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临床试验/NCT01105754
NCT01105754已完成不适用

A Multifaceted Prompting Intervention for Urban Children With Asthma

University of Rochester2 个研究点 分布在 1 个国家目标入组 638 人开始时间: 2008年10月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
638
试验地点
2
主要终点
Symptom Free Days

研究概览

简要总结

The overall goal of this project is to evaluate whether a multifaceted prompting intervention, administered in the urban primary care office setting, reduces morbidity among urban children with asthma. This study builds on our experience with a pilot study in two urban continuity clinics, in which we found that prompting clinicians about asthma severity and care guidelines at the time of an office visit resulted in improved preventive care delivery to inner-city children. This type of prompting program has the potential to substantially improve care for impoverished children with asthma, and we propose to establish: 1) whether these findings can be replicated in a similar study including a larger sample of urban children from different types of practices, and 2) whether the positive effects can be enhanced by more specific prompting directed towards both the provider and the caregiver and by providing practice-level supports and feedback. We hypothesize that children receiving a multifaceted prompting intervention (MPI) will experience less asthma-related morbidity (defined by symptom-free days at the 2-month follow-up) compared to children receiving usual care. Our secondary hypothesis is that children receiving the MPI will receive improved preventive asthma care (defined by guideline-based corrective actions taken at the index visit) compared to children receiving usual care.

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 (Outcomes Assessor)

入排标准

年龄范围
2 Years 至 12 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Physician-diagnosed asthma
  • Mild persistent or more severe asthma severity, or poor asthma control
  • Age >2 and <12 years.
  • Parent or caregiver must give permission to the study, and children >7 will must provide assent.

排除标准

  • Inability to speak and understand English or Spanish
  • No access to a working phone for follow-up surveys
  • The child having other significant medical conditions,
  • Children in foster care or other situations in which consent cannot be obtained from a guardian.
  • Prior enrollment in the study.
  • Child will not be seen by a physician or nurse practitioner during their visit

结局指标

主要结局

Symptom Free Days

时间窗: 2 month follow-up assessment

The primary outcome is asthma morbidity measured by the number of symptom-free asthma days (SFD) reported over 2 weeks at the 2-month follow-up assessment.

次要结局

  • Number of Children Who Received Guideline-based Asthma Care During the Intervention Visit.(2 week follow-up, and medical record review)

研究者

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

Jill Halterman

Associate Professor of Pediatrics

University of Rochester

研究点 (2)

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