Rhode Island Community-based Maternal Support Services
Part of paid clinical trials in Pawtucket, Rhode Island.
- Sponsor
- Women and Infants Hospital of Rhode Island
- Study ID
- NCT07446374
- Status
- Recruiting
Conditions
- Health Disparity, Minority and Vulnerable Populations
- Perinatal Outcomes
- Pregnancy
- Social Determinants of Health (SDOH)
Eligibility Criteria
- Sex
- FEMALE
- Age
- N/A - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Perinatal health screening — OTHERPatients 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 — OTHERPatients 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
Study Details
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.
Key Dates
- Start date
- May 19, 2025
- Status verified
- Mar 2026
- Primary completion
- Dec 31, 2028
- Completion
- Dec 31, 2028
Study Design
- Enrollment
- 3,000 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- CROSSOVER
- Primary purpose
- TREATMENT
Arms
- Experimental: Community-based Maternal Support Services (COMSS) modelPatients 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 Intervention: BaselineNo active intervention. Data will be collected during this baseline phase to compare to measures post-intervention
Primary Outcome Measure
Rate of severe maternal morbidity and mortality [ Time Frame: from enrollment through 1 year postpartum ]
Locations (7)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Women's Care | Pawtucket | Rhode Island | 02860 | 401-921-6924 |
| Brown University OBGYN | Providence | Rhode Island | 02904 | |
| Obstetrics and Gynecology Care Center | Providence | Rhode Island | 02905 | Medical Director (401) 274-1122 |
| Providence Community Health Center - Prairie | Providence | Rhode Island | 02905 | 401-444-0570 |
| Providence Community Health Centers - Central | Providence | Rhode Island | 02907 | |
| Women and Infants Hospital of Rhode Island | Providence | Rhode Island | 02905 | |
| Care New England Medical Group (CNEMG) | Warwick | Rhode Island | 02886 | (401) 737-7000 |
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