MOMs Chat and Care Study
- Conditions
- Severe Maternal Morbidity
- Interventions
- Other: Northwell Pregnancy & Peds ChatsBehavioral: Prenatal Telehealth VisitsOther: Postpartum Telehealth VisitsOther: Home Blood Pressure MonitorOther: Fitbit
- Registration Number
- NCT06335381
- Lead Sponsor
- Northwell Health
- Brief Summary
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.
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Female
- Target Recruitment
- 674
- 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.
• 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
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description MOMs High Touch (MOMs-HT) Northwell Pregnancy & Peds Chats 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. MOMs High Touch (MOMs-HT) Prenatal Telehealth Visits 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. MOMs High Touch (MOMs-HT) Postpartum Telehealth Visits 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. MOMs High Touch (MOMs-HT) Home Blood Pressure Monitor 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. MOMs High Touch (MOMs-HT) Fitbit 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. MOMs Low Touch (MOMs-LT) Northwell Pregnancy & Peds Chats 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. MOMs Low Touch (MOMs-LT) Postpartum Telehealth Visits 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. MOMs Low Touch (MOMs-LT) Fitbit 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.
- Primary Outcome Measures
Name Time Method Severe maternal morbidity (SMM) Labor and delivery; 1-month postpartum; 1-year postpartum The Centers for Disease Control \& Prevention define SMM as having ≥ 1 ICD-10 diagnosis codes that correspond to 21 SMM indicators. SMM indicator diagnoses that occur at labor and delivery, from delivery to 1-month postpartum during a hospital admission, or from delivery to 1-year postpartum during a hospital admission will be extracted from the electronic health record.
- Secondary Outcome Measures
Name Time Method Preeclampsia During prenatal period (from study enrollment to labor and delivery), estimated 9 months. We will use the electronic health record to capture date preeclampsia diagnosis is documented at any time between study enrollment and labor and delivery (i.e., during the prenatal period) in both study arms. The following ICD-10 codes will be used to determine preeclampsia diagnosis: O14.1, O14.10, O14.12, O14.13, O14.14, or O14.15. Also, using the electronic health record and surveys, we will assess when treatment for preeclampsia (i.e., low-dose aspirin) has been initiated.
Informational Support Baseline; 1-month postpartum; 1-year postpartum he PROMIS 10-item Informational Support measure will be administered to all participants to assess degree of support in terms of having someone to provide information or offer advice. The validated measure is on a 5-point Likert scale (ranging from 'never' to 'always') and is available in English and Spanish.
Emotional Support Baseline; 1-month postpartum; 1-year postpartum The PROMIS 12-item Emotional Support measure will be administered to all participants to assess degree of feeling like they have someone who cares and expresses concern. The validated measure is on a 5-point Likert scale (ranging from 'never' to 'always') and is available in English and Spanish.
Tangible Support Baseline; 1-month postpartum; 1-year postpartum This is a newly developed 8-item measure based on findings from qualitative interview with previous MOMs Program participants. The measure is designed to assess the degree to which patients feel supported in accessing clinical care and social services.
Trial Locations
- Locations (1)
Northwell Health
🇺🇸Manhasset, New York, United States