Improving Coronary Prevention in a County Health System

NCT ID: NCT00128687

Last Updated: 2014-02-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 419 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-04-30
• Study Completion Date: 2008-03-31

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.

Conditions

Cardiovascular Diseases; Coronary Disease; Risk Reduction; Heart Diseases

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Immediate Intervention

Participants in both arms continue to receive usual medical care throughout the study period. In addition, participants randomized to Immediate Intervention receive intensive case management for Coronary heart disease (CHD) risk reduction for 15 months and then a maintenance program for a minimum of 12 months to assess the durability of initial intervention changes.

Group Type: EXPERIMENTAL

risk reduction

Intervention Type: BEHAVIORAL

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.

Delayed Intervention

Participants randomized to Delayed Intervention serve as control for Immediate Intervention patients for the first 15 months and then receive intensive case management for 15 months. The switching-over design not only addresses ethical concerns about withholding treatment from half the study sample, but will also enable us to assess whether the intervention had equal impact whether provided to a naïve population or to a group followed in usual care for 15 months.

Group Type: PLACEBO_COMPARATOR

risk reduction

Intervention Type: BEHAVIORAL

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.

Interventions

risk reduction

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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.

• Minimum Eligible Age: 35 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role: collaborator

Stanford University

OTHER

Sponsor Role: lead

Responsible Party

Randall Stafford

Professor of Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Randall Stafford

Role: PRINCIPAL_INVESTIGATOR

Stanford University

References

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.

Reference Type: DERIVED

PMID: 19933961 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 18091408 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 17718658 (View on PubMed)

Other Identifiers

R01HL070781

Identifier Type: NIH

Identifier Source: secondary_id

View Link

240

Identifier Type: -

Identifier Source: org_study_id