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Completed

NCT Number: NCT00537433

Improving Parental Understanding of Medication Instructions Through a Pictogram-Based Intervention

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.

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Key information

Age range

1 month–8 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

NYU School of Medicine Department of Pediatrics

New York, 10016, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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

Treatment and study plan

Pictogram

Other

The plain language, pictogram-based medication instruction sheets (available in English and Spanish) utilize pictograms to convey information about the medication name, indication, dose, dose frequency, and length of treatment, along with information about preparation and storage. The sheets also include a medication log for parents to keep track of when they administer the medication.

Research staff reference the sheets as they demonstrate dosing with a standardized dosing instrument; teachback is performed to reinforce concepts. For medications in which a standardized dosing instrument was not included at dispensing, a standardized oral dosing syringe is provided for the caregiver to use at home. After counseling, the caregiver is given the instruction sheet to take home.

Primary outcomes

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

    Time frame: 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.

Secondary outcomes

  1. Medication Knowledge and Related Medication Practices (dose frequency, preparation, storage, dosing instrument use)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

NYU Langone Health

Other

Registry information

Official study title

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

Important dates

Study start
2006
Study completion
2007
First posted
Oct 1, 2007
Registry last updated
Oct 1, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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