Data Accountability + Doula Support for Maternal Health Disparities

(ACURE4Moms Trial)

Overseen By Rabab S Hussain, MIS

Age: Any Age

Sex: Female

Trial Phase: Academic

Sponsor: University of North Carolina, Chapel Hill

Disqualifiers: Non-Black, Non-English speaking, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

30000 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to reduce disparities in pregnancy care and outcomes between Black and White expectant mothers. It tests various approaches, including standard care, data-driven improvements (Data Accountability and Transparency), and additional support from community doulas (trained companions who assist during and after childbirth, known as Community-Based Doula Support). Set in prenatal practices across North Carolina, the trial seeks to determine which combination of these methods is most effective. Black or African American pregnant patients on Medicaid who begin prenatal care at one of the participating clinics may find this trial suitable. As an unphased trial, it offers a unique opportunity to contribute to research that could enhance pregnancy care for future generations.

Will I have to stop taking my current medications?

The trial information does not specify whether participants need to stop taking their current medications.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that support from community-based doulas can positively impact the health of mothers and their babies. Doulas, trained to assist during pregnancy and childbirth, are linked to better experiences and outcomes for both mothers and infants. Studies have not identified any safety concerns or negative effects from using community-based doulas.

The Data Accountability and Transparency intervention differs slightly. It uses data to track and improve maternal health outcomes. Although this approach is newer and lacks specific safety data, it focuses on enhancing healthcare practices rather than involving physical procedures, suggesting a low risk of negative effects.

Both approaches aim to improve maternal health and reduce health disparities without introducing new medications or invasive procedures. Based on current research and their nature, they are generally considered safe. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Data Accountability and Doula Support trial because it tackles maternal health disparities using a fresh approach. Unlike standard care, which typically involves basic risk screening and management, this trial combines two innovative strategies: Community-Based Doula (CBD) support and enhanced data accountability methods. The CBD support provides pregnant patients with personalized care and education, fostering a trusted relationship and potentially improving outcomes. Meanwhile, the data accountability approach uses advanced tools like a Maternal Warning System and Data Dashboard to monitor and address health indicators proactively, ensuring more equitable care across diverse populations. This trial aims to find out if these combined strategies can effectively reduce the risks associated with low birthweight and improve maternal health equity.

What evidence suggests that this trial's treatments could be effective in reducing maternal health disparities?

Research has shown that having a community-based doula, one of the interventions in this trial, can improve birth outcomes, such as fewer C-sections and healthier birth weights. Doulas offer emotional, physical, and informational support to mothers before, during, and after childbirth. These benefits have been observed across various groups, particularly in communities with limited access to healthcare.

Another intervention in this trial is data accountability and transparency. Research indicates that using data to hold healthcare providers accountable can reduce disparities in maternal care. This approach aims to improve practices for better outcomes, such as reducing low birth weight in Black infants. Tools like data dashboards highlight these differences and encourage better healthcare practices. ^{2 3 4 6 7}

Who Is on the 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

Are You a Good Fit for This Trial?

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

Patient participants must be able to give consent and complete surveys and interviews in English

Doula participants must provide doula care to patients at one of the 40 clinic groups in this study

Practices must be willing to adhere to the study protocol

Exclusion Criteria

Practices already integrated with Community-Based Doulas

Practices already have an Early Warning System or Disparities Dashboard

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants receive interventions based on their assigned arm, including Data Accountability, Community-Based Doula Support, or both.

2 years

Regular visits as per intervention protocol

Follow-up

Participants are monitored for outcomes such as low birthweight and experiences of discrimination up to 1 year post-delivery.

1 year

What Are the Treatments Tested in This Trial?

Interventions

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

Trial Overview

ACURE4Moms tests interventions against racial disparities in maternal health: standard Medicaid management, plus either data accountability measures, community-based doula support during/after pregnancy, or both. The outcomes from these four approaches will be compared.

How Is the Trial Designed?

Group I: Community-Based Doula (CBD) Support Active Control 1 Intervention

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 II: Data Accountability and Transparency + Community-Based Doula Support Active Control 2 Interventions

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 III: Data Accountability and Transparency Active Control 1 Intervention

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 IV: Standard Care Active Control 1 Intervention

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

Who Is Running the Clinical Trial?

University of North Carolina, Chapel Hill

Lead Sponsor

Trials

1,588

Recruited

4,364,000+

Patient-Centered Outcomes Research Institute

Collaborator

Trials

592

Recruited

27,110,000+

The Duke Endowment

Collaborator

Trials

17

Recruited

48,100+

UNC Health Foundation

Collaborator

Trials

1

Recruited

30,000+

Published Research Related to This Trial

Continuous labor support from trained doulas significantly improves maternal and infant health outcomes, enhances satisfaction with maternity care, and can reduce healthcare costs.

To increase access to doula services, especially for at-risk women, eliminating cost barriers through Medicaid and private insurance coverage is essential, with various pathways identified for reimbursement.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Overdue: Medicaid and Private Insurance Coverage of Doula Care to Strengthen Maternal and Infant Health. Strauss, N., Sakala, C., Corry, MP.[2020]

Foreign-born women in Sweden reported that community-based doulas (CBDs) not only supported them during labor but also provided crucial information and continuity of care, enhancing their satisfaction and trust in maternity health services.

The training of CBDs can improve equitable maternity care, highlighting its importance in diverse populations, not just in Sweden but in other countries with similar demographic changes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Foreign-born women's experiences of Community-Based Doulas in Sweden--a qualitative study. Akhavan, S., Edge, D.[2012]

A randomized trial involving 367 participants at an urban safety net hospital found that community doula support did not significantly change overall birth outcomes compared to standard care, but showed promising trends for Black non-Hispanic participants, including a 12% reduction in cesarean births and an 11.5% increase in exclusive breastfeeding rates.

The study highlights the potential benefits of community doula support in improving health equity for Black birthing people, suggesting that further research is needed to explore these effects more comprehensively.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of an Enhanced Community Doula Intervention in a Safety Net Setting: A Randomized Controlled Trial. Mottl-Santiago, J., Dukhovny, D., Cabral, H., et al.[2023]

This randomized controlled trial aims to evaluate the effectiveness of community-based doulas (CBDs) in improving the childbirth experiences and postnatal well-being of 200 migrant women in Sweden, addressing issues like communication barriers and feelings of fear and isolation during labor.

The study will assess the impact of CBD support on women's ratings of care and postnatal mental health, using validated questionnaires, with results expected to inform better maternity care practices for migrant populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Community-based doula support for migrant women during labour and birth: study protocol for a randomised controlled trial in Stockholm, Sweden (NCT03461640). Schytt, E., Wahlberg, A., Eltayb, A., et al.[2021]

The study developed seven theories explaining how volunteer doula support can improve outcomes for socially disadvantaged women, focusing on critical implementation elements and the benefits for both women and doulas.

These theories suggest that effective doula support enhances maternity care by providing companionship, facilitating social connections, and holding the healthcare system accountable, which can lead to better experiences during pregnancy and early parenting.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An Australian doula program for socially disadvantaged women: Developing realist evaluation theories. O'Rourke, KM., Yelland, J., Newton, M., et al.[2020]

Continuous labor support from trained doulas or birth companions significantly improves birth outcomes, especially for historically underserved communities, by addressing health disparities and structural racism in perinatal care.

A volunteer birth companion program, developed through collaboration with community organizations and healthcare providers, aims to increase access to labor support, emphasizing the importance of client-centered care and the need for universal insurance coverage for doula services to enhance accessibility and improve outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Grounded in Community: Development of a Birth Justice-Focused Volunteer Birth Companion Program. Kivlighan, KT., Gardner, T., Murphy, C., et al.[2023]

Migrant women who received community-based bilingual doula (CBD) support during labor showed a significant reduction in the use of pain relief methods compared to those who did not receive CBD support, indicating potential benefits in managing pain during childbirth.

Despite having higher risk factors for adverse pregnancy outcomes, CBD support was not linked to negative birth outcomes such as non-instrumental births or low Apgar scores, suggesting that CBD services may help improve the childbirth experience for vulnerable migrant women.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Community-based bilingual doulas for migrant women in labour and birth - findings from a Swedish register-based cohort study. Byrskog, U., Small, R., Schytt, E.[2021]

Doulas have been shown to positively impact maternal health outcomes, especially for underserved populations, highlighting the need to expand access to doula services.

Barriers such as high training costs, varying roles, and insufficient funding hinder the development of robust doula services in the U.S., particularly affecting community-based organizations that aim to support underserved communities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Health Workforce Challenges Impact the Development of Robust Doula Services for Underserved and Marginalized Populations in the United States. Van Eijk, MS., Guenther, GA., Jopson, AD., et al.[2023]

SisterWeb's community-based doula program effectively addresses racial inequities in maternal health by providing culturally congruent support, highlighting the importance of meeting the unique needs of diverse clientele.

Key factors for success include establishing strategic partnerships with maternal health stakeholders and ensuring sustainable payment models for community doulas, which are essential for the program's long-term viability.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Barriers and Facilitators to the Implementation of a Community Doula Program for Black and Pacific Islander Pregnant People in San Francisco: Findings from a Partnered Process Evaluation. Marshall, C., Arteaga, S., Arcara, J., et al.[2022]

Black doulas play a crucial role in supporting Black birthing individuals, with 70% of them serving primarily Black clients, highlighting the need for advocacy in the face of high Black maternal mortality rates and mistrust in medical systems.

The study emphasizes the necessity for improved doula training that incorporates cultural sensitivity and humility, as well as expanding access to doula care for Asian and Latinx communities to address language and cultural barriers affecting maternal health outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

"We really are seeing racism in the hospitals": Racial identity, racism, and doula care for diverse populations in Georgia. Sayyad, A., Lindsey, A., Narasimhan, S., et al.[2023]

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC10292163/

The Effect of Doulas on Maternal and Birth Outcomes

The studies in this review indicated that doula guidance in perinatal care was associated with positive delivery outcomes including reduced cesarean sections.

2.

countyhealthrankings.org

countyhealthrankings.org/strategies-and-solutions/what-works-for-health/strategies/community-based-doulas

Community-based doulas

Our evidence rating is not based on these outcomes, but these benefits may also be possible: Reduced low birthweight births. Reduced preterm ...

3.

aspe.hhs.gov

aspe.hhs.gov/sites/default/files/documents/dfcd768f1caf6fabf3d281f762e8d068/ASPE-Doula-Issue-Brief-12-13-22.pdf

Doula Care and Maternal Health: An Evidence Review

KEY POINTS. • Doulas provide emotional, physical, and informational support before, during, and after labor and birth.

4.

sciencedirect.com

sciencedirect.com/science/article/pii/S1049386724000215

United States Doula Programs and Their Outcomes

Studies have found that doula care is associated with lower rates of low birthweight newborns across settings and populations, in community-based settings and ...

5.

commonwealthfund.org

commonwealthfund.org/publications/issue-briefs/2021/mar/community-models-improve-maternal-outcomes-equity

Community-Based Models Improve Maternal Outcomes ...

Community-based models of care, including group prenatal care and pregnancy medical homes, may improve maternal health outcomes.

6.

reporter.nih.gov

reporter.nih.gov/project-details/10175760

amutah-onukagha, ndidiamaka - NIH RePORTER

Abstract (Project Summary) Black women experience stark disparities in pregnancy care, complications, and outcomes, compared to White women.

7.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC9257331/

Doula care across the maternity care continuum and impact ...

The use of doulas appears an effective strategy for improving maternal health, especially among socioeconomically vulnerable and marginalized minority ...