MOMs Chat and Care Study

Официальное название

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

Обзор

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.

Подробное описание

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). MOMs-HT will consist of access to maternal health education resources, along with 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 access to maternal health education resources, 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.

Вмешательства

• Другое 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. T
• Поведенческое 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 ad
• Другое 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
• Другое 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 the
• Другое 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 t

Первичные конечные точки

• Severe maternal morbidity (SMM) [Срок оценки: Labor and delivery; 1-month postpartum; 1-year postpartum]

Вторичные конечные точки (4)

• Preeclampsia [Срок оценки: During prenatal period (from study enrollment to labor and delivery), estimated 9 months.]
• Informational Support [Срок оценки: Baseline; 1-month postpartum; 1-year postpartum]
• Emotional Support [Срок оценки: Baseline; 1-month postpartum; 1-year postpartum]
• Tangible Support [Срок оценки: Baseline; 1-month postpartum; 1-year postpartum]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• Pregnant women 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/

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Профилактика

Центры проведения

США · 1 центр

• Northwell Health — Manhasset

Публикации

• Fitzpatrick SL, Polo J, Ephraim P, Vrany E, Chiuzan C, Basile M, Friel CP, Moon KC, Silvia E, Bleau H, Nicholson W, Lewis D; MOMs Chat Care Research Group. MOMs Chat & Care Study: Rationale and design of a pragmatic randomized clinical trial to prevent severe maternal morbidity among Black birthing people. Contemp Clin Trials. 2025 May;152:107850. doi: 10.1016/j.cct.2025.107850. Epub 2025 Feb 21. PMID 39987957

Идентификаторы

NCT: NCT06335381 · 24-0131 · 1R01NR021134-01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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