Collaborative Care Model for Perinatal Depression Support Services -- Population-Level Equity-Centered Systems Change (COMPASS-PLUS): A Hybrid Type 2 Cluster Randomized Trial

围产期抑郁症支持服务协作护理模式——以人口水平公平为中心的系统变革 (COMPASS-PLUS)：混合 2 型集群随机试验

• 批准号: 10835287
• 负责人: EMILY FEINBERG
• 金额: $ 85.34万
• 依托单位: WOMEN AND INFANTS HOSPITAL-RHODE ISLAND
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-09-19 至 2028-06-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10835287
• 关键词: Address; Advocate; Algorithms; Attention; Behavioral; Black race; Caring; Clinic; Clinical; Cluster randomized trial; Communities; Data; Databases; Diagnosis; Discrimination; Disease remission; Disparity; Equity; Ethnic Origin; Ethnic Population; Family; Feeling suicidal; Foundations; Goals; Health Status; Health system; Hybrids; Impaired health; Impairment; Individual; Inequity; Intervention; Interview; Latinx; Lead; Left; Major Depressive Disorder; Maternal Mortality; Measurement; Mental Depression; Mental Health; Mental Health Services; Modeling; Outcome; Patients; Perinatal; Perinatal Care; Persons; Population; Postpartum Depression; Postpartum Period; Pregnancy; Pregnancy Complications; Pregnancy Outcome; Primary Care; Provider; Psyche structure; Psychiatric therapeutic procedure; Publishing; Quality of life; Race; Randomized; Reach, Effectiveness, Adoption, Implementation, and Maintenance; Recommendation; Research; Rhode Island; Risk Factors; Sample Size; Services; Severities; Site; Structural Racism; Structure; Suicide; Support Groups; Supportive care; Symptoms; System; Testing; Treatment Efficacy; United States; Validation; Woman; anti-racism; care coordination; collaborative care; cost; depressive symptoms; effectiveness evaluation; effectiveness outcome; effectiveness/implementation design; ethnic difference; ethnic disparity; ethnic health disparity; evidence base; evidence based guidelines; experience; health disparity; health equity; implementation evaluation; implementation outcomes; implementation strategy; implementation/effectiveness; improved; innovation; maternal morbidity; obstetric care; patient oriented; perinatal mental health; peripartum depression; personalized care; population based; post pregnancy; pregnant; primary care setting; primary outcome; racial difference; racial disparity; racial health disparity; racial population; randomized trial; reducing suicide; research to practice; response; screening; severe maternal morbidity; single episode major depressive disorder; social determinants; standard care; study population; success; therapy design; treatment as usual; treatment optimization

PROJECT SUMMARY/ABSTRACT Over 15% of women in the United States are impacted by depression during or after pregnancy. Untreated perinatal depression dramatically impairs maternal quality of life and, in its most extreme form, can lead to suicide which remains a leading contributor to maternal mortality. Despite recognition of its importance, multiple barriers exist in the depression care cascade. One of these barriers is the existing health system structure, wherein obstetric and psychiatric care exists in silos and social determinants of mental health (SDoMH) are not systematically integrated into care plans. Without a synergistic approach to the whole woman, both physically and mentally, screening for depressive symptoms occurs inconsistently. Even when screening occurs and depression is diagnosed, treatment is often not initiated, depressive symptoms are not tracked, and care is not escalated with the goal of symptom remission. This lack in coordinated and personalized care has left thousands of women vulnerable each year in the United States. Moreover, there are significant inequities in perinatal depression care which contribute to the widening racial and ethnic disparities in quality of life, maternal morbidity, and maternal mortality. It is imperative that we identify alternative mechanisms to adequately identify and treat perinatal depression in an equitable manner and incorporate mental healthcare as a component of interventions designed to reduce maternal mortality and severe maternal morbidity. The collaborative care model (CCM), when implemented in the primary care context, leads to improvements in mental health outcomes. However, the perinatal context is unique on the patient, clinician, and systems levels. Thus the perinatal CCM (pCCM) requires its own validation. One small (n=168), randomized trial suggests the pCCM is efficacious in reducing depressive symptoms. Despite these data, pCCM remains rarely utilized due to two existing gaps in the research-to-practice continuum. First, the existing efficacy data lack generalizability needed for broad dissemination. Second, no studies have been published to inform best practices with respect to an implementation strategies package for pCCM, with attention to the unique aspects of the perinatal context. Moreover, while the pCCM is an equity-centered intervention, the persistent disparities observed in pregnancy outcomes and perinatal mental health require an intentional, innovative, inclusive, anti-racist approach that builds upon the traditional equity-centered CCM foundations and centers identification and mitigation of SDoMH. We will leverage existing clinical algorithms and databases developed for an established and successful pCCM to perform a rigorous stepped-wedge cluster-randomized trial to evaluate the effect of an equity-enhanced pCCM [COMPASS-PLUS (Collaborative Care Model for Perinatal Depression Support Services – Population-Level Health Equity-Centered Structural Changes)] on maternal mental health outcomes and mental health disparities. We will optimize an implementation strategy package tailored to perinatal care via a hybrid type 2 implementation-effectiveness design with the goal of broad dissemination of the pCCM.

项目摘要/摘要 在美国，超过15%的女性在怀孕期间或怀孕后受到抑郁症的影响。未处理 围产期抑郁症严重损害母亲的生活质量，在其最极端的形式，可导致自杀 这仍然是导致孕产妇死亡的主要因素。尽管认识到其重要性， 存在于抑郁症护理级联中。这些障碍之一是现有的卫生系统结构， 产科和精神病护理存在孤岛，精神健康的社会决定因素（SDoMH） 系统地纳入护理计划。如果没有一个协同的方法，整个女人，无论是身体上 在精神上，抑郁症状的筛查并不一致。即使发生筛选， 抑郁症被诊断出来，治疗往往没有开始，抑郁症状没有跟踪，护理也没有。 以缓解症状为目标这种缺乏协调和个性化的护理使成千上万的人 在美国，每年有50%的女性处于弱势。此外，在围产期保健方面存在着严重的不平等。 抑郁症护理，这有助于扩大种族和民族之间的差异，生活质量，孕产妇发病率， 和产妇死亡率。我们必须确定替代机制，以充分识别和治疗 公平地对待围产期抑郁症，并将心理保健作为干预措施的一部分 旨在降低孕产妇死亡率和严重孕产妇发病率。 协作护理模式（CCM）在初级保健环境中实施时， 心理健康的结果。然而，围产期的情况是独特的病人，临床医生和系统的水平。 因此，围产期CCM（pCCM）需要自己的验证。一项小型（n=168）随机试验表明， pCCM在减轻抑郁症状方面有效。尽管有这些数据，pCCM仍然很少使用，因为 研究到实践连续体中存在的两个差距。一是现有疗效数据缺乏普遍性 需要广泛传播。第二，没有发表任何研究报告， （c）制定一套预防儿童感染综合方案的执行战略，同时关注围产期环境的独特方面。 此外，虽然pCCM是一种以平等为中心的干预措施，但在怀孕期间观察到的持续差异 结果和围产期心理健康需要一个故意的，创新的，包容性的，反种族主义的方法， 在传统的以公平为中心的CCM基础上，以SDoMH的识别和缓解为中心。 我们将利用现有的临床算法和数据库开发的一个既定的和成功的pCCM 进行一项严格的逐步楔形随机分组试验，以评估公平增强型pCCM的效果 [COMPASS-PLUS（围产期抑郁症支持服务的协作护理模式-人口水平 以健康公平为中心的结构变化）]对孕产妇心理健康结果和心理健康差异的影响。 我们将通过混合型2优化针对围产期护理的实施战略包 实施效果设计，目标是广泛传播预防腐败和犯罪措施。