Ignite Creation Date:
2024-05-06 @ 8:18 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06335381
Status:
RECRUITING
Last Update Posted:
2024-06-07
First Post:
2024-03-15
Brief Title:
MOMs Chat and Care Study
Sponsor:
Northwell Health
Organization:
Northwell Health
Study Overview
Official Title:
Maternal OutcoMes MOMs Program Testing Integrated Maternal Care Model Approaches to Reduce Disparities in Severe Maternal Morbidity
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MOMs-CC
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 birthing people and reduce risk for severe maternal morbidity SMM Eligible Black 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 birthing people High-risk Black 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 CDCs 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 ie Fitbit Determinants of implementation will be captured via semi-structured qualitative interviews and discrete process measures
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 1R01NR021134-01 | NIH | None | httpsreporternihgovquickSearch1R01NR021134-01 |