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“What Are the Influences of Patient Literacy, HbA1c
Understanding, and Socio-Demographic Variables on the
Effectiveness, Attendance and Retention of VA Diabetes
Patient Educational Initiatives?”
Diabetes Exploratory Pilot Research Study
Department of Veterans Affairs Medical Center
3001 Green Bay Road, North Chicago, IL 60031
Dr. Tariq Hassan, M.D. Veterans Affairs Medical Center, North Chicago, IL
Dr. Boby G. Theckedath, M.D. Veterans Affairs Medical Center, North Chicago, IL
Dr. Sant Singh, M.D. Veterans Affairs Medical Center, North Chicago, IL
Dr. Barry D. Weiss, M.D. University of Arizona, Tucson
Dr. George Lutz, Ph.D, Veterans Affairs Medical Center, North Chicago, IL
Dr. Tom Muscarello, M.S., Ph.D, DePaul University, Chicago, IL
David R. Donohue. M.A., Qualitative Technologies Inc. and Northwestern University
Janine Stoll, RN, BSN, CDE, Veterans Affairs Medical Center, North Chicago, IL
INTRODUCTION
NORTH CHICAGO VA DIABETES STUDY FOCUS
The (NCVAMC) North Chicago VA Medical Center in 2006 had 625 high-risk diabetes patients
defined as those with a HbA1c of 9.5 or greater of whom 48% either dropped out from, or did not
participate in a prescribed VA Diabetes self-management education intervention program. The
remaining 52% of these high-risk patients participated by attending a one-day self-management
education seminar. They showed an overall HbA1c improvement of 1.13% in one year, and those
with an HbA1c of 9.0%, demonstrated a 3% improvement after one year. A 1.13 and 3% HbA1c
improvement rate is significantly lower, than what is seen with other diabetes education
initiatives, such as the 2006 Q-source HbA1c education project in the State of Tennessee that
resulted in a significantly higher level of (12% of diabetes population) improvement in HbA1c
compliance. (1, 2, 3)
Education is the cornerstone of effective diabetes treatment, and one of the most important factors
influencing adherence and patient safety outcomes. (4, 5, 6) Today, alternative strategies and
education/communication interventions are clearly needed to attract, educate and retain
NCVAMC patients in order to increase patient compliance and safety, among its growing patient
population, now numbers 5,500, of whom, as noted, more than 750 are at high-risk because of
poor HbA1c control and utilization of health care services.
Hundreds of NCVAMC patients with diabetes (high-risk group HbA1c = 9.5% or greater) do not
adhere to therapy, experience repeated hospital admissions, and have or are at risk for multiple
diabetes complications. The lack of complance, higher diabetes complication rates are often due
to poor HbA1c knowledge, understanding and control of diabetes, resulting, in turn from
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unrecognized low health literacy. Indeed, research elsewhere (3) has shown that individuals with
low literacy skills have worst diabetic control than those with adequate literacy skills, even when
controlling for a host of other socio-demographic variables.
Today, more than 90 million adults in the United States have poor literacy levels, which would
cause them to have trouble finding pieces of information or numbers in a lengthy text, integrating
multiple pieces of information in a document, or finding two or more numbers in a chart and
performing a calculation. Those with poor literacy skills are believed to have greater difficulty
navigating the health care system and to be at greater risk of experiencing diminished healthcare
outcomes, according to a major federal government study. (4)
OBJECTIVES OF THE NCVAMC DIABETES STUDY
The overall objective of the study is to examine the association between health literacy,
individual HbA1c control knowledge and socio-demographic variables, and their impact on
education attendance and retention of high-risk NCVAMC diabetic patients in prescribed diabetes
educational initiatives.
Specific study goals are to:
1. Measure NCVAMC diabetic patients for literacy level using the (NVS) Newest Vital
Sign instrument: This will result in patient measurement of: low literate likely, low
literate possible, or literate
2. Identify the level of a patient’s knowledge of their HbA1c level
3. Identify and measure patient’s factor-group characteristics (socio-demographic variables)
that make up shared traits and attitudes influencing diabetes education and adherence. For
example, control of a patient’s HbA1c level may depend on an adequate health literacy
level. In addition, HbA1c control, maybe depend upon certain other traits, such as patient
attitudes towards dealing with fear, stress or worry. Knowledge gained through
identifying similar traits shared by members of a factor group, tells us about that patient’s
potential behavior; their shared attitudes, feelings and opinions. Once we know a
patient’s factor group, we can better understand their (MO) method-of-operation and
behavioral characteristics, consequently able to design educational interventions to serve
that factor group’s learning style
4. Recommend new VA diabetes patient educational interventions based on findings in 1, 2,
and 3 above. Implement 6-Key Questions and three questions ABC’s of Good Diabetes,
and three survey questions on understanding the importance of HbA1c levels. Health
among selected NCVAMC intervention diabetes patient groups, analyze and track finds
of DSME differences in compliance scores between intervention and control group.
RESEARCH DESIGN AND METHOD
STUDY POPULATION AND SAMPLING
For this research study, our VA diabetes population size is 5,500 individuals and we will be using
a 95% confidence level with a margin-of-error of 4.65%, and a response distribution of 50%
requiring a minimum sample size of 408 participants with diagnosed type 2 diabetes at the North
Chicago VA Medical Center, North Chicago, IL who have received diabetes care in
2006, 2007 and 2008. Project execution will take place at the North Chicago VA Medical Center,
North Chicago, IL. Our proposed timeline for project execution is from June 1st, 2009 to June
1st, 2010.
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This project will use probability and stratified sampling modeling, because it allows a
calculation of the sampling error and controls for the following factors.
1. A desire to minimize variance and sampling errors and to increase precision
2. A desire to estimate the parameters of each stratum and have a readable sample size for
each.
3. A desire to keep the sample element selection process simple.
Study subject frame will be identified and selected through electronic VA medical records (with
an HbA1c level <> 9.5%) in 2006, 2007 and 2008.
♦Be at least 18-years old
♦ Have a prescription for a glucose control medication or supplies, or one hospitalization, or two
outpatient visits with a diabetes related ICD-9 code
♦ Has seen their primary care provider (PCP) in the prior 12 months
♦ Scheduled to see the same PCP, in the next 6 months.
Subjects will be contacted by in-person clinic invitation, e-mail or USPS letter to invite them to
participate in the study. The survey protocols will receive (IRB) institutional review board
approval, and written informed consent obtained from all participants.
Cognitively impaired VA patients will not be asked to participate in this study; patient’s who
cannot read sample questions, due to poor eye sight will be included, provided subjects can read
larger type instructions.
All research participants will be asked to take a (NVS) Newest Vital Sign Health Literacy Test,
complete a three-question HbA1c questionnaire, and a qualitative/quantitative Q-methodology
survey, designed to place each participant in a defined factor groups, according to their opinions,
feelings and attitudes on diabetes treatment and education.
VARIABLES
The diabetes self-management regimen is one of the most challenging of any for chronic illness.
Patients often must perform self-monitoring of blood glucose, manage multiple medications, visit
multiple providers, maintain foot hygiene, adhere to diet and meal plans, and engage in an
exercise program. Patients also must be able to identify when they are having problems across
these functions and effectively problem-solve to divert crises. Diabetes outcomes may be
especially sensitive to problems involving literacy, communications, understanding the
importance of HbA1c control and self-management education.
The VA Medical Sstem has the largest and most comprehensive digital patient record systems in
the world. (5) Regular testing of HbA1c values is now the principal way to measure and track
glycemic control in diabetic patients. Because of its importance, as a marker of disease control, it
makes sense that patient knowledge of recent and target HbA1c values might be a useful
precondition for involvement in diabetes management and education. HbA1c variables will be
extremely important to our study, in relationship to health literacy, education and most
importantly identifying socio-demographic variables that impacts patient behavior.
Principle Variables
1. Age
2. Race/ethnic origin
3. Years with diabetes
4. Sex
5. Education level
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6. Income
7. Hypoglycemic regimen
8. Last HbA1c checked (%)
9. Percent with > 80% treatment at VA facility
10. Percent with >80% treatment at other medical facility
11. Health Literacy NVS (low literacy, low literacy possible, literate)
12. Patient understood correctly HbA1c value
13. Had biomedically accurate assessment of diabetes
14. Diabetes care self-efficacy
15. Diabetes education
16. Q-Methodology factor group, socio-demographic variables
Table 1—Variables of NCVAMC diabetes patient respondents
Ethnic Origin White % Black % Latino % Other %
P=value
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Age
Years with diabetes
Sex
Years of education
Income
$10,000 or less
$10,001 to $20,000
$20,001 to $30,000
> $30,000
Length of diabetes
< > 1 to 3 years
< > 4 to 10
Hypoglycemic regimen
Oral medication only
Insulin +- oral medication
No medication
Health Status
Excellent to very good
Fair
Poor
Outpatients visits in past year
Last HbA1c checked (%)
VA outpatient visits in last year
Percent with > 80% at VA facility
Dollar value of VA diabetes care, as % of care
Percent with >80% treatment at other medical facility
Percent with > than two outpatient VA visits in past year
Health Literacy Test NVS
Patient understood correctly HbA1c value
Had biomedically accurate assessment of diabetes
Diabetes care self-efficacy *
* Range of understanding scale was 1-5 and range of self-efficacy was 0-100; for both,
higher score was better.
Study Sampling and Patient Confidentiality Requirements
Insuring patient data security and confidentially of information is a top priority of this research
study. At no time will we identify patients by name or other identifying means. VA patient
medical record data will be used to support the project information needs, as required. U.S.
Department of Health and Human Services (“HHS”) issued the Privacy Rule to implement the
requirement of the Health Insurance Portability and Accountability Act of 1996 (“HIPAA”). A
major goal of the Privacy Rule is to assure that individuals’ health information is properly
protected while allowing the flow of health information needed to provide and promote high
quality health care and to protect the public's health and well being. The Rule strikes a balance
that permits important uses of information, such as research to build positive health care
outcomes, while protecting the privacy of people who seek care and healing.
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HIPAA Compliance Requirements
o Building initial organizational awareness of HIPAA
o Comprehensive assessment of the organization's privacy practices, information security
systems and procedures, and use of electronic transactions
o Developing an action plan for compliance with each rule
o Developing a technical and management infrastructure to implement the plans
o Implementing a comprehensive implementation action plan, including
o Developing new policies, processes, and procedures to ensure privacy, security
and patients' rights
o Building business associate agreements with business partners to support HIPAA
objectives
o Developing a secure technical and physical information infrastructure
o Updating information systems to safeguard protected health information (PHI)
and enable use of standard claims and related transactions
o Training of all workforce (research) members
o Developing and maintaining an internal privacy and security management and
enforcement infrastructure, including providing a Privacy Officer and a Security
Officer
1. Defining and Measuring NCVAMC Diabetes Patient Health Literacy
OBJECTIVE
We believe low-health literacy to be a contributing factor that adversely impacts diabetes
adherence and contributes to a 48% drop out rate among high risk NCVAMC diabetes patients
(HbA1c level of > 9.5%) (6). A recent North Chicago VA Medical Center 2006 research study,
“Analyzing Factors Affecting Functional Literacy in the Context of Primary Care
Patient/Provider Communication” concluded that 82% of study participants said, “Literacy and
communications are major challenges incurred by VA patients while they navigate through the
VA healthcare systems. (7, 8)
INSTRUMENT
The (NVS) Newest Vital Sign was developed by the University of Arizona, College of Medicine
and the University of North Carolina. After testing with more than 1,000 patients, the NVS has
been shown to address some of the limitations of previously available instruments. The
instrument assesses general literacy and numeracy skills as applied to health information, yielding
an overall estimate of health literacy. In contrast to the previous instruments, however, it can be
administered in about three-minutes and is available in both English and Spanish.
The Newest Vital Sign is based on a nutrition label from an ice cream container. Patients are
given the label and then asked 6 questions about how they would interpret and act on the
information contained on the ice cream label.
Specifically, the NCVAMC diabetes patient is handed a copy of the nutrition label and then asked
a series of 6 questions about it. Patients can and should retain the label so they can refer to it
while answering questions. It is not necessary to give the patient time to review the label before
asking the questions. Rather, they will review the label as they are asked and answer the
questions. The questions are asked orally and the responses recorded by a VA clinical staff
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member on a special score sheet, which contains the correct answers. Based on the number of
correct responses, the health care provider can assess the patient’s health literacy level.
In a 2007 published study, if health providers are aware of their patients’ literacy skills, they can
more appropriately tailor their communication with patients. Few providers, however, assess
patient’s literacy skills for fear of offending patients, but no research has ever determined if
patients object to such assessments.
This University of Miami and Dade County study revealed that the objective was to determine the
percentage of patients seen for routine health care that would agree to undergo literacy
assessment and if satisfaction of patients differs in practices that perform literacy assessments,
using the NVS, versus practices that do not. Of 289 patients asked to undergo literacy assessment
in the intervention practices, 284 (98.3%) agreed to do so, including 125 (46.1%) with low or
possibly low literacy skills. There was no difference in satisfaction between the intervention
group patients are willing to undergo literacy assessments during routine office visits and
performing such assessments does not decrease patient satisfaction. (77)
NVS Scoring
• The mean time to deliver either the English or Spanish version of the NVS instrument is
2.9 and 3.4 minutes, respectively. There has been no major difference between men and
women in their performance on the NVS from results in other studies.
• The internal consistency of both versions of the NVS is good.
• The NVS is superior to either age or educational level in predicting health literacy.
• A score of less than 2 on the NVS-English was associated with a sensitivity and
specificity of 72% and 87% for predicting limited literacy, while a score of less than 4
had a sensitivity and specificity of 100% and 64%. (9)
• A score of less than 2 on the NVS-Spanish was associated with a sensitivity and
specificity of 77% and 57% for predicting limited literacy, while a score of less than 4
had a sensitivity and specificity of 100% and 19%.
• Based on these values, a score of higher than 4 on the NVS is associated with adequate
health literacy, whereas a score less than 2 indicates at least a 50% chance of having
marginal or inadequate health literacy. (9)
RELIABILITY, VALIDITY, AND ACCURACY
The internal consistency of the NVS is good (Cronbach = 0.76), as was the criterion validity (r =
0.59, P <.001). Supplemental Appendix 2 (which is available online only at the following address
http://www.annfammed. org/cgi/content/full/3/6/514/ DC1) plots the relationship between scores
on the NVS .The area under the ROC curve for predicting (95% CI, 0.63-0.81; P <.001) found for
educational level or the 0.71 (95% CI, 0.63-0.79; P <.001) found for age. Thus, the NVS score is
more accurate than educational level or age. (9)
Properties and Clinical Significance of NVS
The NVS has good sensitivity; in fact, based on the distribution of scores, NVS may be more
sensitive than the TOFHLA literacy screening instrument (Test of Functional Health Literacy in
Adults) to marginal health literacy. Its specificity, although less than optimal, is similar to or
better than that of other widely used clinical screening methods, such as questionnaires to detect
alcohol abuse, breast self-examinations to screen for cancer, and methods to detect arthritis and
measure osteoporosis risk. Although the specificity of NVS may result in overestimating the
percentage of patients with limited literacy, using the test can alert physicians to patients who
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may need more attention and help physicians focus on physician-patient communication using
recommended techniques.
All patients who score >4 on the NVS will have adequate literacy when measured by the
TOFHLA. A score <4 on the NVS, on the other hand, indicates the possibility of limited literacy.
Clinicians should be particularly careful in their communication with patients who score < 2, as
they have a greater than 50% chance of having marginal or inadequate literacy skills. Such
patients cannot be reliably identified by questions about their education level, as education does
not always predict literacy—it only measures the number of years an individual attended school.
Indeed, about one-quarter of participants who scored at the very lowest of 5 literacy levels in the
2003 U.S. Department of Education’s National Adult Literacy Survey were high school
graduates.
NVS LIMITATIONS
The full TOFHLA version is the standardized instrument from which the short version was
derived, so its psychometric properties are an appropriate reference standard for the development
of new instruments. Health literacy is a complex construct that encompasses many aspects of how
individuals use health information and the health care system. Test research has shown the
TOFHLA and the REALM, (Rapid Estimate of Adult Literacy in Medicine) measures reading
and interpretation skills (ie, general literacy, reasoning, and the ability to use numbers) as applied
to material with health content, rather than all aspects of health literacy.
The psychometric properties of the Spanish version of the NVS, although adequate to screen
patients for limited literacy, were not as good as those of the English version. This fact may stem
from the greater heterogeneity of language and culture among our Spanish- speaking patients,
who come from all regions of South America, Central America, and Mexico.
Testing of the NVS on other patient populations could further validate the accuracy of the
instrument. The NVS has advantages over currently available instruments. Specifically, it is
available in Spanish, whereas the REALM is not, and it can be administered much more quickly
than the TOFHLA.
The NVS also does not have the ceiling effect seen with the TOFHLA and, therefore, particularly
in the English version, the NVS provides better discrimination of skill levels among individuals
in the upper part of the distribution of literacy skills. Future investigations should examine (A)
how to best introduce and implement NVS in primary care practice, (B) the validity of NVS in
other primary care practices and also in non-primary care settings, (C) whether raising clinicians’
awareness of patients’ literacy by using NVS results in improved clinician-patient communication
and better health outcomes, and (D) whether a similar nutrition label scenario can assess literacy
in speakers of languages other than English and Spanish. (9)
DATA ANALYSIS
The NCVAMC diabetes study will use means, standard deviation (SD), standard error of the
means, histograms, t tests, and analysis of covariance to summarize the participant’ demographic
characteristics and their performance on the tests. Participant items on the NVS will be accorded
1-point for each correct answer. Reliability of the NVS will in terms of internal consistency
(Cronbach 2005). Criterion validity is determined by calculating the correlation (Pearson r)
between scores on the NVS. Quantify the relative accuracy of age, educational level, and NVS
scores as predictors of adequate literacy. The ROC will be used to calculate the sensitivity and
specificity for selected cutoff scores on the NVS test. Stratum-specific likelihood ratios will be
calculated for each NVS score. (9)
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POTENTIAL BENEFITS
The primary goals of quality diabetes education and communication are:
A. Provide patient knowledge and skill training
B. Help individuals identify barriers
C. Facilitate problem-solving and develop coping skills to achieve effective self-care
management and behavior change that produce a positive health outcome for the
patient/provider team. (10)
All health communication interventions directed towards patients must be individualized and
delivered to enhance comprehension and understanding among patients with low literacy.
Intervention patients (low literacy) should receive intensive disease management from a
multidisciplinary team. Control patients should receive an initial management session and
continue with usual care regimen, but be monitored for changes at regular patient appointments.
Poor Diabetes control is a common state, especially among poor and elderly patients that is
revealed in other national studies. Within the VA healthcare system today, the average VA
patient age is 62-year old male. VA patients, for the most part are male, with many patients
suffering from multiple chronic disease states that can adversely impact their health outcomes and
safety, due to poor communications, comprehension and understanding of their basic health state
and treatment. (10)
In addition, patients with low health literacy levels produce a complex array of communications
difficulties, such patients report worse health status and have less understanding about their
medical conditions and treatments; they may also have increased hospitalization rates, and
increased use of costly emergency room facilities (11). While a variety of methods have been
recommended and studied for communicating with patients who have limited literacy skills, our
research of health literacy and health care literature found little experimental research to
determine which method(s) is optimal and leads to the best health outcomes. Such ongoing
research is vital to developing optimal levels of patient safety and quality of outcomes for all
health care stakeholders.
POTENTIAL RISKS
None: There are no procedures, lab tests, drug or medical interventions
2: HbA1c Survey---Understanding Patient’s Knowledge of Their HbA1c Level
OBJECTIVE—Knowledge of one’s actual and target health outcomes (HbA1c values) is
hypothesized to be a prerequisite for effective patient involvement in managing chronic diseases
such as diabetes. We will research:
A. The frequency and correlates of knowing one’s most recent HbA1c test result.
B. Whether knowing one’s HbA1c value is associated with a more accurate assessment of
diabetes control and better diabetes self-care understanding, self-efficacy, and behaviors related
to glycemic control. (2,3)
A growing body of evidence suggests that patients with chronic diseases, such as diabetes who
are engaged and active participants in their health care have better health outcomes (12, 13). For
example, patients who have completed chronic disease self-management training programs have
improved self-efficacy and physical functioning and less acute care use than non-participants.
Chronic illness care self-efficacy is positively associated with health outcomes.
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Respondents who know their HbA1c values reported significantly better diabetes care
understanding and assessment of their biomedical level of glycemic control than those who did
not. Our findings in other studies support the importance of providers actively discussing HbA1c
test results with patients and ensuring that patients understand the meaning of their HbA1c
level. In other studies (14, 15) Knowledge of HbA1c alone, however, was not always associated
with better diabetes care self-efficacy and self-management behaviors.
As with other areas of diabetes care; knowledge of one’s last HbA1c value appears to be useful
but not always sufficient for translating increased understanding of diabetes care into the
increased confidence and motivation necessary to improve patients’ diabetes self-management.
Strategies to provide information must be combined with other behavioral strategies to motivate
and help patients effectively manage their diabetes.
It is our goal to research into these other socio-demographic areas to build strong patient profile’s
that combine knowledge of patient’s health literacy level, understanding of the importance of
their HbA1c level, and how socio-demographic factors impact patient’s as a member of a diabetic
attitudinal factor-group with shared traits, feelings, attitudes and opinions.
INSTRUMENT
We will use a three-question survey to measure diabetic patient’s knowledge of their reported and
actual HbA1c level. Regular testing of HbA1c values is now the principal way to measure and
track glycemic control in diabetes patients. Because of its importance, as a major marker of
disease control, it makes sense that patient knowledge of their recent and target HbA1c values
will be a useful precondition for involvement in diabetes management and education. HbA1c
variables will be extremely important to our study, in relationship to health literacy, education
and socio-demographic variables impacting diabetes education and adherence.
Principle Variables: Refer to variables list on pages 3 and 4
1. Question: What has your HbA1c (sugar-blood level) been in the past 12-months?
Respondents can choose one of six response categories:
●<7
● Between 7 and 8
● Between 8 and 9
● Between 9 and 10
● >10
● I don’t know.
We can classify respondents as knowing their HbA1c value if their actual test result was within
0.5 percentage points of the lower or upper boundary of the chosen response category. For
example, if respondents reported that their HbA1c was <7, they were grouped as knowing their
HbA1c if their recorded HbA1c was <7.5. Respondents were coded as not knowing their value if
their estimate differed by >0.5% percentage points or if they responded, "I don’t know."
DATA ANALYSIS
To assess whether respondents had a biomedically accurate assessment of their HbA1c value, we
will create a variable comparing the self-evaluation of the level of diabetes control in the past 12
months with the actual HbA1c test value. On our survey, respondents will be asked whether,
based on their HbA1c value in the past 12 months, their diabetes was in excellent, good, fair, or
poor control. We will classify respondents as having an accurate assessment of their HbA1c
value if they evaluated their diabetes control as poor and have HbA1c values >8.5; reported "fair"
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and have HbA1c between 7.5 and 8.5; or reported "good" or "excellent" and have HbA1c 7.5/<.
Results of this table will be incorporated into the proposed Table. (16)
Table —Comparison of respondents reported HbA1c with their most recent
documented HbA1c
Actual HbA1c level (%)
< 7 7-8 8-9 9-10 >10
Reported HbA1c level (%)
<7
7-8
8-9
9-10
>10
I Don’t Know
(1) excellent (2) good (3) fair (4) poor control.
To assess diabetes care self-efficacy, we will use a validated four-item scale, with higher scores
reflecting higher self-efficacy in managing diabetes. This measure has been associated with
glycemic control in prospective studies. To assess self-care behaviors related to glycemic control,
we used respondents’ answers to a validated measure asking on how many of the past 7 days
(days 0–7) they performed the following as their doctor/nurse had recommended: take diabetes
medications, follow a diabetic eating plan, exercising, and monitoring blood glucose.
We will explore patient, provider, and health care system characteristics associated with knowing
one’s most recent HbA1c value. We also will use multivariate linear and logistic regression to
assess whether knowledge of one’s last HbA1c was associated with an accurate assessment of
one’s level of diabetes control, diabetes care understanding, self-efficacy, and self-management
behaviors related to glycemic control.
2. Question: How well do you understand the importance of knowing your HbA1c level in
managing your diabetes? Question from (DCP) Diabetes Care Profile.
To evaluate self-rated understanding of diabetes care, we will use the following question from the
Diabetes Care Profile, Michigan Diabetes Research and Training Center, University of Michigan,
Ann Arbor, MI (17).
Question, "How well do you understand how to manage your diabetes?" Higher values of this
measure rated on a 1–5 Likert scale reflected higher levels of self-reported understanding. To
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assess diabetes care self-efficacy, we will use a validated four-item scale, with higher scores
reflecting higher self-efficacy in managing diabetes.
This measure has been associated with glycemic control in prospective studies. To assess self-
care behaviors related to glycemic control, we will use respondents’ answers to a validated
measure asking on how many of the past 7 days (days 0–7) they performed the following five-
items as their doctor had recommended: take diabetes medications, follow a diabetic eating plan,
and monitor blood glucose, exercising, and monitoring blood glucose. Because adherence in one
area of diabetes care does not correlate strongly with adherence in others, we can examine each
behavior separately. We will review medical records and laboratory data to document
respondents’ most recent HbA1c results taken within 12 months before the survey. If respondents
have no documented HbA1c results in the prior 12 months, we will record this value as missing.
(18)
RELIABILITY, VALIDITY, AND ACCURACY
Reliability and validity of 4-point and 6-point Likert scales can be assessed using a new model-
based approach to fit empirical data. Different measurement models will be fit by confirmatory
factor analyses of a multitrait-multimethod covariance matrix. For example, 165 graduate
students responded to nine-items measuring three quantitative attitudes. Separation of method
from trait variance led to greater reduction of reliability and heterotrait-monomethod coefficients
for the 6-point scale than for the 4-point scale. (19)
Criterion-related validity was not affected by the number of scale points. The issue of selecting 4-
point versus 6-point scales may not be generally resolvable, but may rather depend on the
empirical setting and the subjects among other things. Response conditions theorized to influence
the use of scale options are discussed to provide directions for further research.
Since Likert (1932) introduced the summative rating scale, now known as the Likert-type scale,
researchers have attempted to find the number of scale point item response options that maximize
reliability. Findings from these studies are contradictory. Some have claimed that reliability is
independent of the number of scale points (Bendig, 1953; Boote, 1981; Brown, Widing,&Coulter,
1991; Komorita, 1963; Matell & Jacoby, 19719 Peabody, 1962; Remington, Tyrer, Newson-
Smith, & Cicchetti, 1979). Others have maintained that reliability is maximized using 7-point
(Cicchetti, Showalter, & Tyrer, 1985; Finn, 1972; Nunnally, 1967; ~arnsay, 1973; Symonds,
1924), 5-point Reliability and validity of 4-point and 6-point. (19)
In a University of Michigan study, (20) the DCP and several previously validated scales were
administered to individuals with diabetes receiving care at a university medical center (n = 352).
Cronbach's alphas of individual DCP scales ranged from .60 to .95 (Study 1) and from .66 to .94
(Study 2). Glyco hemoglobin levels correlated with three DCP scales (Study 1). Several DCP
scales discriminated among patients with different levels of disease severity. The results of the
studies indicate that the DCP is a reliable and valid instrument for measuring the psychosocial
factors related to diabetes and its treatment. We will review medical records and laboratory data
to document respondents’ most recent HbA1c results taken within 12 months before our survey.
If respondents had no documented HbA1c results in the prior 12 months, we will record this
value as missing.
DATA ANALYSIS
In our NCVAMC study, we will conduct bivariate and multivariate logistic regression analyses.
Higher values of this measure rated on a 1–5 Likert scale reflect higher levels of self-reported
understanding. To assess diabetes care self-efficacy, we will use a validated four-item scale, with
12
higher scores reflecting higher self-efficacy in managing diabetes. This measure has been
associated with glycemic control in prospective studies. To assess self-care behaviors related to
glycemic control, we will use respondents’ answers to a validated measure asking on how many
of the past 7- days (days 0–7) they performed the following as their doctor/nurse had
recommended: take diabetes medications, follow a diabetic eating plan, exercising, and
monitoring blood glucose.
In addition, for all three questions in our diabetes survey, we will conduct bivariate and
multivariate logistic regression analyses to explore patient, provider, and health care system
characteristics associated with knowing one’s most recent HbA1c value. We also will use
multivariate linear and logistic regression to assess whether knowledge of one’s last HbA1c was
associated with an accurate assessment of one’s level of diabetes control, diabetes care
understanding, self-efficacy, and self-management behaviors related to glycemic control.
3. Question: "My VA doctor answers my diabetic treatment questions fully and carefully"
To evaluate thoroughness of provider communication, we will assess the degree to which
respondents agreed with the following statement from the well-validated Autonomy Support
Scale: "My VA doctor answers my diabetic treatment questions fully and carefully" (with
five response categories from "strongly disagree" to "strongly agree") (15, 16). Because responses
are positively skewed toward the highest rating, we will dichotomize responses between those
who "strongly agreed" with the statement versus all other responses. We also will have mean
number of outpatient visits in the prior year (continuous), and duration of the relationship with
the doctor who takes care of the patient’s diabetes (<6 months, 6 months to 1 year, 1–5 years, >5.
(21, 22)
LIMITATIONS
The VA HbA1c study has a number of limitations. First and most importantly, its cross-sectional
design does not allow us to establish that patients’ assessment of their diabetes self-management
was causally associated with glycemic control. Patients with better glycemic control may evaluate
their self-management as better than those who have more serious disease and higher HbA1c
levels, and those patients who receive more recommended services may also have better reported
self-management for another reason not measured in our analyses.
Regarding this point, it is worth noting that patients’ reported self-management might not be
associated with either of our two measures of health services use. This lack of association
suggests that fewer outpatient visits is not the reason patients who evaluate their self-management
poorly are less likely to receive necessary tests.
Second, this VA study population will probably consist predominantly of males and older age
groups, based on the current overall demographics of the NCVAMC population. We will make
every effort to include qualified female VA diabetic patients in this study. Important note, our
findings may not be generalized to younger or predominantly female populations and should be
repeated in other settings.
Third, it is important to emphasize that the measure we used provides both a general assessment
of how difficult patients found carrying out recommended activities in five areas of diabetes self
care and their evaluation of their level of success in undertaking these activities. Future research
should explore how the scale we will use in this study correlates with self-reported measures that
provide more precise descriptions of the frequency with which respondents performed various
self-care activities and with scales explicitly assessing patients’ "self-efficacy". It would also be
13
useful to evaluate the utility of this scale in measuring the impact of outpatient education
programs and other interventions on patients’ assessments of their diabetes self-management.
Potential Benefits
The primary goal of diabetes communication/education is to provide knowledge and skill
training, as well as to help VA patients identify barriers, facilitate problem-solving and develop
coping skills to achieve effective self-care management and behavior change that produce a
positive health outcome for the patient/provider team. We need some decision making data for
VA management to plan new educational and communication intervention designed to help
reverse a 48% drop out rate among high-risk diabetes patients not involved actively in their
diabetes treatments. (23)
Diabetes in 2007 impacted over 23 million people (about 9.0 % of the population) in the United
States. In addition, an estimated additional 14 million people in the United States have diabetes
and don't even know it. From an economic perspective, the total annual cost of diabetes care in
2007 was estimated by American Diabetes Association to be $137-billion dollars in the United
States. The per capita cost resulting from diabetes in 2007 amounted to $16,071.00; while
healthcare costs for people without diabetes incurred a per capita cost of $4,699.00. During this
same year, 16.9 million days of hospital stay were attributed to diabetes, while 36.3 million
physician office visits were diabetes related. These numbers reflect only the population in the
United States. Globally, the diabetes statistics are staggering.
POTENTIAL RISKS
None: There are no procedures, lab tests, drug or medical interventions
3: Q-Methodology Survey: Understanding Socio-Demographic Variables
Influencing Diabetic Patient Behaviors.
OBJECTIVE
Q-Methodology Survey—Reaching High-Risk NCVAMC Diabetes Patient Groups
We know more about the importance of prevention in medicine than we do about how to achieve
it. We are learning that efforts must be targeted to patient groups most-at-risk. Those people are
often disadvantaged in several ways beyond health. Attitudes about their disease state(s), stress,
anger and fear and other social challenges interfere with a patient’s treatment efforts. We have a
very limited understanding of how to change self-destructive behavior in substance use, nutrition,
exercise and family life, as it relates to the individual treatment needs of the high-risk diabetic
patients.
But, case studies of high-risk patient’s from around the country suggest that carefully developed
plans in these areas will yield good returns-on-investment of time, resources, and human capital
including systemic efforts. The cost of the failure in prevention is often borne by the VA
healthcare provider, who takes care of large and very diverse groups of American veterans, as is
the case with the North Chicago VA Medical Center; including not only veterans, but tens-of-
thousands of active duty military personnel and their dependents.
Q-Methodology
Q-methodology was invented in 1935 by British physicist-psychologist William Stephenson
(1953) and is most often associated with quantitative analysis due to its involvement with factor
analysis. Statistical procedures aside, however, what Stephenson was interested in providing was
a way to reveal the subjectivity involved in any situation -- e.g., in aesthetic judgment, poetic
14
interpretation, perceptions of organizational role, political attitudes, appraisals of health care,
experiences of bereavement, perspectives on life and the cosmos It is life as lived from the
standpoint of the person living it that is typically passed over by quantitative procedures, and it is
subjectivity in this sense that Q-methodology is designed to examine and that frequently engages
the attention of the qualitative researcher interested in more than just life measured by the pound.
Q-methodology "combines the strengths of both qualitative and quantitative research traditions"
and in other respects provides a bridge between the two. (24)
The instrumental basis of Q-methodology is the Q-sort technique, which conventionally involves
the rank-ordering of a set of statements from agree to disagree. Usually the statements are taken
from interviews or focus groups, hence are grounded in concrete existence; for purposes of
convenience, however, the Q-sample in this example consisted of 24 statements taken from
Larson's (1984) CARE-Q set. (Q-samples can also be composed of pictures, recordings, and any
other stimuli amenable to appraisal.) K was initially invited to characterize the care rendered by
his surgeon by sorting the 24 statements (each typed on a separate card) into a quasi- normal
distribution ranging from "most like the care given by my surgeon" (+4) to "most unlike" (-4), the
result being the Q-sort shown in Table 1. The Q-sorting session was followed by a focused
interview during which K was invited to expand on his experience.
Table 1: (Example)
A Q-Sort Representing Surgeon's Care
-4 -3 -2 -1 0 +1 +2 +3 +4
----------------------------------
1 3 10 4 5 2 11 6 20
9 21 13 18 7 14 12 8 24
22 23 15 17 19
16
In this example, K agreed most strongly with statements 20 and 24, and disagreed in equal
measure with 1 and 9, which read as follows: (25)
20. was honest with me about my condition
24. gave me good physical care
1. volunteered to do "little" things for me
9. touched me when I needed comforting
As is apparent, the surgeon's care was of a "professional" kind -- competent, informative, direct --
and this was all that K desired and expected.
Q- Methodology Diabetes Sort Statements
26-SAMPLE Q-STATEMENTS: (EXAMPLES)
I am afraid of my diabetes.
Diabetes education is very important to me
It’s hard to do all the things needed in my diabetes care.
15
I feel satisfied with my life.
My VA diabetes education is useful.
I am able to handle my feelings (fear, worry, anger) about my diabetes.
I am able to keep my blood sugar in control.
I have a hard time managing my diabetes.
I’m able to do the things to help my diabetes (diet, medicine, exercise, etc.)
I feel dissatisfied with life because of my diabetes.
My VA diabetes education is over my head.
My family or friends are a big help in my diabetes care.
I find it hard to exercise, follow a diet plan and take meds
It easy to understand my doctor’s instructions and information
I am pretty well off, all things considered.
I have problems with reading and understanding the doctor and nurses
I feel unhappy and depressed because of my diabetes.
My family or friends help and support me a lot in my diabetes care
I need help from my family or friends for my diabetes care
I can’t understand the doctor or nurse instructions
I feel down or have the blues, because of my diabetes
I know the importance of my blood sugar level
I don’t understand what my blood sugar level is.
I feel in control of my diabetes
I don’t understand my diabetes treatment directions
I’m worried, fearful and stressed managing my diabetes
Q-INSTRUMENT
Data = Q-sort (A respondent constructed representation of feelings about the subjective topic in
the context established by the researcher)
16
◘ Clinical uses of individual Q-sorts as a guide for structuring follow-up interviews with
respondents
◘ Assessment of interpersonal skills
o empathy and sensitivity to patient needs
o development of communication and education skills
o counseling skills
o negotiation dynamics
o basis of comparison of researcher’s self perception of interpersonal skills with the
perception of a standardized patient regarding the researcher’s interpersonal skills
◘ Data reduction tool for collection of many Q-sorts = person-person factor analysis
◘ Generates factor space and permits inductive interpretations
◘ Useful in structural analysis of subjectivity
◘ Become the basis for data analysis of multi-respondent (extensive) R-method studies (24, 25,
26, 27)
VARIABLES
Requirements for conduct of the study require that data be:
Contextually relevant
Responses/statements in subjects’ “own words”
Uninfluenced by researchers’ own views
Unconstrained by theoretical framework
Unrestricted by constraints of multiple choices, true/false, rating scales
A. Standard statistical research measures compare by individual items in which the variables are
the individual items at question.
B. We propose to compare the subject’s attitudinal response to the research topic with those of all
other subjects. In this case, we will use the individual subject as the unit of measure. We then use
each question as contributing to the subject’s attitude.
Condition of Instruction
Q-SORT
EXECUTION
17
CONCOURSE
Q-SAMPLE
C. The individual subject is then the independent variable.
The patients’ attitudes are then analyzed by mathematical factor analysis techniques. The output
of this process is a list of clusters (or factor types) with accompanying identification of the
patients comprising membership of each group. These factor types can be viewed as dependent
variables. What factor analysis does is this: it takes thousands and potentially millions of
measurements and qualitative observations and resolves them into distinct patterns of occurrence.
It makes explicit and more precise the building of fact-linkages going on continuously in the
human mind.
Study Hypothesis
There exist multiple medical literacy levels or types, within the VA patient population. These are
identifiable and describable, each factor type having distinct characteristics. In addition we want
to measure socio demographic variables, such as fear, worry and stress and their potential impact
on diabetes education and patient retention, and how they impact patient compliance and safety.
Materials to be used
Focus group questions and transcripts, survey instruments, SPSS factor analysis software
DATA ANALYSIS AND SCORING
Q-factor analysis
● Proceeds from inter-correlated individual Q-sorts
This results in a small number of homogeneous “person clusters,” (factor
Groups).
Q-factor analysis performed
● Factor analysis inter-correlated Q-sort-sort matrix using standard methods
Respondents = variables; statements = stimuli (by-person factor analysis)
Factor extraction by centroid method chosen for its indeterminacy
● Rotation of axes statistically to produce simple factor structure, each with its own exclusive
Set of Q-sorts.
Analytic software used
● Standard factor analysis procedures in statistical packages, examples (SPSS, Varimax
Rotation, SAS)
Interpretation – factor structure
● A very small set of attitudinal clusters (usually 1-6 factor groups) results from the
indeterminate factoring process
● A set of shared perspectives which emerge entirely from within the sorters operations on
The Q-set under conditions of instruction
● Expect factors to emerge
● How many factors and what each mean are indeterminable
Quantitative by person factorization produces:
● Factor definers
Q-sorts that load very strongly on only one factor
18
● Factor loaders
All Q-sorts with a statistically significant loading on one or more factors
● Factor scores
Theoretical Q-sorts obtained by weighting all definers on one factor at a time
Interpretation – finding meaning
● Assess degree of factor correlations
● Cross comparison of the Factor Scores (synthetic Q-sorts) across the factors
● Compare/contrast areas of high/low neutral item salience
● Look for areas of consensus and divergence
● By the process of induction, ascribe tentative meanings to the different factors
Based on the meaning, describe new hypotheses which may subsequently be tested with
standard variance analytic methods and/or large group surveys. (28, 29)
RELIABILITY, VALIDITY, AND ACCURACY
Assessing the validity of qualitative research
There are no mechanical or "easy" solutions to limit the likelihood that there will be errors in
qualitative research. However, there are various ways of improving validity, each of which
requires the exercise of judgment on the part of researcher and their team. (30)
Triangulation
Triangulation compares the results from either two or more different methods of data collection
(for example, interviews and observation) or, more simply, two or more data sources (for
example, interviews with members of different interest groups). The researcher looks for patterns
of convergence to develop or corroborate an overall interpretation. This is controversial as a
genuine test of validity because it assumes that any weaknesses in one method will be
compensated by strengths in another, and that it is always possible to adjudicate between different
accounts (say, from interviews with clinicians and patients). Triangulation may therefore be
better seen as a way of ensuring comprehensiveness and encouraging a more reflexive analysis of
the data (see below) than as a pure test of validity.
Respondent validation
Respondent validation, or "member checking," includes techniques in which the investigator's
account is compared with those of the research subjects to establish the level of correspondence
between the two sets. Study participants' reactions to the analyses are then incorporated into the
study findings. Some researcher’s view this as the strongest available check on the credibility of a
research project. (31). For example, the account produced by the researcher is designed for a wide
audience and will, inevitably, be different from the account of an individual informant simply
because of their different roles in the research process. As a result, it is better to think of
respondent validation as part of a process of error reduction which also generates further original
data, which in turn requires interpretation. (32)
Clear exposition of methods of data collection and analysis
Since the methods used in research unavoidably influence the objects of inquiry (and qualitative
researchers are particularly aware of this), a clear account of the process of data collection and
analysis is important. By the end of the VA study, it should be possible to provide a clear account
of how early, simpler systems of classification evolved into more sophisticated coding structures
and thence into clearly defined concepts and explanations for the data collected. Although it adds
to the length of research reports, the written account should include sufficient data to allow the
reader to judge whether the interpretation proffered is adequately supported by the data.
19
Reflexivity
Means sensitivity to the ways in which the researcher and the research process have shaped the
collected data, including the role of prior assumptions and experience, which can influence even
the most avowedly inductive inquiries. Personal and intellectual biases need to be made plain at
the outset of any research reports to enhance the credibility of the findings. The effects of
personal characteristics such as age, sex, social class, and professional status (doctor, nurse,
physiotherapist, sociologist, etc) on the data collected and on the "distance" between the
researcher and those researched also needs to be discussed.
Attention to negative cases
As well as exploration of alternative explanations for the data collected, a long established tactic
for improving the quality of explanations in qualitative research is to search for, and discuss,
elements in the data that contradict, or seem to contradict, the emerging explanation of the
phenomena under study. Such "deviant case analysis" helps refine the analysis until it can explain
all or the vast majority of the cases under scrutiny.
LIMITATIONS
Advantages Challenges Ways forward
holistic a more accurate reflection
of complex reality
investigation can be so all-
encompassing that it is
difficult to focus
continual refinement of
hypotheses to focus
investigation
recognition of
multiple
realities
more balanced
representation of different
stakeholders
may be difficult to reconcile
differences and assess how
representative they are
careful targeting
heuristic,
interpretative
and inductive
a better understanding of
processes
again investigation can be so
all-encompassing that it is
difficult to focus
• continual refinement of
hypotheses
• skilled and focused probing
• systematic use of computer
analysis
requires in-
depth face-to-
face field work
better rapport with
respondents and more
continuous contact leading
to more accurate
information
• requires skilled
investigators
• training and close
supervision of field assistants
central
importance of
outside
researcher
external understanding
may enable a more
balanced understanding
than that of insiders
investigation may be overly
influenced by the subjective
views of the researcher
• continually reflecting on
own biases and prejudices
• detailed recording
20
focus on
information
from
individuals as
well as groups
Better understanding of
difference and ability to
get sensitive information
• may be difficult to
reconcile differences and
assess how representative
they are
• the close relationship
may give greater scope for
manipulation and false
application by informants
• raises ethical issues of
confidentiality
• Detailed recording
• Triangulation
• Developing good levels of
rapport
• Adherence to ethical code
record what is
happening
rather than
influencing
events
Information may be more
reliable if the investigation
is not influenced by
expectations or fear of
consequences.
The assessment process is
extractive and may not make
a contribution to program or
policy development
• Attention to methods of
dissemination
BENEFITS
Q-Methodology Strengths
● Does not generalize beyond the immediate respondent set
● Use qualitative methods to allow respondents to say something about their own
subjective attitudes that can be tested
● Uses quantitative factor analysis data reduction and induction to generate testable
hypotheses
POTENTIAL RISKS
None. There are no procedures, lab tests, drug or medical interventions
4. NCVAMC Diabetes Communications and Education Interventions: The Key
to Improved Diabetes Education, Compliance and Patient Safety
The Indian Health Service, (IHS) a division of the U.S. Department of Health and Human
Services has one of the largest and most successful diabetes treatment programs in the United
States. The mission of the IHS, in partnership with American Indian and Alaska Native people, is
to raise their physical, mental, social, and spiritual health to the highest level. The IHS goal is to
ensure that comprehensive, culturally acceptable personal and public health services are available
and accessible to all Indian people.
American Indian and Alaska Native communities suffer a disproportionately high rate of type 2
diabetes when compared with other populations in the U. S. and throughout the world. According
to the 2007 U. S. Census there are 3.3 million American Indians and Alaska natives; 16.3% of
this population has been diagnosed with diabetes (compared to 8.7% of non-Hispanic white
population) with 95% of American Indians and Alaska Natives with type 2 diabetes.
The IHS, since 1995, has been actively engaged in designing and developing, “best practices,” for
diabetes patients who are impacted by major socio-demographic factors and challenges with
health literacy. The IHS has used their “best practices,” over the years, but has not engaged them
in concert, outside of the IHS with a significantly challenged > 9.5% HbA1c high risk population,
such as the NCVAMC population. We are recommending using a number of tested and proven
21
“best practices,” of the IHS in concert at the North Chicago VA Medical Center to improve
diabetes education compliance and patient safety.
We recommend adding the following IHS diabetes “best practices” to the NCVAMC diabetes
health care patient practice to increase VA patient compliance and safety.
1. Developing a Case Management Based Approach for Driving NCVAMC Quality
Diabetes Education and Patient Safety.
2. Adding Six Key Questions to every NCVAMC Diabetes Health Care Visit, and ABC
questions, and three question HbA1c survey
3. Develop NCVAMC Diabetes Team Provider Interventions with their Diabetes Patient’s
that include the following three steps
Step 1: Increasing VA Patient’s Knowledge about their Diabetes
Step 2: Knowing the ABC’s of Quality VA Diabetes Care
Step 3: Importance of Getting Regular VA Health Care Visits and Keeping a
Longitudinal VA Diabetes Patient Care Record that is Understandable and Useful to the
Patient
Hypothesis
We expect to find high levels of North Chicago VA Medical Center diabetes patient’s with
challenges involving their health literacy and treatment regimes; socio-demographic factors (fear,
stress, worry, and cultural issues); discovering patients with a lack-of-understanding of the VA
healthcare brand. These factors of challenged health literacy, socio-demographic, and low brand
awareness of the benefits of VA healthcare have produced hundreds of high-risk, >9.5% HbA1c
NCVAMC diabetes patient’s that avoid attending and participating in VA educational
intervention, designed to enhance their healthcare knowledge, quality-of-life and safety.
What is a Brand?
A brand is an intangible asset that resides in people’s minds, which is defined by the expectations
people have about the benefits they will receive. These expectations of benefits are developed
over time by communication, and more importantly—by actions.
Understanding the Role of Patient and Provider Communications
A successful patient-provider relationship is a partnership where the provider brings medical
knowledge to diagnose and treat, and the patient contributes to his/her health and recovery
by providing useful and necessary information and by acting on the recommendations and
advice provided. As part of their responsibility towards the well-being of individuals, health
care providers must not only alleviate patients from disease but are also obligated to educate them
in a culture of prevention and promoting health-oriented behavior in all areas of their daily life.
Both written and oral communications are critically important in building strong patient-provider
relationships. The interaction between oral and written language is decisive to health care
promotion and to enabling patients to become effective health care partners. Written material,
including handouts, leaflets, brochures and written medication instructions, can enhance patient-
provider encounters and are extremely useful, since they can be consulted wherever and
whenever patients need to do so. To be effective and to promote adoption and use of health
information, written materials must reflect an understanding of the patient’s way-of-life; their
feelings, attitudes and opinions must be addressed in designing new integrated communication
interventions.
The Health Information Gap
22
Bridging the information gap between patients and their health care providers is a major hurdle to
improving overall health literacy. According to a Roper poll (33) in 2002, 70 percent of
physicians say they provide patients with additional resources that help them understand their
medications, but just 41 percent of those patients say they have received this kind of assistance.
In addition, many patients simply are either unaware of or unwilling to admit to having difficulty
with health care information.
Health literacy is a multidimensional issue. The understanding of written materials and the
adequacy of patient-provider communications have been the subject of extensive health literacy
work to date. Issues involving socio-demographic factors (fear, stress, worry) and cultural
relevance and sensitivity also have become part of the mix, as the diversity of the U.S.
population, which requires that appropriate messages and images be tailored to meet the diverse
values, beliefs, attitudes and traditions of those receiving the healthcare information.
It is important to distinguish health literacy from health education and health communication.
Health literacy is the goal; health education is one tool for reaching that goal. Similarly, the terms
"health literacy" and "literacy" should not be freely interchanged. Health literacy encompasses
more than just the ability to read written materials; it also means understanding the information so
that a person can take an active role in managing his or her health care outcomes, and levels of
safety.
A 2007 Study, “Does literacy education improve symptoms of depression and self-efficacy in
individuals with low literacy and depressive symptoms, concluded that among persons with low
literacy and symptoms of depression, depression symptoms lessen as self-efficacy scores improve
during participation in adult basic literacy education. (34)
NCVAMC Diabetes Educational Interventions
Current ENDOCRINE Section Diabetes Education, North Chicago VA Medical Center,
North Chicago, IL
A serious gap currently exists between the promise and the reality of diabetes care at the North
Chicago VA Medical Center, resulting in hundreds of VA diabetic patients experiencing lower
levels of compliant in their diabetic treatment regime, adding millions of dollars in additional
health care costs. Practical interventions that facilitate collaborative relationships, case
management and foster greater VA patient-centered practices are the key to closing this gap. The
5,500 diabetic patients at the North Chicago VA Medical Center are under treatment within all
the major clinical sections. Today, patients receive diabetes treatment information and education
from many sources with the NCVA medical center.
NCVAMC Diabetes Education Protocols
Patients are referred to the RN/DCE (Diabetes Certified Educator) from NCVAMC Primary Care
or Mental Health Clinic
Patients are evaluated in a consultation appointment for either individual or group education in
the ENDOCRINE Section
1. Individual consultation with the diabetes nurse educator for assessment and
recommendations IF a specific need is assessed by the referring provide or if the patient is
unable to attend group class.
INDIVIDUAL appointments are scheduled during Endocrine Clinic times. It is at the individual
appointment that the patient has VITAL signs taken, a education history is taken, their glucose
23
meter is uploaded and problem focused teaching is provided (usually with follow up a couple of
weeks later)
2. GROUP class for the majority of patients referred for “education” (no specific needs
assessed by the requesting provider). Lunch is included in the class educational training
session
In the GROUP class (offered twice per month from 9 a.m. to 2 p.m.) patients bring in a diabetes
health and education history form that they completed at home. The form is reviewed and
documented in the progress note. NO VITAL signs are taken at class.
In the diabetes education class, patients perform their own CAPILLARY GLUCOSE test (not HgbA1c)
before eating lunch and again 2-hours AFTER eating lunch. For patients not yet monitoring their blood
sugars, glucose meter kits/instructions are supplied at the class and instruction/demo of meter use if
provided during this blood sugar check.
The NCVAMC diabetes education curriculum includes:
Basic diabetes management concepts (taught by RN, CDE)
Foot Care – foot care/skin care/when to seek help (taught by Podiatrist)
Nutrition – basic information on healthy eating (taught by RD,CDE)
Medication – basic information on oral/insulin treatment (taught by Pharm D)
Exercise – benefits (taught by Kinesiotherapist)
The NCVAMC ENDOCRINE Education Team consists of: (RD, Podiatrist, Pharmacist, KT
and RN) is only together twice per month for the group education class.
At the conclusion of class, patients are offered 1:1 follow up with the diabetes nurse and/or
dietician and provided with our contact phone numbers. Typically patients follow up with the
dietician in 2-4 weeks. There is no routine patient follow up to the group education class, at this
time.
For NCVAMC patients with HgbA1c >9%, 3-4 education follow up visits are suggested to
get these NCVAMC patients more involved in their diabetes self-management. Patients are
scheduled more frequently if they are being followed along with the Nurse Practitioner in our
unofficial diabetes intensive management clinic.
Note: The group diabetes education classes are open to all veterans – with controlled or
uncontrolled diabetes – new onset or long duration of the disease
Developing a New VA Partnership for Clear Health Communication,
Developing a “VA Partnership for Clear Health Communication,” will help NCVAMC
physicians, nurses and clinicians gain access to important patient insight, information and
develop simple practical tools to communicate and build stronger relationships with their patients.
Among these tools is a new patient education program called Ask Me 3 ™and the Indian Health
Service Technique, which are designed to enhance communication and trust in healthcare
relationships.
All NCVAMC diabetes patients should ask six-key questions in every healthcare encounter to
optimize their patient/provider communications and enhance their self-efficacy, resulting in a
more actively engaged and educated patient. In addition for high risk diabetes patients and
patient’s with low health literacy
24
Ask Me 3 ™ promotes three questions to build knowledge, communication and strengthen
relationships between patients and healthcare providers. In a 2007, University of Texas Research
Study designed to implement Ask-Me-3™, a simple program that encourages patients to ask
questions of physicians, in a low-income, predominantly Hispanic pediatric practice was
instituted, resulting in 20% of practice patients were using the Ask-Me-3 technique, after six
months. (35) For the NCVAMC diabetes study we will be using a more focused use of Ask Me 3
and HIS questions relating to actual diabetes treatment and medication compliance.
1. What is my main diabetes problem?
2. What do I need to do?
3. Why is it important for me to do this?
American Indian and Alaska Native communities suffer a disproportionately high rate of type 2
diabetes when compared with other populations in the U. S. and throughout the world. According
to the 2007 U. S. Census there are 3.3 million American Indians and Alaska natives; 16.3% of
this population has been diagnosed with diabetes (compared to 8.7% of non-Hispanic white
population) with 95% of American Indians and Alaska Natives with type 2 diabetes.
Indian Health Service Technique, U.S. Department of Health and Human Services, promotes
three simple, but essential questions for every pharmacy interaction that produces a more
educated and actively engaged patient. In a 2007 Study, “Limited health literacy is a barrier to
medication reconciliation in ambulatory care. Institute for Healthcare Studies, Feinberg School of
Medicine, Northwestern University, Chicago, IL, found that nearly 50 percent of patients taking
antihypertensive drugs in three community health centers were unable to accurately name a single
one of their medications listed in their medical chart. That number climbed to 65 percent for
patients with low health literacy. (36)
4. What is the diabetes medication for?
5. How do I take the medication?
6. What should I expect from the medication?
The 2003, U.S. Department of Education, National Adult Literacy Study revealed that the
average American reads at the 8th-9th grade level; however, health information is usually written
at a higher reading level. Most patients – regardless of their reading or language skills – prefer
medical information that is simple, easy to understand in layman terms.
• Additional socio-demographic factors that hinder quality healthcare outcomes and safety
include:
– Intimidation, fear, vulnerability
– Shock upon hearing a diagnosis
– Extenuating stress within the patient’s family and social environment
– Multiple chronic health conditions to understand and treat
Along with encouraging VA diabetes patients to use the Ask Me 3 and Indian Health Service
Technique approach, other tested techniques can increase patients’ comfort level with asking
questions, as well as increase compliance with a health providers instructions after they leave
appointments. We have adapted these two proven techniques to our own diabetes patient
• Create a safe environment where patients feel comfortable talking openly with health providers
25
• Use plain language instead of technical jargon. Sit down (instead of standing) to achieve eye
level with your patient
• Use simple visual models to illustrate a procedure or condition
• Ask patients to “teach back” the care instructions you gave to them
NCVAMC Diabetes Educational Intervention Focus
Diabetes Self-Management Education (DSME) is recognized as a key fundamental component of
total diabetes care. (33) The goal of DSME is to help patients acquire the knowledge,
information, self-care practices, coping skills, and attitudes required for the effective self-
management of their diabetes. Several reviews and meta-analyses have found DSME
interventions to have a positive impact on diabetes-related health and psycho social outcomes,
specifically increasing diabetes-related knowledge and improving blood glucose monitoring,
dietary and exercise habits, foot care, medication taking, coping, and glycemic control. (34–38)
Individual versus Group DSME Interventions
Although a large body of evidence supports the efficacy of DSME interventions in improving
diabetes-related health outcomes, few studies to date have investigated the impact of the DSME
delivery format on diabetes health-related outcomes. According to Mensing and Norris (39) a
group is “a gathering or an assembly of persons with a common interest.” The Centers for
Medicare and Medicaid Services (CMS) has recommended a group size for diabetes patient
education to comprise from 2 to 22 members, with an average of 8-15 participants, as optimal
to effective learning. (44) Compared to individual-based approaches, group-based approaches
typically invite greater interaction and interpersonal dynamics. Moreover, the group setting can
foster certain educational activities, such as social modeling or problem-based learning better
than the individual setting. (37)
Some providers believe group based DSME is better than individual based DSME at improving
diabetes related health outcomes. Group education is also thought to be less costly than individual
education. (45-46) In fact, the Balanced Budget Act of 1997 provided a further economic
incentive for group-based programs because it specifically recognized diabetes education via a
group format for uniform reimbursement by the CMS.
In recent years, group-based approaches have been associated with several advantages e.g., cost-
effectiveness, patient satisfaction, and interactive learning (43, 45- 46) to date, the literature has
only begun to investigate and describe different approaches to group-based DSME. Although the
evidence supports the efficacy of DSME programs as a whole, variability in program goals,
outcome measures, length of intervention, frequency of sessions, learning format and
demographic background of participants has meant that there is no known best prototype for the
optimal DSME program. (45, 47)
New Focus for NCVAMC Educational Intervention Guiding Principles
Informational research on current DSME standards has identified important basic learning model
principles that we can use to guide the review and revision of the DSME standards for the
NCVAMC Endocrinology Diabetes Educational Intervention focus. These principles are:
VA Patient Learning Models
♦ Adult learning model: supports self management and control. The learning session is related
to personal interactive processes. Incremental, “need to know” information is given in a
supportive and social learning environment. (48)
26
♦ Public health nursing model: focuses on disease prevention and health promotion, with
reductions in long-term complications. (49)
♦ Health belief model: addresses the patient’s belief that behavior change can enhance control
over their diabetes and facilitates this effort. The support of these behavior changes and attitudes
is demonstrated in the methodology and educational materials used. (50)
♦ Trans-theoretical model: incorporates the stages of change, which moves a patient from pre-
contemplation to action by using cognitive learning concepts. The group support concept serves
to enhance the support system, which moves the patient from action to continued compliance
over the long term. (51)
Primary Outcomes Goals for NCVAMC Group-Based DSME Programs
The core empowerment-based principles for new NCVAMC diabetes education intervention
should call for all programs to be patient centered (i.e., focused on concerns and questions
introduced by patients), problem based (i.e., used real problems encountered by participants to
guide the teaching/learning process), culturally relevant, inclusive of the clinical and psycho
social aspects of living with diabetes, and evidence based. (60-65)
1. Patient-Centered
Patients come from unique social and cultural environments; have different learning needs,
priorities, and diabetes self-management experience; and encounter different challenges over the
course of their lives.
2. Problem Based
This approach to learning helps patients acquire the knowledge and skills to solve problems that
are important to them. The learning begins with patient-identified problems and focuses on
helping patients acquire the knowledge and skills needed to address those problems.
3. Socio-Demographic Relevant
Using a patient-centered, problem based approach is by definition culturally and socially relevant
because the education focuses on problems as prioritized and perceived by the patients in the
diabetes program. (62-65)
New NCVAMC Diabetes Educational Intervention Focus
1. Diabetes education is effective for improving clinical outcomes, safety and quality-of-life, in
the long- term (52–58).
2. DSME has evolved from primarily didactic presentations to more theoretically based
empowerment models (54, 59).
3. There is no one “best” education program or approach; however, programs incorporating
behavioral and psycho-social strategies demonstrate improved outcomes (45- 47). Additional
studies show that culturally and age appropriate programs improve outcomes (48–52) and that
group education is effective. (53, 54, 55, 57, 58).
4. Ongoing support is critical to sustain progress made by participants during the DSME program
(54, 64, 70, 71).
27
5. Behavioral goal-setting is an effective strategy to support self-management behaviors in
diabetic patients (57, 72, 73).
Designing New Integrated Communication Education Tools
Effective health communication is the very foundation of the healthcare delivery system.
Inadequate communication affects the spectrum of care, from prevention and screening to history
taking and explaining diagnosis and treatment. (74) As a result, tools and interventions to
improve understanding of health information for all patients must be integrated into written and
oral communications among caregivers, public health officials, patients and their family and
community members.
Although the greatest immediate impact may be focusing on the patient-provider relationship,
addressing this crisis in a meaningful way must go beyond focusing solely on the doctor/patient
dynamic. Holistic approaches that embrace participatory group learning environments,
empowerment health education and peer interaction will be equally critical, as will be the
involvement of our public and private institutions. Health care providers have the opportunity to
effectively communicate with patients during the individual encounters in which they diagnose,
treat or help patients to incorporate preventive health behaviors. In addition, other industry
information providers and health educators have the opportunity to incorporate clear health
communication into their informational pieces, written or verbal, to impact the diverse patient
groups being exposed to their information and educational initiatives.
Create a Blame-Free Environment
It is important for health care providers who encounter an individual exhibiting signs of low
health literacy to create a “blame-free” environment in which the individual with low health
literacy skill levels can seek help without feeling ashamed or stigmatized. Recent trends in 2007
point to overall drops in basic literacy competency across all sectors of American society.
Rethink Spoken Communication
In addition to understanding written communications, adequate health literacy also means that a
person can understand and engage in spoken language communication, or dialogue, that occurs in
a wide range of health contexts. For example, conversations with physicians, nurses, pharmacists
and insurers occur more frequently than they do in written materials. Being able to discuss and
ask questions is necessary to all aspects of healthy behaviors and to informed decision-making.
There is a large body of research in the areas of sociolinguistics, anthropology and reading
research that discusses both the similarities and differences between spoken and written language,
and how together they create the most powerful communication channel.
Revise Written Materials for Greater Understanding
Although innovative alternatives to written materials, such as pictograms, comic strips, videos
and graphics-rich computer-based training programs, should be explored more fully, often the use
of written materials cannot be avoided. Letters, forms, discharge instructions and even hospital
signage all require the use of the written word.
The solution is that written materials for patients with low health literacy be aimed at the fourth to
fifth grade reading level. Most patient education materials and brochures currently included with
medications are written at a 10th-grade reading level or above. (75)
Simple words and short sentences, larger type and generous use of “white” (unprinted) space
should be used when developing these documents. Complicated medical or technical words
should be replaced with simpler wording in layman terms when appropriate.
28
Comic-strip formats have been found to be very useful for presenting a range of patient
information and self-care regimens to patients with low health literacy skills.
When using comic-strip formats or other forms of illustration, however, care should be taken to
ensure that readers don’t find the materials condescending. The objective for any pictorial or
simple image is the same as it is for written materials, that is, to deliver key messages. Images,
therefore, should focus on desired behavior rather than on medical facts, and the information
should be both culturally sensitive and personally relevant. (75, 76 )
5. We Recommend NEW NCVAMC Diabetes Patient Interventions
5.1 Developing a Case Management Based Approach for driving NCVAMC Quality
Diabetes Education and Patient Safety.
We strongly recommend the use of Case Management within the NCVAMC diabetes program as
a catalyst to re-engineer health care, and serve to facilitate coordinated care, reducing
fragmentation, and increasing effective use of resources. Case Management promotes the
development of a comprehensive and mutually agreed upon treatment plan- from the
patient/client’s perspective. This is the primary force in improving adherence to the treatment
plan. Lack of adherence to just the medication portion of the treatment plan is thought to cost the
U.S. national economy $100 billion annually (Moreo, 2002). Case management has the potential
to improve health care outcomes and resource efficiencies, leading to a reduction in costs across
sectors of the VA healthcare system.
Instituting VA Diabetes Case Management
Case Management has been shown to improve adherence to standards of care and patient
outcomes. Several examples might include an RN who coordinates the care of people with
diabetes who are seen by VA or other healthcare providers or an RN/CDE who is actively
involved in the care and follow-up of a set group of people with diabetes.
• Level I: 1 RN coordinates the care and education of the diabetic population.
• Level II: RN Case Manager tracks follow-up, appointments not kept, and people with
diabetes lost to follow-up. Also coordinates the annual diabetes audit.
• Level III: RN Case Manager is an active participant in the care of a set group of people
with diabetes. This could include phone or in-office follow-up for blood sugars and blood
pressure, facilitating medication refills, and so on.
VA Diabetes Team
To meet ADA guidelines, the NCVAMC diabetes program should have a clearly identified
diabetes team with the responsibility of ensuring the quality of all diabetes care offered at
NCVAMC site. The NCVAMC Team should meet and exceed ADA guidelines for quality care.
• Level I: Diabetes Team consists of at least an RN and an RD
• Level II: Diabetes Team is multidisciplinary both in composition and in delivering
services to people with diabetes. A Team must include a physician.
• Level III: At least one team member should be a Certified Diabetes Educator (CDE) and
the program should have achieved both Education Program and Provider Recognition by
the ADA
• Ratio between an RN and diabetes patients: 800 to 1,000 patients to one RN.
VA Patient Education/Self-management Support
All quality diabetes programs have a strong education and self-management support component
to help people actively direct their care and manage their diabetes every day.
29
• Level I: A basic body of diabetes knowledge is taught to each patient.
• Level II: Organized Education Plan with a defined curriculum and lesson plans.
• Level III: Inclusion of empowerment strategies, including support groups, training in
coping skills, and problem-solving/behavior-change interventions as part of self-
management support.
VA Specialty Exams and Services
Diabetes care often requires the services of specialists, both for screening and treatment of
complications (e.g. eye, foot. kidney). Whether a VA site contracts outside for the exams or
provides them on-site, ensuring access to specialty care is an essential part of a diabetes system
• Level I: Most/all screening exams and specialty services are provided by contract
providers.
• Level II: Screening exams and basic services are available on-site.
• Level III: Subspecialty services are available on-site.
Staging of NCVAMC Diabetes Population
The care needs of people with diabetes change as their disease progresses. Following a patient at
high risk for diabetes requires a different set of skills than management of one experiencing end-
stage complications. For example, a program may choose to assign the follow- up of people at
high risk for diabetes to an RN and/or an RD, the care of recently diagnosed diabetics to mid-
level practitioners, and the care of patients with complications to physicians. This fully utilizes
the skills of available staff in a cost-effective manner and matches people with diabetes' needs
with the most appropriate providers.
• Level I: Optimal use of existing diabetes team specialties.
• Level II: Provide prevention/early detection services to people at high risk for diabetes.
• Level III: Resources are specifically directed toward the care of people with advanced
diabetes complications.
STEP 4: HIGH-RISK NCVAMC DIABETES PATIENT INTERVENTION
A serious gap currently exists between the promise and the reality of diabetes care at the North
Chicago VA Medical Center, resulting in hundreds of VA diabetic patients experiencing lower
levels of compliant in their diabetic treatment regime, adding millions of dollars in additional
health care costs. Practical interventions that facilitate collaborative relationships and foster VA
patient-centered practices are the key to closing this gap.
Recent effort’s to aggressively lower blood sugar levels among high risk diabetes patients groups
in a major national study of 10,251 participants has resulted in 460 deaths among study
participants. The ACCORD Study, Action to Control Cardiovascular Risk in Diabetes funded
by the NIH was halted in February 2008 by the National Institute of Health. The primary focus of
the study was to aggressively lower blood sugar levels of high risk patients as a major
intervention to control diabetes. The study was halted for three primary reasons. (92)
●Major study on diabetes and heart disease halted because of 460 unexpected deaths
●Study aimed to cut blood sugar of type 2 diabetics' at high risk of heart attack, stroke
●Risk found in intensively lowering blood sugar of at-risk patients
Medication intervention is only one vital component of total diabetes control, and these points to
the continuing need to expand education and communication interventions among high risk
patient groups, along with medication regimes, as the best long term solution in achieving greater
levels of overall compliance and patient safety.
30
Although primary care physicians, in America today currently provide 80% to 95% of diabetes
care in this country, they cannot do all that is required and often are discouraged that the current
medical system does not function adequately for people with diabetes. Components of aggressive
and comprehensive diabetes care that many physicians find difficult to provide because of various
systems constraints include telephone management of glycemia, ongoing education and
behavioral interventions, risk factor reduction, health promotion, and periodic examination for
early signs of complications. (78)
BUILDING NCVAMC DIABETES PATIENT CENTERED TEAM CARE
The challenge at NCVAMC is to find a way to meet the needs of patients with diabetes by
broadening the care delivery opportunities available to primary care providers (physicians, nurse
practitioners, and physician assistants) and other health care professionals. We see that diabetes
team care meets this challenge by integrating the skills of different health care professionals with
those of the patient and family members into a comprehensive lifetime diabetes management
program. Short- and long-term benefits of diabetes team care include improved glycemic control,
increased patient follow-up, higher patient satisfaction, lower risk for the complications of
diabetes, improved quality of life, and cut millions of dollars in health care costs at North
Chicago VA Medical Center. (79, 80)
For the NCVAMC diabetes team care to succeed, the following elements must be in place:
● Commitment of policy makers (e.g., purchasers of health care, medical directors, benefits
managers, chief executive officers, HR director) to establish and sustain an infrastructure
supportive of VA team care program.
● Reimbursement for the services of core team members proportional to their expertise and
time involved in diabetes team care.
● Regular communication among team members and documentation of provided care. (81)
Forming a NCVAMC diabetes team requires a planning group to do the following:
● Ensure the commitment of NCVA medical center leadership.
● Gain support from VA care providers and other key decision makers within the system.
● Identify team members: Including physicians, RN nurses, clinicians, pharmacists, pharmacist
assistants, nursing assistants, educators, administrative assistance, HR, management persons,
including support staff and other medical assistants, and VA volunteers.
● Identify the patient population. (use information from the NCVAMC proposed study)
● Stratify the patient population according to the intensity of services needed. (use information
from the NCVAMC proposed study).
● Assess VA resources and other potential outside assets
● Develop a system for coordinated, continuous, quality care.
31
● Evaluate outcomes and adjust services as necessary. (82, 83)
Team composition will vary according to patient need, patient load, organizational constraints,
resources, clinical setting, and professional skills. A VA diabetes core team usually includes a
physician, nurse, and a dietitian, at least one of whom is a certified diabetes educator. Many other
health professionals can be team members or collaborative consultants if needed. It is essential
that a key individual coordinate the team effort at all levels.
It is easier to coordinate services, communicate effectively, evaluate patient outcomes and
satisfaction, and monitor costs when all team members are employed by the same organization
and payment for their services is from the same source. This structure is usually present in staff
model health maintenance organizations or in large clinics, such as in the case of the North
Chicago VA Medical Center. (84)
The VA diabetes team can minimize patients’ health risks by assessment, intervention, and
surveillance to identify problems early and initiate prompt treatment.
Increased use of effective treatments to improve both glycemic control and cardiovascular risk
profiles can prevent or delay progression to renal failure, blindness, nerve damage, lower-
extremity amputation, and serious cardiovascular disease. When VA patients actively participate
in treatment decisions, set personally selected behavioral goals, receive adequate education, and
actively manage their disease, improved diabetes control is achieved. This in turn leads to
improved patient satisfaction with care, better quality of life, improve health outcomes, and
ultimately, significantly lower health care costs at all levels.
This is our primary focus in using the, “6 Key Questions to Ask for Your Good Health and
“Knowing Your ABC’s of Good Diabetes Health,” educational interventions, as important patient
centered interventions designed to achieve higher levels of diabetic compliance and enhance
safety for high-risk, potentially low literacy NCVAMC diabetic patients. (85, 86)
VA APPROVED DIABETES TREATMENT PROTOCOLS
VA DIABETES TREATMENT PROTOCOLS
VETERAN AFFAIRS HEALTH CARE/DEPARTMENT OF DEFENSE
VAH/DoD Clinical Practice Guidelines for Management of Diabetes Mellitus
Approved Protocols—September 2003 (93)
http://www.oqp.med.va.gov/cpg/DM/DM_GOL.htm
A. Patient with Diabetes Mellitus
Diabetes mellitus (DM) is a state of absolute or relative insulin deficiency resulting in
hyperglycemia. This algorithm applies to adults only (age 17), both diabetes type 1 and type 2
(formerly referred to as insulin-dependent and non-insulin dependent diabetes mellitus), but not
to gestational diabetes mellitus (GDM).
B. Refer To Pediatric Diabetes Management
OBJECTIVE
Provide appropriate management for diabetic children.
C. Is Patient A Female Of Reproductive Potential?
OBJECTIVE
32
Assess the risk of maternal and fetal complications of an unintended pregnancy and implement
prevention strategies.
D. Identify Comorbid Conditions
OBJECTIVE
Evaluate DM management in the context of the patient's total health status.
E. Is the Patient Medically, Psychologically, and Socially Stable?
OBJECTIVE
Stabilize the patient before initiating long-term disease management.
F. Identify/Update Related Problems from Medical Record, History, Physical Examination,
Laboratory Tests, and Nutritional and Educational Assessment
OBJECTIVE
Obtain and document a complete medical evaluation for the patient with DM, annually.
EDUCATIONAL ASSESSMENT AND INTERVENTION
The following questions were developed based on expert opinion and are believed to reflect the
patient’s general knowledge and ability to adequately self-manage his or her diabetes:
1. Is there anything you do or have been advised to do because of your diabetes that you have
difficulty with or are unable to do?
2. Do you know what to do when your sugar is high/low (describe both hyperglycemia and
hypoglycemia symptoms)? Who and when do you call?
3. Do you remember your target goals: HbA1c, low-density lipoprotein (LDL), weight, exercise,
and BP?
4. Which food affects your blood sugar the most—chicken breast, salad, or potato?
North Chicago VA Medical Center-Education Intervention
“Improving Control Patient Education Class-Risk focused Intervention
“Home Management Patient Education Class—Core Competency Education”
G. Determine and Document if Diabetes Mellitus is Type 1 or 2 (If Not Already Done)
OBJECTIVE
Determine what treatment components are needed for a particular patient.
CLINICAL CLASSIFICATION OF TYPE 1 OR 2
H. Consider Aspirin Therapy
OBJECTIVE
Prevent cardiovascular disease.
I. Review All Diabetes-Related Complications and Set Priorities
OBJECTIVE
Identify DM-related complications requiring special attention.
Summary of the Management of Hypertension in Diabetes Mellitus
Recommendations
Blood Pressure Targets
33
Pharmacotherapy
Summary of the Management of Lipids in Diabetes Mellitus
Recommendations
Discussion: Summarizes the thresholds and goals for dyslipidemia treatment
NCVAMC DIABETES INTERVENTION STUDY EFFICACY
Developing a “VA Partnership for Clear Health Communication,” will help NCVAMC
physicians, nurses and clinicians, and other health care providers gain important new patient
insight, information and develop simple practical tools to communicate and build stronger
relationships with their patients. Among these tools is a new patient education intervention,
“Asking the 6-Key Questions to Ask For Your Good Health and Knowing Your ABC’s of Good
Diabetes Health,” which are designed to enhance active patient participation in their diabetes
treatment regime, as well as, build new confidence, communication and trust among high risk
diabetes patients, and their VA health care team partners.
High risk diabetes patients, with potential low literacy (>9.5% HgbA1a) NCVAMC diabetes
patients should ask six-key questions in every healthcare encounter, test and procedure; in
addition know their ABC’s of Good Diabetes Health to help them optimize their patient/provider
communications, enhancing self-efficacy, resulting in a more actively engaged and educated VA
patient.
NCVAMC Diabetes Education Team Intervention Session (60 to 90 minutes)
Effective diabetes self-management education is an interactive, collaborative, ongoing process
group meeting involving the person with diabetes and the VA diabetes treatment team. DSME
Diabetes Self-Management Education is not a static process, but a continuous, long term initiative
by all stakeholders to work collaboratively to achieve optimal health status. (87) VA patient’s
must feel comfortable and encouraged in taking the intervention session more once, if they feel
they don’t understand something, or need more coaching in understanding how to better manage
their diabetes care.
Group diabetes education is currently receiving a great deal of attention among educators, policy-
makers, and payors. Some educators prefer groups whenever possible and recommend using
groups as a first-line approach to improve diabetes outcomes. Diabetes group education is a cost-
effective alternative to individual education. Fiscal intermediaries and reimbursement constraints
are important factors influencing the format of diabetes education in today’s practice. The federal
Balanced Budget Act of 1997 resulted in changes in reimbursement by the Centers for Medicaid
and Medicare Services (CMS, formerly the Health Care Financing Administration) that supported
group delivery of diabetes education. (88, 89, 90, 91)
The NCVAMC Diabetes Team will comprise of a physician or RN nurse, dietician, or certified
diabetes educator. The diabetes educators typically are physicians and nurses, but can be as varied
as the practice can afford and may include dietitians, pharmacists, physical trainers, podiatrists,
social workers, or psychologists. A minimum of two NCVAMC diabetes educational
professionals will facilitate the group educational meeting.
34
The group session will takes place in a large conference room or waiting room and last from 60–
90 minutes, comprising from 8 to15 diabetic patients. Successful diabetes education tends to be
interactive with a lot of patient participation encouraged. Ideally, there will be a strong focus on
understanding disease physiology, self-care, and enhancing new diabetes patient skills building.
Step 1: The Six Key Questions are designed to build knowledge, communication and strengthen
relationships between patient and VA healthcare team members at all levels of the system, and
increase patient involvement and responsibility for their health care outcomes. Patients will learn
the importance of asking these 6 Key Questions in every health visit, procedure or test to improve
their diabetes compliance level.
Each patient will be given a two-page instruction sheet, “Six Key Questions to Ask for Your
Good Health.” In addition, each patient will be given a business card size two panel laminated
copy of the 6-Key Questions To Ask to keep in their wallet or purse for future reference.
1. What is my main diabetes problem?
2. What do I need to do?
3. Why is it important for me to do this?
4. What is my diabetes medication for?
5. How do I take my diabetes medication?
6. What should I expect from the medication?
Step 2: NCVAMC Diabetes Patients will be given a “Knowing Your ABC’s of Good
Diabetic Health,” information recording sheet before every medical visit.
Patients will be educated to ask their VA Diabetes Team Member at each healthcare visit, test, or
procedure:
1. What is my A1C, blood pressure, and cholesterol numbers?
2. What should my ABC numbers be?
3. What you can do to reach your targets?
Each patient will be given a preprinted form with their numbers on a VA medical record card, and
asked to keep this form with them, and to bring it to every visit, test, and procedure. Every
diabetes patients will be given a “KNOWING YOUR ABC’S OF GOOD DIABETIC
HEALTH FORM.” Record a patient’s targets and the date, time, and results of their tests. Take
this card with them on their VA health care visits. Show it to their VA health care team member
to remind them of tests they need, and targets to be reached.
Knowing Your ABC’s of Good Diabetes Health
35
VA Diabetes Education Research Project
VA Diabetes Education Research Project
VA Diabetes Education Research Project
VA Diabetes Education Research Project
VA Diabetes Education Research Project
VA Diabetes Education Research Project
VA Diabetes Education Research Project
VA Diabetes Education Research Project
VA Diabetes Education Research Project
VA Diabetes Education Research Project
VA Diabetes Education Research Project
VA Diabetes Education Research Project

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VA Diabetes Education Research Project

  • 1. “What Are the Influences of Patient Literacy, HbA1c Understanding, and Socio-Demographic Variables on the Effectiveness, Attendance and Retention of VA Diabetes Patient Educational Initiatives?” Diabetes Exploratory Pilot Research Study Department of Veterans Affairs Medical Center 3001 Green Bay Road, North Chicago, IL 60031 Dr. Tariq Hassan, M.D. Veterans Affairs Medical Center, North Chicago, IL Dr. Boby G. Theckedath, M.D. Veterans Affairs Medical Center, North Chicago, IL Dr. Sant Singh, M.D. Veterans Affairs Medical Center, North Chicago, IL Dr. Barry D. Weiss, M.D. University of Arizona, Tucson Dr. George Lutz, Ph.D, Veterans Affairs Medical Center, North Chicago, IL Dr. Tom Muscarello, M.S., Ph.D, DePaul University, Chicago, IL David R. Donohue. M.A., Qualitative Technologies Inc. and Northwestern University Janine Stoll, RN, BSN, CDE, Veterans Affairs Medical Center, North Chicago, IL INTRODUCTION NORTH CHICAGO VA DIABETES STUDY FOCUS The (NCVAMC) North Chicago VA Medical Center in 2006 had 625 high-risk diabetes patients defined as those with a HbA1c of 9.5 or greater of whom 48% either dropped out from, or did not participate in a prescribed VA Diabetes self-management education intervention program. The remaining 52% of these high-risk patients participated by attending a one-day self-management education seminar. They showed an overall HbA1c improvement of 1.13% in one year, and those with an HbA1c of 9.0%, demonstrated a 3% improvement after one year. A 1.13 and 3% HbA1c improvement rate is significantly lower, than what is seen with other diabetes education initiatives, such as the 2006 Q-source HbA1c education project in the State of Tennessee that resulted in a significantly higher level of (12% of diabetes population) improvement in HbA1c compliance. (1, 2, 3) Education is the cornerstone of effective diabetes treatment, and one of the most important factors influencing adherence and patient safety outcomes. (4, 5, 6) Today, alternative strategies and education/communication interventions are clearly needed to attract, educate and retain NCVAMC patients in order to increase patient compliance and safety, among its growing patient population, now numbers 5,500, of whom, as noted, more than 750 are at high-risk because of poor HbA1c control and utilization of health care services. Hundreds of NCVAMC patients with diabetes (high-risk group HbA1c = 9.5% or greater) do not adhere to therapy, experience repeated hospital admissions, and have or are at risk for multiple diabetes complications. The lack of complance, higher diabetes complication rates are often due to poor HbA1c knowledge, understanding and control of diabetes, resulting, in turn from 1
  • 2. unrecognized low health literacy. Indeed, research elsewhere (3) has shown that individuals with low literacy skills have worst diabetic control than those with adequate literacy skills, even when controlling for a host of other socio-demographic variables. Today, more than 90 million adults in the United States have poor literacy levels, which would cause them to have trouble finding pieces of information or numbers in a lengthy text, integrating multiple pieces of information in a document, or finding two or more numbers in a chart and performing a calculation. Those with poor literacy skills are believed to have greater difficulty navigating the health care system and to be at greater risk of experiencing diminished healthcare outcomes, according to a major federal government study. (4) OBJECTIVES OF THE NCVAMC DIABETES STUDY The overall objective of the study is to examine the association between health literacy, individual HbA1c control knowledge and socio-demographic variables, and their impact on education attendance and retention of high-risk NCVAMC diabetic patients in prescribed diabetes educational initiatives. Specific study goals are to: 1. Measure NCVAMC diabetic patients for literacy level using the (NVS) Newest Vital Sign instrument: This will result in patient measurement of: low literate likely, low literate possible, or literate 2. Identify the level of a patient’s knowledge of their HbA1c level 3. Identify and measure patient’s factor-group characteristics (socio-demographic variables) that make up shared traits and attitudes influencing diabetes education and adherence. For example, control of a patient’s HbA1c level may depend on an adequate health literacy level. In addition, HbA1c control, maybe depend upon certain other traits, such as patient attitudes towards dealing with fear, stress or worry. Knowledge gained through identifying similar traits shared by members of a factor group, tells us about that patient’s potential behavior; their shared attitudes, feelings and opinions. Once we know a patient’s factor group, we can better understand their (MO) method-of-operation and behavioral characteristics, consequently able to design educational interventions to serve that factor group’s learning style 4. Recommend new VA diabetes patient educational interventions based on findings in 1, 2, and 3 above. Implement 6-Key Questions and three questions ABC’s of Good Diabetes, and three survey questions on understanding the importance of HbA1c levels. Health among selected NCVAMC intervention diabetes patient groups, analyze and track finds of DSME differences in compliance scores between intervention and control group. RESEARCH DESIGN AND METHOD STUDY POPULATION AND SAMPLING For this research study, our VA diabetes population size is 5,500 individuals and we will be using a 95% confidence level with a margin-of-error of 4.65%, and a response distribution of 50% requiring a minimum sample size of 408 participants with diagnosed type 2 diabetes at the North Chicago VA Medical Center, North Chicago, IL who have received diabetes care in 2006, 2007 and 2008. Project execution will take place at the North Chicago VA Medical Center, North Chicago, IL. Our proposed timeline for project execution is from June 1st, 2009 to June 1st, 2010. 2
  • 3. This project will use probability and stratified sampling modeling, because it allows a calculation of the sampling error and controls for the following factors. 1. A desire to minimize variance and sampling errors and to increase precision 2. A desire to estimate the parameters of each stratum and have a readable sample size for each. 3. A desire to keep the sample element selection process simple. Study subject frame will be identified and selected through electronic VA medical records (with an HbA1c level <> 9.5%) in 2006, 2007 and 2008. ♦Be at least 18-years old ♦ Have a prescription for a glucose control medication or supplies, or one hospitalization, or two outpatient visits with a diabetes related ICD-9 code ♦ Has seen their primary care provider (PCP) in the prior 12 months ♦ Scheduled to see the same PCP, in the next 6 months. Subjects will be contacted by in-person clinic invitation, e-mail or USPS letter to invite them to participate in the study. The survey protocols will receive (IRB) institutional review board approval, and written informed consent obtained from all participants. Cognitively impaired VA patients will not be asked to participate in this study; patient’s who cannot read sample questions, due to poor eye sight will be included, provided subjects can read larger type instructions. All research participants will be asked to take a (NVS) Newest Vital Sign Health Literacy Test, complete a three-question HbA1c questionnaire, and a qualitative/quantitative Q-methodology survey, designed to place each participant in a defined factor groups, according to their opinions, feelings and attitudes on diabetes treatment and education. VARIABLES The diabetes self-management regimen is one of the most challenging of any for chronic illness. Patients often must perform self-monitoring of blood glucose, manage multiple medications, visit multiple providers, maintain foot hygiene, adhere to diet and meal plans, and engage in an exercise program. Patients also must be able to identify when they are having problems across these functions and effectively problem-solve to divert crises. Diabetes outcomes may be especially sensitive to problems involving literacy, communications, understanding the importance of HbA1c control and self-management education. The VA Medical Sstem has the largest and most comprehensive digital patient record systems in the world. (5) Regular testing of HbA1c values is now the principal way to measure and track glycemic control in diabetic patients. Because of its importance, as a marker of disease control, it makes sense that patient knowledge of recent and target HbA1c values might be a useful precondition for involvement in diabetes management and education. HbA1c variables will be extremely important to our study, in relationship to health literacy, education and most importantly identifying socio-demographic variables that impacts patient behavior. Principle Variables 1. Age 2. Race/ethnic origin 3. Years with diabetes 4. Sex 5. Education level 3
  • 4. 6. Income 7. Hypoglycemic regimen 8. Last HbA1c checked (%) 9. Percent with > 80% treatment at VA facility 10. Percent with >80% treatment at other medical facility 11. Health Literacy NVS (low literacy, low literacy possible, literate) 12. Patient understood correctly HbA1c value 13. Had biomedically accurate assessment of diabetes 14. Diabetes care self-efficacy 15. Diabetes education 16. Q-Methodology factor group, socio-demographic variables Table 1—Variables of NCVAMC diabetes patient respondents Ethnic Origin White % Black % Latino % Other % P=value 4
  • 5. Age Years with diabetes Sex Years of education Income $10,000 or less $10,001 to $20,000 $20,001 to $30,000 > $30,000 Length of diabetes < > 1 to 3 years < > 4 to 10 Hypoglycemic regimen Oral medication only Insulin +- oral medication No medication Health Status Excellent to very good Fair Poor Outpatients visits in past year Last HbA1c checked (%) VA outpatient visits in last year Percent with > 80% at VA facility Dollar value of VA diabetes care, as % of care Percent with >80% treatment at other medical facility Percent with > than two outpatient VA visits in past year Health Literacy Test NVS Patient understood correctly HbA1c value Had biomedically accurate assessment of diabetes Diabetes care self-efficacy * * Range of understanding scale was 1-5 and range of self-efficacy was 0-100; for both, higher score was better. Study Sampling and Patient Confidentiality Requirements Insuring patient data security and confidentially of information is a top priority of this research study. At no time will we identify patients by name or other identifying means. VA patient medical record data will be used to support the project information needs, as required. U.S. Department of Health and Human Services (“HHS”) issued the Privacy Rule to implement the requirement of the Health Insurance Portability and Accountability Act of 1996 (“HIPAA”). A major goal of the Privacy Rule is to assure that individuals’ health information is properly protected while allowing the flow of health information needed to provide and promote high quality health care and to protect the public's health and well being. The Rule strikes a balance that permits important uses of information, such as research to build positive health care outcomes, while protecting the privacy of people who seek care and healing. 5
  • 6. HIPAA Compliance Requirements o Building initial organizational awareness of HIPAA o Comprehensive assessment of the organization's privacy practices, information security systems and procedures, and use of electronic transactions o Developing an action plan for compliance with each rule o Developing a technical and management infrastructure to implement the plans o Implementing a comprehensive implementation action plan, including o Developing new policies, processes, and procedures to ensure privacy, security and patients' rights o Building business associate agreements with business partners to support HIPAA objectives o Developing a secure technical and physical information infrastructure o Updating information systems to safeguard protected health information (PHI) and enable use of standard claims and related transactions o Training of all workforce (research) members o Developing and maintaining an internal privacy and security management and enforcement infrastructure, including providing a Privacy Officer and a Security Officer 1. Defining and Measuring NCVAMC Diabetes Patient Health Literacy OBJECTIVE We believe low-health literacy to be a contributing factor that adversely impacts diabetes adherence and contributes to a 48% drop out rate among high risk NCVAMC diabetes patients (HbA1c level of > 9.5%) (6). A recent North Chicago VA Medical Center 2006 research study, “Analyzing Factors Affecting Functional Literacy in the Context of Primary Care Patient/Provider Communication” concluded that 82% of study participants said, “Literacy and communications are major challenges incurred by VA patients while they navigate through the VA healthcare systems. (7, 8) INSTRUMENT The (NVS) Newest Vital Sign was developed by the University of Arizona, College of Medicine and the University of North Carolina. After testing with more than 1,000 patients, the NVS has been shown to address some of the limitations of previously available instruments. The instrument assesses general literacy and numeracy skills as applied to health information, yielding an overall estimate of health literacy. In contrast to the previous instruments, however, it can be administered in about three-minutes and is available in both English and Spanish. The Newest Vital Sign is based on a nutrition label from an ice cream container. Patients are given the label and then asked 6 questions about how they would interpret and act on the information contained on the ice cream label. Specifically, the NCVAMC diabetes patient is handed a copy of the nutrition label and then asked a series of 6 questions about it. Patients can and should retain the label so they can refer to it while answering questions. It is not necessary to give the patient time to review the label before asking the questions. Rather, they will review the label as they are asked and answer the questions. The questions are asked orally and the responses recorded by a VA clinical staff 6
  • 7. member on a special score sheet, which contains the correct answers. Based on the number of correct responses, the health care provider can assess the patient’s health literacy level. In a 2007 published study, if health providers are aware of their patients’ literacy skills, they can more appropriately tailor their communication with patients. Few providers, however, assess patient’s literacy skills for fear of offending patients, but no research has ever determined if patients object to such assessments. This University of Miami and Dade County study revealed that the objective was to determine the percentage of patients seen for routine health care that would agree to undergo literacy assessment and if satisfaction of patients differs in practices that perform literacy assessments, using the NVS, versus practices that do not. Of 289 patients asked to undergo literacy assessment in the intervention practices, 284 (98.3%) agreed to do so, including 125 (46.1%) with low or possibly low literacy skills. There was no difference in satisfaction between the intervention group patients are willing to undergo literacy assessments during routine office visits and performing such assessments does not decrease patient satisfaction. (77) NVS Scoring • The mean time to deliver either the English or Spanish version of the NVS instrument is 2.9 and 3.4 minutes, respectively. There has been no major difference between men and women in their performance on the NVS from results in other studies. • The internal consistency of both versions of the NVS is good. • The NVS is superior to either age or educational level in predicting health literacy. • A score of less than 2 on the NVS-English was associated with a sensitivity and specificity of 72% and 87% for predicting limited literacy, while a score of less than 4 had a sensitivity and specificity of 100% and 64%. (9) • A score of less than 2 on the NVS-Spanish was associated with a sensitivity and specificity of 77% and 57% for predicting limited literacy, while a score of less than 4 had a sensitivity and specificity of 100% and 19%. • Based on these values, a score of higher than 4 on the NVS is associated with adequate health literacy, whereas a score less than 2 indicates at least a 50% chance of having marginal or inadequate health literacy. (9) RELIABILITY, VALIDITY, AND ACCURACY The internal consistency of the NVS is good (Cronbach = 0.76), as was the criterion validity (r = 0.59, P <.001). Supplemental Appendix 2 (which is available online only at the following address http://www.annfammed. org/cgi/content/full/3/6/514/ DC1) plots the relationship between scores on the NVS .The area under the ROC curve for predicting (95% CI, 0.63-0.81; P <.001) found for educational level or the 0.71 (95% CI, 0.63-0.79; P <.001) found for age. Thus, the NVS score is more accurate than educational level or age. (9) Properties and Clinical Significance of NVS The NVS has good sensitivity; in fact, based on the distribution of scores, NVS may be more sensitive than the TOFHLA literacy screening instrument (Test of Functional Health Literacy in Adults) to marginal health literacy. Its specificity, although less than optimal, is similar to or better than that of other widely used clinical screening methods, such as questionnaires to detect alcohol abuse, breast self-examinations to screen for cancer, and methods to detect arthritis and measure osteoporosis risk. Although the specificity of NVS may result in overestimating the percentage of patients with limited literacy, using the test can alert physicians to patients who 7
  • 8. may need more attention and help physicians focus on physician-patient communication using recommended techniques. All patients who score >4 on the NVS will have adequate literacy when measured by the TOFHLA. A score <4 on the NVS, on the other hand, indicates the possibility of limited literacy. Clinicians should be particularly careful in their communication with patients who score < 2, as they have a greater than 50% chance of having marginal or inadequate literacy skills. Such patients cannot be reliably identified by questions about their education level, as education does not always predict literacy—it only measures the number of years an individual attended school. Indeed, about one-quarter of participants who scored at the very lowest of 5 literacy levels in the 2003 U.S. Department of Education’s National Adult Literacy Survey were high school graduates. NVS LIMITATIONS The full TOFHLA version is the standardized instrument from which the short version was derived, so its psychometric properties are an appropriate reference standard for the development of new instruments. Health literacy is a complex construct that encompasses many aspects of how individuals use health information and the health care system. Test research has shown the TOFHLA and the REALM, (Rapid Estimate of Adult Literacy in Medicine) measures reading and interpretation skills (ie, general literacy, reasoning, and the ability to use numbers) as applied to material with health content, rather than all aspects of health literacy. The psychometric properties of the Spanish version of the NVS, although adequate to screen patients for limited literacy, were not as good as those of the English version. This fact may stem from the greater heterogeneity of language and culture among our Spanish- speaking patients, who come from all regions of South America, Central America, and Mexico. Testing of the NVS on other patient populations could further validate the accuracy of the instrument. The NVS has advantages over currently available instruments. Specifically, it is available in Spanish, whereas the REALM is not, and it can be administered much more quickly than the TOFHLA. The NVS also does not have the ceiling effect seen with the TOFHLA and, therefore, particularly in the English version, the NVS provides better discrimination of skill levels among individuals in the upper part of the distribution of literacy skills. Future investigations should examine (A) how to best introduce and implement NVS in primary care practice, (B) the validity of NVS in other primary care practices and also in non-primary care settings, (C) whether raising clinicians’ awareness of patients’ literacy by using NVS results in improved clinician-patient communication and better health outcomes, and (D) whether a similar nutrition label scenario can assess literacy in speakers of languages other than English and Spanish. (9) DATA ANALYSIS The NCVAMC diabetes study will use means, standard deviation (SD), standard error of the means, histograms, t tests, and analysis of covariance to summarize the participant’ demographic characteristics and their performance on the tests. Participant items on the NVS will be accorded 1-point for each correct answer. Reliability of the NVS will in terms of internal consistency (Cronbach 2005). Criterion validity is determined by calculating the correlation (Pearson r) between scores on the NVS. Quantify the relative accuracy of age, educational level, and NVS scores as predictors of adequate literacy. The ROC will be used to calculate the sensitivity and specificity for selected cutoff scores on the NVS test. Stratum-specific likelihood ratios will be calculated for each NVS score. (9) 8
  • 9. POTENTIAL BENEFITS The primary goals of quality diabetes education and communication are: A. Provide patient knowledge and skill training B. Help individuals identify barriers C. Facilitate problem-solving and develop coping skills to achieve effective self-care management and behavior change that produce a positive health outcome for the patient/provider team. (10) All health communication interventions directed towards patients must be individualized and delivered to enhance comprehension and understanding among patients with low literacy. Intervention patients (low literacy) should receive intensive disease management from a multidisciplinary team. Control patients should receive an initial management session and continue with usual care regimen, but be monitored for changes at regular patient appointments. Poor Diabetes control is a common state, especially among poor and elderly patients that is revealed in other national studies. Within the VA healthcare system today, the average VA patient age is 62-year old male. VA patients, for the most part are male, with many patients suffering from multiple chronic disease states that can adversely impact their health outcomes and safety, due to poor communications, comprehension and understanding of their basic health state and treatment. (10) In addition, patients with low health literacy levels produce a complex array of communications difficulties, such patients report worse health status and have less understanding about their medical conditions and treatments; they may also have increased hospitalization rates, and increased use of costly emergency room facilities (11). While a variety of methods have been recommended and studied for communicating with patients who have limited literacy skills, our research of health literacy and health care literature found little experimental research to determine which method(s) is optimal and leads to the best health outcomes. Such ongoing research is vital to developing optimal levels of patient safety and quality of outcomes for all health care stakeholders. POTENTIAL RISKS None: There are no procedures, lab tests, drug or medical interventions 2: HbA1c Survey---Understanding Patient’s Knowledge of Their HbA1c Level OBJECTIVE—Knowledge of one’s actual and target health outcomes (HbA1c values) is hypothesized to be a prerequisite for effective patient involvement in managing chronic diseases such as diabetes. We will research: A. The frequency and correlates of knowing one’s most recent HbA1c test result. B. Whether knowing one’s HbA1c value is associated with a more accurate assessment of diabetes control and better diabetes self-care understanding, self-efficacy, and behaviors related to glycemic control. (2,3) A growing body of evidence suggests that patients with chronic diseases, such as diabetes who are engaged and active participants in their health care have better health outcomes (12, 13). For example, patients who have completed chronic disease self-management training programs have improved self-efficacy and physical functioning and less acute care use than non-participants. Chronic illness care self-efficacy is positively associated with health outcomes. 9
  • 10. Respondents who know their HbA1c values reported significantly better diabetes care understanding and assessment of their biomedical level of glycemic control than those who did not. Our findings in other studies support the importance of providers actively discussing HbA1c test results with patients and ensuring that patients understand the meaning of their HbA1c level. In other studies (14, 15) Knowledge of HbA1c alone, however, was not always associated with better diabetes care self-efficacy and self-management behaviors. As with other areas of diabetes care; knowledge of one’s last HbA1c value appears to be useful but not always sufficient for translating increased understanding of diabetes care into the increased confidence and motivation necessary to improve patients’ diabetes self-management. Strategies to provide information must be combined with other behavioral strategies to motivate and help patients effectively manage their diabetes. It is our goal to research into these other socio-demographic areas to build strong patient profile’s that combine knowledge of patient’s health literacy level, understanding of the importance of their HbA1c level, and how socio-demographic factors impact patient’s as a member of a diabetic attitudinal factor-group with shared traits, feelings, attitudes and opinions. INSTRUMENT We will use a three-question survey to measure diabetic patient’s knowledge of their reported and actual HbA1c level. Regular testing of HbA1c values is now the principal way to measure and track glycemic control in diabetes patients. Because of its importance, as a major marker of disease control, it makes sense that patient knowledge of their recent and target HbA1c values will be a useful precondition for involvement in diabetes management and education. HbA1c variables will be extremely important to our study, in relationship to health literacy, education and socio-demographic variables impacting diabetes education and adherence. Principle Variables: Refer to variables list on pages 3 and 4 1. Question: What has your HbA1c (sugar-blood level) been in the past 12-months? Respondents can choose one of six response categories: ●<7 ● Between 7 and 8 ● Between 8 and 9 ● Between 9 and 10 ● >10 ● I don’t know. We can classify respondents as knowing their HbA1c value if their actual test result was within 0.5 percentage points of the lower or upper boundary of the chosen response category. For example, if respondents reported that their HbA1c was <7, they were grouped as knowing their HbA1c if their recorded HbA1c was <7.5. Respondents were coded as not knowing their value if their estimate differed by >0.5% percentage points or if they responded, "I don’t know." DATA ANALYSIS To assess whether respondents had a biomedically accurate assessment of their HbA1c value, we will create a variable comparing the self-evaluation of the level of diabetes control in the past 12 months with the actual HbA1c test value. On our survey, respondents will be asked whether, based on their HbA1c value in the past 12 months, their diabetes was in excellent, good, fair, or poor control. We will classify respondents as having an accurate assessment of their HbA1c value if they evaluated their diabetes control as poor and have HbA1c values >8.5; reported "fair" 10
  • 11. and have HbA1c between 7.5 and 8.5; or reported "good" or "excellent" and have HbA1c 7.5/<. Results of this table will be incorporated into the proposed Table. (16) Table —Comparison of respondents reported HbA1c with their most recent documented HbA1c Actual HbA1c level (%) < 7 7-8 8-9 9-10 >10 Reported HbA1c level (%) <7 7-8 8-9 9-10 >10 I Don’t Know (1) excellent (2) good (3) fair (4) poor control. To assess diabetes care self-efficacy, we will use a validated four-item scale, with higher scores reflecting higher self-efficacy in managing diabetes. This measure has been associated with glycemic control in prospective studies. To assess self-care behaviors related to glycemic control, we used respondents’ answers to a validated measure asking on how many of the past 7 days (days 0–7) they performed the following as their doctor/nurse had recommended: take diabetes medications, follow a diabetic eating plan, exercising, and monitoring blood glucose. We will explore patient, provider, and health care system characteristics associated with knowing one’s most recent HbA1c value. We also will use multivariate linear and logistic regression to assess whether knowledge of one’s last HbA1c was associated with an accurate assessment of one’s level of diabetes control, diabetes care understanding, self-efficacy, and self-management behaviors related to glycemic control. 2. Question: How well do you understand the importance of knowing your HbA1c level in managing your diabetes? Question from (DCP) Diabetes Care Profile. To evaluate self-rated understanding of diabetes care, we will use the following question from the Diabetes Care Profile, Michigan Diabetes Research and Training Center, University of Michigan, Ann Arbor, MI (17). Question, "How well do you understand how to manage your diabetes?" Higher values of this measure rated on a 1–5 Likert scale reflected higher levels of self-reported understanding. To 11
  • 12. assess diabetes care self-efficacy, we will use a validated four-item scale, with higher scores reflecting higher self-efficacy in managing diabetes. This measure has been associated with glycemic control in prospective studies. To assess self- care behaviors related to glycemic control, we will use respondents’ answers to a validated measure asking on how many of the past 7 days (days 0–7) they performed the following five- items as their doctor had recommended: take diabetes medications, follow a diabetic eating plan, and monitor blood glucose, exercising, and monitoring blood glucose. Because adherence in one area of diabetes care does not correlate strongly with adherence in others, we can examine each behavior separately. We will review medical records and laboratory data to document respondents’ most recent HbA1c results taken within 12 months before the survey. If respondents have no documented HbA1c results in the prior 12 months, we will record this value as missing. (18) RELIABILITY, VALIDITY, AND ACCURACY Reliability and validity of 4-point and 6-point Likert scales can be assessed using a new model- based approach to fit empirical data. Different measurement models will be fit by confirmatory factor analyses of a multitrait-multimethod covariance matrix. For example, 165 graduate students responded to nine-items measuring three quantitative attitudes. Separation of method from trait variance led to greater reduction of reliability and heterotrait-monomethod coefficients for the 6-point scale than for the 4-point scale. (19) Criterion-related validity was not affected by the number of scale points. The issue of selecting 4- point versus 6-point scales may not be generally resolvable, but may rather depend on the empirical setting and the subjects among other things. Response conditions theorized to influence the use of scale options are discussed to provide directions for further research. Since Likert (1932) introduced the summative rating scale, now known as the Likert-type scale, researchers have attempted to find the number of scale point item response options that maximize reliability. Findings from these studies are contradictory. Some have claimed that reliability is independent of the number of scale points (Bendig, 1953; Boote, 1981; Brown, Widing,&Coulter, 1991; Komorita, 1963; Matell & Jacoby, 19719 Peabody, 1962; Remington, Tyrer, Newson- Smith, & Cicchetti, 1979). Others have maintained that reliability is maximized using 7-point (Cicchetti, Showalter, & Tyrer, 1985; Finn, 1972; Nunnally, 1967; ~arnsay, 1973; Symonds, 1924), 5-point Reliability and validity of 4-point and 6-point. (19) In a University of Michigan study, (20) the DCP and several previously validated scales were administered to individuals with diabetes receiving care at a university medical center (n = 352). Cronbach's alphas of individual DCP scales ranged from .60 to .95 (Study 1) and from .66 to .94 (Study 2). Glyco hemoglobin levels correlated with three DCP scales (Study 1). Several DCP scales discriminated among patients with different levels of disease severity. The results of the studies indicate that the DCP is a reliable and valid instrument for measuring the psychosocial factors related to diabetes and its treatment. We will review medical records and laboratory data to document respondents’ most recent HbA1c results taken within 12 months before our survey. If respondents had no documented HbA1c results in the prior 12 months, we will record this value as missing. DATA ANALYSIS In our NCVAMC study, we will conduct bivariate and multivariate logistic regression analyses. Higher values of this measure rated on a 1–5 Likert scale reflect higher levels of self-reported understanding. To assess diabetes care self-efficacy, we will use a validated four-item scale, with 12
  • 13. higher scores reflecting higher self-efficacy in managing diabetes. This measure has been associated with glycemic control in prospective studies. To assess self-care behaviors related to glycemic control, we will use respondents’ answers to a validated measure asking on how many of the past 7- days (days 0–7) they performed the following as their doctor/nurse had recommended: take diabetes medications, follow a diabetic eating plan, exercising, and monitoring blood glucose. In addition, for all three questions in our diabetes survey, we will conduct bivariate and multivariate logistic regression analyses to explore patient, provider, and health care system characteristics associated with knowing one’s most recent HbA1c value. We also will use multivariate linear and logistic regression to assess whether knowledge of one’s last HbA1c was associated with an accurate assessment of one’s level of diabetes control, diabetes care understanding, self-efficacy, and self-management behaviors related to glycemic control. 3. Question: "My VA doctor answers my diabetic treatment questions fully and carefully" To evaluate thoroughness of provider communication, we will assess the degree to which respondents agreed with the following statement from the well-validated Autonomy Support Scale: "My VA doctor answers my diabetic treatment questions fully and carefully" (with five response categories from "strongly disagree" to "strongly agree") (15, 16). Because responses are positively skewed toward the highest rating, we will dichotomize responses between those who "strongly agreed" with the statement versus all other responses. We also will have mean number of outpatient visits in the prior year (continuous), and duration of the relationship with the doctor who takes care of the patient’s diabetes (<6 months, 6 months to 1 year, 1–5 years, >5. (21, 22) LIMITATIONS The VA HbA1c study has a number of limitations. First and most importantly, its cross-sectional design does not allow us to establish that patients’ assessment of their diabetes self-management was causally associated with glycemic control. Patients with better glycemic control may evaluate their self-management as better than those who have more serious disease and higher HbA1c levels, and those patients who receive more recommended services may also have better reported self-management for another reason not measured in our analyses. Regarding this point, it is worth noting that patients’ reported self-management might not be associated with either of our two measures of health services use. This lack of association suggests that fewer outpatient visits is not the reason patients who evaluate their self-management poorly are less likely to receive necessary tests. Second, this VA study population will probably consist predominantly of males and older age groups, based on the current overall demographics of the NCVAMC population. We will make every effort to include qualified female VA diabetic patients in this study. Important note, our findings may not be generalized to younger or predominantly female populations and should be repeated in other settings. Third, it is important to emphasize that the measure we used provides both a general assessment of how difficult patients found carrying out recommended activities in five areas of diabetes self care and their evaluation of their level of success in undertaking these activities. Future research should explore how the scale we will use in this study correlates with self-reported measures that provide more precise descriptions of the frequency with which respondents performed various self-care activities and with scales explicitly assessing patients’ "self-efficacy". It would also be 13
  • 14. useful to evaluate the utility of this scale in measuring the impact of outpatient education programs and other interventions on patients’ assessments of their diabetes self-management. Potential Benefits The primary goal of diabetes communication/education is to provide knowledge and skill training, as well as to help VA patients identify barriers, facilitate problem-solving and develop coping skills to achieve effective self-care management and behavior change that produce a positive health outcome for the patient/provider team. We need some decision making data for VA management to plan new educational and communication intervention designed to help reverse a 48% drop out rate among high-risk diabetes patients not involved actively in their diabetes treatments. (23) Diabetes in 2007 impacted over 23 million people (about 9.0 % of the population) in the United States. In addition, an estimated additional 14 million people in the United States have diabetes and don't even know it. From an economic perspective, the total annual cost of diabetes care in 2007 was estimated by American Diabetes Association to be $137-billion dollars in the United States. The per capita cost resulting from diabetes in 2007 amounted to $16,071.00; while healthcare costs for people without diabetes incurred a per capita cost of $4,699.00. During this same year, 16.9 million days of hospital stay were attributed to diabetes, while 36.3 million physician office visits were diabetes related. These numbers reflect only the population in the United States. Globally, the diabetes statistics are staggering. POTENTIAL RISKS None: There are no procedures, lab tests, drug or medical interventions 3: Q-Methodology Survey: Understanding Socio-Demographic Variables Influencing Diabetic Patient Behaviors. OBJECTIVE Q-Methodology Survey—Reaching High-Risk NCVAMC Diabetes Patient Groups We know more about the importance of prevention in medicine than we do about how to achieve it. We are learning that efforts must be targeted to patient groups most-at-risk. Those people are often disadvantaged in several ways beyond health. Attitudes about their disease state(s), stress, anger and fear and other social challenges interfere with a patient’s treatment efforts. We have a very limited understanding of how to change self-destructive behavior in substance use, nutrition, exercise and family life, as it relates to the individual treatment needs of the high-risk diabetic patients. But, case studies of high-risk patient’s from around the country suggest that carefully developed plans in these areas will yield good returns-on-investment of time, resources, and human capital including systemic efforts. The cost of the failure in prevention is often borne by the VA healthcare provider, who takes care of large and very diverse groups of American veterans, as is the case with the North Chicago VA Medical Center; including not only veterans, but tens-of- thousands of active duty military personnel and their dependents. Q-Methodology Q-methodology was invented in 1935 by British physicist-psychologist William Stephenson (1953) and is most often associated with quantitative analysis due to its involvement with factor analysis. Statistical procedures aside, however, what Stephenson was interested in providing was a way to reveal the subjectivity involved in any situation -- e.g., in aesthetic judgment, poetic 14
  • 15. interpretation, perceptions of organizational role, political attitudes, appraisals of health care, experiences of bereavement, perspectives on life and the cosmos It is life as lived from the standpoint of the person living it that is typically passed over by quantitative procedures, and it is subjectivity in this sense that Q-methodology is designed to examine and that frequently engages the attention of the qualitative researcher interested in more than just life measured by the pound. Q-methodology "combines the strengths of both qualitative and quantitative research traditions" and in other respects provides a bridge between the two. (24) The instrumental basis of Q-methodology is the Q-sort technique, which conventionally involves the rank-ordering of a set of statements from agree to disagree. Usually the statements are taken from interviews or focus groups, hence are grounded in concrete existence; for purposes of convenience, however, the Q-sample in this example consisted of 24 statements taken from Larson's (1984) CARE-Q set. (Q-samples can also be composed of pictures, recordings, and any other stimuli amenable to appraisal.) K was initially invited to characterize the care rendered by his surgeon by sorting the 24 statements (each typed on a separate card) into a quasi- normal distribution ranging from "most like the care given by my surgeon" (+4) to "most unlike" (-4), the result being the Q-sort shown in Table 1. The Q-sorting session was followed by a focused interview during which K was invited to expand on his experience. Table 1: (Example) A Q-Sort Representing Surgeon's Care -4 -3 -2 -1 0 +1 +2 +3 +4 ---------------------------------- 1 3 10 4 5 2 11 6 20 9 21 13 18 7 14 12 8 24 22 23 15 17 19 16 In this example, K agreed most strongly with statements 20 and 24, and disagreed in equal measure with 1 and 9, which read as follows: (25) 20. was honest with me about my condition 24. gave me good physical care 1. volunteered to do "little" things for me 9. touched me when I needed comforting As is apparent, the surgeon's care was of a "professional" kind -- competent, informative, direct -- and this was all that K desired and expected. Q- Methodology Diabetes Sort Statements 26-SAMPLE Q-STATEMENTS: (EXAMPLES) I am afraid of my diabetes. Diabetes education is very important to me It’s hard to do all the things needed in my diabetes care. 15
  • 16. I feel satisfied with my life. My VA diabetes education is useful. I am able to handle my feelings (fear, worry, anger) about my diabetes. I am able to keep my blood sugar in control. I have a hard time managing my diabetes. I’m able to do the things to help my diabetes (diet, medicine, exercise, etc.) I feel dissatisfied with life because of my diabetes. My VA diabetes education is over my head. My family or friends are a big help in my diabetes care. I find it hard to exercise, follow a diet plan and take meds It easy to understand my doctor’s instructions and information I am pretty well off, all things considered. I have problems with reading and understanding the doctor and nurses I feel unhappy and depressed because of my diabetes. My family or friends help and support me a lot in my diabetes care I need help from my family or friends for my diabetes care I can’t understand the doctor or nurse instructions I feel down or have the blues, because of my diabetes I know the importance of my blood sugar level I don’t understand what my blood sugar level is. I feel in control of my diabetes I don’t understand my diabetes treatment directions I’m worried, fearful and stressed managing my diabetes Q-INSTRUMENT Data = Q-sort (A respondent constructed representation of feelings about the subjective topic in the context established by the researcher) 16
  • 17. ◘ Clinical uses of individual Q-sorts as a guide for structuring follow-up interviews with respondents ◘ Assessment of interpersonal skills o empathy and sensitivity to patient needs o development of communication and education skills o counseling skills o negotiation dynamics o basis of comparison of researcher’s self perception of interpersonal skills with the perception of a standardized patient regarding the researcher’s interpersonal skills ◘ Data reduction tool for collection of many Q-sorts = person-person factor analysis ◘ Generates factor space and permits inductive interpretations ◘ Useful in structural analysis of subjectivity ◘ Become the basis for data analysis of multi-respondent (extensive) R-method studies (24, 25, 26, 27) VARIABLES Requirements for conduct of the study require that data be: Contextually relevant Responses/statements in subjects’ “own words” Uninfluenced by researchers’ own views Unconstrained by theoretical framework Unrestricted by constraints of multiple choices, true/false, rating scales A. Standard statistical research measures compare by individual items in which the variables are the individual items at question. B. We propose to compare the subject’s attitudinal response to the research topic with those of all other subjects. In this case, we will use the individual subject as the unit of measure. We then use each question as contributing to the subject’s attitude. Condition of Instruction Q-SORT EXECUTION 17 CONCOURSE Q-SAMPLE
  • 18. C. The individual subject is then the independent variable. The patients’ attitudes are then analyzed by mathematical factor analysis techniques. The output of this process is a list of clusters (or factor types) with accompanying identification of the patients comprising membership of each group. These factor types can be viewed as dependent variables. What factor analysis does is this: it takes thousands and potentially millions of measurements and qualitative observations and resolves them into distinct patterns of occurrence. It makes explicit and more precise the building of fact-linkages going on continuously in the human mind. Study Hypothesis There exist multiple medical literacy levels or types, within the VA patient population. These are identifiable and describable, each factor type having distinct characteristics. In addition we want to measure socio demographic variables, such as fear, worry and stress and their potential impact on diabetes education and patient retention, and how they impact patient compliance and safety. Materials to be used Focus group questions and transcripts, survey instruments, SPSS factor analysis software DATA ANALYSIS AND SCORING Q-factor analysis ● Proceeds from inter-correlated individual Q-sorts This results in a small number of homogeneous “person clusters,” (factor Groups). Q-factor analysis performed ● Factor analysis inter-correlated Q-sort-sort matrix using standard methods Respondents = variables; statements = stimuli (by-person factor analysis) Factor extraction by centroid method chosen for its indeterminacy ● Rotation of axes statistically to produce simple factor structure, each with its own exclusive Set of Q-sorts. Analytic software used ● Standard factor analysis procedures in statistical packages, examples (SPSS, Varimax Rotation, SAS) Interpretation – factor structure ● A very small set of attitudinal clusters (usually 1-6 factor groups) results from the indeterminate factoring process ● A set of shared perspectives which emerge entirely from within the sorters operations on The Q-set under conditions of instruction ● Expect factors to emerge ● How many factors and what each mean are indeterminable Quantitative by person factorization produces: ● Factor definers Q-sorts that load very strongly on only one factor 18
  • 19. ● Factor loaders All Q-sorts with a statistically significant loading on one or more factors ● Factor scores Theoretical Q-sorts obtained by weighting all definers on one factor at a time Interpretation – finding meaning ● Assess degree of factor correlations ● Cross comparison of the Factor Scores (synthetic Q-sorts) across the factors ● Compare/contrast areas of high/low neutral item salience ● Look for areas of consensus and divergence ● By the process of induction, ascribe tentative meanings to the different factors Based on the meaning, describe new hypotheses which may subsequently be tested with standard variance analytic methods and/or large group surveys. (28, 29) RELIABILITY, VALIDITY, AND ACCURACY Assessing the validity of qualitative research There are no mechanical or "easy" solutions to limit the likelihood that there will be errors in qualitative research. However, there are various ways of improving validity, each of which requires the exercise of judgment on the part of researcher and their team. (30) Triangulation Triangulation compares the results from either two or more different methods of data collection (for example, interviews and observation) or, more simply, two or more data sources (for example, interviews with members of different interest groups). The researcher looks for patterns of convergence to develop or corroborate an overall interpretation. This is controversial as a genuine test of validity because it assumes that any weaknesses in one method will be compensated by strengths in another, and that it is always possible to adjudicate between different accounts (say, from interviews with clinicians and patients). Triangulation may therefore be better seen as a way of ensuring comprehensiveness and encouraging a more reflexive analysis of the data (see below) than as a pure test of validity. Respondent validation Respondent validation, or "member checking," includes techniques in which the investigator's account is compared with those of the research subjects to establish the level of correspondence between the two sets. Study participants' reactions to the analyses are then incorporated into the study findings. Some researcher’s view this as the strongest available check on the credibility of a research project. (31). For example, the account produced by the researcher is designed for a wide audience and will, inevitably, be different from the account of an individual informant simply because of their different roles in the research process. As a result, it is better to think of respondent validation as part of a process of error reduction which also generates further original data, which in turn requires interpretation. (32) Clear exposition of methods of data collection and analysis Since the methods used in research unavoidably influence the objects of inquiry (and qualitative researchers are particularly aware of this), a clear account of the process of data collection and analysis is important. By the end of the VA study, it should be possible to provide a clear account of how early, simpler systems of classification evolved into more sophisticated coding structures and thence into clearly defined concepts and explanations for the data collected. Although it adds to the length of research reports, the written account should include sufficient data to allow the reader to judge whether the interpretation proffered is adequately supported by the data. 19
  • 20. Reflexivity Means sensitivity to the ways in which the researcher and the research process have shaped the collected data, including the role of prior assumptions and experience, which can influence even the most avowedly inductive inquiries. Personal and intellectual biases need to be made plain at the outset of any research reports to enhance the credibility of the findings. The effects of personal characteristics such as age, sex, social class, and professional status (doctor, nurse, physiotherapist, sociologist, etc) on the data collected and on the "distance" between the researcher and those researched also needs to be discussed. Attention to negative cases As well as exploration of alternative explanations for the data collected, a long established tactic for improving the quality of explanations in qualitative research is to search for, and discuss, elements in the data that contradict, or seem to contradict, the emerging explanation of the phenomena under study. Such "deviant case analysis" helps refine the analysis until it can explain all or the vast majority of the cases under scrutiny. LIMITATIONS Advantages Challenges Ways forward holistic a more accurate reflection of complex reality investigation can be so all- encompassing that it is difficult to focus continual refinement of hypotheses to focus investigation recognition of multiple realities more balanced representation of different stakeholders may be difficult to reconcile differences and assess how representative they are careful targeting heuristic, interpretative and inductive a better understanding of processes again investigation can be so all-encompassing that it is difficult to focus • continual refinement of hypotheses • skilled and focused probing • systematic use of computer analysis requires in- depth face-to- face field work better rapport with respondents and more continuous contact leading to more accurate information • requires skilled investigators • training and close supervision of field assistants central importance of outside researcher external understanding may enable a more balanced understanding than that of insiders investigation may be overly influenced by the subjective views of the researcher • continually reflecting on own biases and prejudices • detailed recording 20
  • 21. focus on information from individuals as well as groups Better understanding of difference and ability to get sensitive information • may be difficult to reconcile differences and assess how representative they are • the close relationship may give greater scope for manipulation and false application by informants • raises ethical issues of confidentiality • Detailed recording • Triangulation • Developing good levels of rapport • Adherence to ethical code record what is happening rather than influencing events Information may be more reliable if the investigation is not influenced by expectations or fear of consequences. The assessment process is extractive and may not make a contribution to program or policy development • Attention to methods of dissemination BENEFITS Q-Methodology Strengths ● Does not generalize beyond the immediate respondent set ● Use qualitative methods to allow respondents to say something about their own subjective attitudes that can be tested ● Uses quantitative factor analysis data reduction and induction to generate testable hypotheses POTENTIAL RISKS None. There are no procedures, lab tests, drug or medical interventions 4. NCVAMC Diabetes Communications and Education Interventions: The Key to Improved Diabetes Education, Compliance and Patient Safety The Indian Health Service, (IHS) a division of the U.S. Department of Health and Human Services has one of the largest and most successful diabetes treatment programs in the United States. The mission of the IHS, in partnership with American Indian and Alaska Native people, is to raise their physical, mental, social, and spiritual health to the highest level. The IHS goal is to ensure that comprehensive, culturally acceptable personal and public health services are available and accessible to all Indian people. American Indian and Alaska Native communities suffer a disproportionately high rate of type 2 diabetes when compared with other populations in the U. S. and throughout the world. According to the 2007 U. S. Census there are 3.3 million American Indians and Alaska natives; 16.3% of this population has been diagnosed with diabetes (compared to 8.7% of non-Hispanic white population) with 95% of American Indians and Alaska Natives with type 2 diabetes. The IHS, since 1995, has been actively engaged in designing and developing, “best practices,” for diabetes patients who are impacted by major socio-demographic factors and challenges with health literacy. The IHS has used their “best practices,” over the years, but has not engaged them in concert, outside of the IHS with a significantly challenged > 9.5% HbA1c high risk population, such as the NCVAMC population. We are recommending using a number of tested and proven 21
  • 22. “best practices,” of the IHS in concert at the North Chicago VA Medical Center to improve diabetes education compliance and patient safety. We recommend adding the following IHS diabetes “best practices” to the NCVAMC diabetes health care patient practice to increase VA patient compliance and safety. 1. Developing a Case Management Based Approach for Driving NCVAMC Quality Diabetes Education and Patient Safety. 2. Adding Six Key Questions to every NCVAMC Diabetes Health Care Visit, and ABC questions, and three question HbA1c survey 3. Develop NCVAMC Diabetes Team Provider Interventions with their Diabetes Patient’s that include the following three steps Step 1: Increasing VA Patient’s Knowledge about their Diabetes Step 2: Knowing the ABC’s of Quality VA Diabetes Care Step 3: Importance of Getting Regular VA Health Care Visits and Keeping a Longitudinal VA Diabetes Patient Care Record that is Understandable and Useful to the Patient Hypothesis We expect to find high levels of North Chicago VA Medical Center diabetes patient’s with challenges involving their health literacy and treatment regimes; socio-demographic factors (fear, stress, worry, and cultural issues); discovering patients with a lack-of-understanding of the VA healthcare brand. These factors of challenged health literacy, socio-demographic, and low brand awareness of the benefits of VA healthcare have produced hundreds of high-risk, >9.5% HbA1c NCVAMC diabetes patient’s that avoid attending and participating in VA educational intervention, designed to enhance their healthcare knowledge, quality-of-life and safety. What is a Brand? A brand is an intangible asset that resides in people’s minds, which is defined by the expectations people have about the benefits they will receive. These expectations of benefits are developed over time by communication, and more importantly—by actions. Understanding the Role of Patient and Provider Communications A successful patient-provider relationship is a partnership where the provider brings medical knowledge to diagnose and treat, and the patient contributes to his/her health and recovery by providing useful and necessary information and by acting on the recommendations and advice provided. As part of their responsibility towards the well-being of individuals, health care providers must not only alleviate patients from disease but are also obligated to educate them in a culture of prevention and promoting health-oriented behavior in all areas of their daily life. Both written and oral communications are critically important in building strong patient-provider relationships. The interaction between oral and written language is decisive to health care promotion and to enabling patients to become effective health care partners. Written material, including handouts, leaflets, brochures and written medication instructions, can enhance patient- provider encounters and are extremely useful, since they can be consulted wherever and whenever patients need to do so. To be effective and to promote adoption and use of health information, written materials must reflect an understanding of the patient’s way-of-life; their feelings, attitudes and opinions must be addressed in designing new integrated communication interventions. The Health Information Gap 22
  • 23. Bridging the information gap between patients and their health care providers is a major hurdle to improving overall health literacy. According to a Roper poll (33) in 2002, 70 percent of physicians say they provide patients with additional resources that help them understand their medications, but just 41 percent of those patients say they have received this kind of assistance. In addition, many patients simply are either unaware of or unwilling to admit to having difficulty with health care information. Health literacy is a multidimensional issue. The understanding of written materials and the adequacy of patient-provider communications have been the subject of extensive health literacy work to date. Issues involving socio-demographic factors (fear, stress, worry) and cultural relevance and sensitivity also have become part of the mix, as the diversity of the U.S. population, which requires that appropriate messages and images be tailored to meet the diverse values, beliefs, attitudes and traditions of those receiving the healthcare information. It is important to distinguish health literacy from health education and health communication. Health literacy is the goal; health education is one tool for reaching that goal. Similarly, the terms "health literacy" and "literacy" should not be freely interchanged. Health literacy encompasses more than just the ability to read written materials; it also means understanding the information so that a person can take an active role in managing his or her health care outcomes, and levels of safety. A 2007 Study, “Does literacy education improve symptoms of depression and self-efficacy in individuals with low literacy and depressive symptoms, concluded that among persons with low literacy and symptoms of depression, depression symptoms lessen as self-efficacy scores improve during participation in adult basic literacy education. (34) NCVAMC Diabetes Educational Interventions Current ENDOCRINE Section Diabetes Education, North Chicago VA Medical Center, North Chicago, IL A serious gap currently exists between the promise and the reality of diabetes care at the North Chicago VA Medical Center, resulting in hundreds of VA diabetic patients experiencing lower levels of compliant in their diabetic treatment regime, adding millions of dollars in additional health care costs. Practical interventions that facilitate collaborative relationships, case management and foster greater VA patient-centered practices are the key to closing this gap. The 5,500 diabetic patients at the North Chicago VA Medical Center are under treatment within all the major clinical sections. Today, patients receive diabetes treatment information and education from many sources with the NCVA medical center. NCVAMC Diabetes Education Protocols Patients are referred to the RN/DCE (Diabetes Certified Educator) from NCVAMC Primary Care or Mental Health Clinic Patients are evaluated in a consultation appointment for either individual or group education in the ENDOCRINE Section 1. Individual consultation with the diabetes nurse educator for assessment and recommendations IF a specific need is assessed by the referring provide or if the patient is unable to attend group class. INDIVIDUAL appointments are scheduled during Endocrine Clinic times. It is at the individual appointment that the patient has VITAL signs taken, a education history is taken, their glucose 23
  • 24. meter is uploaded and problem focused teaching is provided (usually with follow up a couple of weeks later) 2. GROUP class for the majority of patients referred for “education” (no specific needs assessed by the requesting provider). Lunch is included in the class educational training session In the GROUP class (offered twice per month from 9 a.m. to 2 p.m.) patients bring in a diabetes health and education history form that they completed at home. The form is reviewed and documented in the progress note. NO VITAL signs are taken at class. In the diabetes education class, patients perform their own CAPILLARY GLUCOSE test (not HgbA1c) before eating lunch and again 2-hours AFTER eating lunch. For patients not yet monitoring their blood sugars, glucose meter kits/instructions are supplied at the class and instruction/demo of meter use if provided during this blood sugar check. The NCVAMC diabetes education curriculum includes: Basic diabetes management concepts (taught by RN, CDE) Foot Care – foot care/skin care/when to seek help (taught by Podiatrist) Nutrition – basic information on healthy eating (taught by RD,CDE) Medication – basic information on oral/insulin treatment (taught by Pharm D) Exercise – benefits (taught by Kinesiotherapist) The NCVAMC ENDOCRINE Education Team consists of: (RD, Podiatrist, Pharmacist, KT and RN) is only together twice per month for the group education class. At the conclusion of class, patients are offered 1:1 follow up with the diabetes nurse and/or dietician and provided with our contact phone numbers. Typically patients follow up with the dietician in 2-4 weeks. There is no routine patient follow up to the group education class, at this time. For NCVAMC patients with HgbA1c >9%, 3-4 education follow up visits are suggested to get these NCVAMC patients more involved in their diabetes self-management. Patients are scheduled more frequently if they are being followed along with the Nurse Practitioner in our unofficial diabetes intensive management clinic. Note: The group diabetes education classes are open to all veterans – with controlled or uncontrolled diabetes – new onset or long duration of the disease Developing a New VA Partnership for Clear Health Communication, Developing a “VA Partnership for Clear Health Communication,” will help NCVAMC physicians, nurses and clinicians gain access to important patient insight, information and develop simple practical tools to communicate and build stronger relationships with their patients. Among these tools is a new patient education program called Ask Me 3 ™and the Indian Health Service Technique, which are designed to enhance communication and trust in healthcare relationships. All NCVAMC diabetes patients should ask six-key questions in every healthcare encounter to optimize their patient/provider communications and enhance their self-efficacy, resulting in a more actively engaged and educated patient. In addition for high risk diabetes patients and patient’s with low health literacy 24
  • 25. Ask Me 3 ™ promotes three questions to build knowledge, communication and strengthen relationships between patients and healthcare providers. In a 2007, University of Texas Research Study designed to implement Ask-Me-3™, a simple program that encourages patients to ask questions of physicians, in a low-income, predominantly Hispanic pediatric practice was instituted, resulting in 20% of practice patients were using the Ask-Me-3 technique, after six months. (35) For the NCVAMC diabetes study we will be using a more focused use of Ask Me 3 and HIS questions relating to actual diabetes treatment and medication compliance. 1. What is my main diabetes problem? 2. What do I need to do? 3. Why is it important for me to do this? American Indian and Alaska Native communities suffer a disproportionately high rate of type 2 diabetes when compared with other populations in the U. S. and throughout the world. According to the 2007 U. S. Census there are 3.3 million American Indians and Alaska natives; 16.3% of this population has been diagnosed with diabetes (compared to 8.7% of non-Hispanic white population) with 95% of American Indians and Alaska Natives with type 2 diabetes. Indian Health Service Technique, U.S. Department of Health and Human Services, promotes three simple, but essential questions for every pharmacy interaction that produces a more educated and actively engaged patient. In a 2007 Study, “Limited health literacy is a barrier to medication reconciliation in ambulatory care. Institute for Healthcare Studies, Feinberg School of Medicine, Northwestern University, Chicago, IL, found that nearly 50 percent of patients taking antihypertensive drugs in three community health centers were unable to accurately name a single one of their medications listed in their medical chart. That number climbed to 65 percent for patients with low health literacy. (36) 4. What is the diabetes medication for? 5. How do I take the medication? 6. What should I expect from the medication? The 2003, U.S. Department of Education, National Adult Literacy Study revealed that the average American reads at the 8th-9th grade level; however, health information is usually written at a higher reading level. Most patients – regardless of their reading or language skills – prefer medical information that is simple, easy to understand in layman terms. • Additional socio-demographic factors that hinder quality healthcare outcomes and safety include: – Intimidation, fear, vulnerability – Shock upon hearing a diagnosis – Extenuating stress within the patient’s family and social environment – Multiple chronic health conditions to understand and treat Along with encouraging VA diabetes patients to use the Ask Me 3 and Indian Health Service Technique approach, other tested techniques can increase patients’ comfort level with asking questions, as well as increase compliance with a health providers instructions after they leave appointments. We have adapted these two proven techniques to our own diabetes patient • Create a safe environment where patients feel comfortable talking openly with health providers 25
  • 26. • Use plain language instead of technical jargon. Sit down (instead of standing) to achieve eye level with your patient • Use simple visual models to illustrate a procedure or condition • Ask patients to “teach back” the care instructions you gave to them NCVAMC Diabetes Educational Intervention Focus Diabetes Self-Management Education (DSME) is recognized as a key fundamental component of total diabetes care. (33) The goal of DSME is to help patients acquire the knowledge, information, self-care practices, coping skills, and attitudes required for the effective self- management of their diabetes. Several reviews and meta-analyses have found DSME interventions to have a positive impact on diabetes-related health and psycho social outcomes, specifically increasing diabetes-related knowledge and improving blood glucose monitoring, dietary and exercise habits, foot care, medication taking, coping, and glycemic control. (34–38) Individual versus Group DSME Interventions Although a large body of evidence supports the efficacy of DSME interventions in improving diabetes-related health outcomes, few studies to date have investigated the impact of the DSME delivery format on diabetes health-related outcomes. According to Mensing and Norris (39) a group is “a gathering or an assembly of persons with a common interest.” The Centers for Medicare and Medicaid Services (CMS) has recommended a group size for diabetes patient education to comprise from 2 to 22 members, with an average of 8-15 participants, as optimal to effective learning. (44) Compared to individual-based approaches, group-based approaches typically invite greater interaction and interpersonal dynamics. Moreover, the group setting can foster certain educational activities, such as social modeling or problem-based learning better than the individual setting. (37) Some providers believe group based DSME is better than individual based DSME at improving diabetes related health outcomes. Group education is also thought to be less costly than individual education. (45-46) In fact, the Balanced Budget Act of 1997 provided a further economic incentive for group-based programs because it specifically recognized diabetes education via a group format for uniform reimbursement by the CMS. In recent years, group-based approaches have been associated with several advantages e.g., cost- effectiveness, patient satisfaction, and interactive learning (43, 45- 46) to date, the literature has only begun to investigate and describe different approaches to group-based DSME. Although the evidence supports the efficacy of DSME programs as a whole, variability in program goals, outcome measures, length of intervention, frequency of sessions, learning format and demographic background of participants has meant that there is no known best prototype for the optimal DSME program. (45, 47) New Focus for NCVAMC Educational Intervention Guiding Principles Informational research on current DSME standards has identified important basic learning model principles that we can use to guide the review and revision of the DSME standards for the NCVAMC Endocrinology Diabetes Educational Intervention focus. These principles are: VA Patient Learning Models ♦ Adult learning model: supports self management and control. The learning session is related to personal interactive processes. Incremental, “need to know” information is given in a supportive and social learning environment. (48) 26
  • 27. ♦ Public health nursing model: focuses on disease prevention and health promotion, with reductions in long-term complications. (49) ♦ Health belief model: addresses the patient’s belief that behavior change can enhance control over their diabetes and facilitates this effort. The support of these behavior changes and attitudes is demonstrated in the methodology and educational materials used. (50) ♦ Trans-theoretical model: incorporates the stages of change, which moves a patient from pre- contemplation to action by using cognitive learning concepts. The group support concept serves to enhance the support system, which moves the patient from action to continued compliance over the long term. (51) Primary Outcomes Goals for NCVAMC Group-Based DSME Programs The core empowerment-based principles for new NCVAMC diabetes education intervention should call for all programs to be patient centered (i.e., focused on concerns and questions introduced by patients), problem based (i.e., used real problems encountered by participants to guide the teaching/learning process), culturally relevant, inclusive of the clinical and psycho social aspects of living with diabetes, and evidence based. (60-65) 1. Patient-Centered Patients come from unique social and cultural environments; have different learning needs, priorities, and diabetes self-management experience; and encounter different challenges over the course of their lives. 2. Problem Based This approach to learning helps patients acquire the knowledge and skills to solve problems that are important to them. The learning begins with patient-identified problems and focuses on helping patients acquire the knowledge and skills needed to address those problems. 3. Socio-Demographic Relevant Using a patient-centered, problem based approach is by definition culturally and socially relevant because the education focuses on problems as prioritized and perceived by the patients in the diabetes program. (62-65) New NCVAMC Diabetes Educational Intervention Focus 1. Diabetes education is effective for improving clinical outcomes, safety and quality-of-life, in the long- term (52–58). 2. DSME has evolved from primarily didactic presentations to more theoretically based empowerment models (54, 59). 3. There is no one “best” education program or approach; however, programs incorporating behavioral and psycho-social strategies demonstrate improved outcomes (45- 47). Additional studies show that culturally and age appropriate programs improve outcomes (48–52) and that group education is effective. (53, 54, 55, 57, 58). 4. Ongoing support is critical to sustain progress made by participants during the DSME program (54, 64, 70, 71). 27
  • 28. 5. Behavioral goal-setting is an effective strategy to support self-management behaviors in diabetic patients (57, 72, 73). Designing New Integrated Communication Education Tools Effective health communication is the very foundation of the healthcare delivery system. Inadequate communication affects the spectrum of care, from prevention and screening to history taking and explaining diagnosis and treatment. (74) As a result, tools and interventions to improve understanding of health information for all patients must be integrated into written and oral communications among caregivers, public health officials, patients and their family and community members. Although the greatest immediate impact may be focusing on the patient-provider relationship, addressing this crisis in a meaningful way must go beyond focusing solely on the doctor/patient dynamic. Holistic approaches that embrace participatory group learning environments, empowerment health education and peer interaction will be equally critical, as will be the involvement of our public and private institutions. Health care providers have the opportunity to effectively communicate with patients during the individual encounters in which they diagnose, treat or help patients to incorporate preventive health behaviors. In addition, other industry information providers and health educators have the opportunity to incorporate clear health communication into their informational pieces, written or verbal, to impact the diverse patient groups being exposed to their information and educational initiatives. Create a Blame-Free Environment It is important for health care providers who encounter an individual exhibiting signs of low health literacy to create a “blame-free” environment in which the individual with low health literacy skill levels can seek help without feeling ashamed or stigmatized. Recent trends in 2007 point to overall drops in basic literacy competency across all sectors of American society. Rethink Spoken Communication In addition to understanding written communications, adequate health literacy also means that a person can understand and engage in spoken language communication, or dialogue, that occurs in a wide range of health contexts. For example, conversations with physicians, nurses, pharmacists and insurers occur more frequently than they do in written materials. Being able to discuss and ask questions is necessary to all aspects of healthy behaviors and to informed decision-making. There is a large body of research in the areas of sociolinguistics, anthropology and reading research that discusses both the similarities and differences between spoken and written language, and how together they create the most powerful communication channel. Revise Written Materials for Greater Understanding Although innovative alternatives to written materials, such as pictograms, comic strips, videos and graphics-rich computer-based training programs, should be explored more fully, often the use of written materials cannot be avoided. Letters, forms, discharge instructions and even hospital signage all require the use of the written word. The solution is that written materials for patients with low health literacy be aimed at the fourth to fifth grade reading level. Most patient education materials and brochures currently included with medications are written at a 10th-grade reading level or above. (75) Simple words and short sentences, larger type and generous use of “white” (unprinted) space should be used when developing these documents. Complicated medical or technical words should be replaced with simpler wording in layman terms when appropriate. 28
  • 29. Comic-strip formats have been found to be very useful for presenting a range of patient information and self-care regimens to patients with low health literacy skills. When using comic-strip formats or other forms of illustration, however, care should be taken to ensure that readers don’t find the materials condescending. The objective for any pictorial or simple image is the same as it is for written materials, that is, to deliver key messages. Images, therefore, should focus on desired behavior rather than on medical facts, and the information should be both culturally sensitive and personally relevant. (75, 76 ) 5. We Recommend NEW NCVAMC Diabetes Patient Interventions 5.1 Developing a Case Management Based Approach for driving NCVAMC Quality Diabetes Education and Patient Safety. We strongly recommend the use of Case Management within the NCVAMC diabetes program as a catalyst to re-engineer health care, and serve to facilitate coordinated care, reducing fragmentation, and increasing effective use of resources. Case Management promotes the development of a comprehensive and mutually agreed upon treatment plan- from the patient/client’s perspective. This is the primary force in improving adherence to the treatment plan. Lack of adherence to just the medication portion of the treatment plan is thought to cost the U.S. national economy $100 billion annually (Moreo, 2002). Case management has the potential to improve health care outcomes and resource efficiencies, leading to a reduction in costs across sectors of the VA healthcare system. Instituting VA Diabetes Case Management Case Management has been shown to improve adherence to standards of care and patient outcomes. Several examples might include an RN who coordinates the care of people with diabetes who are seen by VA or other healthcare providers or an RN/CDE who is actively involved in the care and follow-up of a set group of people with diabetes. • Level I: 1 RN coordinates the care and education of the diabetic population. • Level II: RN Case Manager tracks follow-up, appointments not kept, and people with diabetes lost to follow-up. Also coordinates the annual diabetes audit. • Level III: RN Case Manager is an active participant in the care of a set group of people with diabetes. This could include phone or in-office follow-up for blood sugars and blood pressure, facilitating medication refills, and so on. VA Diabetes Team To meet ADA guidelines, the NCVAMC diabetes program should have a clearly identified diabetes team with the responsibility of ensuring the quality of all diabetes care offered at NCVAMC site. The NCVAMC Team should meet and exceed ADA guidelines for quality care. • Level I: Diabetes Team consists of at least an RN and an RD • Level II: Diabetes Team is multidisciplinary both in composition and in delivering services to people with diabetes. A Team must include a physician. • Level III: At least one team member should be a Certified Diabetes Educator (CDE) and the program should have achieved both Education Program and Provider Recognition by the ADA • Ratio between an RN and diabetes patients: 800 to 1,000 patients to one RN. VA Patient Education/Self-management Support All quality diabetes programs have a strong education and self-management support component to help people actively direct their care and manage their diabetes every day. 29
  • 30. • Level I: A basic body of diabetes knowledge is taught to each patient. • Level II: Organized Education Plan with a defined curriculum and lesson plans. • Level III: Inclusion of empowerment strategies, including support groups, training in coping skills, and problem-solving/behavior-change interventions as part of self- management support. VA Specialty Exams and Services Diabetes care often requires the services of specialists, both for screening and treatment of complications (e.g. eye, foot. kidney). Whether a VA site contracts outside for the exams or provides them on-site, ensuring access to specialty care is an essential part of a diabetes system • Level I: Most/all screening exams and specialty services are provided by contract providers. • Level II: Screening exams and basic services are available on-site. • Level III: Subspecialty services are available on-site. Staging of NCVAMC Diabetes Population The care needs of people with diabetes change as their disease progresses. Following a patient at high risk for diabetes requires a different set of skills than management of one experiencing end- stage complications. For example, a program may choose to assign the follow- up of people at high risk for diabetes to an RN and/or an RD, the care of recently diagnosed diabetics to mid- level practitioners, and the care of patients with complications to physicians. This fully utilizes the skills of available staff in a cost-effective manner and matches people with diabetes' needs with the most appropriate providers. • Level I: Optimal use of existing diabetes team specialties. • Level II: Provide prevention/early detection services to people at high risk for diabetes. • Level III: Resources are specifically directed toward the care of people with advanced diabetes complications. STEP 4: HIGH-RISK NCVAMC DIABETES PATIENT INTERVENTION A serious gap currently exists between the promise and the reality of diabetes care at the North Chicago VA Medical Center, resulting in hundreds of VA diabetic patients experiencing lower levels of compliant in their diabetic treatment regime, adding millions of dollars in additional health care costs. Practical interventions that facilitate collaborative relationships and foster VA patient-centered practices are the key to closing this gap. Recent effort’s to aggressively lower blood sugar levels among high risk diabetes patients groups in a major national study of 10,251 participants has resulted in 460 deaths among study participants. The ACCORD Study, Action to Control Cardiovascular Risk in Diabetes funded by the NIH was halted in February 2008 by the National Institute of Health. The primary focus of the study was to aggressively lower blood sugar levels of high risk patients as a major intervention to control diabetes. The study was halted for three primary reasons. (92) ●Major study on diabetes and heart disease halted because of 460 unexpected deaths ●Study aimed to cut blood sugar of type 2 diabetics' at high risk of heart attack, stroke ●Risk found in intensively lowering blood sugar of at-risk patients Medication intervention is only one vital component of total diabetes control, and these points to the continuing need to expand education and communication interventions among high risk patient groups, along with medication regimes, as the best long term solution in achieving greater levels of overall compliance and patient safety. 30
  • 31. Although primary care physicians, in America today currently provide 80% to 95% of diabetes care in this country, they cannot do all that is required and often are discouraged that the current medical system does not function adequately for people with diabetes. Components of aggressive and comprehensive diabetes care that many physicians find difficult to provide because of various systems constraints include telephone management of glycemia, ongoing education and behavioral interventions, risk factor reduction, health promotion, and periodic examination for early signs of complications. (78) BUILDING NCVAMC DIABETES PATIENT CENTERED TEAM CARE The challenge at NCVAMC is to find a way to meet the needs of patients with diabetes by broadening the care delivery opportunities available to primary care providers (physicians, nurse practitioners, and physician assistants) and other health care professionals. We see that diabetes team care meets this challenge by integrating the skills of different health care professionals with those of the patient and family members into a comprehensive lifetime diabetes management program. Short- and long-term benefits of diabetes team care include improved glycemic control, increased patient follow-up, higher patient satisfaction, lower risk for the complications of diabetes, improved quality of life, and cut millions of dollars in health care costs at North Chicago VA Medical Center. (79, 80) For the NCVAMC diabetes team care to succeed, the following elements must be in place: ● Commitment of policy makers (e.g., purchasers of health care, medical directors, benefits managers, chief executive officers, HR director) to establish and sustain an infrastructure supportive of VA team care program. ● Reimbursement for the services of core team members proportional to their expertise and time involved in diabetes team care. ● Regular communication among team members and documentation of provided care. (81) Forming a NCVAMC diabetes team requires a planning group to do the following: ● Ensure the commitment of NCVA medical center leadership. ● Gain support from VA care providers and other key decision makers within the system. ● Identify team members: Including physicians, RN nurses, clinicians, pharmacists, pharmacist assistants, nursing assistants, educators, administrative assistance, HR, management persons, including support staff and other medical assistants, and VA volunteers. ● Identify the patient population. (use information from the NCVAMC proposed study) ● Stratify the patient population according to the intensity of services needed. (use information from the NCVAMC proposed study). ● Assess VA resources and other potential outside assets ● Develop a system for coordinated, continuous, quality care. 31
  • 32. ● Evaluate outcomes and adjust services as necessary. (82, 83) Team composition will vary according to patient need, patient load, organizational constraints, resources, clinical setting, and professional skills. A VA diabetes core team usually includes a physician, nurse, and a dietitian, at least one of whom is a certified diabetes educator. Many other health professionals can be team members or collaborative consultants if needed. It is essential that a key individual coordinate the team effort at all levels. It is easier to coordinate services, communicate effectively, evaluate patient outcomes and satisfaction, and monitor costs when all team members are employed by the same organization and payment for their services is from the same source. This structure is usually present in staff model health maintenance organizations or in large clinics, such as in the case of the North Chicago VA Medical Center. (84) The VA diabetes team can minimize patients’ health risks by assessment, intervention, and surveillance to identify problems early and initiate prompt treatment. Increased use of effective treatments to improve both glycemic control and cardiovascular risk profiles can prevent or delay progression to renal failure, blindness, nerve damage, lower- extremity amputation, and serious cardiovascular disease. When VA patients actively participate in treatment decisions, set personally selected behavioral goals, receive adequate education, and actively manage their disease, improved diabetes control is achieved. This in turn leads to improved patient satisfaction with care, better quality of life, improve health outcomes, and ultimately, significantly lower health care costs at all levels. This is our primary focus in using the, “6 Key Questions to Ask for Your Good Health and “Knowing Your ABC’s of Good Diabetes Health,” educational interventions, as important patient centered interventions designed to achieve higher levels of diabetic compliance and enhance safety for high-risk, potentially low literacy NCVAMC diabetic patients. (85, 86) VA APPROVED DIABETES TREATMENT PROTOCOLS VA DIABETES TREATMENT PROTOCOLS VETERAN AFFAIRS HEALTH CARE/DEPARTMENT OF DEFENSE VAH/DoD Clinical Practice Guidelines for Management of Diabetes Mellitus Approved Protocols—September 2003 (93) http://www.oqp.med.va.gov/cpg/DM/DM_GOL.htm A. Patient with Diabetes Mellitus Diabetes mellitus (DM) is a state of absolute or relative insulin deficiency resulting in hyperglycemia. This algorithm applies to adults only (age 17), both diabetes type 1 and type 2 (formerly referred to as insulin-dependent and non-insulin dependent diabetes mellitus), but not to gestational diabetes mellitus (GDM). B. Refer To Pediatric Diabetes Management OBJECTIVE Provide appropriate management for diabetic children. C. Is Patient A Female Of Reproductive Potential? OBJECTIVE 32
  • 33. Assess the risk of maternal and fetal complications of an unintended pregnancy and implement prevention strategies. D. Identify Comorbid Conditions OBJECTIVE Evaluate DM management in the context of the patient's total health status. E. Is the Patient Medically, Psychologically, and Socially Stable? OBJECTIVE Stabilize the patient before initiating long-term disease management. F. Identify/Update Related Problems from Medical Record, History, Physical Examination, Laboratory Tests, and Nutritional and Educational Assessment OBJECTIVE Obtain and document a complete medical evaluation for the patient with DM, annually. EDUCATIONAL ASSESSMENT AND INTERVENTION The following questions were developed based on expert opinion and are believed to reflect the patient’s general knowledge and ability to adequately self-manage his or her diabetes: 1. Is there anything you do or have been advised to do because of your diabetes that you have difficulty with or are unable to do? 2. Do you know what to do when your sugar is high/low (describe both hyperglycemia and hypoglycemia symptoms)? Who and when do you call? 3. Do you remember your target goals: HbA1c, low-density lipoprotein (LDL), weight, exercise, and BP? 4. Which food affects your blood sugar the most—chicken breast, salad, or potato? North Chicago VA Medical Center-Education Intervention “Improving Control Patient Education Class-Risk focused Intervention “Home Management Patient Education Class—Core Competency Education” G. Determine and Document if Diabetes Mellitus is Type 1 or 2 (If Not Already Done) OBJECTIVE Determine what treatment components are needed for a particular patient. CLINICAL CLASSIFICATION OF TYPE 1 OR 2 H. Consider Aspirin Therapy OBJECTIVE Prevent cardiovascular disease. I. Review All Diabetes-Related Complications and Set Priorities OBJECTIVE Identify DM-related complications requiring special attention. Summary of the Management of Hypertension in Diabetes Mellitus Recommendations Blood Pressure Targets 33
  • 34. Pharmacotherapy Summary of the Management of Lipids in Diabetes Mellitus Recommendations Discussion: Summarizes the thresholds and goals for dyslipidemia treatment NCVAMC DIABETES INTERVENTION STUDY EFFICACY Developing a “VA Partnership for Clear Health Communication,” will help NCVAMC physicians, nurses and clinicians, and other health care providers gain important new patient insight, information and develop simple practical tools to communicate and build stronger relationships with their patients. Among these tools is a new patient education intervention, “Asking the 6-Key Questions to Ask For Your Good Health and Knowing Your ABC’s of Good Diabetes Health,” which are designed to enhance active patient participation in their diabetes treatment regime, as well as, build new confidence, communication and trust among high risk diabetes patients, and their VA health care team partners. High risk diabetes patients, with potential low literacy (>9.5% HgbA1a) NCVAMC diabetes patients should ask six-key questions in every healthcare encounter, test and procedure; in addition know their ABC’s of Good Diabetes Health to help them optimize their patient/provider communications, enhancing self-efficacy, resulting in a more actively engaged and educated VA patient. NCVAMC Diabetes Education Team Intervention Session (60 to 90 minutes) Effective diabetes self-management education is an interactive, collaborative, ongoing process group meeting involving the person with diabetes and the VA diabetes treatment team. DSME Diabetes Self-Management Education is not a static process, but a continuous, long term initiative by all stakeholders to work collaboratively to achieve optimal health status. (87) VA patient’s must feel comfortable and encouraged in taking the intervention session more once, if they feel they don’t understand something, or need more coaching in understanding how to better manage their diabetes care. Group diabetes education is currently receiving a great deal of attention among educators, policy- makers, and payors. Some educators prefer groups whenever possible and recommend using groups as a first-line approach to improve diabetes outcomes. Diabetes group education is a cost- effective alternative to individual education. Fiscal intermediaries and reimbursement constraints are important factors influencing the format of diabetes education in today’s practice. The federal Balanced Budget Act of 1997 resulted in changes in reimbursement by the Centers for Medicaid and Medicare Services (CMS, formerly the Health Care Financing Administration) that supported group delivery of diabetes education. (88, 89, 90, 91) The NCVAMC Diabetes Team will comprise of a physician or RN nurse, dietician, or certified diabetes educator. The diabetes educators typically are physicians and nurses, but can be as varied as the practice can afford and may include dietitians, pharmacists, physical trainers, podiatrists, social workers, or psychologists. A minimum of two NCVAMC diabetes educational professionals will facilitate the group educational meeting. 34
  • 35. The group session will takes place in a large conference room or waiting room and last from 60– 90 minutes, comprising from 8 to15 diabetic patients. Successful diabetes education tends to be interactive with a lot of patient participation encouraged. Ideally, there will be a strong focus on understanding disease physiology, self-care, and enhancing new diabetes patient skills building. Step 1: The Six Key Questions are designed to build knowledge, communication and strengthen relationships between patient and VA healthcare team members at all levels of the system, and increase patient involvement and responsibility for their health care outcomes. Patients will learn the importance of asking these 6 Key Questions in every health visit, procedure or test to improve their diabetes compliance level. Each patient will be given a two-page instruction sheet, “Six Key Questions to Ask for Your Good Health.” In addition, each patient will be given a business card size two panel laminated copy of the 6-Key Questions To Ask to keep in their wallet or purse for future reference. 1. What is my main diabetes problem? 2. What do I need to do? 3. Why is it important for me to do this? 4. What is my diabetes medication for? 5. How do I take my diabetes medication? 6. What should I expect from the medication? Step 2: NCVAMC Diabetes Patients will be given a “Knowing Your ABC’s of Good Diabetic Health,” information recording sheet before every medical visit. Patients will be educated to ask their VA Diabetes Team Member at each healthcare visit, test, or procedure: 1. What is my A1C, blood pressure, and cholesterol numbers? 2. What should my ABC numbers be? 3. What you can do to reach your targets? Each patient will be given a preprinted form with their numbers on a VA medical record card, and asked to keep this form with them, and to bring it to every visit, test, and procedure. Every diabetes patients will be given a “KNOWING YOUR ABC’S OF GOOD DIABETIC HEALTH FORM.” Record a patient’s targets and the date, time, and results of their tests. Take this card with them on their VA health care visits. Show it to their VA health care team member to remind them of tests they need, and targets to be reached. Knowing Your ABC’s of Good Diabetes Health 35