Reducing Racial Disparities in SMM: Assessing the Integration of Maternal Safety Bundles and Community Based Doulas to Improve Outcomes for Black Women
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 1,538
- 试验地点
- 2
- 主要终点
- Patient experience - Respect
研究概览
简要总结
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).
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Patient experience - Respect
时间窗: 6 -12 weeks postpartum
Measure through the mothers on respect index (MORi). Range is 14-84 with higher scores indicating more respect.
Severe maternal morbidity (SMM) 20
时间窗: At delivery
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
时间窗: At delivery
The proportion of women with live births who have a C-section.
Severe maternal morbidity (SMM) 21
时间窗: At delivery
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.
Patient experience - Autonomy
时间窗: 6 -12 weeks postpartum
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.
次要结局
- 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 - Quantified Blood Loss Measurement Utilization(Monthly up to 6 months)
- Process Measure for Obstetric Hemorrhage - Risk Assessment(Monthly up to 6 months)
- Structure Measure for Obstetric Hemorrhage - Patient, Family & Staff Support System(Monthly up to 6 months)
- Structure Measure for Obstetric Hemorrhage - Hemorrhage Cart(Monthly up to 6 months)
- Structure Measure for Obstetric Hemorrhage - Unit Policy and Procedure(Monthly up to 6 months)
- Structure Measure for Obstetric Hemorrhage - EHR Integration(Monthly up to 6 months)
- Outcome Measure for Severe Hypertension/Preeclampsia - Severe Maternal Morbidity among Preeclampsia Cases(Monthly up to 6 months)
- Process Measure for Severe Hypertension/Preeclampsia - Treatment of Severe HTN(Monthly up to 6 months)
- SMM 20 by Race and Ethnicity(Monthly up to 2 years)
- Process Measure for Severe Hypertension/Preeclampsia - Nursing Education(Monthly up to 6 months)
- Process Measure for Obstetric Hemorrhage - Unit Drills(Monthly up to 6 months)
- Structure Measure for Obstetric Hemorrhage - Multidisciplinary Case Reviews(Monthly up to 6 months)
- SMM 21 by Race and Ethnicity(Monthly up to 2 years)
- Process Measure for Severe Hypertension/Preeclampsia - Unit Drills(Monthly up to 6 months)
- Process Measure for Severe Hypertension/Preeclampsia - Provider Education(Monthly up to 6 months)
- Process Measure for Obstetric Hemorrhage - Provider Education(Monthly up to 6 months)
- Structure Measure for Obstetric Hemorrhage - Debriefs System(Monthly up to 6 months)
- Process Measure for Obstetric Hemorrhage - Nursing Education(Monthly up to 6 months)
- Outcome Measure for Severe Hypertension/Preeclampsia - Severe Maternal Morbidity (excluding transfusion codes) among Preeclampsia Cases(Monthly up to 6 months)
研究者
Ndidiamaka Amutah-Onukagha
Associate Professor
Tufts University