A randomized comparative-effectiveness study of two enhanced prenatal care models for low-income pregnant people: Engaging Mothers & Babies; Reimagining Antenatal Care for Everyone (EMBRACE)
Miriam Kuppermann , Alice Pressman , Kimberly Coleman-Phox , Patience Afulani , Bridgette Blebu , Kristin Carraway , Brittany Chambers Butcher , Venise Curry , Chris Downer , Brittany Edwards , Jennifer N. Felder , Jazmin Fontenot , Mary A. Garza , Deborah Karasek , Lauren Lessard , Erica Martinez , Charles E. McCulloch , Christy Oberholzer , Guadalupe R. Ramirez , Martha Tesfalul , Andrea Wiemann
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Abstract
Background
Improving perinatal mental health and care experiences and preventing adverse maternal and infant outcomes are essential prenatal care components, yet existing services often miss the mark, particularly for low-income populations. An enhanced group prenatal care program, “Glow! Group Prenatal Care and Support,” was developed in California's Central Valley in response to poor perinatal mental health, disrespectful care experiences, and high rates of adverse birth outcomes among families with low incomes.
Methods
Engaging Mothers & Babies; Reimagining Antenatal Care for Everyone (EMBRACE) is a pragmatic, two-arm, randomized, comparative-effectiveness study designed to assess depression (primary outcome), the experience of care (secondary outcome), and preterm birth (exploratory outcome) among Medi-Cal (California's Medicaid program)-eligible pregnant and birthing people, comparing those assigned to Glow! Group Prenatal Care and Support (Glow/GC) with those assigned to enhanced, individual prenatal care through the California Department of Public Health's Comprehensive Perinatal Services Program (CPSP/IC). Participating clinical practices offer the two comparators, alternating between comparators every 6 weeks, with the starting comparator randomized at the practice level. Participant-reported outcomes are assessed through interviewer-administered surveys at study entry, during the participant's third trimester, and at 3 months postpartum; preterm birth and other clinical outcomes are abstracted from labor and delivery records. Patient care experiences are further assessed in qualitative interviews. The protocol complies with the Standard Protocol Items for Randomized Trials.
Conclusions
This comparative-effectiveness study will be used to determine which of two forms of enhanced prenatal care is more effective, informing future decisions regarding their use.
背景：改善围产期心理健康和护理体验以及预防不良母婴结局是产前护理的重要组成部分，但现有的服务往往未能达到预期目标，尤其是对低收入人群而言。最近，一项名为 "Glow！集体产前护理和支持"，是针对低收入家庭围产期心理健康状况不佳、不尊重产妇的护理经历以及不良分娩结局发生率高的情况而在加利福尼亚中央山谷开发的：方法："让母亲和婴儿参与进来；为每个人重新构想产前护理"（EMBRACE）是一项务实、双臂、随机、比较效益研究，旨在评估符合医疗补助条件的孕妇和产妇的抑郁情况（主要结果）、护理体验（次要结果）和早产情况（探索性结果），并对分配到 "Glow.Group Prenatal Care and Support"（"Glow.Group Prenatal Care and Support"）的孕妇和产妇进行比较！集体产前护理和支持项目（Glow/GC）与通过加州公共卫生部的围产期综合服务项目（CPSP/IC）接受强化个人产前护理的人员进行比较。参与的临床实践提供两种比较方案，每 6 周交替使用比较方案，起始比较方案在实践层面进行随机分配。参与者报告的结果将在研究开始时、参与者怀孕三个月期间和产后 3 个月时通过访问者管理的调查进行评估；早产和其他临床结果将从分娩记录中提取。通过定性访谈进一步评估患者的护理经验。研究方案符合随机试验标准方案项目：这项比较效果研究将用于确定两种强化产前护理形式中哪一种更有效，为今后使用这两种护理形式提供参考：试验注册：ClinicalTrials.gov：NCT04154423.
期刊介绍：
Contemporary Clinical Trials is an international peer reviewed journal that publishes manuscripts pertaining to all aspects of clinical trials, including, but not limited to, design, conduct, analysis, regulation and ethics. Manuscripts submitted should appeal to a readership drawn from disciplines including medicine, biostatistics, epidemiology, computer science, management science, behavioural science, pharmaceutical science, and bioethics. Full-length papers and short communications not exceeding 1,500 words, as well as systemic reviews of clinical trials and methodologies will be published. Perspectives/commentaries on current issues and the impact of clinical trials on the practice of medicine and health policy are also welcome.
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