MOMs Chat and Care Study (MOMs-CC)

Northwell Health

Status: Enrolling

Conditions: Severe Maternal Morbidity

Treatments: Other: Fitbit; Other: Postpartum Telehealth Visits; Other: Northwell Pregnancy & Peds Chats; Behavioral: Prenatal Telehealth Visits; Other: Home Blood Pressure Monitor

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06335381

1R01NR021134-01 (U.S. NIH Grant/Contract)

24-0131

Details and patient eligibility

About

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 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.

Full description

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 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). 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 calls with the MOMs team during the prenatal period; and 5 bi-weekly postpartum clinical check-in calls 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 as needed and 5 bi-weekly postpartum clinical check-in calls 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.

Enrollment: 674 estimated patients

Sex: Female

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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.

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/

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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674 participants in 2 patient groups

MOMs High Touch (MOMs-HT)

Experimental group

Description:

Participants randomized to the MOMs-HT arm will receive close clinical and behavioral health monitoring via weekly chats (text or email) using chatbot technology and 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.

Treatment:

Other: Home Blood Pressure Monitor

Behavioral: Prenatal Telehealth Visits

Other: Postpartum Telehealth Visits

Other: Northwell Pregnancy & Peds Chats

Other: Fitbit

MOMs Low Touch (MOMs-LT)

Active Comparator group

Description:

Participants randomized to the MOMs-LT arm will receive close clinical and behavioral health monitoring via weekly chats (text or email) using chatbot technology and 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.

Treatment:

Other: Postpartum Telehealth Visits

Other: Northwell Pregnancy & Peds Chats

Other: Fitbit