Innovative Approaches to Comprehensive Cardiovascular Disease Risk Reduction: Focus on Therapeutic Lifestyle Changes

NEIL F. GORDON, MD, PhD, MPH, FACC
President and CEO, INTERxVENTUSA, Inc,
Clinical Professor of Medicine, Emory University
Medical Director, Center for Heart Disease Prevention
St. Joseph's/Candler Health System
Savannah, Georgia

Despite impressive technologic advances in the field of medicine during the 20th century, atherosclerotic cardiovascular disease (CVD) remains the leading cause of death in the United States and most developed countries.^1,2 Modification of multiple risk factors through a combination of comprehensive lifestyle interventions and appropriate pharmacological therapy is now widely recognized as the cornerstone of initiatives aimed at the primary and secondary prevention of CVD.

Recent studies emphasize the need to intensify efforts aimed at the control of multiple CVD risk factors.^3,4 To help facilitate this objective, national clinical guidelines advocate a multifactorial lifestyle approach to CVD risk reduction. This approach has been designated "therapeutic lifestyle changes" or "TLC" and includes exercise training together with correct nutrition and other appropriate lifestyle interventions such as cigarette smoking cessation.^5-7

Primary care physicians and cardiologists generally work in an intensely busy environment. Typically, physicians do not have the time, infrastructure, or resources to focus adequate attention on certain prevention-related services, especially TLC. Moreover, physicians in the United States receive little or no compensation for the provision of TLC. In view of these and other barriers, it is not surprising that physicians in this country tend to limit most of their attention to acute medical problems presented during office visits, give low priority to preventive interventions in general, and when focusing on CVD risk reduction, prescribe pharmacologic therapy in preference to TLC. Indeed, because of the widespread availability of powerful cardioactive medications, the value of TLC per se in contemporary medical practice is often discounted by physicians, health insurers, and patients.

This article briefly summarizes the findings of the landmark lifestyle intervention trials that refute the commonly held notion among clinicians that TLC is not worth the effort and presents a "case study" of an innovative model for comprehensive lifestyle management and CVD risk reduction that we have successfully integrated into regular medical care.

Landmark Lifestyle Intervention Trials

Overwhelming evidence from a variety of sources, including epidemiological, prospective cohort, and intervention studies, links CVD and most other chronic diseases seen in the world today to physical inactivity, inappropriate diet consumption, and cigarette smoking.⁸ Recently, Iestra et al. performed a literature search on the effect of the generally agreed upon lifestyle recommendations (Table 1) on mortality in patients with coronary artery disease.⁹ Prospective cohort studies and randomized controlled trials of patients with established coronary artery disease were included if they reported all-cause mortality and had at least 6 months of follow-up. Increased physical activity, dietary changes, smoking cessation, and moderate alcohol use were all associated with a statistically significant risk reduction, the magnitude of which was similar to that observed with low-dose aspirin, statins, beta-blockers, and ACE inhibitors after myocardial infarction (Table 2).

In a recent study of ours, 2,390 ethnically diverse men and women with hypertension, hyperlipidemia, and/or impaired fasting glucose or diabetes mellitus and who were not taking medication for these risk factors were evaluated before and after 12 weeks of participation in a community-based comprehensive lifestyle management program.¹⁰ TLC included exercise training, a low fat/cholesterol diet, weight management, smoking cessation, and stress management. Of the participants with an elevated baseline systolic blood pressure, diastolic blood pressure, LDL cholesterol, and/or fasting glucose, 64%, 67%, 11%, and 39%, respectively, achieved the goal value with TLC (without using pharmacotherapeutic agents, Figure 1). Of the patients with a baseline fasting glucose compatible with a diagnosis of diabetes, 37% decreased that value to <126 mg/dl. This study adds to the existing literature by reporting on the effectiveness (i.e., extent to which TLC works in actual practice) rather than on the efficacy (i.e., determining whether TLC can work when administered in a clinical trial) of TLC. Moreover, it should be noted that TLC can generally be implemented less expensively than most medications and, unlike single-drug therapy, favorably affects multiple risk factors. Therefore, these findings also have potentially important policy implications for health care payers, including the federal government, who often do not provide reimbursement for TLC but do provide prescription drug coverage.

Innovative Models for Comprehensive Lifestyle Management and CVD Risk Reduction: A Case Study

Through contact with millions of patients each year, physicians and other health care providers have an opportunity to favorably impact public health by promoting TLC. Clearly, however, innovative approaches are needed to assist physicians in the provision of long-term lifestyle management services to their patients. One example of such an approach is a program (called the INTERVENT Lifestyle Management and Cardiovascular Risk Reduction Program) that we have developed, tested and successfully implemented in a variety of clinical and community-based settings in the United States, Canada, and South Africa.¹¹ Outcome data, including results from randomized clinical trials, have documented the clinical- and cost-effectiveness of this approach.^10-12

Briefly, the program content is organized into two core sets of services. One set is "mentor-assisted" (involving one-on-one counseling of participants by a non-physician health professional/case manager, called a "mentor"). The other set is an array of individualized "self-help" products, all of which are web-enabled. The programs can be administered in, or from, a variety of physical settings (including physician offices, hospitals, cardiac rehabilitation programs, work sites, and public locations) and via telephone and the Internet. In each of these settings, the program content has been adapted to enhance the applicability to the specific settings and clinical circumstances. Key program steps are as follows:

Step 1: Participant enrollment. Typically, patients are referred by their physicians or identified through health risk appraisals or various other referral channels (including, self-referral following marketing of the program to the community, health plan members, or employees). On enrollment, each participant in a mentor-assisted program is assigned to an appropriately trained health professional who serves as the participant's case manager. Participants in a self-help program are provided instructions for accessing their individualized program via the Internet or mail. Participants often pay to participate in the program themselves (retail pricing currently ranges from approximately $40 for 12 weeks of participation in a web-enabled self-help program to $400 for 1 year of participation in a mentor-assisted program with telephone and Internet counseling). In certain instances, employers and/or health plans pay for program participation (discounted pricing, including capitation pricing, is used when working with employers, health plans, and other groups of program participants).

Step 2: Initial/intake assessment. Participants complete a comprehensive medical history and health habits questionnaire, with the option to include biometric measurements (such as, height, weight, waist circumference, blood pressure, fasting serum lipids and lipoproteins, fasting glucose, hemoglobin A1c, C-reactive protein, homocysteine, etc.) and exercise test and other test results, if available. Questionnaires may be completed online via a secure server, in hard copy ("pen and paper"), or via the telephone. The initial assessment evaluates current health status, risk factors for CVD, past medical history, medications, current lifestyle practices, readiness for change, barriers to change, resources for change, and other relevant information.

Step 3: Goal setting. Based on the initial assessment, computer-generated individualized short- and long-term goals are set for multiple CVD risk factors and health behaviors in accordance with national clinical guidelines.

Step 4: Action plan formulation. Based on the initial assessment, a computer generated individualized action plan is formulated to achieve the short- and long-term goals. The action plan focuses on important health habits (including physical activity/exercise training, nutrition, weight management, tobacco cessation and stress management). In addition to behavior modification, the action plan identifies the need for other self-care activities and physician referrals for prescription medications to optimize CVD risk reduction consistent with national guidelines. Physician letters notify the participants' physicians of their participation in the program and the CVD risk reduction goals and action plans.

Step 5: Review/revision of goals and action plan. For participants in mentor-assisted programs, referring physicians have an opportunity to review, revise, and authenticate the goals and action plan reports for their patients. Using an approach that has been favorably reviewed by the United States' Department of Health and Human Services, physicians are sometimes compensated for providing this service for their patients. Participants access their goals and action plan reports via program visits, the Internet or mail. Reports are accompanied by an audio explanation, which can be accessed online or via CD. For participants in mentor-assisted programs, mentors review goals and action plans with participants at face-to-face program visits or via the telephone and make revisions, if appropriate. When reviewing reports, mentors are guided by written instructions, referred to as mentor prompt sheets (or lesson plans). If the action plan includes physician referral for consideration of institution or adjustment of prescription medications, the mentor helps facilitate this and documents the outcome of the referral in the program database.

Step 6: Action plan implementation. Action plans are implemented using an individualized series of behavior change and education modules, each of which can be read and/or listened to by the participant during a 15-minute or so session. The modules are provided in printed form and via audio recordings, both of which can be accessed via the Internet and via "hard copy" form. The modules are effective in helping modify each participant's behavior, using single concept learning theory, stages of readiness for change, and other behavior change strategies. Materials and messages are matched with each participant's stage of readiness for change and personal circumstances, both clinical and otherwise.

At each program interaction, the participant listens to a CD or web-enabled recording on the specific behavior modification topic, receives the accompanying written educational materials on the specific topic, and, if applicable, meets briefly with his/her program mentor (either physically or telephonically) for further counseling and to update the participant's individualized lifestyle modification and prevention program. Mentors assist participants in implementing individualized action plans through proactive, structured, one-on-one counseling sessions via face-to-face program visits or prescheduled telephone appointments. With assistance from a web-enabled participant management and tracking database, mentors typically guide participants through approximately 20 modules in the first year of program participation in an individualized, carefully sequenced, structured fashion.

Step 7: Follow-up assessment. After 12 weeks and 1 year of program participation, and at least annually thereafter, participants have an opportunity to complete a follow-up medical history and health habits questionnaire, with the option to include biometric measurements. Questionnaires may be completed online, in hard copy, or via telephone.

Step 8: Progress report and revision of goals/action plan. Based on program participation and the follow-up assessments, participants are provided computer generated reports documenting their progress and updating their goals/action plan. For participants in mentor-assisted programs, progress reports are reviewed at counseling sessions. As with the initial goals and action plan reports, physicians may be asked to review, revise, and sign progress reports for their patients, and in certain instances receive financial compensation for this service. Similarly, if the revised action plan includes physician referral for consideration of institution or adjustment of prescription medications, the mentor helps facilitate this and documents the outcome of the referral in the program database.

Step 9: Maintenance. Participants typically enroll in the program for either 12 weeks or 1 year at a time, but have access to continuing years of mentor-assisted program delivery or to self-help programs. Compliance with scheduled mentoring sessions, lifestyle interventions, and prescribed CVD risk reduction medications is tracked using the web-enabled participant management and tracking database.

Step 10: Outcomes assessment. Using a computerized outcomes analysis system, detailed outcomes reports are generated on a regular basis for specific program locations, individual physicians and groups of physicians, individual mentors, employers, and other groups of program participants. In certain instances, benchmarking is included. To date, the program database has also been used to generate data for approximately 70 published scientific abstracts and/or manuscripts.

It is our belief that the first decade of this new millennium will be remembered as the "decade of CVD prevention." New and innovative approaches, such as the above "case study," will be needed to fulfill the potential for improving quality of life and longevity through TLC and other CVD risk reduction interventions.
Author address for correspondence:

Neil F. Gordon, MD, PhD, FACC
INTERxVENTUSA, Inc.
340 Eisenhower Drive
1400 Central Park, Suite 17
Savannah, GA 31406
Tel: (912) 353-9997

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