Reducing Racial Disparities in Severe Maternal Morbidity

Maternal Death Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04879797
• Other study ID #: M530001 NIH172
• Secondary ID: 1R01MD016026-01
• Status: Recruiting
• Phase: N/A
• Start date: October 1, 2021
• Est. completion date: June 30, 2025

Study information

• Verified date: September 2023
• Source: Tufts University
• Contact: Ndidiamaka Amutah Onukagha, PhD
• Phone: (617) 636-3809
• Email: ndidiamaka.amutah_onukagha[@]tufts.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1538
• Est. completion date: June 30, 2025
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Maternal Death

Intervention

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

Locations

Country	Name	City	State
United States	Tufts University	Boston	Massachusetts

Sponsors (8)

Lead Sponsor	Collaborator
Tufts University	Baystate Medical Center, Beth Israel Medical Center, Boston Medical Center, Brigham and Women's Hospital, National Institute on Minority Health and Health Disparities (NIMHD), Steward St. Elizabeth's Medical Center of Boston, Inc., UMASS Memorial Medical Center

Country where clinical trial is conducted

United States, 

References & Publications (25)

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* Note: There are 25 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	Cesarean Birth	The proportion of women with live births who have a C-section.	At delivery
Primary	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	Nulliparous, Term, Singleton, Vertex (NTSV) Cesarean Birth Rate	Of all NTSV births the proportion that result in C-section	At delivery
Secondary	Severe Maternal Morbidity among Hemorrhage Cases	Denominator: All mothers during their birth admission, excluding ectopics and miscarriages, meeting one of the following criteria: Presence of an Abruption, Previa or Antepartum hemorrhage diagnosis code; Presence of transfusion procedure code without a sickle cell crisis diagnosis code; Presence of a Postpartum hemorrhage diagnosis code Numerator: Among the denominator, all cases with any SMM code	Monthly up to 6 months
Secondary	Severe Maternal Morbidity (excluding cases with only a transfusion code) among Hemorrhage Cases.	Denominator: All mothers during their birth admission, excluding ectopics and miscarriages, meeting one of the following criteria: Presence of an Abruption, Previa or Antepartum hemorrhage diagnosis code; Presence of transfusion procedure code without a sickle cell crisis diagnosis code; Presence of a Postpartum hemorrhage diagnosis code Numerator: Among the denominator, all cases with any non-transfusion SMM code	Monthly up to 6 months
Secondary	Process Measure for Obstetric Hemorrhage - Unit Drills	Report number of Drills and the drill topics P1a: In this quarter, how many OB drills (In Situ and/or Sim Lab) were performed on your unit for any maternal safety topic? P1b: In this quarter, what topics were covered in the OB drills?	Monthly up to 6 months
Secondary	Process Measure for Obstetric Hemorrhage - Provider Education	Report estimate in 10 percent increments (round up) At the end of this reporting period, what cumulative proportion of delivering physicians and midwives has completed within the last 2 years an education program on Obstetric Hemorrhage that includes the unit-standard protocols and measures?	Monthly up to 6 months
Secondary	Process Measure for Obstetric Hemorrhage - Nursing Education	Report estimate in 10 percent increments (round up) At the end of this reporting period, what cumulative proportion of OB nurses (including L&D and Postpartum) has completed within the last 2 years an education program on Obstetric Hemorrhage that includes the unit-standard protocols and measures?	Monthly up to 6 months
Secondary	Process Measure for Obstetric Hemorrhage - Risk Assessment	Report estimate in 10 percent increments (round up) At the end of this quarter, what cumulative proportion of mothers had a hemorrhage risk assessment with risk level assigned, performed at least once between admission and birth and shared among the team?	Monthly up to 6 months
Secondary	Process Measure for Obstetric Hemorrhage - Quantified Blood Loss Measurement Utilization	Report estimate in 10 percent increments (round up) In this quarter, what proportion of mothers had measurement of blood loss from birth through the recovery period using quantitative and cumulative techniques?	Monthly up to 6 months
Secondary	Structure Measure for Obstetric Hemorrhage - Patient, Family & Staff Support System	Report Completion Date Has your hospital developed OB specific resources and protocols to support patients, family and staff through major OB complications?	Monthly up to 6 months
Secondary	Structure Measure for Obstetric Hemorrhage - Debriefs System	Report Start Date Has your hospital established a system in your hospital to perform regular formal debriefs after cases with major complications?	Monthly up to 6 months
Secondary	Structure Measure for Obstetric Hemorrhage - Multidisciplinary Case Reviews	Report Start Date Has your hospital established a process to perform multidisciplinary systems-level reviews on cases of severe maternal morbidity (including, at a minimum, birthing patients admitted to the ICU or receiving = 4 units RBC transfusions?	Monthly up to 6 months
Secondary	Structure Measure for Obstetric Hemorrhage - Hemorrhage Cart	Report Completion Date Does your hospital have OB hemorrhage supplies readily available, typically in a cart or mobile box?	Monthly up to 6 months
Secondary	Structure Measure for Obstetric Hemorrhage - Unit Policy and Procedure	Report Completion Date Does your hospital have an OB hemorrhage policy and procedure (reviewed and updated in the last 2-3 years) that provides a unit-standard approach using a stage-based management plan with checklists?	Monthly up to 6 months
Secondary	Structure Measure for Obstetric Hemorrhage - EHR Integration	Report Completion Date Were some of the recommended OB Hemorrhage bundle processes (i.e. order sets, tracking tools) integrated into your hospital's Electronic Health Record system?	Monthly up to 6 months
Secondary	Outcome Measure for Severe Hypertension/Preeclampsia - Severe Maternal Morbidity (excluding transfusion codes) among Preeclampsia Cases	Denominator: All mothers during their birth admission, excluding ectopics and miscarriages, with one of the following diagnosis codes: Severe Preeclampsia; Eclampsia; Preeclampsia superimposed on pre-existing hypertension Numerator: Among the denominator, all cases with any non-transfusion SMM code	Monthly up to 6 months
Secondary	Outcome Measure for Severe Hypertension/Preeclampsia - Severe Maternal Morbidity among Preeclampsia Cases	Denominator: All mothers during their birth admission, excluding ectopics and miscarriages, with one of the following diagnosis codes: Severe Preeclampsia; Eclampsia; Preeclampsia superimposed on pre-existing hypertension Numerator: Among the denominator, all cases with any non-transfusion SMM code	Monthly up to 6 months
Secondary	Process Measure for Severe Hypertension/Preeclampsia - Treatment of Severe HTN	Report N/D Denominator: Birthing patients with acute-onset severe hypertension that persists for 15 minutes or more, including those with preeclampsia, gestational or chronic hypertension Numerator: Among the denominator, birthing patients who were treated within 1 hour with IV Labetalol, IV Hydralazine, or PO Nifedipine. The 1 hour is measured from the first severe range BP reading, assuming confirmation of persistent elevation through a second reading.	Monthly up to 6 months
Secondary	SMM 20 by Race and Ethnicity	Severe maternal morbidity (SMM) by Race and Ethnicity 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.	Monthly up to 2 years
Secondary	SMM 21 by Race and Ethnicity	Severe maternal morbidity (SMM) by Race and Ethnicity 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.	Monthly up to 2 years
Secondary	Process Measure for Severe Hypertension/Preeclampsia - Unit Drills	Report number of Drills and the drill topics P1a: In this quarter, how many OB drills (In Situ and/or Sim Lab) were performed on your unit for any maternal safety topic? P1b: In this quarter, what topics were covered in the OB drills?	Monthly up to 6 months
Secondary	Process Measure for Severe Hypertension/Preeclampsia - Provider Education	Report estimate in 10 percent increments (round up) At the end of this reporting period, what cumulative proportion of delivering physicians and midwives has completed within the last two years an education program on Severe Hypertension/Preeclampsia that includes the unit-standard protocols and measures?	Monthly up to 6 months
Secondary	Process Measure for Severe Hypertension/Preeclampsia - Nursing Education	Report estimate in 10 percent increments (round up) At the end of this reporting period, what cumulative proportion of OB nurses (including L&D and postpartum) has completed within the last two years an education program on Severe Hypertension/Preeclampsia that includes the unit-standard protocols and measures?	Monthly up to 6 months