Treatment of Depression Following Bypass Surgery

描述(申请人提供)：抑郁在冠状动脉旁路移植(CABG)手术后的患者中非常普遍，并与与健康相关的生活质量(HRQOL)降低以及心血管发病率和死亡率增加有关。由于抑郁症是HRQL的一个可治疗的决定因素，在初级保健环境中为CABG术后抑郁症提供循证治疗并使用被证明有效的传播方法是一种改善结果和潜在降低医疗费用的新方法。我们将招募300名患者，他们在CABG手术后3-5天和出院后2周重新评估时都支持抑郁症状水平升高。我们将随机对这些患者进行以下两种治疗：(1)医生对抑郁症的“常规护理”；或(2)分级协作护理计划，包括电话护士护理经理定期联系患者，以评估抑郁症的治疗偏好(咨询、自我管理工作手册、药物治疗或专科转介)；促进护理的依从性；并与患者的POP协调并在研究临床医生的监督下监测治疗反应。我们还将随机选择150名CABG术后非抑郁症患者作为对照队列，以便于与我们的抑郁症患者在各种基线和后续措施上进行比较，并更好地了解抑郁症治疗的好处(总N=450)。我们将在CABG术后2个月、4个月、8个月和12个月进行电话盲法评估，然后每6个月进行一次，直到最后一个研究患者完成他/她的8个月评估(范围：8-44个月随访)。我们将使用意向治疗分析来检验我们的主要假设，即与接受POP治疗抑郁症的患者相比，我们的干预将在CABG后8个月产生至少有临床意义的0.5效果大小的HRQL改善，通过SF-36心理成分摘要评分来衡量。我们的第二个假设是，与“常规护理”患者相比，干预性患者将：(1)体验更高水平的功能状态、更低水平的抑郁症状、未来心血管事件的风险和医疗服务成本；(2)报告与非CABG后抑郁患者相似的HRQL水平。 为冠状动脉搭桥术后抑郁患者提供循证的阶段性协作治疗可能是有组织的医疗服务系统改善预后的理想方法。我们将重点放在HRQL和医疗服务成本上，这将有助于将我们的干预与其他既定的心血管风险因素治疗和其他慢性病护理的好处进行比较。这项研究将加深我们对冠状动脉搭桥术后抑郁的影响和过程的理解。

DESCRIPTION (provided by applicant): Depression is highly prevalent among patients following coronary artery bypass graft (CABG) surgery and is associated with reduced health-related quality of life (HRQoL) and increased cardiovascular morbidity and mortality. Since depression is a treatable determinant of HRQoL, evidence-based treatment for post-CABG depression provided in a primary care setting and using proven effective dissemination methods is a novel approach to improve outcomes and potentially reduce health care costs. We will recruit 300 patients who endorse elevated levels of depressive symptoms at both 3-5 days following CABG surgery and when reassessed 2-weeks after hospital discharge. We will randomize these patients to receive either: (1) their physicians' "usual care" for depression; or (2) a stepped collaborative care program involving a telephone based nurse care manager who will contact patients at regular intervals to assess treatment preferences for depression (counseling, self-management workbook, pharmacotherapy, or specialty referral); promote adherence with care; and monitor the therapeutic response in concert with patients' POPs and under the supervision of a study clinician. We will also randomly select 150 non-depressed post-CABG patients to serve as a control cohort to facilitate comparisons with our depressed patients on various baseline and follow-up measures, and to better understand the benefits derived from depression treatment (total N=450). We will conduct blinded telephone assessments at 2-, 4-, 8-, and 12-months post-CABG and then every six months until the Last study patient completes his/her 8-month assessment (range: 8-44 months follow-up). We will use intent-to-treat analyses to test our primary hypothesis that our intervention will produce at least a clinically meaningful 0.5 effect size improvement in HRQoL at 8-months post-CABG, as measured by the SF-36 Mental Component Summary score, compared to patients who receive their POPs' "usual care" for depression. Our secondary hypotheses are that compared to "usual care" patients, intervention patients will: (1) experience higher levels of functional status, and lower levels of depressive symptoms, risk for future cardiovascular events, and health services costs; and (2) report similar levels of HRQoL as non-depressed post-CABG patients. Providing evidence-based stepped collaborative care treatment for post-CABG depression may be an ideal method for organized health care delivery systems to improve outcomes. Our focus on HRQoL and on health services costs will facilitate comparisons of the benefits derived from our intervention to that of other established treatments of cardiovascular risk factors and care for other chronic conditions. This study will enhance our understanding of the impact and course of post-CABG depression.