吸引母亲和婴儿;重新构想每个人的产前护理 (EMBRACE) 研究 (EMBRACE)
比较加强产前护理以改善加州中部妇幼健康的方法
研究概览
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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California
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Fresno、California、美国、93710
- Central Valley Health Policy Institute
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San Francisco、California、美国、94143
- UCSF
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参与标准
资格标准
适合学习的年龄
- 孩子
- 成人
- 年长者
接受健康志愿者
描述
纳入标准:
- 入组时妊娠 8 至 20 周
- 有资格享受 Medi-Cal(等于或低于联邦贫困线的 213%)
- 说英语或西班牙语
排除标准:
- 无法参加集体产前护理课程
- 不打算继续接受现场提供者的产前护理
- 不能合法同意参与研究
学习计划
研究是如何设计的?
设计细节
- 主要用途:卫生服务研究
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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有源比较器:辉光!团体产前护理
提供全方位服务的团体产前护理。
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辉光!是一种增强的团体产前护理模式,提供由已建立的社区计划提供的共同定位的社会服务,这些计划具有针对低收入家庭的独立资金流。
光辉!团体产前护理模式将训练有素的协调员与实践场所的持牌产前护理从业者配对,为诊所自己的患者提供收费的产前护理。
在 8-10 节课程中,10-12 名孕龄在 6 周内的妇女接受产前医疗、风险评估和社会支持,并获得与怀孕、分娩和育儿相关的知识和技能。
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有源比较器:个人产前护理 - CPSP
CPSP 承保的带有补充服务的个人产前护理。
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综合围产期服务计划 (CPSP) 是一项由国家资助的计划,旨在帮助符合 Medi-Cal 资格的家庭获得更好的护理和服务协调。
被分配到 CPSP 个人护理的参与者可以在其产前护理站点与综合围产期卫生工作者一起参加 CPSP 评估,在那里将提供个人产前护理
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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患者健康调查问卷 (PHQ-9) 分数的变化
大体时间:从研究注册到产后三个月收集
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从基线到产后抑郁症状严重程度的变化。
使用患者健康问卷 (PHQ-9) 进行评估,在基线时亲自进行,并在产后三个月进行电话访谈。
总分范围为0-27,分数越高表明抑郁症越严重。
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从研究注册到产后三个月收集
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Person-centered Prenatal Care
大体时间:Collected during third trimester
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This outcome focuses on the extent to which the participants feels their prenatal care was person centered. The title of the measure is Person Centered Prenatal Care (primary). This measurement tool is a questionnaire that includes series of items that were developed in collaboration with community members to measure their experience of care. In addition to the overall score, the scale includes three subscales identified as important by community members: dignity and respect, communication and autonomy, and responsive and supportive care. The measures have been validated in several languages. The total scores range from 0-100 with higher scores indicating the receipt of more person centered care. |
Collected during third trimester
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Preterm Birth
大体时间:0-12 weeks after delivery
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Whether the participant had a baby born less than 37 weeks gestation, as noted in the participant's medical record.
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0-12 weeks after delivery
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Changes in Anxiety Symptom Severity
大体时间:Collected from study enrollment to three months postpartum
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Changes in anxiety symptom severity from baseline to postpartum. Assessed using the 7-item Generalized Anxiety Disorder (GAD-7) scale, administered in-person at baseline and during telephone interview at three months postpartum. The total scores range from 0-21 with higher scores indicating more severe anxiety. |
Collected from study enrollment to three months postpartum
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Perceptions of Respectful/Disrespectful Maternity Care
大体时间:Collected at three months postpartum
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Extent to which the participant feels that the maternity care they received was respectful. Assessed using the Mothers on Respect Index (MORi), administered during telephone interview or in-person at three months postpartum. The total scores range from 14-100 with higher scores indicating a higher level of respect. |
Collected at three months postpartum
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Satisfaction With Prenatal Care
大体时间:Collected during third trimester
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Extent to which the participant feels satisfied with the prenatal care they received. Assessed using the Prenatal Care Satisfaction Scale, administered during telephone interview or in-person interview at third trimester. The total scores range from 0-100 with higher scores indicating higher levels of satisfaction. |
Collected during third trimester
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Gestational Age at Delivery
大体时间:0-12 weeks after delivery
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The gestation age at which the baby was born (number of weeks), as noted in the participant's medical record.
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0-12 weeks after delivery
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Person Centered Maternity Care
大体时间:3 months postpartum
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Extent to which birthing person feels their prenatal and birthing experience was person centered, as measured by the Person-Centered Maternity Care scale. This measure focuses on the extent to which the participants feels their prenatal and maternity/birthing care was person centered. The title of the measure is Person Centered Maternity Care. This measurement tool is a questionnaire that includes series of items that were developed in collaboration with community members to measure their experience of care. In addition to the overall score, the scale includes three subscales identified as important by community members: dignity and respect, communication and autonomy, and responsive and supportive care. The measures have been validated in several languages. The total scores range from 0-100 with higher scores indicating the receipt of more person centered care. |
3 months postpartum
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合作者和调查者
调查人员
- 首席研究员:Miriam Kuppermann, PhD, MPH、University of California, San Francisco
出版物和有用的链接
一般刊物
- Kroenke K, Spitzer RL, Williams JB. The PHQ-9: validity of a brief depression severity measure. J Gen Intern Med. 2001 Sep;16(9):606-13. doi: 10.1046/j.1525-1497.2001.016009606.x.
- Spitzer RL, Kroenke K, Williams JB, Lowe B. A brief measure for assessing generalized anxiety disorder: the GAD-7. Arch Intern Med. 2006 May 22;166(10):1092-7. doi: 10.1001/archinte.166.10.1092.
- Raube K, Handler A, Rosenberg D. Measuring satisfaction among low-income women: a prenatal care questionnaire. Matern Child Health J. 1998 Mar;2(1):25-33. doi: 10.1023/a:1021841508698.
- Vedam S, Stoll K, Rubashkin N, Martin K, Miller-Vedam Z, Hayes-Klein H, Jolicoeur G; CCinBC Steering Council. The Mothers on Respect (MOR) index: measuring quality, safety, and human rights in childbirth. SSM Popul Health. 2017 Jan 19;3:201-210. doi: 10.1016/j.ssmph.2017.01.005. eCollection 2017 Dec.
- Peek ME, Nunez-Smith M, Drum M, Lewis TT. Adapting the everyday discrimination scale to medical settings: reliability and validity testing in a sample of African American patients. Ethn Dis. 2011 Autumn;21(4):502-9.
- Krieger N, Smith K, Naishadham D, Hartman C, Barbeau EM. Experiences of discrimination: validity and reliability of a self-report measure for population health research on racism and health. Soc Sci Med. 2005 Oct;61(7):1576-96. doi: 10.1016/j.socscimed.2005.03.006. Epub 2005 Apr 21.
- Afulani PA, Leon-Martinez D, Carraway K, Curry VC, Chambers Butcher BD, Simard B, Blat C, Coleman-Phox K, Blebu BE, Felder JN, Karasek D, Tesfalul MA, Garza MA, Mcculloch CE, Kuppermann M. Comparative Effect of Two Enhanced Prenatal Care Models on Care Experiences: A Randomized Controlled Trial. Obstet Gynecol. 2026 Jul 1;148(1):121-131. doi: 10.1097/AOG.0000000000006237. Epub 2026 Mar 12.
- Felder JN, Leon-Martinez D, Karasek D, Curry V, Carraway K, Afulani PA, Blebu B, Chambers-Butcher B, Coleman-Phox K, Simard BJ, Blat C, Garza MA, McCulloch CE, Kuppermann M. Enhanced Prenatal Care Models and Postpartum Depression: The EMBRACE Randomized Clinical Trial. JAMA Netw Open. 2026 Feb 2;9(2):e2559883. doi: 10.1001/jamanetworkopen.2025.59883.
- Kuppermann M, Pressman A, Coleman-Phox K, Afulani P, Blebu B, Carraway K, Butcher BC, Curry V, Downer C, Edwards B, Felder JN, Fontenot J, Garza MA, Karasek D, Lessard L, Martinez E, McCulloch CE, Oberholzer C, Ramirez GR, Tesfalul M, Wiemann A. 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). Contemp Clin Trials. 2024 Aug;143:107568. doi: 10.1016/j.cct.2024.107568. Epub 2024 May 14.
- Felder JN, Afulani PA, Coleman-Phox K, Omowale SS, McCulloch CE, Lessard L, Kuppermann M. Pregnancy-related COVID worry, depressive symptom severity, and mediation through sleep disturbance in a low-income, primarily Latinx population in California's Central valley. J Psychiatr Res. 2023 Jan;157:96-103. doi: 10.1016/j.jpsychires.2022.11.019. Epub 2022 Nov 23.
- Keeton VF, Leon-Martinez D, Robles DC, Martinez E, Lessard L, Garza MA, Kuppermann M, Chambers Butcher BD. Latina Women's Perinatal Experiences and Perspectives Around Discrimination, Anti-immigrant Policies, and Community Violence. J Obstet Gynecol Neonatal Nurs. 2024 Nov;53(6):635-647.e1. doi: 10.1016/j.jogn.2024.07.007. Epub 2024 Sep 7.
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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