Implementing a Social Determinants of Health Screening and Referral Care Model in the Neonatal Intensive Care Unit
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 882
- 试验地点
- 14
- 主要终点
- Penetration of SDOH intervention
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Health Services Research
- 盲法
- None
盲法说明
None (Open Label)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •Mothers or infants who die before anticipated infant discharge.
- •Infant discharged after 52 weeks postmenstrual age.
研究组 & 干预措施
Social needs screening and referral care
As a step wedge cluster randomized trial all sites will be assigned to receive the intervention in a randomized order. There is no difference in the intervention by site, the only difference is the timing of the beginning of the intervention. Therefore, we have only identified one arm.
干预措施: Implementation of social determinants of health screening and referral (Other)
结局指标
主要结局
Penetration of SDOH intervention
时间窗: Monthly for approximately 12 months
Penetration is the rate of administration of social needs screener and appropriate referral for community resources to eligible families.
Receipt of ANY Community Resource
时间窗: 3 months Post-NICU discharge
Receipt of any community resource as collected via participant survey specifying receipt of the resource.
次要结局
- SDOH Risk(Baseline, 3 months, 6 months, and 12 months Post-NICU discharge)
- SDOH Desire Assistance(Baseline, 3 months, 6 months, and 12 months Post-NICU discharge)
- Acceptability of SDOH intervention(Approximately 7, 9, and 12 months)
- Feasibility of SDOH intervention(Approximately 7, 9, and 12 months.)
- Sustainability of SDOH intervention(Monthly for approximately 6 months.)
- Equity of implementation(Monthly for approximately 18 months (during both penetration and sustainability).)
- Equity of receipt of community resources(3 months Post-NICU discharge)
- SDOH Community Resource(Baseline, 3 months, 6 months, and 12 months Post-NICU discharge)
- Family Economic Pressure(Baseline, 3 months, 6 months, and 12 months Post-NICU discharge)
- Maternal Wellbeing(Baseline, 3 months, 6 months, and 12 months Post-NICU discharge)
- Postpartum maternal primary care utilization(3 months, 6 months, and 12 months Post-NICU discharge)
- Maternal Postpartum Obstetric Care Utilization(3 months, 6 months, and 12 months Post-NICU discharge)
- Maternal emergency room utilization(3 months, 6 months, and 12 months Post-NICU discharge)
- Maternal hospital readmission(3 months, 6 months, and 12 months Post-NICU discharge)
- Maternal Depression(Baseline, 3 months, 6 months, and 12 months Post-NICU discharge)
- Length of Lactation(Baseline, 3 months, 6 months, and 12 months Post-NICU discharge)
- Infant primary care utilization(3 months, 6 months, and 12 months Post-NICU discharge)
- Infant utilization of emergency care(3 months, 6 months, and 12 months Post-NICU discharge)
- Infant hospital readmission(3 months, 6 months, and 12 months Post-NICU discharge)
- Receipt of necessary infant services and equipment(3 months, 6 months, and 12 months Post-NICU discharge)
- Infant Respiratory Symptoms (shortness of breath, wheezing, coughing, clinically demonstrated need for oral corticosteroids)(3 months, 6 months, and 12 months Post-NICU discharge)
- Infant growth(Baseline, 3 months, 6 months, and 12 months Post-NICU discharge)
- Infant Quality of Life(3 months, 6 months, and 12 months Post-NICU discharge)
研究者
Margaret Parker
Professor
University of Massachusetts, Worcester