EnCoRe MoMS: Engaging Communities to Reduce Morbidity From Maternal Sepsis

Sponsor

Columbia University (Other)

Overall Status

Enrolling by invitation

CT.gov ID

NCT06145724

Collaborator

Northern Manhattan Perinatal Partnership (Other), Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) (NIH)

24,040

Enrollment

Locations

Arms

32.9

Anticipated Duration (Months)

6010

Patients Per Site

182.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Maternal Sepsis Infections	Behavioral: Maternal Sepsis Safety Bundle	N/A

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

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

24040 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

EnCoRe MoMS Aim 1: Develop and Implement a Community-informed Institutional Obstetric Sepsis Bundle

Anticipated Study Start Date :

Jan 2, 2024

Anticipated Primary Completion Date :

Aug 31, 2026

Anticipated Study Completion Date :

Sep 30, 2026

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: Hospital Stakeholders Hospital stakeholders at the partnering hospitals who participate in 90 min focus group discussion about maternal sepsis bundle implementation.
No Intervention: Patients Admitted for Delivery (Pre-implementation) Patients admitted for delivery at one of the partnering hospitals. EHR records from Columbia, Lincoln, Harlem, and Allen hospitals will be reviewed to evaluate process and outcome measures pre-maternal sepsis bundle implementation. EHR data will be used from delivery hospitalizations from 2021-2022.
Experimental: Patients Admitted for Delivery (Post-Implementation) Patients admitted for delivery at one of the partnering hospitals. EHR records from Columbia, Lincoln, Harlem, and Allen hospitals will be reviewed to evaluate process and outcome measures post-maternal sepsis bundle implementation. EHR data will be used from delivery hospitalizations.	Behavioral: Maternal Sepsis Safety Bundle Maternal sepsis safety bundle implemented at Columbia, Lincoln, Harlem, and Allen hospitals.

Arm

Intervention/Treatment

No Intervention: Hospital Stakeholders

Hospital stakeholders at the partnering hospitals who participate in 90 min focus group discussion about maternal sepsis bundle implementation.

No Intervention: Patients Admitted for Delivery (Pre-implementation)

Patients admitted for delivery at one of the partnering hospitals. EHR records from Columbia, Lincoln, Harlem, and Allen hospitals will be reviewed to evaluate process and outcome measures pre-maternal sepsis bundle implementation. EHR data will be used from delivery hospitalizations from 2021-2022.

Experimental: Patients Admitted for Delivery (Post-Implementation)

Patients admitted for delivery at one of the partnering hospitals. EHR records from Columbia, Lincoln, Harlem, and Allen hospitals will be reviewed to evaluate process and outcome measures post-maternal sepsis bundle implementation. EHR data will be used from delivery hospitalizations.

Behavioral: Maternal Sepsis Safety Bundle

Maternal sepsis safety bundle implemented at Columbia, Lincoln, Harlem, and Allen hospitals.

Outcome Measures

Primary Outcome Measures

Number of Participants Diagnosed with Maternal Sepsis [Post-partum, Up to 8 Weeks]
The number of patients diagnosed with maternal sepsis pre- and post- material sepsis bundle implementation. Sepsis as evaluated by the following scoring systems: Sepsis-2 (proven or suspected infection in combination with at least two systemic inflammatory response syndrome criteria); Sepsis-3 (organ dysfunction as defined by an acute change in total organ dysfunction score within 24 hours of suspected infection); and Center for Disease Control (CDC) Sepsis (presumed infection and organ dysfunction based on CDC criteria).

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	NYC Health + Hospitals/Lincoln	Bronx	New York	United States	10451
2	Columbia Unviersity Irving Medical Center	New York	New York	United States	10032
3	NewYork-Presbyterian Allen Hospital	New York	New York	United States	10034
4	NYC Health+Hospitals/Harlem	New York	New York	United States	10037