~.

.4 u... h

a
,
é
r

-

 

‘i‘gn. ;«
‘ ewe-51'!" .
“pl?! 453:1”

V:

r
“A, z. 1.. "g r.
Mama?

 

aim

cums

ON 4

N

This is to certify that the
thesis entitled

IMPROVING SECONDARY PREVENTION OF CORONARY
HEART DISEASE

USING DECISION SUPPORT INTERVENTIONS IN
OUTPATIENT SETI'INS;

A GRANT PROPOSAL SUBMITTED TO NATIONAL HEART
LUNG AND BLOOD INSTITUTE

presented by

ADESUWA B. OLOMU

has been accepted towards fulfillment
of the requirements for the

MASTER OF degree in EPIDEMIOLOGY

 

 

SCIENCE
,4' /‘
Wu C) .20de

 

Major Professor’s Signature

7‘1/ _‘
D€<_’@xuxéZ/..”2€); yZCI’CJG

Date

 

MSU is an Affirmative Action/Equal Opportunity Institution

_.-._.-.--.-.-.-.-o-

 

.UBRARY
Michigan State
University

 

 

 

PLACE IN RETURN BOX to remove this checkout from your record.
TO AVOID FINES return on or before date due.
MAY BE RECALLED with earlier due date if requested.

 

DATE DUE DATE DUE DATE DUE

 

 

 

 

 

 

 

 

 

 

 

 

 

 

6/07 p:/ClRC/DateDue.indd-p.1

 

IMPROVING SECONDARY PREVENTION OF CORONARY HEART DISEASE
USING DECISION SUPPORT INTERVENTIONS IN OUTPATIENT SETTINGS;
A GRANT PROPOSAL SUBMITTED TO NATIONAL HEART LUNG AND
BLOOD INSTITUTE

By

Adesuwa B. Olomu

A THESIS

Submitted to
Michigan State University
in partial fulfillment of the requirements
for the degree of

MASTER OF SCIENCE

DEPARTMENT OF EPIDEMIOLOGY
2 00 7

_ ABSTRACT
IMPROVING SECONDARY PREVENTION OF CORONARY HEART DISEASE
By
Adesuwa B. Olomu

The proposed research will focus on improving secondary prevention of coronary heart disease
(CHD) for both Afi'ican American (AA) and low socioeconomic (SES) populations. AA have
higher mortality and morbidity from heart disease than whites. They are less likely than whites to
receive appropriate cardiac medications and basic clinical services.

Specific Aims of this project are to:

1) Develop and pilot test a patient-centered intervention, Office-Guideline Applied to
Practice (Office-GAP) to improve the implementation of evidence-based guidelines
for secondary prevention of CPD for both AA and low SES populations in an
outpatient clinical setting. The intervention will include the use of Office-GAP tools
as part of clinician workflow. The intervention will embed the content of secondary
prevention into the care process. The principle of shared decision-making (SDM)
will also be used to negotiate lifestyle/behavior change goals with the patient.
Provider and patient educational modules will be developed and implemented.

2) Develop an Office-GAP follow-up program that will include reminders to reinforce
secondary prevention goals.

3) Evaluate the implementation of Office-GAP using a cluster-randomized design at
Ingham County Health Centers.

We believe that these decision support tools will translate research into practice and
improve physician and patient adherence to evidence-based recommendations. This should lead
to a decrease in cardiovascular morbidity and mortality for both AA and low SES populations.
Elements of the proposed system can be applied to the treatment of other chronic diseases

following successful implementation.

DEDICATION

To My Farnily

who encouraged, prodded, supported, sacrificed
and consoled through these years.

iii

ACKNOWLEDGEMENTS

Special thanks to all those who helped me through this degree. In particular, I would like
to thank Drs. Margaret Holmes-Rovner, Mathew Reeves, David Todem and Nigel
Paneth, my mentors and committee members; students I have had the pleasure to work

with over the years; and of course, my assistant, Jinie Shirey.

iv

TABLE OF CONTENTS

LIST OF TABLES ........................................................................... vi
LIST OF FIGURES ......................................................................... vii
KEY TO SYMBOLS OR ABBREVIATIONS ......................................... viii
THE CANDIDATE .......................................................................... 1
RESEARCH PLAN ......................................................................... 18
A. SPECIFIC AIMS ........................................................................ 18
B. BACKGROUND AND SIGNIFICANCE .......................................... 22
C. PRELIMINARY STUDIES ........................................................... 35
D. RESEARCH DESIGN AND METHODS .......................................... 44
E. HUMAN SUBJECT RESEARCH ................................................... 77
F. VERTEBRATE ANIMALS ........................................................... 85
G. SELECT AGENT RESEARCH ...................................................... 86
APPENDICES

APPENDIX A: RESOURCE SHARING PLAN ................................... 87

APPENDIX B: UCRIHS PRELIMINARY APPROVAL ......................... 89

APPENDIX C: PHYSICIAN PDM SYTLE QUESTIONNAIRE ............... 90

APPENDIX D: PROJECT TIMELINE .............................................. 91

APPENDIX E: TRAINING IN THE RESPONSIBLE

CONDUCT OF RESEARCH ....................................... 92
APPENDIX F: ACC/OFFICE GAP PROJECT/HEART ATTACK
PREVENTION CONTRACT ...................................... 93

APPENDIX G: FIMDM GUIDEBOOK “LIVING WITH
CORONARY ARTERY DISEASE- DOING YOUR PART”. 96

BIBLIOGRAPHY ........................................................................... 124

LIST OF TABLES

Table 1: PROGRAMS TO ACHIEVE AIMS 1-3 ................................. 51

Table 2: TARGETED/PLANNED ENROLLMENT TABLE .................. 83

vi

LIST OF FIGURES

Figure 1: EFFECTIVENESS EXPRESSED AS PERCENT RISK
REDUCTION OF RECURRENT HEART ATTACK
THROUGH SECONDARY PREVENTION ............................ 25

Figure 2: CONCEPTUAL MODEL TO FACILITATE ADHERENCE
TO GUIDELINES WITHIN PRIMARY CARE ....................... 45

Figure 3: SAMPLE SIZE AND POWER BASED ON GEE MODELS... . . ....62

vii

AMI

ACC

ACEI
CVD
CAD
CHD
DST

GAP

LDL

QI
SES

KEY TO SYMBOLS OR ABBREVIATIONS

Acute Myocardial Infarction
African Americans

American College of Cardiology
American Heart Association
Angiotensin Converting Enzyme Inhibitor
Cerebrovascular Disease
Coronary Artery Disease
Coronary Heart Disease
Decision Support Tools
Guideline Applied to Practice
High Density Lipoprotein

Low Density Lipoprotein
Quality Improvement

Socio-Economic Status

viii

1. THE CANDIDATE:

A. BACKGROUND

My background demonstrates a consistent interest and commitment to research.
Previous research experiences have expanded my knowledge base and research skills, as
well as focused my research efforts on health services research, particularly in areas of
prevention of cardiovascular diseases and quality improvement. I began my research
career during my graduate training in Internal Medicine at the Queen Elizabeth Hospital
and University of Birmingham, England, UK. Under the mentorship of Dr. Elwyn Elias, I
successfully completed a research project and wrote a dissertation on gender differences
in primary biliary cirrhosis. The results, published in the New England Journal of
Medicine1 and Lancet“) furthered my interest in clinical research and studies involving

patients with chronic disease.

On return to Nigeria from my medical training in England, I became involved in
epidemiological studies among black populations before coming to the United States
(U S). Selected studies involving black populations, included, an epidemiological study of
determinants of hypertension in blacksm, body fat distribution and other anthropometric
blood pressure correlates in a black elderly population“, and the correlates of serum lipids
in a lean black populations. These studies sharpened my skills in research design, data

interpretation, scientific writing and presentation.

I did my residency in general internal medicine at Michigan State University
(MSU), and soon after graduation, was appointed to the position of Assistant Professor in
the Department of Medicine. With a. keen interest in health services research, I became a

member of an active health services research group engaged in the study of the process

and outcomes of care provided to patients with acute myocardial infarction. I gained
substantial experience from involvement in the data analysis of the Michigan State Inter-
institutional Collaborative Heart (MICH) study. MICH is an observational study of the
process and outcomes of care for patients hospitalized with acute myocardial infarction in

two mid- Michigan communities.

I am currently involved in studies determining the rate of use of recommended
evidenced based medications in patients following acute myocardial infarction (AMI).
Results of our studies revealed an under use of evidence-based medications for secondary
prevention of heart disease. Furthermore, our results showed that African American
patients were less likely than whites to be on daily aspirin at the time of admission.
Findings from the MICH study, on the rate of use of beta-blockers and aspirin following
AMI were presented at the Regional and National meetings of the Society of General
Internal Medicine (SGIM) 6'7. Another study, regarding changes in rate of use of beta-
blockers following acute myocardial infarction was published in the Journal of General
Internal Medicine, Oct 20048 (see Preliminary study 3 on pages 32-40). In addition, I am
a co-investigator in “Translating Research Into Practice: Patient Decision Support and
Coaching”, a novel approach to improving the use of secondary prevention following
hospitalization for myocardial infarction. Dr. Holmes-Romer is the PI on this R01
HSlOS3l from AHRQ. I am the clinical consultant on the project, and the lead

investigator on minority health issues on the team.

I was awarded a minority supplementary grant 3 R01 HS] 0531 from AHRQ,
based on the above R01 parent grant. I am completing data analysis, assessing outcomes

in patients with acute coronary syndrome. I have presented the following abstracts from

data analyzed so far: 1) “Evaluation and Treatment of High Cholesterol during
Hospitalization for Acute Coronary Syndrome”9 2) “Self— Report Comorbidity Data and
Functional Outcomes in Acute Coronary syndrome”lo 3) “The Effect of Evidence-Based
Cardiac Medication Use on Hospital Readmission for Post Acute Coronary Syndrome
(ACS) Patients””. 4) “Quality Improvement Efforts And Hospital Performance: Rates of
Beta-Blocker Prescription for Acute Coronary Syndrome ”. 12 These were at the Midwest
Regional Meeting of Society of General Internal Medicine (SGIM) in October 2004 and
at the National meeting of the SGIM in May 2005 and April 2006. Working on each of
these abstracts improved my health services research skills and strengthened my interest

and commitment to quality improvement and prevention of heart disease.

As I pursued my research interests, I became aware of the need to supplement
practical research experiences with formal didactic training in clinical epidemiology and
biostatistics. I successfully applied to MSU’s NIH K30 program “Training Clinical
Researchers in Community Settings (T RECOS)” to begin formal research training in
epidemiology. The fellowship award has allowed me to pursue a Masters in
Epidemiology at MSU while working on various research projects. I have completed 33
of 40 required credits towards the masters’ program. The anticipated date of completion
is December 2006. This program covers a broad range of topics relevant to clinical
research including observational studies, controlled clinical trials, and survey research. It
also provided training in biostatistics, epidemiology, statistical modeling and research

management.

I am confident that, with the training, experience, and mentoring I will receive

during a five-year NHLBI Mentored Minority Faculty Development Award, I will

become an independent investigator and a role model for minority medical students,

residents and fellows in training.

Establishment of mentor relationship.

My research interests are in the area of health services research, specifically in the
area of prevention, decision support, disease management and quality of care of
cardiovascular disease among blacks and low-income populations. This interest has led
me to work closely with Dr. Margaret Holmes-Rovner, the primary mentor for this
application. Dr. Holrnes-Rovner is a Professor of Health Services Research at MSU’s
College of Human Medicine. She is an internationally known expert in development and
evaluation of decision support tools. She is a past president of the Society for Medical
Decision Making and past chairperson of the AHRQ study section on Health Care
Technology and Decision Sciences. We are currently working together in the MICH, the
Heart After-Hospital Recovery Program (HARP) and minority supplementary projects.
She has worked closely with me in the preparation of this application. I am also working
closely with Dr. Kim Eagle, a co-mentor on this application, who is the Clinical Director
of the University of Michigan Cardiovascular Center, and the principal investigator of the
American College of Cardiology’s Guidelines Applied to Practice (GAP) in Michigan.

He is involved in the design of the quality improvement aspect of this proposal.

B. Career Goals and Objectives: Scientific biography

My career goal is to establish myself as an independent investigator in health
services research with a focus on research to improve the quality of care of blacks and
low-income populations with heart disease by translating research into practice. This is

not traditional health services research, but is an emerging area that involves process

improvement and decision support for doctors and patients. To develop this career
trajectory, I need additional knowledge and skills related to successful models of process
improvement and decision support in order to design and implement the interventions. In
addition, enhanced skills in epidemiology to evaluate the interventions and their impact
on care of underserved populations are needed. My goal is to move to a tenure-track
position from my present Human Health Program (HI-1P) medical track position and to

achieve independence as a health services minority investigator.
My objectives are to:

l. Acquire health services research expertise that will enhance my clinical expertise
and epidemiology training.

2. Gain new skills in improving clinical processes of care to improve outcomes for
patients and increase the effectiveness of clinicians.

3. Gain new skills in qualitative research methodology and development of decision
support tools.

4. Develop a research program of interventions and evaluation of their effect on

patient health outcomes and quality of care in diverse primary care settings.

5. Disserrrinate research findings of the current proposal through presentations at
local, regional and national meetings, peer- reviewed publications and through

professional community health centers.

Completed postgraduate training relevant to this application: Masters Degree

Courses in Epidemiology at MSU.

EPI 810 - Introduction to Descriptive and Analytical Epidemiology (3 credits).
Study of disease from a population perspective as the interaction of host, agent, and

environment.

LCS 829 — Design and Conduct of Epidemiological Studies and Clinical Trials (3
credits)
Applied analytic methods in experimental design. Assessment of health and disease

status of human populations. Risk assessment and interpretation of clinical trials.

STT 421- Statistics I (3 credits) and STT 422- Statistics II (3 credits).

Basic probability, random variables and common distributions. Estimation and tests for
one, two and paired sample problems. Introduction to simple linear regression and
correlation, l-way AN OVA.

EPI 825- SAS Programming (3 credits).

A programming approach to plan and write simple SAS programs to solve common data

management and data analysis problems in research settings.

EPI 815- Cardiovascular Disease Epidemiology and Prevention (3 Credits)

This course discussed the methodologies used in epiderniologic studies of cardiovascular
disease. We reviewed genetic, environmental, and behavioral causes of cardiovascular
disease as well as Surveillance and Validity issues. Approaches to the prevention and

control of cardiovascular disease were emphasized.

EPI 812- Causal Inference in Epidemiology (3 Credits)
This course discussed causal models, criteria, and causality related to study design and
analysis in epidemiology. Application of theoretical concepts to the design, analysis and

assessment of epidemiologic research was also studied.

EPI 826 — Research Methods in Epidemiology (3 Credits)

Analyses of epidemiologic and clinical data applying statistical methods, based on
logistic and survival models, using standard software was studied.

EPI 827- The Nature and Practice of Scientific Integrity (3 Credits)

Historical development of where and how science is practiced in the United States.
Scientific culture, sociology, and ethical standards were discussed. Principles, standards,
and practices which define scientific integrity and responsible research conduct were also
discussed.

EPI 813- Investigation of Disease Outbreaks (3 Credits)

Principles of and practice in investigating disease outbreaks was discussed in this class.
EPI 935- How to write a Write a Grant Proposal (3 Credits)

This course discussed how to write a grant proposal and get funding. We developed a
research proposal during this class and made a presentation at the end of the course.

C. Career Development Activities during Award Period

Objective 1. Acquiring health services research (epidemiology, decision making,
and process improvement) expertise that will enhance my clinical expertise and

epidemiology training.
Planned academic work
a. Epidemiology, Qualitative Methodology and Health Services Research Skills

i) EPI 820 — Evidence Based Medicine (3 Credits) Course at MSU. Instructor; Dr
Mathew Reeves; MSU
The objective is to gain further expertise in methods of clinical epidemiology, health

services and outcomes research. This course will cover the application of evidence-based

medicine. Topics will include: 1) Effectively searching the literature 2) General
assessment of methodology and statistics. 4) Assessing the quality of reports of drug
trials, diagnostic and screening tests, systematic reviews or meta-analysis, guidelines,
economic analyses, qualitative research, and 5) implementation of evidence-based

findings.

ii) Combining Qualitative and Quantitative Methods: Introduction and Overview
(1.5 credits) 4 weeks course

Instructors: William Axinn, University of Michigan; Jennifer Barber, University of
Michigan

In this course, we will become familiar with multiple methods of data collection and how
to combine them within a single research project. We will focus on collecting data using
unstructured or in-depth interviews, focus groups, participant observation, archival
research, survey interviews, and hybrid methods. We will discuss the strengths and
weaknesses of each approach, and we will focus on how each different method can
contribute to the research question in unique ways. These skills will contribute to

evaluating the fidelity and implementation of planned interventions.

iii) Qualitative Data Analysis: With and Without the Use of Computers (1.5 credits)
4 weeks course Instructor: Eben Weitzman, University of Massachusetts-Boston
This course will cover methods for organizing, interpreting, and drawing and verifying
conclusions from qualitative data. The approach throughout will be active, participatory,
and engaged with real data. We will learn how to make intelligent, individualized
selections of software that best meet the needs of a particular research. We will apply

what we learn to the analysis of real data, as we use selected software to enter,

summarize, and code data collected in the previous qualitative methods courses, ending

in a research report.

iv) Qualitative Methods Workshop: Indiana University, Schuessler Institute for
Social Research Intensive Program. Instructor: Sue E. Estroff, UNC-Chapel Hill.
Intensive training in ethnography, in-depth interviewing, and other qualitative techniques.

Opportunities for hands-on-research, one-on-one consultation.

v) Workshop in Focus Group Interviewing and Systematic Focus Group Analysis at
University of Minnesota. Professor Richard Krueger will conduct the 5 days workshop.
Professor Krueger is a member of the graduate faculty at the University of Minnesota and
teaches course in program evaluation and research methods. He is a well-known expert

in teaching and analyzing focus groups.

vi) The Michigan State University Health Services Research/Epidemiology
Seminars/Research meetings. The Health Services Research Group sponsors 90-minute
research meetings weekly. Topics are diverse and include presentation of research
projects in various stages of development. We discuss grant proposals and review data
and papers to be sent for publications. My mentor is the coordinator of these weekly
meetings. In addition I will attend the bi-monthly seminars and weekly Journal club in

the Department of Epidemiology.
b. Decision Making
Intensive short summer courses

i) Decision Making Models in Health care HMP 655 - 3 credits. Instructor: Mendez

David.

I will take this intensive advanced short course at the University of Michigan. We will be
exposed to Monte Carlo Simulation, Multiple Regression analysis, Discriminant analysis,
Project Management, Integer Linear Programming and Multi-Criteria Optimization. Use
of computers and spreadsheet modeling will be emphasized throughout the class. A better
understanding of this discipline will inform the qualitative study and the development of

the decision support tools.

ii) Society of Medical Decision Making Pre-conference Short Courses
The annual meeting of the society for Medical Decision Making and pre-conference short
courses are the best resources available for advanced topics and new methodological
advances in decision sciences for healthcare. I will attend annually throughout the
period of the award. Examples of such courses are:

0 Basic and advanced decision analysis

0 Reducing bias in observational studies- propensity methods

a Decision quality-learning from common pitfalls of stated preference methods.

0 Using information technology to improve safety and quality in the ambulatory

setting

Objective 2. Gaining new skills in improving clinical processes of care in
organizational settings. a) I plan to attend a learning section and participate in a
conference on Improving Chronic Illness Care (ICIC) at the ICIC MacColl Institute for
Healthcare Innovation, Center for Health Studies, and Group Health Cooperative at
Seattle, WA. Edward Wagner is the leader of the group. This learning section will also
offer me the privilege of meeting with the faculty of the Bureau of Primary Healthcare

collaborative project. I am in contact with Connie Davis, ICIC’s Associate Director for

10

Clinical Improvement regarding my interest. I will also learn more about the ICIC model
by 1) joining the Ingham county new diabetic collaborative and 2) visiting the Detroit and
Sterling community health sites that have completed the CHD collaborative and
improvement model in the first year. This will allow me to learn the quality improvement
model and become part of a process improvement team. In addition this will enable me to
develop a model that builds on, and extends the patient decision support and reminder
system within the ICIC/1H1 model. The Michigan Primary Care Association (MPCA)
Collaborative Coordinator Faye Theil and Ingham County administrator Sue Dumeney

have approved my participation.

b) Annual National Forum on Quality Improvement in Health Care: I plan to attend
annually the National Forum on Quality Improvement in Health Care (IHI), the premier
"meeting place" for people committed to the mission of improving health care. Dr Donald
M. Berwick is the President and CEO. IHI is a source of energy, knowledge, and support
for a never-ending campaign to improve health care worldwide. The Institute helps
accelerate change in health care by cultivating promising concepts for improving patient
care and turning those ideas into action. Knowledge gained from this meeting will be
helpful in the implementation of our research design. Future National Forum dates and
Locations; Dec 9-12 2007 Orlando FL, Dec 7-10, 2008 Nashville, TN; Dec 6-9, 2009

Orlando, FL.

c) Forum on Quality of Care and Outcome Research in Cardiovascular disease and
Stroke: I plan to attend annually this American Heart Association scientific program
that gives attendees the opportunity to learn the most recent information on: 1) measuring

and improving quality of care and outcomes for persons with or at risk for cardiovascular

ll

disease and stroke. 2) new and innovative approaches to quantifying and improving
clinical effectiveness. 3) efforts by national groups to assess and improve care. 4) new
research with_implications for improving clinical care and healthcare delivery. 5)
methodological innovations in studying outcomes and conducting clinical research. The

meeting occurs every year in Washington DC.

d) University of Michigan Cardiovascular Outcomes Research and Reporting
Program (M-CORRP) Meetings. I will continue to attend the M-CORRP bi-monthly
meeting at University of Michigan, Ann Arbor. The goal of M-CORRP is to improve the
quality of cardiovascular care for patients. The research team led by my co-mentor Dr
Kim Eagle studies common cardiovascular conditions and procedures among large
populations; developing modern mathematical tools to assess risk and outcomes;
promoting evidence-based care models which incorporate the best science into care itself

by targeting physicians, nurses, and patients.

Objective 3. Gaining expertise in developing decision support tools. a) Dr. Holmes-
Rovner has extensive experience in the development and evaluation of decision support
tools (see preliminary studies). She will provide mentorship through our weekly
meetings in which we will review progress, including my written work, and determine
my tasks for the coming week. In addition, Dr. Kim Eagle, one of the leaders in the
application of guidelines to practice of cardiovascular medicine will provide mentorship

in this area through the bi-monthly M-CORRP meetings.

b) Ottawa Patient Decision Support Laboratory, Decision Center and Ottawa

Health Research Institute.

12

Professor Annette O’Connor of the School of Nursing and Department of Epidemiology
leads this program. Dr. O’Connor has developed a research program to understand and
support decision making of practitioners and consumers facing a variety of health care
choices. Dr. O’Connor has been involved in over 50 projects funded for over $8 million.
I plan to visit the Health Decision center for 2 weeks, during the first two years of the
grant to gain experience in the development of decision support tools and to obtain
consultation on our draft decision support tools. Dr. 0’ Connor is a consultant for this

project.

Independent Readings/Training

I will build on my formal learning experiences with on-going independent study both in
my content area of cardiovascular prevention, theory and method of decision sciences,
and quality improvement. I expect this activity to be partly guided by my mentors and
partly based on my own searches of the literature. The program of independent

readings/training designed by my mentors and myself includes:

1) Process of Care: MSU Cochrane Review of Patient centered care. Dr. Hohnes-Rovner
is the co-PI on an approved update of the Cochrane review, "Interventions for providers
to promote a patient-centered approach in clinical consultations”. I will participate as a
reviewer. This review will provide methodological training in systematic reviews and
content that will guide the design of the intervention. The results of the review of the
relative effectiveness of interventions directed to 1) provider alone, 2) patient alone, 3)

tool to both, or combinations of interventions will guide the implementation of our study.

2) Decision Support Tools: Review of tools for patient decision support in outpatient.

Dr. Holmes-Romer is a co-investigator on a second Cochrane Review, “Decision aids for

13

people facing health treatment or screening decisions” (2001 , 2003). The current update
is being completely re-reviewed, to test decision aids against new international standards.
The two databases will be combined to form a subset of trials of tools designed to support
patient decisions either as free-standing interventions, or in patient-centered
consultations. Dr. Olomu will become the first author on a new review of decision
support tools. She will evaluate specifically the evidence about use of tools in primary
care, especially those designed to improve decisions and outcomes in cardiovascular
disease. A second Cochrane Review, under the direction of Dr. O’Connor is being
updated. Dr. Olomu will specifically evaluate the literature related to decision support

tools in chronic disease.

3) Qualitative Methods: Readings under the supervision of Dr Linda Hunt; Associate
Professor of Anthropology. This will involve weekly readings/assignments over the first

one year of the award fi'om the following texts:

Bernard HR. Research Methods in Anthropology: Qualitative and Quantitative

Approaches, Third Edition AltaMira Press. 2001

Joseph A. Maxwell. Qualitative Research Design: An Interactive Approach. 2“d Ed. Sage

Publications; 2004.

Objective 4. Developing a research program of interventions and evaluation of their
effect on patient health outcomes and quality of care in diverse primary care
settings.

In both Dr. Holmes-Rovner’s and Dr. Eagle’s research programs, I will be exposed to
dynamic research laboratories with multiple related projects. This exposure will provide

me with experience in on-going research and publication opportunities from existing data

14

sets. During the final 18 months of the award period I will write and submit an ROI
proposal for a randomized controlled trial to evaluate the proposed program’s effect on
patient health outcomes and quality of care in 20 diverse primary care settings. My
Mentors, Dr. Holmes Rovner, Dr. Kim Eagle, will provide guidance and feedback on my
proposal. Dr Nigel Paneth, one of my advisors that teaches a course in NIH grant writing

at MSU has agreed to provide guidance for writing the R01 proposal.

Objective 5. Dissemination of Research findings I will submit results of the several
phases of the research to traditional research venues such as national and international
meetings in cardiology and primary care, and cardiology specialty and general medical
journals. In addition to the traditional dissemination venues of professional meetings and
journals, I will work directly with “safety net provider organizations” to obtain feedback
on the organizational implications of results of my pilot and planned studies. Two
opportunities exist in Michigan for this process as a first step. The first is to work with
the professional organization of Community Health Centers, the Michigan Primary Care
Association (MPCA). Since they work constantly to improve the quality as well as
productivity of their Centers, this will provide the first opportunity to incorporate the
early results and determine the next steps toward an ROI grant of significance. Further,
the Area Health Education Center (AHEC) is housed at Michigan State University. The
AHEC director was formerly employed by MPCA, and the purpose of the AHEC is both
to train health professions students in underserved areas, but also to incorporate the safety
net providers into the faculty of Michigan State University. The AHEC has extensive
experience working with both safety net providers (providers that deliver a significant

level of health care to uninsured, Medicaid, and other vulnerable patients) and provider

15

organizations. They will work with us to further develop the research results of the K01
into a larger project. As we move beyond the local “proving ground” for real world
dissemination, we will continue to learn from interacting with health professionals and

communities in national and international venues as described above.

Additional Responsibilities. During all five years of the grant, I will spend 75% of my
time in career development and research activities. In each year, 25% of my time will be
devoted to patient care and teaching. Patient care will consist of seeing patients for 4
hours per week at the in the MSU Internal Medicine out patient clinic, and supervising 4
residents during a weekly 4 hours resident clinic. Teaching by outpatient, case
management will occur in this setting. These activities will allow me to remain current in
the provision of primary care to patients, which will include preventive medicine to both
diabetic and cardiac patients. I will serve as a managing attending physician for in-
patients, 6 weeks per year, during the grant period. This is a reduction of 75% from the
usual duties of attending in my Division. The inpatient services will provide me with a
unique chance to understand how evidence- based medicine in the area of cardiovascular

diseases and diabetes are implemented in the community.

16

Time distribution for work effort
Year 1 Year 2 Year 3 Year 4 Year 5

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Training 35% 35% 35% 40% 45%
1.Formal course work and 25% 15% 10% 5% 5%
independent study

2.Mentored decision tools 10% 5% 5% - -
development -

3. Mentored shared decision- - 10% 10% 10% -
mak'g/quality improvement

4. Presentations and publications - 5% 10% 10% 20%
5. Mentored R0 grant writing - - - 15% 20%
Research Aims 40% 40% 40% 35% 30%
6. Patient care and clinical teaching 25% 25% 25% 25% 25%
Total 100% 100% 100% 100% 100%

 

D. Training in the Responsible Conduct of Research

EPI 827- Nature and Practice of Scientific Integrity (3 Credits) at Michigan State
University

I received instruction on the overview of the historical development of where and how
science is practiced in the United States with an emphasis on its culture, sociology, and
ethical standards. There was emphasis on the principles, standards, and practices, which
define scientific integrity and commitment to the responsible conduct of research. This
course was completed in spring of 2005. I have attached a list of topics that were covered

in the class in the appendix section.

17

 

RESEARCH PLAN
A. SPECIFIC AIMS
Project Overview

African Americans (AA) and low social economic status (SES) populations have
a high prevalence of coronary heart disease (CHD), as well as a high CHD-related
mortality13 '16. Afiican Americans are less likely than whites to receive appropriate
cardiac medications17 and are likely to receive a lower quality of basic clinical services”.
These differences in medical care have been shown to be associated with increased
mortality among AA patientsl4'16’ 19’ 20. Over recent years, the reduction of these racial
differences has been a central aim of health policy in the US. Surveys and audits have
documented failures of practitioners to comply with well-established clinical guidelines
for the care of patients with CHD2 1’ 22. The goal of this project is to test and evaluate the
design and implementation of decision support tools (DSTs), in primary care practices,
with the aim of facilitating adherence to key quality indicators. Quality indicators
(ACC/AHA guidelines) include the appropriate use of aspirin/antiplatelets, beta-blockers,
angiotensin converting enzyme (ACE) inhibitors, smoking cessation, cholesterol
assessment, and lipid lowering therapy during routine office visits. The study will serve
as a foundation for a subsequent, randomized control trial to evaluate the program’s
effect on patient -oriented health outcomes and quality of care in diverse primary care
settings. Achievement of our goal will improve physician and patient communication

and adherence to evidence- based recommendations in primary care. This will improve

secondary prevention of heart disease and should decrease cardiovascular morbidity and

18

mortality for the target population (blacks and patients of low SES). The specific aims
are:

AIM 1. Develop and pilot test a patient-centered intervention, Office-Guideline
Applied to Practice (Office-GAP) to improve the implementation of evidence-based
guidelines for secondary prevention of CHD for both African Americans and low
socio-economic populations in an outpatient clinical setting. To accomplish this aim,
we will

a) Develop Secondary Prevention of Myocardial Infarction Decision Support Tools that
will contain guideline oriented standard orders for secondary prevention of CHD.
The Hospital-based Guideline Applied to Practice (GAP) Tool kit will be adapted to
primary care and will be called the Office-GAP Tools. Office-GAP DST will be
incorporated into routine office visit for use by patients and physicians. The DST
will provide Quality Improvement (QI) infrastructure to build a systems-based
approach to helping physicians, nurses and patients remember to take advantage of
the proven therapies that national guidelines recommend.

b) Develop and implement provider education modules that include interactive
educational meetings to implement the evidence-based patient-centered method for
communication and tool use.

c) Develop and implement a patient education module. This will include sharing
recommendations with patients and requesting documentation from the patients
themselves about barriers to following clinical recommendations.

AIM 2: Develop an Office-GAP follow-up program to reinforce secondary

prevention goals

19

The follow up program will include a systems-based Office GAP follow up
telephone call by the research assistant after the first visit and use of reminders to inform
overdue appointments and reinforce compliance with set goals. It is anticipated that
reminders will include postcards, e-mail, and telephone contact.

Hypothesis Follow-up program will reach > 70% of patients enrolled in Office -GAP
project, using a research assistant dedicated to the project.

AIM 3: Evaluate the implementation of Office-GAP using a cluster-randomized
design. This will include:

a) Pre and post evaluation of rate of use of aspirin/antiplatelets, beta-blockers, ACEI,
cholesterol assessment and treatment and smoking counseling/status in both the
intervention and control arms of the study.

b) DST utilization rate and acceptability of the intervention by the clinic and medical
staff in the intervention arm of the study.

0) Patient perception of the physician participatory decision style before and after
program implementation.

Hypothesis: Successful implementation of the program will: a) Increase the
proportion of patients on aspirin/antiplatelets, beta-blockers, cholesterol lowering agents,
and ACEI.

b) Increase the proportion of patients having cholesterol assessed, attaining LDL-
cholesterol _<_ 100 mg/dl, and increase in rate of smoking counseling and reduction

in proportion of patients smoking.

20

0) Lead to at least 75% of patients having documented evidence that the Office Gap
Tools were used during the study window and DST will be acceptable to the clinic

and medical staff.

d) Improve patient perception of physician participatory decision style.

21

B. BACKGROUND AND SIGNIFICANCE
B. 1.1. Racial Disparity in Coronary Heart Disease Mortality in the United States

Despite advances in diagnosis and treatment, CHD remains the leading cause of
death in African Americans (AA) and whites in the US. More than 12 million patients
are known to have CHD in the US alone. It accounts for l in 3 US deaths. The economic
cost for the evaluation and care of patients with acute coronary syndrome is estimated to
be $100 to $200 billion a year”. The 2010 Progress Review of Heart Disease and Stroke
by the Acting Assistant Secretary of Health in April 2003 estimated the burden of heart
disease and stroke to be more than $351 billion in 2003 and to grow in the decades
immediately ahead. Among racial/ethnic groups, blacks showed the greatest disparity
from the average in 2000, with a CHD death rate of 243 deaths per 100,000. The goal for
the Healthy People 2010 is 166 per 100,000 for the entire population.

On average, CHD develops about 5 years earlier and has a higher associated
mortality rate among blacks than among whites of the same age, at least through age 64
for men and age 74 for women24’ 25 . Although the age-adjusted CHD death rate in the US
has been declining, the rapid rate of decline is less for African Americans than for
whites“. From 1992 to 2000, age adjusted heart disease death rates remained 29% higher
among AA. Myocardial infarction (MI) declined 28% among whites but only 19% among
AA. Studies have also confirmed higher mortality and morbidity among persons of lower
SESZ7’ 28. Higher rates of several cardiovascular risk factors” 29’ 30, compounded by
delays in obtaining care”, underutilization of acute perfusion therapie526’ 29’ 3 1, lower
usage of invasive cardiac interventionsls’ 20’ 29’ 31' 32 and difficulties for black patients in

accessing longitudinal care25’ ”’36 have all been previously documented. Racial factors

22

also affect health care utilization patterns, and there is considerable underutilization of
preventive health services among black populations”.

SES appears to influence cardiovascular disease prevalence by affecting health
care utilization patterns, environmental stress, and health risk behaviors” 39. Low income
affects medical care choices and reduces the likelihood of utilization of preventive health
care. Dietary habits associated with lower education levels and poverty increases CHD
morbidity and mortality"). SES significantly affects outcomes in AMI patients. Low-
income AMI patients had less favorable outcomes than the higher income patients,
irrespective of the type of health insurance. The overall goal of this proposal is to deliver
the right medical care to Ms and patients of lower SES with heart disease on a reliably
basis in routine clinical practice. This should lead to a reduction in the gap that exists
between AAs and whites in area of cardiovascular morbidity and mortality.

B. 1.2. Increasing Numbers of Patients are Surviving Acute Myocardial Infarction

Since the mid-1960’s, short-term mortality (30 days) fiom AMI, has decreased
from approximately 30% to 6.5%“. Modern therapy for AMI has led to an increasing
number of patients surviving AMI, creating a growing group of high-risk individuals,
often elderly, who need further treatment and care. The survival rate among the
approximately lmillion cases of AMI that occur annually is approximately 70% to 80%
42’ 43 in the first year. The rate of recurrent events in this population remains high.
Almost half a million patients with prior myocardial infarction have a recrurent
infarction. A history of cardiovascular disease (CVD) increases the relative risk of
44, 45

subsequent premature cardiovascular morbidity and mortality by 5 to 7 times

Among survivors of a first M1, the rate of subsequent MI is increased 3 to 6 times, and

23

risk of any cardiovascular event may be as high as 80%“. Approximately 70% of CHD
deaths and 50% of M15 occur in patients who have previously established coronary artery
disease“. A major challenge in taking care of these patients is trying to prevent
progression and recurrence of clinical events. During the past two decades, major
improvements in survival of post myocardial infarction patients are related to medical
therapy that attenuates the threats of recurrent ischemia and reinfarction. Much of the
advantage is a matter of consistent use of available therapies.
B. l. 3. Diabetes Mellitus is Associated with an Increased Risk of Cardiovascular
Disease

Type 2 diabetes mellitus is an independent risk factor for future cardiovascular

events48.50

. The risk of cardiovascular event is as high among patients with diabetes as
among nondiabetic patients who have had a cardiovascular event51’52. Cardiovascular
risk factors such as hypertension, obesity, dyslipidemia, also tend to be more common in
patients with diabetes. Accordingly, it may be advantageous to target risk reduction
strategies in these patients. In a study by Haffner et al the seven-year incidence rates for
myocardial infarction in nondiabetic subjects with and without prior M1 at baseline were
18.8% and 3.5% respectively (P < 0.001) 48. The seven-year incidence rates of NH in
diabetic subjects with and without prior M1 at baseline were 45% and 20.2%, respectively
(P < 0.001). Recent clinical trials of lipid therapy and intensive blood pressure control
have demonstrated significant reductions in cardiovascular outcomes among patients with

diabete551'54. Treatment guidelines recommend aggressive control of both dyslipidemia

and hypertension in diabetic patients that is consistent with recommendations for patients

24

with known cardiovascular disease55 . Therefore, diabetic patients will be included in the
proposed project to decrease their risk for developing myocardial infarction.
B. 1.4. Effectiveness of Secondary Preventive Therapy

The efficacy of heart disease related medical and behavioral secondary prevention
is well established. The evidence is summarized in several guidelines, including the
Agency for Health Care Policy and Research (AHCPR) Cardiac Rehabilitation

“'58, American College of Cardiology/American Heart Association Guidelines

Guidelines
(ACC/AHA)“ 59, and the NHLBI Consensus Statements on physical activity and
cardiovascular health. The use of aspirin“), cholesterol-lowering agents“, beta-blockers62,
angiotensin-converting enzymes“, physical activity“, and smoking cessation65 have all

been shown to decrease the risk of recurrent ischemia and reinfarction following AMI, as

shown in Figure 1.

Figure 1. Effectiveness expressed as Percent Risk Reduction of Recurrent
Heart Attack through Secondary Prevention.

 

 

Lower Cholesterol 42%
Take ACE Inhibitors
Take Beta Blockers
Physical Activity
Take Aspirin

Not Smoking

 

 

         

 

 

0% 10% 20% 30% 40% 50%

 

 

 

B. 1.5. Under-Utilization of Secondary Prevention in Heart Disease
Surveys and audits have documented failures of practitioners to comply with

well-established guidelines for the clinical aspects of care of patients with hypertension“,

25

diabetes“, CHDD’ 68, frailty in the elderly”, and other chronic conditions. National Study
of Physician Awareness and Adherence to Cardiovascular Disease Prevention Guidelines
in 2005 revealed that only 40% - 50% of primary care physicians and cardiologist
incorporate guidelines into clinical practice”. Recent studies have shown that African
American and less educated patients were less likely to receive cholesterol-lowering
therapy after AMI; despite most having insurance that covers this therapy"). Similar
differences have been demonstrated for other effective cardiac drugs. For example,
studies that have analyzed large Medicare data sets have documented racial disparities in
beta-blocker prescription post AMI at discharge“ 72. Hayward et al 2005 reported in
their paper “Sins of Omission ” that getting too little medical care may be the greatest
threat to patient safety. They found that the overwhelming majority of substantive
medical errors identifiable from the medical records were related to people getting too
little medical care, especially for those with chronic medical conditions73 . These findings
underscore the ongoing need to monitor, improve and evaluate the use of effective
therapies for appropriate patients.
B. 1.6. Interventions to Improve Chronic Illness Care

There are three overlapping initiatives in the effort to improve the management of
chronic illness: the Report card initiative", Disease management”, and “Chronic Care
Model” 76. The report card initiative provides report/feedback to institutions regarding
their specific performance on clinical quality measures, addressing the management of
specific diseases like AMI, diabetes or heart failure. Wagner defined disease
management as a population based approach to health care that identifies patients at risk,

intervenes with specific programs of care and measures outcomes75’ 76.

26

The third of the three initiatives proposes the Chronic Care Model (CCM)77 to assist
provider organizations in chronic care improvement. The CCM is like an evidence-based
guideline because it represents a synthesis of system changes used to guide quality
improvement. Its feasibility and acceptability in helping to improve quality of care in
health care organizations has been reported-’7. However, disease management programs
like CCM can be costly to develop, implement, and evaluate. According to the Disease
Management Association of America, an estimated $1 billion was spent in 1999 to
develop and implement disease management programs". Despite the investment,
evidence supporting their effectiveness is sparse”. In addition, commercial disease-
management programs target only the “high-risk” patients, and do not address the
inadequacy of care for the millions of other “low risk” Americans with chronic diseases.
The proposed project builds on components of the CCM and our previous
research in patient decision support, to encourage implementation of secondary
prevention strategies by patients and physicians within the primary care system. Our
program, “Office Guideline Applied to Practice (Office-GAP)” will target all CHD
patients and diabetic patients regardless of risk status. Should the program prove
successful, it could serve as a prototype delivery vehicle for other evidence-based
interventions during routine office visits. Unlike disease management programs that are
offered mainly in staff-model HMOs or as a carved-out service by pharmaceutical-
benefits management firms, this program would operate within the structure of most

primary care offices.

27

B. 1.7. Decision Support Interventions

Decision Support Interventions (DSIs) grew out of expected utility theory80 and
shared decision —making (SDM) 8’ approaches. Effective DSIs or “decision aids” are
designed to promote clinical care that is consistent with scientific evidence and patient
preferences. They 1) integrate evidence-based guidelines into daily clinical practice, 2)
share evidence-based guidelines and information with patients to encourage their
participation, 3) use proven provider education methods, 4) integrate specialist expertise
and primary care". The value of evidence-based guidelines or protocols, if integrated
into practice and supported by effective provider training and behavioral change methods,
is widely recognizedsz'“, but generally not practiced”. The DSI approach assists patients
making personal treatment choices consistent with evidence about consequences of
medical alternatives and making use of their own values. DSI formats have included
workbook/guidebook”, video“, computer”, and interactive video formats. We will use a
guidebook and video format in this intervention, the materials will be adaptable to audio
and Internet formats.
B. 1.8. Improving Clinical Practice Using Clinical Decision Support Systems
(CDSS)
A nation wide audit assessing 439 quality indicators found that US adults receive only
about half of recommended care88 and the US Institute of Medicine has estimated that up
to 98,000 US residents die each year as the result of preventable medical errors”. To
address these deficiencies in care, health care organizations are increasingly turning to
CDSS, which provide clinicians with patient-specific assessments and recommendations

to aid clinical decision-making” 91. CDSS is defined as any system designed to aid

28

directly in clinical decision-making, in which characteristics of individual patients are
used to generate patient-specific assessment or recommendations that are presented to
clinicians for considerations”. Examples include manual or computer based systems that
attach care reminders to the charts of patients needing specific preventive care services,
and computerized physician ordering systems that provide patient —specific
recommendations as part of the order entry process. Such systems have been shown to

92-94

improve prescribing practices , reduce serious medication errors95’ 96, enhance the

delivery of preventive care services” 98

and improve adherence to recommended care
standards 90.21.99.100. These systems have been shown to be more effective and more
likely to result in lasting improvements in clinical practice compared with other
approaches” 79' 101'105. CDSS do not always improve clinical practice. They improved
clinical practice in 68% of 70 trials (77% in outpatient settings) reviewed by a study
designed to identify features critical to success 9'. They identified four features as
independent predictors of improved clinical practice: automatic provision of decision
support as part of clinician work flow, provision of recommendation rather than just
assessment, provision of decision support at the time and location of decision making and
computer based decision support”. This proposed proj ect will incorporate these features
in the development and implementation of Office GAP for our target population. Where
computer-based decision support is not possible, paper and pencil tools will be used. The

Ingham County Health Department is planning to install a new electronic medical record

into all the clinics.

29

B. 1.9. Optimizing the Provider-Patient Relationship

The need for change in how physicians interact with minority patients was so
important that the Institute of Medicine (IOM) report on unequal treatment106 suggested
that economic incentives should be considered for practices that improve provider-patient
communication and trust, and reward appropriate screening, preventive and evidence-
based clinical care. The IOM further suggested that both patients and providers could
benefit from education. Provider-patient relationships can influence patient satisfaction,
adherence to treatment and health outcomes positively.

Existing models of physician-patient relationships reflect one of three approaches
to clinical management; Paternalism, informative, or shared decision- making (SDM).
The degree of patient participation in medical decisions varies widely across different
models of the physician patient relationship. According to the paternalistic model, the
physician knows best what is in the patient’s interest; patient participation is limited. This
model clearly does not take into account patients’ autonomy and desire for information.
In contrast, the informative model claims that the patient can make his/her own decisions
while the physician role is restricted to providing him or her information. However,
patients expect their doctors not to be only technical experts, but also caring persons. In
SDM, both the physician and patient engage in an open discussion about the values the
patient could and should pursue. The physician is allowed to present his or her
preferences, and conflicting values are discussed explicitly. Thus, the patient is
empowered to choose between alternative treatments. A recent study demonstrated that
patients and physicians will use SDM instruments in their clinical encounter and they

attributed multiple functions to the instrument (reference tool, organizes discussion,

30

develops concordance, customizes care, improves education, motivational tool),
especially as a tool to facilitate agreement with treatment goals and plansm.

This study will build on the work to optimize the provider patient relationship,
through shared-decision-making conducted by Braddocklos, Elwynm, Towle and
Godolphinl 10. The study will use the established Smith patient-centered physician
interviewing method (described in section D. 4.3.) developed and tested and in current
use in our Internal Medicine Residency Program at MSU1 ”. Dr. Smith is a consultant for
this application. The patient centered approach provides the appropriate first skills for
shared decision-making. Our proposed study is sensitive to physician time constraints and
need for physician autonomy. We will also emphasize the importance of flexibility in the
way that providers structure the decision-making process so that individual differences in
patient preferences can be respected.

B. 1.10. Patient Education and Empowerment
Increasingly, researchers are recognizing the important role of patients as active

participants in clinical encounters112

. With a few exceptions, the tested interventions do
not include long-term support for patient self-management or efforts to engage the
primary care team. A wealth of educational tools and resources such as materials online,
in print, and on audio, and decision support videos that present information to help
individuals understand complex medical issues will increase patient’s confidence in
making the changes to improve and maintain his or her health. Decision support videos
may be more acceptable for people of low literacy that are unable to read. While

evaluation data on decision support materials are limited, particularly with respect to

racial and ethnic minority patients, preliminary evidence suggests that patient education

31

can improve patients’ skills and knowledge of clinical encounters and improve their
participation in care decisions. The IOM recommended implementation of patient
education programs to increase patients’ knowledge of how to best access care and
participate in treatment decisions'“. Thus, we propose the current study to integrate
patient education and empowerment into routine clinical practice using a system
approach.
B. 1.11. Reminder Systems

Patient safety is an increasingly important focus of quality improvement
113

activities . Most interventions to improve safety focus on preventing errors of

commission (doing the wrong thing) “4

yet arguably more damage is done by errors of
omission (not doing the right thing). For example, recent reports have shown under
prescription of aspirin and beta-blockers following AMI ”, errors of omission that could
cost more lives and cause more disability than errors resulting from negligent practice1 ‘4.
In caring for patients with chronic conditions, errors of omission might be reduced by
physician adherence to simple rules or algorithms based on well-documented efficacy
studiesl ‘5 '1 18. Failure to adhere to accepted guidelines and practice standards can be due
to the complexity of the health care system, medical decisions1 19’ 120, difficulty in

121,122

applying available clinical knowledge , physicians’ idiosyncrasies123 and human

errorsm. In a recent meta-analysis of disease management programs for patient with
chronic illnesses, Weingarten et al. found that programs using education, feedback, or

reminders for healthcare providers produced significant improvements in provider

adherence to care guidelines”.

32

B. 1.12. Moving Research into Practice

It is crucial that research findings are implemented in outpatient clinics if high
quality care is to be achieved. As described by Wagner et al. high quality medical care
for chronic illness must accomplish three objectives“: I) assure the delivery of those
interventions that have been shown by rigorous evidence to be effective, 2) empower
patients to take responsibility for the management of their condition, and 3) provide
information, support, and resources to assist patients in self -management tasks. The
proposed project will be designed to fulfill these goals.
B. 2. Significance

One of the goals of the President’s Race and Health Disparities Initiative is to
eliminate by year 2010 the differences in outcomes and health status for racial and ethnic
minority populations in six clinical areas including cardiovascular disease. The proposed
research will develop and evaluate the implementation of office based decision support
tools designed to facilitate adherence to evidence-based treatment recommendations for
AAs and low socio-economic status populations in primary care. The patient centered
approach of the program aims to improve effective patient - physician collaboration,
while the strengthening of physician-patient communication through the use of shared
decision-making, should improve the use of secondary prevention among patients with
heart diseases.

Should this project succeed, it may help to close the gap that exists between the
rate of use of medications in-hospital and post discharge. Furthermore, improved
secondary prevention of heart disease should decrease cardiovascular morbidity and

mortality for AAs and low socio-economic status populations. It is expected that the

33

quality of life of these patients would improve and the cost of their health care decrease.
Elements of the proposed system can be applied to the treatment of other chronic
diseases. In addition, the program provides an opportunity to collect essential descriptive
data about where problems occur in the system and the roles of patients and providers in

creating and eliminating problems.

34

C. PRELIMINARY STUDIES:
C. 1 Overview

Our core research team has established working relationships and complementary
expertise to undertake the project we propose. Our on-site primary research team consists
of Dr. Ade Olomu, PI, Dr. Margaret Holmes-Rovner, a health service researcher with
whom Dr Olomu has worked on a weekly basis for the past 5 years, Dr Mathew Reeves,
an epidemiologist, and Dr David Todem, the statistician on Dr Olomu’s pilot studies. The
consultants include Dr Olomu’s mentors and teachers in medicine and epidemiology: Dr
Robert Smith, an expert in patient centered interviewing skills at MSU, Dr Kim Eagle,
Professor of Internal Medicine and Cardiology at the University of Michigan and co-
mentor on this application, and Dr Annette O’ Connor, director of the Ottawa Patient
Decision Support Laboratory, with whom Dr. Holmes-Rovner has collaborated for the
past 20 years. The prior work of our team provides both the rationale and methodologies
for the research proposed. The team has the appropriate depth and breath of research and
clinical knowledge to undertake this project.

C. 2. Prior Work Done by Members of the Team Regarding Under-Use of Evidence-
Based Medications in Secondary Prevention.

The proposal builds directly upon previous work conducted by our team, and it
combines the interests of the team in health services research, development and testing of
decision support systems, use of practice guidelines in cardiovascular care, risk
assessment and outcome analysis as follows.

Preliminary study 1. Under- Use of Aspirin following Acute Myocardial

infarction in Community Hospital. Funded by the Blue-Cross Blue-Shield of Michigan

35

Foundation and MSU Foundation. Dr. Olomu, Dr. Holmes-Rovner, The MSU Inter-
Institutional Collaborative Heart (MICH) Study group determined the rate of use of
Aspirin following Acute Myocardial Infarction (AMI) in five hospitals, in two Michigan
communities (1994-1995). The MICH Study was a hospital study of management and
outcomes following AMI. 1,163 patients were enrolled; 1,021 were ideal candidates for
aspirin therapy. In the index hospitalization 80.4% received aspirin, and only 72.6%
were discharged on aspirin. Logistic regression showed that AA patients with previous
AMI were less likely than white patients to be on daily aspirin, at the time of admission
(OR 0.36%, 95 % CI 0.15-0.86). AA patients were less likely to be discharged on aspirin
(OR 0.48, 95% CI 0. 03-0077). We found a significant underutilization of this potentially
life-saving therapy in our community hospitals in patients following AMI. This was
especially true for AA patients and underscores the need to improve awareness of the
benefits of aspirin in AMI among practicing physicians and patients. The PI presented
this finding at the National Meeting of the Society of General Internal Medicine (SGIM)
in May 20026 at Atlanta Georgia.

Preliminary study 2. Under- Use of Beta-blockers following Acute Myocardial
infarction in Community Hospital, Dr. Olomu, Dr. Holmes-Rovner. The MICH Study
group studied Beta-blocker (BB) use in community hospitals in Michigan. Out of 1,163
AMI patients, we found 347 patients were ideal candidates for BB therapy. Of these, 81
had a previous AMI and only 26% of them were on BB at the time of admission. During
their hospitalization, only 54% received a BB, and only 34% were discharged on BB. In
conclusion, we found significant under-utilization of this relatively inexpensive but

efficacious medication. This finding again, further highlighted the need to designs ways

36

of increasing the use of these medications following AMI. PI also presented this paper
at the National Meeting of the Society of General lntemal Meeting in May 2002'.

Preliminary study 3: Changes in rates of Beta-blocker Use in Community
hospital patients with acute myocardial infarction. Dr. Olomu, Dr. Margaret Holmes-
Rovner. This study, aimed to determine change in beta-blocker use on admission, in
hospital, and at discharge between 1994-1995 (MICH I) and 1997 (MICH II) in patients
with acute myocardial infarction (AMI) in two prospectively enrolled cohorts from five
mid-Michigan community hospitals, prescription of BBs to ideal patients with AMI
increased in patients with previous history of myocardial infarction on arrival at the
hospital, (12.5% vs. 36.0% p = 0.01), in-hospital (47.0 vs. 76%; p< 0 .01) and at
discharge (34.0% vs. 61.9%; p<0.01). The increase BB use is most likely the result of
regional and national quality improvement initiatives in these hospitals. Our results
suggest that outpatients programs to insure continued use of BB post AMI are urgently
needed. (Olomu AB, et a1 “Changes in Rates of Beta-blocker Use in Community
Hospital Patients with Acute Myocardial Infarction”). J Gen Intern Med 2004; 19 (Issue
10): 999-1005). The findings from our preliminary studies 1-3 led to the current proposal.
C. 3. Decision Support Tools

Preliminary study 1. Women 's judgment of estrogen replacement therapy,
funded by the National Center for Nursing Research from 1986-1994. M. Rothert, PI.
Co-investigator, M. Holmes-Rovner. This work sought to understand how women make
judgments to take hormone therapy (HT) or not. It showed that people often find
mortality and morbidity information difficult to use in reaching a decision. The

125-127

experimental study tested a formal program to teach decision-making skills. Three

37

groups were compared, 1) lecture/workshop, 2) lecture/only, and 3) an educational
booklet control group. The unanticipated result was that all three groups were
significantly more able to make a decision that they felt reflected both their own values
and the research evidence after intervention than before. The booklet designed as an
information-only control was also a powerful intervention, in fact, the most efi‘icient route
to teaching patients the outcomes data and how to structure the decision processlzs’ 129.
The knowledge gained from this study will be used to guide the design of our decision
support tools.

Preliminary study 2. Greater Flint Shared Decision Project, funded by the Blue
Cross Blue Shield of Michigan Foundation, 04/ 1/97 to 8/31/99. M. Holmes-Rovner, Pl.
This study evaluated decision supports (in-depth interactive videodisks) developed by the
Foundation for Informed Medical Decision Making (FIMDM). This project attempted to
implement them in office practices and was only marginally effective13 0. We learned that
use of decision aids alone, outside the office visit is insufficient. For that reason, we will
develop a tool kit that can be integrated into routine office practice, and can be supported
by follow-up and reminders.

Preliminary study 3. The Shared Decision-making Forum 2000: Oxford, funded
by the Nuffreld Trust, 1/1/2000-8/1/2000. PI. A Coulter, Co-investigator, Dr. Holrnes-
Rovner. This grant brought together the Oxford, Cardiff, MSU, Ottawa, and Dartmouth
decision aid development groups in a six-month “think tank” in Oxford to further develop
the field of shared decision-making and decision aids. The group extended their

collaboration, contributed to the book, Evidence-Based Patient Choice131 and proposed

future direction for the fieldm. This work established collaborative relationships with

38

primary care faculty in the UK that led to an international standards-setting process
(results forthcoming in BMJ). Those standards and the consultation with Dr. O’Connor at
the University of Ottawa will guide toolkit development. Dr. O’Connor is the PI of the
Cochrane Collaboration decision aid review. She has developed extensive training
programs in shared decision-making. She will provide access to all decision aids being
evaluated in the Cochrane Collaboration128’133'l34.

Preliminary study 4. Developing Patient Decision Support Materials for
Prostate Cancer Treatment, funded by the Centers for Disease Control and Prevention,
4/1/02-4/30/03. Holmes-Rovner, PI. This project developed new decision support
materials for men with prostate cancer. The Prostate Cancer Action Committee of the
Michigan Cancer Consortium developed new decision support tools132 that use plain
language and apply principles of effective communication with limited literacy audiences
in the design of a new decision support prototype booklet. The prototype attempts to
optimize inclusion of quantitative treatment evidence and patient-centered personal and
social contextual issues. Formative evaluation studies are in progress. The booklet and an
Internet version and an audio tape/CD version can be found at
wwwprostatecancgdecision.org. Our proposed Office-GAP guidebook will be designed
in a similar manner to meet the need of low literacy populations.

Preliminary study 5. Shared Decisions to Manage Diabetes, funded by the Blue
Cross Blue Shield of Michigan Foundation, 02/01/2004 to 01/31/2005. B. Corset, PI. M.
Holmes-Rovner, Co-Investigator. This pilot study, Shared Decisions to Manage Diabetes
(SDM-D), teaches patients to use a decision support booklet, and teaches resident doctors

to engage patients in shared decision-making within the clinical encounter. While the

39

diabetes study did not develop the full toolkit for quality improvement, it provides
experience in implementing a shared decision-making program in primary care and will
guide the development of our training program for providers. Dr. Olomu supervised
residents in the project as the Residents’ Clinic Attending.

C. 4. Quality Improvement in Cardiovascular Disease

Dr. Kim A. Eagle, a Co-mentor, has worked extensively in various studies,
improving the Quality of Care for AMI. Dr. Eagle has been the principal investigator of
the American College of Cardiology's Guidelines Applied into Practice (GAP) project in
Michigan studying the application of guidelines to care processes for patients with ACS
in 33 Michigan hospitals. This work has shown that by embedding key priorities of
guideline-based care into care itself, that both process indicators and outcomes can be
improved. Most recently, Dr. Eagle presented the overall experience of the GAP initiative
for acute MI care in Medicare beneficiaries in Michigan showing that guideline based
care resulted in 21% to 26% reduction in both 30 day and one year mortality in patients
being admitted to Michigan hospitalsl”. He will provide his wealth of experience in the
development and implementation of the proposed project. The proposed project combines
the hospital GAP principles with our experience in outpatient decision support to produce
the new Oflice GAP intervention.

Preliminary study 1. Improving Quality of Care for Acute Myocardial
Infarction-In hospital: The Guideline Applied in Practice (GAP) Initiative21’l36'138. PI
Kim A. Eagle. The Gap project tested the implementation of a structured initiative to
improve care of patients with AMI in 10 acute-care hospitals in southeast Michigan. The

project developed a multifaceted intervention aimed at key players in the care delivery

40

triangle: the physician, nurse, and patients. Results: Increases in adherence to key
treatments were seen in the administration of aspirin (81% vs. 87%; P = .02) and BB
(65% vs. 74%; P = .04) on admission and use of aspirin (84% vs. 92%; P = .002) and
smoking cessation counseling (53% vs. 65%; P = .02) at discharge. Evidence of tool use
during chart review was associated with a very high level of adherence to most quality
indicators!” 100. This initial in-hospital GAP project provides a foundation for this
proposal, which aim to reinforce and continue quality improvement issues on out patient
basis.

Preliminary study 2. Translating Research Into Practice: Patient Decision
support and Coaching Project.
R01 HS1053 1-01 A1 from AHRQ Jan 2001 — 6/31/04. PI Dr. Margaret Holmes-Rovner.
Co-investigator, Dr. Olomu. This study was a patient-level randomized trial to compare
the effectiveness of the combination of decision support and the hospital GAP quality
improvement intervention with GAP alone to improve medication use, patient health
status and physical activity in the 8 months following acute coronary syndrome (ACS)139’
140. The study was done at 5 hospitals in two Mid-Michigan communities. The
intervention, Heart After Hospital Recovery Program (HARP), was a brief nurse-
managed telephone intervention. It engaged the patient and HARP nurse in reviewing
evidence about medical and behavioral secondary prevention strategies and developing a
plan for the patients’ recovery. The nurse counselor, made follow up telephone calls at l,
2, 4 weeks to help solve problems and reinforce decisions made using a decision support

tool, the HARP booklet. The PI, Dr. Ade Olomu presented three abstracts from this

project at the National SGIM meeting in New Orleans May 2005 (detailed in the

41

biographical sketch). Our study on “The eflect of evidence-based cardiac medication use
on hospital readmission for post coronary syndrome patients” Yang et al, 2005ll
revealed that in addition to the prescription of effective discharge medications timely and
appropriate medication changes in outpatient settings appears to improve health outcomes
in acute coronary syndrome patients. In April 2006 Dr. Olomu presented “Quality
Improvement Eflorts And Hospital Performance: Rates of Beta-Blocker Prescription for
Acute Coronary Syndrome” at the National meeting of SGIM in Los-Angeleslz.
C. 5. Approach to Modules and Tools

The patient and physician modules to be adapted for this project are drawn
directly from previous work by our collaborators and us. Office-GAP will adapt the
hospital GAP tools to the outpatient setting. In the present project, we will work with
providers in the Community Health Center setting to develop standard orders, and a
patient contract, and involve a physician champion and a nurse champion in
implementation in ways that fit their level of electronic data collection and organization.
The decision support tools will be adapted from an existing video for secondary
prevention of CHD developed by our colleagues at the Foundation for Informed Medical
Decision Making (FIMDM). FIMDM was founded by Dr. Jack Wennberg, Director of
the Center for Evaluative Clinical Sciences at Dartmouth Medical School and Dr. Albert
Mulley, professor of Medicine and Health Policy at Harvard Univ. and Scientific Director
of FIMDM. Working independently and collaboratively with others, including our
consultant, Dr. Annette O’Connor, we have developed a consistent approach to content
and approach to decision aids that has resulted in international standardsm. We will use

an updated version of the FIMDM video that is included in the review packet as part of

42

our patient educational module. The video itself is presently being updated (see support
letter from Dr. Levin). Dr. Holmes-Rovner will supervise Dr. Olomu in the adaptation of
the accompanying booklet to plain language to address the needs of patients with limited
literacy. We will incorporate the Office-GAP contract and follow up telephone call by a
research assistant in a package that can be systematically used in primary care clinical
settings.

C. 6. Summary. We have built this project on our team’s prior research in shared
decision-making, goal setting, disease management, and application of guidelines into
care processes for patients with acute MI. Since patient empowerment rarely occurs
spontaneously, we propose to use decision aids to assist patients to understand evidence-
based guidelines and adhere to it, directly address the pros and cons of treatment, address

their values and negotiate a plan for management of their heart disease.

43

D. RESEARCH DESIGN AND METHODS

D. 1. Overview

This study will develop and evaluate the design and implementation of decision support
tools for secondary prevention of coronary heart disease in outpatient settings for AA
patients and low socio-economic status populations using a small cluster randomized
trial. The study will lay the foundation for a full-scale randomized control trial to
evaluate the program’s effect on patient health outcomes and quality of care in diverse 20
primary care settings. The emphasis of this study design is on establishing the feasibility
of embedding evidence-based knowledge into the process of care, teaching patients and
healthcare providers how to use decision support tools that will remind caregivers to
consider evidence-based therapies in every patient. Development and evaluation will be
done collaboratively with patients and providers using both qualitative and quantitative

approaches to developing decision support interventions.

D. 2. Conceptual Model

Figure 2. Conceptual Model to Facilitate
Adherence to Guidelines Within Primary Care

 

 

 

 

Improved clinical and system process
0m adherence to guidelines
improved satisfaction level
olmprove use of medications
'Imorove cholesterol level

45

Our conceptual model in figure 2 provides the context for this project. It builds on
components of the Chronic Care Model76 that includes decision support tools (DSTs),
educational modules, self management support, and reminders and our previous research

130,132,142, 143, IO produce

in patient decision support and shared decision-making
productive interactions between the informed activated patient and prepared proactive
practice team within primary care settings. We anticipate that DSTs, will promote
clinical care that is consistent with scientific evidence and patient preferences. It will
embed evidence-based guidelines into daily clinical practice. Self-management will
empower and prepare patients to manage their health and health care. Self-management
support strategies include assessment, goal setting, and action planning, problem solving
and follow up. Provider/patient educational modules will assist in producing an activated
patient and a prepared provider. Reminders should help to reinforce the system. The
productive interactions, will likely lead to better adherence to guidelines, achieve better
disease control, and higher patient satisfaction.
D. 3. Study Sites

The study will be conducted at Ingham County Healthcare Centers. Ingham
County is located in the south central portion of Michigan's Lower Peninsula and
includes the capital city of Lansing. The Ingham County Health Department Adult
clinics are currently comprised of three facilities, the Health Center at Sparrow Hospital,
the Adult Health Center at South Cedar, and the Ingham County Health Center at St
Lawrence Hospital. The three healthcare Centers are all within 15-20 minutes drive fi'om

each other. The Centers have one overall medical director and a nursing administrator.

The medical records and data systems are the same, which will ease the conduct of the

46

research project. The Healthcare centers deliver primary health care and
diagnostic/screening services to citizens in mid-Michigan. These services include
general primary medical care, as well as preventive services targeted at specific patient
groups with Cancer, Diabetes, Cardiovascular Disease, HIV/AIDS, and Mental Health
conditions. During 2003, a total of 3,025 clients (47.9% Male, 31% over 40 years of age)
received care at these three facilities, with 91.6% of these clients at or below federal
poverty levels, 56% were non-white, and 7 0% were uninsured or covered by Medicaid.
A total of 8,442 general medical service encounters were recorded during 2003. In 2003,
1,595 patients with either cardiovascular disease or diabetes received care at these
centers. We will recruit 182 patients from this population into the study. Our targeted
patient population table shows the estimate of the ethnic distribution of the patient
population (Table 2, page 80). The professional health care staffs at the clinics currently
include family practice physicians, lntemal medicine physicians, nurse practitioners and
nurses.
D. 3.1. Eligibility criteria

The eligibility criteria in our study are designed to recruit as large a number of
patients as possible who will benefit fiom secondary prevention for CHD. Eligibility
criteria include AA, and low-income populations aged 18 or older, seeking care at any of
the three health centers. With at least 1 of the following:

1) Inpatient, outpatient or emergency department diagnosis of coronary artery
disease, angina, or myocardial infarction at any time in the past. The diagnosis

must be documented in the patients’ chart.

47

2) Definitive diagnostic test (e.g., cardiac catheterization, an echocardiogram or
scintigram showing segmental abnormalities in the left ventricular wall, an
electrocardiogram demonstrating significant Q-waves, or results of cardiac
enzymes studies) indicating acute myocardial injury at any time.

3) Diabetes mellitus, type 1 or type 2
In addition, patients must be able to speak English and able to provide informed

consent. Low SES will be based on patient’s income, number of people in the household
and insurance status. SES data will be obtained through self-report and from chart
abstraction. Many of the patients that attend the Ingham County clinics have neither job
nor insurance.

Exclusion Criteria include cognitive impairment, dementia, psychosis, and
inability to understand spoken English. The race/ethnicity of each patient will be
determined by self-report. The study team is experienced in recruiting participants for
decision-making and qualitative research in clinical and community settings. We do not
anticipate much difficulty recruiting our sample. We will compensate participants with
$35 for their time during their 6 months visit to the clinic.

D. 3.2. Recruitment strategy

Two Ingham Health Centers will be randomized to receive intervention and a
third will be used as control site (as described in section D. 6.1). The research plan
proposes to enroll 182 patients diagnosed with CAD or Diabetes Mellitus from the 3
health center (91 fiom the 2 intervention sites and 91 from the control site). Patient
recruitment will proceed as follows: Eligible patients will be identified fiom the clinic

registry using ICD 9 codes for CAD and Diabetes Mellitus (e.g. ICD 9; 410- 414 for

48

CHD and ICD 250 for diabetics). The ICD 9 codes are used for coding patient medical
diagnosis and also used for billing purposes after the office visits. The clinic nurse will
screen each chart to ensure eligibility of the patient. A letter will then be sent to the
eligible patients from their primary care physician to invite them to participate in the
study. Those who are interested will be given a self —addressed envelope to return to the
clinic indicating their interest in the study. Interested patients will also be given the
opportunity to indicate their interest in the study by calling the clinics. Those who are not
interested will be asked to return a stamped self-addressed card. Those that did not return
the card will be contacted by telephone and offered opportunity to participate. Clinic
nurse will log all responses positive and negative. The PI and/or research assistant will
obtain informed consent fi'om all patients that agree to participate during their first office
visit with the physician after the invite or just before the focus group or patient
educational session. We will enroll 91 consecutive eligible patients that agree to
participate into the interventional arm of the study from the 2 interventional health
centers, and 91 consecutive patients will be enrolled into the control arm of the study
from the control health care center. After patients’ recruitment PI and trained Research
Assistant will give initial training and further explanation of the study.
D. 3.3. Orienting Physician Practices

All health professionals i.e., internal medicine/farme practice physicians, muse
practitioners, nurses, social workers, public health nurses and other health care workers at
Ingham County health centers will be recruited into the study. Members of staff work
only at one location, they do not move fi'om site to site. All the providers at the healthcare

centers randomized into the interventional arm of the study will be expected to participate

49

in at least one of the physician/healthcare worker orientation/ interactive educational
meetings that will be provided. Interactive educational meetings are one of the
consistently effective interventions shown to promote behavioral change among health
professionals 1 03 .

The PI and the project team will prepare the physicians and their office staff to
implement the program into their daily practice pattern during the developmental phase.
We have had a series of discussions and meetings regarding this project with Director and
staff of Ingham county health centers and they have pledged their support for this project.
D. 3.4. Methods for Aim 1. Develop and pilot test a patient-centered intervention,
Office-Guideline Applied to Practice (Office-GAP) to improve the implementation of
evidence-based guidelines for secondary prevention of CHD for African Americans and
low socio-economic populations in an outpatient clinical setting.

To accomplish our objectives, it will be crucial to understand the factors relevant
for collaborative care based on the needs of patients and their providers. We will conduct
patient focus groups. The focus groups are expected to yield enhanced insights into
patients’ decision-making, their needs, what motivate them and what the barriers are, that
will assist in the modification of DSTs. The type of information that patients need in their
guidebook will also be determined.

The intent is to use findings fiom patient focus groups and physician educational
interactive meeting to modify the DST s development and implementation.

The rationale for use of the patient focus groups is that any successful intervention must

be relevant to both the providers of such intervention and the recipients. Consequently, to

50

foster collaboration among patients, their providers, and the health care system,
understanding the perspectives of all groups is mandatory.

D. 4. Programs to achieve Aim 1. Table 1.

 

 

Table 1. PROGRAMS TO ACHIEVE AIMS 1-3

PROGRAMS TO ACHIEVE AIM l
6 Patient focus group
4' Development of decision support tolls
0 Office -GAP contract
0 FIMDM Video
0 Patient Office — GAP Guidebook
PROGRAMS TO ACHIEVE AIM 2
Reminders
4' Nurse phone calls
9:0 Postcard maiVletter
4- Email reminder
PROGRAMS TO ACHIEVE AIM 3
02° Pre and post evaluation of rate and use of evidence-based medications, in both the study
and control group
LDL cholesterol and smoking counseling/status
Office-GAP Tool Utilization
Assessment of Patient perception of Physician Participatory Decision Style
Evaluation of the program effect on other aspects of patients’ care and acceptability of
intervention

##0##

 

 

D. 4.1. Program In. Focus Groups

Focus groups are qualitative research methods that provide an in-depth
understanding of social and behavioral attitudes of individualsm. They are a cost-
effective and successful way to obtain in-depth information about a homogenous group,
and to develop interventions to reduce the risk of chronic diseases‘“.

There will be 4-patient focus groups comprised of 8 participants in each group.

There will be 2 all black focus groups and 2 all white focus groups matched with

51

facilitators of the same race to maximize candor and trust. Moderator or facilitators will
be chosen based on three criteria, including familiarity with the subject matter, expertise
in leading focus groups and acquaintances with the group dynamics. The focus group
participants will be recruited from the group of patients from the intervention arm of the
study that meet our eligibility criteria and agreed to participate. The themes to be
explored in the patient focus groups are beliefs and attitudes about heart disease self-
management, barriers to receiving culturally sensitive care, perceptions about medication
use, facilitators/barriers to medication use, health care providers and the health care
system, beliefs about patient autonomy and shared decision-making. Participants’ will be
shown the DSTs and asked for example: “How might the DSTs help or hinder your
discussions with your physicians? and “What changes would you make?” “What were
your first impressions of the patient Guidebook mailed to you? “What is the book
trying to say?” “How will you describe Oflice- GAP guidebook to your family?”

Standardized probes to encourage elaboration and discussion of the participant
initial responses will be used'“. Each focus group will last for about an hour. Focus
group interactions will be recorded and transcribed for detailed review and analysis. The
PI will observe all focus groups and take notes. Participants in the focus group will not
be excluded from the study because they are part of the interventional arm of the study.
4. 2. Program 1b. Development of Decision Support Tools
4. 2.1. Office-Guideline Applied to Practice - Contract (Office-GAP Contract)

The Guideline Applied to Practice (GAP) hospital discharge contract for patients
following AMI will be adapted for the design of the Office-GAP Contract. The

discharged contract improved the quality of care for patients post AMI in hospital and

52

significantly increased the rate of use of secondary preventive agents” 135’ '36. The
Office-GAP Contract will contain guideline oriented standard orders. It will be designed
to aid patients and physicians in considering the use of all the evidenced based
medications for secondary prevention. The patient will be asked to check whether they
are taking each medication currently and if not they will be required to docrnnent the
reasons why they are not on it. Similarly the practice of healthy life style (e. g. exercise,
health diet) will be documented (a copy of the Office-GAP contract is included in the
appendix). Both the patient and the physician/nurse will sign the Office-GAP Contract
form. It will provide decision support at the time and location of decision-making for
both patients and physicians/nurses and serve as a reminder. Office-GAP-Contract form
will be attached to the front of patient’s chart and reviewed with patients by the
physician/nurse during the patient’s office visits. Its use will be documented in the
patient chart. Finally, the patient will be given a copy to take home.

4. 2.2. Office-Guideline Applied to Practice — Video and Guidebook (Office-GAP -
GB)

The updated version of the F IMDM video for secondary prevention of CHD
developed by our colleagues “Living With Coronary Artery Disease-Doing Your Part.”
will be used as part of our patient educational module. The video will prepare patients to
make informed values-based decisions with their provider. The 37 minutes video discuses
in plain language what CAD is, how to manage CAD, how medications helps, common
side effects of the medications, managing cholesterol and Blood pressure, quitting
smoking, managing exercise and stress and how much benefit the patients gets fiom

participating in each of these preventive measures. The video will particularly be helpful

53

for patients of low literacy who cannot read. Dr. Holmes-Rovner will supervise Dr.
Olomu in the adaptation of the accompanying booklet to plain language to address the
needs of patients with limited literacy. (See Appendix G for accompanying booklet). In
addition, a Tracking sheet (TS) will be developed as part of the Office-GAP-GB. The
specific components include; a) patient-provider management goals for their BP, LDL,
and evidence-based medication use (ASA, Beta-blocker, lipid lowering agents, ACEI)
smoking cessation, and physical activity and b) a reminder document for each subsequent
office visit. The Office-GAP Video/CD and -GB will be mailed to the patient at home for
review before their attendance at the focus group or the patient educational session.
Patient who cannot watch the video at home will have the opportunity of watching the
video during the educational section.
D. 4.3. Procedures to Achieve Aim lb
Provider educational module

A four—hour orientation for CME credit will be conducted for providers in the
interventional arm. This will be done in three sessions to meet the schedule needs of the
providers. This is not traditional CME, but is CME in the context of community
physicians participating in a research study. Our team used this technique, in both the
MICH and HARP studies. The activities to be provided by Dr. Olomu, Dr. Holmes-
Rovner and a local cardiologist, Dr. Prieto will include: 1) Limited didactic presentations
on evidence for the effectiveness and cost-effectiveness of medical therapy and
behavioral changes in the management of heart disease. The ACC and AHRQ and other
guidelines will be reviewed as well as other recent data on secondary prevention. 2)

Limited didactic teaching concerning the theories, concepts and design of the program.

54

Participants will be shown the DSTs and there will be discussions regarding the best way
to implement their use in their practice. Smith evidence-basedl ” patient-centered method

for communication and establishing the provider-patient relationshipm’ '48

to optimize

providers’ ability to integrate patient-centered method with goal setting and screening -

oriented protocol with patients during office visit will also be discussed. We are

fortunate to have Dr. Smith, who described this published method in our institution as a

consultant on this project. He has agreed to teach this approach during the educational

session with the providers.

The Smith approach supplies the patient-centered foundation for this project. In
addition, shared decision-making skills by Braddockm, and 1~31wyti109 will be included.
The draft sequence of skills we will teach is:

I . Setting the stage for the clinical encounter by welcoming the patient, using the
patient’s name, assessing the patient’s readiness to be interviewed and ensuring
privacy, and remove any communication barriers to put the patient at case.

2. Assessing the patient ’s agenda by setting time limit, obtaining information about
what the patient would like to discuss, and negotiating their chief complaint.

3. Non-focused and focused open-ended interviewing to obtain the history of present
illness through open-ended questions and skills focused open-ended questions, closed
ended questions and obtaining information through non-verbal cues.

4. Transition to goal setting, including checking progress in the guidebook on past

goals, trouble shooting barriers, exploring ideas, fears and expectations of possible

options, portrayals of physician equipoise, checking how patient is taking their

55

medications, exercise activities, diet, smoking cessation is being done. New goals
can be negotiated.
5. Reminders about laboratory test and any referrals.

The nurse/nursing assistant responsible for taking the patient vital signs and
getting the patient ready for the physician/practitioner will be responsible for going over
the guidebook/ tracking sheet with the patient and making a stick-on note for the
physician/practitioner regarding areas of care that need to be discussed with patient,
medications that need to be prescribed or cholesterol that need to be checked. This will
help the physician/practitioner to use limited time more efficiently with the patient.
Providers will complete a pre- intervention survey at the onset of the meeting to
determine their perceptions regarding the use of DSTs in their clinical practice.

D. 4.4. Procedures to Achieve Aim 1c.
Patient / Support Person Training Program

We will offer a series of training sections during the day for small groups of
patients (n-8) from the interventional arm of the study that meet our eligibility criteria
and agree to participate through out the recruitment period. The training program will
consist of 1) showing the FIMDM video 2) teaching patients how to set their heart
disease management goals using the Office-GAP- guidebook, 3) training in shared
decision-making and how to use the Office-GAP-Contract and 4) the role of the doctor
and patient in shared decision-making. Patients will have opportunity to ask questions.
This small group meeting can be adapted for a group office visit with physician.
Physicians can bill for this form of group visit. This will encourage physicians’ continued

practice of the process. At the end of the patient educational module, all participants will

56

complete a self-administered written survey asking patients to rate all aspects of the
DSTs, their perceived barriers to self management and the best time they will like to be
contacted after their visit with their provider. The PI and the Research Assistant will
assist patients in completing the questionnaires if help is needed. The training session will
be scheduled for one and half hours. Patients in the control site will not be involved in
the focus group or any of patient training programs. Neither the video nor the Office-
GAP book will be mailed to the patients. However, the American Heart Association
(AHA) handouts for patients with CAD or the American Diabetes Association handouts
for healthy life style will be mailed to patients with CAD and diabetics respectively.
D. 4.5. Expected results

At the completion of the objectives for aim 1, adequate information on the
components that the patients and providers expect in the collaborative care of patients
with CHD in AAs and patients of low SES will become available. In addition, DSTs will
be developed. Both providers and patients will become familiar with the use of the DSTs
and its application using the principle of SDM to negotiate life style/behavior change
goal. The results of this section will not only foster provider-patient collaboration; it will
emphasize the need to include the ultimate recipients of care (patients), in the decision-
making process and system design for the outpatient care of patient with CHD.
D. 5. AIM 2: Develop an Office-GAP Follow-Up Program to Reinforce Secondary
Prevention Goals

A research assistant/nurse will provide reinforcement through a brief (1 0-1 5min)
structured,” Nurse Initiated telephone contact” within a week of the first doctor’s visit.

She will obtain information on the following a) how the visit went, b) if goal setting

57

occurred, c) if the patient has any questions regarding the medications, d) if needed
laboratory tests were done, e) if he/she has any questions about any aspect of the visit, f)
if the next doctor visit has been scheduled and date recorded in the guidebook, g) if more
reminders are necessary and how often? Patients will be informed of their follow up
appointment.

The research assistant will document each encounter with the patient and detail
the issues discussed and problems solved. The research assistant will report to the PI any
problems that she could not solve over the phone. PI will follow up on all unresolved
issues. The PI will review all documented encounters with patients on a weekly basis for
purposes of program improvement, as well as reinforcement. The phone calls will
provide individualized information, support and problem solving around barriers based
on the patients’ ongoing report of goals and problem areas. Other reminders will include
the use of post card mail/letter as some patients may not have access to a phone and /or
E-mail reminder, for some patients that may prefer to be contacted through the Internet.
Study patients who fail to keep their appointments will be contacted by phone or sent
letters. In general when the research assistant/nurse experiences an unforeseen situation
that is new she will contact the PI who will be “on call” for such occurrences. Standard
responses will be developed at weekly meetings and incorporated into the developing
Office-GAP manual.

Chart stickers: We will design a sticky note to flag the patients’ charts. This will
be placed in front of each patient’s chart. The goal is to remind providers and office staff
of patient’s participation in the project, to use the DSTs, to sign the Office-GAP Contract

and to review the patient-tracking sheet

58

D. 6. AIM 3: Evaluate the Implementation of the Office-GAP Using a Cluster-
Randomized Design

Office-GAP will be implemented at the 3 Adult Health Centers at Ingham County
described above. Evaluation will include:

a) Pre and post evaluation of rates of use of evidence-based medications (aspirin,
beta-blocker, ACEI, cholesterol assessment and treatment and smoking
counseling/smoking status in both the intervention arms and the control group.
Cholesterol and smoking has high impact on mortality.

b) DST utilization rate and acceptability of the intervention by the clinic and medical
staff.

c) Patient perception of the physician participatory decision style in the
interventional centers.

d) Determine the impact of the program on other aspects of patient care.

Patient charts will be reviewed for relevant data and evidence of DST use during
chart abstraction. We will look for the presence of Office-GAP contracts in the charts.
Documentation that patient came into the clinic with his/her Office-GB and tracking
sheet. Details are described in section D.8 under data collection. Throughout the study the
PI and the research assistant will take notes and document barriers to use of DSTs and the
impact on patient flow. Providers’ views regarding the effects of the DST and
intervention will be determined through the use of a survey that will be administered pre
and post the intervention. To determine the beneficial or detrimental effects that this
focus on patients’ cardiovascular care could have on other aspects of patient care; pre and

post intervention rates of colonoscopy, flu vaccine, pneumovax, and stool occult blood

59

test in both the interventional and control arms will be determine through chart
abstraction data. We expect that the program implementation will make communication
more efficient and lead to enhance care in other areas.

D. 6.1. Study Design

The study to be conducted during the K01 training will be a pilot study; a two-
arm cluster randomized interventional trial will be designed to test the feasibility of
implementing the program (Aim 3) at three health care centers in Ingham County,
Michigan. Based on the results of this pilot study, the PI anticipates submitting an R01
proposal for a full scale randomized controlled trial to evaluate the program’s effect on
patient health outcomes and quality of care in twenty health care centers providing
primary care to underserved populations in Michigan.

We considered 3 possible options for the randomization of patients into the study:
patient level, physician level or center level. Randomization at the patient level would
result in the possibility of a physician managing both the intervention patient and the
control patient at the same time resulting in significant contamination and bias.
Randomization at the physician level would also lead to a degree of contamination since
both the interventional physicians and the control physicians would be at the same center
and their patients would cross over and be seen by other physicians. Randomization at
the center level means that all the physicians and patients at one center will either be in
the interventional arm or control arm of the study. This will minimize the risk of
contamination and greatly improve the feasibility of delivering the intervention. Two
centers will be in the interventional arm of the study and the third one in the control arm.

By incremental accrual patients with CVD or Diabetes Mellitus will be enrolled into the

60

study at both the interventional and control centers. The providers at the intervention
centers will participate in the provider educational module as described above. The
patients at the intervention center will be invited to participate in the patient educational
module that includes the use of DSTs, education, use of contracts and reminders similarly
described above. The physicians and their patients in the control center of the study will
continue with their usual care but patients be mailed the AHA handouts on living a
healthy lifestyle. The usual care at all three centers currently does not include the use of
educational modules for either providers or patients or the use of DST. All patients will
be followed for 6 months. Patients will be expected to visit their primary care physician
at baseline, 3 months and at 6 months.

The following 6 primary outcome measures: aspirin, beta-blockers, ACEI,
assessment of cholesterol or lipid panel, use of lipid lowering agents, and smoking
counseling/ status will be determined at baseline (before any intervention), and after six
months for patients at both the interventional centers and control center fiom chart review
The same information will be obtained over the telephone at 6 months if the patient was
unable to keep his/her 6 months follow up appointments. The effectiveness of the
intervention will be measured by comparing the differences in the rate of use of these
medications (from baseline to the end of the study) between the intervention arm and the

control arm.

61

D. 6.2. Sample Size Calculation

 

Figure 3. Sample size and Power based on GEE models

 

 

 

Sample size calculations for the pilot study assume the simplest case of a binary
exposure (intervention /control group) without any covariate adj ustrnent. The primary
outcome related to beta-blocker (BB) intake, one of the most important outcome
variables was used to compute the minimum sample size using 80% power. Due to the

longitudinal design of the study, a Generalized Estimating Equations (GEE) model is

used to compute the sample size. Specifically, the GEE model for an outcome wi/‘k for
example taking BB ( wijk =1 if BB is taken and o if otherwise), for a subject i at time

point j=1 (baseline), or 2 (6 months) in the group k, (k=T for the treated group and k=C

pr (Wijk :1)

0
control group). can be written as g 1 _ [yr-(W1 : 1)
ll

 

:fljk

, where

62

fljk is the log odds of taking BB for group R at time point j. Let us denote by pjk

the probability pr (Wijk = 1) . The intervention effect can be measured by the ratio

P2T / Pir
ch / Pic

, which represents the ratio of improvement rates between the intervention

and the control groups. Note that the ratio ka / p 1k represents the improvement in

the group k between the baseline and the follow-up time.

If the intervention has a positive effect we have p 2T / p 1T > pzc / p 1C or

P2T / P17 > O
equivalently, pzc / plc . Although, we expect the alternative to be a

one sided when the intervention is effective, the sample size calculations are based on a
two-sided test. Therefore, the intervention effect can be measured by the interaction

between the time component and the intervention variable represented by the term

(fin _ flu) _ (flzc — fllc) . Hence, if there is no intervention effect, we have

(1621" — 131T) " (flzc — 181(3) = O , which represents the null hypothesis. For

inferences, due the longitudinal nature of the binary outcomes, the standard error of an

estimate of (fin _ fllT) _ (182C — 16m) is computed using the sandwich

estimator approach. Based on this methodology, our sample size calculation shows that to

_ _ o
detect an intervention effect based on plT "' 5 0% , pZT — 80 /0 (increase from

63

50% to 80% in the intervention arm), PIC = 50% and pic 2 60% (increase from

50% to 60% in the control arm), which corresponds to (flu - flu ) _ (flzc " fllC)

= log (.8*.6/(.2*.4))=1.79, at 80% power and at 5% significance level, we need about 55
subjects in each arm (See Fig 3 above).This then corresponds to 110 patients for the
entire study. Although we anticipate that about 30% of patients will drop prematurely
from the study, we will however recruit 182 patients to make up for any possible higher
attrition rate. Our assumption of a 30% increase in rate of use of medications was based
on our recently completed HARP study “Outpatient medication use and health outcomes
in post acute coronary syndrome patients” in which we demonstrated a 35% increase in
the rate of beta-blocker use among 323 patients that were followed up for 8 months in an
outpatient telephone intervention study ”.

D. 7. Study Measures

D. 7.1. The Primary Objective of this Proposal

To determine the influence of the program on the rate of use of key quality

indicators. We will determine:

a. Change in proportion of patients on aspirin, beta-blocker, cholesterol lowering
agents, and ACEI.

b. Change in proportion of patients that have their cholesterol accessed LDL-
cholesterol 5 100 mg/dl, smoking counseling, and reduction in proportion of
patients smoking. Information regarding medication use will be abstracted
from the chart or per patient self report. Patient will be asked to read the

name of their medications off the containers.

64

D. 7.2. The Secondary Objective of This Proposal

To ensure that physicians/other healthcare providers can implement the program
We will look for documentation of:

a. Use of the Office-GAP Contract, Office-GAP guidebook and tracking sheet.

b. Documentation of patient goals, regarding medication use, exercise, blood

pressure, smoking cessation, and weight control.

c. Documentation of laboratory test and results e. g. cholesterol.
D. 7.3. Patient Perception of Physician Participatory Decision Style

Participatory Decision Style (PDS) is a 3-item scale developed in the Medical
Outcomes Studym. It is completed by patients to describe their physicians’ propensity
to: a) Involve them in treatment decisions b) Give them a sense of control over medical
care, c) enable them to take some responsibility for their own care. Participatory
decision-making style has been shown in the Medical Outcomes Study and subsequent
studies to predict provider switchingm. It is positively related to patient satisfaction and
loyalty to the physician and length of office visits. While our program is not anticipated
to increase the length of the office visit, it constitutes care provided before the office visit
(patient educational modules) and provides a structure for patient/physician collaboration
in secondary prevention planning. The PDS will measure the extent to which the
outcome of the program is patient perception of increased involvement, control and
responsibility for care of their heart disease. All patients will complete the patient
perception of physicians PDS questionnaire during their enrollment at the group meeting

and at the end of the study, during their 6-month’s physician office visit. The

65

questionnaire will be administered over the phone for patients that are unable to keep
their follow up appointment.
D. 7.4. Effect of Program on Physician Practices and Barriers to Program
Implementation

A pre and post survey of patients and physician/nurse practitioner/staff perception
of the use of DSTs in outpatient settings will be completed. In addition, a survey of the
impact of the program on the practices will be determined at frequent intervals. We will
also document any barriers to implementation of the program. The information will assist
in the design and implementation of the subsequent RCT to evaluate the program’s effect
on patient health outcomes.
D. 8.1. Data Collection

After the group meeting (focus group/educational meeting) patient will complete
a baseline questionnaire to collect information on age, gender, race/ethnicity, income,
education, marital/partner status, insurance, insurance coverage of secondary prevention,
and number of people in the household. In addition information on risk factors, coronary
heart disease history, and comorbidities will be obtained. Types of reminders that patients
prefer (e. g. phone calls, postcards, etc) will also be ascertained and information regarding
barriers and facilitators to medication use will be obtained. The best time for patient to be
called by the nurse after the doctor’s visit will also be obtained. Patients will complete
questionnaire about DST. The PI and the research assistant will assist any patient that
needs help to complete the questionnaires.

D. 8.2. Questionnaire Development and Modification

66

Prior to being used in our study, our questionnaire will be field tested for clarity,
ease of use and accuracy of data responses among 20 English-speaking patients at
another clinic site, the MSU lntemal Medicine Clinic. The MSU lntemal Medicine
Residents’ Clinic provides services for low- income indigent populations similar to those
seen at Ingham County Healthcare Centers.

D. 8.3. Chart Abstraction

We will set up a centralized data-coordinating center at MSU. Patient charts will
be abstracted in the clinic at baseline and at 6 months i.e. before and after implementation
of the program. Information will include, use of aspirin, Beta-blockers, ACEI, smoking
counseling/ status, cholesterol assessment and treatment. Other data to be abstracted
from the chart will include cardiac procedures and treatment, comorbidities and hospital
admissions. Severity of coronary artery disease (number of vessels occluded, ejection
fraction), previous surgeries, including cardiac bypass, height, weight, blood pressure and
contraindication to medications will also be abstracted. All completed forms will be
forwarded to the study office, at the clinical center, Department of Medicine, where the
information will be entered into a database. A paper print out of a summary of the chart
abstraction will also be kept in addition to the chart abstraction form for each patient. All
confidential patient information will be entered into a separate secure database to protect
patients’ identity. A patient study record number will link confidential patient
information to the patient identifier.

D. 8.4. Medications Prescribed
Patient medications will be obtained at baseline, and 6 months post program

implementation. Current medications will be enquired about during their routine office

67

visits at baseline and at 6 months. If a patient forgets to bring in his/her medications to
the clinic, patient will be requested to call in their medications to the clinic nurse over the
telephone.
D. 8.5. Cholesterol

Fasting Low-density lipoprotein (LDL) cholesterol, total cholesterol (TC), and
triglyceride will be gathered from the outpatient chart review, pre and post-
implementation of the program. Cholesterol will be measured as increase in the
proportion of patients who have their cholesterol measured and are at or below the target
values for patients with coronary heart disease established by the National Cholesterol
Education Project (NCEP, ATP III), LDL ilOOmg/dl, and TC 1 200 mg/dl. Triglyceride
< ZOOmg/dl '50
D.8.6. Data Entry of Survey Questionnaires

The PI and Research Assistant will scan for missing responses at the time the
completed surveys are turned in. They will ask that the subject complete any missing
items. At the stage of data entry, double entry verification will be used to minimize data
entry error. An access database will be used. A paper print out summary of the data
collected will also be kept.
D. 8.7. Quality Assurance

The PI and the research assistant will train the medical record chart abstractors on
specific chart abstraction protocols for the project. Acceptable inter-rater reliability
(kappa >. 8) will be achieved for all new chart abstractors before independent chart
abstraction will occur. For quality assurance purposes data will be reabstracted by the

trained chart abstractors from a 10% random samples of chart at both baseline and

68

remeasurement. Intra-rater and inter-rater reliability will be determined. The goal is to
have a kappa coefficient > 0.8.

Treatment fidelity strategies (strategies to ensure that the content of the
intervention is being delivered as specified) will be included in our research design and
implementation in order to monitor and enhance the reliability and validity of our
behavioral interventions. A high degree of treatment fidelity is needed for successful
replication and dissemination of the project. We will adopt the treatment fidelity
framework by Borrelli et al15 ‘. The areas of focus will include, 1) DST design, 2) training
providers, 3) delivery of educational modules and DST, 4) receipt of DST and
educational modules, 5) enactment of intervention skills. We will ensure that the content
of the intervention was being delivered as specified e. g. by development of treatment
manuals, protocols, check list and conduct weekly meetings of the research team. We
will include mechanism to assess if the provider actually adhered to the intervention plan
by a follow -up phone call to the patient and check for use of DST.

D. 8.8. Data Back-Up

Periodically, an encrypted back up copy of electronic data will be created and
stored in a secured location in the in the Department of Medicine.
D.9. DATA ANALYSIS
D. 9.1. Creation of Study Database

Datasets for statistical analyses will be created and cleaned afier merging data
from different data sources. We will define ranges for each variable collected and
examine the accuracy of outliers. We will check for internal consistency of inter-related

and calculated variables and resolve inconsistencies by reviewing primary data sources.

69

We will complete a series of descriptive statistical analyses to profile the study sample in
terms of demographic and clinical characteristics. All analyses will be performed using
the statistical program SAS (Statistical Analysis System, version 9.1 Inc, Cary NC). The
research analytic sequence will vary according to the type of data and study outcome
being analyzed. Qualitative type-recorded data will be analyzed on an on-going basis.
D. 9.2. Focus Group Analysis

Data will be obtained from multiple close readings of the transcripts of focus
group interactions; the moderator/ facilitator notes and from the notes kept from
observations of the PI. The unit of analysis for Specific Aim 1 is a thematic unit 146.
Thematic units for this study are the recurring systems of beliefs or explanations that
emerge from the patient focus groups describing attitude towards heart disease self-
management, medication use, patient autonomy, SDM, use of DSTs, and collaborative
care across racial and provider groups. Emphasis will be placed on recurrent themes
regarding attitudes towards heart disease self-management, SDM and collaborative care
across racial groups. To be considered a theme, a topic will have to be mentioned by
more than one participant across provider groups and across racial categories of patients.
Sampling within thematic units will be done to provide themes that are representative of
the beliefs of the study populations. Emergent themes will be used to classify the content
of focus group interactions into categories. The categories will be organized so that the
meanings of discussions are maintained.

Coding: Initial coding categories will be created and refined by a team comprised
of Dr. Holmes-Rovner, the PI, and the moderators of the focus groups based on the

literature and personal experiences with the study populations. These coding categories

70

 

will then be applied to part of the focus group data to check for relevance and
consistency. Finally, a separate group of coders will apply the refined categories to a
subset of the data to determine the reliability of the coding categories. Once reliability is
established then coding of the focus group data will be done.
Qualitative Analysis: Since Specific Aim 1 is exploratory in nature, content analysis
and resulting statistics will be descriptive. We will summarize emergent themes in order
of decreasing frequency. Relationship between themes will be determined by cross-
tabulation of the fiequencies of co-occurrences. Images, discriminant analysis, and
association analyses will be conducted to determine the uniqueness of the information
from the patient focus groups. Our findings will provide a rational and culturally sensitive
framework on which to develop interventions in these populations. The focus groups are
expected to produce data that captures the perceptions of patients that are impossible to
accomplish through close-end question surveys.
D. 9.3. Office-GAP Follow-Up Program

We will determine the increase in the proportion of patients adhering to
recommended medications in response to our interventions and reinforcement with
reminders. Analysis is as described in next section.
D. 9.4. Data Analysis for Aim 3
Assessment of the influence of the Office-GAP implementation on the rate of use of
key quality indicators.

In our preliminary descriptive analyses, the outcome variables related to
likelihood of use of aspirin, beta-blockers, ACEI, and cholesterol assessment and

treatment, smoking counseling/status will be considered. We will begin our analysis by

71

computing the sample proportion at each single time point and for each treatment group,
together with the corresponding sample standard deviation. Because the study involves
repeated measurements on the same subject, we will compute measures of association
between time-point responses of a given outcome. Specifically, we will use pairwise
odds ratios and Pearson correlations to measure the temporal association between two
different time points. These measures of association will provide an indication on how
the association between responses of a given outcome could be modeled over time in the
regression models. It is widely known that putting some structure on the working
correlation matrix, improves efficiency for time dependent covariates in GEE models.
To assess the intervention effect on the outcome variables, we will use regression
models for which their specification will depend on the format of the outcomes under
investigation. We will use GEE models with explanatory variables, which include the
time variable, the intervention variable and their interaction. We will also adjust for the
clinics effects in order to account for unmeasured clinics’ specific differences. GEE
models, which are specified in the sample size calculation section, for binary outcomes is
an extension of the classical logistic regression model that takes into account the
correlation of an outcome measured repeatedly over time within a subj ectm. They treat
the within-subj ect association as a nuisance parameter and assume a “working
correlation” structure which needs not be the correct correlation structure. The standard
errors are robustly computed using the sandwich-based approach which takes into
account the correlation within a given subject. Since the marginal probabilities are
modeled as those of a classical logistic regression, the slope estimates from the model

have, a population-averaged interpretation. However, these models may produce biased

72

inferences when the completely missing at random assumption (MCAR) is violated. A
weighted GEE model or likelihood methods for correlated binary data such as that based
on the Multivariate Plackett distribution can then be invoked for their robustness against
any violation of the MCAR assumption in the direction of the Missing at random (MAR)
mechanism ”7- For model diagnostics, all model fits will be evaluated for individual and
systematic departures of the observed and fitted values using informal (e. g. inspection of
residuals) and formal methods (e. g. based on Wald tests for extra parameters).
Handling and treatment of missing data and intention to treat analysis

It is most likely that we will have missing data in the course of the study. The
missing data are mostly dropouts in that some participants will be lost to follow-up as the
study progresses. The primary concern in analyzing the resulting (unbalanced) data rests

on the nature of the missing data. Using terminology from Rubin and Little”2

, missing
data mechanisms are classified as missing completely at random (MCAR), missing at
random (MAR) and missing not at random (MN AR), if missingness is allowed to depend
on (1) none of the outcomes, (2) the observed outcomes only, or (3) unobserved
outcomes as well, respectively. The models proposed above (weighted GEE models) are
known to provide valid inferences when the missingness mechanism depends on the
observed outcomes and not on the unobserved ones. However, when the missingness
mechanism depends on the unobserved outcomes, these models may yield biased
inferences. In this context, we can assess the impact of this class of missingness process
on inferences through sensitivity analyses. We will then formulate a non-ignorable model

that takes into account the missing data indicator and the measurement data into a unified

likelihood. We will then use this model to study how the missingness process influences

73

the inferences.
Intention to treat analysis

It is likely that there will be some non-compliance in the study in that some
participants randomized to the intervention arm may not comply with instructions of the
intervention. To address this issue, we will consider an intention to treat analysis, i.e.
participants will be analyzed according to the group they were randomized to, regardless
of whether they actually comply with the intervention process. Due to the nature of the
delivery of the intervention, we do not expect participants on the control arm to have
access to the intervention.

D. 10. Quantitative Patient Perception of Physician Participatory Decision Style
(PDS)

The difference between pre and post intervention data will be used to create a
composite PDS score differences for each study patient. Statistical significance will be
tested at the 0.05 level using a series of matched pair test. The anticipated sample size
will provide an adequate level of statistical power to test these differences.

D. 10.1. Baseline Patient Characteristics

To be used as Covariates are age, sex, race, income, insurance status, marital
status, number of people in the household, comorbidity as measured by Charlson
Comorbidity Index (CCI) 153, severity of coronary heart disease (number of vessels
diseased, ejection fraction <40), history of coronary heart disease and cardiac procedures,
(coronary artery bypass graft, angioplasty, diagnostic catheterization), hospitalizations
after implementation of the program.

D. 10.2. Anticipated Problems/Study Limitations

74

1) Patient Recruitment: We propose to enroll 182 patients. We do not anticipate
significant difficulties in recruiting our sample. The study team is experienced in
recruiting participants for decision-making and qualitative research in clinical and
community settings. The PI has held a series of meetings with the medical director,
health administrator and the physicians at the health centers. However, we have
allowed ample time to extend recruitment if necessary.

2) Physician Recruitment: We have assumed that all the physicians and nurse
practitioners at a given site would participate. However, some may not be able to do
so for scheduling and other unanticipated reasons. The PI has met with all the
physicians/nurse practitioners that work at the health centers and they expressed their
interest in the study and willingness to cooperate with the team to ensure that the
program succeeds.

3) Focus groups: A concern that is often raised is the validity of focus group analyses.
Based on the exploratory nature of the study question, focus groups when conducted
properly are most likely to provide the desired results. Dr. Holmes-Rovner, Dr.
Smith and Dr. Hunt are skilled in the conduct, analysis and interpretation of focus
group data. The availability of these mentors, skilled at qualitative analysis, will
ensure that valid and reliable inferences can be deduced at the completion of Specific
Aim 1.

4) Decision support tools (DS Ts) and reminder systems: While DSTs and reminders
have been previously shown to affect physicians’ ordering of recommended
medications and tests, they don’t always work. In a recent study by Tierney et al.

computerized reminders were mostly ignored, and did not affect any patient

75

outcomesm. However, the Guideline Applied to Practice Tools by Dr. Eagle and his
team were very successful in increasing secondary prevention for inpatients. We
propose to adapt these tools for outpatient use in our study. Dr. Eagle, a co-mentor is
actively involved in the design of this program. In addition, involvement of both
patients and physicians in designing the system will increase the chances of
successful implementation. Patients follow up program should help to reinforce the
system.

5) Limitation of Cluster randomized trials: One of the limitations of cluster randomized
trial is that it may have substantially reduced statistical efficiency relative to trials that
randomize the same number of individuals.

6) Ability to meet relevant timetables: We have ample time for patient recruitment and
data collection, and we do not anticipate a significant deviation fi'om the schedule.

Timeline is attached in the appendix.

76

E. HUMAN SUBJECT RESEARCH
E. l. Risks to the Subjects
E. 1.1. Human Subjects Involvement and Characteristics

The research plan proposes to enroll 182 patients with coronary heart disease and
diabetes mellitus from the three health centers at Ingham County. The eligibility criteria
in our study are designed to recruit as large a number of patients as possible, who will
benefit from secondary prevention for CHD. Eligible patients will be African Americans
and other low-income populations attending any of the three health centers, aged 18 or
older, with l of the following:

1) Inpatient, outpatient or emergency department diagnosis of coronary artery
disease, angina, or myocardial infarction.

2) Definitive diagnostic test (e. g., cardiac catheterization, an echocardiogram or
scintigram showing segmental abnormalities in the left ventricular wall, an
electrocardiogram demonstrating significant Q-waves, or results of cardiac
enzymes studies indicating acute myocardial injury or

3) Coronary Heart Disease risk equivalent - Diabetes mellitus
In addition, patients must be fluent in English and able to provide informed
consent. Low SES will be based on patient’s income, number of people in the
household, (using the US poverty thresholds 2005 levels as defined by the US
Census Bureau, Housing and Household Economic Statistics Division) and

insurance status.

77

Patients will be excluded if there is any evidence cognitive impairment, dementia,
psychosis, and inability to understand spoken English. The race/ethnicity of each patient
will be determined by self-report.

We will conduct 4 patients’ focus groups. Each group will consist of 8 subjects.
The sample composition will consist of women and men.

No patient is denied care in this study. All patients will receive usual care for
heart disease and diabetes and patients and providers will only be expected to respond to
interview questions, participate in focus groups and educational modules with emphasis
on improving secondary prevention of heart disease.

E. 1.2. Sources of Research Materials

Data obtained specifically for research pmposes will include personal opinion
information fiom focus groups, surveys, and interviews. Some information such as
demographics and clinical status and list of medication use will also come from medical
records.

E. 1.3. Potential Risks

This study poses no additional risk to patients or providers. The subjects will
have the option of withdrawing from the study at any time without jeopardizing access to
care.

E. 2. Adequacy of Protection Against Risks
E. 2.1. Recruitment and Informed Consent

Subjects will be recruited from the three health centers in Ingham County. Patient

recruitment will proceed as follows: A letter will be sent by patients’ primary care

physicians or his clinic nurse/ clinic research assistant (RA) to patients with evidence of

78

CHD or diabetes that meet the eligibility criteria in the interventional centers at Ingham
County health centers inviting them to participate in the study. The letter will include a
stamped addressed post card that interested patients can return to the research office
indicating their interest to participate in the study. Clinic Nurse/ clinic RA will log all
responses positive and negative and will follow up with a phone call from the clinic in 2
weeks to patients that did not respond. In addition a phone number to a phone with a
voice mail in the research office or clinic will also be included that patients can call to
indicate their interest in participating in the study. Those who would like to discuss the
program further will be offered an appointment unless one had already been scheduled as
part of routine care. PI and Research Assistant will obtain informed consent from all
patients that agreed to participate after their office visit with their physician or before the
focus group or patient educational section. Consistent with HIPPA regulation patient
identifiers will not be obtained by research team for recruitment purposes without patient
consent. After patients’ recruitment PI and trained Research Assistant will give initial
training and further explanation of the study. Consent to participate in the study will also
be obtained fi'om all the providers who will participate in the study. IRB Preliminary
human_subj ects’ approval has been obtained (attached in the Appendix). Full IRB
approval will be obtained before the onset of the study. All recruitment procedures are
consistent with present HIPAA regulations, and no individual data will be obtained prior

to patient consenting to join the study.

79

E. 2.2 Protection Against Risk

The project team will establish a uniform procedure for handling patient questions
regarding their continued participation in the study or expressed desire to withdraw from
the study addressed in a confidential manner.

Data obtained from participants will be linked to personal information only
through identification codes that will be stored in a locked drawer separate from the data.
Access to data will be restricted to the research team. Reported data and publications will
list patients in groups and will never report information that is personally identifiable.
We expect these precautions to be effective safeguards against the risks imposed by
participation in this research.

Michigan State University’s Human Research Protection Programs

Michigan State University is dedicated to the highest standards of ethical research
conduct and the protection of human subjects in research. The Human Research
Protection Programs at Michigan State University (MSU) are fully accredited by the
Association for the Accreditation of Human Research Protection Programs (AAHRPP).
MSU has an F WA on file with the Office of Human Research Protection (# 00004556).
When appropriate, MSU develops collaborating relationships with other institutions
holding an FWA through IRB Authorization Agreements and with individual
investigators in non-FWA institutions through Individual Investigator Agreements.
Michigan State University has three Institutional Review Boards with expertise relevant
to each focus area: Biomedical and Health IRB (BIRB), Social
Science/Behavioral/Education IRB (SIRB) and the Community Research IRB (CRIRB).

MSU provides extensive required and supplemental human subject research education for

80

faculty, staff and students, including conferences, seminars, guest lectures and online
training. MSU requires that investigators and all key personnel complete the MSU online
tutorial and then six CITI modules, or equivalent, every 2 years. The MSU HRPP
conducts random and performs audits on a regular basis of all categories of review
(exempt, expedited and full board) to ensure compliance with University policies and
federal regulations. In addition, MSU has a university [HIPAA] Privacy Board and
follows and enforces the HIPAA law for the protection and confidentiality of protected
health information. If there are any questions about the MSU HRPP please contact Peter
Vasilenko, PhD, the Director of the MSU Human Research Protection Programs at 517-
355-2180 or irbchair@ores.msu.edu.
E. 3. Potential Benefits of the Proposed Research to the Subjects and Others

The potential benefit to the participants is the possibility that they may find it
helpful learning how to best prevent occurrence/recurrence of coronary heart disease by
improving the rate of use of evidence-based medications, maintaining healthy lifestyle
and improving their self-management skills. The research may lead to learning better
ways of improving secondary prevention of coronary heart disease for AA and low socio-
economic status populations within primary care.
E. 4. Importance of the Knowledge to be Gained

It is hoped that knowledge gained from the patients and providers’ participation in
the proposed project will assist in the development of decision support tools that will be
adaptable for use within primary care. This is likely to enhance adherence to evidence-
based treatment recommendations for Afiican Americans and low socio-economic status

populations in primary care. Elements of the proposed system can be applied to the

81

treatment of other chronic diseases. In addition, the program provides an opportunity to
collect essential descriptive data about where problems occur in the system and the roles
of patients and providers in creating and eliminating problems. We are confident that the
possible benefits of this research clearly outweigh the risks to subjects.
E. 5. Collaborating Sites

None.
E. 6. Women and Minority Inclusion

This project will include both men and women. About 52% of patients that attend
Ingham County clinics are women. We anticipate that this proportion will be reflected in
our recruitment of subjects. This study is specifically for AA and low-income
populations; we anticipate the enrollment of the minority population, the elderly and

patients with chronic illnesses.

82

Table 2. Targeted/Planned Enrollment Table

This report format should NOT be used for data collection from study participants.

Study Title: Improving Secondary Prevention of Coronary Heart Disease

Total Planned Enrollment: 182

 

TARGETED/PLANNED ENROLLMENT: Number of Subjects

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Ethnic Category Sex/Gender
Females Males Total

Hispanic or Latino 8 9 17
Not Hispanic or Latino 93 72 165
Ethnic Category: Total of All Subjects * 101 81 182

Racial Categories
American Indian/Alaska Native 1 0 1
Asian 5 3 7
Native Hawaiian or Other Pacific Islander 0 0 0
Black or Afiican American 46 38 84
White 50 40 90
Racial Categories: Total of All Subjects * 101 81 182

 

 

 

 

 

 

* The “Ethnic Category: Total of All Subjects” must be equal to the “Racial Categories”

 

83

E. 7. Inclusion of Children

Children will not be included as this study pertains to patients with CHD and
Diabetes who are aged 18 or older.
E. 8. Priority Populations

This entire project focuses entirely on priority populations. African American
and low socio ~economic status populations are the focus of this research. The elderly and
patients with chronic illnesses are included. Our study populations are patients with

history of previous M1 or CAD and patients with diabetes.

84

F. VERTEBRATE ANIMALS

Not applicable.

85

G. SELECT AGENT RESEARCH

Not applicable.

86

APPENDIX A: RESOURCE SHARING PLAN

Data Sharing Plan
While the proposed work does not request greater than $500,000 in any year, and does

not propose to develop a model organism, we expect to share all data generated by this
proposal as follows:
Presentations at regional and national meetings:

From the project it is expected that approximately four to six presentations will be
generated during the research project. The PI will submit abstracts of the initial findings
and data analysis at the regional and national meetings of the Society of General lntemal
Medicine. This meeting is designed and implemented to meet the educational and
professional needs of the primary care general internist community. The meeting offers
an unparallel opportunity to network with the community of scholars devoted to primary
care internal medicine and research. The PI will also submit her work at the Society of
Medicine Decision Making and Annual meeting of the American Heart Association.
Annual Meeting of the Training Clinical Researchers in Community Settings
(TRECOS)

TRECOS is MSU’s NIH K30 program that provides training for community physicians.
The TRECOS program conducts a one-day meeting of all current and past TRECOS
fellows from MSU. During the meeting, fellows present their ongoing projects for
evaluation and feedback. Fellows interact with other colleagues and the Board of
Directors of the program. The PI is a TRECOS fellow and will present the results of her

findings during the annual meeting throughout the five years.

87

In addition, if our decision supports tools are successfully implemented in the
outpatient setting, we will plan to publish our findings in J. Gen Intern Medicine, Annals
of Intern Med, and Health Services Research. In addition, we will share these tools
directly with other practices. Since our work will be conducted in Community Health
Center (CHC) settings, our first dissemination effort will take place in other CHCs,
serving low-income and minority populations. The Michigan Primary Care Association
(MPCA) is the professional association of CHCs in Michigan. We will work through the

MPCA to make these tools available and to plan for evaluating them further.

88

APPENDIX B

 

N I v
E R 5 IT Renewal
Appllcatlon
somw 16.2006 'Prellmlnary
T0! Adesuwa OLOMU Approva|
83290llnlcal Ctr.
Re: lneaowso .Cafeoory': PRELIMINARY PRELIMINARY

Renewal Approval Date: September 16. 2006
W Explretlon DI“: WW 14. 2007

TIIIe: IMPROVING SECONDARY PREVENTION OF CORONARY HEART DISEASE

ThelnelltufionalRevlewBoardhascompletedthelrrevlewofyourprolect. lampleaeedtoadvlaeyouthatthe
renewalforPlelllnlnaryApprovalhaaheenapproved.

PrellmlnaryApprbvalanwshvesfigatoretoopenfireeronu'actaandGrantaaccountandependtundsfor
madame.dewbpumymuumnhwpmceduea.umwbemededtoeubmfiwmhomnba

'appllcatlons

Under Prellmlnary Approval you cannot contact human eublecte or collect data from them. Prlor to
lrnplementatlon of the reeeerch, the lnveetlgator must eubrnlt a complete Appllcatlon fer Initial
Review for approval.

Renewals: lRBapprovallevallduntlltheexplratlondatelstedabove. lfyouwlshtocontlnuePrellmlnary
Approvalolyourpmlecl. youmustsubmfianAppllcadonforRenewalatleaetonemonthbeforeexpfiefion.
lltheplellmlnatyepprovallsnolongerrequlredandyoudonotplantcsubmltanhlfialappficefion. please
eubmlt an Application for Permanent Closure.

Whenyousubrnlaeubsequentapplcatlon. pleaseusethelRBnumberlletedabove.evenlnanewlnltlal
Applcatlo'n. AlsorebrtothatnumberlnanyconeepondencewlththelRBoffice.

'Goodluckwllhyourpmlect. llwecanbeofturtherasslstance. pbaseccntactusat517-355-21800rvlaelnall
at lRBOmeu. edu. Thank you for your cooperatlon. .

3W.
#444

Peter Vaallenko. mo.
BlRB Chair

C: Margaret HOLMES-ROWER
C 203 E. Fee Hall

89

APPENDIX C

Physician Participatory Decision Making (PDM) Style questionnaire

 

Physician Participatory Decision Making (PDM) Style

“People who are experiencing depression symptoms may
be considering various options for what to do. If anything,
about managing or taking care of their symptoms. Thinking
about your past exgrience with your health care provider:
if there was a choice between treatments for your
depression symptoms:

 

“Would your health care provider ask you to help make the
decision?”

 

o Read the response options to the participant. C] Definitely no
0 A participant may indicate that slhe has more than one D Probably "0
health care provider. As the participant to answer the 1:] Maybe
questions for the health care provider who D Probably yes
suggested/prescribed treatment, or would be most likely [:1 Definitely yes
to do so. Make a note here of who the participant is [I Don’t know
making the ratings for, i.e., “primary care doctor,” “nurse 1:] Refused
practitioner,” etc.
“How often does your health care provider make an effort [I Never
to give you some control over your treatment?” [:1 Seldom
I] Sometimes
E] Often
I] Very often
I] Don’t know
[I Refused

 

 

“How often does your health care provider ask you to take some
of the responsibility of your treatment?”

0 If the participant asks what “taking responsibility" means,
examples of the HOP asking the patient to assume roles
in “carrying out” treatment can be given (examples
should be tailored to the history of treatment the patient
has already provided, if possible). For example, HCPs
may ask patients to follow through with taking prescribed
medications, record response of symptoms to prescribed
treatments, report new symptoms, openly discuss with
the HOP beliefs about possible causes of symptoms,
etc. One or two examples that the patient may have
already mentioned can be used.

 

 

90

 

Project Timellne

APPENDIX D

The major tasks for the proposed research will be scheduled over 5 years as follows:

Actlvltles

Year 1

Year 2

Year 3

Year 4

Year 5

 

 

Training

Principal Investigator

Chart Abstractorisesearch
Assistants

Preparation of Instruments
Focus Group Questions
Chart Abstraction Tools
Reminder System

Patient/Physician/Support Person _

Training Modules

Decision Support Tools (DSTs)
Focus Groups

Patient Focus Groups

Pilot Instruments (DSTs)
Refine Instruments

Pt Recruit/Data Collection
Intervention group

Chart Abstraction

Data Handling

Focus Group Transcription
Data Entry and Cleaning
Data Analysis

Ending

Post Program Questionnaire
Prepare Abstracts for
Presentation

Prepare Manuscripts
Prepare R01 Grant

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

91

 

 

 

 

APPENDIX E

Training in the Responsible Conduct of Research

The Nature and Practice of Scientific Integrity
Spring Semester 2005

Beginnings:
o Integrity in research and scholarly activities: an educational imperative
0 Introduction, Overview, and “The Issues”
US Support of Science and Technology
0 US public support for research & development, including education and
training
0 Academic Freedom and National Security in a Time of Crisis
Strategic Planning & the Future of Science
0 The US Federal Budget Process
Lapses in the Name of Science
0 Significant Examples
0 Whistleblowing
Modern Science — Relevance, Meanings & Purpose
0 The Beneficiaries of Science & Technology — To Share or Not to Share
The Practice of Science
0 Program Planning & Proposal Writing
0 The NIH Process
0 The Human Subjects Process at MSU
Responsible Conduct of Science
0 Research Initiatives Requiring Institutional and/or Federal Review &
Approval: Can Scientists do Whatever They Want?
The role of the IRB in the human subject process
Research in International Settings
The Role of the IACUC in the Animal Subject Process
Scientific Misconduct; Integrity in the Research Record: Laboratory
Notebook & Data Management; Quality Control
0 Conflict of Interest; Objectivity in Research
0 Publication Practices & Responsible Authorship
o What is Science? Analogies from the Law
In-Class Mock Review Boards
0 Humans
0 Animals

0000

92

APPENDIX F

American College of Cardiology Foundation, Guidelines, Applied in Practice, Acute
Myocardial Infarction - Heart Attack Discharge form

OFFICE GAP PROJECT

HEART ATTACK PREVENTION CONTRACT
To decrease my risk of having a heart attack, I need to do the following:

I. TAKE MEDICINE. I understand that there are certain mediations which
may help to prevent a future heart attack and may help to extend my life.

 

[I Yes
a. Aspirin mg daily D Does not apply to me because:
b. ACE inhibitor El Yes

D Does not apply to me because:

 

A measure of how well my heart is pumping is my ejection fraction.

 

My ejection fraction = %. D I do not know my ejection fraction.
1:] Yes
c. Beta blocker D Does not apply to me because:
d. Cholesterol lowering CI Yes

C] Does not apply to me because:

 

My cholesterol values are as follows:

Total Cholesterol (TC) = (goal: less than
200)

Low Density Cholesterol (LDL) = (goal: less than
100)

High Density Cholesterol (HDL — good cholesterol) = (goal: between 40-
96)

D Yes
Sublingual nitroglycerin tablets [:I Does not apply to me because:

 

 

93

QUIT SMOKING. I understand that smoking increases my chances
of suffering from a future heart attack and that smoking causes other
illnesses which may shorten my life.

I smoke and have been counseled to stop. [:I Yes
E] [do not smoke.

I will stop smoking by (date) . D I am not ready to stop smoking yet.

I have been given medication to help me stop:

 

. Referral to smoking cessation classes: Call: at phone

 

 

 

EAT A LOW-FAT DIET. I understand that a diet that is low in
cholesterol and fat may help to reduce my chances of suffering a future
heart attack.

 

a. l have received counseling about a low fat diet. I] Yes

D No

[I Does not apply to me because:
b. Nutrition Services Contact: Call at phone

 

 

 

4.

EXERCISE REGULARLY.
a. I have received activity instructions. D Yes
I] No
b. I walk, jog, or run at least 40 minutes to 1 hour, 5 to 6 times a week D Yes
E] No
c. I have received information regarding exercise opportunities in my community. El Yes
D No

 

94

5. LEARN ABOUT HEART DISEASE.

 

 

 

a. I have seen the video on heart disease prevention D Yes
I] No
b. I have received cardiac education (office GAP) booklet in the mail. [:1 Yes
E] No
c.. I have received instructions on how to use my medications at home. I] Yes
I] No
6. FOLLOW UP WITH MY PHYSICIAN.
a. I have a follow-up appointment made with my physician. [3 Yes
D No
I] Does not apply
b. The number to call if I have not received a follow-up
appointment in 2 weeks is -
Nurse/Physician Signature / Date: Patient Signature / Date:

 

 

95

APPENDIX G

FIMDM GUIDEBOOK “LIVING WITH CORONARY ARTERY DISEASE:

DOING YOUR PART”

 
  
  

     
   
 

    

Tiff a:

mi

‘:._~_§-o,r',.ii;tf-”~ .. ‘
Living With

Coronary Arte

A Shared Declalon-llaklnu’ Program

l The Foundation for
Informed Medical Declslon Making

Whale "'.. ““"‘_‘“‘ “ ,’

{ naszcopyrlditprotadadbyTlnFoumonlorlrlomed

l WDaclslmMaklnngaldlorHadterlalogecllsM

l monounsatmummm

I parlounorfiplayllisprwanbralanoummtmodtytha
motelouxwmynotrenmorddammyldnlsormtlms
Mhhmm

96

 

 

. Table of Contents

About This Program ...................... 1
Shared Decision-Malling .................. 3
Coronary Artery Disease .................. 4
Managing Coronary Artery Disease ........... 5
How Medications llelp ................... 10
Managing Cholesterol ................... 14
Controlling Blood Pressure ................ 19
Quitting Smoking ....................... 20
Managing Exercise and Stress .............. 21
'wmrs In II tor You? .................... 23
What’s Best for You? .................... 25
Medical Terms ............... q .......... 27
Common Heart Medications ............... 30
Resources ........................... 32
References ........................... 34

97

About This Program

This program is intended for people with coronary artery disease. If you have had a heart
attack, experienced episodes of angina, or have had a procedure such as angioplasty or
coronary bypass surgery, this video program and booklet contain information that may be
valuable to you.

This program is go; intended for:

0 People with congenital heart disorders

0 People with heart valve disorders

0 People with cardiomyopathy

0 People with congestive heart failure not due to coronary artery disease
0 Pregnant women

This booklet summarizes the information presented in the video. In addition, the booklet
contains many of the numbers that summarize the benefits of medication and lifestyle
changes so you can take time to review them.

This program is intended for your individual use as part of a multi-faceted Shared
Decision-Making® (SDM) support system provided by Health Dialog through your
health service. SDM programs are designed to support an informed dialog with your
doctor as you work together to make important decisions about your healthcare.

98

SDM programs are based on medical evi-
dence researched and evaluated by the
Foundation for Informed Medical Decision
Making. The programs are regularly reviewed
to ensure they contain the most current and
accurate information, and each program is
updated as necessary. If you have received
this program from a source other than your

health service, it may be out of date and
should not be used.

Information on Health Dialog program edi-
tions and updates can be found on our Web

site—www.healthdialog.com—or you may call
800-966-8405.

Please use the product number located on
the videotape label for all inquiries.

99

Shared Decision-Making

Making decisions about how to manage coronary artery disease can be challenging.
Depending on the specifics of your case, you may be asked to consider making a lot of
changes to your lifestyle. Decision which of these changes make sense and
understanding how they may benefit you will take time and effort.

The choices you make about smoking, diet, exercise, and managing stress as well as
taking medications can significantly affect your risk for future heat attacks and death.

But all of these choices involve tradeoffs. The decisions you make will probably depend
on how you feel about those tradeoffs and how much risk you are willing to live with.

Although many people believe their doctors should decide which choices are right, you
own point of view is very important. Once you understand these choices, you and your
doctor can make decisions together. If you do this, you may be more satisfied with your
decisions and the outcomes of your treatment.

This approach is called shared decision-making.
Coronary Artery Disease

Coronary artery disease results when deposits (called plaque) made up of fat, cholesterol,
and calcium build up in one or more of the coronary arteries, which supply blood to the
heart muscle itself. Although you can’t see this happen, you can sometimes feel what it
does to your heart. Plaque can narrow the arteries and interfere with the heart’s supply of
blood and oxygen. This can cause symptoms, called angina, such as chest pain or
discomfort, or pain or pressure in the arm, shoulder, or neck.

100

Heart and Coronary Arteries

 

   
 
 
 
  
 
  
       

Lelt Main

Coronary Coronary Artery
Artery

Clrcumtlex

Artery

Left Anterior
Descending
Artery

 

 

The coronary arteries supply the heart muscle with blood and
oxygen. Plaque can build up inside the arteries

101

Angina sometimes comes on predictably, such as when you climb a flight of stairs or
when you are emotionally upset. Resting or taking prescribed medications often relieves
it. But if angina pain is new or different, or if it doesn’t respond to rest and medication as
it has in the past, it can signal a major heart event, such as a heart attack.

Not everyone has the same symptoms of angina, so it’s important that you know how to
recognize and respond to your heart symptoms. Your plan might include taking
medications, calling your doctor, or calling emergency medical services. Being prepared
will help build your confidence and lower your anxiety.

If the blood flow through a coronary artery is completely blocked, it can cut off the
supply of blood and oxygen to a portion of the heart muscle. This is called a heart attack.

Complete Blockage

    

Some heart attacks occur when a large plaque
completely blocks a coronary artery.

102

Scientists used to believe that most heart attacks happened when a large plaque
completely blocked blood flow in a coronary artery. But not all plaques are alike. In
fact, it now appears that large plaques are responsible for only about 15% of heart
attacks.

Many heart attacks involve a different kind of plaque. In these cases, it’s not the size of
the plaque that’s the main problem, but rather its tendency to break open or rupture.
When this happens, even if the plaque is small, it can trigger a blood clot that causes a
heart attack. Our new understanding of these “unstable” or “vulnerable” plaques helps
explain why some heart attacks occur in coronary arteries that are only partially narrowed

by plaque.

    

Many heart attacks occur when a plaque of any
she breaks open (ruptures), causing a blood
clot that blocks an artery.

103

Doctors have increasingly focused their
attention on plaque—why it builds up, how
it behaves, and how to control it. There are
many different ways to reduce or slow down
the buildup of plaque. Controlling choles-
terol is one important way. Medications
help, and so do a healthy diet and regular
exercise.

104

Manafl' g Coronagy Artery Disease

Living with coronary artery disease often means taking medications and changing some
parts of your lifestyle. What is the goal of these lifestyle changes?

Relieve symptoms

Reduce risk of heart attacks and death

Reduce need for procedures such as angioplasty or bypass surgery
Reduce need for medications

Prolong life

Many people have procedures such as angioplasty or bypass surgery to treat their
coronary disease. But although these procedures help relieve symptoms, prevent heart
attacks, and may prolong life, they do not address the underlying problem. Fortunately,
medications and lifestyle changes do. In fact, one of the most effective ways to control
coronary artery disease is to live a “heart-healthy” lifestyle. That means:

Taking prescribed medications
Lowering cholesterol
Controlling blood pressure
Quitting smoking (if you smoke)
Getting regular exercise
Reducing stress

Each of these lifestyle changes can help you feel better or live longer - or both. But they
can present challenges for some people.

How Medications Help

Medicines are very helpful for managing coronary artery disease. Some medications
relieve symptoms or help reduce blood pressure or cholesterol. Others help stabilize
plaque or prevent blood clots. Some medications have multiple benefits. The list at the
back of this booklet includes some common heart medications, but it’s not a complete
list. Depending on your situation, you may be taking one or more of these medications,
or others that are not listed.

Many medications have possible side effects. Not everyone has side effects, but they can
be bothersome for people who have them. It’s important to know that if a medication
causes side effects, your doctor can often prescribe a different one. Don’t stop taking any
medication without talking with your doctor, and tell your doctor about any bothersome
symptoms that start soon after you start taking any medication. Some medications have
rare but serious side effects, so make sure you know what to watch for.

ACE inhibitors

0 Lower blood pressure

105

o Stabilize plaque
0 Help prevent heart attacks

In addition to lower cholesterol, statins have other benefits. They help make plaque
smaller and less likely to break open (rupture), which helps lower the chance of heart
attack. In fact, statins can lower the risk of heart attack and deaths related to coronary
artery disease by 24 to 30 percent, or even more in some people.

A Common Misconception
Taking a cholesterol-lower medication does not make it “ok” to eat unhealthy foods.

People taking statins still need to stick to a heart-healthy diet of lean meats,
vegetables, fruits, and whole grains.

Possible side eflects:
0 Dry cough
0 Dizziness
o Diarrhea

Angiotensin receptor blockers (ARBs)

0 Lower blood pressure
0 Help prevent heart attacks

Possible side eflects:

- Dizziness or lightheadedness
o Headache, muscle aches, back pain
0 Cough, congestion, runny nose, sore throat

Beta blockers

0 Lower blood pressure
0 Slow heartbeat and help prevent irregular heartbeats
0 Help prevent heart attacks

Possible side efibcts:

Fatigue

Depression

Reduced sex drive

Impotence (erectile dysfunction)
Cold hands and feet

Shortness of breath

106

e Vivid dreams
0 Difficulty sleeping

Calcium channel blockers
0 Lower blood pressure
Possible side efihcts:

Ankle swelling
Constipation or diarrhea
Headache

Dry mouth

Flushing, feeling warm

Fibrates or fibrinic acid

0 Lower cholesterol
0 Increase “good” or HDL cholesterol

Possible side eflects:

o Nausea or diarrhea
0 Stomach pain, gas, or heartburn

Aspirin or other platelet inhibitors
0 Help prevent blood clots and heart attacks

Possible side eflects:

o Stomach pain or heartburn
0 Headache, muscle aches, or back pain
0 Bleeding (occasionally serious)

Nitrates

- Improved blood flow to heart
0 Relieves symptoms

Possible side eflects:

e Headache
o Dizziness or lightheadedness
o Flushing of face and neck

107

Statins

0 Lower cholesterol
0 Stabilize plaque
0 Help prevent heart attacks

Possible side effects:

0 Muscle and joint pain
0 Stomach pain, heartburn, or nausea
o Constipation or diarrhea

Manam‘ g Cholesterol

Cholesterol is a natural substance found in the blood stream. The liver normally creates
all the cholesterol the body needs. Certain kinds of foods high in saturated fats, however,
can significantly increase cholesterol levels. Too much cholesterol in the blood
contributes to the buildup of plaque in the coronary arteries.

Doctors measure cholesterol with a blood test called a “cholesterol” or “lipid” profile.
The types of cholesterol are referred to by their initials:

0 LDL stands for low-density lipoprotein cholesterol.
0 HDL stands for high-density lipoprotein cholesterol.

LDL is the bad cholesterol. HDL is the good cholesterol. Triglycerides are another
type of fat found in the blood.

Recommended cholesterol targets for people with coronary artery disease are:

Total cholesterol: below 200.

LDL (bad) cholesterol: less than 100 (a goal of less than 70 may be reasonable
for some people at very high risk).

HDL (good) cholesterol: above 40 (higher is better).

Triglycerides: less than 150.

Managing cholesterol means reaching your target cholesterol numbers for LDL and HDL
cholesterol and for triglycerides. Not everyone with coronary artery disease has high
cholesterol or high triglycerides, but if you do, there is a lot you can do to help improve
your numbers. Diet and exercise can help, but most people whose LDL cholesterol is
higher than 129 also need medications to reach their target of 100 or lower.

108

What kind of diet helps lower cholesterol?

0 Low in total fat (less than 30% of daily calories), saturated fat (less than 7% of
calories), cholesterol (less than 200 mg per day), and trans-unsaturated or trans
fats (found in partially hydrogenated oils).

0 High in soluble fiber (10 to 25 grams per day) from vegetables, fi'uits, beans
(legumes), oat bran and whole-grain cereals, breads, and pastas.

o Replaces butter or margarine with polyunsaturated or monounsaturated oils
(such as canola, flaxseed, olive, and safflower oils) or with margarines or
spreads that contain plant sterol ester (1.3 grams per day) or stanol esters (3.4
grams per day).

Read labels carefully on “diet” foods. Some may be low in fat but contain a lot of sugar
and just as many calories per serving as the regular food. Extra calories from sugar can
be a particular problem for people who are trying to lower their triglycerides, and for
people with diabetes who need to manage their blood sugar levels.

What kinds of foods should you avoid, or enjoy only once in a while, in small portions?
Those that are high in saturated fat, such as:

Fatty meats, such as sausage and cold cuts

Fast food sandwiches

Fried foods such as French fries or fiied chicken
Baked goods such as donuts, cookies, cakes, and pies
Cheese, cream, butter, and ice cream

Diet and Your Heart

There’s intriguing evidence that certain dietary patterns, such as diets that include more
vegetables, fruit, fish and olive oil, may dramatically reduce the risk of certain fatal heart
attacks. In particular, eating two servings per week of fish that contains omega-3 fatty
acids, such as salmon, trout, mackerel, and albacore tuna, has been strongly linked to a
lower risk of death in people who have had heart attacks. And in at least one study, fish
oil supplements (about 1000 mg per day) also helped prevent certain heart-related deaths.
Other good sources of omega-3 fatty acids include flaxseed oil and walnuts.

Alcohol in Moderation

If you already drink, you will be happy to know that for many people, moderate drinking
has heart benefits. But if you have high triglycerides, it’s usually recommended that you
avoid alcohol. People with heart failure also need to avoid alcohol because it can
decrease the heart’s pumping function. Drinking too much can contribute to other health
problems, too. So, moderation is important, which means no more than one ounce per
day for men and 0.5 ounce per day for women and lighter weight men. Take time to find
out if alcohol is safe for you and your heart.

109

Exercise and Cholesterol

Exercise can help increase HDL (good) cholesterol levels. It also helps lower blood
pressure, helps maintain a healthy body weight, and many people find it helps them
manage stress.

Cholesterol-Lowering Medication

Some people can’t reach their target cholesterol levels with diet and exercise alone.
Medications called statins are often prescribed to further reduce cholesterol levels. Other
medications, such as fibrates or nicotinic acid may be prescribed for some people, either
instead of or in addition to statins.

Controlling Blood Pressure

Blood pressure is the amount of force your bloodstream exerts against the walls of your
blood vessels. Over time, if high blood pressure (hypertension) goes untreated, it can
harm the heart and blood vessels, which increases the risks of coronary artery disease.

What should your blood pressure goal be?

0 Less than 140/90, if you have coronary disease
0 Less than 130/80, if you have diabetes

Regular exercise is one of the most effective ways to lower blood pressure. For some
people, daily exercise may be as good as medication for lowering blood pressure. But
many people also need medications. ACE inhibitors, beta blockers, and calcium channel
blockers, as well as other medications, help lower blood pressure. Some of these
medications have other benefits, such as helping to stabilize plaque. ACE inhibitors and
beta blockers can reduce the risk of heart attack and death fiom coronary artery disease
by about 25% or more in some people.

Quitting Smoking

If you smoke, quitting is one of the best ways to reduce your risk of future heart
problems. People with coronary disease who continue to smoke face a much higher risk
of heart attack and other heart problems. Within about a year of quitting smoking, heart
risks drop by about 50%.

Now, maybe you’ve tried to quit smoking before. Most people try several times before
they succeed. Here are some proven ways to help you quit:

a Nicotine replacement therapy — the nicotine patch, chewing gum, lozenges, or

nasal spray
o Prescription medication called buproprion (Zyban)

110

Up to 30% of people who use these methods while taking part in support groups are
successful at quitting smoking.

Managm’ g Exercise and Stress

Daily exercise is one of the most important lifestyle changes for people with coronary
artery disease. Getting 30 minutes of exercise most days of the week can help lower
blood pressure, keep weight within a healthy range, and relieve stress.

The best place to begin an exercise program is under the guidance of coronary disease
specialists, such as the nurses and providers at a cardiac rehab or wellness program.

There are many different ways to fit exercise into your life. A brisk walk, gardening or
yard work, dancing and other activities that you might already do also count as exercise.

Stress

Exercise also helps relieve stress. Stress doesn’t cause coronary disease but it does affect
the body in ways that can make it harder to manage. It can increase stress hormones that
affect the heart and blood vessels, increase blood pressure, make the heart work harder,
and may even affect cholesterol levels.

There are many stress — reduction techniques. Here’s one of the easiest.

Sit or lie with a pillow at the small of your back.

Breathe in or out slowly, pushing your belly out as you breath in.
Exhale slowly, and let your belly relax.

Repeat 10 times with slow, deep breaths.

Practice several times a day.

What’s in it for You?

So, what’s in it for you? How much benefit might you get fi'om taking medications,
managing your cholesterol and blood pressure, quitting smoking, or exercising regularly?
In part, it depends on your risk of future heart problems, such as heart attack, heart
failure, or needing a procedure such as angioplasty or bypass surgery. And that risk
depends on a number of things:

You’re at higher risk if:

0 You have had one or more heart attacks, especially if a previous heart attack
damaged a lot of heart muscle

0 You have diabetes or heart failure

11]

You’re at lower risk if:

0 You have not had a heart attack, or a previous heart attack did not damage a lot of
heart muscle

0 You do not have diabetes or heart failure

If you’re at higher risk, you have more to gain. If you are at lower risk, your benefit will
be smaller. In either case, what’s in it for you also depends on how you feel about the
tradeoffs involved in making changes. In the tables on page 113, you can review the
numbers for people at high and low risk of future heart problems. The darker grey part of
the bars show how many people will have a heart attack or die of heart-related causes
within 5 years. The lighter grey shows how many people will not.

Whether you are in the higher-risk group or the lower-risk group — or somewhere in

between — you can reduce your chance of firture heart problems. But you have more to
gain if you are at higher risk to start with.

112

Chance of Heart Attack or Heart-Related Death

Within 5 Years (%)
Effect of Medications and Lifestyle Changes
(Exercise, Healthy Diet, Quitting Smoking)

 

20 40 60 80
High-Risk People

Chance of Heart Attack or Heart-Related Death

Within 5 Years (%)
Effect of Medications and Lifestyle Changes

1 medication
2+ medications

exercise

+ medications

100

 

20 40 60 80
Low-Risk People

113

100

What’s Best for You?

How much you stand to gain also depends on what’s important to you, and what tradeoffs
you are willing to accept now in exchange for possible benefits in the future. Everyone’s
different.

For some people, the right choice means making all the changes mentioned in this
booklet and video. For others, it means making only those changes that make sense to
them. Some people have an easy time making changes. Others find it more difficult.
Changing habits such as what you eat, how much exercise you get, and whether you
smoke can be challenging. Medications sometimes have bothersome side effects, and
remembering to take them every day is hard for some people.

Is it worth it to you to give up some things you enjoy, or do some things you may not
enjoy, so that you can live a healthier or longer life? Your doctor would probably say
“yes”. Doctors feel strongly about lifestyle changes, because every day they see the bad
things that can happen to people who have coronary disease. But you are the one who
has to make the choices every day — to take the medication, choose healthy foods, avoid
cigarettes, or find time to take a walk. So, you have to decide if it is worth it to you. Be
honest with your doctor about what you are willing to do, and explain why.

Once you’ve decided which changes are right for you, look for resources that can help
you succeed. The Internet is a good source of information, and some helpful Web sites
are listed at the end of this booklet. Your doctor and other healthcare professionals, such
as cardiac rehab specialists, can also recommend tools and techniques that can help you
get started and help you stay on track.

One final note: You can’t control everything about coronary disease even if you make all
the changes in this program. People who do all the “ri t” things can still have heart
attacks or need heart procedures - in fact, you probably know someone like that. If it
happens to you, it doesn’t mean you failed. The important thing is that you don’t give up
on living a heart-healthy life.

114

Medical Terms

ACE Inhibitors: Medications that lower blood pressure and help stabilize plaque in the
coronary arteries.

Angina: Pain or pressure in the chest, arms, shoulder or jaw, often during exercise or
emotional stress. Angina is a symptoms of coronary artery disease. It’s caused by
reduced blood flow to part of the heart muscle.

Angioplasty: A catheter procedure that compresses plaque against the wall of a coronary
artery.

Angiotensin-II Receptor Blockers (ARBs): Medications that lower blood pressure
through the cardiovascular and renal systems by affecting salt and water balance.

Arrhythmia: Irregular heartbeat.

Beta Blockers: Medications that lower blood pressure and help prevent irregular
heartbeats.

Blood Clot: Blood clots normally help stop blood loss due to injury. A clot that occurs
in a coronary artery can cause a heart attack.

Blood Pressure: The pressure of blood against the walls of the arteries. Systolic blood
pressure is the amount of pressure when the heart pumps. Diastolic blood pressure is the
amount when the heart is at rest between beats.

Bypass Surgery: See Coronary artery bypass surgery.

Cholesterol: A type of fat fond in the blood stream. High cholesterol levels can
contribute to the buildup of plaque and increase the risk of coronary artery disease.

Cholesterol Profile: A report on the levels of various types of cholesterol and
triglycerides in the blood. Also called lipid profile.

Coronary Artery Bypass Surgery: An operation that takes healthy blood vessels fiom the
leg or chest to reroute blood flow around portions of the coronary arteries that are
blocked or narrowed by plaque.

Diabetes: A chronic disease that occurs when blood sugar levels are too high. Diabetes
increases the risk of coronary artery disease.

HDL (High-Density Lipoprotein) Cholesterol: The “good” or protective cholesterol.
HDL levels above 40 are desirable.

115

Heart Attack (Myocardial Infarction or MI): Heart attacks occur when blood flow to a
portion of the heart muscle is complete blocked by ruptured plaque and/or a blood clot.

LDL (Low-Density Lipoprotein) Cholesterol: The “bad” cholesterol. High levels of
LDL cholesterol increase the risk of heart attack. LDL levels below 100 are desirable for
people with coronary disease.

Lipids: See Cholesterol.

Plaque: A buildup of calcium, and other substances within the walls of an artery. Plaque
in the arteries that supply blood to the heart is called coronary artery. Plaque can also
buildup in other arteries such as those in the legs and pelvis.

Platelets: A particle in the blood that is involved in forming blood clots. Some
medications act on platelets to help prevent blood clots that can cause heart attacks.

Saturated Fats: A type of fat the body converts into cholesterol.

Side Effects: A secondary, usually unwanted effect or symptom caused by a medication
or treatment.

Statins: Medications that lower cholesterol levels and help stabilize plaque. Statins help
prevent heart attacks.

Stress: Any emotional or physical factor that causes tension.
Trans Fats: A type of dietary fat that increases LDL cholesterol levels.

Triglycerides: A type of fat found in the blood stream. Triglyceride levels below 150 are
desirable.

Unstable Plaque: A type of plaque that has a tendency to break open or rupture, which

can trigger a blood clot and cause a heart attack. Medications such as ACE inhibitors and
statins help stabilize plaque.

116

Conner llaartMedlcatloas

 

ACE inhibitors

Angiotensin
receptor

Beta blockers

30 HeeltlIDlaiog

Accupril (quinapril)
Aceon (perindopril)
Altace (ramipril)
Capoten (captopril)
Lotensin (benazepril)
Mavik (trandolapril)
Monopril (fosinopril)
Prinivil (Iisinopril)
Univasc (moexipril)
Vasotec (enalapril)
Zestril (Iisinopril)

Atacand (candesartan)
Avapro (irbesartan)
Benicar (olmesartan)
Cozaar (losartan)
Diovan (valsartan)
Micardis (telmisartan)
Teveten (eprosartan)

Betapace (sotalol)
Blocadren (timolol)
Cartrol (carteolol)
Coreg (carvedilol)
Corgard (nadolol)
Inderal (propranolol)
Kerlone (betaxolol)
Levatol (penbutolol)
Lopressor (metoprolol)
Normodyne (labetalol)
Sectral (acebutolol)
Tenormin (atenolol)
Toprol (metoprolol)
Trandate (labetalol)
Visken (pindolol)
Zebeta (bisoprolol)

117

Calcium channel
blockers

Fibrates or

fibrinic acid

Platelet inhibitors

Nicotinic acid

Nitrates

Statins

31 Cannon Head Medications

Adalat (nifedipine)
Calan (verapamil)
Cardene (nicardipine)
Cardizem (diltiazem)
Covera (verapamil)
Dilacor (diltiazem)
Diltia (diltiazem)
DynaCirc (isradipine)
Isoptin (verapamil)
Norvasc (amlodipine)
Nimotop (nimodipine)
Plendil (felodipine)
Procardia (nifedipine)
Sular (nisoldipine)
Tiazac (diltiazem)
Verelan (verapamil)

Clofibrate
Lopid (gemfibrozil)
Tricor (fenofibrate)

Aggrenox (aspirin 8c
dipyridamole)
Aspirin (many brands)

Clopidogrel (Plavix)
Niacor (niacin)
Niaspan (niacin)

Imdur (isosorbide)
Ismo (isosorbide)
Isordil (isosorbide)
Nitro-Dur (nitroglycerin)
Nitrostat (nitroglycerin)

Crestor (rosuvastatin)
Lescol (fluvastatin)
Lipitor (atorvastatin)
Mevacor (lovastatin)
Pravachol (pravastatin)
Zocor (simvastatin)

118

 

American lleart Association National Center

W
7272 Greenville Avenue

Dallas, TX 75231
l-800-AHA-USA-l
(214) 373-6300 or contact your local chapter.

The American Heart Association provides
print, video, and Web-based materials on all
aspects of coronary artery disease. Some
materials are available in Spanish.

Mended Hearts is a support organization
affiliated with the American Heart
Association. Local chapters provide help,
support, and encouragement to heart disease
patients and their families.

llallonal llearl, Lang, and Blood Institute (liiiLDI)
l I] . 'l

The NHBLI Web site provides information
on coronary artery disease, including high
blood pressure, cholesterol, exercise, heart-
healthy eating, and weight control. Some
materials are available in Spanish.

32 HealtlIDlalog
119

FDA lleart Health Site
mfdaacrthcmhcalth

This site provides information about prod-
ucts used to prevent, diagnosis, and treat
coronary artery disease.

Check with your doctor for resources other
than those listed above.

33 Resources
120

 

 

lletereaces

 

Andthrornbotic Mallow Collaboration. Collaborative
meta-analysis of randomised trials of antiplatelet therapy
for prevention of death, myocardial infarction. and
stroke in high risk patients. BM] 2002; 324:71-86.

Arena-Pacheco C, Parrott MA, Raekin P. Hypertension
management in adults with diabetes. Diabetes Care 2004;
27 Suppl 1:865—7.

Cannon CP, Braunwald E, McCabe CH, et al. Intensive
versus moderate lipid lowering with statins after acute

coronary syndromes. New England journal of Medicine
2004; 850:1495—1504.

De Lorgeril M, Salen P, MartinJL, et al. Mediterranean
diet, traditional risk factors, and the rate of cardiovas-
cular complications after myocardial infarction: final

report of the Lyon Diet Heart Study. Circulation 1999;
99:779-85.

Ebrahim S, Smith GD. Lowering blood pressure: a sys-
tematic review of sustained effects of nonopharmacolog-

ical interventions. journal of Public Health and Medicine
1998; 20:441-8.

Falk E, Shah PKI, Fuster V. Coronary plaque disruption.
Circulation 1995; 92:957-71.

Flore MC, Bailey WC, Cohen S], et al. Clinical Practice
Guideline: Treating Tobacco Use and Dependence.
Rockville, MD: USDHHS, PHS (2000). Available online
at http: / /www.cdc. gov/tobacco/quit/canquit. htm

Freemantle N, Cleland J, Young P, et al. Beta blockade
after myocardial infarction: systematic review and meta
regression analysis. BM]1999; 318:1730—7.

34 Health Dlelog
121

Goldbergfl,MoseaL,PianoMR,FlsherEA.AHA
Science Advisory. Wine and Your Heart. Circulation 2001;
103:472-5.

Gottlieb SS, McCarter R], Vogel RA. Effect of beta-
blockade on mortality among high-risk and low-risk
patients after myocardial infarction. New England journal
of Medicine 1998; 839:489—97.

Grundy SM, Cleemanjl, Bairey Men CN, et al.
lrnplications of recent clinical trials for the National
Cholesterol Education Program Adult Treatment Panel
III Guidelines. Circulation 2004; 110:227-239.

HalbertjA, Silagy CA, Finucane P, et al. The effective-
ness of exercise training in lowering blood pressure: a
meta-analysis of randomized controlled trials of 4 weeks
or longer. journal of Human Hypertension 1997; 11:641-9.

Heart Outcomes Prevention Evaluation Study
Investigators. Effects of ramipril on cardiovascular and
microvascular outcomes in people with diabetes mellitus:
results of the HOPE study and MICRO-HOPE substudy.
Lancet 2000; 855:253—9.

Heart Protection Study Collaborative Group. MRC/BHF
Heart Protection Study of cholesterol lowering with sim-
vastatin in 20,536 high-risk individuals. Lancet 2002;
360(9326):7—22.

Kris-Etherton P, Daniels SR, Eckel RH, et al. Summary
of the scientific conference on dietary fatty acids and
cardiovascular health (American Heart Association).
Circulation 2001; 103 (7):]034—9.

LaRosa JC, He J, Vupputuri S. Efl‘ect of statins on risk of
coronary disease: a meta-analysis of randomized con-
trolled trials. journal of the American Medical Association
1999; 282:2340—6.

35 Manes
122

MacMahon S, Cutler], Brittain E, Higgins M. Obesity
and hypertension: epidemiological and clinical issues.
European Hemtjoumal 1987; 8 Suppl 8:57-70.

Marchloli R, Bani P, Bomba E, et al. Early protection
against sudden death by n-S polyunsaturated fatty acids
after myocardial infarction: time-course analysis of the
results of the Gmppo Italiano per lo Studio della
Sopravvivenza nell’lnfarto Miocardico (01881)-
Prevenzione. Circulation 2002; 105(16):1897-903.

National High Blood Pressure Education Program. The
Seventh Report of the Joint National Committee on
Prevention, Detection, Evaluation and Treatment of
High Blood Pressure. 2008; NIH Publication No. 5233.
Available online at http://www.nhlbi.nih.gov/guide-
lines/ hypertension/ index.htm

Third Report of the National Cholesterol Education
Program (NCEP) Expert Panel on Detection, Evaluation,
and Treatment of High Blood Cholesterol in Adults
(Adult Treatment Panel III). 2001; NIH Publication No.
01-3670. Available online at

http:/ /www.nhlbi.nih.gov/health/public/heart/index.hnn

36 Health Dialog
123

 

10.

BIBLIOGRAPHY

Olomu AB, Vickers CR, Waring RH, Clements D, Babbs C, Warnes TW,
Elias E. High incidence of poor sulfoxidation in patients with primary biliary
cirrhosis. N Engl J Med. 1988;318(17):1089-92.

Olomu A, Clements D, Waring R, Elias E. Poor sulphoxidation in primary
biliary cirrhosis. Lancet. 1985;1(8444): 1504.

Obasohan A, Oviasu V.O, Olomu A. B, et al. A ten year follow yp study of
Arterial Blood Pressure in a rural community in Nigeria. Nigerian J of
Physiological Sciences. 1989;6(2): 120-127.

Ukoli FA, Bunker CH, Fabio A, Olomu AB, Egbagbe EE, Kuller LH. Body
fat distribution and other anthropometric blood pressure correlates in a Nigerian
urban elderly population. Cent Afi' J Med. 1995;41(5): 1 54-61.

Kesteloot H, Oviasu VO, Obasohan AO, Olomu A, Cobbaert C, Lissens W.
Serum lipid and apolipoprotein levels in a Nigerian population sample.
Atherosclerosis. 1989;78(1):33-8.

Watson R, Olomu, AB, Dwamena, FC, Ahmed F, Smith S, , Mcintosh B KG,
Ferlinz JJ. Under-use of Aspirin Following Acute Myocardial Infarction in
Community Hospitals. J Gen Intern Med. 2002;17 (Suppl 1):133.

Watson R, Olomu AB, Dwamena FC, Ahmed F,Valilenko P, Mcintosh B, El-
Tamimi H, Ferlinz JJ.. Under-use of Beta-Blockers Following Acute
Myocardial Infarction in Community Hospitals. J Gen Intern Med. 2002;17
(Suppl 1):133.

Olomu AB, Watson RE, Siddiqi AE, Dwamena FC, McIntosh BA, Vasilenko
P, 3rd, Kupersmith J, Holmes-Rovner MM. Changes in rates of beta-blocker

use in community hospital patients with acute myocardial infarction. J Gen Intern
Med. 2004;l9(10):999-1004.

Olomu AB, Corser WD, Yang Z, Siddiqi A, Holmes-Rovner MM. Evaluation
and Treatment of High Cholesterol During Hospitalization for Acute Coronary
Syndrome. J Gen Intern Med. 2005;20 (Suppl 1): 142.

Olomu AB, Corser WD, Holmes-Rovner MM. Self-Report Comorbidity Data

and Functional Outcomes in Acute Coronary Syndrome. J. Gen Intern Med.
2005;20(Supp1 1):72.

124

11.

12.

13.

14.

15.

16.

17.

18.

19.

20.

21.

Yang 2, Olomu A, Corser w, Rovner DR, Holmes-Rovner M. Outpatient
medication use and health outcomes in post-acute coronary syndrome patients.
Am J Manag Care. 2006;12(10):581-7

Olomu AB, Stommel M, Siddiqi A, Prieto A, Corser WD, Holmes-Rovner
MM. Quality Improvement Efi’orts And Hospital Performance: Rates of Beta-

Blocker Prescription for Acute Coronary Syndrome J. Gen Intern Med.
2006;21(Suppl 4):i-300.

Young RF, Waller JB, Jr., Kahana E. Racial and socioeconomic aspects of
myocardial infarction recovery: studying confounds. Am J Prev Med.
1991 ;7(6):438-44.

Traven ND, Kuller LH, Ives DG, Rutan GH, Perper JA. Coronary heart
disease mortality and sudden death among the 35-44-year age group in Allegheny
County, Pennsylvania. Ann Epidemiol. 1996;6(2):130-6.

Francis CK, Grant AO, cochairs. (US Department of Health and Human
Services). Report of the Working Group on Research in Coronary Heart Disease
in Blacks. 1994.

Gillium R, Mussolino M, Madans J. Coronary Heart Disease incidence and
survival in African-American women and men. The NHANES I epidemiology
follow up study. Ann Intern Med. 1997;127:111-118.

Herholz H, Goff DC, Ramsey DJ, Chan FA, Ortiz C, Labarthe DR,
Nichaman MZ. Women and Mexican Americans receive fewer cardiovascular
drugs following myocardial infarction than men and non-Hispanic whites: the
Corpus Christi Heart Project, 1988-1990. J Clin Epidemic]. l996;49(3):279-87.

Ayanian J Z, Weissman JS, Chasan-Taber S, Epstein AM. Quality of care by
race and gender for congestive heart failure and pneumonia Med Care.
1999;37(12):1260-9.

Centers for Disease Control and Prevention (CDC). Disparities in premature
deaths from heart disease- 50 states and District of Columia. 2001. MMWR Morb
Mortal Wkly Rep,. 2004;53:121-5. ‘

Peterson EDSL, DeLong ER, et al. Racial variation in the use of cardiac-
revascularization procedures: Are the diffferences real ? Do they matter 7 N Eng J
Med. 1997;336:480-486.

Mehta RH, Montoye CK, Gallogly M, Baker P, Blount A, Fan] J,
Roychoudhury C, Borzak S, Fox S, Franklin M, Freundl M, Kline-Rogers E,
LaLonde T, Orza M, Parrish R, Satwicz M, Smith MJ, Sobotka P, Winston
S, Riba AA, Eagle KA. Improving quality of care for acute myocardial

125

22.

23.

24.

25.

26.

27.

28.

29.

30.

31.

infarction: The Guidelines Applied in Practice (GAP) Initiative. Jama.
2002;287(10):1269-76.

Mosca L, Linfante AH, Benjamin EJ, Berra K, Hayes SN, Walsh BW,
Fabunmi RP, Kwan J, Mills T, Simpson SL. National study of physician

awareness and adherence to cardiovascular disease prevention guidelines.
Circulation. 2005;] l l(4):499-5 10.

Weinstein MC, Stason WB. Cost-effectiveness of interventions to prevent or
treat coronary heart disease. Annu Rev Public Health. 1985;6z4l -63.

Cooper RS, Simmons B, Castaner A, Prasad R, Franklin C, Ferlinz J.
Survival rates and prehospital delay during myocardial infarction among black
persons. Am J Cardiol. l986;57(4):208-11.

Maynard C, Fisher LD, Passamani ER, Pullum T. Blacks in the Coronary
Artery Surgery Study: risk factors and coronary artery disease. Circulation.
1986;74(1):64-7l.

Taylor HA, Chaitman BR, Rogers WJ, Kern MJ, Terrin ML, Aguirre FV,
Sopko G, McMahon R, Ross RN, Bovill EC. Race and prognosis after
myocardial infarction. Results of the thrombolysis in myocardial infarction
(TIMI) phase II trial. Circulation. 1993;88(4 Pt 1):1484-94.

Pocock SJ, Shaper AG, Cook DG, Phillips AN, Walker M. Social class
differences in ischaemic heart disease in British men. Lancet. 1987;2(8552):197-
201.

Cassel J Hs, Bartel AG, et al. Incidence of coronary heart disease by ethnic
group, social class, and sex. Arch Intern Med. 1971;128:901.

Maynard C, Litwin PE, Martin JS, Cerqueira M, Kudenchuk PJ, Ho MT,
Kennedy JW, Cobb LA, Schaeffer SM, Hallstrom AP, et al. Characteristics of
black patients admitted to coronary care units in metropolitan Seattle: results fi'om
the Myocardial Infarction Triage and Intervention Registry (MITI). Am J Cardiol.
1991;67(l):18-23.

Clark LT, Bellam SV, Shah AH, Feldman JG. Analysis of prehospital delay
among inner-city patients with symptoms of myocardial infarction: implications
for therapeutic intervention. J Natl Med Assoc. 1992;84(1 l):931-7.

Allison JJ, Kiefe CI, Centor RM, Box JB, Farmer RM. Racial differences in

the medical treatment of elderly Medicare patients with acute myocardial
infarction. J Gen Intern Med. l996;11(12):736-43.

126

32.

33.

34.

35.

36.

37.

38.

39.

40.

41.

42.

43.

44.

Wenneker MB, Epstein AM. Racial inequalities in the use of procedures for
patients with ischemic heart disease in Massachusetts. Jama. 1989;261(2):253-7.

Giles WH, Anda RF, Casper ML, Escobedo LG, Taylor HA. Race and sex
differences in rates of invasive cardiac procedures in US hospitals. Data from the
National Hospital Discharge Survey. Arch Intern Med. 1995;155(3):318-24.

Ferguson JA, Tierney WM, Westmoreland GR, Mamlin LA, Segar DS,
Eckert GJ, Zhou XH, Martin DK, Weinberger M. Examination of racial

differences in management of cardiovascular disease. J Am Coll Cardiol.
1997;30(7):1707-13.

Goldberg KC, Hartz AJ, Jacobsen SJ, Krakauer H, Rimm AA. Racial and
community factors influencing coronary artery bypass graft surgery rates for all
1986 Medicare patients. Jama. 1992;267(11):1473-7.

Ayanian JZ, Udvarhelyi IS, Gatsonis CA, Pashos CL, Epstein AM. Racial
differences in the use of revascularization procedures afier coronary angiography.
Jama. 1993;269(20):2642-6.

Bailey. Sociocultural factors and health care seeking behavior among black
Americans. J. Natl Med Assoc. 1987;79:389-92.

Antonovsky. Social class, life expectancy and overall mortality. 2nd ed. Jaco EG
Patient physicians and illness ed New York; 1972.

Syme SL BL. Social class, susceptibility, and sickness. ConraP, Kern R, The
sociology of health and illness ed New York: St Martin's Press; 1986.

Harburg E, Erfurt JC, Chape C, Hauenstein LS, Schull WJ, Schork MA.
Socioecological stressor areas and black-white blood pressure: Detroit. J Chronic
Dis. 1973;26(9):595-61 1.

Om S, Dickstein K. Pharrnacotherapy following myocardial infarction-~a review
of current treatment practices. Expert Opin Pharmacother. 2000; l (6):] 105-16.

Robinson JG, Leon AS. The prevention of cardiovascular disease. Emphasis on
secondary prevention. Med Clin North Am. 1994;78(l):69-98.

Garraway WM, Elveback LR, Connolly DC, Whisnant JP. The dichotomy of
myocardial and cerebral infarction. Lancet. 1983;2(8363):1332-5.

Johansson S, Bergstrand R, Ulvenstam G, Vedin A, Wilhelmsson C, Wedel
H, Wilhelmsen L, Aberg A. Sex differences in preinfarction characteristics and

longterm survival among patients with myocardial infarction. Am J Epidemiol.
1984;] 19(4):610-23.

127

45.

46.

47.

48.

49.

50.

51.

52.

53.

Kannel WB, Sorlie P, McNamara PM. Prognosis after initial myocardial
infarction: the Framingham study. Am J Cardiol. l979;44(1):53-9.

Schlant RC, Forman S, Stamler J, Canner PL. The natural history of coronary
heart disease: prognostic factors after recovery from myocardial infarction in
2789 men. The S-year findings of the coronary drug project. Circulation.
l982;66(2):401-14.

National Cholesterol Education Program. Second Report of the Expert Panel on
Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults (Adult
Treatment Panel 11). Circulation. l994;89(3):1333-445.

Haffner SM, Lehto S, Ronnemaa T, Pyorala K, Laakso M. Mortality from
coronary heart disease in subjects with type 2 diabetes and in nondiabetic subjects
with and without prior myocardial infarction. N Engl J Med. 1998;339(4):229-34.

Miettinen H, Lehto S, Salomaa V, Mahonen M, Niemela M, Haffner SM,
Pyorala K, Tuomilehto J. Impact of diabetes on mortality after the first
myocardial infarction. The FINMONICA Myocardial Infarction Register Study
Group. Diabetes Care. 1998;21(1):69-75.

Pyorala K, Pedersen TR, Kjekshus J, Faergeman O, Olsson AG,
Thorgeirsson G.-Cholesterol lowering with Simvastatin improves prognosis of
diabetic patients with coronary heart disease. A subgroup analysis of the
Scandinavian Simvastatin Survival Study (4S). Diabetes Care. 1997;20(4):614-
20.

Goldberg RB, Mellies MJ, Sacks FM, Moye LA, Howard BV, Howard WJ,
Davis BR, Cole TG, Pfeffer MA, Braunwald E. Cardiovascular events and their
reduction with pravastatin in diabetic and glucose-intolerant myocardial infarction
survivors with average cholesterol levels: subgroup analyses in the cholesterol
and recurrent events (CARE) trial. The Care Investigators. Circulation.
1998;98(23):2513-9.

Hafi'ner SM, Alexander CM, Cook TJ, Boccuzzi SJ, Musliner TA, Pedersen
TR, Kj ekshus J, Pyo rala K. Reduced coronary events in Simvastatin-treated
patients with coronary heart disease and diabetes or impaired fasting glucose
levels: subgroup analyses in the Scandinavian Simvastatin Survival Study. Arch
Intern Med. 1999;159(22):2661-7.

Tight blood pressure control and risk of macrovascular and microvascular
complications in type 2 diabetes: UKPDS 38. UK Prospective Diabetes Study
Group. ij. 1998;317(7160):703-13.

128

 

54.

55.

56.

57.

58.

59.

60.

61.

62.

Grover SA, Coupal L, Zowall H, Weiss TW, Alexander CM. Evaluating the
benefits of treating dyslipidemia: the importance of diabetes as a risk factor. Am J
Med. 2003;] 15(2):122-8.

The sixth report of the Joint National Committee on prevention, detection,
evaluation, and treatment of high blood pressure. Arch Intern Med.
l997;]57(21):2413-46.

AHCRP Guildline Technical Report. Cardiac rehabilitation: secondary
prevention. 1995.

Ryan TJ, Anderson JL, Antman EM, Braniff BA, Brooks NH, Califf RM,
Hillis LD, Hiratzka LF, Rapaport E, Riegel BJ, Russell RO, Smith EE, 3rd,
Weaver WD. ACC/AHA guidelines for the management of patients with acute
myocardial infarction: executive summary. A report of the American College of
Cardiology/American Heart Association Task Force on Practice Guidelines
(Committee on Management of Acute Myocardial Infarction). Circulation.
1996;94(9):2341-50.

Leon AS, Franklin BA, Costa F, Balady GJ, Berra KA, Stewart KJ,
Thompson PD, Williams MA, Lauer MS. Cardiac rehabilitation and secondary
prevention of coronary heart disease: an American Heart Association scientific
statement from the Council on Clinical Cardiology (Subcommittee on Exercise,
Cardiac Rehabilitation, and Prevention) and the Council on Nutrition, Physical
Activity, and Metabolism (Subcommittee on Physical Activity), in collaboration
with the American association of Cardiovascular and Pulmonary Rehabilitation.
Circulation. 2005;] ] 1(3):369-76.

Smith SC, Jr., Allen J, Blair SN, Bonow RO, Brass LM, Fonarow GC,
Grundy SM, Hiratzka L, Jones D, Krumholz HM, Mosca L, Pasternak RC,
Pearson T, Pfeffer MA, Taubert KA. AHA/ACC guidelines for secondary
prevention for patients with coronary and other atherosclerotic vascular disease:
2006 update: endorsed by the National Heart, Lung, and Blood Institute.
Circulation. 2006;] 13(1 9):2363-72.

Antithrombotic Trialists' Collaboration. Collaborative meta-analysis of
randomized trials of antiplatelet therapy for prevention of death, myocardial
infarction, and stroke in high risk patients. BMJ. 2002;324:71-86.

Randomised trial of cholesterol lowering in 4444 patients with coronary heart
disease: the Scandinavian Simvastatin Survival Study (48). Lancet.
1994;344(8934):]383-9.

Gottlieb SS, McCarter RJ, Vogel RA. Effect of beta-blockade on mortality

among high-risk and low-risk patients after myocardial infarction. N Engl J Med.
1998;339(8):489—97.

129

63.

64.

65.

66.

67.

68.

69.

70.

71.

72.

73.

Ambrosioni E, Borghi C, Magnani B. The effect of the angiotensin-converting-
enzyme inhibitor zofenopril on mortality and morbidity afier anterior myocardial
infarction. The Survival of Myocardial Infarction Long-Term Evaluation
(SMILE) Study Investigators. N Engl J Med. l995;332(2):80-5.

Clark AM, Hartling L, Vandermeer B, McAlister FA. Meta-analysis:
secondary prevention programs for patients with coronary artery disease. Ann
Intern Med 2005;143 (9)(Nov 1):659-72.

Hjermann I, Velve Byre K, Holme I, Leren P. Effect of diet and smoking
intervention on the incidence of coronary heart disease. Report fiom the Oslo
Study Group of a randomised trial in healthy men. Lancet. 1981;2(8259): 1303-10.

Stockwell DH, Madhavan S, Cohen H, Gibson G, Alderman MH. The
determinants of hypertension awareness, treatment, and control in an insured
population. Am J Public Health. l994;84(] 1):1768-74.

Kenny SJ, Smith PJ, Goldschmid MG, Newman JM, Herman WH. Survey of
physician practice behaviors related to diabetes mellitus in the US. Physician
adherence to consensus recommendations. Diabetes Care. l993;16(l 1): 1507-10.

Krumholz HM, Radford MJ, Wang Y, Chen J, Heiat A, Marciniak TA.
National use and effectiveness of beta-blockers for the treatment of elderly

patients after acute myocardial infarction: National Cooperative Cardiovascular
Project. Jama. 1998;280(7):623-9.

Hirsch CH, Winograd CH. Clinic-based primary care of frail older patients in
California. West J Med. 1992;156(4):385-91.

Ayanian JZ, Landon BE, Landrum MB, Grana JR, McNeil BJ. Use of
cholesterol-lowering therapy and related beliefs among middle-aged adults after
myocardial infarction. J Gen Intern Med. 2002;17(2):95-] 02.

Schneider EC, Zaslavsky AM, Epstein AM. Racial disparities in the quality of
care for enrollees in medicare managed care. Jama. 2002;287(]0): 1288-94.

Virnig BA, Lurie N, Huang Z, Musgrave D, McBean AM, Dowd B. Racial
variation in quality of care among Medicare+Choice enrollees. Health Afl
(Millwood). 2002;21(6):224-30.

Hayward RA, Asch SM, Hogan MM, Hofer TP, Kerr EA. Sins of omission:

getting too little medical care may be the greatest threat to patient safety. J Gen
Intern Med. 2005;20(8):686-91.

130

74.

75.

76.

77.

78.

79.

80.

81.

82.

83.

84.

85.

86.

Thomson O'Brien MA, Oxman AD, Davis DA, Haynes RB, Freemantle N,
Harvey EL. Audit and feedback versus alternative strategies: effects on

professional practice and health care outcomes. Cochrane Database Syst Rev.
2000(2):CD000260.

Bodenheimer T. Disease management--promises and pitfalls. N Engl J Med.
]999;340(15):1202-5.

Wagner EH, Austin BT, Von Korff M. Improving outcomes in chronic illness.
Manag Care Q. 1996;4(2):12-25.

Wagner EH, Austin BT, Davis C, Hindmarsh M, Schaefer J, Bonomi A.
Improving chronic illness care: translating evidence into action. Health Afl
(Millwood). 2001;20(6):64-78.

Wehrwein P. What happens when politicians play doctor. Manag Care.
1997;6(10):28-34, 37-8.

Weingarten SR, Henning JM, Badamgarav E, Knight K, Hasselblad V, Gano
A, J r., Ofman JJ. Interventions used in disease management programmes for
patients with chronic illness-which ones work? Meta-analysis of published
reports. ij. 2002;325(7370):925.

Von Neumann J MO. Theory of Games and Economic Behavior New York;
1944.

Weinstein MC FH, Elstein et al. Clinical Decision Analysis Philadelphia; 1980.
(Company WBS, ed.

Grimshaw JM, Russell IT. Effect of clinical guidelines on medical practice: a
systematic review of rigorous evaluations. Lancet. 1993;342(8883): 13 17-22.

Katon W, Von Korff M, Lin E, Walker E, Simon GE, Bush T, Robinson P,
Russo J. Collaborative management to achieve treatment guidelines. Impact on
depression in primary care. Jama. 1995;273(13):1026-3 l.

McCulloch DK, Price MJ, Hindmarsh M, Wagner EH. A population-based
approach to diabetes management in a primary care setting: early results and
lessons learned. EflClin Pract. 1998;](1): 12-22.

O'Connor A, Tugwell P, wells G et al. Testing a portable, self-administered
decision aid for post-menopausal women considering long-term hormonal
replacement therapy. Med Decis Making. 1994; 14:438.

Kasper JF MA, Jr, Wennberg JE. Developing shared decision-making
programs to improve quality of health care. QRB Qual Rev Bull. 1992;] 8: 1 83-90.

131

 

87.

88.

89.

90.

91.

92.

93.

94.

95.

96.

97.

Gustafson DH BK, Hawkins RP, Boherg E W, Bricker E. CHESS: a
computer-based system for providing information, referral, decision support and

social support to people facing medical and other health related crises. 1992: 161 -
5.

McGlynn EA, Asch SM, Adams J, Keesey J, Hicks J, DeCristofaro A, Kerr
EA. The quality of health care delivered to adults in the United States. N Engl J
Med. 2003;348(26):2635-45.

Kohn LT, M CJ, Donaldson MS. To err is human: building a safer health
system Washingtom DC: National Academy Press; 1999.

Hunt DL, Haynes RB, Hanna SE, Smith K. Effects of computer-based clinical
decision support systems on physician performance and patient outcomes: a
systematic review. Jama. 1998;280(15):1339-46.

Kawamoto K, Houlihan CA, Balas EA, Lobach DF. Improving clinical practice
using clinical decision support systems: a systematic review of trials to identify
features critical to success. ij. 2005;330(7494):765.

Bennett JW, Glasziou PP. Computerised reminders and feedback in medication
management: a systematic review of randomised controlled trials. Med J Aust.
2003;178(5):217-22.

Walton R, Dovey S, Harvey E, Freemantle N. Computer support for
determining drug dose: systematic review and meta-analysis. ij.
l999;3 18(7189):984-90.

Walton RT, Harvey E, Dovey S, Freemantle N. Computerised advice on drug
dosage to improve prescribing practice. Cochrane Database Syst Rev.
2001(1):CD002894.

Kaushal R, Shojania KG, Bates DW. Effects of computerized physician order

entry and clinical decision support systems on medication safety: a systematic
review. Arch Intern Med. 2003;163(]2): 1409-16.

Bates DW, Teich JM, Lee J, Seger D, Kuperman GJ, Ma'Luf N, Boyle D,
Leape L. The impact of computerized physician order entry on medication error
prevention. J Am Med Inform Assoc. 1999;6(4):3 1 3-21.

Balas EA, Weingarten S, Garb CT, Blumenthal D, Boren SA, Brown GD.

Improving preventive care by prompting physicians. Arch Intern Med.
2000;160(3):301-8.

132

98.

99.

100.

101.

102.

103.

104.

105.

106.

107.

Shea S, DuMoucheI W, Bahamonde L. A meta-analysis of 16 randomized
controlled trials to evaluate computer-based clinical reminder systems for

preventive care in the ambulatory setting. J Am Med Inform Assoc.
1996;3(6):399-409.

Shiffman RN, Liaw Y, Brandt CA, Corb GJ. Computer-based guideline
implementation systems: a systematic review of functionality and effectiveness. J
Am Med Inform Assoc. ]999;6(2):104-14.

Mehta RH, Montoye CK, Faul J, Nagle DJ, Kure J, Raj E, Fattal P, Sharrif
S, Amlani M, Changezi HU, Skorcz S, Bailey N, Bourque T, LaTarte M,
McLean D, Savoy S, Werner P, Baker PL, DeFranco A, Eagle KA. Enhancing
quality of care for acute myocardial infarction: shifting the focus of improvement
from key indicators to process of care and tool use: the American College of
Cardiology Acute Myocardial Infarction Guidelines Applied in Practice Project in
Michigan: Flint and Saginaw Expansion. J Am Coll Cardiol. 2004;43(12):2166-
73.

Hulscher ME, Wensing M, van Der Weijden T, Grol R. Interventions to

implement prevention in primary care. Cochrane Database Syst Rev.
2001(1):CD000362.

Oxman AD, Thomson MA, Davis DA, Haynes RB. No magic bullets: a
systematic review of 102 trials of interventions to improve professional practice.
Cmaj. 1995;153(10):1423-31.

Bero LA, Grilli R, Grimshaw JM, Harvey E, Oxman AD, Thomson MA.
Closing the gap between research and practice: an overview of systematic reviews
of interventions to promote the implementation of research findings. The

Cochrane Effective Practice and Organization of Care Review Group. ij.
1998;317(7156):465-8.

Wensing M, Grol R. Single and combined strategies for implementing changes
in primary care: a literature review. Int J Qual Health Care. l994;6(2):115-32.

Wensing M, van der Weijden T, Grol R. Implementing guidelines and
innovations in general practice: which interventions are effective? Br J Gen Pract.
1998;48(427):991-7.

Smedley BD. Unequal treatment: Confionting Racial And Ethnic Disparities In
Health Care. Institute of Medicine of the National Academies, ed A Y Smith ed
Washington DC: The National Academies Press; 2002.

Naik AD, Schulman-Green D, McCorkle R, Bradley EH, Bogardus ST, Jr.

Will older persons and their clinicians use a shared decision-making instrument? J
Gen Intern Med. 2005;20(7):640-3.

133

108.

109.

110.

111.

112.

113.

114.

115.

116.

117.

118.

119.

Braddock CH, 3rd, Edwards KA, Hasenberg NM, Laidley TL, Levinson W.
Informed decision making in outpatient practice: time to get back to basics. Jama.
1999;282(24):2313-20.

Elwyn G, Edwards A, Kinnersley P, Grol R. Shared decision making and the
concept of equipoise: the competences of involving patients in healthcare choices.
Br J Gen Pract. 2000;50(460):892-9.

Towle A, Godolphin W. Framework for teaching and learning informed shared
decision making. ij. 1999;319(7212):766-71.

Smith RC, Lyles JS, Mettler J, Stoffelmayr BE, Van Egeren LF, Marshall
AA, Gardiner JC, Maduschke KM, Stanley JM, Osborn GG, Shebroe V,
Greenbaum RB. The effectiveness of intensive training for residents in
interviewing. A randomized, controlled study. Ann Intern Med. 1998;128(2):l ]8-
26.

Korsch B M. What do patients and parents want to know ? What did they need
to know ? Pediatrics. 1984;74(5 pt 2):917-919.

American Heart Association. Heart and Stroke Statistical update. 2001.

Brennan TA LL, Laird NM et a]. Incidence of adverse events and negligence in
hospitalized patients. N Engl J Med. 1991;324:370-6.

Effect of enalapril on mortality and the development of heart failure in
asymptomatic patients with reduced left ventricular ejection fractions. The
SOLVD Investigattors. N Engl J Med. l992;327(10):685-91.

Konstam MA, Rousseau MF, Kronenberg MW, Udelson JE, Melin J,
Stewart D, Dolan N, Edens TR, Ahn S, Kinan D, et al. Effects of the
angiotensin converting enzyme inhibitor enalapril on the long-term progression of
left ventricular dysfunction in patients with heart failure. SOLVD Investigators.
Circulation. 1992;86(2):431-8.

Frye RL, Gibbons RJ, Schaff HV, Vlietstra RE, Gersh BJ, Mock MB.
Treatment of coronary artery disease. J Am Coll Cardiol. 1989;l3(5):957-68.

Ridker PM, Manson JE, Gaziano JM, Buring JE, Hennekens CH. Low-dose
aspirin therapy for chronic stable angina. A randomized, placebo-controlled
clinical trial. Ann Intern Med. 1991;] l4(10):835-9.

Institute of Medicine. Assessing Medical Technologies. Vol. 5 Washington D. C:
National Academy Press; 1985.

134

120.

121.

122.

123.

124.

125.

126.

127.

128.

129.

130.

131.

132.

James BC, Hammond ME. The challenge of variation in medical practice. Arch
Pathol Lab Med. 2000;124(7):1001-3.

Park RE, Fink A, Brook RH, Chassin MR, Kahn KL, Merrick NJ, Kosecoff
J, Solomon DH. Physician ratings of appropriate indications for six medical and
surgical procedures. Am J Public Health. l986;76(7):766-72.

Mulley AG, Jr., Eagle KA. What is inappropriate care? Jama. 1988;260(4):540-
l.

McDonald CJ. Medical heuristics: the silent adjudicators of clinical practice. Ann
Intern Med. 1996;124(1 Pt l):56-62.

To err is human, Washington D. C: National Academy Press; 1999 Institute of
Medicine).

Rothert M, Rovner D, Holmes M, Schmitt N, Talarczyk G, Kroll J, Gogate J.
Women's use of information regarding hormone replacement therapy. Res Nurs
Health. 1990;13(6):355-66.

Rothert M, Padonu G, Holmes-Rovner M, Kroll J, Talarczyk G, Rovner D,
Schmitt N, Breer L. Menopausal women as decision makers in health care. Exp
Gerontol. 1994;29(3-4):463-8.

Rothert ML, Holmes-Rovner M, Rovner D, Kroll J, Breer L, Talarczyk G,
Schmitt N, Padonu G, Wills C. An educational intervention as decision support
for menopausal women. Res Nurs Health. 1997;20(5):377-87.

O'Connor AM FV, DeGrasse C et a1. Decision aids for patients considering
options affecting cancer outcomes: evidence of efficacy and policy implications. J
Natl Cancer Inst Monogr. 1999;25:67-80.

Holmes-Rovner M, Rovner DR. Measuring improved patient choice. J Eval Clin
Pract. 2000;6(3):263-72.

Holmes-Rovner M, Valade D, Orlowski C, Draus C, Nabozny-Valerio B,
Keiser S. Implementing shared decision-making in routine practice: barriers and
opportunities. Health Expect. 2000;3(3): 1 82-191 .

Edwards AEG. Evidenced Based Patient Choice New York: Oxford University
Press; 2001.

Holmes-Rovner M, Llewellyn-Thomas H, Entwistle V, Coulter A, O'Connor

A, Rovner DR. Patient choice modules for summaries of clinical effectiveness: a
proposal. ij. 200] ;322(7287):664-7.

135

133.

134.

135.

136.

137.

138.

139.

140.

141.

O'Connor AM, Stacey D, Entwistle V, Llewellyn-Thomas H, Rovner D,
Holmes-Rovner M, Tait V, Tetroe J, Fiset V, Barry M, Jones J. Decision aids
for people facing health treatment or screening decisions. Cochrane Database
Syst Rev. 2003(2):CD001431.

O'Connor AM, Rostom A, Fiset V, Tetroe J, Entwistle V, Llewellyn-Thomas
H, Holmes-Rovner M, Barry M, Jones J. Decision aids for patients facing

health treatment or screening decisions: systematic review. ij.
1999;319(72]2):731-4.

Eagle KA, Montoye CK, Riba AL, DeFranco AC, Parrish R, Skorcz S, Baker
PL, Faul J, Jani SM, Chen B, Roychoudhury C, Elma MA, Mitchell KR,
Mehta RH. Guideline-based standardized care is associated with substantially
lower mortality in medicare patients with acute myocardial infarction: the
American College of Cardiology's Guidelines Applied in Practice (GAP) Projects
in Michigan. J Am Coll Cardiol. 2005;46(7):1242-8.

Eagle KA, Gallogly M, Mehta RH, Baker PL, Blount A, Freund] M, Orza
MJ, Parrish R, Riba AL, Montoye CK. Taking the national guideline for care
of acute myocardial infarction to the bedside: developing the guideline applied in
practice (GAP) initiative in Southeast Michigan. Jt Comm J Qual Improv.
2002;28(1):5-19.

Eagle KA, Koelling TM, Montoye CK. Primer: implementation of guideline-
based programs for coronary care. Nat Clin Pract Cardiovasc Med.
2006;3(3):163-71.

Eagle KA, Mehta RH, Riba AL, Defranco AC, Montoye CK. Taking the
ACC/AHA guidelines for care of Acute Myocardial Infarction to the bedside: the
GAP projects in southeastern Michigan. Am Heart J. 2004;]48(5 Suppl):S49-51.

Dunn SL, Corser W, Stommel M, Holmes-Rovner M. Hopelessness and
depression in the early recovery period after hospitalization for acute coronary
syndrome. J Cardiopulm Rehabil. 2006;26(3): 1 52-9.

Holtrop J S, Corser W, Jones G, Brooks G, Holmes-Rovner M, Stommel M.
Health behavior goals of cardiac patients after hospitalization. Am J Health
Behav. 2006;30(4):387-99.

Elwyn G, O’Connor A, Stacey D, Volk R, Edwards A, Coulter A, Thomson
R, Barratt A, Barry M, S B, Butow P, Clarke A, Entwistle V, D F-S, Holmes-
Rovner M, Llewellyn-Thomas H, Moumjid N, Mulley A, Ruland C, Sepucha
K, Sykes A, T. W. Developing a quality criteria framework for patient decision
aids: an online international modified Delphi consensus process. Forthcoming,
BM]. 2006.

136

142.

143.

144.

145.

146.

147.

148.

149.

150.

151.

152.

153.

Holmes-Rovner M, Kroll J, Rovner DR, Schmitt N, Rothert M, Padonu G,
Talarczyk G. Patient decision support intervention: increased consistency with
decision analytic models. Med Care. 1999;37(3):270-84.

Holmes-Rovner M, Kroll J, Schmitt N, Rovner DR, Breer ML, Rothert ML,
Padonu G, Talarczyk G. Patient satisfaction with health care decisions: the
satisfaction with decision scale. Med Decis Making. 1996;16(l):58-64.

Stillman F. (US Department of Health and Human Services,). Focus group
research: an overview. 1992.

Quatromoni PA MM, Posner BM, Carballeira NP, Brunt M, Chipkin SR.
Use of focus groups to explore nutrition paractices and health beliefs of urban
Caribbean Latinos with diabetes. Diabetes Care. 1994;17:869-73.

Strauss A. Basics of Qualitative Research. 2nd ed Sage ed Thousand Oaks, CA;
1998.

Smith R. Patient-Centered Interviewing: An Evidenced-Based Method. Second
Edition on The Patient’s Story ed. Philadelphia: Lippincott Williams and Wilkins;
2002.

Evidenced-Based Interviewing: (Tape ]) Patient-Centered Interviewing Smith:
Michigan State University Broadcasting Services, Eric Schultz, Producer; 2001.

Kaplan SH, Greenfield S, Gandek B, Rogers WH, Ware JE, Jr.
Characteristics of physicians with participatory decision-making styles. Ann
Intern Med. 1996;124(5):497-504.

Grundy SM, Cleeman JI, Merl. CN, Brewer HB, Jr., Clark LT, Hunninghake
DB, Pasternak RC, Smith SC, Jr. ., Stone NJ. Implications of recent clinical
trials for the National Cholesterol Education Program Adult Treatment Panel 1]]
Guidelines. J Am Coll Cardiol. 2004 ,44(:3) 720- 32.

Borrelli B, Sepinwall D, Ernst D, Bellg AJ, Czajkowski S, Breger R,
DeFrancesco C, Levesque C, Sharp DL, Ogedegbe G, Resnick B, Orwig D. A
new tool to assess treatment fidelity and evaluation of treatment fidelity across 10
years of health behavior research. J Consult Clin Psychol. 2005;73(5):852-60.

Rubin DB, Little RJA. Statistical analysis with missing data New York: John
Wiley and Sons; 1987.

Charlson ME, Pompei P, Ales KL, MacKenzie CR. A new method of

classifying prognostic comorbidity in longitudinal studies: development and
validation. J Chronic Dis. 1987;40(5):373-83.

137

]54. Tierney WM, Overhage JM, Murray MD, Harris LE, Zhou XH, Eckert GJ,
Smith FE, Nienaber N, McDonald CJ, Wolinsky FD. Effects of computerized

guidelines for managing heart disease in primary care. J Gen Intern Med.
2003;] 8(12):967-76.

138

   

uhitting»“MyI