Engaging Mothers & Babies; Reimagining Antenatal Care for Everyone (EMBRACE) Study (EMBRACE)

Comparing Approaches to Enhanced Prenatal Care to Improve Maternal and Child Health in Central CA

This is a randomized comparative effectiveness study of two forms of enhanced prenatal care among 2,600 Medi-Cal eligible pregnant women in Fresno, California. The goal is to see whether group prenatal care with wrap around services versus individual prenatal care supplemented by services covered by the California Department of Public Health Comprehensive Perinatal Services Program (CPSP) results in lower rates of preterm birth, less depression and anxiety, and more respectful and greater satisfaction with prenatal care.

Study Overview

• Status: Recruiting
• Conditions: Premature Birth; Depression, Postpartum; Satisfaction, Patient; Depression, Anxiety; Pregnancy Preterm; Prenatal Stress; Health Problems in Pregnancy
• Intervention / Treatment: Other: Glow! Group Prenatal Care; Other: Individual Prenatal Care with CPSP

• Study Type: Interventional
• Enrollment (Anticipated): 2600
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Miriam Kuppermann, PhD, MPH; Phone Number: (415) 502-4089; Email: miriam.kuppermann@ucsf.edu
• Study Contact Backup: Name: Lauren Lessard, PhD, MPH; Email: llessard@csufresno.edu

Study Locations

• United States
  • California
    • Fresno, California, United States, 93710
      • Recruiting
      • Central Valley Health Policy Institute
      • Contact: Mary Garza, PhD; Email: magarza@csufresno.edu
      • Contact: Miriam Kuppermann, PhD, MPH; Email: miriam.kuppermann@ucsf.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Between 8 and 20 weeks gestation at enrollment
• Eligible for Medi-Cal (at or below 213% of the federal poverty level)
• Speak English or Spanish

Exclusion Criteria:

• Unavailable to attend group prenatal care sessions
• Not planning to continue prenatal care with site provider
• Cannot legally consent to participate in the study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Glow! Group Prenatal Care; Group prenatal care with wrap around services.	Other: Glow! Group Prenatal Care; Glow! is an enhanced group prenatal care model that offers co-located social services provided by established community programs with independent funding streams targeting low-income families. The Glow! group prenatal care model pairs a trained facilitator with a licensed prenatal care practitioner from a practice site to provide billable prenatal care to the practice's own patients. Over the course of 8-10 sessions, 10-12 women (within a 6- week gestational age range) receive prenatal medical care, risk assessments, and social support, and gain knowledge and skills related to pregnancy, birth, and parenting.
Active Comparator: Individual Prenatal Care- CPSP; Individual prenatal care with supplemental services covered by CPSP.	Other: Individual Prenatal Care with CPSP; Comprehensive Perinatal Services Program (CPSP) is a state-funded program for Medi-Cal eligible families to receive enhanced care and service coordination. Participants assigned to CPSP individual care may participate in the CPSP assessments with a Comprehensive Perinatal Health Worker at their prenatal care site, where individual prenatal care will be provided

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Preterm birth	Whether the participant had a baby born less than 37 weeks gestation, as noted in the participant's medical record.	0-12 weeks after delivery
Changes in depressive symptom severity	Changes in depressive symptom severity from baseline to postpartum. Assessed using the Patient Health Questionnaire (PHQ-9) developed by Kroenke et al. (2001), administered in-person at baseline and during telephone interview at three months postpartum.	Collected from study enrollment to three months postpartum
Perceptions of respectful/disrespectful care	Extent to which the participant feels that the prenatal care they received was respectful. Assessed using the Mothers on Respect Index (MORi) developed by Vedam et al. (2017), administered during telephone interview or in-person at third trimester and three months postpartum.	Collected during third trimester and at three months postpartum

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Gestational age at delivery	The gestation age at which the baby was born (number of weeks), as noted in the participant's medical record.	0-12 weeks after delivery
Changes in anxiety symptom severity	Changes in anxiety symptom severity from baseline to postpartum. Assessed using the 7-item Generalized Anxiety Disorder (GAD-7) scale developed by Spitzer et al. (2006), administered in-person at baseline and during telephone interview at three months postpartum.	Collected from study enrollment to three months postpartum
Satisfaction with prenatal care	Extent to which the participant feels satisfied with the prenatal care they received. Assessed using the Prenatal Care Satisfaction (PSQ) Scale developed by Raube et al. (1998), administered during telephone interview or in-person interview at third trimester and three months postpartum.	Collected during third trimester and at three months postpartum

Collaborators and Investigators

• Sponsor: University of California, San Francisco
• Collaborators: Patient-Centered Outcomes Research Institute; California State University, Fresno Foundation
• Investigators: Principal Investigator: Miriam Kuppermann, PhD, MPH, University of California, San Francisco; Principal Investigator: Lauren Lessard, PhD, MPH, California State University, Fresno

Publications and helpful links

General Publications

• Kroenke K, Spitzer RL, Williams JB. The PHQ-9: validity of a brief depression severity measure. J Gen Intern Med. 2001 Sep;16(9):606-13. doi: 10.1046/j.1525-1497.2001.016009606.x.
• Spitzer RL, Kroenke K, Williams JB, Lowe B. A brief measure for assessing generalized anxiety disorder: the GAD-7. Arch Intern Med. 2006 May 22;166(10):1092-7. doi: 10.1001/archinte.166.10.1092.
• Raube K, Handler A, Rosenberg D. Measuring satisfaction among low-income women: a prenatal care questionnaire. Matern Child Health J. 1998 Mar;2(1):25-33. doi: 10.1023/a:1021841508698.
• Vedam S, Stoll K, Rubashkin N, Martin K, Miller-Vedam Z, Hayes-Klein H, Jolicoeur G; CCinBC Steering Council. The Mothers on Respect (MOR) index: measuring quality, safety, and human rights in childbirth. SSM Popul Health. 2017 Jan 19;3:201-210. doi: 10.1016/j.ssmph.2017.01.005. eCollection 2017 Dec.
• Peek ME, Nunez-Smith M, Drum M, Lewis TT. Adapting the everyday discrimination scale to medical settings: reliability and validity testing in a sample of African American patients. Ethn Dis. 2011 Autumn;21(4):502-9.
• Krieger N, Smith K, Naishadham D, Hartman C, Barbeau EM. Experiences of discrimination: validity and reliability of a self-report measure for population health research on racism and health. Soc Sci Med. 2005 Oct;61(7):1576-96. doi: 10.1016/j.socscimed.2005.03.006. Epub 2005 Apr 21.

Study record dates

Study Major Dates

• Study Start (Actual): November 7, 2019
• Primary Completion (Anticipated): September 30, 2024
• Study Completion (Anticipated): September 30, 2024

Study Registration Dates

• First Submitted: October 31, 2019
• First Submitted That Met QC Criteria: November 4, 2019
• First Posted (Actual): November 6, 2019

Study Record Updates

• Last Update Posted (Estimate): May 11, 2023
• Last Update Submitted That Met QC Criteria: May 9, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: Prenatal Care; Premature Birth; Patient Satisfaction; Low Income; Group Prenatal Care; Respectful Care; Prenatal Depression and Anxiety; Health Inequity
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Mood Disorders; Pregnancy Complications; Obstetric Labor Complications; Puerperal Disorders; Obstetric Labor, Premature; Depression; Depressive Disorder; Depression, Postpartum; Premature Birth
• Other Study ID Numbers: AD-2018C2-13227

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No