Clinical trial NCT02169024: Development of a Nationally Scalable Model of Group Prenatal Care to Improve Birth Outcomes: "Expect With Me"
Official title: Development of a Nationally Scalable Model of Group Prenatal Care to Improve Birth Outcomes: "Expect With Me"
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pregnancy
Premature Birth
Infant, Low Birth Weight
Postpartum Period
Sexually Transmitted Diseases
Keywords: prenatal care
group care
Expect With Me
evaluation studies
group prenatal care
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: United Health Foundation
First posted: 2014-06-20
Enrollment: 2402
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Expect With Me group prenatal care vs. Individual Care Only prenatal care
Primary purpose: PREVENTION

Brief summary: 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.

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)

Eligibility criteria: 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

Primary outcomes:
measure: Risk of preterm birth incidence
timeFrame: up to 37 weeks gestation
measure: Risk of low birth weight incidence
timeFrame: delivery
measure: Risk of small for gestational age incidence
timeFrame: delivery
measure: Risk of neonatal intensive care unit (NICU) admission incidence
timeFrame: birth
Secondary outcomes:
measure: breastfeeding
timeFrame: 6 and 12 months postpartum
measure: nutrition
timeFrame: 2nd and 3rd trimester of pregnancy and 6 and 12 months postpartum
measure: physical activity
timeFrame: 2nd and 3rd trimester and 6 and 12 months postpartum
measure: readiness for labor and delivery
timeFrame: measured at 2nd and third trimester
measure: readiness for taking care of baby
timeFrame: 2nd and 3rd trimester of pregnancy
measure: social support
timeFrame: 2nd and 3rd trimester and 6 and 12 months postpartum
measure: condom use self-efficacy
timeFrame: 2nd and 3rd trimester and 6 and 12 months postpartum
measure: substance use
timeFrame: 2nd and 3rd trimester and 6 and 12 months postpartum
measure: care satisfaction
timeFrame: 3rd trimester
measure: adherence to medical recommendations
timeFrame: 6 & 12 months postpartum
measure: postpartum body mass index
timeFrame: measured at 6 and 12 months postpartum
measure: maternal weight gain
timeFrame: measured at 2nd and 3rd trimester and birth
measure: mode of delivery
timeFrame: delivery
measure: sexual risk: condom use
timeFrame: measured at 2nd and 3rd trimester and 6 and 12 months postpartum
measure: sexual risk: contraceptive use (LARC)
timeFrame: measured at 2nd and 3rd trimester and 6 and 12 months postpartum
measure: sexual risk: number of sexual partners
timeFrame: measured at 2nd and 3rd trimester and 6 and 12 months postpartum
measure: sexual risk: sexually transmitted infection
timeFrame: measured at 2nd and 3rd trimester and 6 and 12 months postpartum
Other outcomes:
measure: nurse visitation
timeFrame: 2nd and 3rd trimester of pregnancy
measure: sexual debut
timeFrame: 2nd trimester pregnancy
measure: living situation
timeFrame: 2nd and 3rd trimester and 6 and 12 months postpartum
measure: transfer of motivation
timeFrame: 2nd and3rd trimester and 6 and 12 months postpartum
measure: confidence in parenting skills
timeFrame: 6 and 12 months postpartum
measure: intimate partner violence
timeFrame: measured at 2nd and 3rd trimester and 6 and 12 months postpartum
measure: perceived stress
timeFrame: 2nd and 3rd trimester and 6 and 12 months postpartum
measure: depressive symptomatology
timeFrame: 2nd and 3rd trimester of pregnancy
measure: perceived discrimination
timeFrame: 2nd and 3rd trimester of pregnancy and 6 and 12 months postpartum
measure: resilience
timeFrame: 2nd and 3rd trimester of pregnancy and 6 and 12 months postpartum
Locations:
city: Detroit
country: United States
facility: Wayne State University
state: Michigan
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
Study officials:
affiliation: Yale School of Public Health
name: Jeannette R Ickovics, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Yale School of Public Health
name: Jessica B Lewis, PhD, MFT
role: STUDY_DIRECTOR
References:
citation: Lewis JB, Cunningham SD, Shabanova V, Hassan SS, Magriples U, Rodriguez MG, Ickovics JR. Group prenatal care and improved birth outcomes: Results from a type 1 hybrid effectiveness-implementation study. Prev Med. 2021 Dec;153:106853. doi: 10.1016/j.ypmed.2021.106853. Epub 2021 Oct 20.
citation: Cunningham SD, Lewis JB, Thomas JL, Grilo SA, Ickovics JR. Expect With Me: development and evaluation design for an innovative model of group prenatal care to improve perinatal outcomes. BMC Pregnancy Childbirth. 2017 May 18;17(1):147. doi: 10.1186/s12884-017-1327-3.