RANDOMIZED CONTROLLED TRIAL OF SCREENING FOR DEPRESSION IN CARDIAC OUTPATIENTS

心脏病门诊患者抑郁症筛查的随机对照试验

• 批准号: 8698763
• 负责人: ROBERT M CARNEY
• 金额: $ 49.38万
• 依托单位: WASHINGTON UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2011
• 资助国家: 美国
• 起止时间: 2011-08-01 至 2016-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8698763
• 关键词: RANDOMIZED; CONTROLLED; TRIAL; SCREENING; DEPRESSION

DESCRIPTION (provided by applicant): This proposal is in response to Program Announcement PA-09-070, "AHRQ Health Services Research Projects" Prevention/Care Management Portfolio requesting studies designed to "improve the quality, safety, efficiency, and effectiveness of evidence-based preventive services and chronic care management," and "improving the implementation of evidence-based recommendations on preventive services." Depression and cardiovascular disease are highly comorbid, and depression is a risk factor for psychosocial morbidity, poor adherence to medical treatment regimens, physical inactivity, poor physical functioning, and medical morbidity and mortality in cardiac patients, especially following an acute coronary syndrome (ACS). In 2006, an Evidence Report from the Agency for Healthcare Research and Quality (AHRQ) concluded that, despite strong evidence that depression is a risk factor for cardiac events, there was insufficient evidence to support the utility of depression screening in cardiac patients. There have been no studies since that time to determine the effectiveness of depression screening in cardiac patients. Nevertheless, the American Heart Association and other organizations have called for depression screening for ACS patients to improve identification and treatment of this risk factor. We propose to conduct a randomized, controlled trial comparing the effects of depression screening and case management to usual care in cardiology outpatients with a recent history of ACS. Patients being seen for an outpatient cardiology appointment at the Washington University Center for Advanced Medicine following hospitalization for ACS will be recruited for this study. Medically eligible patients will be administered the Patient Health Questionnaire-9 (PHQ-9) and the Beck Depression Inventory (BDI-II) to screen for depression. The first 300 patients who score 10 or above on the PHQ-9 will be randomly assigned to one of two conditions: Usual care, as provided by their cardiologist and primary care physician, or a collaborative depression screening intervention (CDSI). One hundred patients who score 9 or below on the PHQ-9 will also be recruited to determine the sensitivity and specificity of the PHQ-9 and BDI-II in relation to interview-based diagnosis of major depression. Patients will be followed for six months by a nurse case manager (NCM) who will periodically assess the patient's depression and treatment needs in consultation with a psychiatrist. Treatment recommendations will be made to the patient's primary care physician and monitored by the NCM. Referral to mental health professionals will be made as needed. Patients will be assessed at baseline, 3 and 6 months for current depression, depression treatment history, quality of life, physical functioning, adherence to medical treatment regimens, and the occurrence of adverse medical events in the 12 months following enrollment. Cost effectiveness analysis of the intervention will be conducted.

描述（由申请人提供）：本提案是为了响应计划公告 PA-09-070，“AHRQ 卫生服务研究项目”预防/护理管理组合要求进行旨在“提高证据的质量、安全性、效率和有效性”的研究基于证据的预防性服务和长期护理管理”以及“改进基于证据的预防性服务建议的实施”。抑郁症和心血管疾病高度共存，抑郁症是心脏病患者（尤其是急性冠脉综合征（ACS）患者）心理社会发病率、对医疗方案依从性差、身体活动不足、身体机能差以及医疗发病率和死亡率的危险因素。 2006 年，医疗保健研究与质量机构 (AHRQ) 的一份证据报告得出结论，尽管有强有力的证据表明抑郁症是心脏事件的危险因素，但没有足够的证据支持心脏病患者进行抑郁症筛查的效用。自那时以来，还没有研究确定心脏病患者抑郁症筛查的有效性。尽管如此，美国心脏协会和其他组织仍呼吁对 ACS 患者进行抑郁症筛查，以提高对这一危险因素的识别和治疗。我们建议开展一项随机对照试验，比较抑郁症筛查和病例管理与常规护理对近期有 ACS 病史的心脏病门诊患者的效果。本研究将招募因 ACS 住院后在华盛顿大学高级医学中心进行门诊心脏病预约的患者。符合医疗条件的患者将接受患者健康问卷 9 (PHQ-9) 和贝克抑郁量表 (BDI-II) 来筛查抑郁症。 PHQ-9 得分为 10 分或以上的前 300 名患者将被随机分配到以下两种情况之一：由心脏病专家和初级保健医生提供的常规护理，或​​协作抑郁症筛查干预 (CDSI)。还将招募 100 名 PHQ-9 得分为 9 或以下的患者来确定 PHQ-9 和 BDI-II 与基于访谈的重性抑郁诊断相关的敏感性和特异性。一名护士病例经理（NCM）将对患者进行为期六个月的跟踪，该经理将定期与精神科医生协商评估患者的抑郁情况和治疗需求。将向患者的初级保健医生提出治疗建议，并由 NCM 进行监测。将根据需要转介给心理健康专业人员。将在基线、3个月和6个月时评估患者当前的抑郁症、抑郁症治疗史、生活质量、身体机能、对医疗方案的依从性以及入组后12个月内不良医疗事件的发生情况。将进行干预措施的成本效益分析。