Accountability for care through undoing racism and equity for moms: a study protocol for a cluster randomized trial of data accountability and community-based doula interventions in prenatal practices

BACKGROUND & AIMS: In the United States, Non-Hispanic Black (Black) people are 2-threefold more likely than Non-Hispanic White (White) people to have pregnancy complications, such as a baby with low birthweight. Multi-level, community-based interventions aimed at mitigating the impacts of interpersonal and structural racism may decrease bias, improve the quality of care, and improve pregnancy outcomes. The Accountability for Cancer Care through Undoing Racism and Equity and the Heart Health Now studies reduced disparities in cancer treatment and cardiovascular risk, respectively. The Accountability for Care through Undoing Racism and Equity for Moms Study (ACURE4Moms) was modified from these successful interventions and designed to test the impact of multi-level, community-engaged antiracism interventions delivered on disparities in low birth weight (LBW) (Aim 1), experiences with perinatal depression and experiences with discrimination in medical settings (Aim 2) and other patient-centered outcomes. We will also measure implementation barriers and facilitators (Aim 3). METHODS: ACURE4Moms is a 4-arm, cluster-randomized trial which has enrolled 39 prenatal practices randomized to implement the following interventions for 2 years: Arm 1-Standard Care; Arm 2-Data Accountability and Transparency; Arm 3-Community-Based Doula linkages; and Arm 4-Data and Doula interventions combined. Practice staff in Arms 2-4 will also receive quarterly Maternal Healthcare Equity Education and Training. A subgroup of 100 Black patients from each practice will participate in a longitudinal survey that measures mental health symptoms and experiences with discrimination during pregnancy and postpartum. A stakeholder advisory board including doulas, community members, and policymakers helps to make decisions regarding study design, implementation, and dissemination. Multi-level mixed models will be used to evaluate outcomes using administrative, vital records and survey data. The primary outcome is a reduction in low birth weight for Black infants. Secondary outcomes include reductions in hospitalizations and emergency department use, mental health symptoms, and experiences with discrimination during pregnancy and postpartum. Intermediate outcomes include implementation barriers and facilitators. DISCUSSION: The findings of the ACURE4Moms study will inform policy makers, health systems, clinicians and communities about the effectiveness of multi-level, practice-based interventions to reduce maternal health disparities and provide information regarding scalability. TRIAL REGISTRATION: This trial has been prospectively registered as (7/29/2022) with clinicaltrials.gov under the name Accountability for Care Through Undoing Racism & Equity for Moms (ACURE4Moms), Identifier: NCT05484804. URL: https://clinicaltrials.gov/ct2/show/NCT05484804 .