About 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
All birthing people receiving perinatal care (prenatal, postpartum) at Women and Infants Hospital (WIH) and its affiliated clinics
Disqualifiers
Anyone not meeting the above criteria
Trial design
Crossover
Treatments tested in this trial
Perinatal health screening
Other interventionPatients will be screened by nurses at the first prenatal visit and repeated in the second trimester, third trimester, at delivery and 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.
Support services
Other interventionPatients who screen positive for known perinatal risk factors 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 to address the need identified. 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
Treatment groups
Trial outcomes
Primary outcomes
Rate of severe maternal morbidity and mortality
any severe maternal morbidity or mortality
Secondary outcomes
SDOH screening - Number of prenatal clinics in Rhode Island where COMSS bundle is operational
SDOH screening - # birthing persons screened
Number of birthing persons per year who are screened for high-risk social determinants of health, substance use and behavioral health disorders, and high-risk pregnancy factors
SDOH screening - # receiving case management
Number of individuals per year who receive case management services for addressing high risk SDOH, substance use and behavioral health disorders, and high risk medical and obstetric health diagnoses
Rate of cesarean births among low-risk nulliparous patients
Sponsors and contacts
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