Reducing Racial Disparities in Severe Maternal Morbidity

Tufts University

Status: Enrolling

Conditions: Maternal Death

Treatments: Other: Implementation of Maternal Safety Bundles; Other: Doula Services

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04879797

M530001 NIH172

1R01MD016026-01 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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).

Full 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.

Enrollment: 1,538 estimated patients

Sex: Female

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Intervention I (Maternal Safety Bundles) AIM Bundle Structure, Process and SMM 21 Outcome Measures • Inclusion criteria: Births at the five participating hospital sites for Intervention 1, collecting data one year prior to, during and one year after the study period.

PREM PROM (Patient Reported Experience Measure ( PREM) Patient Reported Outcome Measure (PROM) Surveys for Intervention I

• Inclusion criteria for Pre- and post- surveys for Maternal Safety Bundles Implementation: Birthing individuals who have delivered six weeks to one year prior to the interview at the five participating sites in Intervention 1

Focus groups for Intervention I

• Inclusion criteria: Obstetrical care providers including nurses, midwives, family practitioners, attending obstetricians and trainee obstetricians employed at the five participating hospital sites will be invited to participate in focus groups.

Intervention II (Community doula support) Severe Maternal Mortality (SMM) 21 Outcome Measures • Inclusion criteria: Live births among birthing individuals who identify as Black or African American and who are offered community doula-support at one of the participating four hospitals, either through a hospital-based program or a payer navigation program. The study will include in the intervention arm 340 pregnant women who (1) live in the state of MA, (2) identify as Black or African American, (3) are offered doula care by either their provider or their payer-based navigation program and (4) deliver at one of the four delivering hospitals (Beth Israel Lahey, Boston Medical Center, St. Elizabeth's Medical Center, and Baystate Medical Center). Concurrently, the 340 birthing individuals who were offered doula care in the intervention arm will be matched with birthing individuals who identify as Black or African American, have a live birth, and deliver at one of four hospitals and have similar demographics such as age, comorbidities, payer status, etc.

Focus groups for Intervention II • Inclusion criteria: Persons who practice or identify as community doulas and work with clients who deliver in the state of Massachusetts and have assisted a client in pregnancy, birth, or postpartum within the past 12 months prior to the focus group discussion; obstetrical care provider including nurses, midwives, family medicine practitioners, attending obstetricians, and obstetricians employed at the four participating hospital sites as well as community doula programmatic staff who are employed at participating hospitals sites, or participating community doula organizations, or payers

PREM PROM (Patient Reported Experience Measure Patient Reported Outcome Measure) Surveys for Intervention II

• Inclusion criteria: Live births among birthing individuals who identify as Black or African American and who are offered community doula-support at one of the participating four hospitals, either through a hospital-based program or a payer navigation program.

Intervention I (Maternal Safety Bundles) AIM Bundle Structure, Process and SMM 21 Outcome Measures

• Exclusion criteria: Pregnancies ending prior to 20 weeks and due to ectopic pregnancy not occurring on labor and delivery units of the five participating hospitals

PREM PROM (Patient Reported Experience Measure Patient Reported Outcome Measure) Surveys for Intervention I

• Exclusion criteria: Pregnancies ending prior to 20 weeks and due to ectopic pregnancy not occurring on labor and delivery units of the five participating hospitals

Focus groups for Intervention I

• Exclusion criteria: Staff who have contact with patients but do not identify in the provider types listed in the inclusion criteria

Intervention II (Community doula support) SMM 21 Outcome Measures • Exclusion criteria: Pregnancies ending prior to 20 weeks and due to ectopic pregnancy not occurring on labor and delivery units of the five participating hospitals

Focus groups for Intervention II • Exclusion criteria: Staff who have contact with clients but do not identify in the provider types listed in the inclusion criteria

PREM PROM (Patient Reported Experience Measure Patient Reported Outcome Measure) Surveys for Intervention II

• Exclusion criteria: Pregnancies ending prior to 20 weeks and due to ectopic pregnancy not occurring on labor and delivery units of the four participating hospitals

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,538 participants in 2 patient groups

Maternal Safety Bundles Implementation

Other group

Description:

The first intervention targets obstetric hemorrhage, severe hypertension and maternal health equity by implementing three relevant AIM bundles: Obstetric Hemorrhage, Severe Hypertension in Pregnancy, and Reduction of Peripartum Racial/Ethnic Disparities. The Perinatal Neonatal Quality Improvement Network (PNQIN) will facilitate this collaborative QI project and support participating hospitals by providing guidance, education, and technical assistance to hospitals to support implementation of bundles using the QI process. Implementation strategies are based on the Institute for Healthcare Improvement (IHI) improvement model and the AIM program implementation toolkit and have previously been used by PNQIN to implement the Obstetric Care for Women with Opioid Use Disorder AIM bundle in 22 hospitals, including the five hospitals for this study.

Treatment:

Other: Implementation of Maternal Safety Bundles

Doula Services

Other group

Description:

The second intervention that this study evaluates is doula services. Investigators are evaluating doula services that are offered by two doula organizations at three hospitals. Investigators will provide top-up training to these doulas in order to provide some standardization and quality assurance of the services delivered. The training is developed and delivered by an obstetrician (Meadows) and doula (Gebel) and will take place among providers (staff associated with three chosen hospitals), patient navigators, and two doula groups, Birth Sisters and Accompany Doula Care, on factors that comprise the risk profile and how to offer targeted doula services to women who fit the risk profile. All sites will use standardized data instruments to evaluate the number of factors in the risk profile being met as well as standardized language and recruitment materials for mothers.

Treatment:

Other: Doula Services