Reducing Racial Disparities in Severe Maternal Morbidity

NCT04879797 | Unknown DMC

• 2 other identifiers: M530001 NIH1721R01MD016026-01
• Study Type: interventional
• Target: 1,538
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Maternal Death

Outcome Measures

Primary Outcomes (5)

• Patient experience - Respect

  Measure through the mothers on respect index (MORi). Range is 14-84 with higher scores indicating more respect.

  6 -12 weeks postpartum

• Patient experience - Autonomy

  Mothers autonomy in decision making (MADM). The range is 7- 42 with higher score indicating more opportunities to take an active role and lead decisions.

  6 -12 weeks postpartum

• Severe maternal morbidity (SMM) 20

  Severe maternal morbidity (SMM) includes unexpected outcomes of labor and delivery that result in significant short- or long-term consequences to a woman's health. Based on 20 ICD 10 codes as defined by the CDC.

  At delivery

• Cesarean Birth

  The proportion of women with live births who have a C-section.

  At delivery

• Severe maternal morbidity (SMM) 21

  Severe maternal morbidity (SMM) includes unexpected outcomes of labor and delivery that result in significant short- or long-term consequences to a woman's health. Based on 21 ICD 10 codes as defined by the CDC.

  At delivery

Secondary Outcomes (22)

• Nulliparous, Term, Singleton, Vertex (NTSV) Cesarean Birth Rate

  At delivery

• Severe Maternal Morbidity among Hemorrhage Cases

  Monthly up to 6 months

• Severe Maternal Morbidity (excluding cases with only a transfusion code) among Hemorrhage Cases.

  Monthly up to 6 months

• Process Measure for Obstetric Hemorrhage - Unit Drills

  Monthly up to 6 months

• Process Measure for Obstetric Hemorrhage - Provider Education

  Monthly up to 6 months

Study Arms (2)

Maternal Safety Bundles Implementation

OTHER

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.

Other: Implementation of Maternal Safety Bundles

Doula Services

OTHER

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.

Other: Doula Services

Interventions

Implementation of Maternal Safety Bundles OTHER

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

Maternal Safety Bundles Implementation

Doula Services OTHER

Investigators are evaluating doula services that are offered by two doula organizations at three hospitals.

Doula Services

Eligibility Criteria

• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• PREM PROM (Patient Reported Experience Measure ( PREM) Patient Reported Outcome Measure (PROM) Surveys for Intervention I
• Focus groups for Intervention I
• PREM PROM (Patient Reported Experience Measure Patient Reported Outcome Measure) Surveys for Intervention II
• Intervention I (Maternal Safety Bundles) AIM Bundle Structure, Process and SMM 21 Outcome Measures

You may not qualify if:

• PREM PROM (Patient Reported Experience Measure Patient Reported Outcome Measure) Surveys for Intervention I
• Focus groups for Intervention I
• PREM PROM (Patient Reported Experience Measure Patient Reported Outcome Measure) Surveys for Intervention II

Sponsors & Collaborators

• Tufts University: lead
• National Institute on Minority Health and Health Disparities (NIMHD): collaborator
• Baystate Medical Center: collaborator
• Beth Israel Medical Center: collaborator
• Boston Medical Center: collaborator
• UMass Memorial Health: collaborator
• Steward St. Elizabeth's Medical Center of Boston, Inc.: collaborator
• Brigham and Women's Hospital: collaborator

Study Sites (1)

Tufts University

Boston, Massachusetts, 02128, United States

RECRUITING

Related Publications (25)

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MeSH Terms

Conditions

Maternal Death

Condition Hierarchy (Ancestors)

Parental Death; Death; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Ndidiamaka Amutah Onukagha, PhD

  Tufts University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ndidiamaka Amutah Onukagha, PhD

CONTACT

(617) 636-3809; ndidiamaka.amutah_onukagha@tufts.edu

Judith Jeanty, MPH

CONTACT

judith.jeanty@tufts.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Hybrid type 1 implementation

Study Record Dates

• First Submitted: March 17, 2021
• First Posted: May 10, 2021
• Study Start: October 1, 2021
• Primary Completion: June 30, 2024
• Study Completion: June 30, 2025
• Last Updated: September 13, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)