Multi-Component Behavioral Intervention for Complex Patients with CVD Risk

描述(由申请人提供)：心血管疾病(CVD)是美国主要的死亡原因。尽管有循证指南和有效的治疗方法，但许多患者并没有实现降低心血管疾病风险的全部好处。特别是，患有多种并发慢性病的复杂患者(定义为对目前的疾病管理方法没有反应的患者)是人口中将受益于新的护理方法的关键部分。根据PA-12-024：旨在解决初级保健中多种慢性病的行为干预措施，我们建议实施并严格评估一种综合行为干预措施，旨在提高一套核心的慢性病自我管理技能，并克服这一日益重要的美国成人初级保健人群在护理参与方面遇到的共同障碍。这项随机试验将在Kaiser Permanente North California(KPNC)内进行，KPNC是一种综合护理提供系统，为超过320万成员提供服务，包括通过联邦医疗保险和州医疗补助计划投保的患者。我们将评估我们在3个KPNC初级保健实践中的干预措施，纳入576名复杂的患者，这些患者尽管参加了心血管疾病管理计划，但仍存在持续(e 2年)无法控制的心血管危险因素(例如高血压、高脂血症、糖尿病)。这一行为干预旨在激活和吸引患者，识别潜在的潜在护理障碍，如酒精滥用或亚临床抑郁症，并制定旨在催化更有效的初级保健管理的个性化护理计划。随机抽样将在患者层面进行，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)在12个月时对控制收缩压[主要结果]、低密度脂蛋白胆固醇、Framingham风险评分(如果没有基线心血管疾病)和糖化血红蛋白(如果合并糖尿病)的影响；2)检查(干预+常规护理)与(单独常规护理)在3个月和12个月后对近期结果(患者激活、服药依从性和精神健康状况)的有效性，以及3)确定基线患者因素与介入ARM患者的临床反应更成功或更不成功相关。通过关注核心健康技能和护理障碍，这种以患者为中心的干预措施旨在使复杂的患者能够成为自己护理的更有效的代理人，从而实现与不复杂的患者类似的临床好处。

DESCRIPTION (provided by applicant): 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.