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Data Accountability + Doula Support for Maternal Health Disparities (ACURE4Moms Trial)

N/A

Recruiting

Led By Jennifer H Tang, MD, MSCR

Research Sponsored by University of North Carolina, Chapel Hill

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Timeline

Screening 3 weeks

Treatment Varies

Follow Up duration of prenatal care, up to 36 weeks

Awards & highlights

No Placebo-Only Group

Summary

This trial 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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Since this trial involves non-medical interventions like data transparency and doula support rather than drugs or medical procedures, traditional side effects are not expected; however, there may be emotional or psychological impacts from participating.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ upon delivery

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~upon delivery

This trial's timeline: 3 weeks for screening, Varies for treatment, and upon delivery for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Odds of delivery of low-birthweight infants among non-Hispanic Black patients in each study arm

Secondary study objectives

Odds of any discrimination during prenatal care among non-Hispanic Black patients in each study arm

Odds of incidence of depression during prenatal care among non-Hispanic Black patients in each study arm

Other study objectives

Proportion of patients with high utilization of emergency care (EC) during pregnancy

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

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

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.

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