“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 Center3001 Green Bay Road, North Chicago, IL 60031

Dr. Tariq Hassan, M.D. Veterans Affairs Medical Center, North Chicago, ILDr. Boby G. Theckedath, M.D. Veterans Affairs Medical Center, North Chicago, ILDr. Sant Singh, M.D. Veterans Affairs Medical Center, North Chicago, ILDr. 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, ILDavid R. Donohue. M.A., Qualitative Technologies Inc. and Northwestern UniversityJanine Stoll, RN, BSN, CDE, Veterans Affairs Medical Center, North Chicago, IL

INTRODUCTION

NORTH CHICAGO VA DIABETES STUDY FOCUSThe (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 precision2. 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. Age2. Race/ethnic origin 3. Years with diabetes4. Sex5. Education level

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6. Income7. Hypoglycemic regimen8. Last HbA1c checked (%) 9. Percent with > 80% treatment at VA facility10. Percent with >80% treatment at other medical facility11. Health Literacy NVS (low literacy, low literacy possible, literate)12. Patient understood correctly HbA1c value13. Had biomedically accurate assessment of diabetes14. 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 diabetesSexYears of educationIncome$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 regimenOral medication onlyInsulin +- oral medicationNo medicationHealth StatusExcellent to very goodFairPoorOutpatients visits in past yearLast HbA1c checked (%) VA outpatient visits in last yearPercent with > 80% at VA facilityDollar value of VA diabetes care, as % of care Percent with >80% treatment at other medical facilityPercent with > than two outpatient VA visits in past year

Health Literacy Test NVS

Patient understood correctly HbA1c valueHad biomedically accurate assessment of diabetesDiabetes 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 RequirementsInsuring 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.

HIPAA Compliance Requirements

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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

OBJECTIVEWe 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)

INSTRUMENTThe (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 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. 

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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 ACCURACYThe 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 NVSThe 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 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.

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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 doesnot 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 LIMITATIONSThe 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 ANALYSISThe 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)

POTENTIAL BENEFITSThe primary goals of quality diabetes education and communication are:

A. Provide patient knowledge and skill training

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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 RISKSNone: There are no procedures, lab tests, drug or medical interventions

2: HbA1c Survey---Understanding Patient’s Knowledge of Their HbA1c LevelOBJECTIVE—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.

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 HbA1ctest results with patients and ensuring that patients understand the meaning of their HbA1c

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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.

INSTRUMENTWe 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 41. 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" 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

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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 assess diabetes care self-efficacy, we will use a validated four-item scale, with higher scores reflecting higher self-efficacy in managing diabetes.

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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 ACCURACYReliability 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 ANALYSISIn 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 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

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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)

LIMITATIONSThe 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 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

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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 RISKSNone: 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 GroupsWe 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 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

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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  209  21  13  18  7  14 12   8  24

22  23 15 17  1916

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.

I feel satisfied with my life.

My VA diabetes education is useful.

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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 diabetesI 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)

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◘ 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 needso development of communication and education skillso counseling skillso negotiation dynamicso 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)

VARIABLESRequirements for conduct of the study require that data be:Contextually relevant

Responses/statements in subjects’ “own words”Uninfluenced by researchers’ own viewsUnconstrained by theoretical frameworkUnrestricted 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.

C. The individual subject is then the independent variable.

Condition of Instruction

Q-SORTEXECUTION

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CONCOURSE

Q-SAMPLE

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 usedFocus 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 definersQ-sorts that load very strongly on only one factor

● Factor loadersAll Q-sorts with a statistically significant loading on one or more factors

● Factor scoresTheoretical Q-sorts obtained by weighting all definers on one factor at a time

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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 researchThere 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.

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

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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

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

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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 RISKSNone. 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 “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

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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 DiabetesStep 2: Knowing the ABC’s of Quality VA Diabetes CareStep 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 CommunicationsA successful patient-provider relationship is a partnership where the provider brings medicalknowledge to diagnose and treat, and the patient contributes to his/her health and recoveryby providing useful and necessary information and by acting on the recommendations andadvice provided. As part of their responsibility towards the well-being of individuals, healthcare 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 GapBridging 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

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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 InterventionsCurrent 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 ProtocolsPatients 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 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.

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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

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?

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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

• 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-

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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 InterventionsAlthough 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 PrinciplesInformational 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)

♦ 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

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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 ProgramsThe 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-CenteredPatients 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 BasedThis 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 RelevantUsing 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).

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.

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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.

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 )

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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 ManagementCase 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 withdiabetes 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 TeamTo 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 SupportAll 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.

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

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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 PopulationThe 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 INTERVENTIONA 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.

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)

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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 andtime 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.

● 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.

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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 riskprofiles 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 PROTOCOLSVETERAN AFFAIRS HEALTH CARE/DEPARTMENT OF DEFENSEVAH/DoD Clinical Practice Guidelines for Management of Diabetes MellitusApproved Protocols—September 2003 (93)

http://www.oqp.med.va.gov/cpg/DM/DM_GOL.htm

A. Patient with Diabetes MellitusDiabetes 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 ManagementOBJECTIVEProvide appropriate management for diabetic children.

C. Is Patient A Female Of Reproductive Potential?OBJECTIVEAssess the risk of maternal and fetal complications of an unintended pregnancy and implement prevention strategies.

D. Identify Comorbid ConditionsOBJECTIVEEvaluate DM management in the context of the patient's total health status.

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E. Is the Patient Medically, Psychologically, and Socially Stable?OBJECTIVEStabilize 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 AssessmentOBJECTIVEObtain 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)OBJECTIVEDetermine what treatment components are needed for a particular patient.CLINICAL CLASSIFICATION OF TYPE 1 OR 2

H. Consider Aspirin TherapyOBJECTIVEPrevent cardiovascular disease.

I. Review All Diabetes-Related Complications and Set PrioritiesOBJECTIVEIdentify DM-related complications requiring special attention.

Summary of the Management of Hypertension in Diabetes Mellitus

Recommendations

Blood Pressure Targets

Pharmacotherapy

Summary of the Management of Lipids in Diabetes Mellitus

Recommendations

Discussion: Summarizes the thresholds and goals for dyslipidemia treatment

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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.

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

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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

Talk with your VA health care team member about how to manage your diabetes on each visit, test or procedure

A1C (blood glucose or sugar)Blood pressureCholesterol: This will help lower your chances of having a heart attack, a stroke, or other diabetes problems.

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A for the A1C test (A-one-C) It shows you what your blood glucose has been over the last three months. The A1C goal for most people is below 7. High blood glucose levels can harm your heart and blood vessels, kidneys, feet, and eyes.

B for Blood pressureThe goal for most people is 130/80.High blood pressure makes your heart work too hard. It can cause heart attack, stroke, and kidney disease.

C for Cholesterol The LDL goal for most people is less than 100.The HDL goal for most people is above 40.LDL or "bad" cholesterol can build up and clog your blood vessels. It can cause a heart attack or a stroke. HDL or "good" cholesterol helps remove cholesterol from your blood vessels.

NCVAMC Patients will ask their VA Diabetes Team Member at each health care visit, test or procedure1. 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?

A Longitudinal VA Diabetes Patient Care Record that is Patient Useful Preprint for each diabetes patient their targets and the date, time, and results of their tests. Takethis card with them on their VA health care visits. Show it to their VA healthcare team member to remind them of tests or actions they need to take.

PREPRINT ALL KEY NUMBERS FOR NCVAMC DIABETES PATIENTS

KNOWING YOUR ABC’S OF GOOD DIABETIC HEALTH-Page 1 SAVE FORMA1C - At least twice each yearUsual goal: less than 7 My Target

Date:

Result:        BLOOD PRESSURE (BP) - Each visitUsual goal: less than 130/80 My Target

Date:        

Result:        CHOLESTEROL (LDL) - Once each yearUsual goal: less than 100 My Target

Date:        

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Result:        WEIGHT - Each visitMy Goal: _______ My Target

Date:        

Result:        KNOWING YOUR ABC’S OF GOOD DIABETIC HEALTH-Page 2 SAVE FORM

Diabetes Medicines Date Result

Each visit at VAFoot checkReview self-care    Plan    Weight check  Once each yearDental exam  Dilated eye exam    Complete foot exam  

Flu shot  

Kidney check  At least oncePneumonia shot  

Review all the numbers on a VA diabetic patient medical record card, and encourage each patient keep and bring this record to each visit, test and procedure.

Step 3: “Getting Regular VA Care Visits.”

Review with intervention diabetic patient groups a reminded to see their VA health care team at least twice a year to find and treat any problems early. Ask what steps you can take to reach their optimal goals.

At each visit be sure you have a:

blood pressure check foot check weight check review of your self-care plan

Two times each year get:

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A1C test - it may be checked more often if it is over >7.0 %

Once each year have a:

cholesterol test triglyceride test - a type of blood fat complete foot exam dental exam to check teeth and gums - tell your dentist you have diabetes dilated eye exam to check for eye problems flu shot urine and a blood test to check for kidney problems

Increasing VA Diabetes Patients Knowledge about their Disease

Diabetes means that your blood glucose (blood sugar) is too high. There are two main types of diabetes.

 Type 1 diabetes - the body does not make insulin. Insulin helps the body use glucose from food for energy. People with type 1 need to take insulin every day.

Type 2 diabetes - the body does not make or use insulin well. People with type 2 often need to take pills or insulin. Type 2 is the most common form of diabetes.

Diabetes is very serious, long term chronic disease.

You may have heard people say they have "a touch of diabetes" or "your sugar is a little high." These words suggest that diabetes is not a serious disease. That is not correct. Diabetes is very serious, but all patients can learn to manage it!

All people with diabetes need to make healthy food choices, stay at a healthy weight, and are physically active every day.

Taking good care of yourself and your diabetes can help you feel better. It may help one avoid health problems caused by diabetes such as:

heart disease and stroke. eye problems that can lead to trouble seeing or going blind. nerve damage that can cause your hands and feet to feel numb. Some people may even

lose a foot or a leg. kidney problems that can cause your kidneys to stop working. gum disease and loss of teeth.

When blood glucose is close to normal, an individual is likely to:

have more energy.

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be less tired and thirsty and urinate less often. heal better and have fewer skin, or bladder infections. have fewer problems with your eyesight, feet, and gums.

Key outcomes for VA provider/patient diabetes session intervention  

▼ Educate me on what type of diabetes I have.

▼Why is my diabetes a serious condition?

▼Learn how caring for my diabetes helps me feel better today and in the future.

STUDY STASTICAL ANALYSIS

Descriptive StatisticsA paired sample t Test will first be run. The Mann Whitney U Test will also be performed. Results of both will be examined for significant findings for the potential differences between control and intervention study groups. Missing data values will be eliminated from statistical analysis. Only entries where data values are present will be used.

t-Test The standard t-test compares the means for two groups of test cases. The paired samples t-test compares the means of two variables that represent the same group at different times. It computes the differences between values of two variables for each case and tests whether these averages differ from 0. If the correlation is low and the significance value is high, the independent samples t-test may be used. In a paired samples test, means and 95% confidence intervals are examined. If the confidence interval for the mean difference does not contain zero, this indicates that the difference is significant. A low value for 2-tailed significance also indicates a significant difference between the variables. Statistics calculated for each variable will include:

mean sample size standard deviation standard error for the mean

Statistics calculated for each pair of variables will include: correlation average difference in means t-test standard deviation and standard error of the mean difference confidence interval for the mean difference

This test is commonly used in medical studies to test the effect of some treatment on a group of patients. Patients are measured at the beginning of the study, treated, and then measured again. The general scheme is as follows:

Initial Measurement Intervention Post Measurement

Thus, each subject is a member of two groups.

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In this study, we will measure all subjects for a number of variables initially, provide intervention in the form of a training group intervention, and then measure subjects again for measures of the variables.

Mann-Whitney TestThe Mann-Whitney U Test is the most popular of the two-independent-samples tests. It willtest that two sampled populations are equivalent in location when values are placed inrank-ordered lists. Observations from both groups are combined and ranked. Calculationsare done on the number of times a score from each group precedes a score from the othergroup. The Mann-Whitney U statistic is the smaller of these 2 numbers. The Mann-Whitney test measures a variable value (here HbA1c level) under two groups. We analyze the results obtained by each Group (the grouping Variable.) Group 1 is the control. Group 0 is the intervention group. The two groups will be examined and data ranked.

Mann Whitney U test scores on test variables are converted to ranks independent of membership in any groups. The mean ranks of the two groups are then compared to see if there are any significant differences. We are interested primarily in differences between mean ranks of the study variable values between the control and the intervention groups.

Because ranked scores are used, the distributions do not have to be of any particular form. The descriptive statistics on these tasks indicate the numerical representation of the shape of the distribution. Distributions are generally asymmetrical (positively skewed.) This militates against applying an analysis that assumes a normal distribution. Use of the Mann Whitney test thus alleviates problems that would occur if we relied on statistical tests that assume a normal distribution.

We will present both Mann Whitney U Test results indicating ranking relationships on test variables, as well as raw variable values and distributions. Without the latter, areader would have little idea of what the raw results were like. We will present tables that list rank data for each of the variables found to have a statistically significant test result. The mean rank for each lists the average of the ranks for each group. Similar values would indicate similarity in Group location. Small significance values (< .05) indicate that the two Groups have different locations when placed in rank-ordered lists. This would indicate a significant difference in outcome based on the difference in intervention used.

Attitudinal Data Analysis

Factor RotationThe study will also use a concourse of patient statements to identify patient attitudes toward health literacy and patient education. These statements will be elicited in focus group meetings with patients. They will be summarized and the resulting set of representative statements will be given to study participants for rank ordering according to agreement with each. This will give us attitudinal profiles of each patient. Thus patient attitudinal status is a variable to be studied. This will be done by analyzing the overall similarity in response patterns of each patient to all other patients. By using SPSS Varimax Rotation we will be able to identify the factor groups that exist in the patient population with respect to the attitudinal measures.

Factor analysis is a method of data reduction.  It does this by seeking underlying unobservable (latent) variables that are reflected in the observed variables (manifest variables).  There are many

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different methods that can be used to conduct a factor analysis (such as principal axis factor, maximum likelihood, generalized least squares, unweighted least squares), There are also many different types of rotations that can be done after the initial extraction of factors, including orthogonal rotations, such as varimax and equimax, which impose the restriction that the factors cannot be correlated, and oblique rotations, such as promax, which allow the factors to be correlated with one another.  Analysts must determine the number of factors that they want to extract.  Given the number of factor analytic techniques and options, it is not surprising that different analysts could reach very different results analyzing the same data set.  However, all analysts are looking for simple structure.  Simple structure is a pattern of results such that each variable loads highly onto one and only one factor. 

Analyses of this type usually need a large sample size (on the order of 400 or more) to produce a stable outcome. The study sample size of 400 will be sufficient. The determination of the number of factors to extract should be guided by theory, but also informed by running the analysis extracting different numbers of factors and seeing which number of factors yields the most interpretable results. The resulting factors will be identified by those individual statements that load heavily on them.

CONCLUSION VA Diabetes Patient Interventions All communication interventions to patients must be individualized according to shared attributes that have been identified and categorized from similar diabetes focus group members. After those VA patient’s most-at-risk for poor compliance have been identified, those diabetes patients must receive intensive disease education and monitoring from a multidisciplinary VA team drawn from all levels of the VA healthcare organization. Other diabetes patients should continue with usual diabetes care regimen and be monitored for ways to improve their healthcare status and safety. Issues of diabetes compliance for women veteran have not been addressed with the VA and a concerted effort must be developed to address challenges unique to women veterans.

REFERENCES

(1.) Q-Source, Memphis, TN, Dawson, Raymond 2006, Diabetes Quality Improvement Project

(2.) How Well Do Patients’ Assessments of Their Diabetes Self-Management Correlate WithActual Glycemic Control and Receipt of Recommended Diabetes Services? Michele Heisler, MD, MPA, Dylan M. Smith, PHD, Rodney A. Hayward, MD, Sarah L. Krein, and Eve A. Kerr, MD, MPH. Veterans Affairs Center for Practice Management and Outcomes Research, VA AnnArbor Healthcare System, Ann Arbor, Michigan. Robert Wood Johnson Clinical Scholars Program, University of Michigan School of Medicine, Ann Arbor, Michigan. Department of Internal Medicine, University of Michigan School of Medicine, Ann Arbor, Michigan. Michigan Diabetes Research and Training Center, University of Michigan School of Medicine, Ann Arbor, Michigan. Diabetes Care 26:738-743, 2003

(3.) The Relationship Between Knowledge of Recent HbA1c Values and Diabetes CareUnderstanding and Self-Management Michele Heisler, MD, John D. Piette, PHD, Michael Spencer, PHD , Edie Kieffer, PHD and Sandeep Vijan, MD. Veterans Affairs Center for Practice Management and Outcomes Research, Veterans Affairs Ann Arbor Healthcare System, Ann Arbor, Michigan. Department of Internal Medicine, University of Michigan, Ann Arbor, Michigan. Michigan Diabetes Research and Training Center, University of Michigan School of Medicine, Ann Arbor, MichiganUniversity of Michigan School of Social Work, Ann Arbor, Michigan. Diabetes Care 28:816-822, 2005

(4.) AHRQ) Agency for Healthcare Research and Quality Research Study, “Literacy and Healthcare Outcomes,” April 2004.

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(5.) “The Best Care Anywhere,” Washington Monthly, Jan/Feb 2005, Longman, Philip.

(6.) Low literacy levels in adults: implications for patient education. J Contin Educ Nurs. 1999 Mar-Apr;30(2):56-61. Fisher E. Veterans Affairs Medical Center West Los Angeles, California, USA.

(7.) Lorig KR, Sobel DS, Ritter PL, Laurent D, Hobbs M: Effect of a self-management program on patients with chronic disease. Eff Clin Pract 4:256–262, 2001[

(8.) Approaches to patient education: emphasizing the long-term value of compliance and persistence. Am J Med. 2006 Apr;119(4 Suppl 1):S32-7 Gold DT, McClung B. Department of Psychiatry & Behavioral Science, Sociology, and Psychology, Duke University Medical Center, Durham 27710, North Carolina, USA. dtg@geri.duke.edu

(9.) Quick Assessment of Literacy in Primary Care: The Newest Vital Sign. University of Arizona College of Medicine, Department of Family and Community Medicine, Tucson, Ariz. Barry D. Weiss, MD.Mary Z. Mays, PhD,William Martz, MD, Kelley Merriam, Castro, MA, Darren A. DeWalt, MD, MPH, Michael P. Pignone, MD, MPH, , Joy Mockbee, MD, MPH, Frank A. Hale, PhD. ANNALS OF FAMILY MEDICINE, WWW.ANNFAMMED.ORG, VOL. 3, NO. 6, NOVEMBER/DECEMBER 2005

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NCVAMC Diabetes Research Project Coordinator

DAVID R. DONOHUE, M.A.Qualitative Technologies, Inc.QTINC@ALUMNI.NORTHWESTERN.EDU

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