Ignite Creation Date:
2024-05-06 @ 4:06 PM
Last Modification Date:
2024-10-26 @ 2:04 PM
Study NCT ID:
NCT04879797
Status:
RECRUITING
Last Update Posted:
2023-09-13
First Post:
2021-03-17
Brief Title:
Reducing Racial Disparities in Severe Maternal Morbidity
Sponsor:
Tufts University
Organization:
Tufts University
Study Overview
Official Title:
Reducing Racial Disparities in SMM Assessing the Integration of Maternal Safety Bundles and Community Based Doulas to Improve Outcomes for Black Women
Status:
RECRUITING
Status Verified Date:
2023-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 raceethnicity 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
Research has not yet examined the intersection of raceethnicity 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 raceethnicity 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
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 raceethnicity 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 1R01MD016026-01 | NIH | None | httpsreporternihgovquickSearch1R01MD016026-01 |