Rhode Island Community-based Maternal Support Services (RICOMSS)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Pregnancy; Perinatal Outcomes; Social Determinants of Health (SDOH); Health Disparity, Minority and Vulnerable Populations
• Intervention / Treatment: Other: Perinatal health screening; Other: Support services

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.

• Study Type: Interventional
• Enrollment (Estimated): 3000
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Rhode Island
    • Pawtucket, Rhode Island, United States, 02860
      • Not yet recruiting
      • Women's Care
      • Contact: Phone Number: 401-921-6924
    • Providence, Rhode Island, United States, 02905
      • Recruiting
      • Women and Infants Hospital of Rhode Island
      • Contact: Methodius Tuuli, MD, MPH, MBA; Phone Number: 401-274-1100; Email: mtuuli@wihri.org
    • Providence, Rhode Island, United States, 02904
      • Recruiting
      • Brown University OBGYN
      • Contact: LG Ward; Phone Number: 401-606-3000; Email: lgward@brown.edu
    • Providence, Rhode Island, United States, 02905
      • Not yet recruiting
      • Obstetrics and Gynecology Care Center
      • Contact: Medical Director; Phone Number: 42735 (401) 274-1122
    • Providence, Rhode Island, United States, 02905
      • Not yet recruiting
      • Providence Community Health Center - Prairie
      • Contact: Phone Number: 401-444-0570
    • Providence, Rhode Island, United States, 02907
      • Recruiting
      • Providence Community Health Centers - Central
      • Contact: David Mills; Phone Number: 401-444-0580; Email: dmills@providencechc.org
    • Warwick, Rhode Island, United States, 02886
      • Not yet recruiting
      • Care New England Medical Group (CNEMG)
      • Contact: Phone Number: 48755 (401) 737-7000

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Community-based Maternal Support Services (COMSS) model; 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; 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.; Other: Support 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
No Intervention: Baseline; No active intervention. Data will be collected during this baseline phase to compare to measures post-intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of severe maternal morbidity and mortality	any severe maternal morbidity or mortality	from enrollment through 1 year postpartum

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	from enrollment through 6 weeks postpartum
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	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
Proportion of patients who get screened for postpartum depression	any depression screening	from 4-8 weeks postpartum
Proportion of pregnant people abstinent from alcohol	no alcohol use during pregnancy (based on routine screening measures and information available in medical record)	from enrollment through date of delivery
Proportion of pregnant people abstinent from illicit drugs	no use of any illicit drugs during pregnancy (based on routine screening measures and information available in medical record)	from enrollment through date of delivery
Infant death		delivery through 1 year of life
Preterm birth	Birth at <37 weeks GA	Delivery

Collaborators and Investigators

• Sponsor: Women and Infants Hospital of Rhode Island

Study record dates

Study Major Dates

• Study Start (Actual): May 19, 2025
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2028

Study Registration Dates

• First Submitted: July 16, 2025
• First Submitted That Met QC Criteria: March 2, 2026
• First Posted (Actual): March 3, 2026

Study Record Updates

• Last Update Posted (Actual): March 3, 2026
• Last Update Submitted That Met QC Criteria: March 2, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: pregnancy; social determinants of health; perinatal outcomes
• Other Study ID Numbers: 2146241; 1CPIMP21374-01-00 (Other Grant/Funding Number: Department of Health and Human Services - Office of Minority Health)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No