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

Overview

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.

Full Title of Study: “Development of a Nationally Scalable Model of Group Prenatal Care to Improve Birth Outcomes: “Expect With Me”"

Study Type

  • Study Type: Interventional
  • Study Design
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Prevention
    • Masking: None (Open Label)
  • Study Primary Completion Date: May 2017

Detailed Description

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)

Interventions

  • Behavioral: Expect With Me group prenatal care
    • 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.

Arms, Groups and Cohorts

  • Experimental: Expect With Me group prenatal care
    • receiving prenatal care through an Expect With Me group

Clinical Trial Outcome Measures

Primary Measures

  • preterm birth
    • Time Frame: up to 37 weeks gestation
    • delivery before 37 weeks gestation
  • birth weight
    • Time Frame: delivery
    • infant weight (in grams) at birth
  • small for gestational age
    • Time Frame: delivery
    • infant weight below the 10th percentile for the gestational age at birth
  • neonatal intensive care unit (NICU) admission and duration of stay
    • Time Frame: birth
    • neonatal intensive care unit (NICU) admission and duration of stay and reason for admission

Secondary Measures

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

Participating in This Clinical Trial

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

Gender Eligibility: Female

Minimum Age: N/A

Maximum Age: N/A

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Yale University
  • Collaborator
    • United Health Foundation
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Jeannette R Ickovics, Ph.D., Principal Investigator, Yale School of Public Health
    • Jessica B Lewis, MFT, Study Director, Yale School of Public Health

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