Development of a Nationally Scalable Model of Group Prenatal Care to Improve Birth Outcomes: "Expect With Me"
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 2,402
- 试验地点
- 4
- 主要终点
- Risk of low birth weight incidence
研究概览
简要总结
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:
- 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);
- report greater change in risk-related behaviors and psychosocial characteristics that could be considered potential mechanisms for the program's effectiveness;
- have lower rates of sexually transmitted diseases and rapid repeat pregnancy one year postpartum;
- 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.
详细描述
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:
- 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.
- 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.
- 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
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •less than 24 weeks pregnant
- •able to attend groups conducted in English or Spanish
- •consent to share their data with the study
排除标准
- •severe medical problem requiring individual care only, as determined by the participating clinical practice
结局指标
主要结局
Risk of low birth weight incidence
时间窗: delivery
Incidence risk of infant weight at birth \< 2500 grams
Risk of preterm birth incidence
时间窗: up to 37 weeks gestation
Incidence risk of delivery before 37 weeks gestation
Risk of neonatal intensive care unit (NICU) admission incidence
时间窗: birth
Incidence risk of being admitted to the neonatal intensive care unit (NICU) at birth
Risk of small for gestational age incidence
时间窗: delivery
Incidence risk of infant weight below the 10th percentile for the gestational age at birth
次要结局
- breastfeeding(6 and 12 months postpartum)
- care satisfaction(3rd trimester)
- nutrition(2nd and 3rd trimester of pregnancy and 6 and 12 months postpartum)
- physical activity(2nd and 3rd trimester and 6 and 12 months postpartum)
- maternal weight gain(measured at 2nd and 3rd trimester and birth)
- mode of delivery(delivery)
- adherence to medical recommendations(6 & 12 months postpartum)
- postpartum body mass index(measured at 6 and 12 months postpartum)
- sexual risk: condom use(measured at 2nd and 3rd trimester and 6 and 12 months postpartum)
- sexual risk: contraceptive use (LARC)(measured at 2nd and 3rd trimester and 6 and 12 months postpartum)
- sexual risk: number of sexual partners(measured at 2nd and 3rd trimester and 6 and 12 months postpartum)
- readiness for labor and delivery(measured at 2nd and third trimester)
- readiness for taking care of baby(2nd and 3rd trimester of pregnancy)
- social support(2nd and 3rd trimester and 6 and 12 months postpartum)
- condom use self-efficacy(2nd and 3rd trimester and 6 and 12 months postpartum)
- substance use(2nd and 3rd trimester and 6 and 12 months postpartum)
- sexual risk: sexually transmitted infection(measured at 2nd and 3rd trimester and 6 and 12 months postpartum)