Preeclampsia Clinical Trials

Find Preeclampsia Clinical Trials Near You

Maternal OutcoMes (MOMs) Program: Testing Integrated Maternal Care Model Approaches to Reduce Risk of Severe Maternal Morbidity

Status: Recruiting
Location: See location...
Intervention Type: Behavioral, Other
Study Type: Interventional
Study Phase: Not Applicable
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 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
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 50
Healthy Volunteers: f
View:

• 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.

Locations
United States
New York
Northwell Health
RECRUITING
Manhasset
Contact Information
Primary
Stephanie L Fitzpatrick, PhD
sfitzpatrick1@northwell.edu
646-766-7167
Backup
Lizcary Amarante, MPH
lamarante@northwell.edu
516-618-3633
Time Frame
Start Date: 2024-05-28
Estimated Completion Date: 2028-06-30
Participants
Target number of participants: 674
Treatments
Experimental: MOMs High Touch (MOMs-HT)
Participants randomized to the MOMs-HT arm will receive access to maternal health education resources via digital applications available on their phone, tablet, or computer as well as navigation to timely clinical, behavioral health, and/or social care services by the MOMs team throughout the prenatal and postpartum periods; 12 bi-weekly self-management support telehealth visits with a MOMs care management coordinator (CMC) or registered nurse (RN) during the prenatal period; home blood pressure monitor to measure their blood pressure regularly; Fitbit to track physical activity; and 5 bi-weekly telehealth visits with navigation to clinical, behavioral, and social services as needed by the MOMs team up to 6 weeks postpartum.
Active_comparator: MOMs Low Touch (MOMs-LT)
Participants randomized to the MOMs-LT arm will receive access to maternal health education resources via digital applications available on their phone, tablet, or computer as well as navigation to timely clinical, behavioral health, and/or social care services by the MOMs team throughout the prenatal and postpartum periods; 5 bi-weekly telehealth visits with navigation to clinical, behavioral, and social services as needed by the MOMs team up to 6 weeks postpartum; and a Fitbit to track physical activity.
Related Therapeutic Areas
Sponsors
Collaborators: National Institute of Nursing Research (NINR)
Leads: Northwell Health

This content was sourced from clinicaltrials.gov