Reducing Disparities and Improving Care for Depression in OB-GYN Clinics

描述(由申请人提供)：背景：女性一生中都会出现严重的抑郁发作，在生殖和更年期过渡期的发病率最高。在此期间，妇产科是许多妇女经常见到的唯一提供者。低收入和少数族裔妇女特别有可能在妇产科诊所寻求常规护理。妇产科诊所在抑郁症诊断的准确性和护理质量方面存在着明显的差距，抑郁症护理质量的差距超过了初级保健诊所。将抑郁症护理纳入临床环境的模型可能适用于妇产科环境，但尚未在围产期以外进行测试。妇产科看到的大多数妇女都没有怀孕；因此，只关注围产期抑郁症的研究排除了大量可以从护理中受益的妇女。到目前为止，还没有完成将抑郁症护理模式适应于整个妇产科诊所的研究。研究目标：我们提出了一个由三部分组成的干预措施，与妇产科护理相结合，包括(I)加强教育；(Ii)参与；(Iii)抑郁症护理管理(通过抗抑郁药物监测和/或提供简短的心理治疗)。我们假设，整合到妇产科临床环境中的由三部分组成的抑郁症干预将改善抑郁症的治疗结果、功能结果和对抑郁症护理的满意度。研究设计：在拟议的随机对照试验中，260名患有严重抑郁和/或恶劣心境的妇产科门诊患者将被分配到：1)综合抑郁干预组或2)常规护理组(UC)。我们将在18个月的时间里对在两家城市妇产科诊所预约就诊的大约8,300名患者进行严重抑郁症/恶劣心境的筛查。这些患者中有很大一部分是低收入和少数族裔妇女。潜在的符合条件的患者也可以由诊所提供者推荐，或者回复诊所张贴的信息传单。综合抑郁干预将持续12个月。结果将在基线、6个月、12个月和18个月时通过盲目研究人员的电话采访进行评估。目的：我们的主要目标是：1)与UC相比，评估OB-GYN综合抑郁症干预对抑郁症治疗结果的影响，包括抑郁症状和抑郁治疗反应的变化；以及2)与UC相比，评估OB-GYN综合抑郁症干预对功能结果的影响。我们的次要目标是：3)与UC相比，评估OB-GYN综合抑郁症干预对抑郁症护理指标的影响，包括治疗就诊次数、剂量、持续时间和抗抑郁药物的依从性；以及对抑郁症护理的满意度，包括患者和提供者的满意度，以及OB-GYN诊所提供者对抑郁症护理的态度；以及4)[确定OB-GYN综合干预的潜在促进者和障碍。] 公共卫生相关性：我们建议的随机对照试验的结果将极大地影响公共健康，因为它满足了妇产科临床环境中所有女性对有效抑郁症服务的未满足需求。在这种情况下接受护理的大部分妇女在抑郁症治疗结果和生活质量方面的潜在改善将是巨大的。

DESCRIPTION (provided by applicant): Background: Major depressive episodes occur throughout a woman's lifespan, with the highest rates during the reproductive and menopausal transition years. During this time, OB-GYNs are the only providers whom many women regularly see. Low income and minority women are particularly likely to seek their routine care in OB-GYN clinics. There are marked gaps in accuracy of diagnosis and quality of depression care in OB-GYN clinics, with disparities in quality of depression care which exceed those seen in primary care clinics. Models incorporating depression care into clinical settings may be adaptable to OB-GYN settings but have not been tested outside of the perinatal period. Most women seen by OB-GYNs are not pregnant; thus, studies focusing solely on perinatal depression excludes a large number of women who could benefit from care. No studies to date have been completed that have adapted depression care models to OB-GYN clinics as a whole. Research Goal: We propose a three-part intervention, integrated with OB-GYN care, consisting of (i) enhanced education; (ii) engagement; and (iii) depression care management (with antidepressant monitoring and/or provision of brief psychotherapy). We hypothesize that a three-part depression intervention, integrated into the OB-GYN clinical setting, will improve treatment outcomes for depression, functional outcomes, and satisfaction with depression care. Study Design: In the proposed randomized controlled trial, 260 OB-GYN clinic patients with major depression and/or dysthymia will be assigned to either: 1) an integrated depression intervention or 2) usual care (UC). We will screen approximately 8,300 patients presenting for scheduled clinic appointments at two urban OB-GYN clinics over 18-months for major depression/dysthymia. A large number of these patients are low-income and minority women. Potentially eligible patients may also be referred by a clinic provider or reply to informational flyers posted in the clinics. The integrated depression intervention will last 12 months. Outcomes will be assessed at baseline and at 6, 12, and 18 months by telephone interviews by blinded research staff. Aims: Our Primary Aims are: 1) To evaluate, compared to UC, the impact of an integrated OB-GYN depression intervention on depression treatment outcomes, including change in depressive symptoms and depression treatment response; and 2) To evaluate, compared to UC, the impact of an integrated OB-GYN depression intervention on functional outcomes. Our Secondary Aims are: 3) To evaluate, compared to UC, the impact of an integrated OB-GYN depression intervention on quality of depression care indicators, including number of therapy visits, and dose, duration, and adherence to antidepressant medications; and on satisfaction with depression care, including patient and provider satisfaction, and provider attitudes toward depression care in OB-GYN clinics; and 4) [To identify potential facilitators and barriers to sustainability of the integrated OB-GYN intervention.] PUBLIC HEALTH RELEVANCE: The results of our proposed randomized controlled trial will greatly impact public health by satisfying an unmet need for effective depression services for all women seen in the OB-GYN clinical setting. The potential improvements in depression treatment outcomes and quality of life for the large proportion of women who receive their care in this setting will be substantial.