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

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 | Research Square window.SnipcartSettings = { analytics: { enabled: false } }; (function() { var accessVector = localStorage.getItem('access_vector') || ''; window.dataLayer = window.dataLayer || []; if (accessVector) { window.dataLayer.push({ user: { profile: { profileInfo: { snid: accessVector } } } }); } })(); (function(w,d,s,l,i){w[l]=w[l]||[];w[l].push({'gtm.start':new Date().getTime(),event:'gtm.js'});var f=d.getElementsByTagName(s)[0],j=d.createElement(s),dl=l!='dataLayer'?'&l='+l:'';j.async=true;j.src='https://www.googletagmanager.com/gtm.js?id='+i+dl;f.parentNode.insertBefore(j,f);})(window,document,'script','dataLayer','GTM-K279D39R'); Browse Preprints In Review Journals COVID-19 Preprints AJE Video Bytes Research Tools Research Promotion AJE Professional Editing AJE Rubriq About Preprint Platform In Review Editorial Policies Our Team Advisory Board Help Center Sign In Submit a Preprint Cite Share Download PDF Research Article 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practices Rachel Peragallo Urrutia, Angela Tatum Malloy, Cindy McMillan, and 15 more This is a preprint; it has not been peer reviewed by a journal. https://doi.org/ 10.21203/rs.3.rs-6669094/v1 This work is licensed under a CC BY 4.0 License Status: Published Journal Publication published 24 Feb, 2026 Read the published version in Trials → Version 1 posted 5 You are reading this latest preprint version Abstract Background: In the United States, Non-Hispanic Black (Black) people are 2-3-fold 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 to prenatal practices on maternal and infant health disparities. 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. maternal health healthcare disparities doulas informatics low birth weight racism pragmatic clinical trial Figures Figure 1 Figure 2 Figure 3 Figure 4 Figure 5 Background Non-Hispanic Black (Black) birthing people in the United States (US) have maternal morbidity and mortality ratios that are 2-3-fold higher than that of Non-Hispanic White (White) birthing people.[1, 2] Multi-level, community-based interventions aimed at mitigating structural racism and improving maternal and infant disparities are urgently needed. However, maternal morbidity and mortality are relatively rare (1% and 0.04%, respectively), making it difficult to design a clinical trial with adequate statistical power to improve these outcomes. Infant low birth weight (LBW) affects more patients and is an important marker of maternal health.[3, 4] LBW deliveries, a combination of preterm births and/or fetal growth restriction, are associated with twice the long-term risk for maternal cardiovascular disease (CVD). LBW and preterm birth combined are the second most common cause of infant death in the US, with significant morbidity for surviving infants.[ 5 ] Black infants are also twice as likely than White infants to have a low birth weight (< 2,500 grams, 11.4% versus 5.2% in 2016).[ 6 ] In North Carolina (NC), LBW rates are higher than the national average (15.3% for Black infants versus 7.5% for White infants in 2020).[ 7 ] Experiences with racism have been linked to LBW.[8, 9] One longitudinal study of 420 US women of color found that for every 1-point increase in the Everyday Discrimination Scale during the second trimester, birthweight decreased by approximately 50 grams.[ 8 ] In the CARDIA study, those reporting high levels of discrimination around the time of a singleton birth had almost 5 times the odds of a LBW compared to those reporting no racial discrimination.[ 9 ] Although race is a social construct with no biological basis, experiences with racism can affect biological outcomes.[ 10 ] , [ 11 ] Alhusen, et al. proposed an explanatory model (Fig. 1 )[ 12 ], which distinguishes between two forms of racism: interpersonal and institutional, both of which can lead to differential treatment and access to resources and opportunities. This leads to interrelated negative health consequences including increased inflammation, uteroplacental dysfunction, and maladaptive health behaviors, which contribute to the risk for adverse pregnancy outcomes. 12 By starting to dismantle the many sources of racism facing Black patients every day, it should be possible to reduce the biological impacts of institutional and interpersonal racism. Systematically using data accountability transparency interventions could improve racial inequities in outcomes.[13, 14] Inpatient race equity dashboards have reduced disparities in maternal morbidity when used during the birth hospitalization.[15, 16] Outpatient race equity dashboards and early warning systems have reduced disparities in cancer treatment[ 17 ] and cardiovascular risk[ 18 ] but have not been modified for use during prenatal care. Institutional racism and implicit biases from prenatal providers could be reduced through the transparency of race-stratified data dashboards of outcomes from their own practices, increasing awareness of inequitable race-specific outcomes, while concomitantly undergoing racial equity training. Early warning systems could reduce differential treatment by alerting practices about all patients who could benefit from preventive services. Patients with warnings could be linked to additional community resources as needed.[ 19 ] In the Accountability for Cancer Care Through Undoing Racism and Equity (ACCURE) study, disparities dashboards, race equity training, an early warning system and care navigators at the level of the oncology practice eliminated the disparity between Black and White patients who completed therapy for treatable breast and lung cancers and improved treatment completion for patients of all races.[ 17 ] In the Heart Health Now Study, disparities dashboards, early warning systems, and quality improvement practice coaches reduced disparities in cardiovascular risk in a cluster randomized trial of over 200 primary care practices in North Carolina.[ 18 ]. See Table 1 . Table 1 Data Accountability Interventions from ACCURE and Heart Health Now Studies [17, 18] Interventions Causal Effect Automated real-time registry with an Early Warning System for missed appointments and milestones Decreased institutional racism by preventing differential treatment Nurse Navigator specially trained in exploring and responding to patients’ social and belief-specific barriers and in using ACCURE’s real-time registry Increased personal resources/support and decrease interpersonal racism to prevent differential treatment Site-specific Clinical Feedback reports, according to race and co-morbidity status, delivered by ACCURE Physician Champion to clinicians. Decreased institutional racism by showing differential treatment by race and encouraging the providers to address it Quality Improvement Coaches Decreased structural bias by implementing system-based strategies to reduce bias in care Racial Equity Training + quarterly booster sessions for providers Reduced interpersonal racism + implicit bias among providers The health effects of experiencing institutional and interpersonal racism may be further mitigated via interventions that increase personal resources (Fig. 1 : social support, coping strategies, and self-esteem), such as support from community-based doulas. Doulas are trained professionals who provide emotional, physical, and informational support during pregnancy and postpartum. Community-based doulas are a subset of doulas who are often racially or ethnically concordant, share lived experiences with their clients, are trusted members of their communities, and provide linkages to community resources to mitigate racism.[ 20 ] When relationships are created between community doulas and prenatal practices, they can work together to address: 1) institutional racism by providing patient-centered advocacy, 2) interpersonal racism by developing cross-cultural relationships with the health team, and 3) personal resources through offering social support and coping strategies to patients who are at high risk of delivering a LBW baby.[ 21 ] Community-based doula support has been associated with reduced LBW in several observational studies but has not been tested in a randomized controlled trial. 22–24 Therefore, we have developed the Accountability for Care through Undoing Racism and Equity for Moms (ACURE4Moms) study, a cluster-randomized trial aimed at comparing the effectiveness of two practiced-based interventions (Data Accountability and Transparency, and Community-Based Doula Support) both separately and together, to reduce disparities in LBW (Aim 1). Secondary outcomes include emergency care and hospitalizations during pregnancy and postpartum. A subset of Black patients in each cluster will be surveyed longitudinally to measure experiences with discrimination and other patient-centered outcomes (Aim 2).. We will also measure implementation barriers and facilitators (Aim 3). Methods Study Design : ACURE4Moms is a pragmatic, cluster-randomized, superiority trial taking place at 40 prenatal practices across NC. The study will take place over 5 years, with the first year (April 1, 2022-May 31, 2023) devoted to pre-implementation activities, including recruiting practices, developing protocols, building the Data Accountability Systems, and recruiting community-based doulas. Implementation at the first sites in June 2023, with sites starting the intervention in a rolling fashion between June 2023 and December 2024. Implementation will continue for 2 years (through December 2026 at the last site). See Fig. 2 for details about timeline of enrollment and implementation at each site. Our primary aim is to compare the impact of data accountability and doula support, both separately and in combination, on LBW (< 2,500g) for NHB patients. Secondarily, we will recruit a nested cohort study of up to 4,400 Black patients (100/practice) to complete a survey at 4 time points measuring mental health symptoms, experiences with discrimination, and other patient-centered outcomes at the following time points: 1) Between 14–23 weeks gestational age, 2) 24 weeks gestational age until birth, 3) 2–11 weeks postpartum, and 4) 12–18 weeks post-birth. See SPIRIT Figure (Fig. 3 ). Our secondary aim is to longitudinally assess self-reported discrimination and mood symptoms among Black patients during pregnancy and for up to 30 months postpartum and examine the mediating effect between the intervention and infant LBW using the Discrimination in Medical Settings scale and the Edinburgh Postpartum Depression Survey.[22, 23] Our third aim is to assess and identify intervention implementation factors that support or inhibit intervention uptake and sustainability. We used the SPIRIT checklist when writing our report.[ 24 ] Community Partner Engagement From the inception of our project, we determined it essential to involve representatives from among the populations most impacted by maternal health disparities. The academic Principal Investigators began collaborating with two community-based doula leaders who function as Community Principal Investigators in ACURE4Moms. These individuals identify as Black and have lived experience with adverse pregnancy outcomes themselves or within their immediate family. They are primarily responsible for designing the community-based doula intervention, as well as hiring, training, and managing the study doulas in their region. One was assigned to the Western NC practices and the other to the Eastern NC practices. We also work closely with members of the Greensboro Health Disparities Collaborative, an NC-based organization devoted to improving health disparities. This organization, together with academic researchers, designed the original Accountability for Cancer Care through Undoing Racism and Equity study,[ 17 ] on which our data accountability and transparency interventions are based. They are supportive of our effort to modify these interventions for maternal health disparities.[ 25 ] Our research team has since built relationships with patient advocacy groups, community-based organizations, provider professional organizations, public health leadership, health insurance payers, patients, and doulas. These stakeholders meet quarterly with the research team as part of our Stakeholder Advisory Board Leading with Equity (STABLE, Fig. 4 ). The Board is co-chaired by a community-based doula and an academic health disparities researcher who are both Black, and it includes 22 members, the majority of whom are Black women with lived experience of adverse pregnancy outcomes. The Board has the authority to approve all aspects of study design and implementation. Each stakeholder is respected as an expert and their time is equally compensated, regardless of educational or occupational background. Setting The study is occurring at 40 prenatal practices in NC. NC is a diverse state on many levels: 78 out of 100 counties are rural, and 24%, 16%, and 1% of births are to Black, Hispanic, American Indian/Alaska Native people, respectively. NC Medicaid covers about half of all births in NC; of these, 20% are only covered for birth under “Emergency Medicaid” due to ineligibility for full Medicaid. As mentioned previously, Black North Carolinians experience large disparities in maternal and infant outcomes including morbidity, mortality, LBW, preterm birth, as well as disparities in other social determinants of health, such as sustained access to transportation, employment, and quality education. [26, 27] NC launched the Care Management for High Risk Pregnancies Program in 2011, which uses a screening tool to identify individuals at risk for LBW. A predictive model identifies those most likely to benefit from care management and offers intensive care management to them. 30 All of the approximately 40% of pregnant patients covered by NC Medicaid are screened for eligibility for this program. Recruitment and Eligibility Our team divided NC into Eastern and Western halves with approximately half of all sites located in each region (Fig. 5). This division allows the two community-based doula organizations to supervise a similar number of practices and doulas. The study team identified potentially eligible practices based on the racial composition and numbers of births per county. Practices were recruited by emails, personal phone calls, and in-person visits. Inclusion criteria for prenatal practices are: 1) Care for at least 7–8 Black birthing people who deliver each month; 2) Full participation with the NC Health Information Exchange Authority; 3) Willingness to be randomized; 4) No current community-based doula partnership or outpatient race equity dashboards. New quality improvement measures are not prohibited. In most cases, the sites also provide labor and delivery care. In a few cases, the labor and delivery care is provided by a different group of clinicians. However, the interventions are designed to decrease LBW, so the focus is delivering interventions to health care professionals caring for people in the outpatient setting prior to labor. Based on historical birth volumes, we estimate that the included practices will perform an average of 30–60 deliveries per month, which will result in ~ 30,000–60,000 patients (8,400 − 16,800 Black) who initiate prenatal care during the 2 years of the study. All patients who receive care at each site during the study period will be included in the study. A waiver of informed consent was obtained given the fact that the interventions are provided at the level of the practice, are within the standard of care for pregnancy, require practices to be able to have reliable data about population to improve quality of care, and pose minimal risk to participants. Minors < 15 years were excluded from this waiver. Recruitment for the Longitudinal Patient Survey will occur across each of the practices with the goal of recruiting 100 Black mothers from each practice (N = 4,400). Community-Based Recruitment Consultants (CBRCs) who are also community doulas have been contracted to recruit study participants from a list of potentially eligible participants provided by each practice via telephone. We strive to assign CBRCs to recruit patients from practices where they do not provide pregnancy and birth support. For the implementation research, we will enroll up to 132 practice staff, 50 doulas, and 90 patients for in-depth interviews pre-, mid-, and post-implementation to help determine fit, feasibility, and fidelity of the interventions. Interventions Arm 1 is standard prenatal care including routine social determinants of health (SDoH) assessment for Medicaid patients and intensive care management for those with the highest risk of LBW. Arm 2 will include a suite of data accountability and transparency interventions modified from the ACCURE and HHN studies including disparities dashboards, early warning alert systems, quality improvement practice coaches, and quarterly maternal health equity education and training (MHEET) for staff. Arm 3 will include linkages with community-based doulas, referral workflows, funded doula support for up to 144 births (6 per month), and quarterly MHEET training for staff. Arm 4 will include both data accountability and community doula interventions as well as the MHEET training for staff. For complete detail about each of the arms, see Table 2 . Table 2. ACURE4Moms Study Comparators, Interventions, and Clinical Strategies Comparator Arm Clinical Strategies Included in Arm Arm 1 (Standard Care) > 95% of NC OB practices use the Pregnancy Medical Home (PMH) care model for patients with Medicaid (~ 50% of deliveries)[ 28 ] • First prenatal visit risk screening for low birth weight in all Medicaid patients • Intensive care management to address SDOH in high risk Arm 2 (Data Accountability and Transparency [Data]) 1. Standard Care : PMH if Medicaid insured. 2. Practice Facilitator (PF) : These QI officers from NC Area Health Education Centers ( AHEC ) work with, 1) Practice teams to help implement our real-time Maternal Warning System ( MWS , see below) using rapid QI cycles, and, 2) Practice Provider Champions to present Disparities Dashboard data (see description below).[ 29 ] 3. Maternal Warning System (MWS) : Health Information Exchange Authority ( HIEA ) builds the MWS for each practice with HIEA data from their own and other health care facilities throughout NC. Data from nightly uploads from the HIEA are aggregated, analyzed, and shared with practices through a unique portal for each practice. Alerts include: elevated BP (≥ 140 systolic and/or ≥ 90 diastolic), critical BP (≥ 160 systolic and ≥ 110 diastolic), failure to follow-up within 2 weeks of elevated BP, delay with expected prenatal visit schedule (≥ 6 weeks until 32 weeks; ≥3 weeks 32–36 weeks; ≥2 weeks 36 weeks until birth), patients who qualify for aspirin to prevent preeclampsia who do not have it listed in the medication list. The Nurse and/or Admin Champions review the MWS alerts regularly and follow the pre-specified workflow for each patient’s alert.[17, 29] 4. Disparities Dashboard : Disparities Dashboard reports will be generated from the practice EHR data, stratified by race/ethnicity. Dashboard outcomes, such as the proportion with low birth weight, recommended prenatal visits, controlled BP, and APOs, are defined using ICD and CPT codes and other fields that require direct entry into the EHR. The Provider Champion will present outcomes to practice staff and leadership.[17, 18] 5. Maternal Health Equity Education and Training (MHEET) : Nine quarterly, 1-hour facilitated sessions modified from the ACCURE study, based on the People’s Institute for Survival and Beyond [PISAB] Undoing Racism™ principles[ 30 ] as a conceptual model for medical care for all practice staff (clinicians, nursing, front desk staff, etc.) Session topics include: Maternal Health Inequities Facts, Structural and Systemic Causes of Disparities, Identifying Structural and Systemic Racism in Patient Stories, Implicit Bias, and Communication. Training is grounded in sharing of race-stratified outcomes data from their own practice and interpreting them through a racial-equity lens. Provider Champions, Nurse Navigators, and an Administrative Lead from each practice are supported and encouraged to complete the 2-day Racial Equity Institute Phase 1 Training. Arm 3 (Community-Based Doula Support [Doula]) 1. Standard Care : PMH if Medicaid insured. 2. Maternal Health Equity Education and Training (MHEET) : (as above) 3. Practice partnership with CBDs to support high-risk patients and improve accountability : Designed by Co-Investigators Angela Malloy and Cindy McMillan , NHB women who are CBD leaders at Momma’s Village Fayetteville and MAAME, Inc. , respectively. Forty CBDs with training in birth support, breastfeeding, perinatal mood disorders, Afrocentric Care, postpartum care, and childbirth education have been recruited to provide services for the study, with a focus on serving patients at high-risk for LBW. • Practices refer individuals to the CBD organizations before 28 weeks of gestation for any of these risk factors: 1) Self-identified Black/African American race; 2) medical comorbidity (e.g., Chronic Hypertension, Kidney Disease, Heart Disease); 3) prior history of LBW infant (< 5lb 8oz/2,500grams), preterm birth (< 37 weeks), infant death, and/or stillbirth (2 points); 4) limited social support (e.g., limited partner/family involvement) (2 points); 5) housing instability (2 points); 6) Substance Use Disorder (including tobacco) (2 points); 7) teen Pregnancy (< 19 years old at birth) (1 point); and/or 8) other clinician specified risk (e.g., Intimate Partner Violence) (1 point). • Each patient matched with a CBD receives the following services: 3–4 CBD visits during the antenata l period (including 1 with their OB clinician to help establish collaboration); up to 24 hours of labor support; 1–2 hours of immediate postpartum support; a home visit 7–10 days after delivery; ongoing telephone and/or online support throughout pregnancy and postpartum; and participation in CBD-organized peer support groups , which continue until 1 year post-birth. • CBDs use online HIPPA-compliant EHR systems (IntakeQ and Maternity Neighborhood) to document notes from each patient interaction. Practice staff undergo a co-learning curriculum designed by the CBDs to educate them about scope of practice and communication between health care professionals and CBDs. CBD services are funded by several Medicaid payers and ACURE4Moms ( $ 1000 per client). Arm 4 (ALL) Standard Care + MHEET + Data + Doula as above. Abbreviations: NC (North Carolina); OB (Obstetric); LBW (low birth weight); ACCURE (Accountability for Cancer Care through Undoing Racism and Equity); HHN (Heart Health Now); PF (Practice Facilitator); EHR (Electronic Health Record); HEIA (NC Health Information Exchange Authority); MWS (Maternal Early Warning System); EC (Emergency Care); PISAB (The People’s Institute for Survival and Beyond); CBD (Community Based Doula) Both interventions were designed to be deployed at the practice level and improve outcomes for everyone in the population. The data accountability interventions and the MHEET training sessions were based on the Accountability for Cancer Care through Undoing Racism and Equity Study (ACCURE), which successfully reduced Black-White lung and breast cancer treatment disparities.[ 17 ] Regarding the doula support intervention (arms 3 and 4), this could not be feasibly offered to every person at risk for a LBW in each practice. However, we aimed 1) to support a clinically significant percentage of births to Black-identifying individuals at each practice understanding that not all Black-identifying patients would desire doula support and some who are not Black-identifying would receive doula support and 2) to create relationships and transparency between doulas and clinical providers that would ultimately lead to improvements in care for all patients, not only those who received doula support. The following calculations were used to plan the amount of doula support. Given that we targeted practices with an average of 60 births per month, and that approximately 25% of births in NC are to Non-Hispanic African American individuals, we estimated that this would be about 15 Black patients per month at each clinic. Doulas being able to support about 6 births per month (144 over the course of the 2 year study) would result in approximately 40% of births to Black individuals to be supported which we felt would be a significant dose. Randomization To ensure similar numbers of randomized participants in each arm and similar numbers of doula assigned practices in each of 2 geographic areas, the practices were stratified by Eastern NC and Western NC and then by size prior to randomization. For each geographic stratum (East v. West), we ordered the clinics by number of deliveries per month from highest to lowest, then created groups of 4 clinics in that order and randomized to 1 of 4 arms. Our statistician performed the initial randomization using the online tool ( www.random.org ) to generate all random numbers; it provides a “true” random number generator that derives its randomness from atmospheric noise. The first round of randomization for 42 clinics was performed on December 2, 2022 with 42 sites. Due to dropout prior to implementation, additional recruitment was needed. Therefore, 2 additional rounds of randomization were performed for an additional 7 sites. In these cases, the arms with the fewest sites were identified, and the practices were randomized into those arms. At each point, practices were notified of their allocation after the randomization was complete but before implementation. Given the design of offering differing interventions to practices, participating practices, their patients, and research staff could not be masked to the allocation. Data Sources and Outcomes: Table 2 includes details about the outcomes and data sources, and Appendix B lists the electronic health record outcomes and billing codes. Health Outcomes Data on health outcomes (i.e. LBW, emergency care use (emergency department and labor and delivery), hospitalizations, severe maternal morbidity, mode of delivery, hypertensive disorders) will be accessed from the NC Health Information Exchange Authority and NC Vital Records (birth and death certificates). The Health Information Exchange is a state agency responsible for promoting the access to, exchange of, and analysis of health information among providers .[ 31 ] All health care providers who are in network with NC Medicaid plans and/or the State Health Plan are required to share electronic health data. Some data will also be extracted from NC vital records (birth and death certificates). See Table 3 . Table 3. ACURE4Moms Study Outcomes, Measures, and Timing of Assessment Type of Outcome Name of Outcome Specific measure to be used Timepoints Powered? Yes or No Aim 1: Maternal and Infant Health Outcomes Primary Low Birthweight Infant birthweight <2500g from EHR and birth certificate data Birth Yes Secondary High utilization of EC during pregnancy Proportion of pregnant women with ≥4 EC visits during pregnancy from EHR data From time of 1 st OB visit until birth No Secondary # Maternal hospitalizations & EC Visits during 1 st year post-birth # Maternal hospitalizations & EC visits within 1 year post-birth from EHR data From time of 1 st OB visit to 1 year post-birth No Secondary # Infant hospitalizations & EC Visits during 1 st year post-birth # Infant hospitalizations & EC visits within 1 year post-birth from EHR data From time of birth to 1 year post-birth No ESecondary Postpartum visit attendance Postpartum visit documented in EHR data 14-60 days postpartum No Secondary Severe Maternal Morbidity ICD codes for 21 CDC indicators from EHR data[32] with and without transfusion Birth Hospitalization No Secondary Hypertensive disorders of pregnancy ICD codes for eclampsia, preeclampsia, gestational hypertension from EHR data (See Appendix B) Pregnancy until 6 weeks postpartum No Secondary Nulliparous Singleton Term Vertex Cesarean Section Birth Certificate Data Birth No Aim 2: Longitudinal Patient Survey Patient-Centered Outcomes Primary Racism during OB care Discrimination in Medical Settings Scale from LPS[23] 24-30 weeks of gestation Yes Secondary Depression Edinburgh Postnatal Depression Scale in from LPS[22] 24-30 weeks of gestation Yes Secondary Satisfaction with Care ICHOM Standard Set question from LPS[33] 24-30 weeks of gestation No Aim 3: Implementation Outcomes Primary Identification of intervention barriers and facilitators Completion of key informant interviews and focus groups including Hexagon Tool and structured interview guides Before/midpoint/endpoint of implementation period No Secondary Racism knowledge Knowledge score from Racial Equity Training pre-/post-tests Before/after training No Abbreviations: EHR (Electronic Health Record); EC (Emergency Care); # (number); ICD (International Classification of Disease Codes Clinical Modification 10); OB (Obstetric); CPT (Current Procedure Technology); LPS (ACURE4Moms Longitudinal Patient Survey); ICHOM (International Consortium for Health Outcomes Measurement) Race-identification will be used in our study as a proxy for experiencing anti-Black racism. Race/ethnicity of included patients will be determined by the demographic data provided by practices. Practices will be encouraged and supported by our Quality Improvement experts (the North Carolina Area Health Education Centers Practice Support Program-www.ncahec.net/core_service/practice-support/) to use the best practice of asking patients to self-identify any race(s) and/or ethnicit(ies) with which they identify. However, this recommendation may not always be followed stringently by practices. Therefore, the subset of participants recruited to participate in the Longitudinal Patient Survey will be given an opportunity to self-identify their race(s) and/or ethnicit(ies) with trained recruitment consultants, and any discrepancies with electronic health data will be explored. Patient-Centered Outcomes: Longitudinal patient surveys include survey responses from 4 time points. Surveys data will include the Birth Satisfaction Scale, the Patient-Reported Outcomes Measurement Information System-10 quality of life scale, the Edinburgh Postnatal Depression Scale, the Discrimination in Medical Settings Scale, and items from the International Consortium for Health Outcomes Measurement standard set for pregnancy and childbirth.[22, 23, 33] Maternal Health Equity and Education Training Outcomes: We will also evaluate 3 forms of knowledge about racism, bias, and disparities in healthcare among practice staff in Arms 2-4 through post-tests after each training session: 1) Factual knowledge (e.g. statistics on racial disparities in obstetric care), 2) Conceptual knowledge (e.g. institutional and interpersonal racism), and 3) Process knowledge from hearing the personal and professional experiences of facilitators, colleagues and the case presented during the trainings. Implementation Data: Individual telephonic or video interviews will be conducted with practice staff including the provider, nurse, and administrative champions at 3 time points: prior to implementation, midway through implementation, and at the conclusion of the study. We use structured interview guides, and the interviews are recorded, transcribed, and analyzed using NVivo qualitative software. Data Management and Safety: Prenatal practices will send new prenatal care patient panels, including race and ethnicity, to secure servers at the Cecil G. Sheps Center for Health Services Research. The Sheps Center is a “pan-university” research center within the University of NC which offers Data Management, Statistical Analyses, Secure Research Computing, and Integrated Research Solutions resources. The data sent to the Sheps Center will then be: 1) used by recruitment consultants to recruit participants for our Longitudinal Patient Survey, and 2) sent to the NC Health Information Exchange Authority, who will match patients with statewide health system encounter data and thereby populate the Race Equity Dashboards and the Maternal Warning System. De-identified outcomes data from the Health Information Exchange will then be sent back to the Sheps Center team for analysis by the research team. ACURE4Moms has received Institutional Review Board Approval from the University of North Carolina. We will report findings according to CONSORT guidelines . ACURE4Moms does not have a Data Safety Monitoring Board given that the study interventions present no more than minimal risk; however, the study investigators, Community Advisory Board (STABLE), and an Independent Safety Monitor will review study data quarterly throughout project implementation to ensure no unexpected risks or outcomes arise. Patients referred to doulas can withdraw consent for this support at any time. Statistical Analysis Plan: The primary Aim 1 analysis will compare the odds of LBW among Black birthing persons in Arm 1 (Standard Care Management) compared with Arm 4 (Combined Intervention) using Mixed Linear Logistic Regression Models. The Model will account for nesting of patients (Level 1), within practices (Level 2), adjusting for age, parity, education level, smoking, Body Mass Index category, census tract, and insurance status (variables known to be associated with LBW). Extensive informatics and practice-based quality improvement measures will be taken to limit missingness.[18] Data missingness will be described and associations between practice-level covariates, and missingness will be explored, with differences formally tested using logistic regression models for binary missingness variables. Inverse weighting based on missingness probabilities will be employed to adjust for the effects of practice level covariates on missingness, as needed. Mixed Linear Models will also be used to describe the effects of the intervention on the secondary outcomes. Analyses will be intention to treat with all patients who start prenatal care at each practice included in the arm the practice was originally randomized to with a planned sensitivity analysis only including patients who stayed at each practice through birth. Patients who transfer care will still have outcomes available in the NC Health Information Exchange. Data analysts will be masked regarding study Arm of participants. To perform the sample size calculation, the design effect arising from the clustering inherent to the study’s nested design is estimated using the following formula: Deff=1+(m-1)ρ, where m=average cluster size and ρ=Intercluster Correlation Coefficient. The minimum number of study observations is approximately 8,400 Black mother-infant dyads in 40 clusters, assuming that up to 4 practices (clusters) will drop out after randomization. Using the power function from Stata[34] and assuming an Intercluster Corrrelation Coefficient of 0.015, a two-sided ɑ = 0.05 and 80% power, with 40 total clusters (10 per Arm) and within cluster sample size of 280, we will be able to detect a 38.6% difference in the LBW rate between arms. The coefficient of 0.015 is a conservative estimate chosen based on a literature review of similar studies.[35–37] The detectable effect size improves with smaller coefficients and higher cluster numbers (see Additional Files ). Dissemination Plan We are developing a dissemination plan, together with our stakeholders and community partners that will include peer reviewed manuscripts, scientific presentations at conferences, as well as community forums,meetings, and social media. Our funder will also disseminate the findings on their website and we will report the findings on clinicaltrials.gov. A publication policy was developed at study start which includes pre-planned manuscripts for each study aim as well as a process to propose additional manuscripts by members of the research team or others. Discussion The ACURE4Moms study funded by the Patient Centered Outcomes Research Institute, the Duke Endowment, and the UNC Health Foundation will inform clinical practice and guide policy change in NC and beyond. Implementation began in June of 2023 and will continue through December of 2026. It will be the first randomized trial to test the impact of community-based doula support and prenatal clinic data accountability and transparency interventions on disparities in birth outcomes. It will generate a wealth of implementation data for health systems and policymakers, including costs of such interventions. Though cluster randomized trials are subject to more bias and lower power than individual randomization,[38] we chose this study design because both interventions are designed to be delivered at the level of the practice. For the community-based doula intervention, though it would be possible to randomize patients to receive doula support, the ACURE4Moms practices paired with doulas will develop bi-directional, educational relationships with the ACURE4Moms doulas from their communities. Practice staff can learn from the community-based doulas about improving trust with their patients and about community resources and concerns. The doulas can learn the rationale for certain medical recommendations and help explain this to their clients and communities. This integration of the community-based doulas into the care team will offer the opportunity not only to improve outcomes for specific clients, but also to improve the quality of care for all patients at that practice. A major limitation of the ACURE4Moms interventions is that they started only at the beginning of pregnancy. The factors impacting LBW disparities for Black birthing people, particularly institutional and interpersonal racism, are present well before pregnancy occurs and cannot be completely mitigated during the relatively short duration of a pregnancy and without changing other systems with which these individuals interact. In addition, though we believe doulas may be part of the solution for disparities, we must avoid the possibility that health care professionals and systems will shift the burden of improving health disparities completely to the shoulders of community-based doulas. However, given the preliminary data that both community-based doula support and practice-based data accountability and transparency can improve health disparities, and our plan to combine these in Arm 4, we anticipate our approach to be impactful. There are several potential barriers to successful implementation of the ACURE4Moms study. Perhaps the most important is the increasing time demands and workflow shortages for clinical staff in NC and nationwide that were exacerbated by the COVID-19 pandemic.[39] Despite these challenges, our team believes that the current disparities in maternal and infant health outcomes, also exacerbated by the pandemic,[40] are unacceptable and preventable. The data accountability and transparency interventions will be the most time consuming for clinical staff but are modeled on two successful studies that reduced adult cancer disparities[17] and cardiovascular risk disparities[18]. One of these, the Heart Health Now (HHN) study, found that NC Area Health Education Centers (AHEC) Practice Facilitators (PFs) can effectively help practices establish risk-stratified quality improvement (QI) approaches that resolve racial disparities in CVD risk. HHN was a stepped-wedge, stratified cluster randomized controlled trial (RCT) of 219 primary care practices who participated in NC Medicaid’s medical home program. Where possible, the use of automated data feeds will reduce or eliminate the burden on clinical staff to report data. We will conduct implementation research with the practices to establish workflows that are flexible and workable in real-world clinics. A second barrier is that the Race Equity Dashboards and Maternal Warning Systems will rely on the NC Health Information Exchange Authority to extract analyzable data from the electronic health records of included clinical sites which then is integrated into the race equity dashboards developed by the Sheps Center. Scaling to other states would require similar partnerships with local health information exchanges. However, the goal of United States Department of Health and Human Services is to achieve nationwide interoperability of health information systems by 2024.[41] Building ACURE4Moms interventions within a state-wide exchange, rather than within an individual practice electronic health record, takes advantage of standardizations in interoperability and will allow other prenatal clinics to utilize the Dashboards and Warning Systems in the future. It will also allow us to potentially capture BP measurements and other risk factors from encounters for ACURE4Moms patients in NC health facilities not enrolled in the study. A third barrier is engaging community-based doulas with practices given the history of institutional racism and many doulas’ desires to remain outside of these systems. Our research team is co-led by doula leads from two community-based organizations. Their leadership has been essential to designing an intervention that is acceptable to community members and community-based doulas. They are taking the lead in orienting practices and hospitals to the community-based doula scope of practice and in establishing relationships between the doulas and other members of the health care team. Conclusion The ACURE4Moms study is a cluster randomized trial of data accountability and transparency and community-based doula interventions implemented at diverse prenatal practices across the state of NC. The study of the implementation of these two innovative interventions, applied to maternal health disparities, offers the opportunity to inform maternal health policymakers, providers, and health systems about how to best use available resources to minimize racial disparities in maternal health. Trial Status 39 prenatal practices have been enrolled in the ACURE4Moms study including private practices, health-system owned clinics, academic medical centers with resident clinics, and community health centers. We have achieved approval from the Institutional Review Board for updated protocols, currently version 2.4. The study began recruitment at the first sites June 5, 2023 and the last site in December 15, 2024 and recruitment will be complete December 15, 2026. We have trained 35 doulas who are active in the program. 26 community-based recruitment consultants are actively recruiting participants to the longitudinal patient survey. Recruitment began August 1, 2023 and should be complete January 31, 2027. We have built 3 maternal early warning alerts and (missed prenatal visits, elevated blood pressures, and eligible for aspirin to prevent preeclampsia). A sample disparities dashboard with 3 metrics (low birth weight, timely prenatal care, and preterm birth) has been built and is being tested with clinics. The full disparities dashboards are being built. The MHEET training has been developed for the first 7 sessions. All sites have received MHEET session 1 training, and some have received through session 7. Pre-implementation interviews have been conducted at every practice, and the midpoint interviews are in process. Nine practices dropped out prior to implementation due to either closure, changes in staffing, or inability to contract with the Health Information Exchange Authority. Two practices have dropped out after partial implementation due to the fact that they were unable to continue providing prenatal care. See Figure 2 . Declarations Ethics approval: this research protocol has been approved by the University of North Carolina Institutional Review Board (IRB) as of August 30, 2022 (Review Number 22-1541). Written informed consent will be obtained from all participants in the longitudinal patient survey and for the participants in the implementation interviews. A waiver of informed consent was obtained for obtaining health information exchange authority and vital records data on pregnancy outcomes for participants given that the interventions are delivered at the level of the practice, focused on quality improvement, and pose minimal risk to participants. However, data security contracts were set up between each of the participating practices and UNC to and between UNC and the Health Information Exchange Authority to clarify how data would be stored and protected. Protocol deviations are reported to our sponsor, our independent safety monitor and the IRB. Consent for publication: N/A Availability of data and materials: De-identified longitudinal patient survey data and implementation data will be made available upon request to interested researchers. Due to contractual obligations with the North Carolina Health Exchange Authority, we are unable to share health outcomes data outside of the approved research team at UNC. All data will be kept on the Secure Server at UNC Sheps and only accessible on the server. Only those individuals who need to perform data management and analysis will have access to the data. Competing interests: AM is the founder/CEO of Momma’s Village Fayetteville, a non-profit organization with a mission to provide access to African-centered birth & breastfeeding support, postpartum care, parenting education and mental health resources for Black families in Fayetteville/Ft. Bragg and the surrounding Sandhills region. MJ is the founder/executive director of MAAME, Inc., a non-profit organization that provides compassionate support, education, and resources that empower birthing families to navigate systems of care and overcome barriers. The remaining authors report no conflicts of interest. Funding: ACURE4Moms is primarily funded through the Patient Centered Outcomes Research Institute (PCORI; [email protected] ). It is also funded through the Duke Endowment and the UNC Foundation. The study sponsor provided input into the design of the study and is alerted when manuscripts are submitted for publication but is not involved in the collection, management, analysis, interpretation of data, writing of any manuscripts, or decision to submit a manuscript for publication. Author Contributions: RPU is a principal investigator in the study who co-led conception of the study and led the proposal development along with JT. All authors read and approved the final manuscript. MB led the development of the statistical analysis plan and assisted with preparation of the manuscript. AM, CM, MJ, SV, SC, MB, WN, KM, CY, AM, DB, CY, BC, AA, KB, and RH all contributed to the design of the study and assisted with preparation of the manuscript. 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Chamberlain AT, Seib K, Ault KA, Rosenberg ES, Frew PM, Cortés M, et al. Improving influenza and Tdap vaccination during pregnancy: A cluster-randomized trial of a multi-component antenatal vaccine promotion package in late influenza season. Vaccine. 2015;33:3571–9. Nielsen PE, Goldman MB, Mann S, Shapiro DE, Marcus RG, Pratt SD, et al. Effects of teamwork training on adverse outcomes and process of care in labor and delivery: a randomized controlled trial. Obstet Gynecol. 2007;109:48–55. Turner EL, Platt AC, Gallis JA, Tetreault K, Easter C, McKenzie JE, et al. Completeness of reporting and risks of overstating impact in cluster randomised trials: a systematic review. Lancet Glob Health. 2021;9:e1163–8. McCartha EB. NC Nursecast: Understanding the Nursing Workforce in North Carolina. NC Med J. 2022;83:164–5. United Stated Government Accountability Office. Outcomes Worsened and Disparities Persisted During the Pandemic. U.S. Government Accountability Office; 2022. Office of the National Coordinator for Health Information Technology. Connecting Health and Care for the Nation: a Shared Nationwide Interoperability Roadmap. Office of the National Coordinator for Health Information Technology; 2015. Supplementary Files completedSPIRITchecklist.docx Cite Share Download PDF Status: Published Journal Publication published 24 Feb, 2026 Read the published version in Trials → Version 1 posted Reviewers agreed at journal 02 Oct, 2025 Reviewers invited by journal 02 Oct, 2025 Editor assigned by journal 26 Jun, 2025 First submitted to journal 24 Jun, 2025 Editorial decision: Minor revision 15 Jun, 2025 You are reading this latest preprint version Research Square lets you share your work early, gain feedback from the community, and start making changes to your manuscript prior to peer review in a journal. As a division of Research Square Company, we’re committed to making research communication faster, fairer, and more useful. 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02:03:43","extension":"html","order_by":18,"title":"","display":"","copyAsset":false,"role":"acdc-reference","size":161200,"visible":true,"origin":"","legend":"","description":"","filename":"earlyproof.html","url":"https://assets-eu.researchsquare.com/files/rs-6669094/v1/f5de8078c19105550155be02.html"},{"id":93726398,"identity":"103663ab-2b16-4f95-8878-63872c161cee","added_by":"auto","created_at":"2025-10-17 02:03:42","extension":"png","order_by":1,"title":"Figure 1","display":"","copyAsset":false,"role":"figure","size":487864,"visible":true,"origin":"","legend":"\u003cp\u003e\u003cstrong\u003eConceptual Framework of the Potential Pathways Linking Racial Discrimination to Adverse Birth Outcomes Used with Permission from the Journal of Midwifery \u0026amp; Women’s Health Published by Alhusen et al, 2017\u003c/strong\u003e\u003ca href=\"https://sciwheel.com/work/citation?ids=6715132\u0026amp;pre=\u0026amp;suf=\u0026amp;sa=0\u0026amp;dbf=0\"\u003e[12]\u003c/a\u003e\u003c/p\u003e","description":"","filename":"1.png","url":"https://assets-eu.researchsquare.com/files/rs-6669094/v1/0c1ad5f751be83546fd1852b.png"},{"id":93728583,"identity":"155828e7-d2d1-499f-9fb8-a684e117e366","added_by":"auto","created_at":"2025-10-17 02:11:42","extension":"png","order_by":2,"title":"Figure 2","display":"","copyAsset":false,"role":"figure","size":40158,"visible":true,"origin":"","legend":"\u003cp\u003e\u003cstrong\u003eACURE4Moms Practice Enrollment and Completion Dates by Arm\u003c/strong\u003e\u003c/p\u003e","description":"","filename":"2.png","url":"https://assets-eu.researchsquare.com/files/rs-6669094/v1/8cb2e9ecfa5faf3397974cfa.png"},{"id":93726396,"identity":"4e44d931-4ef2-4053-b5da-6540aca71225","added_by":"auto","created_at":"2025-10-17 02:03:42","extension":"png","order_by":3,"title":"Figure 3","display":"","copyAsset":false,"role":"figure","size":98680,"visible":true,"origin":"","legend":"\u003cp\u003e\u003cstrong\u003eACURE4Moms Longitudinal Patient Survey schedule of enrollments and assessments (SPIRIT figure)\u003c/strong\u003e\u003c/p\u003e","description":"","filename":"3.png","url":"https://assets-eu.researchsquare.com/files/rs-6669094/v1/a47071b0475c83304c004b8f.png"},{"id":93730250,"identity":"8502f93f-5a0b-4bfd-a180-34a5c9c87fcd","added_by":"auto","created_at":"2025-10-17 02:19:42","extension":"png","order_by":4,"title":"Figure 4","display":"","copyAsset":false,"role":"figure","size":611706,"visible":true,"origin":"","legend":"\u003cp\u003e\u003cstrong\u003eFigure 3. ACURE4Moms Study Team and Stakeholder Advisory Board Structure\u003c/strong\u003e\u003c/p\u003e","description":"","filename":"4.png","url":"https://assets-eu.researchsquare.com/files/rs-6669094/v1/a26c84caa19cff215213f974.png"},{"id":93726397,"identity":"9739a9b8-8377-4f4c-a80d-95cb4cbcfc5c","added_by":"auto","created_at":"2025-10-17 02:03:42","extension":"png","order_by":5,"title":"Figure 5","display":"","copyAsset":false,"role":"figure","size":205846,"visible":true,"origin":"","legend":"\u003cp\u003e\u003cstrong\u003eFigure 4. Location of ACURE4Moms Prenatal Clinics by county across the state of NC. \u003c/strong\u003eGreen denotes areas served by Momma’s Village Fayetteville in Eastern NC and Red denotes areas served by Maame, Inc in Western NC.\u003c/p\u003e","description":"","filename":"5.png","url":"https://assets-eu.researchsquare.com/files/rs-6669094/v1/77f95dc639bd8493d0509d98.png"},{"id":103765604,"identity":"0111140e-3a62-4bd2-9fd7-41dc32913203","added_by":"auto","created_at":"2026-03-02 16:05:48","extension":"pdf","order_by":0,"title":"","display":"","copyAsset":false,"role":"manuscript-pdf","size":2976100,"visible":true,"origin":"","legend":"","description":"","filename":"manuscript.pdf","url":"https://assets-eu.researchsquare.com/files/rs-6669094/v1/4876b29b-8ca0-40f4-b6dd-0b9c1e84a61b.pdf"},{"id":93726395,"identity":"5d22f196-ab20-49b4-9de5-aff5a408473e","added_by":"auto","created_at":"2025-10-17 02:03:42","extension":"docx","order_by":1,"title":"","display":"","copyAsset":false,"role":"supplement","size":30716,"visible":true,"origin":"","legend":"","description":"","filename":"completedSPIRITchecklist.docx","url":"https://assets-eu.researchsquare.com/files/rs-6669094/v1/e948fa0bb4c90ac3f3ccc48d.docx"}],"financialInterests":"","formattedTitle":"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","fulltext":[{"header":"Background","content":"\u003cp\u003e\u003cdiv class=\"BlockQuote\"\u003e\u003cp\u003eNon-Hispanic Black (Black) birthing people in the United States (US) have maternal morbidity and mortality ratios that are 2-3-fold higher than that of Non-Hispanic White (White) birthing people.[1, 2] Multi-level, community-based interventions aimed at mitigating structural racism and improving maternal and infant disparities are urgently needed. However, maternal morbidity and mortality are relatively rare (1% and 0.04%, respectively), making it difficult to design a clinical trial with adequate statistical power to improve these outcomes. Infant low birth weight (LBW) affects more patients and is an important marker of maternal health.[3, 4] LBW deliveries, a combination of preterm births and/or fetal growth restriction, are associated with twice the long-term risk for maternal cardiovascular disease (CVD). LBW and preterm birth combined are the second most common cause of infant death in the US, with significant morbidity for surviving infants.[\u003cspan citationid=\"CR5\" class=\"CitationRef\"\u003e5\u003c/span\u003e] Black infants are also twice as likely than White infants to have a low birth weight (\u0026lt;\u0026thinsp;2,500 grams, 11.4% versus 5.2% in 2016).[\u003cspan citationid=\"CR6\" class=\"CitationRef\"\u003e6\u003c/span\u003e] In North Carolina (NC), LBW rates are higher than the national average (15.3% for Black infants versus 7.5% for White infants in 2020).[\u003cspan citationid=\"CR7\" class=\"CitationRef\"\u003e7\u003c/span\u003e]\u003c/p\u003e\u003c/div\u003e\u003c/p\u003e\u003cp\u003eExperiences with racism have been linked to LBW.[8, 9] One longitudinal study of 420 US women of color found that for every 1-point increase in the Everyday Discrimination Scale during the second trimester, birthweight decreased by approximately 50 grams.[\u003cspan citationid=\"CR8\" class=\"CitationRef\"\u003e8\u003c/span\u003e] In the CARDIA study, those reporting high levels of discrimination around the time of a singleton birth had almost 5 times the odds of a LBW compared to those reporting no racial discrimination.[\u003cspan citationid=\"CR9\" class=\"CitationRef\"\u003e9\u003c/span\u003e]\u003c/p\u003e\u003cp\u003eAlthough race is a social construct with no biological basis, experiences with racism can affect biological outcomes.[\u003cspan citationid=\"CR10\" class=\"CitationRef\"\u003e10\u003c/span\u003e]\u003csup\u003e,\u003c/sup\u003e[\u003cspan citationid=\"CR11\" class=\"CitationRef\"\u003e11\u003c/span\u003e] Alhusen, et al. proposed an explanatory model (Fig.\u0026nbsp;\u003cspan refid=\"Fig1\" class=\"InternalRef\"\u003e1\u003c/span\u003e)[\u003cspan citationid=\"CR12\" class=\"CitationRef\"\u003e12\u003c/span\u003e], which distinguishes between two forms of racism: interpersonal and institutional, both of which can lead to differential treatment and access to resources and opportunities. This leads to interrelated negative health consequences including increased inflammation, uteroplacental dysfunction, and maladaptive health behaviors, which contribute to the risk for adverse pregnancy outcomes.\u003csup\u003e12\u003c/sup\u003e By starting to dismantle the many sources of racism facing Black patients every day, it should be possible to reduce the biological impacts of institutional and interpersonal racism.\u003c/p\u003e\u003cp\u003e\u003c/p\u003e\u003cp\u003eSystematically using data accountability transparency interventions could improve racial inequities in outcomes.[13, 14] Inpatient race equity dashboards have reduced disparities in maternal morbidity when used during the birth hospitalization.[15, 16] Outpatient race equity dashboards and early warning systems have reduced disparities in cancer treatment[\u003cspan citationid=\"CR17\" class=\"CitationRef\"\u003e17\u003c/span\u003e] and cardiovascular risk[\u003cspan citationid=\"CR18\" class=\"CitationRef\"\u003e18\u003c/span\u003e] but have not been modified for use during prenatal care. Institutional racism and implicit biases from prenatal providers could be reduced through the transparency of race-stratified data dashboards of outcomes from their own practices, increasing awareness of inequitable race-specific outcomes, while concomitantly undergoing racial equity training. Early warning systems could reduce differential treatment by alerting practices about all patients who could benefit from preventive services. Patients with warnings could be linked to additional community resources as needed.[\u003cspan citationid=\"CR19\" class=\"CitationRef\"\u003e19\u003c/span\u003e] In the Accountability for Cancer Care Through Undoing Racism and Equity (ACCURE) study, disparities dashboards, race equity training, an early warning system and care navigators at the level of the oncology practice eliminated the disparity between Black and White patients who completed therapy for treatable breast and lung cancers and improved treatment completion for patients of all races.[\u003cspan citationid=\"CR17\" class=\"CitationRef\"\u003e17\u003c/span\u003e] In the Heart Health Now Study, disparities dashboards, early warning systems, and quality improvement practice coaches reduced disparities in cardiovascular risk in a cluster randomized trial of over 200 primary care practices in North Carolina.[\u003cspan citationid=\"CR18\" class=\"CitationRef\"\u003e18\u003c/span\u003e]. See Table\u0026nbsp;\u003cspan refid=\"Tab1\" class=\"InternalRef\"\u003e1\u003c/span\u003e.\u003c/p\u003e\u003cp\u003e\u003cdiv class=\"gridtable\"\u003e\u003ctable float=\"Yes\" id=\"Tab1\" border=\"1\"\u003e\u003ccaption language=\"En\"\u003e\u003cdiv class=\"CaptionNumber\"\u003eTable 1\u003c/div\u003e\u003cdiv class=\"CaptionContent\"\u003e\u003cp\u003e\u003cb\u003eData Accountability Interventions from ACCURE and Heart Health Now Studies\u003c/b\u003e[17, 18]\u003c/p\u003e\u003c/div\u003e\u003c/caption\u003e\u003ccolgroup cols=\"2\"\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c1\" colnum=\"1\"\u003e\u003c/div\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c2\" colnum=\"2\"\u003e\u003c/div\u003e\u003cthead\u003e\u003ctr\u003e\u003cth align=\"left\" colname=\"c1\"\u003e\u003cp\u003eInterventions\u003c/p\u003e\u003c/th\u003e\u003cth align=\"left\" colname=\"c2\"\u003e\u003cp\u003eCausal Effect\u003c/p\u003e\u003c/th\u003e\u003c/tr\u003e\u003c/thead\u003e\u003ctbody\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eAutomated real-time registry with an Early Warning System for missed appointments and milestones\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003eDecreased institutional racism by preventing differential treatment\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eNurse Navigator specially trained in exploring and responding to patients\u0026rsquo; social and belief-specific barriers and in using ACCURE\u0026rsquo;s real-time registry\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003eIncreased personal resources/support and decrease interpersonal racism to prevent differential treatment\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eSite-specific Clinical Feedback reports, according to race and co-morbidity status, delivered by ACCURE Physician Champion to clinicians.\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003eDecreased institutional racism by showing differential treatment by race and encouraging the providers to address it\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eQuality Improvement Coaches\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003eDecreased structural bias by implementing system-based strategies to reduce bias in care\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eRacial Equity Training\u0026thinsp;+\u0026thinsp;quarterly booster sessions for providers\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003eReduced interpersonal racism\u0026thinsp;+\u0026thinsp;implicit bias among providers\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003c/tbody\u003e\u003c/colgroup\u003e\u003c/table\u003e\u003c/div\u003e\u003c/p\u003e\u003cp\u003eThe health effects of experiencing institutional and interpersonal racism may be further mitigated via interventions that increase personal resources (Fig.\u0026nbsp;\u003cspan refid=\"Fig1\" class=\"InternalRef\"\u003e1\u003c/span\u003e: social support, coping strategies, and self-esteem), such as support from community-based doulas. Doulas are trained professionals who provide emotional, physical, and informational support during pregnancy and postpartum. Community-based doulas are a subset of doulas who are often racially or ethnically concordant, share lived experiences with their clients, are trusted members of their communities, and provide linkages to community resources to mitigate racism.[\u003cspan citationid=\"CR20\" class=\"CitationRef\"\u003e20\u003c/span\u003e] When relationships are created between community doulas and prenatal practices, they can work together to address: 1) institutional racism by providing patient-centered advocacy, 2) interpersonal racism by developing cross-cultural relationships with the health team, and 3) personal resources through offering social support and coping strategies to patients who are at high risk of delivering a LBW baby.[\u003cspan citationid=\"CR21\" class=\"CitationRef\"\u003e21\u003c/span\u003e] Community-based doula support has been associated with reduced LBW in several observational studies but has not been tested in a randomized controlled trial.\u003csup\u003e22\u0026ndash;24\u003c/sup\u003e\u003c/p\u003e\u003cp\u003eTherefore, we have developed the Accountability for Care through Undoing Racism and Equity for Moms (ACURE4Moms) study, a cluster-randomized trial aimed at comparing the effectiveness of two practiced-based interventions (Data Accountability and Transparency, and Community-Based Doula Support) both separately and together, to reduce disparities in LBW (Aim 1). Secondary outcomes include emergency care and hospitalizations during pregnancy and postpartum. A subset of Black patients in each cluster will be surveyed longitudinally to measure experiences with discrimination and other patient-centered outcomes (Aim 2).. We will also measure implementation barriers and facilitators (Aim 3).\u003c/p\u003e"},{"header":"Methods","content":"\u003cp\u003e\u003cb\u003eStudy Design\u003c/b\u003e: ACURE4Moms is a pragmatic, cluster-randomized, superiority trial taking place at 40 prenatal practices across NC. The study will take place over 5 years, with the first year (April 1, 2022-May 31, 2023) devoted to pre-implementation activities, including recruiting practices, developing protocols, building the Data Accountability Systems, and recruiting community-based doulas. Implementation at the first sites in June 2023, with sites starting the intervention in a rolling fashion between June 2023 and December 2024. Implementation will continue for 2 years (through December 2026 at the last site). See Fig.\u0026nbsp;\u003cspan refid=\"Fig2\" class=\"InternalRef\"\u003e2\u003c/span\u003e for details about timeline of enrollment and implementation at each site. Our primary aim is to compare the impact of data accountability and doula support, both separately and in combination, on LBW (\u0026lt;\u0026thinsp;2,500g) for NHB patients. Secondarily, we will recruit a nested cohort study of up to 4,400 Black patients (100/practice) to complete a survey at 4 time points measuring mental health symptoms, experiences with discrimination, and other patient-centered outcomes at the following time points: 1) Between 14\u0026ndash;23 weeks gestational age, 2) 24 weeks gestational age until birth, 3) 2\u0026ndash;11 weeks postpartum, and 4) 12\u0026ndash;18 weeks post-birth. See SPIRIT Figure (Fig.\u0026nbsp;\u003cspan refid=\"Fig4\" class=\"InternalRef\"\u003e3\u003c/span\u003e). Our secondary aim is to longitudinally assess self-reported discrimination and mood symptoms among Black patients during pregnancy and for up to 30 months postpartum and examine the mediating effect between the intervention and infant LBW using the Discrimination in Medical Settings scale and the Edinburgh Postpartum Depression Survey.[22, 23] Our third aim is to assess and identify intervention implementation factors that support or inhibit intervention uptake and sustainability. We used the SPIRIT checklist when writing our report.[\u003cspan citationid=\"CR24\" class=\"CitationRef\"\u003e24\u003c/span\u003e]\u003c/p\u003e\u003cp\u003e\u003c/p\u003e\u003cp\u003e\u003c/p\u003e\u003cp\u003e\u003c/p\u003e\u003cp\u003e\u003cstrong\u003eCommunity Partner Engagement\u003c/strong\u003e\u003cp\u003eFrom the inception of our project, we determined it essential to involve representatives from among the populations most impacted by maternal health disparities. The academic Principal Investigators began collaborating with two community-based doula leaders who function as Community Principal Investigators in ACURE4Moms. These individuals identify as Black and have lived experience with adverse pregnancy outcomes themselves or within their immediate family. They are primarily responsible for designing the community-based doula intervention, as well as hiring, training, and managing the study doulas in their region. One was assigned to the Western NC practices and the other to the Eastern NC practices. We also work closely with members of the Greensboro Health Disparities Collaborative, an NC-based organization devoted to improving health disparities. This organization, together with academic researchers, designed the original Accountability for Cancer Care through Undoing Racism and Equity study,[\u003cspan citationid=\"CR17\" class=\"CitationRef\"\u003e17\u003c/span\u003e] on which our data accountability and transparency interventions are based. They are supportive of our effort to modify these interventions for maternal health disparities.[\u003cspan citationid=\"CR25\" class=\"CitationRef\"\u003e25\u003c/span\u003e]\u003c/p\u003e\u003c/p\u003e\u003cp\u003eOur research team has since built relationships with patient advocacy groups, community-based organizations, provider professional organizations, public health leadership, health insurance payers, patients, and doulas. These stakeholders meet quarterly with the research team as part of our Stakeholder Advisory Board Leading with Equity (STABLE, Fig.\u0026nbsp;\u003cspan refid=\"Fig5\" class=\"InternalRef\"\u003e4\u003c/span\u003e). The Board is co-chaired by a community-based doula and an academic health disparities researcher who are both Black, and it includes 22 members, the majority of whom are Black women with lived experience of adverse pregnancy outcomes. The Board has the authority to approve all aspects of study design and implementation. Each stakeholder is respected as an expert and their time is equally compensated, regardless of educational or occupational background.\u003c/p\u003e\u003cp\u003e\u003c/p\u003e\u003cp\u003e\u003cstrong\u003eSetting\u003c/strong\u003e\u003cp\u003eThe study is occurring at 40 prenatal practices in NC. NC is a diverse state on many\u003c/p\u003e\u003c/p\u003e\u003cp\u003elevels: 78 out of 100 counties are rural, and 24%, 16%, and 1% of births are to Black, Hispanic, American Indian/Alaska Native people, respectively. NC Medicaid covers about half of all births in NC; of these, 20% are only covered for birth under \u0026ldquo;Emergency Medicaid\u0026rdquo; due to ineligibility for full Medicaid. As mentioned previously, Black North Carolinians experience large disparities in maternal and infant outcomes including morbidity, mortality, LBW, preterm birth, as well as disparities in other social determinants of health, such as sustained access to transportation, employment, and quality education. [26, 27] NC launched the Care Management for High Risk Pregnancies Program in 2011, which uses a screening tool to identify individuals at risk for LBW. A predictive model identifies those most likely to benefit from care management and offers intensive care management to them.\u003csup\u003e30\u003c/sup\u003e All of the approximately 40% of pregnant patients covered by NC Medicaid are screened for eligibility for this program.\u003c/p\u003e\u003cp\u003e\u003cstrong\u003eRecruitment and Eligibility\u003c/strong\u003e\u003cp\u003eOur team divided NC into Eastern and Western halves with approximately half of all sites located in each region \u003cb\u003e(Fig.\u0026nbsp;5).\u003c/b\u003e This division allows the two community-based doula organizations to supervise a similar number of practices and doulas. The study team identified potentially eligible practices based on the racial composition and numbers of births per county. Practices were recruited by emails, personal phone calls, and in-person visits.\u003c/p\u003e\u003c/p\u003e\u003cp\u003eInclusion criteria for prenatal practices are: 1) Care for at least 7\u0026ndash;8 Black birthing people who deliver each month; 2) Full participation with the NC Health Information Exchange Authority; 3) Willingness to be randomized; 4) No current community-based doula partnership or outpatient race equity dashboards. New quality improvement measures are not prohibited. In most cases, the sites also provide labor and delivery care. In a few cases, the labor and delivery care is provided by a different group of clinicians. However, the interventions are designed to decrease LBW, so the focus is delivering interventions to health care professionals caring for people in the outpatient setting prior to labor.\u003c/p\u003e\u003cp\u003eBased on historical birth volumes, we estimate that the included practices will perform an average of 30\u0026ndash;60 deliveries per month, which will result in ~\u0026thinsp;30,000\u0026ndash;60,000 patients (8,400\u0026thinsp;\u0026minus;\u0026thinsp;16,800 Black) who initiate prenatal care during the 2 years of the study. All patients who receive care at each site during the study period will be included in the study. A waiver of informed consent was obtained given the fact that the interventions are provided at the level of the practice, are within the standard of care for pregnancy, require practices to be able to have reliable data about population to improve quality of care, and pose minimal risk to participants. Minors\u0026thinsp;\u0026lt;\u0026thinsp;15 years were excluded from this waiver.\u003c/p\u003e\u003cp\u003eRecruitment for the Longitudinal Patient Survey will occur across each of the practices with the goal of recruiting 100 Black mothers from each practice (N\u0026thinsp;=\u0026thinsp;4,400). Community-Based Recruitment Consultants (CBRCs) who are also community doulas have been contracted to recruit study participants from a list of potentially eligible participants provided by each practice via telephone. We strive to assign CBRCs to recruit patients from practices where they do not provide pregnancy and birth support.\u003c/p\u003e\u003cp\u003eFor the implementation research, we will enroll up to 132 practice staff, 50 doulas, and 90 patients for in-depth interviews pre-, mid-, and post-implementation to help determine fit, feasibility, and fidelity of the interventions.\u003c/p\u003e\u003cp\u003e\u003cstrong\u003eInterventions\u003c/strong\u003e\u003cp\u003eArm 1 is standard prenatal care including routine social determinants of health (SDoH) assessment for Medicaid patients and intensive care management for those with the highest risk of LBW. Arm 2 will include a suite of data accountability and transparency interventions modified from the ACCURE and HHN studies including disparities dashboards, early warning alert systems, quality improvement practice coaches, and quarterly maternal health equity education and training (MHEET) for staff. Arm 3 will include linkages with community-based doulas, referral workflows, funded doula support for up to 144 births (6 per month), and quarterly MHEET training for staff. Arm 4 will include both data accountability and community doula interventions as well as the MHEET training for staff. For complete detail about each of the arms, see \u003cb\u003eTable\u0026nbsp;2\u003c/b\u003e.\u003c/p\u003e\u003c/p\u003e\u003cp\u003e\u003cdiv class=\"gridtable\"\u003e\u003ctable float=\"No\" id=\"Taba\" border=\"1\"\u003e\u003ccolgroup cols=\"6\"\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c1\" colnum=\"1\"\u003e\u003c/div\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c2\" colnum=\"2\"\u003e\u003c/div\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c3\" colnum=\"3\"\u003e\u003c/div\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c4\" colnum=\"4\"\u003e\u003c/div\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c5\" colnum=\"5\"\u003e\u003c/div\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c6\" colnum=\"6\"\u003e\u003c/div\u003e\u003cthead\u003e\u003ctr\u003e\u003cth align=\"left\" colspan=\"4\" nameend=\"c4\" namest=\"c1\"\u003e\u003cp\u003eTable\u0026nbsp;2. ACURE4Moms Study Comparators, Interventions, and Clinical Strategies\u003c/p\u003e\u003c/th\u003e\u003cth align=\"left\" colspan=\"2\" nameend=\"c6\" namest=\"c5\"\u003e\u0026nbsp;\u003c/th\u003e\u003c/tr\u003e\u003c/thead\u003e\u003ctbody\u003e\u003ctr\u003e\u003ctd align=\"left\" colspan=\"2\" nameend=\"c2\" namest=\"c1\"\u003e\u003cp\u003e\u003cb\u003eComparator Arm\u003c/b\u003e\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colspan=\"2\" nameend=\"c4\" namest=\"c3\"\u003e\u003cp\u003e\u003cb\u003eClinical Strategies Included in Arm\u003c/b\u003e\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colspan=\"2\" nameend=\"c6\" namest=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colspan=\"2\" nameend=\"c2\" namest=\"c1\"\u003e\u003cp\u003e\u003cb\u003eArm 1\u003c/b\u003e\u003c/p\u003e\u003cp\u003e\u003cb\u003e(Standard Care)\u003c/b\u003e\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colspan=\"2\" nameend=\"c4\" namest=\"c3\"\u003e\u003cp\u003e\u0026gt;\u0026thinsp;95% of NC OB practices use the \u003cb\u003ePregnancy Medical Home (PMH)\u003c/b\u003e care model for patients with Medicaid (~\u0026thinsp;50% of deliveries)[\u003cspan citationid=\"CR28\" class=\"CitationRef\"\u003e28\u003c/span\u003e]\u003c/p\u003e\u003cp\u003e\u0026bull; First prenatal visit risk screening for low birth weight in all Medicaid patients\u003c/p\u003e\u003cp\u003e\u0026bull; Intensive care management to address SDOH in high risk\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colspan=\"2\" nameend=\"c6\" namest=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colspan=\"2\" nameend=\"c2\" namest=\"c1\"\u003e\u003cp\u003e\u003cb\u003eArm 2 (Data Accountability and Transparency [Data])\u003c/b\u003e\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colspan=\"2\" nameend=\"c4\" namest=\"c3\"\u003e\u003cp\u003e1. \u003cspan type=\"BoldUnderline\" class=\"BoldUnderline\" name=\"Emphasis\"\u003eStandard Care\u003c/span\u003e: PMH if Medicaid insured.\u003c/p\u003e\u003cp\u003e2. \u003cspan type=\"BoldUnderline\" class=\"BoldUnderline\" name=\"Emphasis\"\u003ePractice Facilitator (PF)\u003c/span\u003e: These QI officers from NC Area Health Education Centers (\u003cb\u003eAHEC\u003c/b\u003e) work with, 1) Practice teams to help implement our real-time Maternal Warning System (\u003cb\u003eMWS\u003c/b\u003e, see below) using rapid QI cycles, and, 2) Practice \u003cb\u003eProvider Champions\u003c/b\u003e to present Disparities Dashboard data (see description below).[\u003cspan citationid=\"CR29\" class=\"CitationRef\"\u003e29\u003c/span\u003e]\u003c/p\u003e\u003cp\u003e3. \u003cspan type=\"BoldUnderline\" class=\"BoldUnderline\" name=\"Emphasis\"\u003eMaternal Warning System (MWS)\u003c/span\u003e: Health Information Exchange Authority (\u003cb\u003eHIEA\u003c/b\u003e) builds the MWS for each practice with HIEA data from their own and other health care facilities throughout NC. Data from nightly uploads from the HIEA are aggregated, analyzed, and shared with practices through a unique portal for each practice. Alerts include: elevated BP (\u0026ge;\u0026thinsp;140 systolic and/or \u0026ge;\u0026thinsp;90 diastolic), critical BP (\u0026ge;\u0026thinsp;160 systolic and \u0026ge;\u0026thinsp;110 diastolic), failure to follow-up within 2 weeks of elevated BP, delay with expected prenatal visit schedule (\u0026ge;\u0026thinsp;6 weeks until 32 weeks; \u0026ge;3 weeks 32\u0026ndash;36 weeks; \u0026ge;2 weeks 36 weeks until birth), patients who qualify for aspirin to prevent preeclampsia who do not have it listed in the medication list. The \u003cb\u003eNurse and/or Admin Champions\u003c/b\u003e review the MWS alerts regularly and follow the pre-specified workflow for each patient\u0026rsquo;s alert.[17, 29]\u003c/p\u003e\u003cp\u003e4. \u003cspan type=\"BoldUnderline\" class=\"BoldUnderline\" name=\"Emphasis\"\u003eDisparities Dashboard\u003c/span\u003e: Disparities Dashboard reports will be generated from the practice EHR data, stratified by race/ethnicity. Dashboard outcomes, such as the proportion with low birth weight, recommended prenatal visits, controlled BP, and APOs, are defined using ICD and CPT codes and other fields that require direct entry into the EHR. The \u003cb\u003eProvider Champion\u003c/b\u003e will present outcomes to practice staff and leadership.[17, 18]\u003c/p\u003e\u003cp\u003e5. \u003cspan type=\"BoldUnderline\" class=\"BoldUnderline\" name=\"Emphasis\"\u003eMaternal Health Equity Education and Training (MHEET)\u003c/span\u003e: Nine quarterly, 1-hour facilitated sessions modified from the ACCURE study, based on the People\u0026rsquo;s Institute for Survival and Beyond [PISAB] Undoing Racism\u0026trade; principles[\u003cspan citationid=\"CR30\" class=\"CitationRef\"\u003e30\u003c/span\u003e] as a conceptual model for medical care for all practice staff (clinicians, nursing, front desk staff, etc.) Session topics include: Maternal Health Inequities Facts, Structural and Systemic Causes of Disparities, Identifying Structural and Systemic Racism in Patient Stories, Implicit Bias, and Communication. Training is grounded in sharing of race-stratified outcomes data from their own practice and interpreting them through a racial-equity lens. Provider Champions, Nurse Navigators, and an Administrative Lead from each practice are supported and encouraged to complete the 2-day Racial Equity Institute Phase 1 Training.\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colspan=\"2\" nameend=\"c6\" namest=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colspan=\"2\" nameend=\"c2\" namest=\"c1\"\u003e\u003cp\u003e\u003cb\u003eArm 3 (Community-Based Doula Support [Doula])\u003c/b\u003e\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colspan=\"2\" nameend=\"c4\" namest=\"c3\"\u003e\u003cp\u003e1. \u003cspan type=\"BoldUnderline\" class=\"BoldUnderline\" name=\"Emphasis\"\u003eStandard Care\u003c/span\u003e: PMH if Medicaid insured.\u003c/p\u003e\u003cp\u003e2. \u003cspan type=\"BoldUnderline\" class=\"BoldUnderline\" name=\"Emphasis\"\u003eMaternal Health Equity Education and Training (MHEET)\u003c/span\u003e: (as above)\u003c/p\u003e\u003cp\u003e3. \u003cspan type=\"BoldUnderline\" class=\"BoldUnderline\" name=\"Emphasis\"\u003ePractice partnership with CBDs to support high-risk patients and improve accountability\u003c/span\u003e: Designed by Co-Investigators \u003cb\u003eAngela Malloy\u003c/b\u003e and \u003cb\u003eCindy McMillan\u003c/b\u003e, NHB women who are CBD leaders at \u003cb\u003eMomma\u0026rsquo;s Village Fayetteville\u003c/b\u003e and \u003cb\u003eMAAME, Inc.\u003c/b\u003e, respectively. Forty CBDs with training in birth support, breastfeeding, perinatal mood disorders, Afrocentric Care, postpartum care, and childbirth education have been recruited to provide services for the study, with a focus on serving patients at high-risk for LBW.\u003c/p\u003e\u003cp\u003e\u0026bull; Practices refer individuals to the CBD organizations before 28 weeks of gestation for any of these risk factors: 1) Self-identified Black/African American race; 2) medical comorbidity (e.g., Chronic Hypertension, Kidney Disease, Heart Disease); 3) prior history of LBW infant (\u0026lt;\u0026thinsp;5lb 8oz/2,500grams), preterm birth (\u0026lt;\u0026thinsp;37 weeks), infant death, and/or stillbirth (2 points); 4) limited social support (e.g., limited partner/family involvement) (2 points); 5) housing instability (2 points); 6) Substance Use Disorder (including tobacco) (2 points); 7) teen Pregnancy (\u0026lt;\u0026thinsp;19 years old at birth) (1 point); and/or 8) other clinician specified risk (e.g., Intimate Partner Violence) (1 point).\u003c/p\u003e\u003cp\u003e\u0026bull; Each patient matched with a CBD receives the following services: 3\u0026ndash;4 CBD visits during the \u003cb\u003eantenata\u003c/b\u003el period (including 1 with their OB clinician to help establish collaboration); up to 24 hours of \u003cb\u003elabor\u003c/b\u003e support; 1\u0026ndash;2 hours of immediate \u003cb\u003epostpartum\u003c/b\u003e support; a home visit 7\u0026ndash;10 days after delivery; ongoing telephone and/or online support throughout pregnancy and postpartum; and participation in CBD-organized \u003cb\u003epeer support groups\u003c/b\u003e, which continue until 1 year post-birth.\u003c/p\u003e\u003cp\u003e\u0026bull; CBDs use online HIPPA-compliant EHR systems (IntakeQ and Maternity Neighborhood) to document notes from each patient interaction. Practice staff undergo a co-learning curriculum designed by the CBDs to educate them about scope of practice and communication between health care professionals and CBDs. CBD services are funded by several Medicaid payers and ACURE4Moms (\u003cspan\u003e$\u003c/span\u003e1000 per client).\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colspan=\"2\" nameend=\"c6\" namest=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colspan=\"2\" nameend=\"c2\" namest=\"c1\"\u003e\u003cp\u003e\u003cb\u003eArm 4 (ALL)\u003c/b\u003e\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colspan=\"2\" nameend=\"c4\" namest=\"c3\"\u003e\u003cp\u003eStandard Care\u0026thinsp;+\u0026thinsp;MHEET\u0026thinsp;+\u0026thinsp;Data\u0026thinsp;+\u0026thinsp;Doula as above.\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colspan=\"2\" nameend=\"c6\" namest=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colspan=\"6\" nameend=\"c6\" namest=\"c1\"\u003e\u003cp\u003e\u003cb\u003eAbbreviations: NC (North Carolina); OB (Obstetric); LBW (low birth weight); ACCURE (Accountability for Cancer Care through Undoing Racism and Equity); HHN (Heart Health Now); PF (Practice Facilitator); EHR (Electronic Health Record); HEIA (NC Health Information Exchange Authority); MWS (Maternal Early Warning System); EC (Emergency Care); PISAB (The People\u0026rsquo;s Institute for Survival and Beyond); CBD (Community Based Doula)\u003c/b\u003e\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003c/tbody\u003e\u003c/colgroup\u003e\u003c/table\u003e\u003c/div\u003e\u003c/p\u003e\u003cp\u003eBoth interventions were designed to be deployed at the practice level and improve outcomes for everyone in the population. The data accountability interventions and the MHEET training sessions were based on the Accountability for Cancer Care through Undoing Racism and Equity Study (ACCURE), which successfully reduced Black-White lung and breast cancer treatment disparities.[\u003cspan citationid=\"CR17\" class=\"CitationRef\"\u003e17\u003c/span\u003e] Regarding the doula support intervention (arms 3 and 4), this could not be feasibly offered to every person at risk for a LBW in each practice. However, we aimed 1) to support a clinically significant percentage of births to Black-identifying individuals at each practice understanding that not all Black-identifying patients would desire doula support and some who are not Black-identifying would receive doula support and 2) to create relationships and transparency between doulas and clinical providers that would ultimately lead to improvements in care for all patients, not only those who received doula support. The following calculations were used to plan the amount of doula support. Given that we targeted practices with an average of 60 births per month, and that approximately 25% of births in NC are to Non-Hispanic African American individuals, we estimated that this would be about 15 Black patients per month at each clinic. Doulas being able to support about 6 births per month (144 over the course of the 2 year study) would result in approximately 40% of births to Black individuals to be supported which we felt would be a significant dose.\u003c/p\u003e\u003cp\u003e\u003cstrong\u003eRandomization\u003c/strong\u003e\u003cp\u003eTo ensure similar numbers of randomized participants in each arm and similar numbers of doula assigned practices in each of 2 geographic areas, the practices were stratified by Eastern NC and Western NC and then by size prior to randomization. For each geographic stratum (East v. West), we ordered the clinics by number of deliveries per month from highest to lowest, then created groups of 4 clinics in that order and randomized to 1 of 4 arms. Our statistician performed the initial randomization using the online tool (\u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003ewww.random.org\u003c/span\u003e\u003cspan address=\"http://www.random.org\" targettype=\"URL\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e) to generate all random numbers; it provides a \u0026ldquo;true\u0026rdquo; random number generator that derives its randomness from atmospheric noise. The first round of randomization for 42 clinics was performed on December 2, 2022 with 42 sites. Due to dropout prior to implementation, additional recruitment was needed. Therefore, 2 additional rounds of randomization were performed for an additional 7 sites. In these cases, the arms with the fewest sites were identified, and the practices were randomized into those arms. At each point, practices were notified of their allocation after the randomization was complete but before implementation. Given the design of offering differing interventions to practices, participating practices, their patients, and research staff could not be masked to the allocation.\u003c/p\u003e\u003c/p\u003e\u003cp\u003e\u003cb\u003eData Sources and Outcomes: Table\u0026nbsp;2\u003c/b\u003e includes details about the outcomes and data sources, and \u003cb\u003eAppendix B\u003c/b\u003e lists the electronic health record outcomes and billing codes.\u003c/p\u003e\u003cp\u003e\u003cstrong\u003eHealth Outcomes\u003c/strong\u003e\u003cp\u003eData on health outcomes (i.e. LBW, emergency care use (emergency department and labor and delivery), hospitalizations, severe maternal morbidity, mode of delivery, hypertensive disorders) will be accessed from the NC Health Information Exchange Authority and NC Vital Records (birth and death certificates). The Health Information Exchange is a state agency responsible for promoting the access to, exchange of, and analysis of health information among providers .[\u003cspan citationid=\"CR31\" class=\"CitationRef\"\u003e31\u003c/span\u003e] All health care providers who are in network with NC Medicaid plans and/or the State Health Plan are required to share electronic health data. Some data will also be extracted from NC vital records (birth and death certificates). See \u003cb\u003eTable\u0026nbsp;3\u003c/b\u003e.\u003c/p\u003e\u003cp\u003e\u003cstrong\u003eTable 3. ACURE4Moms Study Outcomes, Measures, and Timing of Assessment\u003c/strong\u003e\u003c/p\u003e\n\u003ctable border=\"1\" cellspacing=\"0\" cellpadding=\"0\" width=\"654\"\u003e\n \u003ctbody\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 101px;\"\u003e\n \u003cp\u003e\u003cstrong\u003eType of Outcome\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 139px;\"\u003e\n \u003cp\u003e\u003cstrong\u003eName of Outcome\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 192px;\"\u003e\n \u003cp\u003e\u003cstrong\u003eSpecific measure to be used\u0026nbsp;\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 162px;\"\u003e\n \u003cp\u003e\u003cstrong\u003eTimepoints\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 60px;\"\u003e\n \u003cp\u003e\u003cstrong\u003ePowered?\u003c/strong\u003e\u003c/p\u003e\n \u003cp\u003e\u003cstrong\u003eYes or No\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd colspan=\"5\" valign=\"top\" style=\"width: 654px;\"\u003e\n \u003cp\u003e\u003cstrong\u003eAim 1: Maternal and Infant Health Outcomes\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 101px;\"\u003e\n \u003cp\u003e\u003cstrong\u003ePrimary\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 139px;\"\u003e\n \u003cp\u003eLow Birthweight\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 192px;\"\u003e\n \u003cp\u003eInfant birthweight \u0026lt;2500g from EHR and birth certificate data\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 162px;\"\u003e\n \u003cp\u003eBirth\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 60px;\"\u003e\n \u003cp\u003e\u003cstrong\u003eYes\u0026nbsp;\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 101px;\"\u003e\n \u003cp\u003eSecondary\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 139px;\"\u003e\n \u003cp\u003eHigh utilization of EC during pregnancy\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 192px;\"\u003e\n \u003cp\u003eProportion of pregnant women with \u0026ge;4 EC visits during pregnancy from EHR data\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 162px;\"\u003e\n \u003cp\u003eFrom time of 1\u003csup\u003est\u003c/sup\u003e OB visit until birth\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 60px;\"\u003e\n \u003cp\u003eNo\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 101px;\"\u003e\n \u003cp\u003eSecondary\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 139px;\"\u003e\n \u003cp\u003e# Maternal hospitalizations \u0026amp; EC Visits during 1\u003csup\u003est\u003c/sup\u003e year post-birth\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 192px;\"\u003e\n \u003cp\u003e# Maternal hospitalizations \u0026amp; EC visits within 1 year post-birth from EHR data\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 162px;\"\u003e\n \u003cp\u003eFrom time of 1\u003csup\u003est\u003c/sup\u003e OB visit to 1 year post-birth\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 60px;\"\u003e\n \u003cp\u003eNo\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 101px;\"\u003e\n \u003cp\u003eSecondary\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 139px;\"\u003e\n \u003cp\u003e# Infant hospitalizations \u0026amp; EC Visits during 1\u003csup\u003est\u003c/sup\u003e year post-birth\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 192px;\"\u003e\n \u003cp\u003e# Infant hospitalizations \u0026amp; EC visits within 1 year post-birth from EHR data\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 162px;\"\u003e\n \u003cp\u003eFrom time of birth to 1 year post-birth\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 60px;\"\u003e\n \u003cp\u003eNo\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 101px;\"\u003e\n \u003cp\u003eESecondary\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 139px;\"\u003e\n \u003cp\u003ePostpartum visit attendance\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 192px;\"\u003e\n \u003cp\u003ePostpartum visit documented in EHR data\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 162px;\"\u003e\n \u003cp\u003e14-60 days postpartum\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 60px;\"\u003e\n \u003cp\u003eNo\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 101px;\"\u003e\n \u003cp\u003eSecondary\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 139px;\"\u003e\n \u003cp\u003eSevere Maternal Morbidity\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 192px;\"\u003e\n \u003cp\u003eICD codes for 21 CDC indicators from EHR data[32] with and without transfusion\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 162px;\"\u003e\n \u003cp\u003eBirth Hospitalization\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 60px;\"\u003e\n \u003cp\u003eNo\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 101px;\"\u003e\n \u003cp\u003eSecondary\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 139px;\"\u003e\n \u003cp\u003eHypertensive disorders of pregnancy\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 192px;\"\u003e\n \u003cp\u003eICD codes for eclampsia, preeclampsia, gestational hypertension from EHR data (See Appendix B)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 162px;\"\u003e\n \u003cp\u003ePregnancy until 6 weeks postpartum\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 60px;\"\u003e\n \u003cp\u003eNo\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 101px;\"\u003e\n \u003cp\u003eSecondary\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 139px;\"\u003e\n \u003cp\u003eNulliparous Singleton Term Vertex Cesarean Section\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 192px;\"\u003e\n \u003cp\u003e\u0026nbsp;Birth Certificate Data\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 162px;\"\u003e\n \u003cp\u003eBirth\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 60px;\"\u003e\n \u003cp\u003eNo\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd colspan=\"5\" valign=\"top\" style=\"width: 654px;\"\u003e\n \u003cp\u003e\u003cstrong\u003eAim 2: Longitudinal Patient Survey Patient-Centered Outcomes\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 101px;\"\u003e\n \u003cp\u003e\u003cstrong\u003ePrimary\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 139px;\"\u003e\n \u003cp\u003eRacism during OB care\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 192px;\"\u003e\n \u003cp\u003eDiscrimination in Medical Settings Scale from LPS[23]\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 162px;\"\u003e\n \u003cp\u003e24-30 weeks of gestation\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 60px;\"\u003e\n \u003cp\u003e\u003cstrong\u003eYes\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 101px;\"\u003e\n \u003cp\u003eSecondary\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 139px;\"\u003e\n \u003cp\u003eDepression\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 192px;\"\u003e\n \u003cp\u003eEdinburgh Postnatal Depression Scale in from LPS[22]\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 162px;\"\u003e\n \u003cp\u003e24-30 weeks of gestation\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 60px;\"\u003e\n \u003cp\u003e\u003cstrong\u003eYes\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 101px;\"\u003e\n \u003cp\u003eSecondary\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 139px;\"\u003e\n \u003cp\u003eSatisfaction with Care\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 192px;\"\u003e\n \u003cp\u003eICHOM Standard Set question from LPS[33]\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 162px;\"\u003e\n \u003cp\u003e24-30 weeks of gestation\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 60px;\"\u003e\n \u003cp\u003eNo\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd colspan=\"5\" valign=\"top\" style=\"width: 654px;\"\u003e\n \u003cp\u003e\u003cstrong\u003eAim 3: Implementation Outcomes\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 101px;\"\u003e\n \u003cp\u003e\u003cstrong\u003ePrimary\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 139px;\"\u003e\n \u003cp\u003eIdentification of intervention barriers and facilitators\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 192px;\"\u003e\n \u003cp\u003eCompletion of key informant interviews and focus groups including Hexagon Tool and structured interview guides\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 162px;\"\u003e\n \u003cp\u003eBefore/midpoint/endpoint of implementation period\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 60px;\"\u003e\n \u003cp\u003eNo\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 101px;\"\u003e\n \u003cp\u003eSecondary\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 139px;\"\u003e\n \u003cp\u003eRacism knowledge\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 192px;\"\u003e\n \u003cp\u003eKnowledge score from Racial Equity Training pre-/post-tests\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 162px;\"\u003e\n \u003cp\u003eBefore/after training\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 60px;\"\u003e\n \u003cp\u003eNo\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003c/tbody\u003e\n\u003c/table\u003e\n\u003cp\u003e\u003cstrong\u003eAbbreviations: EHR (Electronic Health Record); EC (Emergency Care); # (number); ICD (International Classification of Disease Codes Clinical Modification 10); OB (Obstetric); CPT (Current Procedure Technology); LPS (ACURE4Moms Longitudinal Patient Survey); ICHOM (International Consortium for Health Outcomes Measurement)\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eRace-identification will be used in our study as a proxy for experiencing anti-Black racism. Race/ethnicity of included patients will be determined by the demographic data provided by practices. Practices will be encouraged and supported by our Quality Improvement experts (the North Carolina Area Health Education Centers Practice Support Program-www.ncahec.net/core_service/practice-support/) to use the best practice of asking patients to self-identify any race(s) and/or ethnicit(ies) with which they identify. However, this recommendation may not always be followed stringently by practices. Therefore, the subset of participants recruited to participate in the Longitudinal Patient Survey will be given an opportunity to self-identify their race(s) and/or ethnicit(ies) with trained recruitment consultants, and any discrepancies with electronic health data will be explored.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003ePatient-Centered Outcomes:\u0026nbsp;\u003c/strong\u003eLongitudinal patient surveys include survey responses from 4 time points. Surveys data will include the Birth Satisfaction Scale, the Patient-Reported Outcomes Measurement Information System-10 quality of life scale, the Edinburgh Postnatal Depression Scale, the Discrimination in Medical Settings Scale, and items from the International Consortium for Health Outcomes Measurement standard set for pregnancy and childbirth.[22, 23, 33]\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eMaternal Health Equity and Education Training Outcomes:\u0026nbsp;\u003c/strong\u003eWe will also evaluate 3 forms of knowledge about racism, bias, and disparities in healthcare among practice staff in Arms 2-4 through post-tests after each training session: 1) Factual knowledge (e.g. statistics on racial disparities in obstetric care), 2) Conceptual knowledge (e.g. institutional and interpersonal racism), and 3) Process knowledge from hearing the personal and professional experiences of facilitators, colleagues and the case presented during the trainings.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eImplementation Data:\u0026nbsp;\u003c/strong\u003eIndividual telephonic or video interviews will be conducted with practice staff including the provider, nurse, and administrative champions at 3 time points: prior to implementation, midway through implementation, and at the conclusion of the study. We use structured interview guides, and the interviews are recorded, transcribed, and analyzed using NVivo qualitative software.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eData Management and Safety:\u0026nbsp;\u003c/strong\u003ePrenatal practices will send new prenatal care patient panels, including race and ethnicity, to secure servers at the Cecil G. Sheps Center for Health Services Research. The Sheps Center is a \u0026ldquo;pan-university\u0026rdquo; research center within the University of NC which offers Data Management, Statistical Analyses, Secure Research Computing, and Integrated Research Solutions resources. The data sent to the Sheps Center will then be: 1) used by recruitment consultants to recruit participants for our Longitudinal Patient Survey, and 2) sent to the NC Health Information Exchange Authority, who will match patients with statewide health system encounter data and thereby populate the Race Equity Dashboards and the Maternal Warning System. De-identified outcomes data from the Health Information Exchange will then be sent back to the Sheps Center team for analysis by the research team.\u003c/p\u003e\n\u003cp\u003eACURE4Moms has received Institutional Review Board Approval from the University of North Carolina. We will report findings according to CONSORT guidelines\u003cstrong\u003e.\u0026nbsp;\u003c/strong\u003eACURE4Moms does not have a Data Safety Monitoring Board given that the study interventions present no more than minimal risk; however, the study investigators, Community Advisory Board (STABLE), and an Independent Safety Monitor will review study data quarterly throughout project implementation to ensure no unexpected risks or outcomes arise. Patients referred to doulas can withdraw consent for this support at any time.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eStatistical Analysis Plan:\u0026nbsp;\u003c/strong\u003eThe primary Aim 1 analysis will compare the odds of LBW among Black birthing persons in Arm 1 (Standard Care Management) compared with Arm 4 (Combined Intervention) using Mixed Linear Logistic Regression Models. The Model will account for nesting of patients (Level 1), within practices (Level 2), adjusting for age, parity, education level, smoking, Body Mass Index category, census tract, and insurance status (variables known to be associated with LBW). Extensive informatics and practice-based quality improvement measures will be taken to limit missingness.[18] Data missingness will be described and associations between practice-level covariates, and missingness will be explored, with differences formally tested using logistic regression models for binary missingness variables. Inverse weighting based on missingness probabilities will be employed to adjust for the effects of practice level covariates on missingness, as needed. Mixed Linear Models will also be used to describe the effects of the intervention on the secondary outcomes. Analyses will be intention to treat with all patients who start prenatal care at each practice included in the arm the practice was originally randomized to with a planned sensitivity analysis only including patients who stayed at each practice through birth. Patients who transfer care will still have outcomes available in the NC Health Information Exchange. Data analysts will be masked regarding study Arm of participants.\u003c/p\u003e\n\u003cp\u003eTo perform the sample size calculation, the design effect arising from the clustering inherent to the study\u0026rsquo;s nested design is estimated using the following formula: Deff=1+(m-1)\u0026rho;, where m=average cluster size and \u0026rho;=Intercluster Correlation Coefficient. The minimum number of study observations is approximately 8,400 Black mother-infant dyads in 40 clusters, assuming that up to 4 practices (clusters) will drop out after randomization. Using the power function from Stata[34] and assuming an Intercluster Corrrelation Coefficient of 0.015, a two-sided ɑ = 0.05 and 80% power, with 40 total clusters (10 per Arm) and within cluster sample size of 280, we will be able to detect a 38.6% difference in the LBW rate between arms. The coefficient of 0.015 is a conservative estimate chosen based on a literature review of similar studies.[35\u0026ndash;37] The detectable effect size improves with smaller coefficients and higher cluster numbers (see \u003cstrong\u003eAdditional Files\u003c/strong\u003e).\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eDissemination Plan\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eWe are developing a dissemination plan, together with our stakeholders and community partners that will include peer reviewed manuscripts, scientific presentations at conferences, as well as community forums,meetings, and social media. Our funder will also disseminate the findings on their website and we will report the findings on clinicaltrials.gov. A publication policy was developed at study start which includes pre-planned manuscripts for each study aim as well as a process to propose additional manuscripts by members of the research team or others.\u003c/p\u003e"},{"header":"Discussion","content":"\u003cp\u003eThe ACURE4Moms study funded by the Patient Centered Outcomes Research Institute, the Duke Endowment, and the UNC Health Foundation will inform clinical practice and guide policy change in NC and beyond. Implementation began in June of 2023 and will continue through December of 2026. It will be the first randomized trial to test the impact of community-based doula support and prenatal clinic data accountability and transparency interventions on disparities in birth outcomes. It will generate a wealth of implementation data for health systems and policymakers, including costs of such interventions.\u003c/p\u003e\n\u003cp\u003eThough cluster randomized trials are subject to more bias and lower power than individual randomization,[38] we chose this study design because both interventions are designed to be delivered at the level of the practice. For the community-based doula intervention, though it would be possible to randomize patients to receive doula support, the ACURE4Moms practices paired with doulas will develop bi-directional, educational relationships with the ACURE4Moms doulas from their communities. Practice staff can learn from the community-based doulas about improving trust with their patients and about community resources and concerns. \u0026nbsp;The doulas can learn the rationale for certain medical recommendations and help explain this to their clients and communities. This integration of the community-based doulas into the care team will offer the opportunity not only to improve outcomes for specific clients, but also to improve the quality of care for all patients at that practice.\u003c/p\u003e\n\u003cp\u003eA major limitation of the ACURE4Moms interventions is that they started only at the beginning of pregnancy. The factors impacting LBW disparities for Black birthing people, particularly institutional and interpersonal racism, are present well before pregnancy occurs and cannot be completely mitigated during the relatively short duration of a pregnancy and without changing other systems with which these individuals interact. In addition, though we believe doulas may be part of the solution for disparities, we must avoid the possibility that health care professionals and systems will shift the burden of improving health disparities completely to the shoulders of community-based doulas. However, given the preliminary data that both community-based doula support and practice-based data accountability and transparency can improve health disparities, and our plan to combine these in Arm 4, we anticipate our approach to be impactful.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eThere are several potential barriers to successful implementation of the ACURE4Moms study. Perhaps the most important is the increasing time demands and workflow shortages for clinical staff in NC and nationwide that were exacerbated by the COVID-19 pandemic.[39] Despite these challenges, our team believes that the current disparities in maternal and infant health outcomes, also exacerbated by the pandemic,[40] are unacceptable and preventable. The data accountability and transparency interventions will be the most time consuming for clinical staff but are modeled on two successful studies that reduced adult cancer disparities[17] and cardiovascular risk disparities[18]. One of these, the Heart Health Now (HHN) study, found that NC Area Health Education Centers (AHEC) Practice Facilitators (PFs) can effectively help practices establish risk-stratified quality improvement (QI) approaches that resolve racial disparities in CVD risk. HHN was a stepped-wedge, stratified cluster randomized controlled trial (RCT) of 219 primary care practices who participated in NC Medicaid\u0026rsquo;s medical home program.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u0026nbsp;Where possible, the use of automated data feeds will reduce or eliminate the burden on clinical staff to report data. We will conduct implementation research with the practices to establish workflows that are flexible and workable in real-world clinics.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eA second barrier is that the Race Equity Dashboards and Maternal Warning Systems will rely on the NC Health Information Exchange Authority to extract analyzable data from the electronic health records of included clinical sites which then is integrated into the race equity dashboards developed by the Sheps Center. \u0026nbsp;Scaling to other states would require similar partnerships with local health information exchanges. However, the goal of United States Department of Health and Human Services is to achieve nationwide interoperability of health information systems by 2024.[41] Building ACURE4Moms interventions within a state-wide exchange, rather than within an individual practice electronic health record, takes advantage of standardizations in interoperability and will allow other prenatal clinics to utilize the Dashboards and Warning Systems in the future. It will also allow us to potentially capture BP measurements and other risk factors from encounters for ACURE4Moms patients in NC health facilities not enrolled in the study.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eA third barrier is engaging community-based doulas with practices given the history of institutional racism and many doulas\u0026rsquo; desires to remain outside of these systems. Our research team is co-led by doula leads from two community-based organizations. Their leadership has been essential to designing an intervention that is acceptable to community members and community-based doulas. They are taking the lead in orienting practices and hospitals to the community-based doula scope of practice and in establishing relationships between the doulas and other members of the health care team.\u0026nbsp;\u003c/p\u003e"},{"header":"Conclusion","content":"\u003cp\u003eThe ACURE4Moms study is a cluster randomized trial of data accountability and transparency and community-based doula interventions implemented at diverse prenatal practices across the state of NC. The study of the implementation of these two innovative interventions, applied to maternal health disparities, offers the opportunity to inform maternal health policymakers, providers, and health systems about how to best use available resources to minimize racial disparities in maternal health.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eTrial Status\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003e39 prenatal practices have been enrolled in the ACURE4Moms study including private practices, health-system owned clinics, academic medical centers with resident clinics, and community health centers. We have achieved approval from the Institutional Review Board for updated protocols, currently version 2.4. The study began recruitment at the first sites June 5, 2023 and the last site in December 15, 2024 and recruitment will be complete December 15, 2026. We have trained 35 doulas who are active in the program. 26 community-based recruitment consultants are actively recruiting participants to the longitudinal patient survey. Recruitment began August 1, 2023 and should be complete January 31, 2027. We have built 3 maternal early warning alerts and (missed prenatal visits, elevated blood pressures, and eligible for aspirin to prevent preeclampsia). A sample disparities dashboard with 3 metrics (low birth weight, timely prenatal care, and preterm birth) has been built and is being tested with clinics. The full disparities dashboards are being built. The MHEET training has been developed for the first 7 sessions. All sites have received MHEET session 1 training, and some have received through session 7. Pre-implementation interviews have been conducted at every practice, and the midpoint interviews are in process. Nine practices dropped out prior to implementation due to either closure, changes in staffing, or inability to contract with the Health Information Exchange Authority. Two practices have dropped out after partial implementation due to the fact that they were unable to continue providing prenatal care. See \u003cstrong\u003eFigure 2\u003c/strong\u003e.\u003c/p\u003e"},{"header":"Declarations","content":"\u003cp\u003e\u003cstrong\u003eEthics approval:\u003c/strong\u003e this research protocol has been approved by the University of North Carolina Institutional Review Board (IRB) as of August 30, 2022 (Review Number 22-1541). Written informed consent will be obtained from all participants in the longitudinal patient survey and for the participants in the implementation interviews. A waiver of informed consent was obtained for obtaining health information exchange authority and vital records data on pregnancy outcomes for participants given that the interventions are delivered at the level of the practice, focused on quality improvement, and pose minimal risk to participants. However, data security contracts were set up between each of the participating practices and UNC to and between UNC and the Health Information Exchange Authority to clarify how data would be stored and protected. Protocol deviations are reported to our sponsor, our independent safety monitor and the IRB.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eConsent for publication:\u0026nbsp;\u003c/strong\u003eN/A\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eAvailability of data and materials:\u0026nbsp;\u003c/strong\u003eDe-identified longitudinal patient survey data and implementation data will be made available upon request to interested researchers. Due to contractual obligations with the North Carolina Health Exchange Authority, we are unable to share health outcomes data outside of the approved research team at UNC. All data will be kept on the Secure Server at UNC Sheps and only accessible on the server. Only those individuals who need to perform data management and analysis will have access to the data.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eCompeting interests:\u0026nbsp;\u003c/strong\u003eAM is the founder/CEO of Momma\u0026rsquo;s Village Fayetteville, a non-profit organization with a mission to provide access to African-centered birth \u0026amp; breastfeeding support, postpartum care, parenting education and mental health resources for Black families in Fayetteville/Ft. Bragg and the surrounding Sandhills region. MJ is the founder/executive director of MAAME, Inc., a non-profit organization that provides compassionate support, education, and resources that empower birthing families to navigate systems of care and overcome barriers. The remaining authors report no conflicts of interest.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eFunding:\u0026nbsp;\u003c/strong\u003eACURE4Moms is primarily funded through the Patient Centered Outcomes Research Institute (PCORI; [email protected]). It is also funded through the Duke Endowment and the UNC Foundation. The study sponsor provided input into the design of the study and is alerted when manuscripts are submitted for publication but is not involved in the collection, management, analysis, interpretation of data, writing of any manuscripts, or decision to submit a manuscript for publication.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eAuthor Contributions:\u0026nbsp;\u003c/strong\u003eRPU is a principal investigator in the study who co-led conception of the study and led the proposal development along with JT. All authors read and approved the final manuscript. MB led the development of the statistical analysis plan and assisted with preparation of the manuscript. AM, CM, MJ, SV, SC, MB, WN, KM, CY, AM, DB, CY, BC, AA, KB, and RH all contributed to the design of the study and assisted with preparation of the manuscript.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eAcknowledgement:\u0026nbsp;\u003c/strong\u003eNot applicable\u003c/p\u003e"},{"header":"References","content":"\u003col\u003e\u003cli\u003e\u003cspan\u003ePetersen EE, Davis NL, Goodman D, Cox S, Syverson C, Seed K, et al. Racial/Ethnic Disparities in Pregnancy-Related Deaths - United States, 2007\u0026ndash;2016. MMWR Morb Mortal Wkly Rep. 2019;68:762\u0026ndash;5.\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eMacDorman MF, Thoma M, Declcerq E, Howell EA. Racial and ethnic disparities in maternal mortality in the united states using enhanced vital records, 2016\u0026ndash;2017. 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NCHS Data Brief. 2018;:1\u0026ndash;8.\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eNC State Center for Health Statistics. Percent of liveborn infants weighing 2,500 grams or under (5 pounds, 8 ounces or less), regardless of the period of gestation. 2015\u0026ndash;20.\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eEarnshaw VA, Rosenthal L, Lewis JB, Stasko EC, Tobin JN, Lewis TT, et al. Maternal experiences with everyday discrimination and infant birth weight: a test of mediators and moderators among young, urban women of color. Ann Behav Med. 2013;45:13\u0026ndash;23.\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eMustillo S, Krieger N, Gunderson EP, Sidney S, McCreath H, Kiefe CI. Self-reported experiences of racial discrimination and Black-White differences in preterm and low-birthweight deliveries: the CARDIA Study. Am J Public Health. 2004;94:2125\u0026ndash;31.\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eMancilla VJ, Peeri NC, Silzer T, Basha R, Felini M, Jones HP, et al. Understanding the interplay between health disparities and epigenomics. Front Genet. 2020;11:903.\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eSmedley A, Smedley BD. Race as biology is fiction, racism as a social problem is real: Anthropological and historical perspectives on the social construction of race. Am Psychol. 2005;60:16\u0026ndash;26.\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eAlhusen JL, Bower KM, Epstein E, Sharps P. Racial discrimination and adverse birth outcomes: an integrative review. J Midwifery Womens Health. 2016;61:707\u0026ndash;20.\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eCrear-Perry J, Correa-de-Araujo R, Lewis Johnson T, McLemore MR, Neilson E, Wallace M. Social and structural determinants of health inequities in maternal health. J Womens Health (Larchmt). 2021;30:230\u0026ndash;5.\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eHowell EA, Brown H, Brumley J, Bryant AS, Caughey AB, Cornell AM, et al. Reduction of peripartum racial and ethnic disparities: A conceptual framework and maternal safety consensus bundle. Obstet Gynecol. 2018;131:770\u0026ndash;82.\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eMain EK, Chang S-C, Dhurjati R, Cape V, Profit J, Gould JB. Reduction in racial disparities in severe maternal morbidity from hemorrhage in a large-scale quality improvement collaborative. Am J Obstet Gynecol. 2020;223:123.e1-123.e14.\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eWeiss D, Dunn SI, Sprague AE, Fell DB, Grimshaw JM, Darling E, et al. Effect of a population-level performance dashboard intervention on maternal-newborn outcomes: an interrupted time series study. BMJ Qual Saf. 2018;27:425\u0026ndash;36.\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eCykert S, Eng E, Manning MA, Robertson LB, Heron DE, Jones NS, et al. A Multi-faceted Intervention Aimed at Black-White Disparities in the Treatment of Early Stage Cancers: The ACCURE Pragmatic Quality Improvement trial. J Natl Med Assoc. 2020;112:468\u0026ndash;77.\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eCykert S, Keyserling TC, Pignone M, DeWalt D, Weiner BJ, Trogdon JG, et al. A controlled trial of dissemination and implementation of a cardiovascular risk reduction strategy in small primary care practices. Health Serv Res. 2020;55:944\u0026ndash;53.\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eJackson C, DuBard A, Berrien K, Russell M, DeBerry K, Menard MK. THE MATERNAL-INFANT IMPACTABILITYSCORE\u003csup\u003e\u0026trade;\u003c/sup\u003e (MIIS) FOR CARE MANAGERS:A Demonstrated Approachfor Reducing Low BirthWeight ThroughPregnancy Care Management. CCNC Data Brief; 2021.\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eEllmann N. Community-Based Doulas and Midwives: Keys to Addressing the U.S. Maternal Health Crisis. Center for American Progress; 2020.\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eKozhimannil KB, Vogelsang CA, Hardeman RR, Prasad S. Disrupting the Pathways of Social Determinants of Health: Doula Support during Pregnancy and Childbirth. J Am Board Fam Med. 2016;29:308\u0026ndash;17.\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eGibson J, McKenzie-McHarg K, Shakespeare J, Price J, Gray R. A systematic review of studies validating the Edinburgh Postnatal Depression Scale in antepartum and postpartum women. Acta Psychiatr Scand. 2009;119:350\u0026ndash;64.\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eHausmann LRM, Kressin NR, Hanusa BH, Ibrahim SA. Perceived racial discrimination in health care and its association with patients\u0026rsquo; healthcare experiences: does the measure matter? Ethn Dis. 2010;20:40\u0026ndash;7.\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eChan A-W, Tetzlaff JM, G\u0026oslash;tzsche PC, Altman DG, Mann H, Berlin JA, et al. SPIRIT 2013 explanation and elaboration: guidance for protocols of clinical trials. BMJ. 2013;346:e7586.\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eBaker SL, Black KZ, Dixon CE, Yongue CM, Mason HN, McCarter P, et al. Expanding the Reach of an Evidence-Based, System-Level, Racial Equity Intervention: Translating ACCURE to the Maternal Healthcare and Education Systems. Front Public Health. 2021;9:664709.\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003ePerinatal Health Equity Collaborative. NC Perinatal Health Strategic Plan 2022\u0026ndash;2026. NC Department of Health and Human Services, Division of Public Health; 2022.\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eNC Maternal Mortality Review Committee. North Carolina Maternal Mortality Review Report. North Carolina Women Infant and Community Wellness Section; 2021.\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eBerrien K, Ollendorff A, Menard MK. Pregnancy medical home care pathways improve quality of perinatal care and birth outcomes. N C Med J. 2015;76:263\u0026ndash;6.\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eWeiner BJ, Pignone MP, DuBard CA, Lefebvre A, Suttie JL, Freburger JK, et al. Advancing heart health in North Carolina primary care: the Heart Health NOW study protocol. Implement Sci. 2015;10:160.\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003ePeoples Institute for Survival and Beynod. Our Principles. \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003ehttps://pisab.org/our-principles/\u003c/span\u003e\u003cspan address=\"https://pisab.org/our-principles/\" targettype=\"URL\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e. Accessed 5 Feb 2024.\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eRevels C, Burris C. NC HealthConnex and Value-based Care: Statewide Health Information Exchange as a Technology Tool for All. N C Med J. 2019;80:229\u0026ndash;33.\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eHow Does CDC. Identify Severe Maternal Morbidity? | CDC. \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003ehttps://www.cdc.gov/reproductivehealth/maternalinfanthealth/smm/severe-morbidity-ICD.htm\u003c/span\u003e\u003cspan address=\"https://www.cdc.gov/reproductivehealth/maternalinfanthealth/smm/severe-morbidity-ICD.htm\" targettype=\"URL\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e. Accessed 1 Feb 2023.\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eNijagal MA, Wissig S, Stowell C, Olson E, Amer-Wahlin I, Bonsel G, et al. Standardized outcome measures for pregnancy and childbirth, an ICHOM proposal. BMC Health Serv Res. 2018;18:953.\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eStataCorp. Stata 17. Computer software. College Station. TX: StataCorp LLC; 2021.\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eMoore Simas TA, Brenckle L, Sankaran P, Masters GA, Person S, Weinreb L, et al. The PRogram In Support of Moms (PRISM): study protocol for a cluster randomized controlled trial of two active interventions addressing perinatal depression in obstetric settings. BMC Pregnancy Childbirth. 2019;19:256.\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eChamberlain AT, Seib K, Ault KA, Rosenberg ES, Frew PM, Cort\u0026eacute;s M, et al. Improving influenza and Tdap vaccination during pregnancy: A cluster-randomized trial of a multi-component antenatal vaccine promotion package in late influenza season. Vaccine. 2015;33:3571\u0026ndash;9.\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eNielsen PE, Goldman MB, Mann S, Shapiro DE, Marcus RG, Pratt SD, et al. Effects of teamwork training on adverse outcomes and process of care in labor and delivery: a randomized controlled trial. Obstet Gynecol. 2007;109:48\u0026ndash;55.\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eTurner EL, Platt AC, Gallis JA, Tetreault K, Easter C, McKenzie JE, et al. Completeness of reporting and risks of overstating impact in cluster randomised trials: a systematic review. Lancet Glob Health. 2021;9:e1163\u0026ndash;8.\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eMcCartha EB. NC Nursecast: Understanding the Nursing Workforce in North Carolina. NC Med J. 2022;83:164\u0026ndash;5.\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eUnited Stated Government Accountability Office. Outcomes Worsened and Disparities Persisted During the Pandemic. U.S. Government Accountability Office; 2022.\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eOffice of the National Coordinator for Health Information Technology. Connecting Health and Care for the Nation: a Shared Nationwide Interoperability Roadmap. Office of the National Coordinator for Health Information Technology; 2015.\u003c/span\u003e\u003c/li\u003e\u003c/ol\u003e"}],"fulltextSource":"","fullText":"","funders":[],"hasAdminPriorityOnWorkflow":false,"hasManuscriptDocX":true,"hasOptedInToPreprint":true,"hasPassedJournalQc":"","hasAnyPriority":false,"hideJournal":false,"highlight":"","institution":"","isAcceptedByJournal":true,"isAuthorSuppliedPdf":false,"isDeskRejected":"","isHiddenFromSearch":false,"isInQc":false,"isInWorkflow":true,"isPdf":false,"isPdfUpToDate":true,"isWithdrawnOrRetracted":false,"journal":{"display":true,"email":"[email protected]","identity":"trials","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":false,"externalIdentity":"trls","sideBox":"Learn more about [Trials](http://trialsjournal.biomedcentral.com/)","snPcode":"13063","submissionUrl":"https://www.editorialmanager.com/trls","title":"Trials","twitterHandle":"MedicalEvidence","acdcEnabled":true,"dfaEnabled":true,"editorialSystem":"em","reportingPortfolio":"BMC/SO AJ","inReviewEnabled":true,"inReviewRevisionsEnabled":true},"keywords":"maternal health, healthcare disparities, doulas, informatics, low birth weight, racism, pragmatic clinical trial","lastPublishedDoi":"10.21203/rs.3.rs-6669094/v1","lastPublishedDoiUrl":"https://doi.org/10.21203/rs.3.rs-6669094/v1","license":{"name":"CC BY 4.0","url":"https://creativecommons.org/licenses/by/4.0/"},"manuscriptAbstract":"\u003cp\u003e\u003cstrong\u003eBackground: \u003c/strong\u003eIn the United States, Non-Hispanic Black (Black) people are 2-3-fold 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 to prenatal practices on maternal and infant health disparities.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eMethods: \u003c/strong\u003eACURE4Moms 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.\u003c/p\u003e\n\u003cp\u003eMulti-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.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eDiscussion: \u003c/strong\u003eThe 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.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eTrial Registration: \u003c/strong\u003eThis trial has been prospectively registered as (7/29/2022) with clinicaltrials.gov under the name \u003cem\u003eAccountability for Care Through Undoing Racism \u0026amp; Equity for Moms (ACURE4Moms), \u003c/em\u003eIdentifier: NCT05484804. \u0026nbsp;URL: https://clinicaltrials.gov/ct2/show/NCT05484804.\u0026nbsp;\u003c/p\u003e","manuscriptTitle":"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","msid":"","msnumber":"","nonDraftVersions":[{"code":1,"date":"2025-10-17 02:03:37","doi":"10.21203/rs.3.rs-6669094/v1","editorialEvents":[{"type":"communityComments","content":0},{"type":"reviewerAgreed","content":"","date":"2025-10-02T15:12:22+00:00","index":0,"fulltext":""},{"type":"reviewersInvited","content":"","date":"2025-10-02T13:59:05+00:00","index":"","fulltext":""},{"type":"editorAssigned","content":"","date":"2025-06-26T11:48:23+00:00","index":"","fulltext":""},{"type":"submitted","content":"Trials","date":"2025-06-24T09:19:37+00:00","index":"","fulltext":""},{"type":"decision","content":"Minor revision","date":"2025-06-16T03:03:48+00:00","index":"","fulltext":""}],"status":"published","journal":{"display":true,"email":"[email protected]","identity":"trials","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":false,"externalIdentity":"trls","sideBox":"Learn more about [Trials](http://trialsjournal.biomedcentral.com/)","snPcode":"13063","submissionUrl":"https://www.editorialmanager.com/trls","title":"Trials","twitterHandle":"MedicalEvidence","acdcEnabled":true,"dfaEnabled":true,"editorialSystem":"em","reportingPortfolio":"BMC/SO AJ","inReviewEnabled":true,"inReviewRevisionsEnabled":true}}],"origin":"","ownerIdentity":"b617b08d-a009-49ea-a8a0-a81f7b1bf18d","owner":[],"postedDate":"October 17th, 2025","published":true,"recentEditorialEvents":[],"rejectedJournal":[],"revision":"","amendment":"","status":"published-in-journal","subjectAreas":[],"tags":[],"updatedAt":"2026-03-02T16:02:21+00:00","versionOfRecord":{"articleIdentity":"rs-6669094","link":"https://doi.org/10.1186/s13063-026-09514-9","journal":{"identity":"trials","isVorOnly":false,"title":"Trials"},"publishedOn":"2026-02-24 15:58:10","publishedOnDateReadable":"February 24th, 2026"},"versionCreatedAt":"2025-10-17 02:03:37","video":"","vorDoi":"10.1186/s13063-026-09514-9","vorDoiUrl":"https://doi.org/10.1186/s13063-026-09514-9","workflowStages":[]},"version":"v1","identity":"rs-6669094","journalConfig":"researchsquare"},"__N_SSP":true},"page":"/article/[identity]/[[...version]]","query":{"redirect":"/article/rs-6669094","identity":"rs-6669094","version":["v1"]},"buildId":"8U1c8b4HqxoKbykW_rLl7","isFallback":false,"isExperimentalCompile":false,"dynamicIds":[84888],"gssp":true,"scriptLoader":[]}