Support Services for Pregnancy
(RICOMSS Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
The purpose of this project is to improve perinatal health outcomes in Rhode Island by bringing together the hospital, community health workers (CHWs), doulas, and community-based organizations to build a service delivery model that addresses care coordination and social determinants of health (SDOH) as a part of a concerted effort towards achieving equitable perinatal health outcomes. Over 4 years, the hospital-led project team will implement the community-based maternal support services (COMSS) bundle in 6 affiliated clinics, including care coordination, doula care, and referrals and linkages to community-based organizations that address key SDOH (food, housing, transportation). Maternal and infant health outcomes will be compared pre and post program implementation.
The central hypothesis is that COMSS will reduce adverse maternal and infant outcomes and associated racial disparities.
Are You a Good Fit for This Trial?
Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Baseline
No active intervention. Data collected to compare to measures post-intervention
Community-based Maternal Support Services (COMSS) model
Patients receive care coordination, doula care, and referrals to address SDOH
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Community-based Maternal Support Services
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
Patients will be screened by nurses at the first prenatal visit and repeated in the second trimester, third trimester, at delivery and at 2-6 weeks postpartum for three sets of risk factors for adverse perinatal outcomes - high risk SDOH, substance use and mental health conditions, and high risk pregnancy factors. Patients who screen positive will be assigned to a care manager who will work with community health workers (CHW) to provide care navigation, care linkage, and connection with community-based partner services. Care managers and the CHWs will keep a secure registry of patients and will follow up with them on a weekly or biweekly basis, as appropriate, to ensure continuity of care
No active intervention. Data will be collected during this baseline phase to compare to measures post-intervention
Find a Clinic Near You
Who Is Running the Clinical Trial?
Women and Infants Hospital of Rhode Island
Lead Sponsor
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