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临床试验/NCT03126851
NCT03126851已完成不适用

Identifying "Best Practices" for the Safe Use of Pediatric Cough and Cold Medications

NYU Langone Health1 个研究点 分布在 1 个国家目标入组 312 人开始时间: 2017年5月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
312
试验地点
1
主要终点
# of parents making correct decision about whether medication should be given based on age restriction information (survey)

研究概览

简要总结

This study seeks to identify ways to help parents safely use cough/cold medications with their children. The study focuses on 3 key tasks that have been found to be difficult for parents: 1) decision-making about whether medicines should be given based on a child's age, 2) use of active ingredient information to determine which medications are safe to give together, and 3) medication dosing.

Specific ways that labels and dosing tools can be changed to improve parent understanding and ability to use pediatric cough and cold medications will be tested. This includes looking at whether including age restriction information on the front panel helps parents make better decisions about whether a medication should be given to a child, as well as whether presence of a specific warning or pictogram can help improve this understanding. In addition, the role of font size, including a box around ingredients, and use of a specific warning to look at and compare active ingredients, will be examined to see if these can help parents decide if two medications can be given together safely. Finally, dosing charts with pictograms of dosing tools, and provision of certain dosing tools, can lead to fewer parent dosing errors.

A label/dosing tool combination that incorporates what is learned from the first part of the study will be developed based on findings from the first part of the study, and then tested to see whether this improves parent understanding and use of pediatric cough and cold medicines.

Hypotheses include: 1) changes in labels and dosing tools, such as including explicit warnings, and pictographic warnings/instructions can improve parent understanding and ability to act on of medication instructions, 2) parents with low health literacy and/or LEP will especially benefit from strategies such as explicit wording, warnings, and pictogram, and 3) parents receiving the comprehensive labeling and dosing strategy will have a better understanding of appropriate use of cough/cold medications, including fewer dosing errors, compared to standard labels.

A multi-part experiment will be conducted. Findings will be merged with known evidence around health literacy best practices to develop a comprehensive, consumer-centered strategy for English and Spanish-speaking parents. Pilot testing of the comprehensive strategy in comparison to existing labels will then take place.

详细描述

See Brief summary.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Parent/Legal guardian 18 years or older
  • Parent/Legal guardian with children <6 years old
  • English or Spanish speaking

排除标准

  • Visual acuity worse than 20/50 (Rosenbaum Pocket Screener)
  • Uncorrectable hearing impairment
  • Parents/ children too ill to participate will also be excluded

结局指标

主要结局

# of parents making correct decision about whether medication should be given based on age restriction information (survey)

时间窗: on day of enrollment (all assessments performed on day of enrollment; study subjects will be enrolled over ~1 year period)

# of parents making correct decision about whether medication should be given to their child based on age restriction information, assessed by survey question

次要结局

  • # of parents with correct knowledge of age group that medication can be given to (survey)(on day of enrollment (all assessments performed on day of enrollment; study subjects will be enrolled over ~1 year period))

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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Promoting Safe Use of Children's Cough/Cold Medicines | 临床试验