A COMBINED LIFESTYLE AND MEDICATION INTERVENTION TO REDUCE CVD RISK

描述（由申请人提供）：心血管疾病仍然是美国死亡和残疾的主要原因。虽然生活方式和药物使用可以大大降低CVD风险，但两者都是未充分使用的治疗形式。因此，我们建议结合联合收割机以前测试和有效的生活方式和药物干预，以减少心血管疾病的风险和测试这种干预在不同的一组病人照顾家庭的做法在北卡罗来纳州。我们的计划是确定一种潜在的干预措施，这种干预措施在社区资源支持下适用于普通办公室环境，以便它可以覆盖大部分人口，从而产生重大的公共卫生影响。在认识到越来越多的访问互联网和不同的成本和投入相关的基于网络与基于辅导员的干预，我们将比较两种形式，基于网络和基于辅导员的组合干预的有效性和可行性。使用比较有效性研究框架，我们计划比较这些干预形式对估计的CVD风险降低和其他重要结果对关键临床和公共卫生利益相关者（患者，付款人和决策者）的影响;特别是可行性，可接受性和成本效益结果。为此，我们将在5个家庭诊所开展本研究，每个诊所入组120例患者。我们将研究中心内的受试者随机分配至2种治疗条件之一，均包括基线评估和理论知情干预，包括4个月强化期（4次治疗）和8个月维持期（3次接触）。将在4个月和12个月时评估结局，主要结局是通过Fracket方程确定的冠心病估计10年风险降低。除了可行性、可接受性和成本外，饮食摄入、体力活动、血压、血脂和药物使用的变化也是重要的次要结局。为了优化研究结果向决策者和干预措施向从业者的传播，我们将1）从一开始就征求利益相关者的意见，以指导我们制定干预措施，2）使用现有的基于网络的机制（培训和研究翻译卓越中心）进行干预培训，翻译和传播。 项目摘要：问题陈述：心血管疾病仍然是美国发病率和死亡率的主要原因。虽然生活方式和适当使用药物可以大大降低这种风险，但两者都是未充分使用的治疗形式。 拟议研究的目的：结合联合收割机以前测试和有效的生活方式和药物干预，以减少心血管疾病的风险和测试这种干预在不同的一组病人照顾在家庭的做法在北卡罗来纳州。我们的计划是确定一种有效的干预措施，在社区资源的支持下，在普通办公室环境中使用，以便它可以覆盖大部分人口，从而产生重大的公共卫生影响。 本研究涉及IOM公共卫生CER的哪些优先领域？此应用程序解决了14个IOM优先主题中的4个，包括第一四分位数中的2个主题（首先列出）：1。比较各种预防肥胖、高血压、糖尿病和心脏病的策略在高危人群（如城市贫民和美洲印第安人）中的有效性。比较干预措施的有效性，以减少心血管疾病，糖尿病，癌症，肌肉骨骼疾病和出生结果3的健康差距。比较替代性重新设计策略的有效性-使用决策支持功能，电子健康记录和个人健康记录-以提高卫生专业人员对循证指南的依从性和患者对慢性病护理指南方案的依从性。比较不同的质量改进策略在疾病预防、急性护理、慢性病护理和康复服务方面对不同儿童和成人人群的有效性。

DESCRIPTION (provided by applicant): 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.