Improving Coronary Prevention in a County Health System
Condition: Cardiovascular Diseases; Coronary Disease; Risk Reduction; Heart Diseases
MeSH terms: Cardiovascular Diseases; Heart Diseases; Coronary Disease
Study type: Interventional

Summary: 
      To examine whether the Stanford Health Education and Risk Reduction Training (HEAR2T) program
      , a case management approach, can be effectively used to manage the risk of coronary artery
      disease.
    

Detailed description: 
      BACKGROUND:

      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 which will be evaluated in this study. HEAR2T has been developed and
      evaluated in several studies at Stanford. It is based upon the social cognitive model of
      Bandura and uses case managers to work intensely with patients to educate them and change
      their overall behavior related to health.

      DESIGN NARRATIVE:

      The Stanford Health Education and Risk Reduction Training (HEAR2T) program will be evaluated
      in a high-risk population of low socioeconomic status (SES) served by the county health care
      system of San Mateo County (SMC), California. The study will: 1) enhance the HEAR2T program
      for use in low-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. The primary outcome measure will be
      change in aggregate CAD risk score, calculated from a Framingham model based on individual
      CAD risk factors. The 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. An estimated 200 intervention and 200 usual care patients will be enrolled
      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 low-SES population.
    

Intervention name(s): risk reduction
Intervention type(s): Behavioral
Intervention description(s): Participants receive intensive case management for CHD risk reduction for 15 months and then a maintenance program for a minimum of 12 months. Lifestyle modification was strongly emphasized as a critical component of achieving CHD prevention goals. Dietary management was emphasized, including recommendation of a low saturated fat (less than 7% of caloric intake), low cholesterol (< 150 mg/day), mainly plant-based diet with calorie restrictions for overweight/obese persons. Stress management and coping skills were emphasized, including a regular exercise regimen (≥ 30 minutes of moderate intensity on most days). Cigarette smokers were encouraged to join a stop smoking program.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention