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 — 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.
  • 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

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) 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
  • No Intervention: Baseline
    No 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)

FacilityCityStateZIPSite coordinators
Women's CarePawtucketRhode Island02860
401-921-6924
Brown University OBGYNProvidenceRhode Island02904
LG Ward
401-606-3000
Obstetrics and Gynecology Care CenterProvidenceRhode Island02905
Medical Director
(401) 274-1122
Providence Community Health Center - PrairieProvidenceRhode Island02905
401-444-0570
Providence Community Health Centers - CentralProvidenceRhode Island02907
David Mills
401-444-0580
Women and Infants Hospital of Rhode IslandProvidenceRhode Island02905
Methodius Tuuli, MD, MPH, MBA
401-274-1100
Care New England Medical Group (CNEMG)WarwickRhode Island02886
(401) 737-7000

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