MOMs Chat and Care Study

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.

Conditions

• Severe Maternal Morbidity

Interventions

OTHER

Maternal Health Education Resources

Maternal health education will be provided via digital applications that participants can access on their smart phone, tablet, or computer. One of the maternal health education resources will be the Northwell Pregnancy \& Peds Chats, a personalized care digital chatbot delivered via the Conversa platform and accessible on a smartphone, tablet, and computer. During the prenatal and postpartum periods, participants will receive a weekly chat via text message or email with a link to the platform. The chats provide timely, brief educational tools and resources. They are also designed to capture clinical, behavioral health, and social health concerns that alert the 24/7 nurse-led call center who follows up to connect the participant to services as needed. The other education resource that participants will be encouraged to use is the Pregnancy+ app, a publicly available application where participants can view educational videos and articles as well as a list of community resources.

BEHAVIORAL

Prenatal Telehealth Visits

The MOMs CMC/RN (interventionists) will deliver up to 12 bi-weekly self-management support telehealth visits during the prenatal period. The first telehealth visit will be 30-45 minutes in duration and follow-up visits will be 15-20 minutes. These telehealth visits will involve clinical and behavioral health check-ins; navigation to clinical, behavioral health, and social services as needed; screening for social needs during the initial telehealth visit; follow-up on referrals to resources to address social needs; and self-management support. MOMs CMCs/RNs will assess progress with engagement in self-management behaviors including asking about minutes and type of physical activity, self-monitoring (blood pressure, blood sugar, weight), and taking medications. The MOMs CMC/RN will provide brief maternal health education and support the participant in establishing behavior change goals and facilitating problem solving to address barriers to achieving goals each session.

OTHER

Postpartum Telehealth Visits

The MOMs CMC/RN will conduct a telehealth visit (with navigation as needed) by phone 24 and 72 hours after labor and delivery. After the 72-hour call, telehealth visits with navigation will occur bi-weekly until 6 weeks postpartum. These telehealth visits will be 15-20 minutes in duration. Telehealth visits will include a brief clinical and behavioral health check-in, screening for social needs, navigation to clinical, behavioral health, and social services as needed, and follow-up on referrals to community resources and social services. During each visit, participants will be asked if they have experienced any signs or symptoms of concern (e.g., pain, discomfort, headaches, bleeding), screened for depression and anxiety, and be reminded about upcoming medical appointments. The CMC or RN will navigate the participant to the appropriate provider (e.g., OB, cardiologist, behavioral health) or services (e.g., emergency, social, community-based resources) as needed in a timely manner.

OTHER

Home Blood Pressure Monitor

Participants will receive an Omron 10 home blood pressure monitor to use throughout the study period. Along with the cuff, participants will receive written (postcard) and video instructions (https://youtu.be/p9UEDv6nvwU) on how to accurately measure their blood pressure. Participants with diagnosed chronic hypertension or preeclampsia during the prenatal period will be encouraged to measure their blood pressure twice a day; participants without these conditions will be encouraged to measure their blood pressure twice a week. During the postpartum period, participants will be encouraged to follow their provider recommendations in terms of how often they should measure their blood pressure. Participants will be allowed to keep the blood pressure monitor after the study has completed.

OTHER

Fitbit

Participants will receive a Fitbit to use during the study period. Participants will be asked to wear the Fitbit on their wrist throughout the day to track all activity (e.g., walking, other physical activity, sedentary activity, and sleep). All data including minutes of activity and step counts will be stored on a secure web-based platform that aggregates data from the Fitbit device. Participants will be encouraged to sync their Fitbit device every 5 days with their phone to ensure data is up to date. Participants will be allowed to keep the Fitbit after the study has completed.

Sponsors & Collaborators

• National Institute of Nursing Research (NINR)

  collaborator NIH

• Northwell Health

  lead OTHER

Principal Investigators

• Stephanie L Fitzpatrick, PhD · Northwell Health

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

50 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-05-28

Primary Completion

2027-12-31

Completion

2028-06-30

Countries

• United States

Study Locations