NCT04879797

Reducing Racial Disparities in Severe Maternal Morbidity

Reducing Racial Disparities in SMM: Assessing the Integration of Maternal Safety Bundles and Community Based Doulas to Improve Outcomes for Black Women

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,538 (estimated)
• Sponsor: Tufts University · Academic / Other
• Sex: Female
• Age: —
• Healthy volunteers: Accepted

Summary

There is a paucity of research examining the intersection of race, ethnicity, maternal safety bundles, doulas, and maternal outcomes in Black women at increased risk of severe maternal morbidity and mortality. The proposed mixed-methods study is the first systematic investigation of pregnancy complications and outcomes among Black women with whom maternal safety bundles are being implemented including racial disparities, hemorrhage, and hypertension. Additionally, through the analysis of secondary state level data, this study will examine perinatal care, maternal outcomes, and healthcare utilization of Black women at increased risk of severe maternal morbidity and mortality compared with non-Latino white women. Finally, through individual interviews with Black women and focus groups with obstetric health providers and doulas, the study will examine disparities and improve care by creating and disseminating a set of practice recommendations for maternity care for Black women at increased risk of morbidity and mortality. Research has not yet examined the intersection of race/ethnicity, doulas, and quality improvement (QI) interventions, such as maternal safety bundles, on reducing SMM and mortality among non-Hispanic Black (NHB) women. The overall goal of this mixed-methods study is to use analysis of existing big data and the evaluation of two interventions to ultimately develop targeted recommendations for addressing these inequities. Our approach leverages multiple data sources to study maternal outcomes and access to care during the prenatal, birth, and postpartum periods in order to identify commonalities among women who experienced SMM and use those findings to create a risk profile of women who are more likely to experience SMM; examine the implementation of maternal safety bundles on SMM and MM outcomes for women up to 1 year postpartum (Intervention 1); gather in-depth data from obstetric care providers on factors that support or hinder safety bundle implementation (Intervention 1); and gather in-depth data from individual women and doulas on facilitators of barriers to the use of doulas to improve care and address inequities (Intervention 2).

Detailed description

Background / Literature Review / Rationale for the study: Black women experience stark disparities in pregnancy complications and outcomes compared to White women. Recognizing, tracking and understanding patterns of severe maternal morbidity (SMM) and associated inequities by race/ethnicity, along with developing and carrying out interventions to improve the quality of maternal care, are essential to reducing SMM and thereby maternal mortality. To date, there has been little research specifically aimed at understanding whether the maternal health inequities as experienced by Black women can be ameliorated through an integrated care model that includes engagement of providers in the planning and implementation of maternal safety bundles or engaging mothers in prenatal, birth and postpartum support from community doulas. The investigators will use the Health Impact Pyramid and CFIR Framework (Consolidated Framework for Implementation) to develop, implement and assess the effectiveness of such a system in reducing disparities in SMM and mortality. The data sources for this study will include state-level and hospital-specific discharge data collected as part of the Alliance for Innovation on Maternal Health (AIM) project and the Pregnancy to Early Life Longitudinal (PELL) data system, which focuses on population-level data needed to examine health inequities among racial and ethnic minorities in Massachusetts. In addition to these existing data sources, the investigators intend to establish a data collection tool to assess doula services as well as analyze qualitative data from interviews with Black women, and focus groups with obstetrical care providers and doulas to explore the effect of implementing safety bundles and incorporating doula-provided services into prenatal, birth and postpartum care.

Conditions

• Maternal Death

Interventions

Type	Name	Description
OTHER	Implementation of Maternal Safety Bundles	In the second phase, implementation of the bundles will take place. During this phase investigators will conduct quarterly surveys with the health facilities to measure implementation progress, including an index of evidence-based practices. Investigators will conduct surveys with postpartum women to measure their patient experience. Surveys will be conducted using RedCap software. Participants will be given the opportunity to complete the survey online or if they prefer, a research assistant can call them to conduct the survey over the phone. Data on SMM will be collected through PELL
OTHER	Doula Services	Investigators are evaluating doula services that are offered by two doula organizations at three hospitals.

Timeline

• Start date: 2021-10-01
• Primary completion: 2024-06-30
• Completion: 2025-06-30
• First posted: 2021-05-10
• Last updated: 2023-09-13

Locations

1 site across 1 country: United States