30000 Participants Needed

Data Accountability + Doula Support for Maternal Health Disparities

(ACURE4Moms Trial)

JH
LC
RS
Overseen ByRabab S Hussain, MIS
Age: Any Age
Sex: Female
Trial Phase: Academic
Sponsor: University of North Carolina, Chapel Hill
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

Will I have to stop taking my current medications?

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

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.12345

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.36789

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.134510

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.

Research Team

JH

Jennifer H Tang, MD, MSCR

Principal Investigator

University of North Carolina, Chapel Hill

RP

Rachel P Urrutia, MD, MSCR

Principal Investigator

University of North Carolina, Chapel Hill

Eligibility Criteria

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
See 4 more

Exclusion Criteria

Practices already integrated with Community-Based Doulas
Practices already have an Early Warning System or Disparities Dashboard

Timeline

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

Treatment Details

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.
Participant Groups
4Treatment groups
Active Control
Group I: Data Accountability and Transparency + Community-Based Doula SupportActive Control2 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) SupportActive Control1 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 TransparencyActive Control1 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 CareActive Control1 Intervention
Pregnant patients with Medicaid insurance are screened for risk factors for low birthweight, and high-risk patients receive intensive care management.

Find a Clinic Near You

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+

Findings from Research

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

References

Health Workforce Challenges Impact the Development of Robust Doula Services for Underserved and Marginalized Populations in the United States. [2023]
"We really are seeing racism in the hospitals": Racial identity, racism, and doula care for diverse populations in Georgia. [2023]
Overdue: Medicaid and Private Insurance Coverage of Doula Care to Strengthen Maternal and Infant Health. [2020]
An Australian doula program for socially disadvantaged women: Developing realist evaluation theories. [2020]
Grounded in Community: Development of a Birth Justice-Focused Volunteer Birth Companion Program. [2023]
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]
Community-based bilingual doulas for migrant women in labour and birth - findings from a Swedish register-based cohort study. [2021]
Foreign-born women's experiences of Community-Based Doulas in Sweden--a qualitative study. [2012]
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 Statespubmed.ncbi.nlm.nih.gov
Effectiveness of an Enhanced Community Doula Intervention in a Safety Net Setting: A Randomized Controlled Trial. [2023]
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