Clinical trial NCT00128687: Improving Coronary Prevention in a County Health System
Official title: Improving Coronary Prevention in a County Health System
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiovascular Diseases
Coronary Disease
Risk Reduction
Heart Diseases
Lead sponsor: Stanford University
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2005-08-10
Enrollment: 419
Sex: ALL
Minimum age (years): 35
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Framingham Risk Score
timeFrame: 15 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Stanford University
name: Randall Stafford
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ma J, Berra K, Haskell WL, Klieman L, Hyde S, Smith MW, Xiao L, Stafford RS. Case management to reduce risk of cardiovascular disease in a county health care system. Arch Intern Med. 2009 Nov 23;169(21):1988-95. doi: 10.1001/archinternmed.2009.381.
citation: Berra K, Ma J, Klieman L, Hyde S, Monti V, Guardado A, Rivera S, Stafford RS. Implementing cardiac risk-factor case management: lessons learned in a county health system. Crit Pathw Cardiol. 2007 Dec;6(4):173-9. doi: 10.1097/HPC.0b013e31815b5609.
citation: Stafford RS, Berra K. Critical factors in case management: practical lessons from a cardiac case management program. Dis Manag. 2007 Aug;10(4):197-207. doi: 10.1089/dis.2007.103624.