Can a Novel Telemedicine Tool Reduce Disparities Related to the Identification of Preschool
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 148
- 试验地点
- 2
- 主要终点
- Diagnostic Certainty: Tele-assessment
研究概览
简要总结
Families seeking evaluation for autism spectrum disorder (ASD) often face barriers such as low availability of specialists, lengthy waitlists, and long distances to tertiary care diagnostic centers. This is especially true for children from traditionally underserved groups and communities. Without innovative approaches for enhanced identification of ASD, families and clinicians will continue to struggle with accessing and providing care. Telemedicine offers tremendous potential for addressing this need, but there are few psychometrically sound, validated tools that can be administered remotely, via telehealth platforms. This team of investigators developed and conducted a preliminary evaluation of a novel parent-administered, clinician-guided tele-diagnostic tool, the TAP (TELE-ASD-PEDS), designed specifically for direct-to-home and community clinic use with toddlers. Remote administration of the TAP yielded a very high level of agreement with blinded comprehensive evaluation regarding ASD risk classification. Subsequently, the unanticipated broad dissemination of the TAP during COVID-19 demonstrated its value for traditionally underserved groups, spanning broad geographies. Although promising, this work was limited by its specific focus on toddlers with ASD concerns. A telemedicine tool designed for the unique context and population of preschool-aged children referred for diagnostic assessment could have tremendous value in terms of both accurate identification as well as family engagement with service. In the current work, the investigators will now evaluate the performance, usability, and utility of the TAP-Preschool, a new telemedicine tool for ASD risk assessment in preschoolers, through a clinical trial. The TAP-Preschool was developed through a computationally informed co-production in which the targeted population were recruited as active partners in designing the tool. The investigators will gather critical data not only regarding its structure and accuracy, but also its potential deployment across systems responsible for engaging children and families from underserved groups in meaningful service. This work has potential to transform the ASD evaluation process and dramatically improve care access for traditionally underserved groups.
详细描述
Innovative telemedicine practices could address many existing traditional barriers to ASD identification. Telemedicine has the potential to put linguistically and culturally competent clinical expert virtual providers directly into communities during a critical window in which many vulnerable families may approach, or re-approach, care systems about developmental concerns that become more prominent with age. In the current proposal, the investigators will evaluate the potential clinical and familial value of a telemedicine-based ASD assessment tool, the TAP-Preschool (TELE-ASD-PEDS-Preschool), designed to overcome traditional barriers to diagnosis and service access in underserved preschool populations that may not be readily identified or engaged by early screening and intervention systems.
A growing body of literature supports the use of telemedicine-based approaches to ASD assessment and intervention. This includes remote activities to assess infant social communication skills in the first year of life, coaching parents through administration of gold standard diagnostic tests, and provider coding and analysis of interactions that are video-recorded by caregivers. Results reflect high levels of caregiver and provider satisfaction and satisfactory agreement with traditional in-person evaluations, illustrating both the promise and feasibility of tele-assessment. However, most existing approaches are limited by a focus on screening rather than diagnosis, protocols requiring specific materials, or asynchronous analysis of submitted videos, which require resources that preclude broader use. Moreover, in current form, these tools are not designed or intended to yield a quantitative formal assessment of core ASD symptoms to support diagnostic decision-making. Further, although providers are increasingly exploring telemedicine approaches to ASD assessment in the context of the COVID-19 pandemic, there is limited published work to date on the use of real-time, caregiver-led ASD assessment in home settings with diverse populations. Prior work from the investigators' team has focused almost exclusively on toddlers in this regard. Ultimately, very few viable tools with validated psychometric properties are available for use in current models of telehealth assessment and care.
In earlier work, we applied machine learning models and the principles of feature engineering to a phenotypically rich clinical research data set of preschoolers with ASD and other developmental concerns (N=914: 594 ASD and 320 Non-ASD) to identify key behavioral targets for tool development. We then engaged in a rigorous adaptation and translation approach to optimize design of the TAP-Preschool. We included leading ASD assessment experts, providers dedicated to caring for underserved populations, and parents of preschool children with ASD from underserved racial/ethnic and linguistic groups. We lead these groups in a collaborative design process in order to yield a set of interactive and play-based, parent-coached tele-assessment activities designed to 1) elicit observations tied to key computational features, 2) be deployed within a 30-minute timeframe, 3) employ inexpensive materials found in most homes, and 4) use accessible assessment instructions for real-time coaching of parents.
The investigators will now deploy the preliminary TAP-Preschool with a small sample (n = 30) to assess acceptability/feasibility, potential clinical value for remote observation, and challenges that warrant revision. These data will then be used to modify the TAP-Preschool and the refined tool will be deployed with a new sample of clinically referred children (n=120). The investigators will evaluate its ability to facilitate accurate telemedicine supported diagnostic decision-making.
Initial deployment, evaluation, and refinement of the TAP-Preschool:
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 36 Months 至 72 Months(Child)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Initial deployment (n = 30):
- •English/Spanish Speaking families
- •Children 36-72 months of age
- •access to a device capable of supporting Zoom
- •already has participated in a diagnostic evaluation
- •Novel sample (n = 120):
- •English/Spanish Speaking families
- •Children 36-72 months of age
- •access to a device capable of supporting Zoom
- •has not participated in a diagnostic evaluation
排除标准
- •Initial deployment (n = 30):
- •severe sensorimotor impairments
- •Novel sample (n = 120):
- •severe sensorimotor impairments
结局指标
主要结局
Diagnostic Certainty: Tele-assessment
时间窗: Single timepoint: Immediately after completing tele-assessment, an average of 90 minutes
Clinicians rated diagnostic certainty on a 4-point Likert Scale. Possible scores range from 1 to 4, with 1 indicating "Completely Uncertain," 2 indicating "Somewhat Uncertain," 3 indicating "Somewhat Certain" and 4 indicating "Completely Certain." Higher values reflect stronger clinician diagnostic certainty.
Family Satisfaction
时间窗: Single timepoint: Immediately after completing tele-assessment, an average of 90 minutes
Parents will complete the Parent Perceptions of Telehealth survey to assess perceptions of tele-assessment procedures. The survey includes seven questions with three response options per questions (Very True, Somewhat True, Not True). The percentage of parents endorsing "very true" is reported.
Diagnostic Certainty: In-person Assessment
时间窗: Single timepoint: Immediately after completing tele-assessment, an average of 180 minutes
Clinicians rated diagnostic certainty on a 4-point Likert Scale. Possible scores range from 1 to 4, with 1 indicating "Completely Uncertain," 2 indicating "Somewhat Uncertain," 3 indicating "Somewhat Certain" and 4 indicating "Completely Certain." Higher values reflect stronger clinician diagnostic certainty.
Diagnostic Accuracy of TAP-P
时间窗: Single timepoint: Calculated immediately after completion of in-person assessment
For the preliminary tele-assessment only arm, diagnostic accuracy reflects the percentage of participants for whom the tele-assessment clinician's diagnostic impression (autism vs not autism) was in agreement with the child's existing diagnosis (autism vs not autism). For the tele-assessment + in-person assessment arm, diagnostic accuracy reflects the percentage of participants for whom the tele-assessment clinician's diagnostic impression (autism vs not autism) was in agreement with the diagnostic determination following in-person assessment (autism vs not autism).
次要结局
未报告次要终点
研究者
Zachary Warren
Professor of Pediatrics; Director of the Division of Developmental Medicine
Vanderbilt University Medical Center
