About this trial
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 greater than or equal to 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
Qualifiers
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,
Disqualifiers
None
Trial design
Treatments tested in this trial
- Maternal Health Education Resources
- Prenatal Telehealth Visits
- Postpartum Telehealth Visits
- Home Blood Pressure Monitor
- Fitbit
Treatment groups
Sponsors and collaborators
Northwell Health
Lead sponsor
National Institute of Nursing Research (NINR)
Collaborator