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

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

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00537433
Enrollment
251
Registered
2007-10-01
Start date
2006-07-31
Completion date
2007-01-31
Last updated
2007-10-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Medication Errors

Keywords

Medication errors, Patient nonadherence, Literacy, Communication

Brief summary

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.

Detailed description

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.

Interventions

OTHERPictogram

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.

Sponsors

NYU Langone Health
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
1 Months to 8 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

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

MeasureTime frame
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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 4, 2026