Back to resultsReducing Racial Disparities in Severe Maternal Morbidity
Primary Purpose
Maternal Death
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Implementation of Maternal Safety Bundles
Doula Services
Sponsored by
About this trial
This is an interventional prevention trial for Maternal Death
Eligibility 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
Sites / Locations
- Tufts UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
Maternal Safety Bundles Implementation
Doula Services
Arm 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.
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.
Outcomes
Primary Outcome Measures
Patient experience - Respect
Measure through the mothers on respect index (MORi). Range is 14-84 with higher scores indicating more respect.
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.
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.
Cesarean Birth
The proportion of women with live births who have a C-section.
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.
Secondary Outcome Measures
Nulliparous, Term, Singleton, Vertex (NTSV) Cesarean Birth Rate
Of all NTSV births the proportion that result in C-section
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
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
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?
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?
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?
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?
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?
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?
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?
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?
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?
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?
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?
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
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
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.
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.
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.
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?
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?
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?
Full Information
NCT ID
NCT04879797
First Posted
March 17, 2021
Last Updated
September 12, 2023
Sponsor
Tufts University
Collaborators
National Institute on Minority Health and Health Disparities (NIMHD), Baystate Medical Center, Beth Israel Medical Center, Boston Medical Center, UMASS Memorial Medical Center, Steward St. Elizabeth's Medical Center of Boston, Inc., Brigham and Women's Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04879797
Brief Title
Reducing Racial Disparities in Severe Maternal Morbidity
Official Title
Reducing Racial Disparities in SMM: Assessing the Integration of Maternal Safety Bundles and Community Based Doulas to Improve Outcomes for Black Women
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 1, 2021 (Actual)
Primary Completion Date
June 30, 2024 (Anticipated)
Study Completion Date
June 30, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tufts University
Collaborators
National Institute on Minority Health and Health Disparities (NIMHD), Baystate Medical Center, Beth Israel Medical Center, Boston Medical Center, UMASS Memorial Medical Center, Steward St. Elizabeth's Medical Center of Boston, Inc., Brigham and Women's Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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).
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Maternal Death
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Hybrid type 1 implementation
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
1538 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Maternal Safety Bundles Implementation
Arm Type
Other
Arm 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.
Arm Title
Doula Services
Arm Type
Other
Arm 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.
Intervention Type
Other
Intervention Name(s)
Implementation of Maternal Safety Bundles
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
Doula Services
Intervention Description
Investigators are evaluating doula services that are offered by two doula organizations at three hospitals.
Primary Outcome Measure Information:
Title
Patient experience - Respect
Description
Measure through the mothers on respect index (MORi). Range is 14-84 with higher scores indicating more respect.
Time Frame
6 -12 weeks postpartum
Title
Patient experience - Autonomy
Description
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
Title
Severe maternal morbidity (SMM) 20
Description
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
Title
Cesarean Birth
Description
The proportion of women with live births who have a C-section.
Time Frame
At delivery
Title
Severe maternal morbidity (SMM) 21
Description
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
Secondary Outcome Measure Information:
Title
Nulliparous, Term, Singleton, Vertex (NTSV) Cesarean Birth Rate
Description
Of all NTSV births the proportion that result in C-section
Time Frame
At delivery
Title
Severe Maternal Morbidity among Hemorrhage Cases
Description
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
Title
Severe Maternal Morbidity (excluding cases with only a transfusion code) among Hemorrhage Cases.
Description
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
Title
Process Measure for Obstetric Hemorrhage - Unit Drills
Description
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
Title
Process Measure for Obstetric Hemorrhage - Provider Education
Description
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
Title
Process Measure for Obstetric Hemorrhage - Nursing Education
Description
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
Title
Process Measure for Obstetric Hemorrhage - Risk Assessment
Description
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
Title
Process Measure for Obstetric Hemorrhage - Quantified Blood Loss Measurement Utilization
Description
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
Title
Structure Measure for Obstetric Hemorrhage - Patient, Family & Staff Support System
Description
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
Title
Structure Measure for Obstetric Hemorrhage - Debriefs System
Description
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
Title
Structure Measure for Obstetric Hemorrhage - Multidisciplinary Case Reviews
Description
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
Title
Structure Measure for Obstetric Hemorrhage - Hemorrhage Cart
Description
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
Title
Structure Measure for Obstetric Hemorrhage - Unit Policy and Procedure
Description
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
Title
Structure Measure for Obstetric Hemorrhage - EHR Integration
Description
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
Title
Outcome Measure for Severe Hypertension/Preeclampsia - Severe Maternal Morbidity (excluding transfusion codes) among Preeclampsia Cases
Description
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
Title
Outcome Measure for Severe Hypertension/Preeclampsia - Severe Maternal Morbidity among Preeclampsia Cases
Description
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
Title
Process Measure for Severe Hypertension/Preeclampsia - Treatment of Severe HTN
Description
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
Title
SMM 20 by Race and Ethnicity
Description
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
Title
SMM 21 by Race and Ethnicity
Description
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
Title
Process Measure for Severe Hypertension/Preeclampsia - Unit Drills
Description
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
Title
Process Measure for Severe Hypertension/Preeclampsia - Provider Education
Description
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
Title
Process Measure for Severe Hypertension/Preeclampsia - Nursing Education
Description
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
10. Eligibility
Sex
Female
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ndidiamaka Amutah Onukagha, PhD
Phone
(617) 636-3809
Email
ndidiamaka.amutah_onukagha@tufts.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Judith Jeanty, MPH
Email
judith.jeanty@tufts.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ndidiamaka Amutah Onukagha, PhD
Organizational Affiliation
Tufts University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tufts University
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02128
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Judith Jeanty
Phone
617-636-3847
Email
judith.jeanty@tufts.edu
12. IPD Sharing Statement
Plan to Share IPD
No
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Reducing Racial Disparities in Severe Maternal Morbidity
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