Rhode Island Community-based Maternal Support Services

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
AgeNot listed
SponsorWomen and Infants Hospital of Rhode Island

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Anyone not meeting the above criteria

Trial design

Design model

Crossover

Treatments tested in this trial

  • Perinatal health screening

    Other intervention

    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 intervention

    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

Treatment groups

3,000 Participants
are divided into 2 treatment groups
Group A: Community-based Maternal Support Services (COMSS) modelExperimental treatment 2 interventions
Group B: BaselineNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Rate of severe maternal morbidity and mortality

any severe maternal morbidity or mortality

Time frame
from enrollment through 1 year postpartum

Secondary outcomes

1

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

Time frame
from enrollment through 6 weeks postpartum
2

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

Time frame
from enrollment through 6 weeks postpartum
3

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

Time frame
from enrollment through 6 weeks postpartum
4

Rate of cesarean births among low-risk nulliparous patients

Time frame
delivery

Other outcomes

Sponsors and contacts

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