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Handbook of Diabetes Management

i


Handbook of Diabetes Management

Edited by

Donna ZazworskyCarondelet Health Network Diabetes Care and Community Outreach Centers

St. Elizabeth of Hungary ClinicCase Manager Solutions, LLC

Tucson, Arizona

Jane Nelson BolinSchool of Rural Public Health

Texas A&M Health Sciences CenterCollege Station, Texas

Vicki B. GaubecaMel and Enid Zuckerman College of Public Health

University of ArizonaTucson, Arizona

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Library of Congress Cataloging-in-Publication Data

Handbook of diabetes and diabetes management / edited by Donna Zazworsky, Jane Bolin,Vicki B. Gaubeca.

p. ; cm.Includes bibliographical references and indexes.ISBN 0-387-23489-6 (Hardbound : alk. paper)1. Diabetes—Handbooks, manuals, etc. I. Zazworsky, Donna. II. Bolin, Jane, RN.

III. Gaubeca, Vicki B.[DNLM: 1. Diabetes Mellitus—epidemiology—United States. 2. Diabetes

Mellitus—therapy—United States. 3. Diabetes Mellitus—ethnology—United States.WK 810 H2366 2005]RC660.H356 2005616.4′62—dc22

2004063189

Springer Science+Business Media, Inc.New York, Boston, Dordrecht, London, Moscow

ISBN 10: 0-387-23489-6 (Hardbound) ISBN 13: 978-0387-23489-2ISBN 0-387-23490-X (eBook)

Printed on acid-free paper.

C© 2006 Springer Science+Business Media, Inc.All rights reserved. This work may not be translated or copied in whole or in part without the written permission ofthe publisher (Springer Science+Business Media, Inc., 233 Spring Street, New York, NY 10013, USA), except for

brief excerpts in connection with reviews or scholarly analysis. Use in connection with any form of informationstorage and retrieval, electronic adaptation, computer software, or by similar or dissimilar methodology now know

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Printed in the United States of America. (HPC/TB)

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This book is dedicated to the memory of Carter Marshall, MD, MPH who passed awaythis year. Dr. Marshall is remembered for his lifetime commitment and achievementsin improving the quality of our healthcare system. We deeply thank Dr. Marshall forproviding inspiration and professional guidance to many of the contributing authors.

About the Editors

Donna Zazworsky, MS, RN, CCM, FAAN,is an internationally known expert in casemanagement and disease management withcommunity populations. She is the managerof the Diabetes Care and Community Out-reach Centers for Carondelet Health Network,a three hospital healthcare organization anda member of Ascension Health. The Centershave provided the longest ADA-recognizeddiabetes self-management programs to peopleliving in Southern Arizona’s Pima and SantaCruz counties. Ms. Zazworsky also workswith St. Elizabeth of Hungary Clinic as a vol-unteer consultant on diabetes disease man-agement issues and is the managing partnerfor Case Manager Solutions, LLC. On a per-sonal note, Donna’s mother and two maternalaunts have experienced the devastating com-plications of type 2 diabetes. Nine years ago,her mother suffered a stroke that has left herwith left-sided weakness. Both aunts died ofdiabetes complications related to above theknee bilateral amputations and end stage renaldisease. Not only is diabetes prevention a

personal motivation for Donna, but case man-agement and disease management systemsprovide a primary focus for her work in under-standing and reducing barriers for people withdiabetes.

Jane Nelson Bolin, RN, JD, PhD, is a profes-sor and researcher in rural health and diseasemanagement at Texas A&M. On a personalnote, Jane has had gestational diabetes duringboth of her pregnancies. Knowing that the in-cidence of getting type 2 diabetes at a laterage is very high, Jane practices a personalprevention program that includes diet andexercise.

Vicki B. Gaubeca, MPH, is director of PublicAffairs for the University of Arizona Mel andEnid Zuckerman College of Public Health.On a personal note, Vicki has had type 1 dia-betes since she was a teenager. She knows theday-to-day struggles of self management andhopes that this handbook will lend insight topublic health workers who help people withdiabetes.

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Contributors

Jorge A. Arzac, MD, FACOG, MethodistMedical Center, Dallas, Texas

Barbara J. Aung, DPM, Aung FootHealthClinics and Wound Management CenterTucson, Arizona

Lourdes G. Barrera, Arizona InternationalCollege, University of Arizona, Tucson,Arizona

Judith Beck, MD, St. Elizabeth of HungaryClinic, Tucson, Arizona

Jane Nelson Bolin PhD, JD, RN, TexasA&M Health Sciences Center School ofRural Public Health, College Station, Texas

Patrick J. Boyle, MD, Division ofEndocrinology, Diabetes, and Metabolism,University of New Mexico Health SciencesCenter, Albuquerque, New Mexico

Lynda Juall Carpenito-Moyet, CRNP,MSN, LJC Consultants, Inc., Mickleton,New Jersey, and ChesPenn Health Services,Chester, Pennsylvania

Daniel Casto, MD, Department of Familyand Community Medicine, College ofMedicine, University of Arizona, Tucson,Arizona

Larry Cooper, MA, Health ServicesAdvisory Group, Phoenix, Arizona

Karen D’Huyvetter, ND, MS, Mel andEnid Zuckerman College of Public Health,University of Arizona, Tucson, Arizona

Betsy Dokken, NP, MSN, CDE,Department of Physiology, University ofArizona, and University PhysiciansHealthcare, Tucson, Arizona

Jean Donie, RN, MBA, CPHQ, Dell WebbHospital, Sun Health System, Sun City,Arizona

James L. Dumbauld, DO, Department ofFamily Medicine, St. Elizabeth of HungaryClinic, and University of Arizona, Tucson,Arizona

Scott Endsley, MD, MSc, Health ServicesAdvisory Group, Phoenix, Arizona

Larry Gamm, PhD, Texas A&M HealthSciences Center School of Rural PublicHealth, Department of Health Policy andManagement, College Station, Texas

Brian L. Foster, MBA, Health ServicesAdvisory Group, Phoenix, Arizona

Cindy Fraser, MS, Health SystemsResearch Center, Carle Foundation, Urbana,Illinois

Vicki B. Gaubeca, MPH, Mel and EnidZuckerman College of Public Health,Tucson, Arizona

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viii CONTRIBUTORS

Terilene Glasses, Mel and Enid ZuckermanCollege of Public Health,University of Arizona, Tucson, Arizona

Scott Going, PhD, Departments ofNutritional Science & Physiology,University of Arizona, Tucson, Arizona

Cecelia Hofberger, RN, Mountain ParkHealth Center, Inc., Phoenix, Arizona

Maia Ingram, MPH, Mel and EnidZuckerman College of Public Health,University of Arizona, Tucson, Arizona

Bita Kash, MBA, FACHE, TexasA&M Health Sciences Center Schoolof Rural Public Health, College Station,Texas

Christine Kucera, BFA, Health SystemsResearch Center, Carle Foundation, Urbana,Illinois

Kathleen Lambert, BSN, RN, JD, PrivatePractice Attorney at Law, CarondeletSt. Joseph’s Hospital, Tucson,Arizona

James C. Leonard, MD, Carle Foundation,Urbana, Illinois

Isela Luna, PhD, RN, Healthcare LegalConsultant, Tucson, Arizona

Carrie M. Maffeo, PharmD, BCPS, CDE,Health Education Center, Butler University,College of Pharmacy and Health Sciences,Indianapolis, Indiana

Rose Marie Manchon, MN, APRN,Carondelet Health Network, Tucson,Arizona

Carter L. Marshall, MD, MPH, ClinicalQuality Assessment, Health ServicesAdvisory Group, Inc., Phoenix,Arizona

Nancy J. Metzger, RN, PhD, St. Elizabethof Hungary Clinic, Tucson, Arizona

Tim Moore, MA, LISAC, Marana HealthCenter, Marana, Arizona

Anita C. Murcko, MD, FACP, HealthcareGroup of Arizona/AHCCCS, Phoenix,Arizona

Hirisaradaharally N. Nagaraja, MD,Division of Endocrinology, Diabetes, andMetabolism, University of New MexicoHealth Sciences Center, Albuquerque, NewMexico

Linda Parker, BSN, RN, St. Elizabeth ofHungary Clinic, Tucson, Arizona

B. Mitchell Peck, PhD, Texas A&M HealthSciences Center School of Rural PublicHealth, College Station, Texas

Annette I. Peery, MSN, RN, CDE,Department of Adult Health Nursing, Schoolof Nursing, East Carolina University,Greenville, North Carolina

Juanita Peterman, RN, BSN, MAOM,CPHQ, Clinica Adelante, Inc., Phoenix,Arizona

Michael Reis, MD, Department of Family &Community Medicine, Texas A&MUniversity System HSC College ofMedicine, Scott and White MemorialHospital, Temple, Texas

Catherine M. Robinson, MEd, RD, CDE.,St. Elizabeth of Hungary Clinic, Tucson,Arizona

Jennifer Ryan, MBA, PhD, ChiricahuaCommunity Health Centers, Inc., Elfrida,Arizona

Paul Shelton, EdD, Health SystemsResearch Center, Carle Foundation, Urbana,Illinois

Leslie Spry, MD, FACP, LincolnNephrology & Hypertension, Lincoln,Nebraska


CONTRIBUTORS ix

John Stoll, MD, Primary Care and PediatricSub-Specialties, General Internal Medicine,Carle Clinic Association, Urbana, Illinois

Barbalee Symm, RN, MS, Department ofFamily and Community Medicine, TexasA&M University System, HSC College ofMedicine, Scott and White MemorialHospital, Temple, Texas

Charmaine Trujillo, RN, MountainPark Health Center, Inc., Phoenix,Arizona

Donna Zazworsky, MS, RN, CCM, FAAN,Carondelet Diabetes Care and CommunityOutreach Centers; St. Elizabeth of HungaryClinic; and Case Manager Solutions, LLC,Tucson, Arizona


Foreword

Diabetes—you read about it everywhere to-day. It’s a hot topic in the news magazines,on the talk shows, in professional journals, inthe daily paper—even in the rags at the gro-cery counter. Should you be interested? Ofcourse! If you do not have diabetes, you prob-ably know someone who does. You probablyknow many people who are either diabetic orprediabetic. I am interested in the topic be-cause I was diagnosed almost two years agowith type 2 diabetes.

Many years ago, I was in the MissAmerica Pageant as Miss Arizona. I was aletterwoman on the University of Arizonawomen’s swim team. I modeled for Mr. Black-well of Hollywood, then I married my highschool sweetheart and am now the motherof four children and the grandmother of six(number seven is on the way.). I knew howimportant it was to stay in shape, but life andtime added pounds to my frame. I worked longhours, and pushed my limits. Even though Ihad been a nurse for more than 30 years, I re-fused to see the initial symptoms of diabetesand I rationalized the excessive thirst and fre-quent urination. I ignored how sleepy I felt attimes, especially after a big meal. I told my-self that I just wasn’t able to sleep throughthe night like I used to do. I had recurrentyeast infections. All of these symptoms coin-cided with the thrills of menopause. I would

tell myself also that this was what aging wasabout.

Then came the diagnosis of diabetes andI actually felt relief. Facing this reality mademe understand why my body had become astranger to me. I looked for all the informa-tion that I could get my hands on. And I foundquite a bit of information in book stores andon the Internet. But I really wanted a com-prehensive resource, something that wouldgive me both educational and practical in-formation about the diabetes epidemic thatwas facing the nation. I wanted to not onlyhelp myself but prepare my children so theywould not have the same diagnosis in theirfuture. I also wanted a manual to add tomy professional library that would be a re-source to me in both my nursing and lawcareers.

This handbook by expert professionalscovers every aspect of diabetic care. It isa sound, evidence-based, culturally informa-tive, practical approach to diabetes preven-tion and disease management. It also pro-vides case studies which reflect the variousclinical settings in which diabetes care takesplace. There is information on the financialconsiderations of the population with diabetesand methods for computing direct and indi-rect costs of treatment. Special care issues ofthe prediabetic and the gestational diabetic are

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xii FOREWORD

addressed. It includes sample diets, exerciseprograms, and tools for assessing depression.This handbook is both interesting and fun.As a comprehensive resource, it is a bonus to

health care professionals who appreciate thedramatic impact that the diagnosis of diabetesis having and will continue to have on thenation.

Kathleen Lambert, BSN, RN, JDAttorney at Law

Administrative SupervisorCarondelet St. Joseph’s Health

Tucson, Arizona


Preface

The focus of this book is on the problemof diabetes and principles of effective dia-betes population management. No one dis-putes that America is in the midst of an epi-demic of diabetes. Recent estimates from theCenters for Disease Control and Prevention(CDC) on the percentage of the populationwith diabetes is 6.3%, or 18.2 million people,with the percentage of Hispanics at 8.2% (2million) and Non-Hispanic blacks at 11.4%(2.7 million) (CDC, 2004). Conservatively,diabetes affects over 17 million Americanswith another 16 million diagnosed as pre-diabetic, or at risk. In a recent study to bepublished in Obesity Research, researchers es-timated that in the U.S., obesity-attributablemedical expenditures reached $75 billion in2003 and that taxpayers financed about half ofthese costs through Medicare and Medicaid.Obesity leads to a myriad of chronic healthconditions; most common among those con-ditions is diabetes with all of its associatedmorbidity. Clearly, we all have a vested inter-est in finding solutions to this public healthcrisis.

Users of this book will notice that thesubstance of each chapter is enhanced by theauthors’ own personal and professional ex-perience of dealing personally with the chal-lenges of diabetes. Collectively, each of ourclinical and professional lives have been af-fected by diabetes compelling us to create pre-vention programs, investigate treatments, and

create methods of managing this complex anddeceitfully subtle disease that manages to stealproductivity and health from such a large per-centage of the American public.

The concerns that launched our effortsto document methods of disease managementwere formed through daily exchanges with pa-tients and clinicians each attempting to bet-ter understand this disease known as diabetes.Concerns led to development of models ofclinical and community management whichin turn led to documentation that these meth-ods had resulted in reduced morbidity and ul-timately reduced mortality.

A recurring theme of every chapter, fromevery contributor, is the vast complexity anddiversity of the population of persons withdiabetes. While statistics are fairly straight-forward, they tell us that diabetes is a signif-icant, national problem that will require theefforts of all health professionals and their pa-tients if it is to be addressed in a meaningfulway.

Fittingly, our book is divided into the fol-lowing four sections:

Part 1: The Diabetes Framework. Thissection addresses the picture of diabetes dis-ease management and population manage-ment. The challenging issues of the diabetesquality initiatives and the chronic care modelare thoughtfully explained to provide insightfor those beginning to step into this nextlevel of care. The cultural competency and

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xiv PREFACE

technology chapters offer a broader overviewof development and application.

Part 2: Caring for People with Diabetes.This section covers evidence-based practicefor the complex facets of diabetes care. Thechapters on the Origins of Diabetes and Med-ication Management cover the most up-to-date research on these two topics. These chap-ters also offer the latest standards of practicein diabetes management. The Nutrition andGlycemic Index chapter provides the readerswith a plethora of information related to theglycemic index, diet recommendations, andhow other highly promoted diets measure upto the scientific rubric. Behavioral health andself-management issues and interventions areexplained and practice applications are given.Finally, sick day planning, travel, surgery andfoot care are covered, including specific tips togive patients when facing any of these issues.

Part 3. Special Care Issues. This sectionaddresses the complexities of caring for a di-verse population. First there is the area of Pre-diabetes. A relatively new term describing astage of diabetes serves as a trigger for peopleand providers to look at lifestyle issues moreaggressively—with the intent to prevent theonset of diabetes.

Gestational diabetes must be addressed.Although usually a temporary condition trig-gered by pregnancy, gestational diabetes hasbeen a precursor to the onset of diabetes at alater age.

Chronic kidney disease (CKD) has be-come more pronounced with the newly-defined stages of CKD. Diabetes is one of theleading causes of renal disease leading to dial-ysis and transplantation. A more aggressiveeffort is being made to promote early detec-tion of disease.

Other issues related to the uninsured,rural populations and border communitiesare also confronted in this section. Each ofthese issues present difficult challenges forproviders and the healthcare team. Helpfultips are offered and are based on many yearsof hands-on experience.

Finally, two other areas that are cov-ered in this section are ComplimentaryMedicine and the emerging technology ofSelf–Management Systems and telehealthcare. This section offers a summary of otheruses of technology to support the patient intheir quest to be better self managers.

Part 4: Business Issues. Without ques-tion, diabetes disease management cannot beperformed without addressing the business as-pects related to legal and regulatory issues,health policy initiatives, economic rationale,funding sources and marketing components.This section provides the reader with valuableknowledge to start and manage a successfuldiabetes program.

Part 5: Case Studies. Finally, this sec-tion provides case studies that have demon-strated success with evidence-based practicesshaped for a variety of populations. Thesecase studies offer helpful tools and share theirlessons learned—following the motto: Sharewillingly and steal mercilessly.

This handbook only begins to cover theincredible work that is going on around thecountry. It is time to share our experiences sothat other providers will glean those piecesthat fit for their practices. In the long run, itwill be our communities that will benefit.

Donna Zazworsky, Tucson, ArizonaJane Bolin, College Station, Texas

Vicki B. Gaubeca, Tucson, Arizona


Contents

I. THE DIABETES FRAMEWORK

1 Essentials of Quality Improvement with Special Reference to Diabetes 3Carter L. Marshall

2 The Chronic Care Model: Blueprint for Improving Total Diabetes Care 19Anita C. Murcko, Jean Donie, Scott Endsley, and Larry Cooper

3 Promoting Cultural Competence through Community Partnerships 35Isela Luna

3A Hispanic American Culture and Diabetes 41Lourdes G. Barrera

3B Cultural Competency: Native Americans 45Terilene Glasses

4 Preparing for the Technology Revolution in Health Care 49Brian L. Foster

II. CARING FOR PEOPLE WITH DIABETES

5 Concepts on the Origin of Diabetes 61Hirisadarahally N. Nagaraja and Patrick J. Boyle

6 Medication Management 69Carrie M. Maffeo

7 Nutrition for Individuals with Diabetes 79Catherine M. Robinson and Judith Beck

8 Diabetes and Exercise 125Scott Going and Betsy Dokken

9 Living Well with Diabetes: An Approach to Behavioral Health Issues 143Tim Moore

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xvi CONTENTS

10 Planning for Sick Days, Surgery, and Travel 151Betsy Dokken

11 Self-Management 161Donna Zazworksy and Lynda Juall Carpenito-Moyet

12 The Diabetic Foot 175Barbara J. Aung

III. SPECIAL CARE ISSUES

13 Prediabetes: A Risky Prodrome to Diabetes 183James L. Dumbauld

14 Gestational Diabetes 189Jorge A. Arzac

15 Chronic Kidney Disease 199Leslie Spry

16 Caring for the Uninsured and Diabetes 215Daniel Casto

17 Disease Management in Rural Populations: Can It Be Done? 223Jane Nelson Bolin, Larry Gamm, Bita Kash, and B. Mitchell Peck

18 Caring for the Border Communities 237Maia Ingram

19 Utilizing Community Health Advisors in Diabetes Care Management 247Nancy J. Metzger and Linda Parker

20 Complementary and Alternative Medicine in Diabetes 257Karen D’Huyvetter

21 Leading Edge Technologies Related to Diabetes Care 273Vicki B. Gaubeca and Donna Zazworsky

IV. BUSINESS ISSUES

22 Disease Management Research and Policy Initiatives 283Larry Gamm, Jane Nelson Bolin, and Bita Kash

23 Legal and Regulatory Considerations of Diabetes Disease Management 301Jane Nelson Bolin, Bita Kash, and Larry Gamm

24 Economics 311Jennifer Ryan

25 Funding 317Donna Zazworsky


CONTENTS xvii

26 Tools for Getting Your Message Out About Diabetes: Marketing/PublicRelations, Social Marketing and Media Advocacy 323Vicki B. Gaubeca

V. CASE STUDIES

Case Study 1: Diabetes Disease Management Program 347Donna Zazworsky and James Dumbauld

Case Study 2: Carle’s Diabetes Management Program 355Christine Kucera, John Stoll, Cindy Fraser, James C. Leonard, andPaul Shelton

Case Study 3: The Scott and White Experience: Chronic Disease Managementon a Shoe String 361Barbalee Symm and Michael Reis

Case Study 4: Nutrition Survival Skills for Diabetes: A Personal Experience 367Annette I. Peery

Case Study 5: Diabetes Continuing Care Clinic Group Visits for theUninsured: A Case Study of Three Community Health Centers 371Donna Zazworsky, James Dumbauld, Charmaine Trujillo, CeceliaHofberger, and Juanita Peterman

Case Study 6: A Hospital Case Study in Diabetes Management: CarondeletHealth Network 387Rose Marie Manchon

Index 395

P1: FCG/SPH P2: FCG/SPH QC: FCG/SPH T1: FCGSVNY014-Zazworsky ISBN 0387234896 September 6, 2005 10:16

I

The Diabetes Framework

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1

Essentials of Quality Improvement withSpecial Reference to Diabetes

Carter L. Marshall

Vice President, Clinical Quality Assessment, Health Services Advisory Group, Inc., Phoenix, Arizona

ORIGINS OF QUALITYIMPROVEMENT IN DIABETES

Quality improvement (QI) in medicinecan be traced to Sir Thomas Percival (1740–1804) who, in 1803, advocated hospital prog-rams to improve the quality of care providedby physicians (www.whonamedit.com/doctor.cfm/2558.html, 2005). QI in the UnitedStates began with Ernest Codman (1869–1940), a Boston surgeon who lost his appoint-ment to the Harvard Medical School facultybecause of his persistent call for study of sur-gical outcomes. Codman’s ideas were even-tually incorporated into the newly establishedAmerican College of Surgery and he was in-strumental in the establishment of the JointCommission on Accreditation of Health CareOrganizations (JCAHO) (Murray, 2000). Theprinciples and methodology of QI owe muchto the process of continuous quality im-provement (CQI) pioneered by business guruEdward Deming (Aguayo, 1990).

The application of quality concepts to di-abetes was problematic as long as medicinewas more or less powerless to restrain a

virtually inevitable downhill course resultingin death a few years after diagnosis. The dis-covery of insulin by Banting and Best in 1921revolutionized diabetes care and establishedinsulin as the sine qua non of quality diabetesmanagement. While it was immediately clearthat insulin prolonged the lives of patientswith diabetes, it was far less clear whether thestrict control of diabetes led to fewer compli-cations and still longer life. The answer to thisquestion appeared with the publication of thefamous Diabetes Control and ComplicationsTrial (DCCT) in 1993. This study showedfor the first time that strict control in patientswith type 1 diabetes greatly reduced compli-cations of the disease. The equally importantUnited Kingdom Prospective Diabetes Study(UKPDS) provided similar evidence in favorof strict control in patients with type 2 diabetes(Straaton et al., 2000). Subsequent studies ofpatients with type 2 diabetes produced similarresults. DCCT made QI a reality in diabetesmanagement by enabling the development ofmanagement standards that were both mea-surable and known to improve patient well-being.

3


4 ESSENTIALS OF QUALITY IMPROVEMENT

WHY DO QUALITYIMPROVEMENT

Obviously, QI is carried out to better theprognosis of individual patients with diabetesand other diseases, but there are other rea-sons as well. First, the quality of health careneeds improvement (Institute of Medicine[IOM], 2001). As Robert Brook of the RANDCorporation once said of American healthcare, “When it’s good, it’s very, very good,but it’s not very good very often.” McGlynnet al. examined 439 performance measures for30 acute and chronic illnesses. Of these 439indicators, patients received 55% (McGlynnet al., 2003). This level of care extends to di-abetes as well. Of 2,865 diabetes patients in55 Midwestern community health centers, an-nual rates for diabetes performance measuresincluded 26% for dilated eye examination,51% for foot care, 66% for dietary instruction,and 27% for two or more HbA1c tests (Chinet al., 2000). Mean HbA1c in this group was8.6%.

Second, the quality of care can beimproved. In collaboration with HealthServices Advisory Group (HSAG), Arizona’sMedicare Quality Improvement Organization(QIO), six Medicare managed care organi-zations reduced mean HbA1c values from8.9% to 7.9% and increased the proportionof patients with HbA1c values below 8.0%from 40% to 62%. The proportion of 14performance measures provided to patientsrose from 35% to 55% (Marshall et al.,2000).

Third, disparities in the level of care byrace and income can be addressed through QIactivities. Even when Medicare is paying thebill, minorities receive care that is inferior towhites (Skinner et al., 2003; Lavizzo-Moureyand Knickman, 2003).

Fourth, quality improvement can con-tribute to efforts to reduce the cost of medicalcare. Partly because of quality deficiencies,all illness and especially diabetes are very ex-pensive both to the society as a whole and tothe individual patient. Caring for a diabetes

patient managed by diet and exercise alonewho has no microvascular, cardiovascular, orneuropathic complications costs about $2,000a year. The use of oral antidiabetic or antihy-pertensive agents increases this cost by 10–30% as does increased BMI and renal, cere-brovascular, or peripheral vascular disease.Patients with heart disease, angina, or insulintherapy boost the cost by 60–90%, and thecost is increased 11-fold in patients with end-stage renal disease (Brandle et al., 2003). QIis directed at improving provision of servicesand thereby reducing some of these costs. Themanaged care plans cited above reduced thenumber of physician office visits by 13% anddoubled the number of services provided pervisit.

Out-of-pocket costs for patients haverisen as well. Drug costs have been ris-ing at an annual rate of 13–14% (NationalHealth Statistics Group, 2003) and as in-termediaries such as managed care plansand employer-sponsored insurance shift coststo consumers, utilization of diabetes pre-ventive services such as dilated eye examsand daily self-measurement of blood glu-cose decline as the out-of-pocket costs ofthese services rise (Karter et al., 2003).Once baseline data are available for agiven condition, QI can document suchchanges and highlight the magnitude of unmetneeds.

Finally, there is the question of valuefor money. Health care accounted for 15% ofthe nation’s gross domestic in 2002. AlthoughAmericans spend twice as much on health careas the Europeans or Japanese, life expectancyin the United States is 2–3 years lower than itis in these areas (Mehring and Koretz, 2004).A significant part of this cost is the higherprevalence of obesity in this country and theconcomitant diabetes, heart disease, and can-cer to which it is related. In the absence of away to prevent or cure obesity, diabetes, heartdisease, and cancer, maximizing the qualityof care is the most effective way to increaselife expectancy, improve quality of life, andreduce costs.


ESSENTIALS OF QUALITY IMPROVEMENT 5

THE CENTERS FOR MEDICAREAND MEDICAID SERVICES

The Centers for Medicare and MedicaidServices (CMS), an arm of the Social Secu-rity Administration, is the biggest purchaserof medical care in the country if not the world.Through Medicare directly and through Med-icaid indirectly by way of several states, CMSis in a unique position to change the quality ofmedical care and is actively involved in doingso. It does this through centralized activitiessuch as Pay-for-Performance (see below) and,at the state level, though a network of qualityimprovement organizations (QIOs) that workwith hospitals, nursing homes, home healthagencies, managed care plans, and, increas-ingly, individual physicians to improve qual-ity through improvement projects targetingspecific diseases like pneumonia, heart fail-ure, and acute myocardial infarction (AMI)as well as adverse clinical events like surgicalwound infections. The QIOs also accept andinvestigate complaints of beneficiaries regard-ing providers. CMS maintains two websites:www.cms.hhs.gov and www.medicare.gov.Although anyone can access either site, theformer is oriented to professionals and the lat-ter to consumers.

MEASURING QUALITY

Quality improvement in diabetes andother diseases is a set of activities undertakento assure that patients receive the servicesknown to minimize complications and maxi-mize life expectancy. The essence of QI is theperformance measure, used interchangeablywith the term “indicator.” Performance mea-sures indicate how close to perfection (100%)a provider comes in making a service avail-able to patients. Measures usually contain atime component that specifies the frequencyof the service, e.g., HbA1c determination ev-ery quarter. The results of performance mea-sures are binary and expressed as the pro-portion of patients receiving the service. The

development of performance measures hasbecome a business as QI gains acceptance.The National Quality Foundation, JCAHO,CMS, and a number of private companies alldevelop indicators. Indicators must be basedon scientific evidence and reviewed frequen-tly to assure that the evidence remains firmand that the measure itself has not been su-perseded by a new technology or medication.

Quality improvement projects (QIPs)compare what was to what is, i.e., baselinedata to data collected after some interval oftime, often monthly or quarterly. Projects al-ways produce periodic reports that sum upthe level of performance attained comparedto baseline data. QIPs thus require baselinedata, remeasurement data, and some sort of in-tervention designed to bring about a positivechange during the interval between the two.QIPs typically take place within institutionseither as an entirely internal activity or in col-laboration with other providers and/or a QIO.QIP reports have three main uses: (1) inform-ing the provider of care so they can improvefurther; (2) providing a comparison amongproviders; and (3) informing the consumer tofacilitate an informed choice of provider.

Quality improvement projects must bedistinguished from quality assessments. Qual-ity assessment is a measure of the quality ofcare at a point in time—a cross-sectional snap-shot. Assessments collect what is essentiallybaseline data to see if a QIP is needed. As-sessments are thus searches for opportunitiesto improve care, and they often become thebaseline against which the remeasurement iscompared.

We also must distinguish between QI andthe closely related area of patient safety, aterm that incorporates medical errors. Patientsafety burst upon the national consciousnesswith the Institute of Medicine’s publication ToErr is Human: Building a Safer Health Sys-tem (IOM, 1999). QI and patient safety aredifferent sides of the same coin. The differ-ence is that QI focuses on elevating the qualityof management of specific diseases like di-abetes while patient safety looks across all



TABLE 1.1. The Structural Component of Quality Measurement

Component What the component addresses

Facility The physical environment. Is the building in which care occurs suitable for its use?Organization/culture How efficient and how effectively is the care provided? Does the “culture” of the

organization support or hinder quality of care? What system changes might make carebetter? If the facility treats substantial numbers of minority patients, is it “culturallycompetent” to do so, e.g., in a facility treating Hispanics, is there an adequate cadre ofSpanish-speaking staff? Is there sufficient knowledge of the culture and life situation ofthe patients to support quality care?

Finance Is the facility fiscally sound?Utilization Who uses the facility, for what purpose, how often, and under what circumstances?Manpower Is the staffing adequate to the task, e.g., are there enough nursing staff to adequately

provide for the number of patients served?Societal General problems that impact the quality of health care by influencing consumer behavior,

but lie largely beyond the control of the provider, at least in the short run. Examplesinclude steep annual increases in the price of pharmaceuticals; the high prevalence ofAmericans without health insurance; the decline in the number of people going intonursing at a time when that segment of the population most in need of nursing care, theelderly, is rapidly rising; and the unwitting or inappropriate use of alternative medicinethat harms the user either directly or by delaying the seeking of proper medical care

diseases seeking to prevent adverse events.One of several national hospital improvementprojects now underway addresses the preven-tion of surgical wound infection, an adverseevent that is not tied to a specific disease,condition, or procedure. A second differenceis that disease-oriented QI is primarily con-cerned with acts of omission, e.g., was thepatient’s hypertension treated? Patient safetyusually addresses acts of commission, e.g.,was the hypertensive patient given the wrongmedicine or was he given the wrong dose.These differences should not obscure their un-derlying similarities. Both use the same pro-cess: find errors, be they of commission oromission, quantify them, intervene to bringabout improvement, and remeasure to quan-tify improvement.

Quality improvement has three possiblecomponents: structure, process, and outcome.Two of these (process and outcome) are dy-namic and one (structure) is relatively static.Structure has to do with the environment inwhich patient care takes place. Table 1.1 di-vides “structure” into its component parts.

Structural elements are often interdepen-dent. For example, high fiscal performancein an organization is associated with cultural

qualities that promote innovation (Fisher andAlford, 2000). Structure is often the basis ofoverall evaluation of providers such as the hi-erarchy of “best” hospitals published annuallyby U.S. News and World Report.

Process and outcome measures are dis-ease specific, and, besides obvious structuralproblems like inadequate heating or very lownurse to patient ratios, it is seldom clear ex-actly what role the structural elements playas determinants of hands-on disease manage-ment (DM).

Outcome measures are intuitively ap-pealing. They deal with endpoints such aschanges in heart disease mortality amongdiabetes patients or lowered blood pressureamong hypertensives. Unfortunately, usingoutcomes to measure quality, especially incomparing one provider to another, is fraughtwith difficulty. Different facilities have dif-ferent patients. Even when providers servethe same population, the patients may and of-ten do differ significantly from one providerto another. The provider with the sicker pa-tients will usually have the worse outcome.Disparities in health, income, and educationdiffer between entire population groups, andit is therefore difficult to compare outcomes



between providers who serve a largely poor,uneducated, ethnic minority to one whose pa-tients are preponderantly white, educated, andrelatively affluent. The use of outcomes re-quires risk adjustment—a way of taking intoaccount differences in the patients served bya given provider. Risk adjustment methodolo-gies are plentiful but there is no consensus asto which one is best, and it is inappropriate tocompare outcomes when different risk adjust-ments have been applied. The other problemwith outcomes is that the combination of pa-tients changes over time even within the sameprovider. As a consequence, outcomes alsowill vary even though the quality of care pro-vided remains unchanged. The ultimate out-come, death, is not usually attributable to thespecific act of a given provider and may not,therefore, bear any relation whatever to thequality of care provided. Finally, in many dis-eases and especially in diabetes, the patientplays a major role in determining his ownoutcome. This role is rarely, if ever, includedin quality measurement. For example, onlyabout 75% of patients who receive prescrip-tions for β-blockers are taking this medica-tion 6 months later (Butler et al., 2002). Theoutcome for the remaining 25% may be ad-versely affected by their lack of medication,but it would be most unusual for this factor tobe taken into account in assessing the qualityof care offered by the providers who managethese patients.

Process measures inherently incorporatethe limitations of medicine. The process ofcare, when it includes every service knownto be beneficial, is all the health care systemhas to offer. Every moviegoer is familiar withthe 19th century doctor’s classic line, usuallyspoken to a grieving widow, “We have doneall that is humanly possible.” An unfortunateoutcome does not imply that more might havebeen done.

Process consists of both diagnostic andtherapeutic actions. The latter are sometimesreferred to as follow-up indicators or in-termediate outcomes. Intermediate outcomesspecify what should be done for the pa-

tient once his problem is known. Thus, asshown in Table 1.2, blood pressure determi-nation is the diagnostic measure, the ACEinhibitor the patient receives if hypertensiveis the intermediate measure, and the changein the incidence of the sequelae of hyper-tension, such as heart failure or stroke, isthe outcome. Table 1.2 lists services that arecommonly used as performance measures indiabetes.

It is usual for some subset of these mea-sures, often as few as three or four, to beused as the basis of diabetes QI. HbA1c is al-ways included, and retinal examination, feetexamination, and blood pressure usually ap-pear along with HbA1c. Sets of measures of-ten differ as to frequency—annually, quar-terly, monthly, every visit, etc.—and, unlessthe frequency is known, providers shouldnot be compared even when they use thesame indicators. The major problem with pro-cess indicators is that their application variesby physician provider so results are affectedwhen, for example, a large number of patientsare cared for by a poor physician performer.CMS has been doing national process basedQIPs for about 10 years. Between 1998 and2001, CMS projects that reported on improve-ments in pneumonia, immunizations, and di-abetes among Medicare beneficiaries showedimprovement, albeit modest, in all three areas(Jencks et al., 2003).

QUALITY IMPROVEMENT ANDHEALTH SERVICES RESEARCH

The purpose of health services researchis to uncover new knowledge about the deliv-ery of health services. The purpose of QI isquite different. QI seeks to take informationknown from prior research and integrate it intothe medical mainstream. It is the alchemy ofincorporating the content of articles from theNew England Journal of Medicine into usualpractice by all providers. QI deals with thatwhich is known to benefit patients. Researchis trying to find out what benefits patients. On



TABLE 1.2. Commonly Used Performance Measures (Indicators) in DiabetesManagement

Performance measures Comment

Process measuresBlood pressure quarterly Often required at every visitHbA1c quarterly Sometimes required only once or twice annuallyFoot examination twice a year Often required at every visit; sometimes required at intervals

greater than one yearRetinal examination yearly Almost always specified that this examination must be done

with eyes dilated and/or by an ophthalmologistLipid profile yearly Usually includes total cholesterol, HDL and LDL cholesterol,

triglyceridesUrine testing for protein yearly Usually testing uses Micral; sometimes testing begins with

dipstick and Micral is used if dipstick is negativeSerum creatinineDaily aspirinImmunization against influenzaImmunization against community acquired

pneumoniaBlood pressure at the ankle to test for

peripheral vascular diseaseNot commonly used but will probably become more common

Diabetes educationNutrition instruction Most type 2 patients need to be placed on diets to lose weight

and all need to recognize the relationship between diet anddiabetes

Exercise Complements dieting and lowers blood sugarMedication Necessary to avoid episodes of hypoglycemia and to

encourage proper use of medications, especially insulinUse of home glucose meter Meters are accurate to within ±20% of readout. Meters whose

reading is based on whole blood give lower readouts thanthose based on plasma.a Patients who switch from one typeto the other will find their disease suddenly getting muchbetter or much worse or lead to the conclusion that thedevice does not work.

Follow-up (intermediate outcomes)ACE-I if hypertensive ARBs are commonly substituted for ACE-IsACE-I if protein in urine ARBs are commonly substituted for ACE-IsTreatment if hyperlipemic “Statin” drugs are increasingly used not only for hyperlipemia

but also to prevent AMIs and CVAs.Ophthalmologic referral if abnormal retinal

examNot needed if examined by ophthalmologist

a All meter readings are based on whole blood. “Plasma” meters have a built in algorithm that converts whole blood reading to itsplasma equivalent. The “plasma” reading should be 12–15% higher than the whole blood reading. Plasma readings are popularbecause they are closer to the value obtained when blood sugar is determined by a laboratory.

a practical level, the method of QI necessarilydiffers from that of research. Competent re-search always includes a control group. Butcontrol groups are problematic in QI becauseit is unethical to withhold that which is knownto be beneficial from some patients while pro-viding it to others. This is quite aside fromthe practical reality that no provider wants tobe a control group. Finally, QI is often car-

ried out among providers with no outside sup-port. To conduct QI with the rigor of researchwould be prohibitively expensive without ac-cess to the kind of external support that isavailable to research. At the same time, QIand research are mutually supporting in thatQI often becomes the basis for research justas research provides the knowledge appliedby QI.



QUALITY IMPROVEMENT ANDPATIENT SATISFACTION

A high level of patient satisfaction withthe care they receive has long been consid-ered a hallmark of quality. Providers fre-quently play up patient satisfaction in theiradvertising, and most health care institutionsregularly sample patients to obtain feedback.While patient satisfaction and quality are seenas complementary, it is usually unclear justhow much satisfaction is needed to denotequality. In a free market, a managed careplan with patient satisfaction approval of lessthan 85–90% or better is unusual for the sim-ple reason that the dissatisfied simply disen-roll. Enrollment of Medicare beneficiaries inmanaged care plans has been in free fall forabout 5 years, a trend that began as plans ad-dressed rising costs, first by dropping liberalprescription drug benefits and then by whole-sale abandonment of patients and voluntarilywithdrawal from the market. Generous pro-visions for managed care in the newly en-acted Medicare Prescription Drug and Mod-ernization Act of 2003 are intended to re-verse both trends. Patient satisfaction playeda key role in this downward spiral. As costsbegan to rise, stripping away the drug ben-efit greatly reduced patient satisfaction andreduced enrollment, leaving the plans withnot only rising costs but declining income aswell.

While this kind of patient satisfaction—voting with one’s feet—has obvious ramifica-tions where the patient has free choice, the roleof patient satisfaction and its relationship toquality of care in hospitals is often less clear.A patient with diabetes who is hospitalizedfor an AMI is not likely to know if he wasgiven an ACE inhibitor or β-blocker or evenwhether he should have been given one or bothof these drugs. On the other hand, he wouldknow when pressing the call button brought noassistance or how the food tasted or how wellhe was treated by the admitting staff. Patientsatisfaction is a de facto outcome measure thatreflects both characteristics of the hospital andthe patients who experience the hospital. Like

other outcome measures, patient satisfactionmust be risk adjusted to enable comparisonacross providers. A risk adjustment schemefor patient satisfaction might include age, sex,race, education, self-reported health status,and why the patient is under treatment. Pos-itive and negative experiences spread rapidlyby word-of-mouth, and hospitals are very con-cerned about how its patients feel about themand recognize the importance of pleased clien-tele to market share. CMS and the Agency forHealth Research and Quality (AHRQ) havejointly developed a standardized, risk adjustedpatient satisfaction instrument called the Hos-pital Consumer Assessment of Health PlansSurvey (HCAHPS). It is modeled after a previ-ously developed instrument designed for man-aged care plans known as CAHPS, which isthe same name without the “H.” Instrumentssuch as these can be used across providers andyield valid results.

Patient satisfaction and disease-specificquality assessment measure different aspectsof quality. For this reason, it is not sur-prising that there is frequently no correla-tion between patient satisfaction and clinicalquality as measured by performance indica-tors.

INTERVENTIONS

An intervention is any act that is takento improve the quality of care provided to pa-tients with a specified condition. An outpa-tient facility that provides continuing medicaleducation for its physicians is intervening toimprove diabetes care. Some interventions be-come so standardized and well studied thatthey themselves become quality measuressuch as diabetes education for patients. Thesuccess of interventions in bringing about pos-itive change is far from certain. Interventionsin one setting may seem to have no effect at allin, say, increasing the rate of lipid testing andyet work quite well in another setting. Inter-ventions are influenced by the organizationaland cultural environment in which they oc-cur and the same intervention may be greeted



with enthusiasm by one provider and with dis-dain by another. Change in services providedafter an intervention may thus reflect influ-ence of the cultural climate rather than theintervention. Further, a QI may succeed pri-marily because the provider knows that he isbeing observed, thereby reflecting the well-known “Hawthorne effect.” While the contextof this discussion is interventions as part of QIprojects, some interventions are quite differ-ent. The Medicare program may be seen asa huge intervention intended to improve careby removing financial barriers. The extensiveQI activities of CMS throughout the UnitedStates, while not specifically geared to im-provement directly attributable to the Medi-care program, is intended to measure changesin the quality of care received by beneficiaries.

ORGANIZATIONAL CULTUREAND SYSTEM CHANGE

As experience grows with quality im-provement, more and more emphasis is beingplaced on the environment in which the QIP isoperating, i.e., the culture of the provider orga-nization. It is not unusual for a QIP to producea relative improvement of 30% or so and findthereafter that further improvement becomesextremely difficult. Further, when more thanone provider is involved in the QIP, improvedperformance across providers is often simi-lar and they often share performance charac-teristics. If provider A fails to examine a pa-tient’s feet, it is quite likely that provider Bwill not examine them either. When there isa very large gap between one provider andothers, it often means that the organizationalculture of the outstanding provider differs sig-nificantly from the norm. Organizational cul-ture subsumes the shared perceptions, beliefs,and expectations of its personnel, and organi-zational culture mediates any effort to bringabout change. Financial health, willingnessto innovate, customer and employee satisfac-tion, and especially leadership, all seem to bekey components of an organization’s culture.1

One can confidently expect to see major ef-forts to increase understanding of cultural in-fluence so these can be harnessed in the causeof improved care.

TEN IMPORTANTCONSIDERATIONS INQUALITY IMPROVEMENT

(1) Weighted measures. Most diabetesprojects use several indicators similar to thosein Table 1.2. It is not uncommon for those de-signing QIPs to make some indicators countmore than others. This is the application ofweights to the measures used. Thus, indicatorA might count as 1.0 but indicator B count as2.0, making B twice as important in scoringimprovement than A. There are two problemswith this. First, those being evaluated will con-centrate on B at the expense of lower weightedindicators. Second, it is unusual for those con-sidering the measures or being evaluated bythem to agree on the relative weights to beused, thus undermining the credibility of theproject.

(2) Scoring improvement versus scoringperformance. If the goal of QI is to achieve aspecified level of performance or to developa hierarchy of providers from best to worst,the target of the QI effort is performance,i.e., the remeasurement value. Performancemust be distinguished from improvement.As we have seen, QI requires two measure-ments, baseline and remeasurement follow-ing the application of an intervention. Thedifference between the two expresses the de-gree of improvement. If provider X exam-ines the feet 20% of the time at baseline and40% of the time at remeasurement, this isan improvement of 100% ((Remeasurement –Baseline/Baseline) X 100). Consider anotherprovider, Y, who examined the feet of 70%of patients at baseline and 90% at remeasure-ment. Both providers increased performanceby 20 percentage points, yet Y’s improvementis only 28.6% ((90 − 70/7) × 100 = 28.6%).Y would appear to have improved far less than



X even though Y’s baseline score was 3.5times better and Y’s remeasurement was 2.5times better than X’s. What is wrong withthis picture? The problem has to do with thenature of percentages. The lower the base-line value, the greater the percentage increaseat remeasurement. What is used to correctthis difficulty is the relative improvement,sometimes referred to as the reduction in er-ror rate, where the “error rate” is the differ-ence between the baseline and 100%. Rela-tive improvement thus ties the improvementscore to the goal of all providers, which isproviding the service in question to all pa-tients, or 100%. It shows the extent to whichthe provider has narrowed the gap betweenwhat he provided at baseline and the goalof 100%. The formula is (100 − baseline) −(100 − remeasurement)/(100 − baseline) ×100. Using this formula, X improved 20%while Y improved 67%. Relative improve-ment also takes into consideration the well-known fact that it is easier to improve thelower your baseline score. It is harder to gofrom 90% to 95% than it is to go from 5% to10%. Table 1.3 shows the relative improve-ment for any combination of baseline and re-measurement values. The shaded area shows

the combination of baseline and remeasure-ment performance that result in a relative im-provement of at least 50%.

(3) Absolute versus relative standards.What is the objective of a QI project compar-ing the management of diabetes among physi-cian groups within a managed care plan? Is itabsolute, i.e., everyone is expected to achievea performance level of 90% and anything be-low that is unsatisfactory? Is it relative, i.e.,success is defined by groups in the 90th per-centile based on some sort of benchmarkinghierarchy? For most purposes, relative stan-dards are preferable in part because they areless likely to encounter significant resistancefrom providers and in part because relativestandards are seen as more attainable than ab-solute. In addition, absolute standards maysend the wrong message. If they are too high,no one will reach them, thereby underminingthe face validity of the project and arousingprovider hostility. If they are too low, everyonewill reach them, in which case the project maybe settling for performance that still has muchroom for improvement. Finding the right ab-solute standard can be difficult. One way ofdealing with this problem is to deliberatelystart out with a relatively low standard that

TABLE 1.3. Relative Quality Improvement

Baseline Remeasurement

10 20 30 40 50 60 70 80 90 100

10 0.00 0.11 0.22 0.33 0.44 0.56 0.67 0.78 0.89 1.0020 −0.25 0.00 0.13 0.25 0.38 0.50 0.63 0.75 0.88 1.0030 −0.43 −0.14 0.00 0.14 0.29 0.43 0.57 0.71 0.86 1.0040 −0.67 −0.33 −0.17 0.00 0.17 0.33 0.50 0.67 0.83 1.0050 −1.01 −0.60 −0.40 −0.20 0.00 0.20 0.40 0.60 0.80 1.0060 −1.53 −1.00 −0.75 −0.50 −0.25 0.00 0.25 0.50 0.75 1.0070 −2.38 −1.67 −1.33 −1.00 −0.67 −0.33 0.00 0.33 0.67 1.0080 −4.12 −3.00 −2.50 −2.00 −1.50 −1.00 −0.50 0.00 0.50 1.0090 −8.00 −7.00 −6.00 −5.00 −4.00 −3.00 −2.00 −1.00 0.00 1.00

1 For an excellent review of organizational culture, see Boan & Funderburk (Unpublished).2 One graphic device is the radar chart. Radar charts are not familiar to most consumers and many professionals. They can be

constructed using Microsoft PowerPoint, which also contains a description of their use.3 This may seem to be a small amount but an official from one of the larger Phoenix hospitals told me that for his institution it was

estimated to be worth about 1.5 million dollars.a All meter readings are based on whole blood. “Plasma” meters have a built in algorithm that converts whole blood reading to its

plasma equivalent. The “plasma” reading should be 12–15% higher than the whole blood reading. Plasma readings are popularbecause they are closer to the value obtained when blood sugar is determined by a laboratory.



most can reach. Such “victories” encouragefurther effort and the standard can be gradu-ally raised over time.

(4) Composites versus individual indica-tors. The indicators comprising a QI projectshould be independent of all other indicators.That is, provision of one service should notflow automatically from provision of another.In addition, each indicator used is specificunto itself. It is incorrect to speak of highquality in diabetes care if this is based en-tirely on the proportion of patients receivinga dilated eye examination. It is also incorrectto express the quality of diabetes care as thesimple average of the scores of the individualindicators. The average can be just as mislead-ing as overemphasis on a single indicator. Onthe other hand, averages, also known as com-posites or aggregates, are the easiest way for aconsumer to assess quality. It is the rare con-sumer who has sufficient knowledge to eval-uate individual indicators. One way of deal-ing with this problem is to use average scoresand include scores on individual indicatorsthrough the use of a graphic device so thepatient can see exactly where two providersdiffer if he is so inclined.2 Individual indica-tors on the other hand are most useful to pro-fessionals trying to pinpoint areas that needimprovement. Composites are the preferredway of presenting data to consumers, albeitwith the inclusion of indicator information aswell.

(5) Reliability of data. Quality improve-ment projects get data from medical recordsand other sources of information about pa-tients. Since, for example, the prescribing ofan ACE inhibitor for a diabetes patient withhypertension is not actually observed, the pa-tient’s medical record is the only source ofinformation. Or is it? It is often claimed, es-pecially by those new to QI, that services areprovided that do not find their way into therecord. They feel that QIPs measure qualityof documentation rather than quality of care.From a QI perspective, the two are one andthe same because documentation is the only

evidence that a service was provided. Further,payment is closely tied to documentation ofservices provided and there is thus a strong in-centive for providers to record what they do.Be it reimbursement or QI, the rule is “if itisn’t documented, it didn’t happen.”

(6) Face validity. The success of QI iswholly dependent on the cooperation of theproviders whose data are being examined.This cooperation in turn depends on the facevalidity of the QI project. In other words, theproject must make sense and be comprehensi-ble to the provider-subjects. Project elementslike scoring, weighting, documentation, rulesgoverning patient inclusion, statistical anal-ysis, etc., must be fully explained and fullyunderstood before the project begins.

(7) Evidence-based medicine. Evidence-based medicine (EBM) is the rational ba-sis for face validity. One of EBM’s earliestadvocates, David Sackett offered this defini-tion: “Evidence-based medicine is the con-scientious, explicit, and judicious use of cur-rent best evidence in making decisions aboutthe care of the individual patient” (Sackettet al., 1997, p. 2). Best evidence is most com-monly found in relevant, methodologicallysound medical research and implies physicianfamiliarity with such research. Such familiar-ity is often lacking even for the motivatedphysician due in part to the vastness of themedical literature and in part to the high pro-portion of published material whose method-ology is flawed. Those conducting QI mustuse indicators that reflect a strong evidencebase not only for credibility but also as an in-direct means of educating physicians whoseperformance is being measured. EBM is thesurest way of knowing that what is done forthe patient is likely to benefit him.

(8) The challenge of small case numbers.Ideally, QI is a game everyone should play.However, providers with small numbers of pa-tients are often, if not usually, exempted fromQI because they have so few patients that theproportions are volatile and unreliable. Oneway to deal with this problem and include



all providers regardless of size is the ad-justed percentage fraction (APF) (Weissmanet al., 1999). The APF represents the bestpredictor of how a provider with small casenumbers would perform if there were manypatients. It is done by adding one to thenumerator and two to the denominator, i.e.,APF = (N + 1)/(D + 2) × 100. The APF ispart of a benchmarking methodology calledachievable benchmarks of care (ABC). Be-cause ABC uses relative rather than absolutestandards, it is not universally accepted. How-ever, this in no way depreciates the value ofthe APF. The APF and raw percentages tendto be very close at case numbers above 30, andbeyond this number, raw percentages shouldbe used. The APF is usually acceptable toproviders once they understand its use and itsolves a major difficulty. It is reasonable to ex-pect that all providers who provide the sameservices should be equally accountable. TheAPF lets all the players into the game.

(9) Flexibility in QI. Locking in prac-tices that may be scientifically obsolescentis a danger inherent in QI. Indicators shouldnot be regarded as being beyond criticism orchange. All indicators need to be reviewed atregular intervals to assure that they are nothaving a negative influence on provider prac-tice. For example, if an indicator specifies theuse of an ACE inhibitor for patients with acutemyocardial infarction while many physiciansfavor the use of angiotensin receptor block-ers (ARBs) instead because they have fewerside effects, the indicator should be reviewed.If review fails to demonstrate that ARBs areequal to ACE-Is for AMI patients, there is stillan important problem. If the indicator is onewidely used by CMS in a QIP involving Medi-care patients in all U.S. hospitals, how will theresearch required to definitively demonstratethe value of ARBs relative to ACE-Is be car-ried out? In a case like this, a QIP may have theunintended and paradoxical consequence offreezing practices that should be reassessed.Similar flexibility is required to deal with in-dicators that may not be appropriate for all

patients. The prudent physician would not ad-vise his patient to take aspirin daily to preventAMI if the same patient were taking warfarinfor atrial fibrillation. One common way to dealwith these issues is to count the indicator ashaving been completed if there is a note fromthe physician saying why the indicator ser-vice was withheld. Finally, sets of indicatorsshould be open to additions and deletions aswarranted. The list of process indicators in Ta-ble 1.2 shows what are commonly used; it isnot meant to exclude all other potential indi-cators.

For a number of years, it has beenthe conventional wisdom that mortality fromcoronary artery bypass graft (CABG) is in-versely proportional to hospital volume, anda volume standard for hospitals was usuallyset at no less than 200 cases per year (Hartzand Kuhn, 1994). The HSAG, Arizona’s QIO,did an assessment of CABG surgery in the late1990s and found that although mortality rateswere comparable to national data, only two ofthe 20 hospitals offering CABG averaged 200cases per year and that surgeon volume ratherthan hospital volume was the primary deter-minant of outcome (Marshall and Murcko, un-published). These observations were recentlysupported by Birkmeyer et al. (2003). If, asit appears, CABG mortality does not dependon hospital volume, this standard needs tobe revised and perhaps refocused on the in-dividual surgeon. Volume requirements forCABG are written into law in New Jersey(New Jersey Administrative Code, n.d.) andPennsylvania (Dethlefs et al., 1991) and howsoon they are amended will be a major test offlexibility.

(10) Limitations of indicator-specific QI.The more indicators, the more one learnsabout the management of diabetes patients.However, as the list of indicators grows sodoes the expense of collecting data and, of-ten, the intrusiveness of the entire project.To avoid overwhelming expense, indicatorsshould be reviewed by performance. If an in-dicator service is provided to 95% of patients,



its value as an indicator is dubious because toa considerable extent it no longer representsan opportunity to improve care. The replace-ment of indicators as they become obsolete orreach full compliance also serves to maintainthe attention of providers who are continuallyoffered new challenges. In a somewhat differ-ent vein, QI is always incomplete because itrarely includes structural variables that affectthe process of care such as the financial via-bility of the organization, the availability ofsufficient personnel, or the satisfaction of pa-tients with services provided. Even when thiskind of information is available, it is difficultto relate it to indicator-specific quality as tocause and effect. QI reveals how diabetes ismanaged but does not divulge what changes inthe organization, i.e., system changes, mightserve to further improve care.

QI ON THE NATIONAL, STATE,AND REGIONAL LEVELS

Broadly applied QI activities such asthese do not usually include any kind of for-mal remeasurement. Rather, they have beendemonstrated in smaller venues to be effec-tive and they are utilized based on this evi-dence. Their success is judged by changes inpertinent national, state, or regional data. Anexample would be a national education cam-paign to promote improved eating habits as ameans of countering the related “epidemics”of obesity and diabetes. The success of such aprogram is not formally measured and it mightbe judged by a drop in the average weight ofadults over time, fewer hospitalizations for di-abetes or diabetes-related conditions, a fall inthe sale of antidiabetic pharmaceuticals, etc.Results are rarely “clean” because our educa-tional program is not the only source of infor-mation about nutrition and diabetes. Lots ofsmaller units such as state health departments,managed care plans, health centers, individ-ual physicians, and a major segment of thefood industry are all busy promoting the samething. This is the problem of confounding. The

effects of multiple factors on a response can-not be separated. The extent to which changein the desired direction is the result of the na-tional effort or of a smaller unit effort or bothremains unknown.

DISEASE MANAGEMENT

Targeted as a method to improve care andcontrol rising health costs, DM is a movementbacked primarily by insurers and managedcare plans. DM focuses on high cost, high-riskpatient populations, and aims to reduce costsby making visits to the physician secondary tomeasures taken by the patient himself. This isdone under the guidance of a health care pro-fessional (nurse, educator, pharmacist, dieti-cian, respiratory/physical/occupational thera-pist, etc.) who serves as case manager (alsoknown as a disease manager or care man-ager). Standard protocols using evidenced-base guidelines are drawn up for each dis-ease being managed, including such illnessesas depression, heart failure, and diabetes. Thecase manager communicates with the patienton a regular basis to assure that the patientis adhering to the protocol, thus improvingthe quality of care. Case managers are some-times available 24 hours a day and furthercommunication is provided through websites.The case manager is also in contact with thepatient’s physician and reminds him or herof services needed by specific patients. Dis-ease management is a rapidly growing fieldthat is increasingly offered through employ-ers. A DM trial among Medicare beneficia-ries is part of the Medicare Prescription DrugBenefit and Modernization Act of 2003. DMis not without flaws. Relationships betweendoctors and case managers are often frustrat-ing to both parties, and the involvement ofpharmaceutical houses in DM might be seenas a ploy to push prescription medications.Because it is of greatest interest to its back-ers, DM tends to be judged not by changes inquality but by changes in cost (Clark, Kim,2004).



PUBLIC REPORTING ANDPAY-FOR-PERFORMANCE

By far, the biggest player in contempo-rary QI is the Centers for Medicare and Med-icaid Services. CMS now requires periodicpublic reporting of data on selected conditionsand indicators from nursing homes, homehealth agencies, and managed care plans. Pub-licly reported data from managed care plansincludes diabetes. In addition, hospitals face asmall percentage loss of 0.4% of the increasein Medicare reimbursement for the followingyear if they do not agree to publicly reportdata.3 There is little doubt that the data fromindividual physicians will become public inthe near future. Public reporting is an inter-vention intended to stimulate quality improve-ment efforts and to enable consumers to makeinformed choices about providers. Forty per-cent of consumers say that a hospital’s qual-ity is important to them when choosing whereto be admitted (AHQA Matters, 2004). Howeffective it will prove to be is not known,but it is uncertain that it will significantly af-fect patient’s choice of hospital or nursinghome since many patients have this choicemade for them by their physician or managedcare plan, and others make decisions based onsuch considerations as nearness to home, ex-perience of friends and relatives, and generalreputation.

Pay-for-performance is perhaps the ulti-mate intervention. Carried to its logical endpoint, it means that the patient is not pay-ing for service or time; he is paying in-stead for a level of care identified and re-quired by the payer. Pay-for-performance isnot a new idea to health care. Indeed, in afree market, the consumer chooses to pay theprovider he uses in the belief that the providerprovides care that is worth the fee. Pay-for-performance tied to specific performancemeasures is new, however, and it would seemto be the most powerful of all interventions.A pay-for-performance demonstration is nowunderway involving a nationwide system ofnonprofit hospitals. About 300 hospitals have

agreed to tie their Medicare reimbursementin part to performance on 34 quality indica-tors covering AMI, heart failure, pneumonia,CABG surgery, and hip and knee replace-ment. The indicators bear the imprimatur ofprominent organizations involved in QI suchas JCAHO, National Quality Forum, QualityImprovement Organizations, and CMS itself.Using annual composite quality scores, hos-pitals that finish in the top decile (>90%) willreceive a 2% bonus on Medicare reimburse-ment. Those in the second decile (>80%) willreceive a 1% bonus. At the other end of the hi-erarchy, those in the ninth decile (>20%) willlose 1% whereas those in the bottom decile(<10%) will lose 2% after 2 years of such sub-par performance (Medicare Fact Sheet, 2004).

ELECTRONIC MEDICALRECORDS

Electronic medical records (EMR),sometimes called electronic health records(EHR), is QI’s hitherto impossible dream.EMR compiles all the data on an individ-ual patient in one electronically accessibledatabase. A thorough EMR would includelaboratory tests, radiology reports, inpatientnotes for each hospitalization, outpatientnotes for each visit and each physician visited,surgical notes, and medications. The patient’sentire experience with the health care systemwould be immediately available to the currentprovider. Patient data could be sorted so thatthe specific problem of interest to a providercould be addressed and those interested in QIcould be certain that the patient receives careup to the existing standard. It is the next log-ical step after disease management. To date,EMR is in use at large systems of care such asthe Department of Defense and the Veterans’Administration. EMR is increasingly frequentin hospitals and managed care plans as well,often in a hybrid form that retains some fea-tures of the paper record. In these cases, EMRsreaching across hospitals or managed careplans are exceedingly rare. The biggest hurdle



to expanded use of the EMR is the individ-ual physician or physician group. Cost, steeplearning curves, avoidance of disruption ofan ongoing method of record keeping, anddoubts about the ability of EMR to live upto its advance billing are formidable barriers.Some of the doctor’s concerns are real enough.Like any other electronic data storage device,security and confidentiality are major issues.There is no existing legislation that establishesground rules for how medical information canbe used, who should be able to access it, andwhich parts of the record should be acces-sible. Records accessed through the world-wide web are almost certainly vulnerable toaccess by the unauthorized and the curious.The number of parties with an interest in apatient record includes government agencies,insurance companies, health care administra-tors, managed care plans, physician groups,etc. Each of these is a potential source of unau-thorized access by unauthorized personnel.

SUMMARY

Quality improvement in the managementof a disease entity like diabetes is dependenton the knowledge that how the patient is man-aged has a positive impact on his well-beingto a greater or lesser degree. Thus, one maytrace the origins of QI in diabetes to the dis-covery of insulin in 1922 and the DCCT studyof 1993. In many diseases, the result is deathno matter what the physician does or does notdo. Once the physician does what he can, hecan do no more. For this reason, QI based onthe process of care is more appropriate thanQI based on patient outcomes.

Quality improvement uses specific activ-ities that patients require, called “indicators”or “performance measures,” to determine thequality of care. A typical indicator in diabetescare is whether a patient with diabetes re-ceived a timely eye examination. QI comparesthe difference between the completeness ofthe process of care at a baseline time to that ata later time. This difference in completeness

in the rate of improvement is best expressedat the Reduction in Error Rate, i.e., the dif-ference between the level of care achievedand the highest possible level, which is, ofcourse, 100%. In contrast, quality assessmentis “snapshot” of care as it existed at a pointin time and does not measure improvement.Quality assessment often leads to QI, how-ever, in which case the assessment becomesthe baseline measurement. QI does not pertainonly to diseases. It is equally applicable to is-sues of patient safety and patient satisfaction.

Among providers, hospitals and man-aged care plans probably have the mostwell-developed internal methods of qualityimprovement. QI is relatively new amongnursing homes, home health agencies, and theoffices of individual or groups of physicians.States are involved in QI through Medicaidand the activities of health departments, andthere are a host of private or university-basedprograms that address quality issues. Thebiggest influence on improving quality, how-ever, is the federal CMS. Medicare is thelargest purchaser of health care in the UnitedStates, and Medicare beneficiaries accountfor a disproportionate number of hospital ad-missions, consumption of prescription drugs,and visits to physicians. Since Medicare re-imburses providers for this care, its influenceis enormous. QI activities of CMS are the re-sponsibility of QIOs, one of which serves eachstate.

Recent developments in the field ofQI include public reporting of selected pa-tient care data by hospitals, nursing homes,managed care plans, home health agencies,and, increasingly, individual physicians. Pub-lic reporting is the precursor to pay-for-performance care under which high qualityproviders are rewarded by higher reimburse-ments and poor performers face reduced re-imbursement. Much attention is now focusedon the spread of electronic records to facili-tate the access of patient information to thoseproviding for his care. Attention also is in-creasingly directed to the corporate “culture”under which care is provided and whether the



characteristics that define this culture promoteor impede high-quality care.

Quality improvement is a work inprogress with vast potential benefits for pa-tients. As fiscal rewards become more im-portant, such incentives will not only stimu-late improvement efforts by providers but alsoprovide a concrete payoff for their efforts.

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