跳至主要内容
临床试验/NCT06693778
NCT06693778进行中(未招募)不适用

Utilizing Electronic Clinical Decision Support to Enhance mTBI Care at the Primary Care Point of Entry

Children's Hospital of Philadelphia1 个研究点 分布在 1 个国家目标入组 3,000 人开始时间: 2023年4月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
3,000
试验地点
1
主要终点
Time in care for concussion

研究概览

简要总结

Six primary care practices within a large Philadelphia pediatric care network will use an electronic Clinical Decision Support (eCDS) tool as standard care for concussion evaluation. The eCDS tool will include a prediction rule for children aged 5-18 assessed for mild traumatic brain injury (mTBI). The eCDS tool predicts risk for persistent symptoms and prompts referral to specialty care for those deemed high risk. This research proposes to analyze the clinical and process outcomes in these six practices relative to the rest of the care network, specifically, whether the eCDS tool reduces time to symptom resolution.

详细描述

The electronic Clinical Decision Support tool will include a prediction rule for children aged 5-18 assessed for mild traumatic brain injury (mTBI). It predicts risk for persistent symptoms and prompts referral to specialty care for those who are high-risk. The eCDS tool consists of a validated, age-appropriate symptom scale, risk stratification with indication for specialty referral, personalized return to activity guidance based on symptom exacerbation, and guidance on minimizing prolonged rest and promoting active management.

Each year for three years, the eCDS tool will go live at a new pair of sites (1 urban, 1 suburban). Training will be provided to the primary care providers at these sites on utilizing the eCDS tool. Anonymous questionnaires will be administered among providers who used the eCDS tool in order to evaluate its appropriateness and acceptability. Interviews will be conducted with a subset of providers to obtain more detailed feedback on the eCDS tool. A medical record review will be conducted of mTBI patients evaluated with the eCDS tool.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
5 Years 至 18 Years(Child, Adult)
性别
All
接受健康志愿者
否

入选标准

  • •5-18 year old patients evaluated for mild Traumatic Brain Injury at a Children's Hospital of Philadelphia primary care practice within the study timeframe

排除标准

  • •Evidence of moderate or severe TBI

研究组 & 干预措施

Comparison Primary Care Practices

Pediatric primary care practices that are NOT using the electronic clinical decision support tool to evaluate patients for mild traumatic brain injury.

Select Primary Care Practices

Select pediatric primary care practices (3 urban and 3 suburban) that are evaluating patients for mild traumatic brain injury with an electronic clinical decision support tool.

干预措施: electronic Clinical Decision Support tool for risk stratification of pediatric patients with mTBI (Other)

结局指标

主要结局

Time in care for concussion

时间窗: Up to 1 year post-injury

Review of medical records to determine first and last visit dates for the purposes of calculating number of days in care

次要结局

  • Provider-defined appropriateness of the electronic Clinical Decision Support (eCDS) risk stratification tool(Approximately one year after the eCDS tool is implemented at a primary care location)
  • Provider-defined acceptability of the electronic Clinical Decision Support (eCDS) risk stratification tool(Approximately one year after the eCDS tool is implemented at a primary care location)
  • Incidence of Persisting Post-Concussion Symptoms (PPCS)(28 days post-injury)
  • Provider fidelity to the electronic Clinical Decision Support (eCDS) tool(28 days post-injury)
  • Patient adherence to provider recommendations(3 months post-injury)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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