Treatment of Depression Following Bypass Surgery

描述（由申请人提供）：抑郁症在冠状动脉旁路移植术（CABG）术后患者中非常普遍，并与健康相关生活质量（HRQoL）降低和心血管发病率和死亡率增加相关。由于抑郁症是HRQoL的一个可治疗的决定因素，在初级保健环境中提供基于证据的cabg后抑郁症治疗，并使用经过验证的有效传播方法，是一种改善结果并可能降低医疗保健成本的新方法。我们将招募300名在CABG手术后3-5天和出院后2周重新评估时抑郁症状水平升高的患者。我们将随机分配这些患者接受：(1)他们的医生对抑郁症的“常规护理”；或者(2)一个阶梯式的合作护理项目，其中包括一个基于电话的护理经理，他将定期与患者联系，评估抑郁症的治疗偏好（咨询、自我管理工作手册、药物治疗或专业转诊）；促进护理依从性；并在临床医生的监督下，结合患者的持久性有机污染物监测治疗效果。我们还将随机选择150名cabg后非抑郁患者作为对照队列，以便与我们的抑郁症患者在各种基线和随访措施上进行比较，并更好地了解抑郁症治疗的益处（总N=450）。我们将在cabg后2、4、8和12个月进行盲法电话评估，然后每6个月进行一次，直到最后一位研究患者完成他/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“常规护理”治疗抑郁症的患者相比，我们的干预措施将在cabg后8个月对HRQoL产生至少具有临床意义的0.5效应量改善，以SF-36心理成分总结评分来衡量。我们的次要假设是，与“常规护理”患者相比，干预患者将：(1)经历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)报告的HRQoL水平与cabg后非抑郁患者相似。

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.