Rhode Island Community-based Maternal Support Services

NCT07446374 | Recruiting

• 2 other identifiers: 21462411CPIMP21374-01-00
• Study Type: interventional
• Target: 3,000
• Locations: 1 country
• Sites: 7

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.

Conditions

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

Keywords

pregnancy; social determinants of health; perinatal outcomes

Outcome Measures

Primary Outcomes (1)

• Rate of severe maternal morbidity and mortality

  any severe maternal morbidity or mortality

  from enrollment through 1 year postpartum

Secondary Outcomes (10)

• SDOH screening - Number of prenatal clinics in Rhode Island where COMSS bundle is operational

  from enrollment through 6 weeks postpartum

• SDOH screening - # birthing persons screened

  from enrollment through 6 weeks postpartum

• SDOH screening - # receiving case management

  from enrollment through 6 weeks postpartum

• Rate of cesarean births among low-risk nulliparous patients

  delivery

• Proportion of patients who receive adequate prenatal care

  from enrollment through date of delivery

Study Arms (2)

Community-based Maternal Support Services (COMSS) model

EXPERIMENTAL

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

Other: Perinatal health screening; Other: Support services

Baseline

NO INTERVENTION

No active intervention. Data will be collected during this baseline phase to compare to measures post-intervention

Interventions

Perinatal health screening OTHER

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.

Community-based Maternal Support Services (COMSS) model

Support services OTHER

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

Community-based Maternal Support Services (COMSS) model

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Anyone not meeting the above criteria

Sponsors & Collaborators

• Women and Infants Hospital of Rhode Island: lead

Study Sites (7)

Women's Care

Pawtucket, Rhode Island, 02860, United States

NOT YET RECRUITING

Brown University OBGYN

Providence, Rhode Island, 02904, United States

RECRUITING

Obstetrics and Gynecology Care Center

Providence, Rhode Island, 02905, United States

NOT YET RECRUITING

Providence Community Health Center - Prairie

Providence, Rhode Island, 02905, United States

NOT YET RECRUITING

Women and Infants Hospital of Rhode Island

Providence, Rhode Island, 02905, United States

RECRUITING

Providence Community Health Centers - Central

Providence, Rhode Island, 02907, United States

RECRUITING

Care New England Medical Group (CNEMG)

Warwick, Rhode Island, 02886, United States

NOT YET RECRUITING

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Chair of Obstetrics and Gynecology

Model Details: 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

Study Record Dates

• First Submitted: July 16, 2025
• First Posted: March 3, 2026
• Study Start: May 19, 2025
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: March 3, 2026

Record last verified: 2026-03

Locations

US (7)