Evidence from extensive population studies and clinical trials shows the effectiveness of risk factor management in reducing morbidity and mortality from coronary artery disease (CAD). These studies have generated important national clinical practice guidelines. Current prevention practices, however, fall short of attaining the goals recommended in these national guidelines. These shortfalls lead to unnecessary CAD disease burden, as well as perpetuation of socioeconomic disparities. Case management proves to augment current CAD prevention activities and improve adherence with national guidelines. The Stanford Health Education and Risk Reduction Training (HEAR2T) program is an innovative, yet well-tested, case management tool. By rigorously evaluating HEAR2T in a high-risk population of low socioeconomic status (SES) served by the county health care system of San Mateo County (SMC), CA, this study will: 1) enhance the HEAR2T program for use in Iow-SES populations; 2) implement this program as an integral part of clinical care; 3) implement a randomized controlled trial to evaluate the effectiveness of HEAR2T in lowering aggregate CAD risk; 4) determine if HEAR2T diminishes socioeconomic disparities; 5) estimate HEAR2T's cost effectiveness; and 6) transition the intervention from a research study to an ongoing County CAD case management program. Our primary outcome measure will be change in aggregate CAD risk score, calculated from a Framingham model based on individual CAD risk factors. Our primary hypothesis is that patients case-management via the HEAR2T model will produce favorable changes in aggregate CAD risk score compared to control patients in usual care. We will enroll 200 intervention and 200 usual care patients from four health centers in the SMC system. Usual care patients will crossover to the intervention after 15 months, allowing for additional assessment of the intervention's impact. Continued follow-up of the participants will assess the durability of risk changes achieved during initial intensive case-management. This study will make a critical and innovative contribution to defining optimal disease management in a Iow-SES population. In so doing, we will aid broader national efforts seeking to reap the societal """"""""return on investment"""""""" available from evidence-based prevention.

Agency
National Institute of Health (NIH)
Institute
National Heart, Lung, and Blood Institute (NHLBI)
Type
Research Project (R01)
Project #
1R01HL070781-01A1
Application #
6612014
Study Section
Special Emphasis Panel (ZRG1-SNEM-1 (01))
Program Officer
Einhorn, Paula
Project Start
2003-04-01
Project End
2007-03-31
Budget Start
2003-04-01
Budget End
2004-03-31
Support Year
1
Fiscal Year
2003
Total Cost
$637,718
Indirect Cost
Name
Stanford University
Department
Internal Medicine/Medicine
Type
Schools of Medicine
DUNS #
009214214
City
Stanford
State
CA
Country
United States
Zip Code
94305
Smith, Mark W; Ma, Jun; Stafford, Randall S (2010) Bar charts enhance Bland-Altman plots when value ranges are limited. J Clin Epidemiol 63:180-4
Ma, Jun; Berra, Kathy; Haskell, William L et al. (2009) Case management to reduce risk of cardiovascular disease in a county health care system. Arch Intern Med 169:1988-95
Stafford, Randall S; Berra, Kathy (2007) Critical factors in case management: practical lessons from a cardiac case management program. Dis Manag 10:197-207
Berra, Kathy; Ma, Jun; Klieman, Linda et al. (2007) Implementing cardiac risk-factor case management: lessons learned in a county health system. Crit Pathw Cardiol 6:173-9