Clinical Trial Details
— Status: Recruiting
Administrative data
NCT number |
NCT05484804 |
Other study ID # |
22-1541 |
Secondary ID |
|
Status |
Recruiting |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
June 5, 2023 |
Est. completion date |
April 2026 |
Study information
Verified date |
July 2023 |
Source |
University of North Carolina, Chapel Hill |
Contact |
Jennifer H Tang, MD, MSCR |
Phone |
919-962-4880 |
Email |
jennifer_tang[@]med.unc.edu |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial Summary
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.
Description:
Pregnancy complications are increasing in the United States, and this is worse for Black
patients, who are 3-4 times more likely to die from pregnancy than White patients. Pregnancy
complications and deaths cause large physical, social, and financial burdens for patients and
their families. Black patients who experience higher levels of institutional racism and
discrimination from healthcare providers and institutions are more likely to have pregnancy
complications, such as delivering a baby with low birthweight. Low birthweight (less than 5
pounds 9 ounces) is related to many short-term and long-term health problems for both baby
and mother. The study, Accountability for Care through Undoing Racism and Equity for Moms
(ACURE4Moms), aims to decrease pregnancy complications for all patients, but especially for
Black patients, by decreasing institutional racism and bias in healthcare and improving
community-based social support during pregnancy. The primary outcome will be to decrease low
birthweight deliveries among Black women. The investigators will get information about low
birthweight and other pregnancy outcomes from prenatal practice electronic healthcare
records. A secondary outcome will be to decrease experiences with discrimination during
prenatal care among Black patients; this information will be collected from an internet
survey that will be completed at 4 time points between a patient's first prenatal visit and 3
months after delivery.
To meet the study aims, the investigators will test 2 types of interventions. The first type
(the "Data Accountability and Transparency interventions") will be focused on healthcare
providers and their clinics. The study will improve accountability by setting up electronic
Maternal Warning Systems to notify the clinics whenever a patient has a risk factor for low
birthweight that needs to be treated or misses a scheduled appointment. Nurse navigators and
provider champions from each clinic will make sure the clinic acts on the warning. Secondly,
the study will improve transparency by showing the clinics their pregnancy-related
complication data for different racial groups every 3 months through a "Disparities
Dashboard." This Dashboard will show the providers any differences in pregnancy complications
for people of different races in their clinic and encourage them to come up with ways to
improve the quality of their care to decrease those differences. The study will hire
"Practice Facilitators" to help the clinics improve their workflows and communication with
patients. Finally, all the staff at the clinics will undergo interactive racial equity
training to help them recognize any implicit biases they have and understand how racism
affects pregnancy care for patients of color.
The second type of interventions will be focused on improving community-level support for
high-risk pregnant patients. The study will do this by matching community-based doulas who
are trained to provide culturally-relevant care with high-risk patients after their first
prenatal appointment. The doulas will then provide support to these patients during pregnancy
and up to 1 year after birth by setting up peer support groups for clients with similar due
dates, attending 2 prenatal visits with them, supporting them for up to 24 hours during
labor, and performing a postpartum home visit (the "Community-Based Doula Support
interventions").
To test how these each of these interventions improves low birthweight alone and when
combined together, the study will randomize 40 prenatal practices across North Carolina, into
1 of 4 groups: 1) No interventions; 2) Data Accountability and Transparency interventions; 3)
Community-Based Doula Support interventions; or 4) Both the Data Accountability and
Transparency and Community-Based Doula Support interventions. The investigators predict that
about 30,000 patients will start prenatal care at one of the 40 practices during the study.
For the patient survey, the study plans to enroll 100 Black patients from each of the 40
practices, for a total of 4,000 patients. The investigators will also interview up to 250
practice staff, doulas, patients, and Practice Facilitators to understand how well the study
interventions fit their needs.
The study is led by a Stakeholder Advisory Board, which includes patients of color who have
had a pregnancy complication, community doulas, practice representatives, health insurance
payers, a patient advocacy group, healthcare organizations, and the North Carolina Department
of Public Health. The majority of members will be people of color. The Board will meet every
3 months throughout the study to advise us about patient-centered outcomes, assist with
dissemination of results, and advocate for related policy change.