A Combined Lifestyle and Medication Intervention to Reduce Cvd Risk

Keyserling, Thomas

Abstract

Cardiovascular disease continues to be the leading cause of death and disability in the US. While lifestyle and medication use can substantially reduce CVD risk, both are underused forms of treatment. Accordingly, we propose to combine previously tested and effective lifestyle and medication interventions to reduce CVD risk and test this intervention in a diverse group of patients cared for at family practices in North Carolina. Our plan is to identify a potential intervention that is practical for use in common office settings supported by community resources so that it may reach a large segment of the population and thus have major public health impact. In recognition of increasing access to the internet and differing costs and in-puts related to web-based vs. counselor-based interventions, we will compare the effectiveness and feasibility of the combined intervention in two formats, web-based and counselor-based. Using a comparative effectiveness research framework, we plan to compare these intervention formats for their impact on estimated CVD risk reduction and other important outcomes to key clinical and public health stakeholders (patients, payers, and decision makers);in particular, feasibility, acceptability, and cost-effectiveness outcomes. To do so, we will conduct this study at 5 family practices, enrolling 120 patients per practice. We will randomize participants within site to one of the 2 treatment conditions, both including a baseline assessment and a theory informed intervention with a 4 month intensive phase (4 sessions) and an 8 month maintenance phase (3 contacts). Outcomes will be assessed at 4 and 12 months, with the primary outcome a reduction in the estimated 10 year risk of coronary heart disease as determined by the Framingham equation. Changes in dietary intake, physical activity, blood pressure, blood lipids, and medication use, in addition to feasibility, acceptability and cost, are important secondary outcomes. To optimize dissemination of study findings to decision makers and the interventions to practitioners, we will 1) elicit input from stakeholders at the outset to guide our development of the intervention and 2) use an existing web-based mechanism, (Center of Excellence for Training and Research Translation) for intervention training, translation, and dissemination. Project Summary: Statement of problem: Cardiovascular disease continues to be the leading cause of morbidity and mortality in the US. While lifestyle and appropriate use of medication can substantially reduce this risk, both are underused forms of treatment. Purpose of proposed research: To combine previously tested and effective lifestyle and medication interventions to reduce CVD risk and test this intervention in a diverse group of patients cared for at family practices in North Carolina. Our plan is to identify a potent intervention that is practical for use in common office settings supported by community resources so that it may reach a large segment of the population and thus have major public health impact. Which IOM public health CER priority area are being addressed by this research? This application addresses 4 of the 14 IOM priority topics, includes 2 topics in the first quartile (listed first): 1. Compare the effectiveness of various strategies to prevent obesity, hypertension, diabetes, and heart disease in at-risk populations such as the urban poor and American Indians 2. Compare the effectiveness of interventions to reduce health disparities in cardiovascular disease, diabetes, cancer, musculoskeletal diseases, and birth outcomes 3. Compare the effectiveness of alternative redesign strategies-using decision support capabilities, electronic health records, and personal health records-for increasing health professionals'compliance with evidence - based guidelines and patients'adherence to guideline-based regimens for chronic disease care 4. Compare the effectiveness of different quality improvement strategies in disease prevention, acute care, chronic disease care, and rehabilitation services for diverse populations of children and adults.