About the HEAR2T Program
Background
In the late 1960s and early 1970s scientific advances were made in the medical management of patients with coronary heart disease and stroke that resulted in the implementation of new treatment approaches, including nurse operated hypertension clinics, lipid clinics, diabetes management clinics, and cardiac rehabilitation programs. Over the years these approaches have significantly contributed to improved management of patients with established cardiovascular disease (CVD) and those with major CVD risk factors. However, it is readily apparent that more integrated systems of CVD management are necessary if we are to effectively apply recently gained knowledge about how to reduce major clinical events resulting from advancing CVD. Basic and epidemiological science has established the multifactor etiology of atherosclerotic vascular disease and randomized controlled trials have demonstrated that intensive risk factor reduction results in major clinical benefits.
Over the past two decades, investigators at the Stanford Prevention Research Center, in collaboration with colleagues from various institutions, have developed and evaluated the effectiveness and deliverability of various programs to promote the prevention of atherosclerotic induced cardiovascular disease. One such approach has been the development of a nurse-case management model of multifactor risk reduction for persons at high risk of developing major clinical cardiac events. One version of this model, the Stanford Coronary Risk Intervention Project (SCRIP), was shown to significantly reduce the progression of coronary atherosclerosis and the formation of new lesions, enhance plaque regression and decrease hospitalizations for cardiac events over four years by 40%.
During the past four years; the SCRIP risk reduction model has been tested outside the academic medical center to determine the feasibility of delivering effective risk reduction programs in several different health care environments. This program, known as the HEAR2T (Health Education and Risk Reduction Training) Program, is designed to identify persons at increased risk for CVD clinical events and implement multiple risk reduction to reduce their risk.
Stanford Coronary Risk Intervention Project
The Stanford Coronary Risk Intervention Project (SCRIP) was the first major, large-scale randomized trial to determine the effects of a four-year multifactor risk reduction program using both intensive lifestyle management plus cholesterol lowering medications on the progression and regression of coronary atherosclerosis and clinical cardiac events in men and women with established heart disease. SCRIP was unique compared to other angiographic trials in that it; (1) used an intervention model that is highly generalizable and acceptable to both physicians, other health care professionals and the public; (2) included both men and women with risk factor profiles that represent most adults who get heart disease; and (3) had a large sample of subjects that participated for four years.
This risk reduction program was designed to be practical for all participants and generalizable to most adults. Patients were recruited who had mild to moderate atherosclerosis and, after computer-assisted quantitative coronary arteriography, were randomized to the usual care of their own physician or to an intensive multifactor risk reduction program conducted by the SCRIP staff. This program consisted of lifestyle interventions including a low fat, cholesterol and sodium diet, regular exercise, stress management, smoking cessation, and weight loss. When indicated, combination drug regimens for lowering LDL-cholesterol and raising HDL-cholesterol were used. The risk reduction program was based on a "physician supervised, nurse-manager model" using other health professionals to assist with the intervention. Patients visited the clinic approximately once every two months over the four years for an average of slightly less than six visits per year and the intervention program required no special facilities.
This project was very successful with highly significant reductions occurring in all major risk factors in the special risk reduction group but not in the usual care group. Of the 300 patients that were randomized into the trial, follow-up arteriograms were obtained on 274 (92%). Results demonstrated a 47% reduction in the rate of progression of coronary atherosclerosis, more frequent regression, lower rate of new lesion formation and a reduction in clinical cardiac events. The number of hospitalizations for primary cardiac event was significantly less in the risk reduction group.
Note: For the primary report of the SCRIP results please see: Haskell, WL, et al. Effects of intensive multifactor risk reduction on coronary atherosclerosis and clinical cardiac events in men and women with coronary artery disease: The Stanford Coronary Risk Intervention Project, Circulation 1994:89:975-990.
Health Education and Risk Reduction Training (HEAR2T) Program
After completion of SCRIP and other risk reduction research projects using a "home-based" model for lifestyle interventions, we received funding to evaluate a comprehensive program of risk reduction conducted outside the academic medical center environment. During a year of development, we updated the SCRIP model, included new questionnaires to identify high risk persons, and prepared a curriculum to train health care professionals in the model. This program is called the Health Education and Risk Reduction Training (HEAR2T) Program. Over the past four years, we have evaluated versions this model in several worksite and healthcare settings. These program sites all posed unique challenges for implementation of intensive, multifactor, patient-oriented CVD risk reduction. Based on these unique challenges, the HEAR2T Program has tested heart attack and stroke risk reduction programs in actual practice settings. We have successfully moved scientific research into clinical practice. In all cases, success as measured by program participation, coronary risk factor reduction, and participant satisfaction has been extremely positive.
Selected for initial program evaluation were two worksites and an independent practice association (IPA). The two worksites included the General Electric facility located in San Jose California and the San Mateo County government employees, spouses and retirees. The IPA program involved 11 primary care physicians who were members of the Santa Clara County Practice Association (SCCIPA). These programs were designed to identify persons at increased risk for CVD clinical events and implement multiple risk reduction to reduce their risk. Participants were recruited into an individual counseling program for at least 12 months and the effectiveness of the program was evaluated in terms of participation rates at each step in the program, changes in risk factor status, participant satisfaction and physician awareness of and satisfaction with the program. This initial phase has been successfully completed and evaluated for each of the three program sites.
Implementation and Evaluation of the HEAR2T Program
The HEAR2T Program has been conducted in the following manner at these three sites, being customized to fit the characteristics at each site. The Program is designed to provide cost-effective approaches to CVD risk reduction, integrating the use of lifestyle changes and medications, when indicated. The program provides a systematic approach to the comprehensive, individualized and intensive management of the cardiovascular risk status of patients at substantially increased risk of having a clinical cardiac event during the next 10 years. The program uses a case manager model that provides long-term counseling of high risk persons based on their current risk and clinical status, interests and readiness for change, and personal resource availability. The program is integrated with the care provided by the patient's physician or other health care provider and efforts are made to have the patient's CVD medical management meet current guidelines established by the American Heart Association, the American College of Cardiology and other major medical organizations.
Once baseline data are available, a preliminary Action Plan is designed by the program nurse. This plan includes short and long-term goals for relevant risk factors. This preliminary plan is then reviewed by the nurse with the patient and modifications are made as needed. Selected educational materials are provided to the participant and a follow-up contact schedule is set for the next two to four months. This contact schedule includes clinic or laboratory visits, enrollment in risk reduction classes, phone calls, and mailings. Home-based, self-directed risk reductions approaches developed at the Stanford Medical School provide the core of the counseling program. Also, as many low cost or free community services are used as possible (stop smoking, exercise, weight loss, nutrition education, etc.). Direct referrals are made to these programs or the patient is provided information on how to enroll.
The risk reduction program includes for all participants a low saturated fat (less than 7%), low cholesterol (<150 mg/day), high plant-based diet; an endurance oriented exercise program (= 30 minutes of moderate intensity on most days); and stress management educational materials. A low total fat, calorie restricted diet is provided to overweight persons. In addition to the diet being low in saturated fat and cholesterol, it emphasizes the consumption of vegetables, grains, fruits and fish. Cigarette smokers are entered into a stop smoking program that may include use of the nicotine patch or other medications. The lipoprotein goals include a LDL-C of < 100 mg/dL or a 20% reduction from baseline, whichever is lower for patients with CVD, diabetes or = two CHD risk factors. For patients without CVD, diabetes or two risk factors, the LDL-C goal is set at 130 mg/dL. The triglyceride goal is 140 mg/dL or a 20% reduction, whichever is lower. The HDL-C goal is >45 mg/dL for men and >55 for women or a 20% increase from baseline, whichever is higher. The use of lipid medications is determined on an individual basis according to modified NCEP-II guidelines. The blood pressure goal is <120/80 mm Hg, with the initial treatment being lifestyle (weight loss, low salt and fat diet, exercise) unless these factors are near optimal for the patient or blood pressure is >160/100 mm Hg then drug use or modification of existing drug regimen is recommended according to JNC -VI. The blood glucose goal is =110 mg/dL, with the initial treatment being lifestyle management. If blood glucose is =240 mg/dL, an immediate referral is made to the primary care physician for evaluation and follow-up. Moderate dose antioxidant and folic acid supplementation and low dose aspirin may also be recommended.
The follow-up contact schedule is individualized based on each patient's needs and available resources. The normal priority for risk modification is to assist smokers to stop smoking; reduce LDL-C by diet, weight loss and medications; increase HDL-C by stop smoking, exercise, weight loss, and medications; reduce triglycerides by exercise, diet weight loss and medications; normalized plasma glucose and insulin by exercise, diet, weight loss and medications; reduce adiposity by diet and exercise; and reduce psychological stress using various stress management techniques. Clinic visits are used to assess risk status (e.g., lipids, blood pressure, glucose, etc.) or changes in clinical status (shortness of breath, angina, etc.). Routine phone calls are made by staff according to protocol and progress reports are returned by patients and revised programs or new educational material can be provided by mail.
Completed HEAR2T Projects
Summary
The HEAR2T Program has been successfully implemented in a variety of clinical settings and has been shown to be very effective in reducing risk of cardiovascular disease. The HEAR2T Program is committed to the advancement of multi-factor risk reduction in the primary and secondary prevention of heart disease and stroke. This will be accomplished through: HEAR2T Program conferences; development of healthcare site specific programs which are dedicated to mutually agreed upon goals; interactive and ongoing communication with partners via the Stanford Heart Network; and continued development of HEAR2T Program materials and interventions.
|