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

Pregnancy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02169024
• Other study ID #: 1304011772
• Status: Completed
• Phase: N/A
• Start date: February 2014
• Est. completion date: December 2017

Study information

• Verified date: May 2020
• Source: Yale University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2402
• Est. completion date: December 2017
• Est. primary completion date: December 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

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.

Other:
• Standard individual prenatal care
Standard of care- individual prenatal care

Locations

Country	Name	City	State
United States	Wayne State University	Detroit	Michigan
United States	Vanderbilt University Medical Center	Nashville	Tennessee

Sponsors (2)

Lead Sponsor	Collaborator
Yale University	United Health Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	nurse visitation	participation in a nurse visitation program	2nd and 3rd trimester of pregnancy
Other	sexual debut	age at first intercourse	2nd trimester pregnancy
Other	living situation	where and with whom they live with and the stability of their housing	2nd and 3rd trimester and 6 and 12 months postpartum
Other	transfer of motivation	relation of motivation for self and baby's health	2nd and3rd trimester and 6 and 12 months postpartum
Other	confidence in parenting skills	confidence in parenting skills	6 and 12 months postpartum
Other	intimate partner violence	perpetration and victimization of violence by an intimate partner	measured at 2nd and 3rd trimester and 6 and 12 months postpartum
Other	perceived stress	stress level as reported by patient	2nd and 3rd trimester and 6 and 12 months postpartum
Other	depressive symptomatology	patient endorsement of depressive symptoms	2nd and 3rd trimester of pregnancy
Other	perceived discrimination	patient experiences of discrimination	2nd and 3rd trimester of pregnancy and 6 and 12 months postpartum
Other	resilience	shift and persist scale	2nd and 3rd trimester of pregnancy and 6 and 12 months postpartum
Primary	Risk of preterm birth incidence	Incidence risk of delivery before 37 weeks gestation	up to 37 weeks gestation
Primary	Risk of low birth weight incidence	Incidence risk of infant weight at birth < 2500 grams	delivery
Primary	Risk of small for gestational age incidence	Incidence risk of infant weight below the 10th percentile for the gestational age at birth	delivery
Primary	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	breastfeeding	initiation and duration of breastfeeding	6 and 12 months postpartum
Secondary	nutrition	nutritional choices, food security, and use of mindful eating practices	2nd and 3rd trimester of pregnancy and 6 and 12 months postpartum
Secondary	physical activity	level of physical activity in a typical week	2nd and 3rd trimester and 6 and 12 months postpartum
Secondary	readiness for labor and delivery	readiness for labor and delivery	measured at 2nd and third trimester
Secondary	readiness for taking care of baby	readiness for taking care of baby	2nd and 3rd trimester of pregnancy
Secondary	social support	multidimensional scale of perceived social support subscale	2nd and 3rd trimester and 6 and 12 months postpartum
Secondary	condom use self-efficacy	condom use self efficacy scale	2nd and 3rd trimester and 6 and 12 months postpartum
Secondary	substance use	use of cigarettes, alcohol, and drugs	2nd and 3rd trimester and 6 and 12 months postpartum
Secondary	care satisfaction	satisfaction with Expect With Me group prenatal care and use of program components	3rd trimester
Secondary	adherence to medical recommendations	adherence to medical recommendations (e.g., 6-week postpartum check, pediatric visits, vaccinations, infant feeding)	6 & 12 months postpartum
Secondary	postpartum body mass index	individual's body weight divided by the square of their height (kg/m2)	measured at 6 and 12 months postpartum
Secondary	maternal weight gain	weight gain as compared to medical recommendations	measured at 2nd and 3rd trimester and birth
Secondary	mode of delivery	mode of delivery (e.g., cesarean, vaginal)	delivery
Secondary	sexual risk: condom use	condom use percent (0-100%)	measured at 2nd and 3rd trimester and 6 and 12 months postpartum
Secondary	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
Secondary	sexual risk: number of sexual partners	number of partners	measured at 2nd and 3rd trimester and 6 and 12 months postpartum
Secondary	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