• Our patients are not fundamentally different from others…

• We created processes. We followed processes.

• We used Six Sigma rather than making it up on our own.

What We Found Are The BIGGEST Challenges

1. Challenge to the traditional model of physician identity and professional role(s)

Challenge to the Traditional Model of Physician Identity and Professional Role(s)

• “Doctor as wizard” dies in favor of “Medicine as process”

• Physicians often lack both experience and a concept of “process”

• Controversy of the ICG

• We believe that the difference between PriMed’s results and the other groups that are 20-40% less successful IS process

What We Found Are The BIGGEST Challenges


2. Change in physician and staff work habits

Change in Physician and Staff Work Processes

• Getting 90+% success is a LOT more work than getting 40% success

• Work of performing ICG…do it before the doctor walks into the room.

What We Found are the BIGGEST Challenges


2. Change in physician and staff work habits

3. One project creates new problems and links directly to new medical group challenges

Each Project Creates New ProblemsAnd New Challenges

• Adding the work of the HTN Process to the Diabetes Process to the Osteoporosis Process to the Asthma Process

–Equals too much work…PCP practices were not designed to get all the work done!

Re-thinking Primary Care

• AAFP finding that, for a patient population of 2,500 patients, the time requirements for one PCP to fully meet the needs for

1. Acute care

2. Chronic Disease Management3. WRAP

Would be 22 hours per day with no holidays!

• We need to fundamentally re-think primary care

Questions/Comments

Lean Six Sigma in Outpatient Medicine

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