A $10-million award from the Patient-Centered Outcomes Research Institute (PCORI) will allow researchers from the UNC School of Medicine, Mountain Area Health Education Center (MAHEC), and community partners to address a growing problem in the world of maternal healthcare. Pregnancy complications are increasing in the United States, and this is worse for Black patients, who are three to four times more likely to die from pregnancy than white patients.
Dr. Rachel Peregallo Urrutia
Jennifer Tang, MD
"Inequity in maternal mortality and morbidity is a big problem, and in our field it's the biggest one," said Rachel Urrutia, MD, assistant professor in the UNC Department of Obstetrics & Gynecology. "We need a big solution."
Urrutia, along with Jennifer Tang, MD, associate professor in the UNC Department of Obstetrics & Gynecology, will co-lead the Accountability for Care through Undoing Racism and Equity for Moms (ACURE4Moms) study, which aims to decrease pregnancy complications for all women, but especially for Black women, by decreasing institutional racism and bias in healthcare and improving community-based social support during pregnancy. The study, which will involve 40 prenatal practices across North Carolina and a team of co-investigators, will attempt to do so using two types of interventions. The first type is data accountability.
"We are using methods from previous studies that have shown to improve outcomes, and applying them to maternal care," Tang said. "By creating data accountability and electronic warning systems, the ACCURE trial for breast and lung cancer patients, performed in partnership between UNC and the Greensboro Health Disparities Collaborative, achieved better outcomes for all patients, and markedly reduced the disparity in outcomes between Black and white patients."
The data accountability intervention will be focused on healthcare providers and their clinics. The team will improve accountability by setting up electronic maternal warning systems to notify the clinics whenever a patient has a risk factor for low birthweight that needs to be treated or misses a scheduled appointment. Nurse navigators and provider champions from each clinic will make sure the clinic acts on the warning.
Secondly, the team will improve transparency by showing the clinics their pregnancy-related complication data for different racial groups every three months through a disparities dashboard. This dashboard will show the providers any differences in pregnancy complications for people of different races in their clinic and encourage them to come up with ways to improve the quality of their care to decrease those differences. Practice facilitators from the North Carolina Area Health Education Centers (AHEC) will help the clinics improve their workflows and communication with patients. Finally, all the staff at the clinics will undergo interactive racial equity training to help them recognize any implicit biases they have and understand how racism affects pregnancy care for patients of color.
The second type of intervention will match community-based doulas who are trained to provide culturally relevant care with high-risk patients after their first prenatal appointment. Two community-based co-investigators - Cindy McMillan, a certified doula and the executive director of Sistas Caring 4 Sistas Asheville, and Angela Tatum Malloy, a certified doula and the founder and CEO of Momma's Village Fayetteville - will help facilitate the training of doulas that will be needed for the expansive study, and will provide support to the doulas working with clinics in their communities.
"Doulas are an important resource and provide emotional, physical and evidence-based informational support to moms," McMillan said. "Community-based doulas can provide even more support, as they are from the same community as the moms they are serving, and understand what barriers or challenges that mother may be facing."
The doulas will provide support to patients during pregnancy and up to one year after birth by setting up peer support groups for clients with similar due dates, attending two prenatal visits with them, supporting them for up to 24 hours during labor, and performing a postpartum home visit.
The primary outcome will be to decrease low birthweight deliveries among Black women, and a secondary outcome will be to decrease experiences with discrimination during prenatal care among Black patients. To test how each of these interventions improves low birthweight alone and when combined together, the team will randomize 40 prenatal practices across North Carolina, into one of four groups: (a) no interventions; (b) data accountability intervention; (c) doula intervention; or (d) both the data accountability and doula interventions. The team predicts that about 30,000 patients will start prenatal care at one of the 40 practices during the study. For the patient survey, the team plans to enroll 100 Black patients from each of the 40 practices, for a total of 4,000 patients. The team will also interview up to 463 practice staff, doulas, patients, and practice facilitators to understand how well the study interventions fit their needs.
"I really feel that doctors and healthcare institutions cannot solve this problem," Urrutia said. "The community needs to solve it and they need the resources and the space to do so. This study will provide them with those resources."
This study is led by a stakeholder advisory board, which includes patients of color who have had a pregnancy complication, community doulas, practice representatives, health insurance payers, patient advocacy group Moms Rising, the North Carolina OB-GYN Society, the North Carolina Chapter of the American College of Nurse Midwives, and the North Carolina Department of Public Health. The majority of members will be people of color. The board will meet every three months throughout the study to advise researchers about patient-centered outcomes, assist with dissemination of results, and advocate for related policy change.
"This is the perfect time to make a big impact in Black maternal health," Malloy said. "Other states are looking for models to improve their healthcare systems, so this approach could impact Black mothers across the country."
PCORI's Board has approved this funding award 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 to fund research that will provide patients, their caregivers, and clinicians with the evidence-based information needed to make better-informed healthcare decisions.
Researchers hope to start recruiting practices into the ACURE4Moms study this fall, and begin implementing interventions and collecting data in the summer of 2022.
