The Social Determinants of Health Screening and Referral Project
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: Implementation of social determinants of health screening and referral.
- Кому может быть актуально
- Состояния в реестре: Preterm Birth. Базовые параметры: от 18 лет · 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 →
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Официальное название
Implementing a Social Determinants of Health Screening and Referral Care Model in the Neonatal Intensive Care Unit
Обзор
Up to a quarter of the families with preterm infants have unmet social needs, such as housing or job insecurity, which represent adverse social determinants of health (SDOH). Preterm infants are especially vulnerable to the social conditions they grow up in, with sustained impacts on function across multiple organ systems. The goal of this study is to translate an established model of SDOH screening and referral from the outpatient setting to the NICU, thereby maximizing the potential to offset the effects of adverse SDOH on vulnerable mother-preterm infant dyads.
Подробное описание
The goal of this study is to implement SDOH screening and referral models in 7 safety net NICUs, examining their potential to offset the effects of adverse SDOH for a highly vulnerable population at the earliest stages of life. The investigators propose a hybrid effectiveness-implementation stepped wedge cluster randomized trial using the Proctor Conceptual Model of Implementation Research. The investigators will follow a cohort of 882 mother-infant dyads longitudinally for 12 months after NICU discharge to examine family, maternal, and infant outcomes. Each site will participate in three phases: usual, experimental, and sustainment.
The study aims are to:
Aim 1: Examine the implementation of SDOH screening and referral models into the NICU (acceptability, feasibility, penetration, equity, and sustainability).
Aim 2: Examine the effectiveness and equity of SDOH screening and referral models in the NICU setting on parental receipt of community resources for unmet social needs 3 months post-NICU discharge.
Aim 3: Explore the effectiveness of SDOH screening and referral models in the NICU to improve (a) maternal mental health (depression) and (b) health and developmental outcomes of preterm infants (quality of life, growth, development, and respiratory disease) during the 12 months post-NICU discharge.
Вмешательства
- Другое Implementation of social determinants of health screening and referral
WE CARE is a relatively simple, low-intensity intervention that has two key components: (1) screening individuals using the WE CARE SDOH Screener for unmet social needs, and (2) providing individuals who have unmet social needs with SDOH Community Resource sheets
Первичные конечные точки
- Penetration of SDOH intervention [Срок оценки: Monthly for approximately 12 months]
- Receipt of ANY Community Resource [Срок оценки: 3 months Post-NICU discharge]
Вторичные конечные точки (12)
- Acceptability of SDOH intervention [Срок оценки: Approximately 7, 9, and 12 months]
- Feasibility of SDOH intervention [Срок оценки: Approximately 7, 9, and 12 months.]
- Sustainability of SDOH intervention [Срок оценки: Monthly for approximately 6 months.]
- Equity of implementation [Срок оценки: Monthly for approximately 18 months (during both penetration and sustainability).]
- Equity of receipt of community resources [Срок оценки: 3 months Post-NICU discharge]
- SDOH Risk [Срок оценки: Baseline, 3 months, 6 months, and 12 months Post-NICU discharge]
- SDOH Desire Assistance [Срок оценки: Baseline, 3 months, 6 months, and 12 months Post-NICU discharge]
- SDOH Community Resource [Срок оценки: Baseline, 3 months, 6 months, and 12 months Post-NICU discharge]
- Family Economic Pressure [Срок оценки: Baseline, 3 months, 6 months, and 12 months Post-NICU discharge]
- Maternal Wellbeing [Срок оценки: Baseline, 3 months, 6 months, and 12 months Post-NICU discharge]
- Postpartum maternal primary care utilization [Срок оценки: 3 months, 6 months, and 12 months Post-NICU discharge]
- Maternal Postpartum Obstetric Care Utilization [Срок оценки: 3 months, 6 months, and 12 months Post-NICU discharge]
Критерии участия
Критерии включения
- Infant gestational age <34 weeks' gestation; singleton or multiple.
- Infant hospitalized for at least 14 days of life (to allow for SDOH screening/referral and contact with resources if applicable).
- Mother and infant are alive.
- Mother speaks and reads English or Spanish.
- Infant will be discharged home from the NICU (to allow for follow-up).
- Mother will care for her infant(s) at home in the US for at least 12 months after discharge from the NICU.
Критерии исключения
- Mothers or infants who die before anticipated infant discharge.
- Infant discharged after 52 weeks postmenstrual age.
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Распределение
- Рандомизированное
- Модель
- Одна группа
- Маскирование
- Открытое
- Основная цель
- Организация здравоохранения
Центры проведения
США · 7 центров
- Denver Health Hospital Authority — Denver
- Shands Jacksonville Medical Center, Inc. DBA UF Health Jacksonville — Jacksonville
- Children's Hospital of Michigan — Detroit
- University of Mississippi Medical Center — Jackson
- Children's Hospital at Montefiore — The Bronx
- Cincinnati Children's Hospital Medical Center — Cincinnati
- Temple University Hospital — Philadelphia
Идентификаторы
NCT: NCT06582147 · STUDY00000543 · 5R01HD104772