Clinical trial NCT06145724: EnCoRe MoMS: Engaging Communities to Reduce Morbidity From Maternal Sepsis
Official title: EnCoRe MoMS Aim 1: Develop and Implement a Community-informed Institutional Obstetric Sepsis Bundle
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
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: 2023-11-24
Enrollment: 24040
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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 study is to evaluate a maternal sepsis safety bundle.

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. While American College of Obstetricians and Gynecologists (ACOG) and the Society for Maternal-Fetal Medicine (SMFM) recommend the implementation of safety bundles to prevent maternal mortality as the standard of care, there is limited evidence regarding effectiveness.EnCoRe MoMS will directly evaluate safety bundle performance for maternal sepsis. With extensive community partnerships and community organized leadership advisory board (CoLAB), EnCoRe MoMS: Engaging Communities to Reduce Morbidity from Maternal Sepsis will develop, implement, and evaluate a community-informed maternal sepsis bundle in 4 diverse New York City (NYC) hospitals.

In Aim 1a: a robust community engagement and research infrastructures were established to design a comprehensive obstetric sepsis bundle that i) applies and optimizes standard evidence-based components of readiness, recognition, response, reporting, and respectful care ii) incorporates multidisciplinary obstetric provider implicit bias training, and iii) integrates social determinants of health (SDOH) training and screening.

In this study, Aim 1b, the investigators will assess participant outcomes pre- and post-maternal sepsis bundle implementation. Participants will be followed through their hospitalization until delivery hospitalization discharge or development of sepsis and readmissions pertinent to the study will be assesses. For the pre-implementation cohort, the investigators will use electronic health record (EHR) data from 16,000 delivery hospitalizations to women from 2021-2022 from the four partner NYC hospitals compared to 8,000 deliveries postimplementation during award period (for a total of 24,000 delivery hospitalizations at the four local hospitals).

In the UH3 phase, the investigators will engage the community to implement the maternal sepsis care model, analyze results, and translate findings. Aim 1b. Implement the comprehensive obstetric sepsis bundle and evaluate its effectiveness using process and outcome measures Aim 1c. Define patterns in EHR of provider response to suspected sepsis, pre- vs post-bundle implementation; analyze associations between provider response variation and outcomes.

Eligibility criteria: Inclusion Criteria:

Hospital Stakeholder Focus Groups:

* Speak English or Spanish
* Be 18 years or older
* Clinicians or staff at the 4 hospital sites

  * New York Presbyterian (NYP) Morgan Stanley Children's Hospital (MSCH) of New York at Columbia University
  * NYP Allen
  * Harlem Hospital
  * Lincoln Hospital

Birthing Person (EMR evaluation):

-Delivery hospitalizations and associated postpartum readmissions at the 4 hospital sites between 2021-2025

Exclusion Criteria:

Hospital Stakeholder Interview:

* Under 18 years old
* Speaks a language other than Spanish or English
* Is not associated with one of the 4 hospital sites

Birthing Person (EMR evaluation)

-Delivery hospitalizations (and associated postpartum readmissions)to a hospital other than the 4 hospital sites or outside of 2021-2025 timeframe

Primary outcomes:
measure: Number of Participants Diagnosed with Maternal Sepsis
timeFrame: Post-partum, Up to 8 Weeks
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 Irving Medical Center
state: New York
city: New York
country: United States
facility: NewYork-Presbyterian Allen Hospital
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: