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

Primary Purpose

Premature Birth, Pregnancy Preterm, Prenatal Stress

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Glow! Group Prenatal Care
Individual Prenatal Care with CPSP
Sponsored by
University of California, San Francisco
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Premature Birth focused on measuring Premature Birth, Group Prenatal Care, Respectful Care, Patient Satisfaction, Prenatal Depression and Anxiety, Low Income, Health Inequity, Prenatal Care

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Central Valley Health Policy InstituteRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Glow! Group Prenatal Care

Individual Prenatal Care- CPSP

Arm Description

Group prenatal care with wrap around services.

Individual prenatal care with supplemental services covered by CPSP.

Outcomes

Primary Outcome Measures

Preterm birth
Whether the participant had a baby born less than 37 weeks gestation, as noted in the participant's medical record.
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.
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.

Secondary Outcome Measures

Gestational age at delivery
The gestation age at which the baby was born (number of weeks), as noted in the participant's medical record.
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.
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.

Full Information

First Posted
October 31, 2019
Last Updated
May 9, 2023
Sponsor
University of California, San Francisco
Collaborators
Patient-Centered Outcomes Research Institute, California State University, Fresno Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT04154423
Brief Title
Engaging Mothers & Babies; Reimagining Antenatal Care for Everyone (EMBRACE) Study
Acronym
EMBRACE
Official Title
Comparing Approaches to Enhanced Prenatal Care to Improve Maternal and Child Health in Central CA
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 7, 2019 (Actual)
Primary Completion Date
September 30, 2024 (Anticipated)
Study Completion Date
September 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, San Francisco
Collaborators
Patient-Centered Outcomes Research Institute, California State University, Fresno Foundation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Premature Birth, Pregnancy Preterm, Prenatal Stress, Depression, Anxiety, Depression, Postpartum, Satisfaction, Patient, Health Problems in Pregnancy
Keywords
Premature Birth, Group Prenatal Care, Respectful Care, Patient Satisfaction, Prenatal Depression and Anxiety, Low Income, Health Inequity, Prenatal Care

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
2600 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Glow! Group Prenatal Care
Arm Type
Active Comparator
Arm Description
Group prenatal care with wrap around services.
Arm Title
Individual Prenatal Care- CPSP
Arm Type
Active Comparator
Arm Description
Individual prenatal care with supplemental services covered by CPSP.
Intervention Type
Other
Intervention Name(s)
Glow! Group Prenatal Care
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Individual Prenatal Care with CPSP
Intervention Description
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
Primary Outcome Measure Information:
Title
Preterm birth
Description
Whether the participant had a baby born less than 37 weeks gestation, as noted in the participant's medical record.
Time Frame
0-12 weeks after delivery
Title
Changes in depressive symptom severity
Description
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.
Time Frame
Collected from study enrollment to three months postpartum
Title
Perceptions of respectful/disrespectful care
Description
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.
Time Frame
Collected during third trimester and at three months postpartum
Secondary Outcome Measure Information:
Title
Gestational age at delivery
Description
The gestation age at which the baby was born (number of weeks), as noted in the participant's medical record.
Time Frame
0-12 weeks after delivery
Title
Changes in anxiety symptom severity
Description
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.
Time Frame
Collected from study enrollment to three months postpartum
Title
Satisfaction with prenatal care
Description
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.
Time Frame
Collected during third trimester and at three months postpartum

10. Eligibility

Sex
Female
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Miriam Kuppermann, PhD, MPH
Phone
(415) 502-4089
Email
miriam.kuppermann@ucsf.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Lauren Lessard, PhD, MPH
Email
llessard@csufresno.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Miriam Kuppermann, PhD, MPH
Organizational Affiliation
University of California, San Francisco
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Lauren Lessard, PhD, MPH
Organizational Affiliation
California State University, Fresno
Official's Role
Principal Investigator
Facility Information:
Facility Name
Central Valley Health Policy Institute
City
Fresno
State/Province
California
ZIP/Postal Code
93710
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mary Garza, PhD
Email
magarza@csufresno.edu
First Name & Middle Initial & Last Name & Degree
Miriam Kuppermann, PhD, MPH
Email
miriam.kuppermann@ucsf.edu

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
11556941
Citation
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.
Results Reference
background
PubMed Identifier
16717171
Citation
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.
Results Reference
background
PubMed Identifier
10728256
Citation
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.
Results Reference
background
PubMed Identifier
29349217
Citation
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.
Results Reference
background
PubMed Identifier
22428358
Citation
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.
Results Reference
background
PubMed Identifier
16005789
Citation
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.
Results Reference
background

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

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