Data Accountability + Doula Support for Maternal Health Disparities
(ACURE4Moms Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to reduce disparities in pregnancy care and outcomes between Black and White expectant mothers. It tests various approaches, including standard care, data-driven improvements (Data Accountability and Transparency), and additional support from community doulas (trained companions who assist during and after childbirth, known as Community-Based Doula Support). Set in prenatal practices across North Carolina, the trial seeks to determine which combination of these methods is most effective. Black or African American pregnant patients on Medicaid who begin prenatal care at one of the participating clinics may find this trial suitable. As an unphased trial, it offers a unique opportunity to contribute to research that could enhance pregnancy care for future generations.
Will I have to stop taking my current medications?
The trial information does not specify whether participants need to stop taking their current medications.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research shows that support from community-based doulas can positively impact the health of mothers and their babies. Doulas, trained to assist during pregnancy and childbirth, are linked to better experiences and outcomes for both mothers and infants. Studies have not identified any safety concerns or negative effects from using community-based doulas.
The Data Accountability and Transparency intervention differs slightly. It uses data to track and improve maternal health outcomes. Although this approach is newer and lacks specific safety data, it focuses on enhancing healthcare practices rather than involving physical procedures, suggesting a low risk of negative effects.
Both approaches aim to improve maternal health and reduce health disparities without introducing new medications or invasive procedures. Based on current research and their nature, they are generally considered safe.12345Why are researchers excited about this trial?
Researchers are excited about the Data Accountability and Doula Support trial because it tackles maternal health disparities using a fresh approach. Unlike standard care, which typically involves basic risk screening and management, this trial combines two innovative strategies: Community-Based Doula (CBD) support and enhanced data accountability methods. The CBD support provides pregnant patients with personalized care and education, fostering a trusted relationship and potentially improving outcomes. Meanwhile, the data accountability approach uses advanced tools like a Maternal Warning System and Data Dashboard to monitor and address health indicators proactively, ensuring more equitable care across diverse populations. This trial aims to find out if these combined strategies can effectively reduce the risks associated with low birthweight and improve maternal health equity.
What evidence suggests that this trial's treatments could be effective in reducing maternal health disparities?
Research has shown that having a community-based doula, one of the interventions in this trial, can improve birth outcomes, such as fewer C-sections and healthier birth weights. Doulas offer emotional, physical, and informational support to mothers before, during, and after childbirth. These benefits have been observed across various groups, particularly in communities with limited access to healthcare.
Another intervention in this trial is data accountability and transparency. Research indicates that using data to hold healthcare providers accountable can reduce disparities in maternal care. This approach aims to improve practices for better outcomes, such as reducing low birth weight in Black infants. Tools like data dashboards highlight these differences and encourage better healthcare practices.23467Who Is on the Research Team?
Jennifer H Tang, MD, MSCR
Principal Investigator
University of North Carolina, Chapel Hill
Rachel P Urrutia, MD, MSCR
Principal Investigator
University of North Carolina, Chapel Hill
Are You a Good Fit for This Trial?
This trial is for Black or African American individuals starting prenatal care at one of the 40 North Carolina clinics involved. Participants must be able to consent and communicate in English. Clinics should have a history of at least 180 Black deliveries over two years, agree to randomization, and follow study protocols.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Intervention
Participants receive interventions based on their assigned arm, including Data Accountability, Community-Based Doula Support, or both.
Follow-up
Participants are monitored for outcomes such as low birthweight and experiences of discrimination up to 1 year post-delivery.
What Are the Treatments Tested in This Trial?
Interventions
- Community-Based Doula (CBD) Support
- Data Accountability and Transparency
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of North Carolina, Chapel Hill
Lead Sponsor
Patient-Centered Outcomes Research Institute
Collaborator
The Duke Endowment
Collaborator
UNC Health Foundation
Collaborator