Multi-Component Behavioral Intervention for Complex Patients with CVD Risk

描述（由申请人提供）：在美国，心血管疾病（CVD）是导致死亡的主要原因，尽管有循证指南和有效的治疗方法，然而，许多患者并没有从降低心血管疾病风险中获益。特别是，患有多种并发慢性疾病的复杂患者（定义为对当前疾病管理方法无反应的患者）是将受益于新治疗方法的关键人群。为了回应PA-12-024：行为干预以解决初级保健中的多种慢性疾病，寻求“实际干预……在患有多种合并症的患者中，我们建议实施并严格评估一种综合行为干预，旨在提高慢性疾病自我管理的核心技能，并克服这一日益重要的美国成人初级保健人群中遇到的护理参与的共同障碍。这项随机试验将在Kaiser Permanente Northern California （KPNC）进行，KPNC是一个综合医疗服务系统，服务超过320万会员，包括通过医疗保险和州医疗补助计划投保的患者。我们将通过招募576名持续（2年）未控制心血管疾病危险因素（如高血压、高脂血症、糖尿病）的复杂患者来评估我们在3个KPNC初级保健实践中的干预措施，尽管他们参加了心血管疾病管理项目。这种行为干预旨在激活和吸引患者，识别潜在的护理障碍，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。随机化将在患者水平进行，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）对12个月收缩压[主要结局]、LDL胆固醇、Framingham风险评分（如果没有基线CVD）和HbA1c（如果患有糖尿病）的控制的影响；2)检查（干预+常规护理）与（单独常规护理）在3个月和12个月后对近端结果（患者激活、药物依从性和心理健康状况）的有效性；3)确定干预组患者中与临床反应成功与否相关的基线患者因素。通过关注核心保健技能和护理障碍，这种以患者为中心的干预措施力求使病情复杂的患者能够更有效地进行自身护理，从而获得与病情较轻的患者相似的临床益处。

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.