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 在怀孕期间或怀孕后，超过15％的妇女受到抑郁症的影响。未经处理 围产期抑郁症极大地损害了孕妇的生活质量，并且以其最极端的形式会导致自杀 这仍然是孕产妇死亡率的主要贡献者。尽管承认其重要性，但多个障碍 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，其中 在心理健康的孤岛和社会决定者（SDOMH）中存在产科和精神病护理不是 系统地整合到护理计划中。没有对整个女人的协同方法 在精神上，筛查抑郁症状的发生不一致。即使发生筛查， 诊断出抑郁症，通常不会开始治疗，没有追踪抑郁症状，并且护理不是 随着症状缓解的目标升级。这种缺乏协调和个性化的护理已经剩下数千个 在美国，妇女每年脆弱。此外，围产期存在明显的不平等 抑郁症护理会导致生活质量的扩大种族和种族差异，孕产妇发病率， 和孕产妇死亡。我们必须确定替代机制以充分识别和治疗 以平等的方式围产期抑郁症，并将心理保健纳入干预措施的组成部分 旨在降低孕产妇死亡率和严重的孕产妇发病率。 在初级保健环境中实施时，协作护理模型（CCM）会导致改进 心理健康结果。但是，围产期环境在患者，临床和系统水平上是独一无二的。 围产期CCM（PCCM）需要其自己的验证。一个小（n = 168），随机试验表明 PCCM有效地减少抑郁症状。尽管有这些数据，但由于PCCM仍然很少使用 实践连续性中的两个现有差距。首先，现有的效率数据缺乏普遍性 广泛传播所需的。其次，尚未发表研究以尊重最佳实践 对于PCCM的实施策略包，请注意围产期环境的独特方面。 此外，虽然PCCM是以股权为中心的干预措施，但怀孕中观察到的持续差异 成果和围产期心理健康需要一种有意，创新，包容，反种族主义的方法 在传统的以股权为中心的CCM基础和中心识别和缓解SDDOMH的基础上。 我们将利用为已建立且成功的PCCM开发的现有临床算法和数据库 要执行严格的跨斜向旋转聚类的试验，以评估相等增强的PCCM的效果 [Compass-Plus（围产期抑郁症支持服务的协作护理模型 - 人群级别 以卫生公平为中心的结构性变化）]关于孕产妇的心理健康结果和心理健康差异。 我们将通过Hybrid Type 2优化针对围产期护理量身定制的实施策略软件包 实施效应设计的目的是对PCCM进行广泛传播。