AcademyHealth 2004 Annual Research Meeting June 8, 2004

1. Does Literacy Impact the Effectiveness of a Disease Management Program in Congestive Heart Failure? AcademyHealth 2004 Annual Research Meeting June 8, 2004 Brad Smith, Robert Ellis, Emma Forkner, Richard A. Krasuski, Michael Kwan, Karl Stajduhar, Autumn Dawn Galbreath, and Gregory L. Freeman Presented by: Brad Smith Senior Analyst, Altarum Institute Project Statistician, UTHSCSA-Disease Management Center E-mail: brad.smith@altarum.org Tel: 210-832-3000 Fax: 210-567-9712

2. Introduction • Rising health care expenses have led payors and health care systems to seek out new approaches to cost containment for chronic diseases. • Disease management (DM), a comprehensive, multidisciplinary, therapeutic and educational intervention, has been shown to improve outcomes and reduce utilization costs in a number of trials • Published trials have generally been small and have been conducted in employed, group-insured populations.

3. Introduction • The effectiveness of DM in a more broadly representative group remains relatively unexplored. • Broader population presents a variety of challenges to DM including • Access to primary care and pharmacy • Literacy

4. Introduction • The impact of literacy on the effectiveness of DM is an important issue to explore given • The association of literacy with a number of important chronic disease care outcomes(e.g. AHRQ’s Literacy and Health Outcomes, 2004 and IOM report on health literacy) • Centrality of provider-patient communication to the success of DM programs • Trends toward expansion of DM programs beyond employed, group-insured populations (e.g. mandatory DM for asthma patients in Texas’ Medicaid program)

5. Question • How does literacy, as measured by educational attainment, impact the primary and secondary outcomes in a randomized, controlled trial of a disease management program in congestive heart failure patients?

6. Methods: Study Design • Community-based, single-center, randomized, controlled clinical trial performed between 1999 and 2003 at the University of Texas Health Science Center at San Antonio • Enrolled a total of 1,069 male and female subjects 18+ years old with documented congestive heart failure (CHF) from throughout South Texas • Followed patients over 18 months with 4 equally spaced clinic visits. • This sub-study focuses exclusively on the pooled DM arms (N=710)

7. Methods: DM Intervention • Telephonic intervention by RN with specialized training in CHF management • Comprehensive written patient education guide in both English and Spanish targeted to 8th grade reading level • Key components of the disease management intervention • initiation and upward titration of all recommended drug classes for CHF • Verbal instruction and written reference on • appropriate cardiac diet (low fat, low sodium, fluid restricted) • medication compliance • suitable exercise regimen • appropriate reaction to signs of the onset of a CHF exacerbation.

8. Methods: Measures • Primary outcomes • Clinical: Mortality and event-free survival, ejection fraction, exercise tolerance • Utilization: inpatient stays and emergency department visits • Secondary outcomes • Daily dietary sodium intake in milligrams as measured by the Food Frequency Questionnaire • Self-confidenceto manage the symptoms of CHF (0-100 ordinal scale) • Independent variables: • Educational attainmentis a proxy for literacy (ordinal) • Other controls: • Primary outcome models: type of heart failure, baseline beta blocker status, NYHA class, gender, race/ethnicity, age • Secondary outcome models: NYHA class, gender, race/ethnicity, age, primary language and household composition.

9. Sample Profile • Study sample is less well-educated than the general population in South Texas • 43.7% HS diploma or less in study sample • 34.0% HS diploma or less in South Texas (Census statistics) • Sample is otherwise largely Caucasian (70%), male (70%), older (average age 70.5), English-speaking (94%) and living with family or spouse (77%)

10. Outcomes: Clinical and Utilization Measures • There was no statistically significant difference in change in ejection fraction, exercise tolerance, mortality or cardiac event-free survival by educational attainment. • No statistically significant difference was observed in the rate of visits to the emergency department or in the rate of inpatient hospital stays.

11. Outcomes: Dietary Sodium Reduction • The likelihood of a reduction in daily sodium intake was higher among those with at least some college training than among those with a high school degree or less. • The magnitude of the drop was also larger in the better educated group.

12. Outcomes: Symptom Self-Management Confidence • Confidence in one’s ability to manage the symptoms of CHF was more likely to increase among those with at least four years of college than among those with less education. • The magnitude of the difference in the self-confidence scores between the two groups was not, however, statistically or substantively significant (2.34 on a 100 pt scale, p=ns).

13. Conclusions • Educational attainment had a limited impact on the secondary, but not the primary, outcomes of a disease management program in CHF. • To gain a more complete picture of how literacy impacts DM outcomes, it will be critical to develop and employ state of the art tools for assessment of health literacy in future studies.