EnCoRe MoMS: Engaging Communities to Reduce Morbidity From Maternal Sepsis (Aim 3)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Maternal Sepsis, Infections. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
EnCoRe MoMS Aim 3: Engaging Communities to Reduce Morbidity From Maternal Sepsis
Overview
Sepsis is the second leading cause of maternal death in the U.S. 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. (3a.1) Refine the CoLAB and co-design process; (3a.2) 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 access/quality, outcome disparities, and solutions for care continuity.
In the UH3 phase, the investigators will engage the community toAim 3b. (3b.1) Complete qualitative patient IDIs and stakeholder FGDs for the three additional hospital sites; (3b.2) 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.
Primary outcome measures
- Integrative Supportive Care Model [Time frame: 2023-2025]
Eligibility criteria
Inclusion criteria
Patient Interviews:
- Speak Spanish or English
- Be 18 years or older
- Have a birthing experience in Columbia, Allen, Lincoln, or Harlem Hospitals within the past 8 weeks of enrollment
- Have had at least one early warning sign or risk factor for infection present during their pregnancy, delivery, or postpartum
Community Stakeholder Focus Groups:
- Speak English or Spanish
- Be 18 years or older
- Have academic/professional background relevant to maternal health in New York City.
Exclusion criteria
Patient Interviews
- Under 18 years old
- Speaks a language other than Spanish or English
- Gave birth in a hospital other than Columbia, Allen, Lincoln, or Harlem Hospitals
- Did not have had at least one early warning sign or risk factor for infection present during their pregnancy, delivery, or postpartum
Community Stakeholder Focus Groups
- Under 18 years old
- Speaks a language other than Spanish or English
- Does not have a academic/professional background relevant to maternal health in New York City.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Ecologic or community
Study locations
United States · 3 centers
- Columbia Unviersity Medical Center — New York
- NYC Health+Hospitals/Harlem — New York
- NYC Health + Hospitals/Lincoln — The Bronx
Identifiers
NCT: NCT06160349 · AAAU3697 - Aim 3 · 1UG3HD111247