MOMs Chat and Care Study

Phase

N/A

Condition

N/A

Treatment

Prenatal Telehealth Visits

Postpartum Telehealth Visits

Fitbit

Clinical Study ID

NCT06335381

24-0131

1R01NR021134-01

Ages 18-50
Female

Study Summary

The purpose of this pragmatic, randomized clinical trial designed to test the effectiveness of an integrated care model approach at two different levels of intensity designed to facilitate timely, appropriate care for high-risk Black and Hispanic/Latina birthing people and reduce risk for severe maternal morbidity (SMM). Eligible Black and Hispanic/Latina birthing people (n = 674) will be recruited and randomized 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 address SMM disparities.

Eligibility Criteria

Inclusion

Inclusion Criteria:

Age 18 or older,
Self-identify as Black/African American or Hispanic/Latina (includes Black + anotherrace; 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

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/

Study Design

Prenatal Telehealth Visits

May 28, 2024

June 30, 2028

Study Description

This is a pragmatic, randomized clinical trial designed to compare the effectiveness of an integrated care approach at differing levels of intensity on reducing the prevalence of severe maternal morbidity (SMM) among high-risk Black and Hispanic/Latina birthing people. High-risk Black and Hispanic/Latina birthing people will be identified using the electronic health record (EHR) and 674 birthing people will be recruited and randomized at less than 17 weeks of pregnancy to one of two study arms: MOMs High-Touch (MOMs-HT) vs. MOMs Low-Touch (MOMs-LT). MOMs-HT will consist of close clinical and behavioral health monitoring via chatbot technology and navigation to timely care and services by the MOMs team throughout the prenatal and postpartum periods; 12 bi-weekly self-management support telehealth visits with the MOMs team during the prenatal period; home blood pressure monitor; and bi-weekly postpartum telehealth visits with navigation by the MOMs team up to 6 weeks postpartum. MOMs-LT will also include clinical and behavioral health monitoring via the chatbot along with navigation to services by the MOMs team and bi-weekly postpartum telehealth visits with navigation up to 6 weeks postpartum. Participants in both study arms will receive a Fitbit to track engagement in physical activity. SMM at labor and delivery (primary) and SMM-related hospitalizations at 1-month and 1-year postpartum (secondary) will be based on the CDC's 21 indicators with diagnoses extracted from the EHR. Diagnosis of preeclampsia and initiation of treatment (secondary) will also be captured using the EHR. Questionnaires will be administered to measure domains of social support (secondary). Physical activity behaviors (exploratory) will be assessed via survey and wearable activity monitor (i.e., Fitbit). Determinants of implementation will be captured via semi-structured qualitative interviews and discrete process measures.

Connect with a study center

Northwell Health
Manhasset, New York 11030
United States
Active - Recruiting

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