Clinical trial NCT06335381: MOMs Chat and Care Study
Official title: Maternal OutcoMes (MOMs) Program: Testing Integrated Maternal Care Model Approaches to Reduce Disparities in Severe Maternal Morbidity
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Severe Maternal Morbidity
Keywords: Maternal health
Severe maternal morbidity
Lead sponsor: Northwell Health
Sponsor class: OTHER
Collaborators: name: National Institute of Nursing Research (NINR)
First posted: 2024-03-28
Enrollment: 674
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be assigned to one of two groups in parallel for the duration of the study.
Primary purpose: PREVENTION

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.

Eligibility criteria: 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/

Primary outcomes:
measure: Severe maternal morbidity (SMM)
timeFrame: Labor and delivery; 1-month postpartum; 1-year postpartum
Secondary outcomes:
measure: Preeclampsia
timeFrame: During prenatal period (from study enrollment to labor and delivery), estimated 9 months.
measure: Informational Support
timeFrame: Baseline; 1-month postpartum; 1-year postpartum
measure: Emotional Support
timeFrame: Baseline; 1-month postpartum; 1-year postpartum
measure: Tangible Support
timeFrame: Baseline; 1-month postpartum; 1-year postpartum
Other outcomes:
measure: Minutes of Physical Activity
timeFrame: Continuous (from enrollment to 1-year postpartum)
measure: Barriers to Exercise
timeFrame: Baseline; 1-month postpartum; 1-year postpartum
Locations:
city: Manhasset
country: United States
facility: Northwell Health
state: New York
Study officials:
affiliation: Northwell Health
name: Stephanie L Fitzpatrick, PhD
role: PRINCIPAL_INVESTIGATOR
References: