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

Sponsor

State University of New York - Downstate Medical Center (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05916534

Collaborator

(none)

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Maternal Health Pregnant Women	Behavioral: WeCAB Intervention	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

80 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

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

Anticipated Study Start Date :

Jul 1, 2023

Anticipated Primary Completion Date :

Jun 1, 2024

Anticipated Study Completion Date :

Aug 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: WeCAB Intervention	Behavioral: WeCAB Intervention 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.
No Intervention: Usual Care

Arm

Intervention/Treatment

Experimental: WeCAB Intervention

Behavioral: WeCAB Intervention

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.

No Intervention: Usual Care

Outcome Measures

Primary Outcome Measures

Initiation of postpartum care [13 weeks until 3 months postpartum]
Initiation of postpartum care within 6 weeks of delivery

Secondary Outcome Measures

Maternal death [13 weeks until 3 weeks postpartum]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 49 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

State University of New York - Downstate Medical Center

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

State University of New York - Downstate Medical Center

ClinicalTrials.gov Identifier:

NCT05916534

Other Study ID Numbers:

1R21NR020706-01

First Posted:

Jun 23, 2023

Last Update Posted:

Jun 26, 2023

Last Verified:

Jun 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by State University of New York - Downstate Medical Center

Digital

Study Results

No Results Posted as of Jun 26, 2023