NCT05484804 · University of North Carolina, Chapel Hill
Accountability for Care Through Undoing Racism & Equity for Moms
(ACURE4Moms)
What this study is about
This project-also known as "Accountability for Care through Undoing Racism \& Equity for Moms" or ACURE4Moms-aims to reduce Black-White maternal health disparities using multi-level interventions designed to decrease bias in prenatal care, improve care coordination, and increase social support.
View original scientific description
This project-also known as "Accountability for Care through Undoing Racism \& Equity for Moms" or ACURE4Moms-aims to reduce Black-White maternal health disparities using multi-level interventions designed to decrease bias in prenatal care, improve care coordination, and increase social support. ACURE4Moms is a pragmatic 4-arm cluster randomized controlled trial conducted with 39 prenatal practices across North Carolina. Practices have been randomly assigned to receive either: Arm 1 (Standard Care): North Carolina Medicaid Care management for high-risk pregnancies; Arm 2 (Data Accountability and Transparency): North Carolina Medicaid Care Management + Practice-level Data Accountability interventions; Arm 3 (Community-Based Doula Support): North Carolina Medicaid Care Management + Community-Based Doula support intervention for high-risk patients during pregnancy and postpartum; or Arm 4 (Data Accountability and Transparency + Community-Based Doula Support): North Carolina Medicaid Care Management + Both Arms 2 and 3 interventions. During each practice's 2-year intervention period, the practice will initiate prenatal care for \~750-1,500 patients (up to 60,000 patients total), whose outcomes the investigators will follow and compare between arms until all these patients have reached 1-year post-delivery.
Interventions
OTHER
Data Accountability and Transparency
Collaboration with Practice Facilitators; Maternal Early Warning System; Disparities Dashboard; Racial Equity Training
OTHER
Community-Based Doula (CBD) Support
Community-Based Doula support for high-risk patients; Racial Equity Training
Primary outcome measures
Odds of delivery of low-birthweight infants among non-Hispanic Black patients in each study arm
Time frame: Upon delivery
This Primary Outcome Measure will compare the odds of delivery of low-birthweight infants (less than 2,500 grams) among non-Hispanic Black patients in each study arm as listed in the maternal delivery summary and/or neonatal electronic health record data, with the primary comparison being between the Data Accountability and Transparency + Community-Based Doula Support arm and the Standard Care arm.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Have at least 180 Black patient deliver over 2 years
- Be willing to be randomized
- Be willing to adhere to the study protocol Patient survey participants:
- Start prenatal care at one of the study clinics during study implementation
- Self-identify as Black or African American
- Able to give consent and complete surveys and interviews in English Practice staff member participants:
- Employed as either a provider, nurse/medical assistant, or office administrator at one of the clinics in this study Doula participants:
- Provide doula care to patients at one the clinics in this study
Exclusion criteria
- Already integrated with Community-Based Doulas
- Already have an Early Warning System or Disparities Dashboard
Where
- Chapel Hill, North Carolina
Collaborators
Patient-Centered Outcomes Research Institute, UNC Health Foundation, The Duke Endowment
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Apr 17, 2026 · Source of record for eligibility and locations