Addressing the Role of Nutrition Education and Health Literacy in Diabetes Care

1. Addressing The Role of Nutrition Education and Health Literacy in Diabetes Care Rebecca Pratt Gregory, MS, RD, CDE and Kerri Cavanaugh, MD, MHS

2. Learning Objectives • Review of impact of CDEs and medical nutrition therapy (MNT) on diabetes outcomes • Review health literacy & numeracy in diabetes self-care • Describe design of new randomized controlled trial to: • Examine the value of CDE in diabetes care • Examine the role of different approaches to MNT • Learn about study results, interpretation and applications to clinical practice

3. Role of CDEs in Medical Nutrition Therapy in Diabetes Care • Diabetes self-management education (DSME) can improve patient knowledge, behavior, and glycemic control • Medical Nutrition Therapy is an essential part of DSME • Addressing carbohydrates as a nutritional strategy is endorsed by the ADA and the AADE • Clinical trials have shown that MNT can improve A1C by 1-2% • No studies have compared carbohydrate counting and plate method • Facilitating positive behavior as well as transferring knowledge is a priority, but little research in this area exists

4. Literacy Cultural and Conceptual Knowledge Listening Speaking Numeracy Writing Reading Print Literacy Oral Literacy Defining Health Literacy Components of Literacy IOM, Health Literacy, 2004

5. Health literacy is associated with outcomesDiabetes Schillinger, JAMA, 2002

6. Literacy Cultural and Conceptual Knowledge Listening Speaking Numeracy Writing Reading Print Literacy Oral Literacy Components of Literacy IOM, Health Literacy, 2004

7. Definition of Numeracy • The ability to use numbers in daily life. [Rothman RL et al. AJPM 2006] • Examples of numeracy skills • Calculations • Interpretation of graphs/labels • Time • Probability • Ability to deduce when and what math is needed for a given situation.

8. Numeracy in diabetes care • Glucose monitoring • Carbohydrate counting • Sliding/correction scale Insulin • Calculating insulin:carbohydrate ratios • Insulin pump adjustment • Sick day management

9. Measurement of Diabetes NumeracyDiabetes Numeracy Test (DNT) • Experts • 43-items • Diabetes and Numeracy Domains • No time limit • Calculators could be used • Kuder-Richardson-20 coefficient=0.95 Huizinga MM, et al. BMC Health Services Research 2008: 8;96 http://www.mc.vanderbilt.edu/diabetes/drtc/preventionandcontrol/tools.php

10. Diabetes Numeracy & A1C Adjusted GLS regression model * Also adjusted for income, type of diabetes, and clinic Cavanaugh K, et al. Ann Intern Med 2008; 148: 737-746

11. Diabetes Literacy & Numeracy Education Toolkit (DLNET): A RCT

12. Diabetes Literacy & Numeracy Education Toolkit (DLNET)RCT • Objective • Evaluate a literacy and numeracy-focused diabetes self-management education intervention on patient self-efficacy, satisfaction and glycemic control • Design • Randomized controlled trial • Setting • Enhanced diabetes education programs • Intervention

13. DLNET Intervention

14. DLNET Toolkit • Goals • Facilitate diabetes education and self-management • Type 1 or Type 2 diabetes mellitus • Oral medications or insulin • Individual modules to customize for each patient • Blood Glucose Monitoring • Exercise planning • Foot care • Nutritional management • Carbohydrates • Medications • Logbooks/worksheets Available at: www.mc.vanderbilt.edu/diabetes/drtc/preventionandcontrol/tools.php Wolff K et al. The Diab Educ 2009

15. DLNET Toolkit • Text at 5th grade reading level • Color coding • Pictures for key concepts • Step-by-step instructions • Simplified medication instructions • Practice skills worksheets Wolff K et al. The Diab Educ 2009

16. DLNET Study Results Mean [95% bootstrap Confidence Interval] *Adjusting for age, gender, race, type of diabetes, income level, site of intervention and baseline DNT score and Hba1c levels Cavanaugh KL et al. Diabetes Care 2009

17. Diabetes Nutrition Education Study (DINES): A Randomized Controlled Trial

18. Diabetes Nutrition Study (DINES) • Objectives • To perform a randomized controlled trial to determine the efficacy of RD CDE medical nutrition therapy compared to usual care in the treatment of type 2 diabetes mellitus • To evaluate differences in glycemic control by MNT strategy (carbohydrate counting vs. modified plate method)

19. Diabetes Nutrition Study (DINES)Methods • Design: Randomized controlled trial • Setting: • Vanderbilt University Medical Center • Regional primary care clinics (middle TN) • Participants: Inclusion criteriaExclusion criteria Adults, Type 2 DM Using flexible insulin A1c > 7% Poor vision No MNT past year Cognitive impairment English-speaking Terminal illness

20. Diabetes Nutrition Study (DINES) • Nutrition Education Intervention

21. Control Group 2-3 patient encounters Covered general non- nutrition topics: Foot care Fall prevention Immunizations Osteporosis Diabetic Retinopathy Oral care

22. Diabetes Nutrition Study (DINES) • Nutrition Education Intervention materials

24. Modified Plate Method • Number of carb portions defined • Based on glucose response to meals • Higher carb foods listed with amounts per carb serving

26. Methods: Measures • Primary outcome • Hemoglobin A1C (%) at 3- and 6-Months • Secondary outcomes • Perceived Self-efficacy of Diabetes Self-management Scale (PDSMS) • Summary of Diabetes Self-Care Activities Measure (SDSCA) • Diabetes Treatment Satisfaction Questionnaire (DTSQ) • Potential Confounding variables • Patient characteristics/demographics • Diabetes-related numeracy (DNT) • Health literacy (Rapid Estimate of Adult Literacy in Medicine-REALM) • Statistical Analyses • Wilcoxon rank-sum or Kruskal-Wallis test, as appropriate • Adjusted analyses: Linear regression modeling with Huber-White robust covariance matrix estimate for repeated measurements • Pre-specified subgroup analysis: Baseline A1C 7-10%

27. Referred 293 Refused: 80 Excluded/Not eligible: 63 Enrolled: 150 Carb Counting: 50 Plate Method: 50 Control: 50 Withdrew/Dropped: 8 Withdrew/Dropped: 5 Withdrew/Dropped: 4 6M: 42 (84%) 6M: 45 (90%) 6M: 46 (92%) Diabetes Nutrition Study (DINES)

28. Diabetes Nutrition Study (DINES)Participant Characteristics 28 Median (Interquartile Range)

29. Diabetes Nutrition Study (DINES)Participant Characteristics Baseline 29 Median (Interquartile Range)

30. Diabetes Nutrition Study (DINES)A1C at 3-months & 6-months by study group Median (Interquartile Range) 30

31. Diabetes Nutrition Study (DINES)A1C at 3-months & 6-months by study group 31

32. Diabetes Nutrition Study (DINES)Adjusted A1C • Adjusted for age, gender, race, income, years of diabetes, baseline A1C, and time interval 32

33. Diabetes Nutrition Study (DINES)Adjusted A1C: Subgroup Analysis Participants with baseline A1C > 7.0% & <10.0% • Adjusted for age, gender, race, income, years of diabetes, baseline A1C, and time interval 33

34. Diabetes Nutrition Study (DINES)Secondary outcomes at 3- & 6-months Median (Interquartile Range) 34 • Adjusted for age, gender, race, income, years of diabetes, baseline A1C, and time interval

35. Diabetes Nutrition Study (DINES)Secondary outcomes at 3- & 6-months Median (Interquartile Range) • Adjusted for age, gender, race, income, years of diabetes, baseline A1C, and time interval 35

36. Diabetes Nutrition Study (DINES)Secondary outcomes change: Subgroup Analysis Participants with baseline A1C > 7.0% & <10.0% Median (Interquartile Range) • Adjusted for age, gender, race, income, years of diabetes, baseline A1C, and time interval 36

37. Summary • At 3- and 6-months the A1C of intervention and control groups significantly improved from baseline • At 6-months there was a trend for greater improvement in A1C for both intervention groups compared to control • In subgroups analyses for participants with baseline A1C 7-10%, both plate and carb counting resulted in significant improvement in glycemic control • CDE delivered MNT resulted in greater reduction in weight and improvement in patient satisfaction scores compared to control

38. Limitations • Minimal prevalence of low health literacy subjects limited ability to evaluate literacy intervention effect on A1C • Highly motivated group as shown by significant improvement in glycemic control in control arm • Pts self-initiated changes within meal planning group • Some went from plate to carb gram counting; • Some in carb group didn’t count carbs • Losses to follow-up/ missing data • Short duration of follow-up limits examination of persistence of MNT skills in intervention arms

39. Lessons Learned:Applications to clinical practice • Diabetes MNT must be tailored to the individual: - no pre-determined meal planning strategy - no pre-set calorie/carb levels - nutrition intervention needs to be based on assessment

40. Lessons Learned • The tool is only as good as the user • Carb portioning regardless of method is beneficial

41. Lessons Learned • Low literacy and picture based materials well-received by all DLNET ACP Living with Diabetes Guide

42. Conclusions • CDE delivered MNT is an important component of comprehensive diabetes care and all methods improve glycemic control • Tailored education may benefit patients, but larger studies are needed

43. Acknowledgements • Funding • American Association of Diabetes Educators • NIH/NIDDK • K23DK080952 (Cavanaugh) • K23DK065294 (Rothman) • 5P60DK020593 (VUMC DRTC) • Vanderbilt Program on Effective Health Communication • Russell Rothman, MD, MPP • Kerri Cavanaugh MD MPH • Dianne Davis RD CDE • Becky Gregory RD CDE • Kathleen Wolff, • Ken Wallston PhD • Duff Green BA MDiv • Tom Elasy MD MPH • Robert Dittus MD MPH • Ayumi Shintani PhD • Svetlana Eden, MS • Matt Kennon • Shari Barto

44. Extra slides

45. Health literacy is associated with outcomes Design: RCT Setting: Primary Care Intervention Diabetes Education Evidence-based medication algorithms Database to track and manage patient outcomes Diabetes Care Coordinator Addressed health literacy Individualized verbal education Materials Clear communication “Teach back” techniques Diabetes intervention study 45

46. Factors for health communication MNT 46 Baker DW JGIM 2006; 21: 878-83

47. Health literacy & outcomes Behaviors - Breastfeeding - Medication adherence - Smoking, substance abuse Knowledge - Food label & portion size estimation - Birth control - Emergency department instructions - Asthma - Hypertension - Diabetes Health Outcomes/ Health Services - BMI - General Health Status - Hospitalization - Mortality - Emergency department care - Depression - Diabetes Control - HIV Control - Prostate Cancer Stage - Mammography - Pap smear, STD screening - Immunizations - Cost 47

48. DNT Example Items Your target blood sugar is between 60 and 120. Circle the values below that are in the target range (circle all that apply): 55 145 118 Correct Response: Circle 118 only Percent Correct: 74% If you ate the entire bag of chips, how many total grams of carbohydrate would you eat? Correct Response: 63 g Correct: 44% 48

49. Diabetes Nutrition Study (DINES)Secondary outcomes: Subgroup Analysis Participants with baseline A1C > 7.0% & <10.0% Median (Interquartile Range) • Adjusted for age, gender, race, income, years of diabetes, baseline A1C, and time interval