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?
In the United States, about 10 percent of babies are born premature, which is before 37 weeks. Premature babies have physical and mental problems more often than babies born at full term, and they are at higher risk of dying as newborns. Women with low incomes, and women who are black, Latina, or Native American or Pacific Islander are more likely to have a premature baby than other women.
Having depression or anxiety or experiencing racism while pregnant may raise a woman’s chances of having a premature baby. This study is comparing two programs that provide care to pregnant women with low incomes to see how the programs affect premature births and women’s mental health and care experiences.
Who can this research help?
Clinics may be able to use the findings when considering ways to improve health care for pregnant women at risk for having a premature birth.
What is the research team doing?
The research team is working with 10 health clinics that serve racially and ethnically diverse patients in Fresno County, California. They are enrolling 2,600 women who are less than 24 weeks pregnant, speak English or Spanish, and are eligible for Medicaid.
Each clinic is offering the two prenatal care programs and assigning women to one of them based on their due date. In the first program, called Glow!, women with similar due dates receive pregnancy care in a group. In the second program, the Comprehensive Perinatal Services Program, or CPSP, women receive one-on-one pregnancy care. They also meet with CPSP staff up to three times to report on their health and living situation. In both programs, women 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.
Women in the study are completing surveys about their physical health, mental health, and care experiences when they enroll in the study, during their third trimester, and three months after they give birth. The research team is looking at women’s medical records to find out whether their baby was born premature. The team is also conducting in-depth interviews with some black and Latina participants to learn more about their care experiences.
A study advisory group is helping the research team plan and carry out the study. It includes women who received prenatal care in one of the programs, clinicians, and community organization representatives.
Research methods at a glance
| Design Element | Description |
|---|---|
| Design | Randomized controlled trial |
| Population | Women who are less than 24 weeks pregnant, speak English or Spanish, and are eligible for Medicaid |
| Interventions/ Comparators |
|
| Outcomes |
Primary: premature birth rate Secondary: anxiety, depression, satisfaction with care, perceptions of respectful care |
| 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 |
|---|---|
| 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
This COVID-19 study's final enhancement report is expected to be available by February 2024.