Treatment of Depression Following Bypass Surgery

描述（由申请方提供）：抑郁症在冠状动脉旁路移植术（CABG）术后患者中非常普遍，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的可治疗决定因素，在初级保健环境中提供的CABG后抑郁症循证治疗，并使用已证明有效的传播方法，是改善结局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天以及出院后2周重新评估时证实抑郁症状水平升高的患者。我们将这些患者随机分为两组：（1）他们的医生对抑郁症的“常规护理”;或（2）一个阶梯式的合作护理计划，包括一个基于电话的护士护理经理，他将定期与患者联系，以评估抑郁症的治疗偏好（咨询，自我管理手册，药物治疗或专业转诊）;促进护理依从性;并在研究临床医生的监督下与患者的POP一起监测治疗反应。我们还将随机选择150例CABG术后非抑郁患者作为对照组，以便于与我们的抑郁患者在各种基线和随访指标上进行比较，并更好地了解抑郁治疗的益处（总N=450）。我们将在CABG后2个月、4个月、8个月和12个月进行盲态电话评估，然后每6个月进行一次，直至末例研究患者完成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抑郁症“常规护理”的患者相比，我们的干预将在CABG后8个月时产生至少0.5的具有临床意义的HRQoL效应量改善，通过SF-36精神健康总评进行测量。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费用;（2）报告与非抑郁的CABG后患者相似的HRQoL水平。 为CABG后抑郁症提供循证阶梯式协作护理治疗可能是有组织的医疗保健提供系统改善结局的理想方法。我们对HRQoL和卫生服务成本的关注将有助于将我们的干预措施与其他心血管风险因素的既定治疗方法和其他慢性病护理的益处进行比较。这项研究将加强我们对CABG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.