We Care About Brooklyn - A Digital Behavioral Intervention to Optimize Engagement in Maternal Healthcare

Study Overview
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Brief Summary
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The goal of this clinical trial is to test a behavioral intervention in pregnant women who identify as Black and live in Central Brooklyn. The main question it aims to answer is whether the WeCAB intervention leads to a net improvement in utilization of postpartum care compared to those receiving usual care. The WeCAB group will have a dedicated WeCAB community health worker who will be trained in digital care navigation. Researchers will compare the WeCAB group versus the group receiving usual care to see if the patients randomized to WeCAB will have higher rates of early post-partum care compared to patients in the control group.

Official Title
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Brooklyn Digital Community Care Intervention to Address Unmet Social Needs and Optimize Engagement in Maternal Health Care

Conditions
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Maternal Health, Pregnant Women

Intervention / Treatment
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* Behavioral: WeCAB Intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Eligible participants for the pilot RCT will be patients aged 18-49 years (childbearing age) residing in a Central Brooklyn zip code self-reporting as Black, who speak English or Haitian Creole, and plan to deliver or present for delivery at University Hospital at Downstate (UHD). In NYC, SMM increases incrementally with later entry into prenatal care (1st trimester: 208/10,000 deliveries; 2nd trimester: 252/10,000; 3rd trimester: 297/10,000; None: 575/10,000). 3 Accordingly, in order to capture the full range of SMM risk profiles for our pilot study, any pregnant patient/client visiting our clinics will be eligible for enrollment from 13 weeks gestation through delivery, thus allowing follow-up to 3 months post-partum within the 2-year study timeline. Exclusion Criteria: Patients planning to move outside of New York City in the ensuing 3 months post-partum Patients demonstrating an impairment that limits their ability to provide informed consent.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 49 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: WeCAB Intervention<br> | Behavioral: WeCAB Intervention<br>* The WeCAB intervention will use a dedicated WeCAB community health worker who will administer a social determinants of health (SDOH) tool and use digital care navigation to monitor closed loop referrals.<br>|
| No Intervention: Usual Care<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Initiation of postpartum care | Initiation of postpartum care within 6 weeks of delivery | 13 weeks until 3 months postpartum | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maternal death | Death of a woman while pregnant or within 42 days of termination of pregnancy, irrespective of the duration and site of the pregnancy, from any cause related to or aggravated by the pregnancy or its management but not from accidental or incidental causes. | 13 weeks until 3 weeks postpartum | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Digital