Clinical trial NCT05484804: Accountability for Care Through Undoing Racism & Equity for Moms
Official title: Reducing Racial Disparities in Maternal Care Through Data-Based Accountability and Doula Support
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Pregnancy Related
Maternal Health
Maternal Mortality
Low Birthweight
Racism
Implicit Bias
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: Patient-Centered Outcomes Research Institute
name: UNC Health Foundation
name: The Duke Endowment
First posted: 2022-08-02
Enrollment: 30000
Sex: FEMALE
Minimum age (years): 12
Maximum age (years): 99
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: Arm 1 (Standard Care): NC Medicaid Care Management Arm 2 (Data Accountability and Transparency): NC Medicaid Care Management + Practice-level Data Accountability interventions Arm 3 (Community-Based Doula Support): NC Medicaid Care Management + CBD support intervention for high-risk women during pregnancy and postpartum Arm 4 (Data Accountability and Transparency + Community-Based Doula Support): NC Medicaid Care Management + both Arm 2 and Arm 3 interventions
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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.

Detailed 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.

Eligibility criteria: Inclusion Criteria:

Practices:

* Have at least 180 Black deliveries over 2 years
* Be willing to be randomized
* Be willing to adhere to the study protocol

Patient participants:

* Start prenatal care at one of the 40 study practice groups during study implementation
* Self-identify as Black or African American
* Is able to give consent and complete surveys and interviews in English

Practice staff member participants:

* Employed as either a provider, nurse/medical assistant, or office administrator at one of the 40 clinic groups in this study

Doula participants:

* Provide doula care to patients at one the 40 clinic groups in this study

Exclusion Criteria:

Practices:

* Already integrated with Community-Based Doulas
* Already have an Early Warning System or Disparities Dashboard

Primary outcomes:
measure: Odds of delivery of low-birthweight infants among non-Hispanic Black patients in each study arm
timeFrame: Upon delivery
Secondary outcomes:
measure: Odds of any discrimination during prenatal care among non-Hispanic Black patients in each study arm
timeFrame: 24 weeks of gestation until delivery
measure: Odds of incidence of depression during prenatal care among non-Hispanic Black patients in each study arm
timeFrame: 24 weeks of gestation until delivery
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: University of North Carolina at Chapel Hill
state: North Carolina
Study officials:
affiliation: University of North Carolina, Chapel Hill
name: Jennifer H Tang, MD, MSCR
role: PRINCIPAL_INVESTIGATOR
affiliation: University of North Carolina, Chapel Hill
name: Rachel P Urrutia, MD, MSCR
role: PRINCIPAL_INVESTIGATOR
References: