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.
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)
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
2,402
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.
Standard of care- individual prenatal care
Wayne State University
Detroit, Michigan, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
Risk of preterm birth incidence
Incidence risk of delivery before 37 weeks gestation
Time frame: up to 37 weeks gestation
Risk of low birth weight incidence
Incidence risk of infant weight at birth \< 2500 grams
Time frame: delivery
Risk of small for gestational age incidence
Incidence risk of infant weight below the 10th percentile for the gestational age at birth
Time frame: delivery
Risk of neonatal intensive care unit (NICU) admission incidence
Incidence risk of being admitted to the neonatal intensive care unit (NICU) at birth
Time frame: birth
breastfeeding
initiation and duration of breastfeeding
Time frame: 6 and 12 months postpartum
nutrition
nutritional choices, food security, and use of mindful eating practices
Time frame: 2nd and 3rd trimester of pregnancy and 6 and 12 months postpartum
physical activity
level of physical activity in a typical week
Time frame: 2nd and 3rd trimester and 6 and 12 months postpartum
readiness for labor and delivery
readiness for labor and delivery
Time frame: measured at 2nd and third trimester
readiness for taking care of baby
readiness for taking care of baby
Time frame: 2nd and 3rd trimester of pregnancy
social support
multidimensional scale of perceived social support subscale
Time frame: 2nd and 3rd trimester and 6 and 12 months postpartum
condom use self-efficacy
condom use self efficacy scale
Time frame: 2nd and 3rd trimester and 6 and 12 months postpartum
substance use
use of cigarettes, alcohol, and drugs
Time frame: 2nd and 3rd trimester and 6 and 12 months postpartum
care satisfaction
satisfaction with Expect With Me group prenatal care and use of program components
Time frame: 3rd trimester
adherence to medical recommendations
adherence to medical recommendations (e.g., 6-week postpartum check, pediatric visits, vaccinations, infant feeding)
Time frame: 6 & 12 months postpartum
postpartum body mass index
individual's body weight divided by the square of their height (kg/m2)
Time frame: measured at 6 and 12 months postpartum
maternal weight gain
weight gain as compared to medical recommendations
Time frame: measured at 2nd and 3rd trimester and birth
mode of delivery
mode of delivery (e.g., cesarean, vaginal)
Time frame: delivery
sexual risk: condom use
condom use percent (0-100%)
Time frame: measured at 2nd and 3rd trimester and 6 and 12 months postpartum
sexual risk: contraceptive use (LARC)
use of other contraceptives to prevent pregnancy (no/yes)
Time frame: measured at 2nd and 3rd trimester and 6 and 12 months postpartum
sexual risk: number of sexual partners
number of partners
Time frame: measured at 2nd and 3rd trimester and 6 and 12 months postpartum
sexual risk: sexually transmitted infection
sexually transmitted infection (no/yes, during pregnancy or incident postpartum)
Time frame: measured at 2nd and 3rd trimester and 6 and 12 months postpartum
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