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Rhode Island Community-based Maternal Support Services

Rhode Island Community-based Maternal Support Services (RI COMSS) Bundle for Advancing Perinatal Health Equity

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07446374
Acronym
RICOMSS
Enrollment
3000
Registered
2026-03-03
Start date
2025-05-19
Completion date
2028-12-01
Last updated
2026-03-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Disparity, Minority and Vulnerable Populations, Perinatal Outcomes, Pregnancy, Social Determinants of Health (SDOH)

Keywords

pregnancy, social determinants of health, perinatal outcomes

Brief summary

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.

Detailed description

Despite a decreasing global trend, maternal mortality (MM) and severe maternal morbidity (SMM) in the United States continue to increase. Black, Indigenous, and People of Color (BIPOC) have disproportionately higher rates of MM. The causes of SMM/MM and the associated disparities are complex and multidimensional, but there is increasing awareness of the important role of social determinants of health (SDOH) - the conditions in which people are born, grow, live, work, and age - on perinatal outcomes. Addressing perinatal health disparities requires a multipronged approach targeting not only the health system and clinical factors that contribute to inadequate care, but also the social needs of patients from communities experiencing disparities. The purpose of this project is to improve perinatal health outcomes in RI by bringing together the hospital, community health workers (CHWs), doulas, and community-based organizations in participatory model for integrating community-based maternal support services (COMSS). The COMSS program will be implemented in 6 prenatal clinics in Rhode Island. Under a universal screening protocol, all patients at active COMSS sites 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 including high risk SDOH (safe housing, food insecurity, lack of reliable transportation). Patients who screen positive will be assigned to a care manager who will work with CHWs to provide care navigation, care linkage, and connection and/or with community-based partner services to address food, housing and transportation needs. Patients will be followed by the care team until at least 3 months postpartum, when they will be transitioned to primary care. Randomization into the COMSS program will occur at the clinic level in a stepped wedge cluster randomized trial. All clusters (i.e prenatal clinics) begin the study in baseline conditions and are randomly assigned to cross-over to the intervention condition at pre-determined time points in a sequential, staggered fashion until all groups receive the intervention. Data from all sites will be collected pre and post intervention.

Interventions

OTHERPerinatal health screening

Patients 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.

OTHERSupport services

Patients 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

Sponsors

Women and Infants Hospital of Rhode Island
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

The investigators will use a hybrid implementation-effectiveness stepped wedge cluster randomized trial design for implementation of the Community-based Maternal Support Services (COMSS) model. In a stepped wedge cluster randomized trial, clusters (i.e prenatal clinics) begin the study in baseline conditions and are randomly assigned to cross-over to the intervention condition at pre-determined time points in a sequential, staggered fashion until all groups receive the intervention

Eligibility

Sex/Gender
FEMALE
Healthy volunteers
No

Inclusion criteria

* All birthing people receiving perinatal care (prenatal, postpartum) at Women and Infants Hospital (WIH) and its affiliated clinics

Exclusion criteria

* Anyone not meeting the above criteria

Design outcomes

Primary

MeasureTime frameDescription
Rate of severe maternal morbidity and mortalityfrom enrollment through 1 year postpartumany severe maternal morbidity or mortality

Secondary

MeasureTime frameDescription
Proportion of pregnant people abstinent from alcoholfrom enrollment through date of deliveryno alcohol use during pregnancy (based on routine screening measures and information available in medical record)
Proportion of pregnant people abstinent from illicit drugsfrom enrollment through date of deliveryno use of any illicit drugs during pregnancy (based on routine screening measures and information available in medical record)
Infant deathdelivery through 1 year of life
Preterm birthDeliveryBirth at \<37 weeks GA
SDOH screening - Number of prenatal clinics in Rhode Island where COMSS bundle is operationalfrom enrollment through 6 weeks postpartum
SDOH screening - # birthing persons screenedfrom enrollment through 6 weeks postpartumNumber 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 managementfrom enrollment through 6 weeks postpartumNumber 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 patientsdelivery
Proportion of patients who get screened for postpartum depressionfrom 4-8 weeks postpartumany depression screening
Proportion of patients who receive adequate prenatal carefrom enrollment through date of delivery

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 4, 2026