More than 700 women die each year from pregnancy-related complications in the United States, even though the U.S. Centers for Disease Control and Prevention says two out of three of those deaths are preventable. Pregnancy risks are especially high among women in priority populations that have been historically underserved and experience systemic racism. Black women in the U.S., according to the CDC, are more likely to die during pregnancy or childbirth than any other demographic.
A team of Yale researchers, working collaboratively with Yale New Haven Hospital, community partners, and two regional hospitals, is exploring ways to improve health outcomes for this priority population with the support of a $20.4 million funding award from the Patient-Centered Outcomes Research Institute (PCORI).
The award, announced on March 8, will allow researchers at the Yale School of Public Health and Yale School of Medicine to compare the effectiveness of two community-based interventions designed to improve clinical outcomes among postpartum at-risk women.
The two health care delivery models at the center of the study focus on awareness, early detection, and control of postpartum hypertension, as well as social and mental health factors known to impact maternal health.
“This study has the potential to transform the quality of care received by women of color and their babies in the period surrounding birth and beyond,” said Yale Professor of Public Health Rafael Pérez-Escamilla, PhD, co-leader of the study with Associate Professor of Maternal Fetal Medicine Heather S. Lipkind, MD, MS, of the Department of Obstetrics, Gynecology & Reproductive Sciences at Yale School of Medicine.
“These kinds of interventions are urgently needed,” Pérez-Escamilla said. “Poor blood pressure control, due to a lack of follow-up and identification during the postpartum period, is one of the drivers of racial inequities in maternal morbidity and mortality. These inequities are beyond the pale in the U.S. and totally unacceptable from both a public health and human rights perspective.”
Hypertensive disorders during and after pregnancy, including preeclampsia, gestational hypertension, and postpartum hypertension, have been identified as a major cause of maternal mortality and morbidity, and they disproportionately affect racial and ethnic minorities. Social determinants of health such as poverty, lower education, racism, and lack of access to health care (including mental health care) also contribute to maternal mortality and morbidity rates and health inequities.
In the PCORI-funded study, clinical outcomes for each intervention will be compared against the current standard of care for postpartum mothers. The effectiveness of each intervention will also be compared with the effectiveness of the alternate intervention. The project’s goal is to improve mean postpartum systolic blood pressure at six weeks and reduce depression severity at three months postpartum.
“Growing attention has focused on the postpartum period as an important window to address maternal mortality disparities, as half of pregnancy-related deaths occur postpartum,” said Lipkind. “We are thrilled with the opportunity to partner with the community and medical centers to address this critical time period in women’s lives.”
The three hospitals participating in the study are Yale New Haven Hospital, John R. Oishei Children’s Hospital of Buffalo, N.Y. and UMass Memorial Medical Center in Worcester, MA.
“Yale New Haven Hospital is both excited and fortunate to have this funding awarded by Patient-Centered Outcomes Research Institute (PCORI),” said Katie Donohue, interim vice president for women’s health at Yale New Haven Hospital. “Excited for what this funding will mean for our patients and appreciative and grateful because this helps raise the standard of care for these families.”
Of the two interventions being studied, one will use a remote medical service model that includes the standard delivery of care plus home blood pressure monitoring, weekly virtual visits by a health care provider (nurse practitioner, pharmacist, etc.), screening for social determinants of health such as poor housing and food insecurity, and screening for mental health concerns such as anxiety and depression, with referral to services if necessary.
The other will be based on a community health model that includes standard care and remote medical services, plus the utilization of community health workers trained in a strength-based trauma approach.
Integrating community health workers and doulas into health care management teams is an effective way to reduce inequities and improve health outcomes, Pérez-Escamilla said.
“I am convinced that our study offers a unique opportunity to learn how to strengthen the continuum of care and improve coordination between health care facilities and community-based organizations,” said Pérez-Escamilla, who has 30 years of experience in community-based health care delivery. “Such coordination is key to improving equity in women's health services. Ultimately, we would like to see Medicaid reimburse community health worker and doula services as part of its coverage of maternity services.”
Project leaders worked with mothers who have experienced hypertension and community doulas in designing the interventions. Pérez-Escamilla said the project’s co-design is a “prime illustration of what happens when different units within and across academic institutions come together and work unselfishly side by side with community partners.”
Natasha Ray, M.S., director of New Haven Healthy Start and senior community investigator and advisor for the project, worked closely with researchers in designing the interventions, ensuring that the community engagement aspect is “meaningful, equitable, culturally respectful and valued.”
“Typically, guidelines and recommendations for management of hypertension in pregnancy are written for implementation in an ideal setting, and that is not always possible,” Ray said. “We aim to support timely recognition and response to maternal hypertension and preeclampsia utilizing a community-driven, family-centered and trauma-informed approach. Partnering with the individuals most impacted by the issue will yield us our greatest results.”
The five-year PCORI funding award was approved pending completion of a business and programmatic review by PCORI staff and issuance of a formal award contract.
PCORI is an independent nonprofit organization authorized by Congress in 2010. Its mission is to fund research that will provide patients, their caregivers and clinicians with the evidence-based information needed to make better-informed health care decisions.
“This study was selected for PCORI funding for its potential to fill an important gap in our understanding of how best to improve postpartum care and outcomes among those individuals experiencing the greatest disparities,” said PCORI Executive Director Nakela L. Cook MD, MPH. “We look forward to following the study’s progress and working with Yale and its partners to share the results.”