Trials Today

MOMs Chat and Care Study

Purpose

The purpose of this pragmatic, randomized clinical trial designed to test the effectiveness of an integrated care model approach at two different levels of intensity designed to facilitate timely, appropriate care for high-risk Black and Hispanic/Latina birthing people and reduce risk for severe maternal morbidity (SMM). Eligible Black and Hispanic/Latina birthing people (n = 674) will be recruited and randomized 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 address SMM disparities.

Condition

Severe Maternal Morbidity

Eligibility

Eligible Ages: Between 18 Years and 50 Years
Eligible Genders: Female
Accepts Healthy Volunteers: No

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/

Study Design

Phase: N/A
Study Type: Interventional
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Participants will be assigned to one of two groups in parallel for the duration of the study.
Primary Purpose: Prevention
Masking: Single (Investigator)
Masking Description: The Principal Investigator and Biostatistician will be masked.

Arm Groups

Arm	Description	Assigned Intervention
Experimental MOMs High Touch (MOMs-HT)	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 bi-weekly telehealth visits with navigation to clinical, behavioral, and social services as needed by the MOMs team up to 6 weeks postpartum.	Other: Northwell Pregnancy & Peds Chats The Northwell Pregnancy & Peds Chats is a personalized care digital chatbot delivered via the Conversa platform. At Northwell, birthing people are enrolled automatically to receive the chats when they initiate prenatal care. Chats are accessible on a smartphone, tablet, and computer. During the prenatal and postpartum periods, birthing people receive a weekly chat via text message or email with a link to the platform. Each chat begins with asking if there are any updates the patient wants to share regarding their pregnancy. The chats provide timely, brief educational tools and resources. They are also designed to capture clinical, behavioral health, and social health concerns that triggers yellow flags (e.g., lack of transportation to obstetrics appointment) or red flags (e.g., elevated blood pressure) that go to a 24/7 nurse-led call center who follows up to connect the birthing person to clinical, behavioral health, or social services as needed. 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 birthing person 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.
Active Comparator MOMs Low Touch (MOMs-LT)	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; 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.	Other: Northwell Pregnancy & Peds Chats The Northwell Pregnancy & Peds Chats is a personalized care digital chatbot delivered via the Conversa platform. At Northwell, birthing people are enrolled automatically to receive the chats when they initiate prenatal care. Chats are accessible on a smartphone, tablet, and computer. During the prenatal and postpartum periods, birthing people receive a weekly chat via text message or email with a link to the platform. Each chat begins with asking if there are any updates the patient wants to share regarding their pregnancy. The chats provide timely, brief educational tools and resources. They are also designed to capture clinical, behavioral health, and social health concerns that triggers yellow flags (e.g., lack of transportation to obstetrics appointment) or red flags (e.g., elevated blood pressure) that go to a 24/7 nurse-led call center who follows up to connect the birthing person to clinical, behavioral health, or social services as needed. 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 birthing person 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: 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.

Recruiting Locations

Northwell Health
Manhasset, New York 11030

Contact:
Stephanie L Fitzpatrick, PhD

More Details

NCT ID: NCT06335381
Status: Recruiting
Sponsor: Northwell Health

Study Contact

Stephanie L Fitzpatrick, PhD
646-766-7167
sfitzpatrick1@northwell.edu

Detailed Description

This is a pragmatic, randomized clinical trial designed to compare the effectiveness of an integrated care approach at differing levels of intensity on reducing the prevalence of severe maternal morbidity (SMM) among high-risk Black and Hispanic/Latina birthing people. High-risk Black and Hispanic/Latina birthing people will be identified using the electronic health record (EHR) and 674 birthing people will be recruited and randomized at less than 17 weeks of 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 telehealth visits with the MOMs team during the prenatal period; home blood pressure monitor; and bi-weekly postpartum telehealth visits 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 and bi-weekly postpartum telehealth visits with navigation up to 6 weeks postpartum. 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.