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Recruiting NCT07446374

Rhode Island Community-based Maternal Support Services

No phase Interventional Perinatal Outcomes Social Determinants of Health (SDOH) Health Disparity, Minority and Vulnerable Populations Pregnancy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Perinatal health screening, Support services.
Who it may be relevant to
Registry conditions: Perinatal Outcomes, Social Determinants of Health (SDOH), Health Disparity, Minority and Vulnerable Populations, Pregnancy. Basic parameters: No limits · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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

  • 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

Primary outcome measures

  • Rate of severe maternal morbidity and mortality [Time frame: from enrollment through 1 year postpartum]
Secondary outcome measures (10)
  • SDOH screening - Number of prenatal clinics in Rhode Island where COMSS bundle is operational [Time frame: from enrollment through 6 weeks postpartum]
  • SDOH screening - # birthing persons screened [Time frame: from enrollment through 6 weeks postpartum]
  • SDOH screening - # receiving case management [Time frame: from enrollment through 6 weeks postpartum]
  • Rate of cesarean births among low-risk nulliparous patients [Time frame: delivery]
  • Proportion of patients who receive adequate prenatal care [Time frame: from enrollment through date of delivery]
  • Proportion of patients who get screened for postpartum depression [Time frame: from 4-8 weeks postpartum]
  • Proportion of pregnant people abstinent from alcohol [Time frame: from enrollment through date of delivery]
  • Proportion of pregnant people abstinent from illicit drugs [Time frame: from enrollment through date of delivery]
  • Infant death [Time frame: delivery through 1 year of life]
  • Preterm birth [Time frame: Delivery]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Crossover
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 7 centers
  • Women's Care — Pawtucket
  • Brown University OBGYN — Providence
  • Obstetrics and Gynecology Care Center — Providence
  • Providence Community Health Center - Prairie — Providence
  • Women and Infants Hospital of Rhode Island — Providence
  • Providence Community Health Centers - Central — Providence
  • Care New England Medical Group (CNEMG) — Warwick

Identifiers

NCT: NCT07446374 · 2146241 · 1CPIMP21374-01-00

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗