R01: Maternal OutcoMes Program: Testing Integrated Maternal Care Model Approaches to Reduce Disparities in Severe Maternal Morbidity (MOMs Chat & Care Study)
Overview
Principal Investigator:
Sponsoring Institution: Feinstein Institutes for Medical Research
Collaborators:
- Northwell Health
NIH Institute Providing Oversight: National Institute of Nursing Research (NINR)
Program Official: Nadra Tyus, DrPH, MPH (National Institute of Nursing Research (NINR))
Trial Summary
There is a maternal health crisis in the United States that disproportionately affects Black birthing people. Black birthing people are 2 times more likely than non-Hispanic White birthing people to experience severe maternal morbidity, or unexpected labor and delivery outcomes that result in significant short- or long-term health consequences. Preventing preeclampsia, maintaining or increasing engagement in healthy behaviors such as physical activity, and addressing health-related social needs can enhance receipt of timely, appropriate care and reduce risk for severe maternal morbidity. The Maternal Outcomes (MOMs) program at Northwell Health is an effective integrated care approach that identifies and supports high-risk birthing people immediately after delivery. In a preliminary analysis of data from 2500 participants, the program significantly reduced the risk of severe maternal morbidity–related hospital admissions at 30 days by 77% among Black participants. These findings are promising, but the long-term effectiveness of the program and the feasibility and effectiveness of extending it to the prenatal period have yet to be established. Therefore, the purpose of the MOMs Chat & Care Study is to test the effectiveness of the MOMs approach at 2 levels of intensity designed to facilitate timely, appropriate care for high-risk Black birthing people and reduce risk for severe maternal morbidity. The study team will identify Black birthing people at less than 17 weeks gestation with an Obstetrics Comorbidity Index score of 2 or greater and/or a history of preeclampsia in the electronic health record, and they will randomly assign 674 patients to 1 of 2 study arms: MOMs High-Touch or MOMs Low-Touch. MOMs High-Touch will consist of close clinical and behavioral health monitoring via chatbot technology and navigation to timely care and services throughout the prenatal and postpartum periods; 12 biweekly self-management support calls with the MOMs team during the prenatal period; and biweekly postpartum clinical check-in calls with navigation by the MOMs team up to 6 weeks postpartum. MOMs Low-Touch will include clinical and behavioral health monitoring via the chatbot along with navigation to services by the MOMs team and biweekly postpartum clinical check-in calls with navigation. The study arms will be compared on the incidence of severe maternal morbidity at labor and delivery, the incidence of severe maternal morbidity–related hospitalizations at 1 month and 1 year postpartum, time to preeclampsia diagnosis and initiation of treatment, change in perceived social support domains, and physical activity trajectories. Findings from the MOMs Chat & Care Study will help to determine how to feasibly implement an effective and sustainable integrated care approach to address disparities in severe maternal morbidity.
Data and Resource Sharing
- MOMs-CC Ethics Regulatory Follow-up
MOMs Chat and Care Study Ethics Regulatory Follow-up
- MOMs Ethics and Regulatory Discussion
MOMs Ethics and Regulatory Discussion
News and Interviews
- News_A Year of Trial Results and Innovations From the NIH Pragmatic Trials Collaboratory
December 15, 2025: A Year of Trial Results and Innovations From the NIH Pragmatic Trials Collaboratory
- News_Recently Launched NIH Collaboratory Trials Offer Lessons for Embedded Pragmatic Research
July 24, 2025: Recently Launched NIH Collaboratory Trials Offer Lessons for Embedded Pragmatic Research
- News_Enrollment Begins for Several of the Newest NIH Collaboratory Trials
March 6, 2025: Enrollment Begins for Several of the Newest NIH Collaboratory Trials
- News_Study Design Paper Published for MOMs Chat & Care Study
March 11, 2025: Study Design Paper Published for MOMs Chat & Care Study
- News_Study Snapshot and Updated Ethics Documentation Available for MOMs Chat and Care Study
November 5, 2024: Study Snapshot and Updated Ethics Documentation Available for MOMs Chat & Care Study
- News_MOMs Chat & Care Study Aims to Address Crisis of Black Maternal Morbidity
July 29, 2024: MOMs Chat & Care Study Aims to Address Crisis of Black Maternal Morbidity
- News_Ethics Consultation Documents Now Available for AIM-CP and MOMs Chat & Care Study
January 16, 2024: Ethics Consultation Documents Now Available for AIM-CP and MOMs Chat & Care Study
- News_NIH Pragmatic Trials Collaboratory Welcomes 5 New Demonstration Projects
October 31, 2023: NIH Pragmatic Trials Collaboratory Welcomes 5 New Trials
Publications
- Fitzpatrick et al Contemp Clin Trials 2025
MOMs Chat & Care Study Design Paper
- MOMs Chat and Care Study Snapshot
MOMs Chat and Care Study Snapshot
Presentations
- 00_Volandes_combined_FINAL 2
Emerging Issues from Seasoned Investigators
- SC-Mtg-2024-Day2-Harrington
Expanding the ePCT Ecosystem to Better Serve Minoritized Communities
- SC-Mtg-2024-Day1-Heagerty
Study Design Challenges/ Lessons Learned
- MOMs_NOV 2023 Onboarding Mtg
Onboarding Meeting November 2023 - MOMs