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: 8479332
• 负责人: ROBERT M CARNEY
• 金额: $ 49.13万
• 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 2015-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8479332
• 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）：本提案是对项目公告PA-09-070的回应，“AHRQ卫生服务研究项目”预防/护理管理组合要求研究旨在“提高循证预防服务和慢性护理管理的质量、安全性、效率和有效性”，以及“改进循证预防服务建议的实施”。抑郁症和心血管疾病是高度合并症，抑郁症是心脏病患者，特别是急性冠状动脉综合征（ACS）后，心理社会发病率、对治疗方案的依从性差、缺乏身体活动、身体功能差以及医疗发病率和死亡率的一个危险因素。2006年，医疗保健研究和质量机构（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病事件的一个风险因素，但没有足够的证据支持对心脏病患者进行抑郁症筛查的效用。从那时起，就没有研究确定抑郁症筛查在心脏病患者中的有效性。然而，美国心脏协会和其他组织呼吁对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。我们建议进行一项随机对照试验，比较近期有ACS病史的心脏病门诊患者抑郁症筛查和病例管理与常规护理的效果。在华盛顿大学高级医学中心接受门诊心脏病科预约的ACS住院患者将被纳入本研究。医学上符合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。前300名PHQ-9得分在10分或以上的患者将被随机分配到两种情况中的一种：由他们的心脏病专家和初级保健医生提供的常规护理，或合作抑郁症筛查干预（CDSI）。还将招募100名PHQ-9得分在9分或以下的患者，以确定PHQ-9和BDI-II在基于访谈的重度抑郁症诊断中的敏感性和特异性。患者将由一名病例管理护士（NCM）随访6个月，该护士将定期与精神科医生协商评估患者的抑郁症和治疗需求。治疗建议将提交给患者的初级保健医生，并由NCM监测。如有需要，将转介给心理健康专业人员。患者将在基线、3个月和6个月时评估当前抑郁症、抑郁症治疗史、生活质量、身体功能、对药物治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。将对干预措施进行成本效益分析。