跳至主要内容
临床试验/NCT07446374
NCT07446374招募中不适用

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

Women and Infants Hospital of Rhode Island7 个研究点 分布在 1 个国家目标入组 3,000 人开始时间: 2025年5月19日最近更新:
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
3,000
试验地点
7
主要终点
Rate of severe maternal morbidity and mortality

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
None

入排标准

性别
Female
接受健康志愿者

入选标准

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

排除标准

  • Anyone not meeting the above criteria

研究组 & 干预措施

Community-based Maternal Support Services (COMSS) model

Experimental

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

干预措施: Perinatal health screening (Other)

Community-based Maternal Support Services (COMSS) model

Experimental

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

干预措施: Support services (Other)

Baseline

No Intervention

No active intervention. Data will be collected during this baseline phase to compare to measures post-intervention

结局指标

主要结局

Rate of severe maternal morbidity and mortality

时间窗: from enrollment through 1 year postpartum

any severe maternal morbidity or mortality

次要结局

  • Infant death(delivery through 1 year of life)
  • 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(from enrollment through 6 weeks postpartum)
  • SDOH screening - # receiving case management(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(from 4-8 weeks postpartum)
  • Proportion of pregnant people abstinent from alcohol(from enrollment through date of delivery)
  • Proportion of pregnant people abstinent from illicit drugs(from enrollment through date of delivery)
  • Preterm birth(Delivery)

研究者

发起方
Women and Infants Hospital of Rhode Island
申办方类型
Other
责任方
Principal Investigator
主要研究者

Methodius Tuuli

Professor and Chair of Obstetrics and Gynecology

Women and Infants Hospital of Rhode Island

研究点 (7)

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