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利用远程医疗识别服务不足儿童的神经发育障碍(INvesT):临床试验研究设计

Identification of neurodevelopmental disabilities in underserved children using telehealth (INvesT): Clinical trial study design.

作者信息

Ciccia Angela Hein, Roizen Nancy, Garvey Matt, Bielefeld Roger, Short Elizabeth J

机构信息

Department of Psychological Sciences, Case Western Reserve University, 11635 Euclid Ave., Cleveland, OH, USA.

Department of Behavioral Pediatrics, Case Medical Center, Rainbow Babies and Children's Hospital, 10524 Euclid Ave., Ste. 3150, Cleveland, OH, USA.

出版信息

Contemp Clin Trials. 2015 Nov;45(Pt B):226-232. doi: 10.1016/j.cct.2015.10.004. Epub 2015 Oct 22.

Abstract

BACKGROUND

Children living in poverty are at high risk for delays in development of language and behavior and they experience a discrepancy in diagnosis and access to intervention services. This gap is partially caused by barriers in access as well as traits that are specific to each child and family. The Identification of Neurodevelopmental Disabilities in Underserved Children using Telehealth (INvesT) trial is a novel intervention approach that was specifically designed to address these barriers.

AIMS

The INvesT trial has three primary aims: 1) to reduce the age of identification of neurodevelopmental disability for high-risk, low-income children. 2) To validate the INvesT protocol as a service delivery model that will decrease age of identifications of neurodevelopmental disability for high-risk, low-income children; and 3) to identify important child-specific factors, family-specific factors, and environmental factors that impact feasibility and success of the INvesT trial for high-risk, low-income children.

METHODS

The INvesT trial is an open-label, double-blinded, placebo-controlled multi-level study that includes telehealth risk assessment, telehealth screening, traditional full assessment, and follow through to enrollment in early intervention. The trial is conducted in partnership with an urban community health clinic that largely serves a low-income patient population.

CONCLUSIONS

The results of the INvesT trial will provide evidence for the use of a telehealth service delivery model to improve access to care for neurodevelopmental disabilities for high-risk, low-income children.

摘要

背景

生活贫困的儿童在语言和行为发展方面存在延迟的高风险,并且在诊断和获得干预服务方面存在差异。这种差距部分是由获得服务的障碍以及每个儿童和家庭的特定特征造成的。利用远程医疗识别服务不足儿童的神经发育障碍(INvesT)试验是一种专门设计用于解决这些障碍的新型干预方法。

目的

INvesT试验有三个主要目标:1)降低高危低收入儿童神经发育障碍的识别年龄。2)验证INvesT方案作为一种服务提供模式,该模式将降低高危低收入儿童神经发育障碍的识别年龄;3)识别影响高危低收入儿童INvesT试验可行性和成功的重要儿童特定因素、家庭特定因素和环境因素。

方法

INvesT试验是一项开放标签、双盲、安慰剂对照的多层次研究,包括远程医疗风险评估、远程医疗筛查、传统全面评估以及跟进至早期干预登记。该试验与一家主要为低收入患者群体服务的城市社区健康诊所合作进行。

结论

INvesT试验的结果将为使用远程医疗服务提供模式改善高危低收入儿童获得神经发育障碍护理的机会提供证据。

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