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 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 40 prenatal practices across North Carolina. Practices will be 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 patients (30,000 patients total), whose outcomes the investigators will follow and compare between arms until all these patients have reached 1-year post-delivery.

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 community-based doula support safe for humans?

Community-based doula support is generally considered safe and beneficial for maternal and infant health, as it provides continuous labor support and improves satisfaction with maternity care. ^{1 2 3 4 5}

How does the treatment 'Data Accountability + Doula Support for Maternal Health Disparities' differ from other treatments for maternal health disparities?

This treatment is unique because it combines data accountability with doula support to address maternal health disparities, focusing on providing continuous emotional and educational support from trained doulas, particularly for underserved communities. Unlike traditional medical treatments, this approach emphasizes social support and advocacy to improve maternal and infant health outcomes. ^{1 6 7 8 9}

What data supports the effectiveness of the treatment Community-Based Doula (CBD) Support, Doula Support, Community-Based Doula Care, CBD Support, Data Accountability and Transparency, Data Accountability, Transparency Intervention?

Research shows that doula care, especially for underserved communities, can improve birth outcomes and reduce health disparities. Continuous labor support by trained doulas is recognized as an effective strategy to enhance maternal and infant health and satisfaction with maternity care. ^{1 6 8 9 10}

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: 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 II: 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) Racial Equity Training.

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/parameters and abnormal values with real-time feedback; 3) use of a Perinatal Equity Dashboard that displays outcome data stratified by race; and 2) Racial Equity Training.

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

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]

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]

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]

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]

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]

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]

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]

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]

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]

Citations

1. United States pubmed.ncbi.nlm.nih.gov

Health Workforce Challenges Impact the Development of Robust Doula Services for Underserved and Marginalized Populations in the United States. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

"We really are seeing racism in the hospitals": Racial identity, racism, and doula care for diverse populations in Georgia. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

Overdue: Medicaid and Private Insurance Coverage of Doula Care to Strengthen Maternal and Infant Health. [2020]

4. Netherlands pubmed.ncbi.nlm.nih.gov

An Australian doula program for socially disadvantaged women: Developing realist evaluation theories. [2020]

5. United States pubmed.ncbi.nlm.nih.gov

Grounded in Community: Development of a Birth Justice-Focused Volunteer Birth Companion Program. [2023]

6. United States 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. [2022]

7. England pubmed.ncbi.nlm.nih.gov

Community-based bilingual doulas for migrant women in labour and birth - findings from a Swedish register-based cohort study. [2021]

8. England pubmed.ncbi.nlm.nih.gov

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

9. England 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). [2021]

10. United States pubmed.ncbi.nlm.nih.gov

Effectiveness of an Enhanced Community Doula Intervention in a Safety Net Setting: A Randomized Controlled Trial. [2023]