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临床试验/NCT01143701
NCT01143701已完成4 期

Evaluation of an Intervention for Improving Community-based Pediatric ADHD Care

Children's Hospital Medical Center, Cincinnati2 个研究点 分布在 1 个国家目标入组 577 人开始时间: 2010年5月最近更新:
适应症
干预措施

试验速览

阶段
4 期
状态
已完成
入组人数
577
试验地点
2
主要终点
Parent-rated ADHD Symptoms

研究概览

简要总结

ADHD is the most prevalent mental health disorder of childhood. The majority of children with ADHD receive their care in primary care settings. While the American Academy of Pediatrics (AAP) issued evidence-based guidelines and recommendations for pediatricians, most pediatricians have difficulty adhering to these guidelines. Given observed deficiencies in evidence-based ADHD care and the likely effects on child outcomes, the development and testing of interventions aimed at improving ADHD care in primary care settings is necessary. Cincinnati Children's Hospital Medical Center has developed a model intervention, termed the ADHD Collaborative, to comprehensively address this issue. The ADHD Collaborative intervention model includes academic detailing, quality improvement methods, and innovative tools (e.g., web portal) designed to promote and support the systematic use of the AAP guidelines. This intervention model has been used to train over 200 physicians at 55 practices in the Greater Cincinnati area. The intervention appears to produce 2- to 4-fold increases in the use of evidence-based ADHD-related practice behaviors in participating physicians. To date, the intervention has been implemented as a quality improvement project with few experimental controls. The primary goal of the proposed study is to conduct an experimentally-controlled cluster randomized trial of the ADHD Collaborative intervention. Thirty-two pediatric practices will be randomly assigned to receive the ADHD Collaborative intervention or to provide usual care. Approximately 96 physicians and 576 of their ADHD patients will be included in the study. Chart reviews, parental interviews, and parent and teacher rating scales will be collected. Between- and within-group hierarchical linear modeling analyses will examine whether the intervention produces significant improvements in pediatrician practice behaviors, patient satisfaction with ADHD care, and child outcomes over and above typical ADHD care. Also, the relative cost effectiveness of the ADHD Collaborative intervention over typical care will be established by computing incremental cost-effectiveness ratios using cost and effect size estimates.

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
Single (Care Provider)

入排标准

年龄范围
6 Years 至 11 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Practice must have a minimum of two pediatricians who agree to participate.
  • Practice must have an electronic billing system.
  • Practice must have internet access at office.
  • Practice must not have an on-site mental health professional.
  • Practice must have a member of practice staff willing to be trained in human subjects certification and willing to consent families.
  • Children must be in Grade 1-
  • Children must be newly diagnosed with ADHD.

排除标准

  • 未提供

研究组 & 干预措施

ADHD Collaborative Intervention

Experimental

The ADHD Collaborative intervention model includes academic detailing, quality improvement methods, and innovative tools (e.g., web portal) designed to promote and support the systematic use of the American Academy of Pediatrics consensus recommendation for evidence-based ADHD care.

干预措施: ADHD Collaborative (Other)

Typical ADHD care

No Intervention

Physicians in this group will provide typical ADHD care.

结局指标

主要结局

Parent-rated ADHD Symptoms

时间窗: 12 months

Total Symptom Score on Parent-Rated Vanderbilt ADHD Rating Scale (range=0-54). Higher scores represent more severe ADHD symptom presentation.

Teacher-rated ADHD Symptoms

时间窗: 12 months

Total Symptom Score on Teacher-Rated Vanderbilt ADHD Rating Scale (range=0-54). Higher scores represent more severe ADHD symptom presentation.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Jeff Epstein

Principal Investigator

Children's Hospital Medical Center, Cincinnati

研究点 (2)

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