Project Summary
This research project is in progress. PCORI will post the research findings on this page within 90 days after the results are final.
What is the research about?
Depression is common during and right after pregnancy. People who have depression during pregnancy are at increased risk for having a premature baby, or a baby born before 37 weeks. Premature babies have a higher risk of dying as newborns compared with babies born after 37 weeks. They also have a higher risk of having physical and mental health problems. Pregnant people from racial and ethnic minority groups and those who have low incomes are at increased risk for depression and for having a premature baby.
In this study, the research team is comparing two programs that provide care to pregnant people with low incomes. The team wants to see how the programs affect pregnant people’s mental health, care experiences, and chances of having a premature baby.
Who can this research help?
Results may help clinics when considering ways to improve health care for pregnant people.
What is the research team doing?
The research team is working with 10 health clinics that serve racially and ethnically diverse patients in and around Fresno County, California. The team is enrolling 657 people who are less than 25 weeks pregnant, speak English or Spanish, and are eligible for Medicaid.
Each clinic is offering both prenatal care programs. The first program is called Glow Group Prenatal Care, or Glow/GC. In Glow/GC, people receive pregnancy care and wraparound services, such as help finding housing or mental health care in a group. The second program is called the Comprehensive Perinatal Services Program Individual Care, or CPSP/IC. In CPSP/IC, people receive one-on-one pregnancy care and wraparound services. They also meet with program staff up to three times to report on their health and living situation. In both programs, people have 7–11 prenatal care visits. Both programs offer services for depression, anxiety, smoking, drug and alcohol use, and health problems that could be dangerous during pregnancy.
The research team is assigning clinics by chance to start the study with either Glow/GC or CPSP/IC. If a patient is interested in taking part in the study, their clinic puts them into a group with other patients who have similar due dates. Each group receives either Glow/GC or CPSP/IC depending on due dates and their clinic’s assigned starting program.
Participants in the study are completing surveys about their physical health, mental health, and care experiences. They complete the surveys when they enroll in the study, during their third trimester, and three months after they give birth. The research team is looking at participants’ health records to see if their baby was born premature. The team is also interviewing some Black and Latina participants to learn more about their care experiences.
People who received prenatal care in one of the programs, clinicians, and staff from community organizations are helping to plan and conduct the study.
Research methods at a glance
Design Element | Description |
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Design | Randomized controlled trial |
Population | Pregnant people who are less than 25 weeks pregnant, speak English or Spanish, and are eligible for Medicaid |
Interventions/ Comparators |
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Outcomes | Primary: depression Secondary: anxiety, perceptions of person-centered care and respectful care, satisfaction with care, preterm birth, gestational age at delivery |
Timeframe | 3-month follow-up after birth for primary outcome |
COVID-19-Related Study
Providing Prenatal Care via Telehealth during the COVID-19 Pandemic -- The EMBRACE Study
Results Summary
In response to the COVID-19 public health crisis in 2020, PCORI launched an initiative to enhance existing research projects so that they could offer findings related to COVID-19. The initiative funded this study and others.
What was this COVID-19 study about?
Prenatal care is health care during pregnancy. During the COVID-19 pandemic, prenatal care shifted to include telehealth as well as in-person visits. Telehealth is a way to provide care to patients remotely, using phone or video.
In this study, the research team first looked at how COVID-19 affected prenatal care. The team talked with pregnant people and others in the community. Based on their interviews, the team adapted a group prenatal care program to be delivered via telehealth. In the group program, six to nine pregnant people with similar due dates meet with their doctor together. The program also had education on pregnancy, birth, and parenting. People could have in-person visits with their doctor as needed.
The research team then compared the group telehealth program versus a standard program. In the standard program, pregnant people and doctors met one-on-one either in person or via telehealth. The team looked at how satisfied people were with their care.
What were the results?
Pregnant people reported challenges with in-person care during COVID-19, such as:
- Not getting enough health information
- Spending less time with doctors
- Rules related to COVID-19, like not being allowed to bring partners to visits
Most pregnant people were able to access technology for telehealth visits. But they had concerns about telehealth, such as the strength of their internet connection and their privacy. For telehealth to work well, community interviewees said pregnant people need training and technical support. They also noted an increased need for social contact and mental health care.
Satisfaction with care didn’t appear to differ between the two programs. In both programs, patients who had in-person and telehealth visits were more satisfied with telehealth.
What did the research team do?
The research team talked to 62 people about their prenatal care during the pandemic. Of these, 42 percent were Black, 40 percent were Latinx, and 18 percent identified as Black or Latinx and another race. The average age was 27. The team also talked with 25 clinicians, clinic and program staff, health insurers, telehealth experts, community members, and others with knowledge of the group prenatal care program.
The research team then assigned clinics to provide one of the two programs. The team surveyed pregnant people about their satisfaction with care. Of the 39 people who completed surveys, 64 percent were Latinx, 16 percent were White, 9 percent were Black, 5 percent were Asian, and 7 percent were another race or ethnicity. The average age was 29.
Patients, doctors, and community groups helped design the study.
What were the limits of the study?
Interviews took place in California in 2020. Results may differ in other states and during other phases of the pandemic. The number of people in the two programs was small. Results may differ with a larger study.
How can people use the results?
Clinics and doctors can use the results when considering ways to offer prenatal care.
Professional Abstract
In response to the COVID-19 public health crisis in 2020, PCORI launched an initiative to enhance existing research projects so that they could offer findings related to COVID-19. The initiative funded this study and others.
Background
The EMBRACE study originally sought to compare the effectiveness of two enhanced, in-person prenatal care programs: group and individual. However, during the COVID-19 pandemic, in-person clinic visits were limited, so the study adapted the group care program for telehealth use.
Objective
(1) To describe pregnant peoples’ experiences with prenatal care during the pandemic; (2) To modify a group prenatal care program for telehealth use; and (3) To determine the acceptability and feasibility of the modified telehealth group prenatal care program (Glow/GC) versus an individual prenatal care program delivered in person and via telehealth
Study Design
Design Element | Description |
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Design | Aims 1 and 2: Qualitative interviews Aim 3: Observational cohort study |
Population | Aim 1: 62 Black or Latinx individuals who were pregnant or had recently given birth in Fresno, California, during or before the COVID-19 pandemic Aim 2: 25 individuals, including 5 clinicians, 5 clinic staff/administrators, 4 prenatal program staff, 2 representatives of health insurers, 3 telehealth experts, and 6 community members Aim 3: 39 individuals who were 6–24 weeks pregnant, eligible for Medi-Cal (living at or below 213% of the federal poverty level), and spoke English or Spanish |
Aim 3:
| |
Outcomes | Experience with COVID-19 during pregnancy and after birth, preferred method of monitoring care, new mother satisfaction with care |
Data Collection Timeframe | Aim 1: August 2020–November 2020 Aim 2: September 2020–November 2020 Aim 3: December 2020–July 2021 |
This mixed-methods study examined how COVID-19 affected prenatal care for Black and Latinx pregnant people. The researchers then modified and tested Glow/GC for telehealth. Glow/GC includes group visits with six to nine people with similar due dates and education on pregnancy, birth, and parenting.
The researchers interviewed 62 people who were pregnant or had recently given birth. Of these, 42% were Black, 40% were Latinx, and 18% identified as Black or Latinx and another race. The average age was 27. The researchers also interviewed 25 clinicians, program staff, health insurers, telehealth experts, community members, and others familiar with Glow/GC. Based on emergent themes identified in the interview transcripts, the researchers modified Glow/GC.
In the observational study, researchers assigned participants to one of the two prenatal care programs based on clinic and due date: either the Glow/GC modified for telehealth or the California Department of Public Health’s Comprehensive Perinatal Services Program with individual care (CPSP/IC). Glow/GC was delivered by telehealth; however, participants may have had in-person visits as needed. The individual care program was delivered either in person or by telehealth.
The study included 39 pregnant people. Among participants, 64% were Latinx, 16% were White, 9% were Black, 5% were Asian, and 7% were another race or ethnicity. The average age was 29. Participants completed a postpartum survey about satisfaction with their care.
Patients, clinicians, and community-based organizations provided input throughout the study.
Results
Aim 1. Pregnant people reported challenges with in-person care during the pandemic, including inadequate health information and challenges related to COVID-19 policies. People said their providers spent less time with them, and they could not bring their partners to in-person visits. Most people had access to technology for telehealth visits but expressed concerns about privacy and internet connectivity.
Aim 2. Interviewees reported increased needs for social connection, mental health assessments and services, and telehealth training and technical support.
Aim 3. Researchers did not identify differences in patients’ satisfaction with their prenatal care between the Glow/GC and CPSP/IC groups. Patients in both programs who had in-person and telehealth appointments had higher satisfaction with telehealth (95% confidence interval [CI]: 0.05, 0.73; p=0.03).
Limitations
Researchers interviewed patients in California in 2020. Results may differ in other states or during other phases of the pandemic. The number of participants in the observational study was small. Results should be interpreted with caution.
Conclusions and Relevance
Researchers found it was feasible to adapt an in-person group prenatal care program for telehealth.
Peer Review Summary
Peer review of PCORI-funded research helps make sure the report presents complete, balanced, and useful information about the research. It also assesses how the project addressed PCORI’s Methodology Standards. During peer review, experts read a draft report of the research and provide comments about the report. These experts may include a scientist focused on the research topic, a specialist in research methods, a patient or caregiver, and a healthcare professional. These reviewers cannot have conflicts of interest with the study.
The peer reviewers point out where the draft report may need revision. For example, they may suggest ways to improve descriptions of the conduct of the study or to clarify the connection between results and conclusions. Sometimes, awardees revise their draft reports twice or more to address all of the reviewers’ comments.
Peer reviewers commented and the researchers made changes or provided responses. Those comments and responses included the following:
- The reviewers noted that aim 1 of the study described as the goal of the qualitative interviews to understand how the study intervention would need to be altered to address the economic and social needs of pregnant and parenting people during the COVID-19 pandemic. Despite making this statement several times in the report, the results for aim 1 did not appear to address economic and social needs so it was not clear how these needs were incorporated. In response, the researchers added the theme of inaccessibility to resources meant to improve the well-being of pregnant and parenting people to their presentation of interview results.
- The reviewers requested that the researchers be more explicit in stating that the original study plan was halted due to the pandemic and replaced by the study described, which was more focused on assessing the feasibility of providing the intervention through telehealth instead of in person as originally designed. The researchers added statements to this effect in the background and methods sections of the report.
- The reviewers asked the researchers to provide more information about the two interventions because it was not clear that they would be comparable. The researchers pointed out that the primary difference between the two interventions was that the Glow! Group Prenatal Care (Glow/GC) group received telehealth group prenatal care rather than individual care, either in person or telehealth, provided in the Comprehensive Perinatal Services Program (CPSP/IC) group.
- The reviewers indicated that the study conclusions were overstated in saying that study participants reported higher satisfaction in telehealth rather than in-person care. The researchers acknowledged that this was misstated and clarified that the study results show no significant differences between Glow/GC and CPSP/IC in patient satisfaction.
Final Enhancement Report
View this COVID-19 study's final enhancement report.
DOI - Digital Object Identifier: 10.25302/05.2023.AD.2018C213227_C19