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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
Practices must be willing to be randomized
Timeline
Screening 3 weeks
Treatment Varies
Follow Up upon delivery
Awards & highlights

ACURE4Moms Trial 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.Check my eligibility
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.See study design
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.

ACURE4Moms Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My healthcare provider agrees to be part of a random selection process for treatment.

ACURE4Moms Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~duration of prenatal care, up to 36 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and duration of prenatal care, up to 36 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Odds of delivery of low-birthweight infants among non-Hispanic Black patients in each study arm
Secondary outcome measures
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 outcome measures
Proportion of patients with high utilization of emergency care (EC) during pregnancy

ACURE4Moms Trial Design

4Treatment groups
Active Control
Group I: 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 II: 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 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 Location

Who is running the clinical trial?

Patient-Centered Outcomes Research InstituteOTHER
548 Previous Clinical Trials
29,966,388 Total Patients Enrolled
University of North Carolina, Chapel HillLead Sponsor
1,500 Previous Clinical Trials
4,156,718 Total Patients Enrolled
The Duke EndowmentOTHER
12 Previous Clinical Trials
9,942 Total Patients Enrolled

Media Library

Community-Based Doula (CBD) Support Clinical Trial Eligibility Overview. Trial Name: NCT05484804 — N/A
Implicit Bias Research Study Groups: Community-Based Doula (CBD) Support, Data Accountability and Transparency + Community-Based Doula Support, Data Accountability and Transparency, Standard Care
Implicit Bias Clinical Trial 2023: Community-Based Doula (CBD) Support Highlights & Side Effects. Trial Name: NCT05484804 — N/A
Community-Based Doula (CBD) Support 2023 Treatment Timeline for Medical Study. Trial Name: NCT05484804 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does the criteria for this research study include individuals aged 45 and above?

"According to the study's inclusion criteria, eligible participants must be between 12 and 99 years old. There are 67 studies for minors comprised of those under 18, while 105 studies target individuals over 65."

Answered by AI

Is enrollment available for this experimental research?

"According to clinicaltrials.gov, this particular research venture is now closed for recruitment after having been initiated on December 1st 2022 and last updated on September 6th 2022. However, there are still 189 other studies actively recruiting subjects at the current moment in time."

Answered by AI

Who has the capacity to qualify for this research program?

"Eligibility for this medical trial requires that participants have a maternal health background and are within the age range of 12 and 99. The study is recruiting around 30000 applicants in total."

Answered by AI
~20000 spots leftby Apr 2026