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Development of a Nationally Scalable Model of Group Prenatal Care to Improve Birth Outcomes: "Expect With Me"

2020年5月27日 更新者:Yale University

This study addresses the intractable challenges of adverse birth outcomes, including preterm delivery and low birthweight, by proposing the development, implementation and evaluation of a model of group prenatal care that could be scaled nationally. Group prenatal care models have been demonstrated through rigorous research to provide significantly improved birth outcomes with implications for maternal-child health and substantial cost savings. However, group prenatal care is currently available to only a small fraction of the more than four million women who give birth annually in the US. Through the development, implementation and evaluation of a new model of group prenatal care, we will create an outcomes-focused model of group prenatal care that will be scalable nationally with an eye toward improving US birth outcomes.

The long-term objective of the proposed study is to reduce the risk for adverse perinatal outcomes during and after pregnancy among women and families receiving prenatal care in health centers in 3 geographic locations serving vulnerable populations: Hidalgo County Texas, Nashville Tennessee, and Detroit Michigan. We will develop, disseminate, and evaluate a new and improved model of group prenatal care, "Expect with Me," based on our previous research on group models of prenatal care, which has already yielded favorable behavioral and biological results in two randomized controlled trials.

We hypothesize that, relative to women who receive standard individual prenatal care, the women who receive "Expect with Me" group prenatal care will be significantly more likely to:

  1. have better perinatal outcomes, including better health behaviors during pregnancy (e.g., nutrition, physical activity), better birth outcomes (e.g., decreased preterm labor, low birthweight, Neonatal Intensive Care Unit stays), and better postpartum indicators (e.g., increased breastfeeding);
  2. report greater change in risk-related behaviors and psychosocial characteristics that could be considered potential mechanisms for the program's effectiveness;
  3. have lower rates of sexually transmitted diseases and rapid repeat pregnancy one year postpartum;
  4. have lower healthcare costs through improved outcomes (e.g., appropriate care utilization, fewer complications, reduced NICU admissions/length of stays)

Comparisons based on propensity-score matched sample of women receiving standard individual prenatal care at the same clinical sites.

研究概览

详细说明

This study addresses the intractable challenges of adverse birth outcomes, including preterm delivery and low birthweight, by proposing the development, implementation and evaluation of a model of group prenatal care that could be scaled nationally. Group prenatal care models have been demonstrated through rigorous research to provide significantly improved birth outcomes with implications for maternal-child health and substantial cost savings. However, group prenatal care is currently available to only a small fraction of the more than four million women who give birth annually in the US. Through the development, implementation and evaluation of a new model of group prenatal care, we will create an outcomes-focused model of group prenatal care that will be scalable nationally with an eye toward improving US birth outcomes.

Specific Aims:

The long-term objective of the proposed study is to reduce the risk for adverse perinatal outcomes during and after pregnancy among women and families receiving prenatal care in health centers in 3 geographic locations serving vulnerable populations: Hidalgo County Texas, Nashville Tennessee, and Detroit Michigan. We will develop, disseminate, and evaluate a new and improved model of group prenatal care, "Expect with Me," based on our previous research on group models of prenatal care, which has already yielded favorable behavioral and biological results in two randomized controlled trials. The overall objective of this project is to improve maternal health and reduce adverse birth outcomes. We will meet this objective by achieving three specific goals:

  1. Develop a new and improved model of group prenatal care, including curriculum, training materials, IT infrastructure and marketing materials to support broad adoption of group prenatal care, enhance consumer experience, monitor patient outcomes, and ensure national scalability.
  2. Implement group prenatal care in three communities at high risk for adverse perinatal outcomes (Hidalgo County TX, Nashville TN, Detroit MI), engaging and training providers in group facilitation and the established curriculum, engaging patients through improved in-reach and outreach strategies, and implementing IT infrastructure to improve uptake, patient experience, and sustainability through the monitoring of patient outcomes.
  3. Evaluate the effect of implementing group prenatal care through a rigorous process and outcome evaluation that identifies any barriers to national scalability and examines maternal health and birth outcomes and resultant cost implications.

Specific Study Hypotheses

We hypothesize that, relative to women who receive standard individual prenatal care, the women who receive "Expect with Me" group prenatal care will be significantly more likely to:

  1. have better perinatal outcomes, including better health behaviors during pregnancy (e.g., nutrition, physical activity), better birth outcomes (e.g., decreased preterm labor, low birthweight, Neonatal Intensive Care Unit stays), and better postpartum indicators (e.g., increased breastfeeding);
  2. report greater change in risk-related behaviors and psychosocial characteristics that could be considered potential mechanisms for the program's effectiveness;
  3. have lower rates of sexually transmitted diseases and rapid repeat pregnancy one year postpartum;
  4. have lower healthcare costs through improved outcomes (e.g., appropriate care utilization, fewer complications, reduced NICU admissions/length of stays)

研究类型

介入性

注册 (实际的)

2402

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • Michigan
      • Detroit、Michigan、美国、48201
        • Wayne State University
    • Tennessee
      • Nashville、Tennessee、美国、37232
        • Vanderbilt University Medical Center

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

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

是的

有资格学习的性别

女性

描述

Inclusion Criteria:

  • less than 24 weeks pregnant
  • able to attend groups conducted in English or Spanish
  • consent to share their data with the study

Exclusion Criteria:

  • severe medical problem requiring individual care only, as determined by the participating clinical practice

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:预防
  • 分配:非随机化
  • 介入模型:并行分配
  • 屏蔽:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
实验性的:Expect With Me group prenatal care
receiving prenatal care through an Expect With Me group
Expect With Me group prenatal care was designed based on: principles of group care; evidence from RCTs demonstrating improved birth outcomes; ACOG clinical guidelines; and research on patient and provider engagement through technology. Designed with national dissemination as a primary consideration, Expect With Me incorporates best evidence-based aspects of existing models of group care, with a novel IT platform to improve patient engagement and support, enhance health behaviors and decision making, connect providers and patients, and improve health service delivery. Expect With Me provides care to groups of 8-12 women of the same gestational age, implemented after initial individual assessment through delivery. Group visits are 90-120 minutes each, and follow a structured curriculum that incorporates standard content of prenatal care, and emphasizes critical health issues relevant to pregnancy, such as nutrition, physical activity, stress/mental health and sexual health.
其他名称:
  • group prenatal care
有源比较器:Individual Care Only
Standard of Care- individual prenatal care
Standard of care- individual prenatal care
其他名称:
  • Individual Care Only

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
Risk of preterm birth incidence
大体时间:up to 37 weeks gestation
Incidence risk of delivery before 37 weeks gestation
up to 37 weeks gestation
Risk of low birth weight incidence
大体时间:delivery
Incidence risk of infant weight at birth < 2500 grams
delivery
Risk of small for gestational age incidence
大体时间:delivery
Incidence risk of infant weight below the 10th percentile for the gestational age at birth
delivery
Risk of neonatal intensive care unit (NICU) admission incidence
大体时间:birth
Incidence risk of being admitted to the neonatal intensive care unit (NICU) at birth
birth

次要结果测量

结果测量
措施说明
大体时间
breastfeeding
大体时间:6 and 12 months postpartum
initiation and duration of breastfeeding
6 and 12 months postpartum
nutrition
大体时间:2nd and 3rd trimester of pregnancy and 6 and 12 months postpartum
nutritional choices, food security, and use of mindful eating practices
2nd and 3rd trimester of pregnancy and 6 and 12 months postpartum
physical activity
大体时间:2nd and 3rd trimester and 6 and 12 months postpartum
level of physical activity in a typical week
2nd and 3rd trimester and 6 and 12 months postpartum
readiness for labor and delivery
大体时间:measured at 2nd and third trimester
readiness for labor and delivery
measured at 2nd and third trimester
readiness for taking care of baby
大体时间:2nd and 3rd trimester of pregnancy
readiness for taking care of baby
2nd and 3rd trimester of pregnancy
social support
大体时间:2nd and 3rd trimester and 6 and 12 months postpartum
multidimensional scale of perceived social support subscale
2nd and 3rd trimester and 6 and 12 months postpartum
condom use self-efficacy
大体时间:2nd and 3rd trimester and 6 and 12 months postpartum
condom use self efficacy scale
2nd and 3rd trimester and 6 and 12 months postpartum
substance use
大体时间:2nd and 3rd trimester and 6 and 12 months postpartum
use of cigarettes, alcohol, and drugs
2nd and 3rd trimester and 6 and 12 months postpartum
care satisfaction
大体时间:3rd trimester
satisfaction with Expect With Me group prenatal care and use of program components
3rd trimester
adherence to medical recommendations
大体时间:6 & 12 months postpartum
adherence to medical recommendations (e.g., 6-week postpartum check, pediatric visits, vaccinations, infant feeding)
6 & 12 months postpartum
postpartum body mass index
大体时间:measured at 6 and 12 months postpartum
individual's body weight divided by the square of their height (kg/m2)
measured at 6 and 12 months postpartum
maternal weight gain
大体时间:measured at 2nd and 3rd trimester and birth
weight gain as compared to medical recommendations
measured at 2nd and 3rd trimester and birth
mode of delivery
大体时间:delivery
mode of delivery (e.g., cesarean, vaginal)
delivery
sexual risk: condom use
大体时间:measured at 2nd and 3rd trimester and 6 and 12 months postpartum
condom use percent (0-100%)
measured at 2nd and 3rd trimester and 6 and 12 months postpartum
sexual risk: contraceptive use (LARC)
大体时间:measured at 2nd and 3rd trimester and 6 and 12 months postpartum
use of other contraceptives to prevent pregnancy (no/yes)
measured at 2nd and 3rd trimester and 6 and 12 months postpartum
sexual risk: number of sexual partners
大体时间:measured at 2nd and 3rd trimester and 6 and 12 months postpartum
number of partners
measured at 2nd and 3rd trimester and 6 and 12 months postpartum
sexual risk: sexually transmitted infection
大体时间:measured at 2nd and 3rd trimester and 6 and 12 months postpartum
sexually transmitted infection (no/yes, during pregnancy or incident postpartum)
measured at 2nd and 3rd trimester and 6 and 12 months postpartum

其他结果措施

结果测量
措施说明
大体时间
nurse visitation
大体时间:2nd and 3rd trimester of pregnancy
participation in a nurse visitation program
2nd and 3rd trimester of pregnancy
sexual debut
大体时间:2nd trimester pregnancy
age at first intercourse
2nd trimester pregnancy
living situation
大体时间:2nd and 3rd trimester and 6 and 12 months postpartum
where and with whom they live with and the stability of their housing
2nd and 3rd trimester and 6 and 12 months postpartum
transfer of motivation
大体时间:2nd and3rd trimester and 6 and 12 months postpartum
relation of motivation for self and baby's health
2nd and3rd trimester and 6 and 12 months postpartum
confidence in parenting skills
大体时间:6 and 12 months postpartum
confidence in parenting skills
6 and 12 months postpartum
intimate partner violence
大体时间:measured at 2nd and 3rd trimester and 6 and 12 months postpartum
perpetration and victimization of violence by an intimate partner
measured at 2nd and 3rd trimester and 6 and 12 months postpartum
perceived stress
大体时间:2nd and 3rd trimester and 6 and 12 months postpartum
stress level as reported by patient
2nd and 3rd trimester and 6 and 12 months postpartum
depressive symptomatology
大体时间:2nd and 3rd trimester of pregnancy
patient endorsement of depressive symptoms
2nd and 3rd trimester of pregnancy
perceived discrimination
大体时间:2nd and 3rd trimester of pregnancy and 6 and 12 months postpartum
patient experiences of discrimination
2nd and 3rd trimester of pregnancy and 6 and 12 months postpartum
resilience
大体时间:2nd and 3rd trimester of pregnancy and 6 and 12 months postpartum
shift and persist scale
2nd and 3rd trimester of pregnancy and 6 and 12 months postpartum

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Jeannette R Ickovics, Ph.D.、Yale School of Public Health
  • 研究主任:Jessica B Lewis, PhD, MFT、Yale School of Public Health

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2014年2月1日

初级完成 (实际的)

2016年12月1日

研究完成 (实际的)

2017年12月1日

研究注册日期

首次提交

2014年6月18日

首先提交符合 QC 标准的

2014年6月19日

首次发布 (估计)

2014年6月20日

研究记录更新

最后更新发布 (实际的)

2020年5月29日

上次提交的符合 QC 标准的更新

2020年5月27日

最后验证

2020年5月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

药物和器械信息、研究文件

研究美国 FDA 监管的药品

研究美国 FDA 监管的设备产品

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