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



Status:Recruiting
Conditions:Infectious Disease, Women's Studies, Women's Studies
Therapuetic Areas:Immunology / Infectious Diseases, Reproductive
Healthy:No
Age Range:Any
Updated:4/21/2016
Start Date:February 2014
End Date:December 2016
Contact:Jeannette R Ickovics, Ph.D.
Email:jeannette.ickovics@yale.edu
Phone:203-785-6213

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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:

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)

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)

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
We found this trial at
3
sites
5050 Anthony Wayne Dr
Detroit, Michigan 48201
(313) 577-2424
Principal Investigator: Sonia Hassan, MD
Wayne State University Founded in 1868, Wayne State University is a nationally recognized metropolitan research...
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Detroit, MI
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1211 Medical Center Dr
Nashville, Tennessee 37232
(615) 322-5000
Vanderbilt Univ Med Ctr Vanderbilt University Medical Center (VUMC) is a comprehensive healthcare facility dedicated...
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Nashville, TN
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Edinburg, Texas 78539
Principal Investigator: Efraim Vela, MD
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Edinburg, TX
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