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

NCT ID: NCT02169024

Last Updated: 2020-05-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 2402 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-02-28
• Study Completion Date: 2017-12-31

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)

Conditions

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Expect With Me group prenatal care

receiving prenatal care through an Expect With Me group

Group Type: EXPERIMENTAL

Expect With Me group prenatal care

Intervention Type: 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.

Individual Care Only

Standard of Care- individual prenatal care

Group Type: ACTIVE_COMPARATOR

Standard individual prenatal care

Intervention Type: OTHER

Standard of care- individual prenatal care

Interventions

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.

Intervention Type: BEHAVIORAL

Standard individual prenatal care

Standard of care- individual prenatal care

Intervention Type: OTHER

Other Intervention Names

group prenatal care; Individual Care Only

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

• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

United Health Foundation

UNKNOWN

Sponsor Role: collaborator

Yale University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jeannette R Ickovics, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Yale School of Public Health

Jessica B Lewis, PhD, MFT

Role: STUDY_DIRECTOR

Yale School of Public Health

Locations

Wayne State University

Detroit, Michigan, United States

Vanderbilt University Medical Center

Nashville, Tennessee, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 38439113 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 34678329 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 28521785 (View on PubMed)

Other Identifiers

1304011772

Identifier Type: -

Identifier Source: org_study_id