Presenter Disclosure Information

1. Societal Cost and Cost to Medicare for Enhanced Monitoring Using a Computer Based Telephonic Monitoring System in Older Patients with Heart Failure: The Heart Failure Home Care Trial Ozlem Soran* , Judith R. Lave,Ileana L. Piña, Gervasio A. Lamas, Sheryl F. Kelsey,Faith Selzer, John Pilotte, Arthur M. Feldman University of Pittsburgh, Pittsburgh, PA* , Case Western Reserve University, Cleveland, OH , Mount Sinai Medical Center, Miami Beach, FL, Centers for Medicare & Medicaid Services, Baltimore, MD, Jefferson Medical College, Philadelphia, PA Sponsored by Centers for Medicare and Medicaid Services, Baltimore, Maryland

2. Presenter Disclosure Information ACC. 08 57th Annual Scientific Session March29-April1; Chicago Ozlem Soran, MD, MPH, FACC, FESC No relationships to disclose

3. Background • Prior studies suggest that disease management programs may be effective in improving clinical and economic outcomes in patients with heart failure (HF). Whether these types of programs can lower healthcare cost and be adapted to the primary care setting is unknown.

4. Objective • This study was designed to assess the impact of a computer-based home disease management program (Alere DayLink HF Monitoring System= HFMS) on the clinical and economic outcomes of Medicare beneficiaries who were women and non- white males, recently hospitalized for HF who received the care from a community based primary care practitioner.

5. Methods • Multicenter, randomized, controlled clinical trial of a computer based telephonic HFMS vs standard heart failure care (SC). • April 2002- September 2005 • Utilized an independent adjudication event committee • Monitored by an independent Data Safety Monitoring Board

6. Methods • 315 Medicare eligible patients; women, and non-Caucasian males (African-Americans, and Hispanics) with * heart failure secondary to predominantly systolic dysfunction * had been hospitalized for heart failure within six months of randomization, * had symptoms despite optimal medical treatment • Patients were cared for by primary care physicians in a community setting.

7. Methods • Of those, 304 patients ( 146 SC vs 158 HFMS ) had their Medicare data available. (cost analysis) • Medicare claims data was used to determine the cost to Medicare as well as the societal costs for those services covered by Medicare. • Medicare costs were set at the amount that Medicare paid on a given claim. • We estimated societal costs to be the amount that Medicare determined to be reasonable cost for a given service

8. Inclusion Criteria • Medicare beneficiary • ≥65 years of age • discharged from hospital with a primary (DRG 127) or secondary diagnosis of heart failure within 6 months of randomization • receiving optimal medical care consistent with recent guidelines

9. Exclusion Criteria • significant symptomatic ischemic heart disease • renal failure requiring dialysis • serum creatinine of > 2.5 • chronic or intermittent inotropic therapy • uncorrected primary stenotic valvular disease • COPD with an FEV1 of less than 50%

10. Study end-points The study endpoints included; • cardiovascular death or re-hospitalization for heart failure, • length of hospital stay, • total patient cost and cost to medicare at 6 months of enrollment.

11. Sample Power • We assumed an underlying 40% event rate for the primary end point ( the composite of cardiovascular death or re-hospitalization) in the control group and 25% in the intervention group within the 6 months of enrollment. With a power of 80% and a two-sided alpha level of 0.05,  a total  sample size of 314 patients was required to detect such a difference.

12. Statistical analysis • Intention to treat • Continuous data : t-test where appropriate; otherwise the Wilcoxon rank sum test • Categorical data :chi-square test or the Fisher exact test. • Event rates: The Kaplan-Meier method • Independent risk (hazard) for 6-month outcomes: Cox proportional hazards • Cost analysis : Wilcoxon non-parametric test; t-test; the Anova where appropriate • Multivariate regression was used to determine the effect of treatment assignment and other variables

13. Randomization • 1:1 ratio ; SC vs HFMS • SC: patient one-on one education, education to clinicians, an effort to use evidenced-based optimal medical treatment , digital home scale with management by primary physician

15. Follow-up • Patients were seen in clinic or in their primary care physician’s office at baseline and 6-month visits • telephone contact at 30 days and 3 months post-randomization by non-medical personnel masked to treatment assignment to collect clinical data

16. Patient Demographics

17. Concomitant Therapy

18. Heart Failure Symptoms

19. Disease Characteristics

20. Compliance with HFMS N = 160 patients monitored over the course of the study

21. ADVERSE 6-MONTH OUTCOMES BY TREATMENT ASSIGNMENT

22. Comparison of Cost Variables Between Study Arms *Statistically significant at p=0.05

23. Comparison of Cost Variables Between Study Arms *Statistically significant at p=0.05

24. Conclusion Our study results suggest that enhanced patient education and follow up is as successful as a sophisticated home monitoring device with an interactive program and less costly in patients with HF who are elderly, women and non- caucusian males and receive the care from a community based primary care practitioner.