Project INITIATE: Developing Community Collaborations to Improve Developmental Outcomes Through Prompt and Equitable Transition to Community Therapy Services in High-risk Newborn Infants
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 63
- 试验地点
- 4
- 主要终点
- Parent quality of life questionnaire assessed using the Peds QL Family Impact Module
研究概览
简要总结
Project Initiate is a pilot study of early neuromotor outcomes in high risk newborn infants who are referred to Early Intervention services after NICU discharge. The investigators hypothesize that infants with Medicaid insurance who have prompt access to weekly post-discharge therapy services will have better early neuromotor function at 3 months corrected age and better parent satisfaction than infants who receive only care coordination to help with Early Intervention enrollment and locating outpatient transitional services as indicated.
详细描述
Infants hospitalized in an neonatal intensive care unit with high risk illnesses typically receive physical therapy during the hospital stay to improve neuromotor function and promote optimal development. At discharge, infants residing in Illinois with high risk conditions are eligible for therapy services in the home through Illinois Early Intervention. The initiation of these services is typically delayed for several months or more after discharge and families with private insurance will often obtain transitional services. For children with Medicaid insurance, initiation of services is typically delayed or never occurs and there is concern that gaps in services may worsen outcomes and cause stress to parents.
The investigators hypothesize that infants with Medicaid insurance who have prompt access to weekly post-discharge therapy services will have better early neuromotor function at 3 months corrected age and better parent satisfaction than infants who receive only care coordination to help with Early Intervention enrollment and locating outpatient transitional services as indicated.
The aims of Project Initiate are:
Specific Aim 1: To pilot a NICU to home service delivery model for infants at high-risk for neuromotor complications with Medicaid Insurance.
Specific Aim 2: To test the feasibility of at NICU to home service delivery model for infants at high-risk for neuromotor complications.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
Outcomes will be assessed by blinded neuromotor examiners.
入排标准
- 年龄范围
- 1 Day 至 1 Month（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •At-risk for developmental impairments (enrolled in Early Childhood Clinic and are automatically eligible for Illinois Early Intervention services)
- •Less that 45 weeks post-menstrual age (PMA) at discharge
- •English-speaking
- •Able to be identified and enrolled before discharge from the NICU
排除标准
- •Children in DCFS custody or children of parents who decline therapy services through the State of Illinois Early Intervention Program.
研究组 & 干预措施
Intervention Group
At NICU discharge, infants will be referred to Illinois Early Intervention. A coordinator (the navigator) will assist families in engaging with Early Intervention and completing all enrollment requirements.
At NICU discharge, infants will be provided with standard home pediatric therapy services weekly for up to 14 weeks. These will be initiated within 2 weeks of discharge.
干预措施: pediatric physical therapy (Behavioral)
Intervention Group
At NICU discharge, infants will be referred to Illinois Early Intervention. A coordinator (the navigator) will assist families in engaging with Early Intervention and completing all enrollment requirements.
At NICU discharge, infants will be provided with standard home pediatric therapy services weekly for up to 14 weeks. These will be initiated within 2 weeks of discharge.
干预措施: Care Coordination (Other)
Control Group
At NICU discharge, infants will be referred to Illinois Early Intervention. A coordinator (the navigator) will assist families in engaging with Early Intervention and completing all enrollment requirements. If transitional services were recommended by the NICU providers, the navigator will help families identify these services and obtain the necessary referrals.
干预措施: Care Coordination (Other)
结局指标
主要结局
Parent quality of life questionnaire assessed using the Peds QL Family Impact Module
时间窗: 2-3 months
Parent quality of life will be assessed at the beginning and end of the study. This test asks parents to rate their quality of life in 6 categories. Each item is scored on a Likert Scale from 0-4 and then reverse transformed to a score from 0-100. The investigators will use an overall score averaged from the 6 categories as an outcome, as well as scores for the individual categories. Higher scores indicated better parent reported quality of life.
Test of Infant Motor Performance Score (TIMP)
时间窗: 2-3 months (discharge to first developmental clinic visit)
The TIMP is a motor evaluation conducted by a physical therapist. The test is scored and the scores are converted to standard deviations based on the child's age. Changes in the infant's TIMP standard deviation score from discharge to 3 months of age, corrected for prematurity, assessed by an physical therapist blinded to the intervention group.
Time to initiation of Early Intervention therapy services
时间窗: Discharge to EI initiation (1-6 months)
The time from discharge to the first Early Intervention home therapy service will be assessed
次要结局
- General movements assessment-(At 3 months corrected age)
- Hammersmith Infant Neurologic examination(At 3 months corrected age)
研究者
Raye Ann deRegnier
Professor of Pediatrics
Northwestern University Feinberg School of Medicine