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Pregnancy RelatedACURE4MomsNCT05484804

Accountability for Care Through Undoing Racism & Equity for Moms

A study testing Data Accountability and Transparency and Community-Based Doula (CBD) Support in people with Pregnancy Related and Maternal Health, run by University of North Carolina, Chapel Hill at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 12 to 99 years, women onlyHealthy volunteers can take part
What is being tested?
Data Accountability and Transparency and Community-Based Doula (CBD) Support
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60,000 participants
Where
1 siteUnited States
Study dates
5 Jun 2023to 31 Aug 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 12 to 99 years
  • Women only
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Who may be able to join

  • 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
Show all 12Show fewer
  • 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

Who cannot join

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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

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

United States1 site, 1 recruiting
  • University of North Carolina at Chapel Hill

    Chapel Hill, North Carolina, 27599

    Jennfier H Tang, MD, MSCR, 919-962-4880, jennifer_tang@med.unc.edu

    Rabab S Husain, MA, 919-962-4880, rabab_husain@med.unc.edu

    Recruiting

Other trials in United States

About this study

Official title: Reducing Racial Disparities in Maternal Care Through Data-Based Accountability and Doula Support

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.

Read the 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. 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 with up to 4 visits during the prenatal period, supporting them for up to 24 hours during labor, and performing 1-2 postpartum home visits. The doulas may provide additional services during pregnancy and labor, and through peer support groups lasting up to 1 year after birth (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 up to 4,400 survey participants. The investigators will also interview at least 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.

Being tested
Data Accountability and Transparency, Community-Based Doula (CBD) Support
Medical subject headings
Maternal Death, Racism, Bias, Implicit

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Data Accountability and TransparencyOther

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

  • Community-Based Doula (CBD) SupportOther

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

Study groups in NCT05484804
Study groupRoleWhat they receive
Standard CareNo interventionPregnant patients with Medicaid insurance are screened for risk factors for low birthweight, and high-risk patients receive intensive care management.
Data Accountability and TransparencyActive comparatorPregnant 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.
Receives: Other: Data Accountability and Transparency
Community-Based Doula (CBD) SupportActive comparatorPregnant 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.
Receives: Other: Community-Based Doula (CBD) Support
Data Accountability and Transparency + Community-Based Doula SupportActive comparatorPregnant 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.
Receives: Other: Data Accountability and Transparency; Other: Community-Based Doula (CBD) Support

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Upon delivery

Secondary outcomes (2)
  1. Odds of any discrimination during prenatal care among Black patients in each study arm

    This Secondary Outcome Measure will compare the odds of any perceived discrimination as measured by Discrimination in Medical Settings Scale (i.e., a score greater than or equal to 8 up to a maximum score of 35, where a higher score indicates more frequent experiences of discrimination) among Black patients in each study arm, with the primary comparison being between the Data Accountability and Transparency + Community-Based Doula Support arm and the Standard Care arm.

    Measured: 24 weeks of gestation until delivery

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

    This Secondary Outcome Measure will compare the odds of incidence of depression as measured by the Edinburgh Perinatal Depression Scale (i.e., a score greater than or equal to 10 up to a maximum score of 30, where a higher score indicates greater depressive symptoms) during prenatal care among Black patients in each study arm, with the primary comparison being between the Data Accountability and Transparency + Community-Based Doula Support arm and the Standard Care arm.

    Measured: 24 weeks of gestation until delivery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Aug 2022
  2. Study start5 Jun 2023
  3. Primary completion31 Jul 2027 (estimated)
  4. Study completion31 Aug 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Factorial
Model description
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
Masking
None (open label)
Enrolment
60,000 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05484804
Sponsor's protocol ID
22-1541
Acronym
ACURE4Moms
Status last verified
Apr 2026
First submitted
22 Jul 2022
Last updated
17 Apr 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Research data that documents, supports, and validates research findings will be made available after the main findings from the final research dataset have been accepted for publication. Access to databases will be available for educational, research, and non-profit purposes. All data to be shared will be stripped of any potentially identifying information. Data will be made available through a TBD data repository, in consultation with PCORI.

Publications

  • 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;27(1):252. doi: 10.1186/s13063-026-09514-9.

    PubMed 41731539

Questions about this trial

What is this clinical trial studying?

A study testing Data Accountability and Transparency and Community-Based Doula (CBD) Support in people with Pregnancy Related and Maternal Health, run by University of North Carolina, Chapel Hill at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 17 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Jennifer H Tang, MD, MSCR (919-962-4880, jennifer_tang@med.unc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Odds of delivery of low-birthweight infants among non-Hispanic Black patients in each study arm (time frame: Upon delivery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05484804, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2026.

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