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Recruiting NCT06335381

MOMs Chat and Care Study

Trial Parameters

Condition Severe Maternal Morbidity
Sponsor Northwell Health
Study Type INTERVENTIONAL
Phase N/A
Enrollment 674
Sex FEMALE
Min Age 18 Years
Max Age 50 Years
Start Date 2024-05-28
Completion 2027-12-31
Interventions
Northwell Pregnancy & Peds ChatsPrenatal Telehealth VisitsPostpartum Telehealth Visits

Brief Summary

The purpose of this study is to test the effectiveness of an integrated care model approach at two different levels of intensity designed to facilitate timely, appropriate care to reduce risk for SMM. Black and Hispanic pregnant patients with an Obstetrics-Comorbidity Index Score ³ 2 and/or a history of pre-eclampsia will be identified via the electronic health record and 674 will be recruited and randomized early during pregnancy to one of two study arms: MOMs High-Touch (MOMs-HT) vs. MOMs Low-Touch (MOMs-LT). The two study arms will be compared on incidence of SMM at labor and delivery (Aim 1), incidence rate of SMM-related hospitalizations at 1-month and 1-year postpartum (Aim 1a), time to preeclampsia diagnosis and initiation of treatment (Aim 2), change in perceived social support domains (Aim 3), and physical activity trajectories (exploratory Aim 4). Mixed methods will also be used to examine facilitators and barriers to implementation (Aim 5). Findings from this study will help to determine how to feasibly implement an effective and sustainable integrated care approach to reduce risk for SMM.

Eligibility Criteria

Inclusion Criteria: * Age 18 or older, * Self-identify as Black/African American or Hispanic/Latina (includes Black + another race; Black or Afro Hispanic/Latina; or Hispanic/Latina), * Pregnant, less than 17 weeks gestational age, * OB-CMI risk score ≥ 2 and/or history or preeclampsia, * English or Spanish as primary language, and * Receive care at Northwell Health Physician Partners obstetrics practice site. Exclusion Criteria: • Birthing people who are not able to provide informed consent due to cognitive or psychiatric impairment. If interested in participating in the study, please visit https://www.momschatandcare.com/

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