Clinical trial NCT06160349: EnCoRe MoMS:Engaging Communities to Reduce Morbidity From Maternal Sepsis
Official title: EnCoRe MoMS: Engaging Communities to Reduce Morbidity From Maternal Sepsis
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Maternal Sepsis
Infections
Keywords: Post Partum Period
Pregnancy
Maternal Health
Electronic Health Record
Lead sponsor: Columbia University
Sponsor class: OTHER
Collaborators: name: Northern Manhattan Perinatal Partnership
name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
First posted: 2023-12-07
Enrollment: 200
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: For patient interviews- Adult women have a birthing experience in Columbia, Allen, Lincoln, or Harlem Hospitals within the past 8 weeks of enrollment

For focus groups- stakeholders with academic/professional backgrounds relevant to maternal health

Brief summary: 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.

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.

Primary outcomes:
measure: Integrative Supportive Care Model
timeFrame: 2023-2025
Secondary outcomes:
Other outcomes:
Locations:
city: Bronx
country: United States
facility: NYC Health + Hospitals/Lincoln
state: New York
city: New York
country: United States
facility: Columbia Unviersity Medical Center
state: New York
city: New York
country: United States
facility: NYC Health+Hospitals/Harlem
state: New York
Study officials:
affiliation: Columbia University
name: Uma Reddy, MD
role: PRINCIPAL_INVESTIGATOR
References: