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

NCT02169024 | Completed

• 1 other identifier: 1304011772
• Study Type: interventional
• Target: 2,402
• Locations: 1 country
• Sites: 2

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. 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. 2.report greater change in risk-related behaviors and psychosocial characteristics that could be considered potential mechanisms for the program's effectiveness;
3. 3.have lower rates of sexually transmitted diseases and rapid repeat pregnancy one year postpartum;
4. 4.have lower healthcare costs through improved outcomes (e.g., appropriate care utilization, fewer complications, reduced NICU admissions/length of stays)

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

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (17)

• breastfeeding

  6 and 12 months postpartum

• nutrition

  2nd and 3rd trimester of pregnancy and 6 and 12 months postpartum

• physical activity

  2nd and 3rd trimester and 6 and 12 months postpartum

• readiness for labor and delivery

  measured at 2nd and third trimester

• readiness for taking care of baby

  2nd and 3rd trimester of pregnancy

Other Outcomes (10)

• nurse visitation

  2nd and 3rd trimester of pregnancy

• sexual debut

  2nd trimester pregnancy

• living situation

  2nd and 3rd trimester and 6 and 12 months postpartum

Study Arms (2)

Expect With Me group prenatal care

EXPERIMENTAL

receiving prenatal care through an Expect With Me group

Behavioral: Expect With Me group prenatal care

Individual Care Only

ACTIVE COMPARATOR

Standard of Care- individual prenatal care

Other: Standard individual prenatal care

Interventions

Expect With Me group prenatal care BEHAVIORAL

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.

Also known as: group prenatal care

Expect With Me group prenatal care

Standard individual prenatal care OTHER

Standard of care- individual prenatal care

Also known as: Individual Care Only

Individual Care Only

Eligibility Criteria

• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• less than 24 weeks pregnant
• able to attend groups conducted in English or Spanish
• consent to share their data with the study

You may not qualify if:

• severe medical problem requiring individual care only, as determined by the participating clinical practice

Sponsors & Collaborators

• Yale University: lead
• United Health Foundation: collaborator

Study Sites (2)

Wayne State University

Detroit, Michigan, 48201, United States

Location

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

Related Publications (3)

• Masters C, Carandang RR, Lewis JB, Hagaman A, Metrick R, Ickovics JR, Cunningham SD. Group prenatal care successes, challenges, and frameworks for scaling up: a case study in adopting health care innovations. Implement Sci Commun. 2024 Mar 4;5(1):20. doi: 10.1186/s43058-024-00556-1.

  PMID: 38439113 DERIVED

• 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.

  PMID: 34678329 DERIVED

• 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.

  PMID: 28521785 DERIVED

MeSH Terms

Conditions

Premature Birth; Sexually Transmitted Diseases

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Communicable Diseases; Infections; Genital Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Jeannette R Ickovics, Ph.D.

  Yale School of Public Health

  PRINCIPAL INVESTIGATOR

• Jessica B Lewis, PhD, MFT

  Yale School of Public Health

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Expect With Me group prenatal care vs. Individual Care Only prenatal care

Study Record Dates

• First Submitted: June 18, 2014
• First Posted: June 20, 2014
• Study Start: February 1, 2014
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2017
• Last Updated: May 29, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)