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.

项目概要/摘要 超过 15% 的美国女性在怀孕期间或怀孕后受到抑郁症的影响而未经治疗。 围产期抑郁症严重损害产妇的生活质量，最极端的形式可能导致自杀 尽管人们认识到其重要性，但它仍然是孕产妇死亡率的一个主要因素。 抑郁症护理级联中存在的障碍之一是现有的卫生系统结构， 产科和精神科护理存在各自为政的情况，心理健康的社会决定因素 (SDoMH) 并不存在 系统地纳入护理计划，但没有对整个女性的身体状况采取协同方法。 在心理上，即使进行了筛查，抑郁症状的筛查也不一致。 抑郁症被诊断出来，但往往没有开始治疗，没有跟踪抑郁症状，也没有护理 随着症状缓解的目标不断升级，这种缺乏协调和个性化护理的情况导致了数千人的死亡。 在美国，每年有 80% 的妇女处于弱势地位。此外，围产期也存在严重的不平等。 抑郁症护理导致生活质量、产妇发病率、 我们必须找到替代机制来充分识别和治疗。 以公平的方式治疗围产期抑郁症，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。 当在初级保健环境中实施协作护理模式（CCM）时，可以改善 然而，围产期环境在患者、临床医生和系统层面上都是独特的。 因此，围产期 CCM (pCCM) 需要进行自己的验证，一项小型随机试验 (n=168) 表明这一点。 尽管有这些数据，pCCM 可有效减轻抑郁症状，但由于以下原因，pCCM 仍然很少被使用。 从研究到实践的连续性存在两个差距：首先，现有的疗效数据缺乏普遍性。 其次，尚未发表任何研究来指导尊重的最佳实践。 针对 pCCM 的实施策略包，关注围产期环境的独特方面。 此外，虽然 pCCM 是一种以公平为中心的干预措施，但在怀孕期间观察到的持续差异 结局和围产期心理健康需要采取有意识的、创新的、包容性的、反种族主义的方法， 以传统的以权益为中心的 CCM 基础和中心来识别和缓解 SDoMH。 我们将利用为既定且成功的 pCCM 开发的现有临床算法和数据库 进行严格的阶梯楔形整群随机试验，以评估公平性增强的 PCCM 的效果 [COMPASS-PLUS（围产期抑郁症支持服务协作护理模式 – 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策略包 以广泛传播 PCCM 为目标的实施有效性设计。