Data Accountability + Doula Support for Maternal Health Disparities
(ACURE4Moms Trial)
Trial Summary
Will I have to stop taking my current medications?
The trial information does not specify whether participants need to stop taking their current medications.
What data supports the effectiveness of the treatment Community-Based Doula (CBD) Support, Doula Support, Community-Based Doula Care, CBD Support, Data Accountability and Transparency, Data Accountability, Transparency Intervention?
Is community-based doula support safe for humans?
How does the treatment 'Data Accountability + Doula Support for Maternal Health Disparities' differ from other treatments for maternal health disparities?
This treatment is unique because it combines data accountability with doula support to address maternal health disparities, focusing on providing continuous emotional and educational support from trained doulas, particularly for underserved communities. Unlike traditional medical treatments, this approach emphasizes social support and advocacy to improve maternal and infant health outcomes.134510
What is the purpose of this trial?
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 40 prenatal practices across North Carolina. Practices will be 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 patients (30,000 patients total), whose outcomes the investigators will follow and compare between arms until all these patients have reached 1-year post-delivery.
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
Eligibility Criteria
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
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.
Treatment Details
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