Maternal OutcoMes (MOMs) Program: Testing Integrated Maternal Care Model Approaches to Reduce Risk of Severe Maternal Morbidity
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Northwell Health
- Enrollment
- 674
- Locations
- 1
- Primary Endpoint
- Severe maternal morbidity (SMM)
Study Overview
Brief 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.
Detailed 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 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Single (Investigator)
Masking Description
The Principal Investigator and Biostatistician will be masked.
Eligibility Criteria
- Ages
- 18 Years to 50 Years (Adult)
- Sex
- 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
- •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/
Arms & Interventions
MOMs High Touch (MOMs-HT)
Participants randomized to the MOMs-HT arm will receive access to maternal health education resources via digital applications available on their phone, tablet, or computer as well as 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.
Intervention: Prenatal Telehealth Visits (Behavioral)
MOMs High Touch (MOMs-HT)
Participants randomized to the MOMs-HT arm will receive access to maternal health education resources via digital applications available on their phone, tablet, or computer as well as 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.
Intervention: Fitbit (Other)
MOMs High Touch (MOMs-HT)
Participants randomized to the MOMs-HT arm will receive access to maternal health education resources via digital applications available on their phone, tablet, or computer as well as 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.
Intervention: Postpartum Telehealth Visits (Other)
MOMs High Touch (MOMs-HT)
Participants randomized to the MOMs-HT arm will receive access to maternal health education resources via digital applications available on their phone, tablet, or computer as well as 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.
Intervention: Home Blood Pressure Monitor (Other)
MOMs Low Touch (MOMs-LT)
Participants randomized to the MOMs-LT arm will receive access to maternal health education resources via digital applications available on their phone, tablet, or computer as well as 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.
Intervention: Postpartum Telehealth Visits (Other)
MOMs Low Touch (MOMs-LT)
Participants randomized to the MOMs-LT arm will receive access to maternal health education resources via digital applications available on their phone, tablet, or computer as well as 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.
Intervention: Fitbit (Other)
Outcomes
Primary Outcomes
Severe maternal morbidity (SMM)
Time Frame: 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 Outcomes
- Preeclampsia(During prenatal period (from study enrollment to labor and delivery), estimated 9 months.)
- Emotional Support(Baseline; 1-month postpartum; 1-year postpartum)
- Tangible Support(Baseline; 1-month postpartum; 1-year postpartum)
- Informational Support(Baseline; 1-month postpartum; 1-year postpartum)