Improving Coronary Prevention in a County Health System
Improving Coronary Prevention in a County Health System
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.
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.
Abbreviations: FBS = fasting blood sugar, SBP = systolic blood pressure, DBP = diastolic
 blood pressure, LDL = low-density lipoprotein, HDL = high-density lipoprotein, BMI = body
 mass index, TC = total cholesterol, TG = triglycerides, HbA1c = hemoglobin A1c.

 Inclusion Criteria

 -  The patient has CAD or CAD risk equivalent (abdominal aortic aneurysm, peripheral
 vascular disease, transient ischemic attack, stroke, diabetes, or FBS ≥ 126 mg/dL × 2)
 and has at least one of following: SBP ≥ 130 mmHg, DBP ≥ 80 mmHg, LDL ≥ 100 mg/dL, HDL
 ≤ 40 mg/dL, TG ≥ 150 mg/dL, FBS ≥ 126 mg/dL, BMI ≥ 30, or is a current smoker.

 -  The patient does not have CAD or CAD risk equivalent but has at least one of the
 following: SBP ≥ 160 mmHg, DBP ≥ 100 mmHg, LDL ≥ 190 mg/dL, TC ≥ 240 mg/dL, TG ≥ 500
 mg/dL, HbA1c ≥ 8.0%, BMI ≥ 35, or is a current smoker.

 -  The patient does not have CAD or CAD risk equivalent but has at least two of the
 following: a) SBP ≥ 140 mmHg or DBP ≤ 90 mmHg, b) HDL ≤ 40 mm/dL or TG ≥ 200 mg/dL, c)
 LDL ≥ 160 mg/dL or TC ≥ 240 mg/dL, d) FBS ≥ 110 mg/dL × 2, or e) male age ≥ 45 or
 female age ≥ 55 or with positive family history of CAD.

 Exclusion Criteria:

 -  Resident of long-term facility

 -  Lack of spoken English or Spanish by patient or household member 18 years or older who
 can serve as an interpreter

 -  Moving before end of intervention (30 months)

 -  Age between 35 and 85 (inclusive)

 -  Significant comorbidities such as: uncontrolled metabolic disorders (renal failure,
 liver failure, etc.), active symptoms suggesting acute myocardial infarction or
 decompensated congestive heart failure, Malignancy or other condition limiting life
 expectancy, psychiatric disorder with active manifestations.

 -  Substance abuse.

 -  No telephone or means of contacting patient.

 -  Family household member already enrolled.

 -  Homeless and not living with relatives/friends.

 -  Anticipated absence for more than 4 consecutive months.

 -  Difficulty coming to appointments approximately every 1-2 months

 -  Already participating in the Diabetes program

 -  Currently pregnant or intends to get pregnant the next 3 years.