Over half of all deaths, and many illnesses, can be attributed to four modifiable risk factors: tobacco use, overweight/obesity, physical inactivity, and alcohol use. There are clear links between these modifiable factors and heart disease, cancer, chronic lung disease, and stroke which continue to be the leading causes of death in the United States. We have made significant improvements in controlling conditions that lead to heart disease, cancer and stroke (e.g., hypertension and hyperlipidemia). We have not, however, done as well in addressing the underlying behavioral factors (e.g., obesity, tobacco use, and physical inactivity). Prevention is particularly important for Veterans because of the high prevalence of significant risk factors for poor health. For example, more than 70% of VHA patients are overweight (body mass index [BMI] e 25kg/m2) and one-third are obese (BMI e 30kg/m2), which is significantly higher than the US population. Smoking also remains a significant problem among Veterans, with VHA enrollment data from 2010 indicating a prevalence of 20%. Younger Veterans are at particularly high risk for developing chronic illnesses because they are more likely to be overweight/obese and smoke more heavily than non-Veterans. We propose a two-site, two-arm randomized trial measuring the effectiveness of a Shared Decision Making (SDM) intervention in activating Veterans to enroll in effective prevention services, and improve cardiovascular risk, compared to VA usual care. The study will be performed at the Durham, and Ann Arbor VAMCs. Each arm will have 225 patients; patients will be VA users with at least one modifiable risk factor (obese, inactive, or tobacco user) who are not currently enrolled in a prevention service. The SDM intervention will be conducted by a prevention coach; telephone based, and will use the output from VHA's Health Risk Assessment to engage Veterans in a conversation where individual preferences are matched to behaviors, and choices for specific prevention services. The resulting prevention action plan will be shared with the Veterans primary care team, and documented in the medical record. Outcomes will be obtained at baseline, 1 month and 6 months after enrollment by blinded research personnel. The co-primary outcome will be change in the Patient Activation Measure (PAM) and proportion enrolled in effective prevention services. The secondary outcome is 10-year risk of coronary events, as measured by Framingham Risk Score. We will also conduct process evaluations of the intervention and its implementation to inform future dissemination and implementation should it prove effective.
The VA has committed to disseminate a web-based Health Risk Assessment tool and use it as the cornerstone of a personalized prevention plan to engage patients to improve their health behaviors that lead to high health risk. Health Risk Assessments done in isolation, however, do not generally lead to behavior change. Our study will test the effectiveness of a Shared Decision Making intervention designed to activate Veterans to enroll in effective prevention programs. The intervention will be conducted over the telephone, by a prevention coach, and will be linked to the patients' primary care team. The co-primary outcomes will be patient activation and patient enrollment in prevention programs; we will also measure 10-year risk of major cardiac events.
