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

Study Overview
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Brief Summary
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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.

Detailed Description
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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 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)

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

Conditions
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Pregnancy, Premature Birth, Infant, Low Birth Weight, Postpartum Period, Sexually Transmitted Diseases

Intervention / Treatment
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* Behavioral: Expect With Me group prenatal care
* Other: Standard individual prenatal care


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Expect With Me group prenatal care vs. Individual Care Only prenatal care
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Expect With Me group prenatal care<br>receiving prenatal care through an Expect With Me group | Behavioral: Expect With Me group prenatal care<br>* 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.<br>* Other names: group prenatal care;|
| Active Comparator: Individual Care Only<br>Standard of Care- individual prenatal care | Other: Standard individual prenatal care<br>* Standard of care- individual prenatal care<br>* Other names: Individual Care Only;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Risk of preterm birth incidence | Incidence risk of delivery before 37 weeks gestation | up to 37 weeks gestation | 
| Risk of low birth weight incidence | Incidence risk of infant weight at birth < 2500 grams | delivery | 
| Risk of small for gestational age incidence | 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 | Incidence risk of being admitted to the neonatal intensive care unit (NICU) at birth | birth | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| breastfeeding | initiation and duration of breastfeeding | 6 and 12 months postpartum | 
| nutrition | nutritional choices, food security, and use of mindful eating practices | 2nd and 3rd trimester of pregnancy and 6 and 12 months postpartum | 
| physical activity | level of physical activity in a typical week | 2nd and 3rd trimester and 6 and 12 months postpartum | 
| readiness for labor and delivery | readiness for labor and delivery | measured at 2nd and third trimester | 
| readiness for taking care of baby | readiness for taking care of baby | 2nd and 3rd trimester of pregnancy | 
| social support | multidimensional scale of perceived social support subscale | 2nd and 3rd trimester and 6 and 12 months postpartum | 
| condom use self-efficacy | condom use self efficacy scale | 2nd and 3rd trimester and 6 and 12 months postpartum | 
| substance use | use of cigarettes, alcohol, and drugs | 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 | 3rd trimester | 
| adherence to medical recommendations | adherence to medical recommendations (e.g., 6-week postpartum check, pediatric visits, vaccinations, infant feeding) | 6 & 12 months postpartum | 
| postpartum body mass index | individual's body weight divided by the square of their height (kg/m2) | measured at 6 and 12 months postpartum | 
| maternal weight gain | weight gain as compared to medical recommendations | measured at 2nd and 3rd trimester and birth | 
| mode of delivery | mode of delivery (e.g., cesarean, vaginal) | delivery | 
| sexual risk: condom use | condom use percent (0-100%) | 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) | measured at 2nd and 3rd trimester and 6 and 12 months postpartum | 
| sexual risk: number of sexual partners | number of partners | 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) | measured at 2nd and 3rd trimester and 6 and 12 months postpartum | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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prenatal care, group care, Expect With Me, evaluation studies, group prenatal care