A Randomized, Controlled Trial of a Telephone-Based Developmental Care Coordination System
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 565
- 试验地点
- 8
- 主要终点
- Referral to, Eligibility for, and Receipt of Early Childhood Developmental Services 6 Months After Enrollment
研究概览
简要总结
The proposed project is a randomized controlled trial of a telephone-based early childhood developmental care coordination system, in partnership with 2-1-1 Los Angeles County (211LA), part of a national network of 2-1-1 call centers covering 93% of the US population. The study will test the effectiveness of 211LA in increasing referrals for developmental evaluation, increasing the numbers of children deemed eligible for services, and increasing the number of children actually receiving interventions.
详细描述
The trial will enroll 662 children ages 1-3 years who receive well-child care at one of 10 partner clinic sites (belonging to 4 partner clinic systems). The research study team will conduct developmental screening on all children using the Parental Evaluation of Developmental Status (PEDS) Online system, and randomize children 1:1 into intervention (connection to 211LA for developmental care coordination + usual care) or control (usual care alone, with developmental care coordination conducted by clinic staff).
Primary outcomes will include referrals to early intervention evaluations, eligibility for intervention services, and receipt of services. The investigators will measure these outcomes through parent report, medical record review, and 211LA data, at 6 months after enrollment. For children with elevated developmental risk based on the PEDS Online results, the study will assess development using the PEDS:DM-AL (Parents' Evaluation of Developmental Status: Developmental Milestones - Assessment Level), conducted at baseline as well as 12 and 24 months after enrollment. For all children, research study team personnel will administer the language subscale of the PEDS:DM-AL at baseline, 12 months and 24 months, to evaluate development over time in the two groups. The investigators will measure behavioral outcomes for all children using the externalizing behavior subscale of the Child Behavior Checklist.
Expected findings include higher rates of referrals, eligibility, and receipt of intervention services among intervention group participants, and greater developmental gains among children in the intervention group. The study will also examine the costs of the program in relation to these outcomes, to estimate the costs and potential long-term benefits of this model. If effective, the model has the potential to disseminate rapidly throughout the 2-1-1 network and transform developmental care coordination in the US.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 11 Months 至 42 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •A patient in one of the four partner community clinic systems (ChapCare, Kaiser Permanente LA Medical Center, South Central Family Health Center, and Via Care)
- •A patient with an upcoming one- to three-year old well child appointment scheduled
- •Child aged 11-42 months
排除标准
- •Parent who does not speak English or Spanish
- •Child with history of developmental and/or behavioral diagnosis or having been referred to or received developmental and/or behavioral services.
- •Child has a sibling already enrolled in the study.
研究组 & 干预措施
Intervention + Usual Care + Developmental Screening Results
Intervention group families will receive usual care and developmental screening results will be shared with each child's primary care provider. In addition, they will be connected via telephone to 2-1-1 prior to their scheduled well-child visit for the telephone-based early childhood development care coordination intervention.
干预措施: Telephone-based early childhood developmental care coordination (Behavioral)
Usual Care + Developmental Screening Results
This group will receive usual care. In addition, developmental screening results will be shared with each child's primary care provider.
结局指标
主要结局
Referral to, Eligibility for, and Receipt of Early Childhood Developmental Services 6 Months After Enrollment
时间窗: 6 months after enrollment
The primary outcome will be assessed by 1) the percentage of children who are successfully referred to early childhood service organizations for evaluation, and 2) the percentage of children who receive services.
Child Developmental Outcomes
时间窗: Baseline and 24 months after enrollment
The PEDS:DM-AL (Parents' Evaluation of Developmental Status: Developmental Milestones - Assessment Level) is an assessment measure of development, social-emotional, and behavioral health that provides age-equivalent and percent delay scores for each domain measured. The domains included in the full assessment are: fine motor, gross motor, expressive language, receptive language, self-help, social-emotional, and academic/pre-academic, and cognitive. This study utilizes the expressive language and receptive language domains to measure child developmental outcomes. This measure will be reported as a Rough Standard Score (RSS), the child's "developmental age" as shown by the tool divided by their actual age. A score of 100 means the child is scored by the instrument as being where we would expect developmentally given their age; lower scores mean the child is developmentally delayed, and higher scores mean the child is ahead of the curve.
次要结局
- Number of Children Who Have Received Referrals and Number of Children Who Have Received Services(6 months after enrollment)
研究者
Paul Chung
Adjunct Professor of Pediatrics and Health Policy & Management
University of California, Los Angeles