Accountability for Care Through Undoing Racism & Equity for Moms

NCT05484804 | Recruiting

• 1 other identifier: 22-1541
• Study Type: interventional
• Target: 60,000
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Odds of delivery of low-birthweight infants among non-Hispanic Black patients in each study arm

  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.

  Upon delivery

Secondary Outcomes (2)

• Odds of any discrimination during prenatal care among Black patients in each study arm

  24 weeks of gestation until delivery

• Odds of incidence of depression during prenatal care among Black patients in each study arm

  24 weeks of gestation until delivery

Study Arms (4)

Standard Care

NO INTERVENTION

Pregnant patients with Medicaid insurance are screened for risk factors for low birthweight, and high-risk patients receive intensive care management.

Data Accountability and Transparency

ACTIVE COMPARATOR

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.

Other: Data Accountability and Transparency

Community-Based Doula (CBD) Support

ACTIVE COMPARATOR

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.

Other: Community-Based Doula (CBD) Support

Data Accountability and Transparency + Community-Based Doula Support

ACTIVE COMPARATOR

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.

Other: Data Accountability and Transparency; Other: Community-Based Doula (CBD) Support

Interventions

Community-Based Doula (CBD) Support OTHER

Community-Based Doula support for high-risk patients; Racial Equity Training

Community-Based Doula (CBD) Support; Data Accountability and Transparency + Community-Based Doula Support

Data Accountability and Transparency OTHER

Collaboration with Practice Facilitators; Maternal Early Warning System; Disparities Dashboard; Racial Equity Training

Data Accountability and Transparency; Data Accountability and Transparency + Community-Based Doula Support

Eligibility Criteria

• Age: 12 Years - 99 Years
• Gender Eligibility Details: Female or transgender male
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Practices:
• 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

You may not qualify if:

• Practices:
• Already integrated with Community-Based Doulas
• Already have an Early Warning System or Disparities Dashboard

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• Patient-Centered Outcomes Research Institute: collaborator
• UNC Health Foundation: collaborator
• The Duke Endowment: collaborator

Study Sites (1)

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27599, United States

RECRUITING

Related Publications (1)

• Urrutia RP, Malloy AT, McMillan C, Jackson M, Verbiest S, Cykert S, Boynton MH, Menard M, Nicholson WK, Yongue C, Murphy A, Byrd DP, Cass B, Avis A, Gardner L, Husein R, Bryant K, Tang JH; ACURE4Moms Study Team. Accountability for care through undoing racism and equity for moms: a study protocol for a cluster randomized trial of data accountability and community-based doula interventions in prenatal practices. Trials. 2026 Feb 24. doi: 10.1186/s13063-026-09514-9. Online ahead of print.

  PMID: 41731539 DERIVED

MeSH Terms

Conditions

Maternal Death; Racism; Bias, Implicit

Interventions

Palliative Care

Condition Hierarchy (Ancestors)

Parental Death; Death; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Prejudice; Social Behavior; Behavior; Social Discrimination

Intervention Hierarchy (Ancestors)

Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Jennifer H Tang, MD, MSCR

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

• Rachel P Urrutia, MD, MSCR

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jennifer H Tang, MD, MSCR

CONTACT

919-962-4880; jennifer_tang@med.unc.edu

Rabab S Husain, MA

CONTACT

919-962-4880; rabab_husain@med.unc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Arm 1 (Standard Care): NC Medicaid Care Management Arm 2 (Data Accountability and Transparency): NC Medicaid Care Management + Practice-level Data Accountability interventions Arm 3 (Community-Based Doula Support): NC Medicaid Care Management + CBD support intervention for high-risk women during pregnancy and postpartum Arm 4 (Data Accountability and Transparency + Community-Based Doula Support): NC Medicaid Care Management + both Arm 2 and Arm 3 interventions

Study Record Dates

• First Submitted: July 22, 2022
• First Posted: August 2, 2022
• Study Start: June 5, 2023
• Primary Completion (Estimated): July 31, 2027
• Study Completion (Estimated): August 31, 2027
• Last Updated: April 17, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Data will be available within 6 months of publication for an unlimited period.
• Access Criteria: Deidentified data will be publicly available through a TBD data repository. Research datasets may also be made available to other investigators who request access. Requests will be evaluated on a case-by-case basis by the study investigators. Investigators proposing to use the data will be asked to provide approval from an ethical review committee and will be asked to execute a data use/sharing agreement with UNC. Data may be shared electronically via password-protected files. All data sharing will abide by rules and/or policies defined by PCORI, relevant IRBs, local, state, and federal laws and regulations. Data sharing mechanisms will ensure that the rights and privacy of individuals participating in research will be protected at all times.

Locations

US (1)