Ignite Creation Date:
2024-05-06 @ 7:52 PM
Last Modification Date:
2024-10-26 @ 3:15 PM
Study NCT ID:
NCT06160349
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2023-12-07
First Post:
2023-11-20
Brief Title:
EnCoRe MoMSEngaging Communities to Reduce Morbidity From Maternal Sepsis
Sponsor:
Columbia University
Organization:
Columbia University
Study Overview
Official Title:
EnCoRe MoMS Engaging Communities to Reduce Morbidity From Maternal Sepsis
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2023-11
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:
Sepsis is the second leading cause of maternal death in the US For racial and ethnic minoritized birthing people especially those who are Black living in poverty and from underserved communities labor and postpartum are particularly vulnerable risk periods The goal of this multi-center multidisciplinary observational study is to establish a novel maternal care continuity model to reduce sepsis- related death and disability and increase maternal health equity
Detailed Description:
Maternal sepsis is the second leading cause of maternal death major cause of morbidity and preventable in most cases Labor birth and postpartum are periods of increased sepsis risk particularly for racial and ethnic minoritized birthing people With extensive community partnerships and community organized leadership advisory board CoLAB EnCoRe MoMS Engaging Communities to Reduce Morbidity from Maternal Sepsis Aim 3 Conduct a co-design process and qualitative study to explore the experiences needs and perceived solutions for maternal care continuity sepsis prevention and promotion of equity in postpartum
In the UG3 phase robust community engagement and research infrastructures were established to 3a 3a1 Refine the CoLAB and co-design process 3a2 Conduct in-depth individual patient interviews IDIs and focus group discussions FGDs with community and hospital stakeholders from one site to explore the lived experiences and perspectives of SDOH on care accessquality outcome disparities and solutions for care continuity
In the UH3 phase the investigators will engage the community toAim 3b 3b1 Complete qualitative patient IDIs and stakeholder FGDs for the three additional hospital sites 3b2 Co-design an integrative supportive care model with our community partner co-lead CoLAB and results from other aims that entails maternal sepsis community engagement care linkages education services and policy efforts The resulting model can be scaled to hospitals and communities with lesser resources and applied to other preventable causes of severe maternal morbidity
In the UG3 phase robust community engagement and research infrastructures were established to 3a 3a1 Refine the CoLAB and co-design process 3a2 Conduct in-depth individual patient interviews IDIs and focus group discussions FGDs with community and hospital stakeholders from one site to explore the lived experiences and perspectives of SDOH on care accessquality outcome disparities and solutions for care continuity
In the UH3 phase the investigators will engage the community toAim 3b 3b1 Complete qualitative patient IDIs and stakeholder FGDs for the three additional hospital sites 3b2 Co-design an integrative supportive care model with our community partner co-lead CoLAB and results from other aims that entails maternal sepsis community engagement care linkages education services and policy efforts The resulting model can be scaled to hospitals and communities with lesser resources and applied to other preventable causes of severe maternal morbidity
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 |
|---|---|---|---|
| 1UG3HD111247 | NIH | None | httpsreporternihgovquickSearch1UG3HD111247 |