Rhode Island Community-based Maternal Support Services
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: Perinatal health screening, Support services.
- Кому может быть актуально
- Состояния в реестре: Perinatal Outcomes, Social Determinants of Health (SDOH), Health Disparity, Minority and Vulnerable Populations, Pregnancy. Базовые параметры: Без ограничений · Женщины.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- США
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Не всё понятно в терминах? Прочитайте наш гид для пациентов →
Официальное название
Rhode Island Community-based Maternal Support Services (RI COMSS) Bundle for Advancing Perinatal Health Equity
Обзор
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.
Подробное описание
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.
Вмешательства
- Другое 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. - Другое 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
Первичные конечные точки
- Rate of severe maternal morbidity and mortality [Срок оценки: from enrollment through 1 year postpartum]
Вторичные конечные точки (10)
- SDOH screening - Number of prenatal clinics in Rhode Island where COMSS bundle is operational [Срок оценки: from enrollment through 6 weeks postpartum]
- SDOH screening - # birthing persons screened [Срок оценки: from enrollment through 6 weeks postpartum]
- SDOH screening - # receiving case management [Срок оценки: from enrollment through 6 weeks postpartum]
- Rate of cesarean births among low-risk nulliparous patients [Срок оценки: delivery]
- Proportion of patients who receive adequate prenatal care [Срок оценки: from enrollment through date of delivery]
- Proportion of patients who get screened for postpartum depression [Срок оценки: from 4-8 weeks postpartum]
- Proportion of pregnant people abstinent from alcohol [Срок оценки: from enrollment through date of delivery]
- Proportion of pregnant people abstinent from illicit drugs [Срок оценки: from enrollment through date of delivery]
- Infant death [Срок оценки: delivery through 1 year of life]
- Preterm birth [Срок оценки: Delivery]
Критерии участия
Критерии включения
- All birthing people receiving perinatal care (prenatal, postpartum) at Women and Infants Hospital (WIH) and its affiliated clinics
Критерии исключения
- Anyone not meeting the above criteria
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Распределение
- Рандомизированное
- Модель
- Перекрёстный дизайн
- Маскирование
- Открытое
- Основная цель
- Лечение
Центры проведения
США · 7 центров
- 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
Идентификаторы
NCT: NCT07446374 · 2146241 · 1CPIMP21374-01-00