Accountability for Care Through Undoing Racism & Equity for Moms

Part of paid clinical trials in Chapel Hill, North Carolina.

Sponsor
University of North Carolina, Chapel Hill
Study ID
NCT05484804
Status
Recruiting
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Conditions

  • Implicit Bias
  • Low Birthweight
  • Maternal Health
  • Maternal Mortality
  • Pregnancy Related
  • Racism

Eligibility Criteria

Sex
FEMALE
Age
12 Years - 99 Years
Healthy Volunteers
Accepted

Interventions

  • Data Accountability and Transparency — OTHER
    Collaboration with Practice Facilitators; Maternal Early Warning System; Disparities Dashboard; Racial Equity Training
  • Community-Based Doula (CBD) Support — OTHER
    Community-Based Doula support for high-risk patients; Racial Equity Training

Study Details

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.

Key Dates

Start date
Jun 5, 2023
Status verified
Apr 2026
Primary completion
Jul 31, 2027
Completion
Aug 31, 2027

Study Design

Enrollment
60,000 participants (estimated)
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
HEALTH_SERVICES_RESEARCH

Arms

  • No Intervention: Standard Care
    Pregnant patients with Medicaid insurance are screened for risk factors for low birthweight, and high-risk patients receive intensive care management.
  • Active Comparator: Data Accountability and Transparency
    Pregnant patients with Medicaid insurance are screened for risk factors for low birthweight, and high-risk patients receive intensive care management. Additionally, practices receive 2 additional patient-level interventions, including: 1) Support from a Practice Facilitator to help implement the interventions and build workflows and quality improvement cycles; 2) Use of a Maternal Warning System for missed visits, elevated blood pressures, and prenatal aspirin eligibility; 3) Use of a Data Dashboard that displays outcome data stratified by race, ethnicity, age, and preferred language; and 4) Maternal Health Equity Education \& Training sessions.
  • Active Comparator: Community-Based Doula (CBD) Support
    Pregnant patients with Medicaid insurance are screened for risk factors for low birthweight, and high-risk patients receive intensive care management. Additionally, practices receive 2 additional patient-level interventions, including: 1) Shared care of high-risk patients with Community-Based Doulas; and 2) Maternal Health Equity Education \& Training sessions.
  • Active Comparator: Data Accountability and Transparency + Community-Based Doula Support
    Pregnant patients with Medicaid insurance are screened for risk factors for low birthweight, and high-risk patients receive intensive care management, and practices receive all the Data Accountability and Doula Interventions described in Arms 2 and 3.

Primary Outcome Measure

Odds of delivery of low-birthweight infants among non-Hispanic Black patients in each study arm [ Time Frame: Upon delivery ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of North Carolina at Chapel HillChapel HillNorth Carolina27599
Jennfier H Tang, MD, MSCR
[email protected]
919-962-4880
Rabab S Husain, MA
[email protected]
919-962-4880

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