MOMs Chat & Care Study: Rationale and design of a pragmatic randomized clinical trial to prevent severe maternal morbidity among Black birthing people
Abstract
Background: Black birthing people are disproportionately affected by severe maternal morbidity (SMM). The MOMs Chat & Care Study (R01NR021134) is a pragmatic, randomized clinical trial designed to test the effectiveness of an integrated care model to facilitate timely, appropriate care for high-risk Black birthing people and reduce the risk for SMM. Methods: We will recruit 674 adult, English and Spanish-speaking Black birthing people who are less than 17 weeks gestational age, considered high risk based on the Obstetrics-Comorbidity Index and/or history of preeclampsia, and receive care at a Northwell Health obstetric practice. Participants will be randomized to either MOMs High Touch or Low Touch. In both intervention arms participants will receive close monitoring via chatbot technology and navigation to timely care and services by the MOMs team throughout the prenatal and postpartum periods, Fitbit to track physical activity, and bi-weekly postpartum telehealth visits up to 6-weeks postpartum. MOMs High Touch will also receive 12 bi-weekly self-management support telehealth visits during pregnancy and a home blood pressure monitor. The two arms will be compared on incidence of SMM at labor and delivery (Aim 1), SMM-related hospitalizations at 1-month and 1-year postpartum (Aim 1a), time to preeclampsia diagnosis and treatment (Aim 2), perceived social support (Aim 3), and physical activity trajectories (exploratory Aim 4). Mixed methods will be used to examine…
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Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design.
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