Overview
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 birthing people and reduce risk for severe maternal morbidity (SMM). Eligible Black 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.
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 birthing people. High-risk Black birthing people will be identified using the electronic health record (EHR) and 674 birthing people will be recruited and randomized at less than 15 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 6 weekly postpartum telehealth visits with navigation by the MOMs team immediately post-delivery. MOMs-LT will also include clinical and behavioral health monitoring via the chatbot along with navigation to services by the MOMs team and 6 weekly postpartum telehealth visits with navigation. 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.
Eligibility
Inclusion Criteria:
- Age 18 or older,
- Self-identify as Black/African American (includes Black + another race; Black Hispanic/Latina, African, and Black Caribbean [West Indian]),
- Pregnant, <15 weeks gestational age,
- OB-CMI risk score ≥ 3 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/