Clinical trial NCT00537433: Improving Parental Understanding of Medication Instructions Through a Pictogram-Based Intervention
Official title: An RCT to Reduce Liquid Medication Dosing Errors and Improve Adherence in Caregivers of Young Children Through a Pictogram-Based Intervention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Medication Errors
Keywords: Medication errors
Patient nonadherence
Literacy
Communication
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2007-10-01
Enrollment: 251
Sex: ALL
Minimum age (years): 1
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Medication Dosing Accuracy (observed and reported); Medication Adherence (reported)
timeFrame: 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:
measure: Medication Knowledge and Related Medication Practices (dose frequency, preparation, storage, dosing instrument use)
timeFrame: 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.
Other outcomes:
Locations:
city: New York
country: United States
facility: NYU School of Medicine Department of Pediatrics
state: New York
Study officials:
affiliation: NYU School of Medicine Department of Pediatrics
name: Hsiang (Shonna) Yin, MD, MS
role: PRINCIPAL_INVESTIGATOR
affiliation: NYU School of Medicine Department of Pediatrics
name: Alan L Mendelsohn, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: NYU School of Medicine Department of Pediatrics
name: Benard P Dreyer, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Yin HS, Dreyer BP, van Schaick L, Foltin GL, Dinglas C, Mendelsohn AL. Randomized controlled trial of a pictogram-based intervention to reduce liquid medication dosing errors and improve adherence among caregivers of young children. Arch Pediatr Adolesc Med. 2008 Sep;162(9):814-22. doi: 10.1001/archpedi.162.9.814.