An interventional study of Implementation of Maternal Safety Bundles and Doula Services in Maternal Death, sponsored by Tufts University. Recruiting at 1 site in United States. Open to female participants, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-09-13.
Sponsored by Tufts University · Not applicable, Interventional, and Prevention
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).
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.
77 studies on the registry are indexed under Maternal Death; 19 are open to participants now.
This study's planned enrollment of 1,538 is above the median of 1,126 across 57 interventional studies indexed under Maternal Death.
Browse Maternal Death studies →Tufts University is the lead sponsor of 228 studies on the registry; 23 are open to participants now.
Of its 11 completed or terminated interventional studies of FDA-regulated products, 8 (73%) have results posted.
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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
Focus groups for Intervention I
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
Intervention I (Maternal Safety Bundles) AIM Bundle Structure, Process and SMM 21 Outcome Measures
PREM PROM (Patient Reported Experience Measure Patient Reported Outcome Measure) Surveys for Intervention I
Focus groups for Intervention I
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
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
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
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
Investigators are evaluating doula services that are offered by two doula organizations at three hospitals.
Patient experience - Respect
Measure through the mothers on respect index (MORi). Range is 14-84 with higher scores indicating more respect.
Time frame: 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.
Time frame: 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.
Time frame: At delivery
Cesarean Birth
The proportion of women with live births who have a C-section.
Time frame: 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.
Time frame: At delivery
Nulliparous, Term, Singleton, Vertex (NTSV) Cesarean Birth Rate
Of all NTSV births the proportion that result in C-section
Time frame: At delivery
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
Time frame: Monthly up to 6 months
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
Time frame: Monthly up to 6 months
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?
Time frame: Monthly up to 6 months
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?
Time frame: Monthly up to 6 months
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?
Time frame: Monthly up to 6 months
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?
Time frame: Monthly up to 6 months
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?
Time frame: Monthly up to 6 months
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?
Time frame: Monthly up to 6 months
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?
Time frame: Monthly up to 6 months
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?
Time frame: Monthly up to 6 months
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?
Time frame: Monthly up to 6 months
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?
Time frame: Monthly up to 6 months
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?
Time frame: Monthly up to 6 months
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
Time frame: Monthly up to 6 months
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
Time frame: Monthly up to 6 months
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.
Time frame: Monthly up to 6 months
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.
Time frame: Monthly up to 2 years
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.
Time frame: Monthly up to 2 years
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?
Time frame: Monthly up to 6 months
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?
Time frame: Monthly up to 6 months
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?
Time frame: Monthly up to 6 months
Plan to share: No
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