Accountability for Care Through Undoing Racism & Equity for Moms
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age12-99
SponsorUniversity of North Carolina, Chapel Hill
About 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 39 prenatal practices across North Carolina. Practices have been 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 \~750-1,500 patients (up to 60,000 patients total), whose outcomes the investigators will follow and compare between arms until all these patients have reached 1-year post-delivery.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Have at least 180 Black patient deliver over 2 years
Be willing to be randomized
Be willing to adhere to the study protocol
Start prenatal care at one of the study clinics during study implementation
Disqualifiers
Already integrated with Community-Based Doulas
Already have an Early Warning System or Disparities Dashboard
Trial design
Design model
Factorial
Treatments tested in this trial
Data Accountability and Transparency
Other interventionCollaboration with Practice Facilitators; Maternal Early Warning System; Disparities Dashboard; Racial Equity Training
Community-Based Doula (CBD) Support
Other interventionCommunity-Based Doula support for high-risk patients; Racial Equity Training
Treatment groups
60,000 Participants
are divided into 4 treatment groupsGroup A: Standard CareNo intervention 0 interventions
Group B: Data Accountability and TransparencyActive comparator 1 intervention
Group C: Community-Based Doula (CBD) SupportActive comparator 1 intervention
Group D: Data Accountability and Transparency + Community-Based Doula SupportActive comparator 2 interventions
Trial outcomes
Primary outcomes
1
Odds of delivery of low-birthweight infants among non-Hispanic Black patients in each study arm
This Primary Outcome Measure will compare the odds of delivery of low-birthweight infants (less than 2,500 grams) among non-Hispanic Black patients in each study arm as listed in the maternal delivery summary and/or neonatal electronic health record data, with the primary comparison being between the Data Accountability and Transparency + Community-Based Doula Support arm and the Standard Care arm.
Time frame
Upon deliverySecondary outcomes
1
Odds of any discrimination during prenatal care among Black patients in each study arm
This Secondary Outcome Measure will compare the odds of any perceived discrimination as measured by Discrimination in Medical Settings Scale (i.e., a score greater than or equal to 8 up to a maximum score of 35, where a higher score indicates more frequent experiences of discrimination) among Black patients in each study arm, with the primary comparison being between the Data Accountability and Transparency + Community-Based Doula Support arm and the Standard Care arm.
Time frame
24 weeks of gestation until delivery2
Odds of incidence of depression during prenatal care among Black patients in each study arm
This Secondary Outcome Measure will compare the odds of incidence of depression as measured by the Edinburgh Perinatal Depression Scale (i.e., a score greater than or equal to 10 up to a maximum score of 30, where a higher score indicates greater depressive symptoms) during prenatal care among Black patients in each study arm, with the primary comparison being between the Data Accountability and Transparency + Community-Based Doula Support arm and the Standard Care arm.
Time frame
24 weeks of gestation until deliverySponsors and contacts
Click on the lead sponsor to view all of their trials.
University of North Carolina, Chapel Hill
Lead sponsor
Patient-Centered Outcomes Research Institute
Collaborator
UNC Health Foundation
Collaborator
The Duke Endowment
Collaborator
Source ClinicalTrials.gov