跳至主要内容
临床试验/NCT00537433
NCT00537433已完成1 期

An RCT to Reduce Liquid Medication Dosing Errors and Improve Adherence in Caregivers of Young Children Through a Pictogram-Based Intervention

NYU Langone Health1 个研究点 分布在 1 个国家目标入组 251 人开始时间: 2006年7月1日最近更新:
适应症
干预措施

试验速览

阶段
1 期
状态
已完成
入组人数
251
试验地点
1
主要终点
Medication Dosing Accuracy (observed and reported); Medication Adherence (reported)

研究概览

简要总结

Liquid medication administration errors are common, and place children at risk for adverse events. Caregivers with low socioeconomic status (SES), low education and poor health literacy skills are at increased risk for errors. In this study, we seek to assess whether at-risk parents who received a plain language, pictogram-based intervention would have reduced medication dosing errors and improved medication adherence.

详细描述

Evidence suggests that errors by parents and caregivers in administering medications to their children are frequent. These errors, which include inaccurate dosing as well as nonadherence to medication regimens, place children at risk for morbidity and mortality. Misdosing is prevalent, with 50% or more of pediatric caregivers either measuring an incorrect dose or reporting a dose of liquid medication given outside the recommended range. Of further concern are reports of an overall poor adherence rate of 50% for pediatric medications, with implications for treatment failure and drug resistance.

Few studies have examined strategies for decreasing medication administration errors in pediatric patients. Pictograms represent a promising approach in which simple diagrams are used to improve understanding of concepts. Pictorial-enhanced written materials have been shown to improve comprehension and adherence with medical directions, particularly for patients with low literacy.

We developed a pictogram-based intervention to decrease dosing errors and improve adherence. In this study, we sought to assess whether this intervention would reduce medication dosing errors and improve adherence in a pediatric emergency room serving at-risk families.

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
None

入排标准

年龄范围
1 Month 至 8 Years(Child)
性别
All
接受健康志愿者
是

入选标准

  • •child 30 days through 8 years old
  • •child prescribed a liquid medication (short course (<14 days) daily dose medication or as needed (prn) medication)

排除标准

  • •caregiver accompanying child to visit not primarily responsible for administering medication to the child
  • •caregiver not fluent in English or Spanish
  • •child requiring immediate medical attention
  • •child who typically takes medications in tablet form
  • •child having a visit involving a psychiatric problem or child protection issue

研究组 & 干预措施

Standard counseling

No Intervention

Families in the control group receive standard care, including routine counseling regarding medications prescribed from their physician and post-visit counseling by the pediatric nursing staff. Dosing instruments are given at the discretion of the physician or nurse.

Pictogram

Experimental

Parents randomized to the pictogram-based intervention group receive medication counseling utilizing the pictogram-based medication instruction sheets. These sheets help to facilitate medication counseling, including teaching about dosage and adherence.

干预措施: Pictogram (Other)

结局指标

主要结局

Medication Dosing Accuracy (observed and reported); Medication Adherence (reported)

时间窗: Assessments by phone or in-person, planned at 3-5 days for prn medications, and within 1 day of last dose of prescribed treatment time for daily dose medications.

次要结局

  • Medication Knowledge and Related Medication Practices (dose frequency, preparation, storage, dosing instrument use)(Assessments by phone or in-person, planned at 3-5 days for prn medications, and within 1 day of last dose of prescribed treatment time for daily dose medications.)

研究者

申办方类型
Other

研究点 (1)

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