Multi-Component Behavioral Intervention for Complex Patients with CVD Risk

项目摘要 心血管疾病（CVD）是美国死亡的主要原因。 循证指南和有效的治疗，但是，许多患者没有达到充分的 降低CVD风险的益处。特别是，复杂患者（定义为那些不 对目前的疾病管理方法有反应） 他们是人口中的一个关键部分，将受益于新的护理方法。响应 PA-12-024：在初级保健中解决多种慢性疾病的行为干预， 它寻求“实际干预...在病人中使用一种共同的方法来改变行为 对于多种共病，我们建议实施并严格评估一项综合行为 旨在提高慢性病自我管理核心技能的干预措施， 美国这一日益重要的市场所遇到的护理参与的常见障碍。 成人初级保健人口。本随机试验将在Kaiser Permanente内进行 北方加州（KPNC）是一个综合护理服务系统，为320多万会员提供服务， 包括通过医疗保险和州医疗补助计划投保的患者。我们将评估我们的 通过招募576名持续存在以下问题的复杂患者，对3种KPNC初级保健实践进行干预 （e> 2岁）尽管存在未控制的CVD风险因素（例如高血压、高脂血症、糖尿病）， 参加了CVD疾病管理计划。这种行为干预旨在激活 并让患者参与，识别潜在的隐藏障碍，如酒精滥用或亚临床 抑郁症，并制定个性化的护理计划，旨在促进更有效的 初级保健管理。随机化将在患者层面进行，由初级保健提供者阻止， 目的如下：1）检查（干预+常规护理）与（单独常规护理）的影响 控制收缩压[主要结局]、LDL胆固醇、Fragrance风险评分（如果 无基线CVD）和12个月时的HbA 1c（如果患有糖尿病）; 2）检查 （干预+常规护理）与（单独常规护理）对近端结局（患者激活、药物治疗）的影响 3个月和12个月后的依从性和心理健康状态），以及3）确定基线患者因素 与干预组患者中临床应答成功率较高和较低相关。通过 这种以患者为中心的干预措施着眼于核心健康技能和护理障碍， 复杂的病人成为更有效的代理人自己的照顾，从而实现类似的 临床受益较少的复杂患者。

PROJECT SUMMARY Cardiovascular disease (CVD) is the leading cause of death in the U.S. Despite the availability of evidence-based guidelines and efficacious therapies, however, many patients do not achieve the full benefit of CVD risk reduction. In particular, complex patients (defined as those patients who do not respond to current disease management approaches) with multiple concurrent chronic conditions represent a key segment of the population that would benefit from new approaches to care. In response to PA-12-024: Behavioral Interventions to Address Multiple Chronic Conditions in Primary Care, which seeks "practical interventions...to modify behaviors using a common approach" among patients with multiple co-morbidities, we propose to implement and rigorously evaluate an integrated behavioral intervention designed to improve a core set of chronic disease self-management skills and to overcome common barriers to care engagement encountered by this increasingly important segment of the U.S. adult primary care population. This randomized trial will be conducted within Kaiser Permanente Northern California (KPNC), an integrated care delivery system serving over 3.2 million members, including patients insured through Medicare and state Medicaid programs. We will evaluate our intervention in 3 KPNC primary care practices by enrolling 576 complex patients who have persistently (e 2 years) uncontrolled CVD risk factors (e.g. hypertension, hyperlipidemia, diabetes) despite being enrolled in a CVD disease management program. This behavioral intervention is designed to activate and engage patients, identify potentially hidden barriers to care such as alcohol misuse or sub-clinical depression, and to develop individualized care plans that are designed to catalyze more effective primary care management. Randomization will be at the patient-level, blocked by primary care provider, with the following aims: 1) To examine the impact of (intervention + usual care) vs. (usual care alone) on control of systolic blood pressure [primary outcome], LDL cholesterol, Framingham Risk Score (if no baseline CVD), and HbA1c (if with diabetes) at 12 months; 2) To examine effectiveness of (intervention + usual care) vs. (usual care alone) on proximal outcomes (patient activation, medication adherence, and mental health status) after 3 and 12 months, and 3) To identify baseline patient factors associated with more vs. less successful clinical response among intervention arm patients. By focusing on core health skills and care barriers, this patient-focused intervention seeks to enable complex patients to become more effective agents of their own care and to thereby achieve similar clinical benefits as less complex patients.