Accountability for Care Through Undoing Racism & Equity for Moms

NCT ID: NCT05484804

Last Updated: 2025-08-14

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 30000 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-06-05
• Study Completion Date: 2027-08-31

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.

Detailed Description

Pregnancy complications are increasing in the United States, and this is worse for Black patients, who are 3-4 times more likely to die from pregnancy than White patients. Pregnancy complications and deaths cause large physical, social, and financial burdens for patients and their families. Black patients who experience higher levels of institutional racism and discrimination from healthcare providers and institutions are more likely to have pregnancy complications, such as delivering a baby with low birthweight. Low birthweight (less than 5 pounds 9 ounces) is related to many short-term and long-term health problems for both baby and mother. The study, Accountability for Care through Undoing Racism and Equity for Moms (ACURE4Moms), aims to decrease pregnancy complications for all patients, but especially for Black patients, by decreasing institutional racism and bias in healthcare and improving community-based social support during pregnancy. The primary outcome will be to decrease low birthweight deliveries among Black women. The investigators will get information about low birthweight and other pregnancy outcomes from prenatal practice electronic healthcare records. A secondary outcome will be to decrease experiences with discrimination during prenatal care among Black patients; this information will be collected from an internet survey that will be completed at 4 time points between a patient's first prenatal visit and 3 months after delivery.

To meet the study aims, the investigators will test 2 types of interventions. The first type (the "Data Accountability and Transparency interventions") will be focused on healthcare providers and their clinics. The study will improve accountability by setting up electronic Maternal Warning Systems to notify the clinics whenever a patient has a risk factor for low birthweight that needs to be treated or misses a scheduled appointment. Nurse navigators and provider champions from each clinic will make sure the clinic acts on the warning. Secondly, the study will improve transparency by showing the clinics their pregnancy-related complication data for different racial groups every 3 months through a "Disparities Dashboard." This Dashboard will show the providers any differences in pregnancy complications for people of different races in their clinic and encourage them to come up with ways to improve the quality of their care to decrease those differences. The study will hire "Practice Facilitators" to help the clinics improve their workflows and communication with patients. Finally, all the staff at the clinics will undergo interactive racial equity training to help them recognize any implicit biases they have and understand how racism affects pregnancy care for patients of color.

The second type of interventions will be focused on improving community-level support for high-risk pregnant patients. The study will do this by matching community-based doulas who are trained to provide culturally-relevant care with high-risk patients after their first prenatal appointment. The doulas will then provide support to these patients during pregnancy and up to 1 year after birth by setting up peer support groups for clients with similar due dates, attending 2 prenatal visits with them, supporting them for up to 24 hours during labor, and performing a postpartum home visit (the "Community-Based Doula Support interventions").

To test how these each of these interventions improves low birthweight alone and when combined together, the study has enrolled 39 prenatal practices across North Carolina, into 1 of 4 randomized arms: 1) No interventions; 2) Data Accountability and Transparency interventions; 3) Community-Based Doula Support interventions; or 4) Both the Data Accountability and Transparency and Community-Based Doula Support interventions. The investigators predict that up to 60,000 patients will start prenatal care at one of the 39 practices during the study.

For the patient surveys, the study plans to enroll patients who self-identify as Black or African American from each of the 39 practices, for a total of at least 2,400 survey participants. The investigators will also interview up to 250 practice staff, doulas, patients, and Practice Facilitators to understand how well the study interventions fit their needs.

The study is led by a Stakeholder Advisory Board, which includes patients of color who have had a pregnancy complication, community doulas, practice representatives, health insurance payers, a patient advocacy group, healthcare organizations, and the North Carolina Department of Public Health. The majority of members will be people of color. The Board will meet every 3 months throughout the study to advise us about patient-centered outcomes, assist with dissemination of results, and advocate for related policy change.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Standard Care

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

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.

Group Type: ACTIVE_COMPARATOR

Data Accountability and Transparency

Intervention Type: OTHER

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

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.

Group Type: ACTIVE_COMPARATOR

Community-Based Doula (CBD) Support

Intervention Type: OTHER

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

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.

Group Type: ACTIVE_COMPARATOR

Data Accountability and Transparency

Intervention Type: OTHER

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

Community-Based Doula (CBD) Support

Intervention Type: OTHER

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

Interventions

Data Accountability and Transparency

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

Intervention Type: OTHER

Community-Based Doula (CBD) Support

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

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

Practices:

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

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Patient-Centered Outcomes Research Institute

OTHER

Sponsor Role: collaborator

UNC Health Foundation

UNKNOWN

Sponsor Role: collaborator

The Duke Endowment

OTHER

Sponsor Role: collaborator

University of North Carolina, Chapel Hill

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jennifer H Tang, MD, MSCR

Role: PRINCIPAL_INVESTIGATOR

University of North Carolina, Chapel Hill

Rachel P Urrutia, MD, MSCR

Role: PRINCIPAL_INVESTIGATOR

University of North Carolina, Chapel Hill

Locations

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Jennifer H Tang, MD, MSCR

Role: CONTACT

jennifer_tang@med.unc.edu

919-962-4880

Rabab S Hussain, MIS

Role: CONTACT

rabab_husain@med.unc.edu

919-962-4880

Facility Contacts

Jennfier H Tang, MD, MSCR

Role: primary

jennifer_tang@med.unc.edu

919-962-4880

Rabab S Hussain, MIS

Role: backup

rabab_husain@med.unc.edu

919-962-4880

Other Identifiers

22-1541

Identifier Type: -

Identifier Source: org_study_id